sterilization biological indicator method and system

专利摘要:
METHOD AND SYSTEM OF BIOLOGICAL STERILIZATION INDICATOR. The present invention relates to a system and a method of biological sterilization indicator (IB). The system can include an IB and a reading device that comprises a cavity. The IB may include a compartment, which may include a first movable portion and a second portion between a first "not activated" position and a second "activated" position. The reading apparatus configured to detect at least one of the following conditions (i) when the cavity is empty; (ii) when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position and (iii) when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the second position. The method may include detecting at least one of the above conditions, which can be used to detect an activated state of the biological sterilization indicator.
公开号:BR112013008703B1
申请号:R112013008703-0
申请日:2011-10-28
公开日:2020-10-27
发明作者:Jeffrey C. Pederson；Sailaja Chandrapati；Bryan S. Behun；Barry W. Robole；Leroy J. Longworth；Kaileen Chen
申请人:3M Innovative Properties Company；
IPC主号:

专利说明:

Field of the Invention
[001] The present disclosure generally relates to sterilization indicator systems and methods and, in particular, to biological sterilization indicator systems and methods. Background
[002] In a variety of industries, such as the healthcare industry and also in other industrial applications, it may be necessary to monitor the effectiveness of processes used to sterilize equipment such as medical devices and other disposable and non-disposable items. In such environments, sterilization is generally defined as the process of complete destruction of all viable sources of biological activity, such as microorganisms, including structures such as viruses and spores. As a standard practice, hospitals include a sterility indicator with a batch of articles to test the lethality of the sterilization process. Both biological and chemical indicators of sterilization have been used.
[003] A standard type of biological sterility indicator includes a known quantity of test microorganisms, for example, spores of Geobacillus stearothermophílus (formerly Bacillus stearothermophilus) or Bacillus atrophaeus (formerly Bacillus subtills), which can often be more resistant particular sterilization processes than other contaminating organisms. After the indicator is exposed to the sterilization process, the sources of biological activity (for example, spores) can be incubated in a nutrient medium to determine if any of the sources survived the sterilization process, with source and / or growth metabolism that indicates that the sterilization process was insufficient to destroy all sources of biological activity.
[004] Chemical sterilization indicators can be evaluated immediately at the end of the sterilization process. However, the results only indicate that a particular condition was present during the sterilization process, such as the presence of a particular chemical or temperature, and potentially, that the condition was achieved over a period of time. On the contrary, the response of sources of biological activity to all conditions actually present can be a more direct and reliable test for how effective a sterilization process is in achieving sterilization. summary
[005] Some aspects of this description provide the sterilization biological indicator system. The system can include a biological sterilization indicator and a reading device. The biological sterilization indicator can include a compartment that includes a first portion, and a second portion adapted to be coupled to the first portion, wherein the second portion is movable relative to the first portion, when coupled to the first portion, between a first position and a second position. The biological sterilization indicator can additionally include a container that contains a liquid and be sized to be positioned in the compartment. At least a portion of the container can be frangible, and the container can be positioned at least in the first portion of the compartment. The container can have a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when a second portion of the compartment is in the second position. The reading apparatus may include a cavity. The cavity can be sized to receive at least a portion of the biological sterilization indicator, and the reading apparatus configured to detect at least one of the following conditions: (i) when the cavity is empty; (ii) when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position; and (iii) when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the second position.
[006] Some aspects of the present description provide a method for detecting a state of activation of a biological indicator of sterilization. The method may include providing a biological sterilization indicator and a reading device. The biological sterilization indicator can include a compartment that includes a first portion and a second portion adapted to be coupled to the first portion where the second portion is movable relative to the first portion, when coupled to the first portion, between a first position and a second position. The biological sterilization indicator may additionally include a container that comprises a liquid. At least a portion of the container can be frangible, and the container can be positioned at least in the first portion of the compartment. The container can have a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when a second portion of the compartment is in the second position. The reading apparatus may include a cavity sized to receive at least a portion of the biological sterilization indicator. The cavity may additionally include detecting at least one of the following conditions: (i) when the cavity is empty; (ii) when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position and (iii) when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position.
[007] Some aspects of this description provide the sterilization biological indicator system. The system can include a biological sterilization indicator and a reading device. The biological sterilization indicator can include a compartment, which includes a first portion and a second portion adapted to be coupled to the first portion. The second portion can be movable with respect to the first portion (for example, when coupled to the first portion) between a first position and a second position. The biological sterilization indicator can additionally include a container that contains a liquid and be sized to be positioned in the compartment. At least a portion of the container can be frangible, and the container can be positioned at least in the first portion of the compartment. The container can have a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when a second portion of the compartment is in the second position. The reading apparatus may include at least one cavity. The cavity can be sized to receive at least a portion of the biological sterilization indicator. The reading apparatus can be adapted to generate at least one of a first signal indicating that the cavity is empty; a second signal indicating that the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position; and a third sign indicating that the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the second position.
[008] Some aspects of the present description provide a method for detecting a state of activation of a biological indicator of sterilization. The method may include providing a biological sterilization indicator and a reading device. The biological sterilization indicator can include a compartment, which includes a first portion and a second portion adapted to be coupled to the first portion. The second portion can be movable with respect to the first portion (for example, when coupled to the first portion) between a first position and a second position. The biological sterilization indicator may additionally include a container that comprises a liquid. At least a portion of the container may be extensible, and the container may be positioned at least in the first portion of the compartment. The container can have a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when a second portion of the compartment is in the second position. The reading apparatus may include a cavity sized to receive at least a portion of the biological sterilization indicator. The method may additionally include generating a first signal when the cavity is empty, and placing the biological sterilization indicator in the reading apparatus cavity and generating at least one of the following signals: a second signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position; and a third signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position.
[009] Other characteristics and aspects of this description will become apparent taking into account the detailed description and the attached drawings. Brief description of the drawings
[010] Figure 1 is a perspective view of a biological sterilization indicator system, according to one embodiment of the present description, the biological sterilization indicator system that comprises at least one biological sterilization indicator positioned on a sterilization device. reading.
[011] Figure 2 is an exploded perspective view of a biological sterilization indicator in Figure 1, the biological sterilization indicator includes a compartment comprising a first portion and a second portion.
[012] Figure 3 is a cross-sectional side view of the sterilization biological indicator system of figure 1, taken along line 3-3 of figure 1, of the biological sterilization indicator shown in a first state and the second portion of the biological sterilization indicator compartment shown in a first position.
[013] Figure 4 is a cross-sectional side view of the sterilization biological indicator system of figures 1 to 3, the sterilization biological indicator system is shown in a second state, and the second portion of the biological indicator compartment of sterilization shown in a second position.
[014] Figure 5 is a schematic block diagram of the reading device in Figure 1.
[015] Figure 6 is a perspective view of a second portion of the biological indicator sterilization compartment according to another embodiment of the present description.
[016] Figure 7 is a perspective view of a second portion of the biological indicator sterilization compartment according to another embodiment of the present description.
[017] Figure 8 is a perspective view of a second portion of the biological indicator sterilization compartment according to another embodiment of the present description.
[018] Figure 9 is a perspective view of a biological indicator of sterilization according to another embodiment of the present description.
[019] Figure 10 is a partial partial cross-sectional side view of a biological sterilization indicator system, according to another embodiment of the present description, with the biological sterilization indicator system including a biological sterilization indicator shown in a view. in perspective.
[020] Figure 11 is a top cross-sectional view of a portion of the reading device in Figures 1 to 5, taken along line 11-11 shown in Figure 3, with portions removed for clarity, and with objects in addition to the plane defined by line 11-11 removed for clarity.
[021] Figure 12 is a front cross-sectional view of a portion of the reading device in Figures 1 to 5, taken along line 12-12 shown in Figure 1, with portions removed for clarity, and with objects beyond of the plane defined by line 12-12 removed for clarity. Detailed Description
[022] Before any of the modalities of the present description are explained in detail, it should be understood that the invention is not limited, in its application, to the details of construction and the arrangement of components demonstrated in the description below or illustrated in the drawings below . The invention can comprise other modalities and be practiced or carried out in several ways. It should also be understood that the phraseology and terminology used in the present invention have a descriptive purpose, and should not be considered limiting. The use of "including," "comprising," or "having" and the variations thereof of the present invention are intended to cover the items mentioned after them and their equivalents as well as additional items. Except where specified, or when limited in some way, the terms "sustained" and "coupled" and variations thereof, are widely used and include direct and indirect supports and couplings. Additionally, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings. It should be understood that other modalities can be used, and that structural or logical changes can be made without departing from the scope of this description. In addition, the terms “front part”, “rear part”, “top”, “bottom” and the like are used only to describe the mutual relationship between the elements, however, they are in no way intended to refer to the specific guidelines of the device, indicate or check necessary or required device guidelines or specify how the invention described here will be used, assembled, displayed or positioned in use.
[023] The present disclosure generally relates to biological sterilization indicator systems and methods. A biological indicator of sterilization is also sometimes called a “biological indicator of sterility,” or simply, a “biological indicator”. Some modalities of the biological sterilization indicator systems and methods of the present description include one-piece biological sterilization indicators that can be used to determine the lethality of a sterilization process. A system can include the biological sterilization indicator as well as a reading device or detector configured to test the biological sterilization indicator and inform a user (for example, visually, audibly, etc.) of the lethality of the sterilization process.
[024] Pressurized water vapor or other common sterilizers can be used to sterilize equipment and supplies used in healthcare settings. Small one-piece indicators, such as biological sterilization indicators, can be used to verify the effectiveness of sterilization processes. These indicators can be biological and can contain sources of biological activity.
[025] The nutrient medium used to nourish sources of biological activity (eg spores) after a sterilization procedure may be present throughout the sterilization procedure, but may not be accessible by the sources of biological activity until desired. For example, a frangible containment bag or container (for example, an ampoule, such as a glass ampoule) can house the medium 'on board' separately from the sources of biological activity, and the container can be broken to place the sources of activity biological and the medium in fluid communication with each other, when desired (for example, after a sterilization process). Nutrients and nutrients to facilitate the growth of microorganisms are known in the art and can be found, for example, in Ronald Atlas's “Handbook of Microbiological Media”, published by CRC Press, Boca Raton, FL, USA. Matner et al. (US Patent No. 5,073,488), which is incorporated herein in its entirety by reference, describes a nutrient medium for the growth and detection of bacterial spores in a biological sterilization indicator that can be used in biological sterilization indicators of the present description .
[026] Generally, sources of biological activity (eg microorganisms) are chosen to be used in a biological sterilization indicator that are resistant to a particular sterilization process. The biological sterilization indicators of the present description include a viable amount, or culture, of one or more known sources of biological activity (for example, species of microorganism). Such sources of biological activity may be in the form of microbial spores. The test source in the biological sterilization indicator is wiped out by a successful sterilization cycle, or survives if the sterilization cycle is not adequate for some reason. Bacterial spores, in addition to the vegetative form of organisms, are sometimes used at least partially because vegetative bacteria are known to be killed with relative ease by sterilization processes. Spores can also have superior storage characteristics and can remain in their latent state for years. As a result, in some embodiments, the sterilization of an inoculum from a standardized spore strain can provide a high degree of confidence that the inactivation of all microorganisms in a sterilization chamber has occurred.
[027] Just as an example, this description describes the one or more sources of biological activity used in the biological sterilization indicator as being "spores;" however, it must be understood that the type of source (eg, spore) used in a particular modality of the biological sterilization indicator is selected to be highly resistant to the particular sterilization process contemplated. Consequently, different modalities of the present description can use different sources of biological activity, depending on the sterilization process for which the particular modality is intended. The term “spores” is used throughout the present disclosure for the sake of simplicity, but it should be understood that other sources of biological activity, such as microorganisms (eg bacteria, fungi, viruses, etc.), spores ( for example, bacterial, fungal, etc.), enzymes, substrates for enzyme activity, ATP, microbial metabolites or a combination thereof, may be used in the biological sterilization indicator of the present description instead.
[028] The phrase "biological activity" generally refers to any specific catalytic process or groups of processes associated with a biological cell. Some non-limiting examples of biological activities include catabolic enzymatic activities (for example, carbohydrate fermentation pathways), anabolic enzymatic activities (for example, nucleic acid, amino acid or protein synthesis), coupled reactions (for example, a metabolic pathway), biomolecule-mediated redox reactions (eg electron transport systems) and bioluminescent reactions. “Predetermined” biological activity means that the method is directed towards the detection of a specific biological process (eg, an enzyme reaction) or group of biological processes (eg, a biochemical pathway). It will be observed by an element of common knowledge in the art that certain predetermined biological activities may be associated with a particular type of cell (for example, a cancer cell or a microorganism) or a pathological process.
[029] Similarly, it should be understood that the phrases used in the present disclosure that include the term “spore,” as “spore bearer,” “spore reservoir,” “spore region,” “spore growth chamber spore, ”and the like, are used merely for the sake of simplicity, but that such components, elements or phrases apply equally to other sources of biological activity and are not intended to refer only to spores. For example, the phrases above may also be called "source bearer," "source region," "source reservoir," "source growth chamber," and the like.
[030] The process of putting the spores and the medium together can be called "activating" the biological sterilization indicator. That is, the term “activation” and its variations, when used in relation to a biological sterilization indicator, can generally refer to placing the spores of the biological sterilization indicator in fluid communication with a liquid or medium (for example, an aqueous mixture comprising a nutrient medium for the spores). For example, when a frangible container within the biological sterilization indicator that contains the medium is at least partially broken, punctured, punctured, crushed, broken, or the like, so that the medium has been positioned in fluid communication with the spores, the biological indicator of sterilization can be described as "activated." Otherwise, a biological sterilization indicator was activated when the spores were exposed to the medium that was previously housed separately from the spores.
[031] After a biological sterilization indicator has been exposed to a sterilization cycle, the sterilization charge (for example, which includes the items to be sterilized and the biological sterilization indicator) can be removed from the sterilizer. One of the first steps in processing the biological sterilization indicator may include activating the biological sterilization indicator. In some embodiments, activation may include closing the biological sterilization indicator, which may include moving a portion (for example, a lid) of the biological sterilization indicator in relation to another portion of the biological sterilization indicator (for example, a tube, base, tubular body, etc.). In some embodiments, the interior of the biological sterilization indicator may remain in fluid communication with the environment during sterilization, but closed in relation to the environment after sterilization. For example, in some embodiments, the sterilization biological indicator cover can be attached to the sterilization biological indicator tube during sterilization in a first position that maintains fluid communication between the interior of the sterilization biological indicator and the environment. After sterilization, the cap can be further pressed onto the tube (for example, to a second position where the interior of the biological sterilization indicator is no longer in fluid communication with the environment) to maintain sterility and reduce the rate of evaporation of a medium (for example, a liquid) used to support metabolic activity and / or spore growth (that is, if still viable). The medium can be contained during sterilization and released into the biological sterilization indicator after sterilization. For example, the medium can be housed separately from the spores during sterilization in a frangible container that can be at least partially broken after sterilization (for example, in response to the movement of the lid in relation to the tube or base of the sterilizing biological indicator) to put the medium in fluid communication with the spores to ensure proper spore nutrition.
[032] In some embodiments of the present description, closing the biological sterilization indicator (for example, movement of one portion in relation to another portion to seal the interior) may include or cause the breaking of a frangible container containing the medium , so that closing the biological sterilization indicator causes the activation of the biological sterilization indicator.
[033] The present disclosure generally relates in addition to systems and methods for determining whether a portion of the biological sterilization indicator has been moved by a sufficient amount in relation to another portion of the biological sterilization indicator, for example, to indicate that the biological sterilization indicator has been “activated.” That is, some modalities of the systems and methods of the present description can be used to detect and / or confirm the “closing of the lid”. Also, in some embodiments, the systems and methods of the present description can be used to detect whether the biological sterilization indicator has been activated and the medium and spores are in fluid communication with each other. For example, in some embodiments, the position of the biological sterilization indicator cap relative to another portion of the biological sterilization indicator can be detected to determine whether the frangible container is intact or broken, and such information can indicate whether the medium and the spores are in fluid communication with each other. As a result, some embodiments of the present description can safely test the position of a portion of the biological sterilization indicator relative to another portion to determine whether the biological sterilization indicator has been activated. In some modalities, alternatively or additionally, the activation of the biological sterilization indicator can be confirmed by detecting the presence of liquid (for example, growth medium) in a specific chamber (for example, a spore growth chamber or detection) of the biological sterilization indicator. Such liquid or fluid detection is described in more detail in copending order No. 61 / 408,997, filed on November 1, 2010, entitled “Biological Sterilization Indicator System and Method,” which is hereby incorporated in its entirety by reference.
[034] Confirmation of activation of the biological sterilization indicator may be important, due to the fact that if the liquid or medium is not available for the spores, the biological sterilization indicator may not work properly, which may compromise the result of effectiveness of a particular sterilization process.
[035] The biological sterilization indicator of this description can be used with a variety of sterilization processes that include, but are not limited to, exposure to water vapor (eg, pressurized water vapor), dry heat, gaseous or liquid agents (for example, ethylene oxide, hydrogen peroxide, peracetic acid, ozone, or combinations thereof. In at least some of the sterilization processes, an elevated temperature, for example, 50 ° C, 100 ° C, 121 ° C, 132 ° C, 134 ° C or the like, is included or can be found in the process In addition, high pressures and / or a vacuum can be found, for example, 1 X 105 Pa (15 psi)
[036] The spores used in a particular system are selected according to the sterilization process used. For example, for a water vapor sterilization process, Geobacillus stearothermophilus or Bacillus stearothermophilus can be used. In another example, for a ethylene oxide sterilization process, Bacillus atrophaeus (formerly Bacillus subtilis) can be used. In some embodiments, spores resistant to the sterilization process may include, but are not limited to, Geobacillus stearothermophilus, Bacillus stearothermophilus, Bacillus subtilis, Bacillus atrophaeus, Bacillus megaterium, Bacillus coagulans, Clostridium sporogenes, Bacillus pumilus, or
[037] Enzymes and substrates that may be suitable for use in the biological indicator of sterilization of this description are identified in US patents No. 5,073,488 (Matner et al), 5,418,167 (Matner et al.), And 5,223,401 (Foltz et al.), Which are incorporated herein by reference and in the entirety of their descriptions.
[038] Suitable enzymes may include hydrolytic enzymes and / or enzymes derived from spore-forming microorganisms, such as Bacillus stearothermophilus and Bacillus subtilis. The enzymes of spore-forming microorganisms that may be useful in the biological sterilization indicators of the present description may include beta-D-glucosidase, alpha-D-glucosidase, alkaline phosphatase, acid phosphatase, butyrate esterase, lipase caprylate ester, myristate lipase , leucine aminopeptidase, valine aminopeptidase, chymotrypsin, phosphorhydrolase, alpha-D-galactosidase, beta-D-galactosidase, tyrosine aminopeptidase, phenylalanine aminopeptidase, beta-D-glucuronidase, alpha-L-arabinofuranosidase, N-alpha , beta-D-cellobiosidase, alanine aminopeptidase, proline aminopeptidase and fatty acid esterases.
[039] Some modalities of the biological sterilization indicator may include chromogenic and / or fluorogenic substrates that react with enzymes to form detectable products (M. Roth, Methods of Biochemical Analysis, Vol. 17, D. Block, Ed., Interscience Publishers, New York, USA, 1969, page 89, incorporated herein by way of reference; S. Udenfriend, Fluorescence Assay in Biology and Medicine, Academic Press, New York, USA, 1962, page 312; and DJR Lawrence, Fluorescence Techniques for the Enzymologist, Methods in Enzymology, Vol. 4, SP CoIowick and N. 0. Kaplan, Eds., Academic Press, New York, USA, 1957, page 174). These substrates can be classified into two groups based on the way in which they create a visually detectable signal. The substrates in the first group react with enzymes to form enzyme-modified products that are chromogenic or fluorescent. The substrates in the second group form products modified by enzymes that still need to react with an additional compound, or compounds, to generate a color or fluorescent signal.
[040] As a result, the phrase "detectable product" can refer to any molecule, compound, substance, substrate, or the like, or combinations thereof, that can be detected by any of the detection methods or processes described below. For example, such detectable products can be a sign of the viability of a source of biological activity, and the detection of such products can generally indicate the failure or inadequacy of a sterilization process.
[041] In some embodiments, the source of the active enzyme may be (1) the isolated purified enzyme derived from an appropriate microorganism; (2) a microorganism to which the enzyme is native or added by genetic engineering; and / or (3) a microorganism to which the enzyme was added during sporulation or growth, so that the enzyme is incorporated into or associated with the microorganism, for example, an enzyme added to a spore during sporulation that makes it incorporated into the spore. In some embodiments, microorganisms that can be used as an enzyme source include bacteria or fungi in the spore or vegetative state. In some embodiments, the enzyme source includes Bacillus, Clostridium, Neurospora, Candida, or a combination of these species of microorganisms.
[042] The alpha-D-glucosidase enzyme has been identified in the spores of Bacillus stearothermophilus, such as those commercially available as "ATCC 8005" and "ATCC 7953" from the American Type Culture Collection, Rockville, Md, USA. The beta-D-glucosidase enzyme was found in B. subtilis (for example, commercially available as "ATCC 9372" from the American Type Culture Collection).
[043] In the event that an isolated enzyme is used, or the microorganism used as the source of the enzyme is no more resistant to sterilization conditions than natural contaminants, another microorganism commonly used to monitor sterilization conditions can be exposed to the sterilization cycle together with the enzyme source. In that case, the method of the present description may include the step of incubating any viable microorganism remaining after the sterilization cycle with an aqueous nutrient medium to confirm the sterilization efficacy.
[044] In general, monitoring the effectiveness of the sterilization process may include placing a biological sterilization indicator in a sterilizer. In some embodiments, the sterilizer includes a sterilization chamber that can be sized to accommodate a plurality of articles to be sterilized, and can be equipped with a means of evacuation air and / or other gases from the chamber and a means for adding a sterilizing to the chamber. The biological sterilization indicator of the present description can be positioned in areas of the sterilizer that are more difficult to sterilize (for example, above the drain). Alternatively, the biological sterilization indicator of the present description can be positioned adjacent (or generally in proximity to) an article to be sterilized when the biological sterilization indicator is positioned in the sterilization chamber. In addition, the biological sterilization indicator can be positioned on process challenge devices that can be used as sterilizers.
[045] The sterilization process may also include the exposure of articles to be sterilized and the biological sterilization indicator to a sterilizer. In some embodiments, the sterilizer can be added to the sterilization chamber after evacuating at least a portion of the chamber from any air or other gas present in it. Alternatively, the sterilizer can be added to the chamber without evacuating it. A series of evacuation steps can be used to ensure that the sterilizer reaches all desired areas within the chamber and contacts all items to be sterilized, including the biological sterilization indicator.
[046] In general, after the biological sterilization indicator has been exposed to a sterilization cycle, a liquid (for example, a growth medium, water that can be mixed with a solid growth medium, etc., or combinations of themselves) can be introduced to the spores. As mentioned above, the step in which the liquid is introduced into the spores can be called an "activation step." If the spores survive the sterilization cycle, the liquid will facilitate metabolic activity and / or spore growth, and such activity and / or growth can be investigated. If growth is observed, the sterilization cycle is generally considered to be ineffective.
[047] Figures 1 to 4 illustrate a sterilization biological indicator system 10 according to an embodiment of the present description. The sterilization biological indicator system 10 includes a reading device 12 (also sometimes called a “detector”, “reader,” “test device”, or the like) and one or more biological sterilization indicators 100. Particularly, as shown in figure 1, the reading apparatus 12 can include one or more cavities or recesses 14. Each cavity 14 can be sized to receive at least a portion of a biological sterilization indicator 100. Each cavity 14 can be of any shape, size or desired configuration required to contain and / or retain at least a portion of a biological sterilization indicator 100. In some embodiments, as shown in figure 1, each well 14 of the reading apparatus 12 can be sized to receive a biological sterilization indicator 100 , and each well 14 can be configured to test and output results for one biological sterilization indicator 100 at a time. Examples of various features that can be employed on the reading apparatus 12 are described in US Patent No. 6,025,189 (Bolea et al.), Which is incorporated herein by reference.
[048] As additionally shown in figure 1, the reading device 12 can additionally include a screen and / or user interface 16, which can visually present several outputs of the reading device 12 and / or which can receive input from a user ( for example, via membrane switching with multiple buttons). Various outputs that can be presented may include, but are not limited to, errors or error codes, test results or lethality, presence of a biological sterilization indicator 100 in a given cavity 14, other suitable outputs or combinations thereof. In some embodiments, as shown in figure 1, the reading apparatus 12 may include a front face 18 that includes the screen and / or user interface 16 and that can be angled to facilitate access to the cavities 14 and / or to facilitate the viewing screen 16, or other items on face 18. Additionally, in some embodiments, the reading device 12 may include a substantially horizontal or flat top wall 20 which can facilitate the stacking of multiple reading devices 12 on top of each other, so that multiple reading devices 12 can be operated and read simultaneously, as desired. The reading apparatus 12 and the operation of the biological sterilization indicator system 10 will be described in more detail below, with reference to figures 3 to 5. First, the biological sterilization indicator 100 will be described in detail, with reference to figures 2 to 4. Biological sterilization indicator
[049] Figures 2 to 4 illustrate the biological sterilization indicator 100 in greater detail. Other suitable modalities of biological sterilization indicators are described in copending patent application No. PCT / US2010 / 041010, entitled “Biological Sterilization Indicator and Method of Using Same”; (Precedent No. 65578WO003) in US Patent Application No. 61 / 408,977, entitled “Biological Sterilization Indicator System and Method”; in US patent application no. 61 / 408,988, entitled “Biological Sterilization Indicator and Method of Using Same”; and in US patent application no. 61 / 408.977, entitled “Biological Sterilization Indicator” each of which is incorporated herein, as a reference in its entirety.
[050] The biological sterilization indicator 100 may include a compartment 102, which may include a first portion 104 and a second portion 106 (e.g., a lid) adapted to be coupled thereto to provide the one-piece biological sterilization indicator . In some embodiments, the first portion 104 and the second portion 106 may be formed from the same materials, and in some embodiments, the first portion 104 and the second portion 106 may be formed from different materials. The compartment 102 can define a reservoir 103 of the biological sterilization indicator 100 in which other components can be positioned and in which a sterilizer can be directed during a sterilization process.
[051] The compartment 102 can be defined by at least one liquid impermeable wall, such as the wall 108 of the first portion 104 and / or a wall 110 of the second portion 106. It should be understood that a unitary one-piece compartment 102 can also be employed or that the first and second portions 104 and 106 may adopt other formats, dimensions or relative structures without deviating from the character and scope of the present disclosure. Suitable materials for compartment 102 (for example, walls 108 and 110) may include, but are not limited to, a glass, a metal (for example, foil), a polymer (for example, polycarbonate (PC), polypropylene (PP), polyethylene, polystyrene (PS), polyester (for example, polyethylene terephthalate (PET)), polymethyl methacrylate (PMMA or acrylic), acrylonitrile-butadiene-styrene (ABS), cycloolefin polymer (COP ), cycle olefin copolymer (COC), polysulfone (PSU), polyether sulfone (PES), polyetherimide (PEI), polybutylene terephthalate (PBT)), ceramic, porcelain, or combinations thereof.
[052] In some embodiments, the biological sterilization indicator 100 may also include a frangible container 120 that contains a liquid (for example, an aqueous mixture) 122, and that is sized to be received within the biological sterilization indicator 100 , for example, within at least a portion of compartment 102 (for example, at least within the first portion 104 of compartment 102). The frangible container 120 for being formed by a variety of materials, including, but not limited to, one or more metal (for example, foil), a polymer (for example, any of the polymers mentioned above in relation to the compartment 102), glass (for example, a glass ampoule), and combinations thereof. In some embodiments, only a portion of the container 120 is frangible, for example, the container 120 may include a frangible portion or cover (e.g., a frangible film, membrane or barrier or the like). The frangible container 120 can have a first state in which it is intact and the liquid 122 is contained therein, and a second state in which at least a portion of the container 120 is broken. In the second state of the container 120, the liquid 122 can be in fluid communication with the reservoir 103 of the biological sterilization indicator 100, for example, when the container 120 is positioned in the biological sterilization indicator 100.
[053] As shown in the illustrated embodiment, the container 120 can be held in place within the biological sterilization indicator 100 and / or broken by an insert 130, which is described in greater detail below.
[054] The first portion 104 of compartment 102 can be adapted to house most components of the sterilization biological indicator 100, and can be called "tube," "tubular body," "base," or the like. Compartment 102 may include a reservoir 103 that can be defined by one or both of the first portion 104 and the second portion 106 of compartment 102. The biological sterilization indicator 100 may further include spores or other source (s) ) of biological activity 115 (or a spore locus) positioned in fluid communication with reservoir 103. As shown in figure 2, the second portion 106 of compartment 102 can include one or more openings 107 to provide fluid communication between the interior of the compartment 102 (for example, reservoir 103) and the environment. For example, one or more openings 107 can provide fluid communication between spores 115 and the environment during the sterilization process, and can serve as an input to the biological sterilization indicator 100 and as an input to a sterilizing path 164 (described in more details below). In some embodiments, the second portion 106 of compartment 102 can be coupled to a first end (for example, open) 101 of the first portion 104 of compartment 102, and spores 115 can be positioned on a second end (for example, closed) 105, opposite the first end 101, of the first portion 104 of compartment 102.
[055] In some embodiments, a barrier or filter (for example, a sterile barrier; not shown) can be positioned on the 164 sterilizing path (for example, in the opening formed by opening 107) to inhibit the entry of contamination or foreign organisms , objectives or materials in the biological sterilization indicator 100. This barrier may include a gas transmissive material and is impermeable to microorganisms, and may be coupled to compartment 102 and a variety of coupling means, including, but not limited to, an adhesive, heat seal, sonic welding, or the like. Alternatively, the barrier can be coupled to the sterilizing path 164 via a support structure (such as a second portion 106) that is coupled to the first portion 104 of compartment 102 (for example, in a quick-fit coupling, a coupling by screw, pressure coupling, or a combination thereof). During exposure to a sterilizer, it can cross the barrier in the trajectory of sterilizer 164 and come in contact with spores 115.
[056] In some embodiments, as shown in figure 2 illustrated embodiment, compartment 102 may include a lower portion 114 and an upper portion 116, which may be at least partially separated by an inner wall (or partial wall) 118, protrusion, partition, flange or the like, in which an opening 117 can be formed which provides fluid communication between the lower portion 114 and the upper portion 116. In some embodiments, the lower portion 114 of the first portion 104 of compartment 102 (sometimes simply called "Lower portion 114" or "lower portion 114 of compartment 102") can be adapted to accommodate spores 115 or a spore locus. In some embodiments, the lower portion 114 may be called the "detection portion" or "detection region" of compartment 102, because at least a portion of the lower portion 114 may be interrogated for signs of spore growth. In addition, in some embodiments, the upper portion 116 of the first portion 104 of compartment 102 (sometimes called “upper portion 116” or “upper portion 116 of compartment 102” for the sake of simplicity) can be adapted to accommodate at least a portion of the frangible container 120, particularly prior to activation.
[057] In some embodiments, as shown in figures 2 to 4, the portion of reservoir 103 that is defined at least partially by the upper portion 116 of compartment 102 can be called the first chamber (or reservoir, zone, region or volume) 109 and the portion of reservoir 103 which is defined at least partially by the lower portion 114 of compartment 102 may be called the second chamber (or reservoir, zone, region or volume) 111. In some embodiments, the second chamber 111 may be called “ spore growth chamber ”or a“ detection chamber, ”and may include a volume to be questioned about spore viability to determine the effectiveness of a sterilization process.
[058] The first chamber 109 and the second chamber 111 can be positioned in fluid communication with each other to allow a sterilizer and liquid 122 to move from (i.e., through) the first chamber 109 to the second chamber 111 In some embodiments, the degree of fluid connection between the first chamber 109 and the second chamber 111 (for example, the size of an opening, such as opening 117, which connects the first chamber 109 and the second chamber 111) may increase after , simultaneously with and / or in response to the activation step (i.e., the liquid 122 which is released from the container 120). In some embodiments, control of fluid communication (or extension of fluid connection) between the first chamber 109 (for example, in the upper portion 116) and the second chamber 111 (for example, in the lower portion 114) may be provided by at least a portion of the insert 130.
[059] Container 120 can be positioned and maintained in the first chamber 109 during sterilization and when container 120 is in a first unbroken state. The spores 115 can be housed in the second chamber 111 and in fluid communication with the environment when the container 120 is in the first state. The first chamber 109 and the second chamber 111 can be configured so that the container 120 is not present in the second chamber 111, and particularly, not when the container 120 is in its first unbroken state. A sterilizer can move to the second chamber 111 (for example, through the first chamber 109) during sterilization and the liquid 122 can move to the second chamber 111 (for example, the first chamber 109) during activation, when the container 120 is broken and liquid 122 is released into compartment 102.
[060] As a result, when the container 120 is in the first state, the first chamber 109 and the second chamber 111 can be in fluid communication with each other, and with the environment (for example, during sterilization). For example, the first chamber 109 and the second chamber 111 may be in fluid communication with the environment through one or more openings 107. In some embodiments, the first chamber 109 and the second chamber 111 may be in fluid communication with the environment. such that the first chamber 109 is positioned upstream of the second chamber 111 when a sterilizer is entering the biological sterilization indicator 100. That is, the first chamber 109 can be positioned between the inlet of the sterilizer (for example, one or more openings 107) and the second chamber 111, and the sterilizer inlet can be positioned on the opposite side of the first chamber 109 in relation to the second chamber 111.
[061] As shown in figures 2 and 4, in some embodiments, the first chamber 109 can be defined by one or both of the first portion 104 and the second portion 106, particularly when the container 120 is in the first state. In addition, in some embodiments, the first chamber 109 may include a first end 112 positioned adjacent the open end 101 of the first portion 104 of compartment 102, adjacent to the second portion 106 of compartment 102, and / or at least partially defined by the second portion 106 of compartment 102. The first chamber 109 may additionally include a second end 113 positioned adjacent and in fluid communication with the second chamber 111 and positioned towards the closed end 105 of compartment 102. The first end 112 of the first chamber 109 can be defined first portion 104 and / or second portion 106 of compartment 102.
[062] As shown further in Figures 2 and 4, in some embodiments, the second chamber 111 may include a first end 124 positioned adjacent and in fluid communication with the first chamber 109 and positioned towards the open end 101 of compartment 102, and a second end 125 at least partially defined by, including or positioned adjacent to the closed end 105 of compartment 102.
[063] Otherwise, as shown in figures 2 and 4, the biological sterilization indicator 100 can include a longitudinal direction DL, and in some embodiments, the first chamber 109 can be positioned longitudinally above the second chamber 111.
[064] In some embodiments, the second chamber 111 may be at least partially defined by, may include or may be positioned adjacent to the closed end 105 of the biological sterilization indicator 100. In addition, in some embodiments, the second chamber 111 may be smaller (for example, in volume and / or cross-sectional area) than at least one of the first chamber 109 and the volume of liquid 122 in container 120 that will be released when the sterilization biological indicator 100 is activated. As a result, in such embodiments, the second chamber 111 may have an air-locking effect in which the gas (for example, air) that is present in the second chamber 111 can inhibit fluid movement to the second chamber 111. In some embodiments , as described in greater detail below, a fluid path that allows the second chamber 111 to ventilate another portion of the biological sterilization indicator 100 can facilitate fluid movement in the second chamber 111.
[065] In some embodiments, wall 118 (sometimes referred to as a “separation wall”) can be angled or tilted, for example, oriented at a non-straight or non-zero angle to a longitudinal direction DL of compartment 102 (for example, where the longitudinal direction DL extends along the length of compartment 102). This angulation or inclination of the wall 118 can facilitate the movement of the liquid 122 from the upper portion 116 to the lower portion 114 after sterilization and after the container 120 has been ruptured to release the liquid 122.
[066] As shown in figure 2, in some embodiments, wall 118 may be at least partially formed by a change in the internal dimension of compartment 102. For example, as shown, wall 118 may be formed by a decrease in an area from the cross section of a first longitudinal position in the first chamber 109 to a second longitudinal position in the second chamber 111. In addition, just as an example, the internal cross-sectional shape of compartment 102 can change in the transition from the first chamber 109 to the second chamber 111 from substantially round (for example, with a flat side that produces less than 50% of the perimeter) in the first chamber 109 to substantially parallelepipedal (for example, substantially square) in the second chamber 111.
[067] Additionally, in some embodiments, wall 118 may also be at least partially formed by a change in the external dimension of compartment 102. As shown in figure 2, in some embodiments, compartment 102 includes a step (or protrusion, suspension , transition or similar) 123 which is consistently angled with wall 118 (if wall 118 is angled), and which includes a change in the external shape and dimension of compartment 102. However, it must be understood that in some modalities, even if the internal dimension of compartment 102 changes to create a second chamber 111 that has a shape or cross-sectional dimension different from the first chamber 109, the external shape and dimension of compartment 102 do not need to change, or change consistently with the change in internal format and / or dimension. For example, in some embodiments, step 123 can be oriented substantially and perpendicularly to the longitudinal direction DL.
[068] In some embodiments, reservoir 103 has a volume of at least about 0.5 millimeter (mL), in some embodiments, at least about 1 ml, and in some embodiments, at least about 1.5 mL . In some embodiments, reservoir 103 has a volume not greater than about 5 mL, in some embodiments not greater than about 3 mL, and in some embodiments, not greater than about 2 mL.
[069] In some embodiments, the frangible container 120 has a volume of at least about 0.25 mL, in some embodiments, at least about 0.5 mL, and in some embodiments, at least about 1 mL. In some embodiments, the frangible container 120 has a volume of no more than about 5 ml, in some embodiments, no more than about 3 ml, and in some embodiments, no more than about 2 ml.
[070] In some embodiments, the volume of liquid 122 contained in the frangible container 120 is at least about 50 microliters, in some embodiments at least about 75 microliters, and in some embodiments at least about 100 microliters. In some embodiments, the volume of liquid 122 contained in the frangible container 120 is no greater than about 5 mL, in some embodiments no greater than about 3 mL, and in some embodiments, no greater than about 2 mL.
[071] In some embodiments, the first chamber 109 (that is, formed by the upper portion 116 of the first portion 104 of compartment 102) has a volume of at least about 500 microliters (or cubic mm), in some embodiments, at least about 1000 microliters, in some modalities, at least about 2000 microliters, and in some modalities, at least about 2500 microliters. In some embodiments, the first chamber 109 has a volume no greater than about 5000 microliters, in some embodiments no greater than about 4000 microliters, and in some embodiments, no greater than about 3000 microliters. In some embodiments, the first chamber 109 has a volume of about 2790 microliters or 2800 microliters.
[072] In some embodiments, the second chamber 111 (that is, formed by the lower portion 114 of the first portion 104 of compartment 102) has a volume of at least about 5 microliters, in some embodiments, at least about 20 microliters, and in some modalities, at least about 35 microliters. In some embodiments, the second chamber 111 has a volume of no more than about 250 microliters, in some embodiments, no more than about 200 microliters, in some embodiments, no more than about 175 microliters, and in some embodiments, no more than about 100 microliters. In some embodiments, the second chamber 111 has a volume of about 208 microliters or 210 microliters.
[073] In some embodiments, the volume of the second chamber 111 is at least about 5% of the volume of the first chamber 109, and in some embodiments, at least about 7%. In some embodiments, the volume of the second chamber 111 is no more than about 20% of the volume of the first chamber 109, in some embodiments, no more than about 15%, in some embodiments, no more than about 12%, and in some modalities, no more than about 10%. In some embodiments, the volume of the second chamber 111 is about 7.5% of the volume of the first chamber 109.
[074] In some embodiments, the volume of the second chamber 111 is no more than about 60% of the volume of liquid 122 housed in container 120, in some embodiments, no more than about 50%, and in some embodiments, no more that about 25%. In some embodiments, the design of the second chamber 111 has a volume that is substantially less than that of the liquid 122 housed in the container 120 can ensure that the volume of additional liquid can compensate for unintended evaporation.
[075] In some embodiments, the first chamber 109 (that is, formed by the upper portion 116 of the first portion 104 of compartment 102) has a cross-sectional area (or average cross-sectional area) in the transition between the first chamber 109 and the second chamber 111, or in the position adjacent to the second chamber 111, of at least about 25 mm2; in some modalities, at least about 30 mm2; and in some embodiments, at least about 40 mm2 In some embodiments, the first chamber 109 has a cross-sectional area in the transition between the first chamber 109 and the second chamber 111, or in the position adjacent to the second chamber 111, of no more than about 100 mm2, in some modalities, no more than about 75 mm2, and in some modalities, no more than about 50 mm2.
[076] In some embodiments, the second chamber 111 (i.e., formed by the lower portion 114 of the first portion 104 of compartment 102) has a cross-sectional area at the transition between the first chamber 109 and the second chamber 111, or in position adjacent to the first chamber 109, of at least about 5 mm2, in some embodiments, at least about 10 mm2, and in some embodiments, at least about 15 mm2 In some embodiments, the second chamber 111 has a cross-sectional area (or average cross-sectional area) of no more than about 30 mm2, in some modalities, no more than about 25 mm2, and in some modalities, no more than about mm2
[077] In some embodiments, the cross-sectional area of the second chamber 111 in the transition between the first chamber 109 and the second chamber 111 may be no more than about 60% of the cross-sectional area of the first chamber 109 in the transition, in some modalities, no more than about 50%, in some modalities, no more than about 40%, and in some modalities, no more than about 30%.
[078] In some embodiments, the biological sterilization indicator 100 may additionally include a substrate 119. In some embodiments, as shown in figures 2 to 4, substrate 119 can be sized to be positioned adjacent to wall 118, and particularly, to the rest above wall 118. Substrate 119 can be positioned between the upper portion 116 and the lower portion 114 of the sterilization biological indicator 100 in some embodiments can at least partially define the first chamber 109 and the second chamber 111. As such, in in some embodiments, the substrate 119 can be positioned between the container 120 and the spores 115. In some embodiments, the substrate 119 can be positioned in the first chamber 109, or on one side of the first chamber of the wall 118, so that the substrate 119 do not be positioned in the second chamber 111.
[079] In addition, substrate 119 can be positioned to minimize diffusion of a test signal (e.g., fluorescence) out of second chamber 111. In some embodiments, depending on the material composition of substrate 119, substrate 119 it can also absorb dyes, indicator reagents or other solution materials that can inhibit the accurate reading of a signal from the sterilization biological indicator 100 (ie, "inhibitors"). In some embodiments, as shown in figure 2, substrate 119 can include one or more openings 121, which can be configured to control (ie, facilitate and / or limit, depending on the number, size, shape and / or location) the fluid movement between the first chamber 109 and the second chamber 111 of the biological sterilization indicator 100, and particularly, which can facilitate the movement of the liquid 122 towards the spores 115 when the container 120 is broken. Only by way of example, the particular benefits or advantages were observed when opening 121 was positioned in front of (or "ahead of") the center of substrate 119, as shown. In the embodiment illustrated in figures 1 to 4, the “front” of the sterilization biological indicator 100 or components therein can generally be described as being towards a face plane 126. In general, the “front” of the sterilization biological indicator 100 can be refer to the portion of the biological sterilization indicator 100 that will be interrogated by the reading device 12.
[080] Furthermore, for example only, aperture 121 is illustrated as being circular or round; however, other opening formats in cross section are possible and included in the scope of the present disclosure. Additionally, just as an example, and as shown in figure 2, substrate 119 is shaped to substantially fill the cross-sectional area of the first chamber in the transition between the first chamber 109 and the second chamber 111. However, other shapes of the substrate 119 are possible and can be adapted to accommodate compartment 102, first chamber 109, second chamber 111, wall 118 or another component of the biological sterilization indicator 100.
[081] In some embodiments, substrate 119 may be formed from a variety of materials to perform one or more of the above functions. Examples of substrate materials may include, but are not limited to, cotton, glass wool, cloth, non-woven polypropylene, non-woven rayon, non-woven rayon / polypropylene blend, non-woven nylon, non-woven fiberglass or other fibers non-woven fabrics, filter papers, microporous hydrophobic and hydrophilic films, glass fibers, open cell polymeric foams and semi-permeable plastic films (eg particle-filled films, thermally induced phase separation membranes (TIPS), etc.), and combinations thereof. For example, in embodiments where substrate 119 can be used to selectively concentrate one or more indicator reagents (for example, bromocresol purple (BCP)), substrate 119 can be formed of a charged nylon (such as a charged transfer membrane) probe available from GE Water & Process Technologies, Trevose, PA, USA, under the trade name “MAGNAPROBE” (eg 0.45 micron pore size, 30 cm X 3 m cylinder, catalog number NP0HY00010, material number 1226566)).
[082] Substrate 119 is described in more detail in US copendent patent applications No. 61 / 408,988 and 61 / 408,977, each of which is incorporated herein by reference in its entirety. Examples of methods and systems that can employ substrate 119 are also described in copending US patent application No. 61 / 408,887, entitled "Method of Detecting a Biological Activity," and US patent application No. 61 / 408.966, entitled “Method of Detecting a Biological Activity,” each of which is incorporated herein, as a reference in its entirety.
[083] In some embodiments, at least a portion of one or more within insertion element 130, wall 118, and / or substrate 119, or an opening therein, can provide fluid communication between the first chamber 109 (for example, in the upper portion 116) and the second chamber 111 (for example, in the lower portion 114), and / or can control the fluid communication between the first chamber 109 and the second chamber 111 (for example, by controlling the extent of the fluid connection between the first chamber 109 and the second chamber 111).
[084] The biological sterilization indicator 100 may include a first fluid path 160 that can be positioned to fluidly couple the first chamber 109 and the second chamber 111, and which may allow the sterilizer (for example, during sterilization, when container 120 is in a first, unbroken state) and / or liquid 122 (for example, after sterilization and during activation when container 120 is in a second broken state) to reach spores 115. In the illustrated embodiment, the first fluid path 160 can generally be defined by one or more of the following: (1) the insertion element 130, for example, through an opening 177 described below, an opening formed in the insertion element 130, and / or any open spaces around insertion element 130, such as between insertion element 130 (e.g., a front portion thereof) and compartment 102; (2) wall 118, for example, opening 117 defined by wall 118; (3) substrate 119, for example, opening 121 formed there, or any open spaces around substrate 119, such as between substrate 119 (e.g., a front portion thereof) and compartment 102; (4) compartment 102, for example, any openings or spaces formed there; and combinations thereof. As a result, the first fluid path 160 is generally represented by an arrow, as shown in figure 3.
[085] The biological sterilization indicator 100 may additionally include a second fluid path 162 positioned to fluidly couple the second chamber 111 to another chamber or portion of the biological sterilization indicator 100, such as the first chamber 109. The second fluid path 162 it can be further positioned to allow the gas that was previously present in the second chamber 111 to be displaced and out of the second chamber 111, for example, when the sterilizer and / or liquid 122 is moved to the second chamber 111. As such, the second fluid path 162, which is described in greater detail below, can serve as an internal vent on the sterilization biological indicator 100.
[086] In some embodiments, substrate 119 may provide a physical barrier or blockage between the first chamber 109 and the second chamber 111 that may allow at least one of the following: to control the sterilizer delivery rate / extermination rate at which the sterilizer is delivered to the second chamber 111; controlling the diffusion of spores 115 and / or detectable products out of the second chamber 111; controlling the rate of delivery of liquid 122 to the second chamber 111 (and to the spores 115) when the container 120 is in the second broken state; or a combination of them.
[087] Due to the fact that, in some embodiments, substrate 119 can provide a physical barrier to deliver liquid 122 to the second chamber 111 during activation (that is, when container 120 is in the second state), the opening 121 on substrate 119 and / or the angle of substrate 119 can be controlled to effect a desired liquid delivery rate. In addition, or alternatively, the second fluid path 162 may provide a vent for any gas (e.g., air) that is trapped in the second chamber 111 to facilitate the movement of the liquid 122 through or beyond substrate 119 and into the second chamber 111 when desired.
[088] In addition, or alternatively, compartment 102 can be configured (for example, formed of a suitable material and / or configured with microstructured grooves or other physical surface modifications) to facilitate the movement of liquid 122 into the second chamber 111 when desired.
[089] In some embodiments, liquid 122 may include a nutrient medium for spores, such as a germination medium that will promote the germination of surviving spores. In some embodiments, liquid 122 may include water (or another solvent) which can be combined with nutrients to form a nutrient medium. Suitable nutrients may include nutrients necessary to promote the germination and / or growth of surviving spores in a dry form (for example, spray form, tablet form, capsule form, film or coating, trapped in a microsphere or other support, another suitable shape or configuration, or a combination thereof) in reservoir 103, for example, in a region of the biological sterilization indicator 100 next to the spores 115.
[090] The nutrient medium can generally be selected to induce germination and initial spore growth, if feasible. The nutrient medium can include one or more sugars, including, but not limited to, glucose, fructose, celibiose, or the like, or a combination thereof. The nutrient medium may also include a salt, including, but not limited to, potassium chloride, calcium chloride, or the like, or a combination thereof. In some embodiments, the nutrient may also include at least one amino acid, including, but not limited to, at least one of methionine, phenylalanine, and tryptophan.
[091] In some embodiments, the nutrient medium may include molecules or indicator reagents, for example, indicator molecules that have optical properties that change in response to germination or spore growth. Suitable reagents or indicator molecules may include, but are not limited to, pH indicator molecules (eg, bromocresol purple (BCP), bromocresol green (BCG), chlorophenol red (CPR), bromothymol blue (BTB), bromophenol blue (BPB), other sulfonaphthalene dye, methyl red or combinations thereof), enzyme substrates (eg 4-methylumbelliferill-a-D-glycoside), DNA-binding dyes, RNA-binding dyes, other suitable indicator molecules or a combination thereof. In some embodiments, the combination of bromocresol purple and 4-methylumbelliferill-a-D-glycoside represents an example of a pair of indicator reagents that can be used together. This combination can be used to detect a first biological activity such as the fermentation of a carbohydrate for acidic end products and a second biological activity such as a-D-glucosidase enzyme activity, for example. These activities may indicate the presence or absence of a viable spore after the exposure of a biological sterilization indicator to a sterilization process, for example. Bromocresol purple can be used at a concentration of about 0.03 g / l in the aqueous mixture, for example. 4-methylumbeliferyl-aD-glycoside can be used, for example, at a concentration of about 0.05 to about 0.5 g / l (for example, about 0.05 g / l, about 0, 06 g / l, about 0.07 g / l, about 0.08 g / l, about 0.09 g / l, about 0.1 g / l, about 0.15 g / l, about 0.2 g / l, about 0.25 g / l, about 0.3 g / l, about 0.35 g / l, about 0.4 g / l, about 0.45 g / l, about 0.5 g / l), for example, in an aqueous mixture.
[092] As shown in figures 2 to 4, the biological sterilization indicator 100 can additionally include an insertion element 130. In some embodiments, the insertion element 130 can be adapted to hold or transport container 120, so that the Container 120 is kept intact in a location separate from spores 115 during sterilization. That is, the insert 130 may include (or function as) a support 132 for the container 120, particularly, before the container 120 is broken during the activation step (i.e., the step in which liquid 122 is released from the container 120 and introduced into spores 115, which typically occurs after the sterilization process). In some embodiments, the insert 130 may be additionally adapted to allow the container 120 to move at least a little in the compartment 102, for example, longitudinally relative to the compartment 102. The insert 130 of the embodiment illustrated in figures 1 4 is described in more detail below. Examples of other suitable insertion elements and carriers are described in copending US patent application No. 61 / 226,937 (Precedent No. 65578US002).
[093] In some embodiments, the biological sterilization indicator 100 may additionally include a spore carrier 135, as shown in figures 2 to 4. However, in some embodiments, the insert 130 may be modified to include a portion adapted for housing the spores 115. For example, in some embodiments, the insert 130 and the spore carrier 135 can be integrally formed as an insert element comprising a first portion adapted to contain and eventually break container 120, when desired, and a second portion adapted to house the spores 115 in a region of the biological sterilization indicator 100 that is separated from the container 120 during sterilization (i.e., before breaking).
[094] As shown in figures 2 to 4, spore carrier 135 may include a spore reservoir 136 (which may also be called a depression, orifice, cavity, recess or the like), in which spores 115 can be positioned, directly or on a substrate. In embodiments that employ a nutrient medium that is positioned to be mixed with liquid 122 when it is released from container 120, the nutrient medium can be positioned close to or within the spore reservoir 136, and the nutrient medium can be mixed with (for example, dissolved in) water when water is released from container 120. Only as an example, in modalities in which the nutrient medium is supplied in a dry form, the dry form may be present within the reservoir 103 , the spore reservoir 136, on a substrate for the spores, or a combination thereof. In some embodiments, a combination of liquid and dry nutrient media may be employed.
[095] In some embodiments, the spore reservoir 136 has a volume of at least about 1 microliter, in some embodiments, at least about 5 microliters, and in some embodiments, at least about 10 microliters. In some embodiments, the spore reservoir 136 has a volume no greater than about 250 microliters, in some embodiments no greater than about 175 microliters, and in some embodiments, no greater than about 100 microliters.
[096] As shown in figures 3 and 4, in some embodiments, the biological sterilization indicator 100 may additionally include a rib or protuberance 165 that can be coupled to or integrally formed with a wall 108 of compartment 102, which can be positioned to keeping spore carrier 135 in a desired location in compartment 102 and / or at a desired angle or orientation, for example, in relation to the detection systems (e.g., optical detection systems) of the reading device 12.
[097] As shown in figures 2 to 4, the second portion 106 of compartment 102 can be adapted to be coupled to the first portion 104. For example, as shown in figures 1 to 4, the second portion 106 can be adapted to be coupled to the upper portion 116 (e.g., the first end 101) of the first portion 104 of compartment 102. In some embodiments, as shown in figures 1 to 4, the second portion 106 may be in the form of a lid that can be sized to receive at least a portion of the first portion 104 of compartment 102.
[098] As shown in figures 3, during sterilization and before activation, the second portion 106 may be in a first "not activated" position 148 relative to the first portion 104, and the container 120 may be in a first intact state . As shown in figure 4, the second portion 106 of compartment 102 can be moved to a second "activated" position 150 (for example, where the second portion 106 is completely lowered) relative to the first portion 104, and the container 120 can be in a second broken state. For example, after sterilization, the biological sterilization indicator 100 can be activated by moving the second portion 106 from the first position 148 to the second position 150 (that is, a sufficient amount) to cause the container 120 to break and release the liquid 122 of the container 120, to allow the liquid 122 to be in fluid communication with the spores 115. The biological sterilization indicator 100 can be activated before positioning the biological sterilization indicator 100 in the cavity 14 of the reading device 12, after the positioning of the biological sterilization indicator 100 in the cavity 14, or as the biological sterilization indicator 100 is positioned in the cavity 14 (i.e., the biological sterilization indicator 100 can be slid in place in the cavity 14, and the second portion 106 can continue to be lowered until it is in its second position 150, for example, where the bottom of the cavity 14 provides sufficient strength to see second portion 106 for its second position 150). The second position 150 can be located closer to the closed end 105 of the first portion 104 of the sterilization biological indicator 100 than the first position 148.
[099] A variety of coupling means may be employed between the first portion 104 and the second portion 106 of compartment 102 to allow the first portion 104 and the second portion 106 to be removably coupled to each other, including, but not limited to, limited to, gravity (for example, one component can be fixed on top of another component, or a joined portion thereof), thread threads, press fit couplings (sometimes called “friction fit coupling” or “Forced fit coupling”), snap fit coupling, magnets, adhesives, heat seal, other suitable removable coupling means, and combinations thereof. In some embodiments, the biological sterilization indicator 100 does not need to be reopened and the first portion 104 and second portion 106 do not need to be coupled to each other, but instead can be coupled permanently or semi-permanently to each other. These permanent or semi-permanent coupling means may include, but are not limited to, adhesives, sutures, staples, threads, nails, rivets, headless nails, crimping, welding (eg, sonic welding (eg, ultrasonic)) , any thermosetting technique (for example, heat and / or pressure applied to one or both components to be coupled), press fit coupling, press fit coupling, heat sealing, other permanent or semi-permanent coupling means and combinations thereof. The person skilled in the art will recognize that some of the semi-permanent or permanent coupling means can also be adapted to be removable and vice versa, and are categorized in this way for example only.
[0100] As shown in figures 3 and 4, the second portion 106 can be movable between a first longitudinal position 148 with respect to the first portion 104 and a second longitudinal position 150 with respect to the first portion 104; however, it should be understood that the biological sterilization indicator 100 could instead be configured differently, so that the first and second positions 148 and 150 are not necessarily longitudinal positions with respect to one or both of the first portion 104 and the second portion 106 of compartment 102.
[0101] The second portion 106 may additionally include a seal 156 (for example, a projection, protrusion, flap, flange, seal ring or the like, or combinations thereof) which may be for contacting the first end 101 of the first portion 104, and particularly, an open upper end 157 of the first portion 104 to close or seal (for example, hermetically seal) the biological sterilization indicator 100 after the second portion 106 has been moved to the second position 150 and the liquid 122 has been released from container 120 that is, when the container is in a second broken state. The seal 156 can take a variety of shapes and is shown in figures 3 and 4 by way of example as forming a ring or internal cavity which together with the wall 110 of the second portion 106 is dimensioned to receive the upper end 157 of the first portion 104 of compartment 102 to seal the biological sterilization indicator 100.
[0102] In some embodiments, one or both of the seal 156 and the upper end 157 may additionally include a structure (for example, a protuberance) configured to engage the other between the upper end 157 and the seal 156, respectively, in order to coupling the second portion 106 of compartment 102 to the first portion 104 of compartment 102.
[0103] In addition, in some embodiments, the second portion 106 of compartment 102 can be coupled to the first portion 104 of compartment 102 to seal the biological sterilization indicator 100 from the environment after activation. Such a seal can inhibit contamination, evaporation or spillage of liquid 122 after it has been released from container 120, and / or can inhibit contamination inside the biological sterilization indicator 100.
[0104] The seal 156 can be configured to have a length in the longitudinal direction DL of the biological sterilization indicator 100 to accommodate different degrees or levels of closure. That is, in some embodiments, the "second position" 150 of the second portion 106 of compartment 102 may be any position in which at least a portion of the seal 156 has engaged a portion (for example, the upper end 157) of the first portion 104 compartment 102 so that the interior of the sterilization biological indicator 100 is sealed from the environment. The sterilization biological indicator 100 and the sterilization biological indicator system 10 can be configured accordingly so that if the reading device 12 detects that the second portion 106 has moved to the second position 150, the user knows that the seal 156 is engaged.
[0105] The insert 130 will now be described in greater detail, with particular reference to figures 2 to 4.
[0106] As shown in figure 3, during sterilization and before activation, the second portion 106 can be in a first position 148 in relation to the first portion 104. In the first position 148, the container 120 can be kept intact in one position separated from the lower portion 114 of the spores 115, and the liquid 122 may be contained in the container 120.
[0107] As shown in figure 4, after sterilization, the biological sterilization indicator 100 can be activated to release liquid 122 from container 120 to move liquid 122 to spores 115. That is, the second portion 106 of the compartment 102 can be moved to a second position 150 with respect to the first portion 104. When the second portion 106 is moved from the first position 148 to the second position 150, the seal 156 of the second portion 106 of the compartment 102 can engage the upper end 157 of the first portion 104 to seal the reservoir 103 of the sterilization biological indicator 100 of the environment. In these embodiments, the second portion 106 may be reversibly engaged with the first portion 104 in the second position 150, and in some embodiments, the second portion 106 may be irreversibly engaged with the first portion 104. However, it must be understood that the structures and coupling means for the first portion 104 and the second portion 106 are shown in figures 3 and 4 by way of example only, and any of the coupling means described above may instead be employed between the first portion 104 and second portion 106 of compartment 102.
[0108] The insert 130 can be adapted to hold or transport the container 120, so that the container 120 is kept intact in a location separate from the spores 115 during sterilization. That is, as mentioned above, the insert 130 may include (or function as) a carrier 132 for the container 120, particularly, before the container 120 is broken during the activation step (i.e., the step where the liquid 122 is released from container 120 and introduced to spores 115, which typically after a sterilization process).
[0109] Furthermore, the insert 130 can be adapted to keep the container 120 intact in a position in the compartment 102 that maintains at least a minimum spacing (for example, a minimum cross-sectional area of space) between the container 120 and compartment 102 and / or between container 120 and any other components or structures in compartment 102 (for example, at least a portion of the insert 130, such as carrier 132, etc.), for example, to maintain a path of substantially constant sterilizer 164 in the biological sterilization indicator 100. In some embodiments, the insert 130 may be adapted to hold container 120 in a substantially consistent location in compartment 102.
[0110] In some embodiments, as shown in figure 2, at least a portion of compartment 102 may include a tapered portion 146 in which compartment 102 (for example, wall 108 and / or an internal surface thereof) generally resides tapers in the longitudinal direction DL of compartment 102. As a result, the cross-sectional area in compartment 102 can generally decrease along the longitudinal direction DL.
[0111] In some cases, without providing the means to maintain at least a minimum spacing around the container 120 (for example, between the container 120 and the surrounding structure), there may be a possibility that the container 120 will be positioned in the compartment 102 (for example, in the tapered portion 146) so that it obstructs or blocks the sterilizing path 164. However, the biological sterilization indicator 100 of the present description is designed to prevent this from occurring. For example, in the embodiment illustrated in figures 1 to 4, the insert 130 (and particularly the support 132) can be configured to keep the container 120 out of the tapered position 146 of the compartment 102, so that at least a minimum area of cross section is maintained around the container 120 in any orientation of the sterilization biological indicator 100 prior to activation. For example, in the embodiment shown in figures 1 to 4, even if the biological sterilization indicator 100 is turned upside down, the container 120 may fall out of contact with the insert 130, but in no orientation, the container 120 is moved closer to the tapered portion 146 or spores 115 until activation of the sterilization biological indicator 100. In addition, until activation, at least a minimum spacing (and particularly, a cross-sectional area of that spacing) between the container 120 and the compartment 102 and / or the insert 130 can be maintained to provide a substantially constant sterilizing path 164, for example, around the container 120.
[0112] In some embodiments, the sizing and relative positioning of the components of the biological sterilization indicator 100 can be configured so that, before activation, the container 120 is kept intact in a location substantially consistent with the biological sterilization indicator 100. This The configuration can provide a substantially constant sterilizing path 164 and can hold the container 120 in a position so that the container 120 is not able to move substantially, or in any way, on the sterilization biological indicator 100 prior to activation.
[0113] In some embodiments, at least a portion of the insert 130 may be adapted to allow the container 120 to move in compartment 102, for example, longitudinally in relation to compartment 102, between a first (longitudinal) position in which container 120 is intact and a second (longitudinal) position in which at least a portion of container 120 is broken. For example only, the insert 130 may include one or more projections or arms 158 (two projections 158 spaced on the container 120 are shown by way of example only) adapted to contain and support the container 120 prior to activation and to allow container 120 to move in compartment 102 during activation, for example, when second portion 106 is moved relative to first portion 104 of compartment 102. Projections 158 can also be adapted (for example, shaped and / or positioned ) to break container 120 in a desired manner when the biological sterilization indicator is activated. As a result, the insert 130 can sometimes function to keep the container 120 intact before activation, and can function to break the container 120 during activation. As a result, the insert 130, or a portion thereof, can sometimes be called a "carrier" (for example, carrier 132) and / or a "breaker."
[0114] As an example only, the projections 158 are shown in figures 2 to 4 as attached to a base or support 127 adapted to be in a boundary position with the partition wall 118. For example, the base 127 can be dimensioned for be received in reservoir 103 and sized to sit on the top, be in a borderline position or otherwise cooperate with or be coupled to the separation wall 118. Such coupling with an internal structure of the sterilization biological indicator 100 can provide strength and strength necessary for rupture of container 120 when desired. In some embodiments, however, the insert 130 does not include the base 127, and the projections 158 can be coupled to or form a portion of the compartment 102. In some embodiments, the insert 130 is integrally formed with or provided by the compartment 102.
[0115] As shown in figures 2 to 4, the insert 130 may additionally include a side wall 131 that connects the projections 158 and is shaped to accommodate an inner surface of compartment 102 and / or an outer surface of container 120. Such sidewall 131 can provide support and stiffness for the projections 158 to aid in safely breaking the container 120 in a consistent manner. The side wall 131 can also be shaped and dimensioned to guide the container 120 in a desired manner as it is moved in the compartment 102 during activation, for example, to bring the projections 158 into contact in a desired manner to safely break the container 120 .
[0116] Side wall 131 and / or wall 108 of compartment 102 (or an internal surface thereof) can also be shaped to define at least a portion of the second fluid path 162 of the sterilization biological indicator 100, for example, between an outer surface of insertion element 130 and an inner surface of compartment 102. In some embodiments, a channel can be formed in one or both of insertion element 130 and compartment 102 (for example, on wall 108 of compartment 102 ) that together define the second fluid path 162.
[0117] The second fluid path 162 can provide internal ventilation within the biological sterilization indicator 100 to allow trapped air to escape from the second chamber 111 of the biological sterilization indicator 100 as liquid 122 is released from container 120 (1) during activation, to facilitate the movement of the liquid 122 into the spore chamber 111 of the biological sterilization indicator 100; and / or (2) during sterilization, to facilitate the movement of a sterilizer into the spore chamber 111 (i.e., in contact with the spores 115). The second fluid path 162 is described in more detail in US copending patent application No. 61 / 408,988.
[0118] For example only, projections 158 are illustrated as relatively rigid and stationary. That is, in some embodiments, the projections 158 may not be adapted to substantially flex, distort, deform or otherwise orient container 120 as it is moved in compartment 102. Preferably, in some embodiments, as shown in figures 2 to 4 , the projections 158 can be configured so as to have an upper end 159 at the top where the container 120 can be positioned and kept intact before activation. As shown in figure 3, in some embodiments, projections 158 can be positioned to break container 120 at its radiated end, for example, when an oblong or capsule-shaped container 120 is employed.
[0119] A potential advantage of having projections 158 of at least a portion of carrier 132 is that the bottom of container 120 may be unrestricted when container 120 is broken, so that liquid 122 can be released from container 120 and moved to spores 115 with relative ease and reliability.
[0120] In such embodiments, the insert 130 can be used to break the container 120 in a direction that is substantially perpendicular to a flat side of the container 120, for example, when an oblong or capsule-shaped container 120 is employed . In such embodiments, the breaking of the container 120 along its side can be achieved, together with the maintenance of some open spaces around the lower end of the container 120 to facilitate the movement of the liquid 122 of the container 120 towards the proximity of the spores 115 when container 120 is broken.
[0121] As mentioned above, projections 158 can be adapted to break container 120 as container 120 is moved relative to compartment 102 (for example, along the longitudinal direction DL), for example, in response to the movement of the second portion 106 of compartment 102 with respect to the first portion 104 of compartment 102 (for example, from first position 148 to second position 150).
[0122] In some embodiments, the projections 158 may include one or more edges (for example, tapered edges) or points or otherwise be configured to concentrate the crushing force to increase the pressure in the container 120 in the regions adjacent to the projections 158 , and to facilitate the breaking of the container 120 more easily and in one or more desired regions. In some embodiments, such a concentration of force may reduce the total effort or force required to move the second portion 106 relative to the first portion 104 and to break the container 120 (or a portion thereof).
[0123] As shown in figures 2 to 4, the projections 158 are integrally formed with the base 127 of the insert 130; however, it should be understood that projections 158 can instead be integrally formed with wall 108 of compartment 102. In addition, in some embodiments, projections 158 can be coupled to compartment 102, or projections 158 and the base 127 can be provided by separate inserts. In such embodiments, the projections 158 can be a separate insertion element, or multiple projections 158 can be provided by one or more insertion elements. In addition, the insert 130 can be configured to be in a position bordering the wall 118 to inhibit movement of the first portion of the insert 130 to the proximity of the spores 115 (e.g., the bottom 114 of the compartment 102) .
[0124] In addition, in some embodiments, as shown in figures 2 to 4, the projections 158 may extend a distance along the longitudinal direction DL, and the length and / or thickness (for example, which may vary over time) length) of the projections 158 can be customized to control the breaking of the container 120 in a desired position in compartment 102 and in a desired manner. The configuration of the projections 158 is shown in figures 2 to 4 only as an example.
[0125] In general, each of the projections 158 is shown only as an example as increasing in thickness (for example, inward towards container 120 or center of compartment 102) along the longitudinal direction DL towards spores 115 Such a configuration can decrease the cross-sectional area that is available for the container 120, as the container 120 is moved towards the spores 115, for example, in response to the movement of the second portion 106 to the second position 150.
[0126] Additionally, the biological sterilization indicator 100 is shown in figures 2 to 4 including two projections 158 and a side wall 131 only as an example, but it should be understood that one projection 158 or as many as are structurally possible, and others configurations, can be used. In addition, the projections 158 can be shaped and dimensioned as desired, depending on the shape and dimensions of the compartment 102, the shape and dimensions of the container 120, the shape and dimensions of the insert 130 and / or the way and shape of the container. desired position to break container 120.
[0127] As mentioned above, in some embodiments, at least a portion of compartment 102 can be tapered (see, for example, tapered portion 146 in figure 2). As a result, the cross-sectional area in compartment 102 can generally decrease along the longitudinal direction DL. However, it should be understood that the internal dimensions of compartment 102 can generally decrease in the tapered portion along the longitudinal direction Di without changing the external dimensions of compartment 102. In some embodiments, the outer dimensions of compartment 102 may be uniform throughout its length, even though the inner portion of compartment 102 tapers along its length. In some embodiments, the one or more projections 158 alone may vary in thickness (that is, towards the container 120, for example, in a radial direction) along the longitudinal direction DL, so that the cross-sectional area available for container 120 generally decreases as container 120 is moved in compartment 102 during activation, even if the dimensions of compartment 102 do not change (for example, even if compartment 102 does not include any tapered portion 146, internally or externally).
[0128] As shown in figures 2 to 4, the upper end 159 of each of the projections 158 includes a round, curved or arched surface, which can facilitate the movement of the container 120 from the first position 148 in which the container 120 is positioned at less partially above the upper end 159 of the projection 158 to a position where the container 120 is forced, at least partially, into the region of the smaller cross-sectional area between the projections 158 (or between the wall 108 of the compartment 102 and one or more projections 158). In addition, the rounded upper end 159 can inhibit premature rupture of container 120, which can inhibit premature activation of the biological sterilization indicator 100 (i.e., premature release of liquid 122).
[0129] In some embodiments, as shown in figure 3, the insert 130 can be sized and shaped to allow the container 120 to be kept above the projections 158 and outside the adjacent region of any portion of an inwardly facing surface one or more of the projections 158 to inhibit accidental or premature activation of the biological sterilization indicator 100. This configuration can also inhibit inadvertent rupture due to shock or expansion of the material (for example, due to exposure to heat during a sterilization process) .
[0130] As shown in figures 2 to 4, support 132, which can be formed at least partially by the upper ends 159 of projections 158, can be configured to hold the lower portion of container 120, and projections 158 can be positioned to break container 120 at a location near the bottom of container 120 as it is positioned in compartment 102. This configuration can allow container 120 to rupture near its bottom and can facilitate the removal of liquid 122 from container 120, which it can improve the availability of liquid 122 to spores 115, and can improve the reliability of release of liquid 122 in fluid communication with spores 115 (e.g., spore reservoir 136). This configuration is shown by way of example only, however, it should be understood that the projections 158 can be configured and positioned to break the container 120 in any desired manner.
[0131] Some embodiments of the present disclosure provide an ideal and safe rupture of a frangible container 120 with relatively weak force, while accentuating the transfer of liquid 122 to the spore region (for example, the second chamber 111 of compartment 102) of the biological indicator sterilization 100, and / or accentuates the confinement of liquid 122 in the spore region of the biological sterilization indicator 100. In addition, some embodiments of the present disclosure operate to convey a liquid to a particular area of the biological sterilization indicator 100, such as a spore detection area (for example, second chamber 111) of the biological sterilization indicator 100.
[0132] In the embodiment illustrated in figures 1 to 4, the insert 130 is illustrated as including two projections 158 that are approximate and equally spaced on the container 120 and / or on the side wall 131. However, in some embodiments, the sidewall 131 may include a solid projection (for example, substantially annular or semi-annular) 158 that extends radially into sidewall 131. Additionally, in some embodiments, sidewall 131 may further extend around the inner surface of the compartment 102 that has been illustrated. However, the use of one or more narrower projections 158 (for example, in an angular dimension), such as those shown in Figures 2 to 4, can provide a substantially constant or substantially unobstructed path of sterilizer 164 around the container 120.
[0133] If insertion element 130 includes one or more projections 158 or side walls 131, insertion element 130 can be configured to hold container 120 in compartment 102 in a consistent location to provide a substantially constant sterilizing path 164 during sterilization. For example, instead of allowing the container 120 to move or reach (for example, radially and / or longitudinally) in compartment 102 before activation (for example, during sterilization), the insert 130 can hold the container 120 in a substantially consistent position, which allows a sterilizer to have a substantially consistent and relatively unobstructed path between an outer surface of compartment 120 and an inner surface of compartment 102, as little or no opportunity for inadvertent blocking.
[0134] As shown in figures 2 to 4, the insert 130 may additionally include one or more projections 161 positioned horizontally or perpendicularly substantially with respect to the longitudinal direction DL of a biological sterilization indicator (for example, when the element insert 130 is positioned on a biological sterilization indicator). Projections 161 can be called "second projections" or "horizontal projections," while projections 158 used to contain and / or break container 120 can be called "first projections" or "vertical projections." Second projections 161 are not angled down like base 127. As a result, second projections 161 can be used for a variety of purposes. For example, second projections 161 can stabilize insertion element 130 (for example, aid in retaining insertion element 130 in a desired position in compartment 102 of biological sterilization indicator 100) under the breaking force of container 120. In addition In addition, the second projections 161 can function to retain and / or collect the broken portions of the container 120 after they have been broken to inhibit the movement of those portions in the vicinity of the spores in the biological sterilization indicator, which could negatively affect spore growth. and / or detection of spore growth. Other shapes and configurations of the second projections 161 can be employed that will still allow the movement of fluid to the spores 115 while inhibiting the solid movement to the spores 115.
[0135] In some embodiments, the insert 130 (for example, the base 127) can be adapted to one or more of facilitating or allowing the movement of fluid (for example, movement of liquid 122) to the second chamber 111 ( i.e., the lower portion 114) of compartment 102; minimizing the movement of fractions or portions (e.g., solids) from the broken container 120 to the second chamber 111 of compartment 102, that is, collecting and / or retaining the portions of the broken container 120; and / or minimize the diffusion of spores 115 and / or signals out of the second chamber 111 of compartment 102. For example, in some embodiments, base 127 can be configured to function as a grid or filter. In some embodiments, spore growth is determined by fluorescent indicators / molecules (for example fluorophores) or other markers. In some embodiments, if the liquid level after activation of the biological sterilization indicator 100 is above the spore 115 site, these molecules or markers, or the spores 115 themselves, may move or diffuse away or out spore reservoir 136 and potentially out of the second chamber 111 of compartment 102. As a result, the portions of the sterilization biological indicator 100 (for example, insert 130) can be configured to inhibit unwanted diffusion of various indicators, molecules and / or markers outside the second chamber 111 of the biological sterilization indicator 100. In some embodiments, as described above, substrate 119 can also inhibit such undesirable diffusion.
[0136] In the embodiment illustrated in figures 1 to 4, the base 127 of the insert 130 is generally U-shaped or horseshoe-shaped and includes a central opening 177 (see figure 2) that facilitates the movement of the sterilizer towards to spores 115 during sterilization and the movement of liquid 122 towards spores 115 during activation. The horseshoe shape of the base 127 can increase the gap between the upper portion 116 (i.e., the first chamber 109) and the lower portion 114 (i.e., the second chamber 111) of compartment 102; however, this format is shown as an example only, and other formats can be used.
[0137] In some embodiments, the insert 130 may be described as including one or more downwardly extending projections 127 adapted to be in a borderline position or otherwise coupled to the wall 118 or another internal structure of the biological indicator of sterilization 100 to provide a base or support for insertion element 130, to inhibit movement of insertion element 130 and container 120 with respect to compartment 102 prior to activation, and / or to provide resistance or strength to aid in rupture of the container 120 during activation. As a result, in some modalities, base 127 may instead be called “third projections” 127.
[0138] As shown in figures 2 to 4, in some embodiments, the insertion element 130 can be configured to reside entirely in the first chamber 109 of the sterilization biological indicator 100, so that the insertion element 130 does not extend into the second chamber 111 where it would potentially interfere with the interrogation or detection processes. In addition, the insert 130 can be configured to inhibit movement of other portions of the sterilizing biological indicator 100 (e.g., broken container 120) to the second chamber 111.
[0139] The insertion element 130 shown in figures 2 to 4 is generally symmetrical over a longitudinal center line of symmetry, so that there are two first identical projections 158, two second identical projections 161 and two third identical projections 127. However, the insertion element 130 need not include any lines of symmetry, and the first projections 158 need not be equal to each other, the second projections 161 need not be equal to each other, and the third projections 127 need not be equal to each other. Insertion elements 130 and projections 158, 161 and 127 can be sized and positioned to control the trajectory of sterilizer 164, for example, to adjust the death / survival rate of the biological sterilization indicator 100, to inhibit inadvertent breakage of the container 120, to facilitate movement of container 120 in compartment 120, to join with or engage with compartment 102, and / or to control rupture of container 120.
[0140] Just as an example, the insert 130 is illustrated in figures 2 to 4 shown as a unitary device that includes at least the following: means for holding the container 120, before activation, for breaking the container 120, during activation; to allow movement of container 120 in compartment 102; to provide a substantially constant sterilizing path 164; to collect and / or retain portions of the broken container 120 after activation (or at least partially inhibit movement of portions of the broken container 120 to the second chamber 111 of compartment 102); and / or to minimize the spread of spores 115 and / or signals from the second chamber 111 to the upper portion 116 of compartment 102 after activation. However, it should be understood that in some embodiments, the insert 130 may include multiple portions that may not be part of a single unitary device, and each portion may be adapted to perform one or more of the above functions.
[0141] The insertion element 130 is called the "insertion element" due to the fact that in the embodiment illustrated in figures 2 to 4, the device that performs the above functions is a device that can be inserted in the reservoir 103 (and, particularly, in the first chamber 109) of compartment 102. However, it should be understood that the insertion element 130 can instead be provided by the compartment 102 itself or another component of the biological sterilization indicator 100 and is not necessarily susceptible to insertion in compartment 102. The term “insertion element” will be described throughout this description for the sake of simplicity, but it should be understood that this term is not intended to limit, and it should be considered that other equivalent structures that perform a or more of the above functions can be used instead, or in combination with, the insert 130. In addition, in the embodiment illustrated in figures 2 to 4, the insert 130 is insertable into, and removable from, compartment 102, and particularly, into and out of the first portion 104 (and the first chamber 109) of compartment 102. However, it should be understood that even if the insertion element 130 is insertable in compartment 102, the insert 130 may not be removable from compartment 102, but can instead be fixedly attached to compartment 102 in a way that inhibits the removal of insert 130 from compartment 102 after positioning the insert 130 in a desired location.
[0142] In some embodiments, at least a portion of compartment 102, for example, the lower portion 114 of compartment 102, can be transparent to a wavelength of electromagnetic radiation or wavelength range (for example, transparent to light visible when optical detection methods are employed), which can facilitate the detection of spore growth. That is, in some embodiments, as shown in figures 2 to 4, at least a portion of compartment 102 may include or form a detection window 167.
[0143] Furthermore, in some embodiments, as shown in figure 2, at least a portion of compartment 102, for example, the lower portion 114 may include one or more planar walls 168. These planar walls 168 can facilitate detection, ( for example, optical detection) of spore growth. In addition, in the embodiment illustrated in figures 1 to 5, the wall 108 of the first portion 104 of compartment 102 may include one or more staggered regions, such as step 123 (described above), a transition from round to plane, transition zone or step 152 (described in more detail below) and a tapered wall or step 170. The tapered wall 170 can work to reduce the thickness and total size of the lower portion, or detection portion, 114 of compartment 102, so that the dimensions compartment 102 are reduced beyond the internal dimensions. Such a reduction in size and / or thickness of the lower portion 114 of the sterilization biological indicator 100 can facilitate detection. In addition, the fact of having one or more features, such as steps and / or tapered walls 123, 152, 170 can allow the biological sterilization indicator 100 to be coupled to a reader or detection device (for example, the wall 14 of the reading device 12) in only one orientation, so that the biological sterilization indicator 100 is “registered” in relation to such device, which can minimize user error and enhance the reliability of a detection process. In some embodiments, one or more portions of the biological sterilization indicator 100 can be registered in relation to a reading device.
[0144] The biological sterilization indicator of the present description generally keeps the liquid 122 and the spores 115 separated but in relatively close proximity (for example, inside the biological sterilization indicator 100 one-piece) during sterilization, so that the liquid 122 and spores 115 can be readily combined after exposure to a sterilization process. Liquid 122 and spores 115 can be incubated during a detection process (for example, the reading device 12 can incubate the biological sterilization indicator 100), or the biological sterilization indicator 100 can be incubated before a detection process . In some embodiments, during spore incubation with liquid 122, an incubation temperature above room temperature can be used. For example, in some embodiments, the incubation temperature is at least about 37 ° C, in some embodiments, the incubation temperature is at least about 50 ° C (for example, 56 ° C), and in some embodiments, at least about 60 ° C. In some modalities, the incubation temperature is not greater than about 60 ° C, in some modalities, not greater than about 50 ° C, and in some modalities, not greater than about 40 ° C.
[0145] A detection process can be adapted to detect a detectable change in the spores 115 (for example, from within the spore reservoir 136) of the liquid 122 surrounding the spores 115. That is, a detection process can be adapted to detect a variety of characteristics, including, but not limited to, electromagnetic radiation (for example, in the bands of visible, ultraviolet, and / or infrared light), fluorescence, luminescence, light scattering, electronic properties (for example, conductance, impedance, or similar, or combinations thereof), turbidity, absorption, Raman spectroscopy, ellipsometry, or the like, or a combination thereof. The detection of these characteristics can be performed by one or more of a fluorimeter, spectrophotometer, colorimeter, or similar, or combinations of them. In some modalities, such as those that measure fluorescence, visible light, etc., the detectable change is measured by detection at a particular wavelength.
[0146] Spores and / or liquid 122 can be adapted (for example, labeled) to produce one or more of the following characteristics as a result of a biochemical reaction that is a sign of spore viability. As a result, no detectable change (for example, when compared to a baseline or antecedent reading) can mean an effective sterilization process, while a detectable change can mean an ineffective sterilization process. In some embodiments, the detectable change may include a rate at which one or more of the above characteristics are being altered (eg, fluorescence increase, turbidity decrease, etc.).
[0147] In some embodiments, spore viability can be determined by exploiting enzymatic activity. As described in Matner et al., US Patent No. 5,073,488, entitled “Rapid Method for Determining Efficacy of a Sterilization Cycle and Rapid Read-out Biological Indicator,” which is incorporated here for reference, enzymes can be identified for a particular type of spore in which the enzyme has particularly useful characteristics that can be exploited to determine the effectiveness of a sterilization process. These characteristics may include the following: (1) the enzyme, when subjected to sterilization conditions that would be sufficient to decrease a population of 1 X 106 test microorganisms by about 6 records (that is, to a population of about zero when measured due to the lack of flowering of microorganisms), it has a residual activity that is equal to the “antecedent” as measured by the reaction with a substrate system for the enzyme; and (2) the enzyme, when submitted to sufficient sterilization conditions only to decrease the population of 1 X 106 test microorganisms in at least 1 register, but less than 6 registers, has the enzyme activity greater than the "antecedent" as measured by reaction with the enzyme substrate system. The enzyme substrate system can include a substance, or mixture of substances, that is influenced by the enzyme to produce a product modified by a detectable enzyme, as evidenced by a detectable change.
[0148] In some embodiments, the biological sterilization indicator 100 can be tested in a unilateral mode, in which the biological sterilization indicator 100 includes only a detection window (for example, detection window 167 in figure 2) that is positioned , for example, near spores 115. In some embodiments, however, the biological sterilization indicator 100 may include more than one detection window (for example, a window formed by all or a portion of both parallel walls 168 of the lower portion 114 of compartment 102), so that the sterilization biological indicator 100 can be tested through more than one detection window. In modalities that employ multiple detection windows, the detection windows can be positioned side by side (similar to the one-sided mode), or the detection windows can be oriented at an angle (for example, 90 degrees, 180 degrees, etc.) in relation to each other.
[0149] In general, spores 115 are positioned within spore reservoir 136 which is in fluid communication with reservoir 103. In some embodiments, spore reservoir 136 forms a portion of reservoir 103 (for example, a portion of the second chamber 111). As shown in figure 3, reservoir 103 is in fluid communication with the environment (for example, through opening 107) during sterilization to allow the sterilizer to enter reservoir 103 during the sterilization process to sterilize spores 115. The container 120 can be configured to contain liquid 122 during sterilization to inhibit fluid communication of liquid 122 with spores 115, reservoir 103, and sterilizer during sterilization.
[0150] Various details of spores 115 and / or spore reservoir 136 will now be described in greater detail.
[0151] In some embodiments, spores 115 can be positioned directly at the bottom 114 of compartment 102, or spores 115 can be positioned in a spore reservoir, such as spore reservoir 136 (for example, provided by the spore bearer 135 in the mode illustrated in figures 2 to 4). If spores 115 are positioned directly at the bottom 114 of compartment 102 or in a spore reservoir, such as the spore reservoir, spores 115 can be provided in a variety of ways. In some embodiments, the spores 115 may be a spore suspension that can be positioned at a desired location on the biological sterilization indicator 100 and subjected to drying. In some embodiments, the spores 115 can be supplied on a substrate (not shown) that can be positioned and / or secured at a desired location on the biological sterilization indicator 100. Some modalities may include a combination of spores 115 supplied in a dry form and spores 115 provided on a substrate.
[0152] In some embodiments, the substrate can be positioned to support the spores 115 and / or help keep the spores 115 in a desired location. Such substrate can include a variety of materials, including, but not limited to, paper, a polymer (for example, any of the polymers mentioned above in relation to compartment 102), an adhesive (for example, acrylate, synthetic or natural rubber) , silicone, polyurea silicone, isocyanate, epoxy, or combinations thereof), a woven cloth, a non-woven cloth, a microporous material (for example, a microporous polymeric material), a reflective material (for example, a foil), a glass, a porcelain, a ceramic, a gel-forming material (for example, guar gum), or combinations thereof. In addition, or alternatively, that substrate may include or be coupled to a hydrophilic coating to facilitate intimate contact of the liquid 122 with the spores 115 (for example, when the liquid 122 employed is aqueous). In addition, or alternatively, this hydrophilic coating can be applied to any fluid path positioned to fluidly couple liquid 122 and spores 115. In some embodiments, in addition to, or in place of, a hydrophilic coating, a coating hydrophobic can be applied to other portions of compartment 102 (for example, the lower portion 114 of compartment 102) and / or of the spore reservoir 136, so that the liquid 122 is preferably moved to come in contact with the spores 115.
[0153] Some modalities of the biological sterilization indicator 100 do not include spore carrier 135. Preferably, the spore reservoir 136 is provided by the lower portion 114 of compartment 102 itself, and spores 115 can be positioned in the lower portion 114 , adsorbed on an inner wall of the lower portion 114, or combinations thereof. In some embodiments, spores 115 may be provided on a substrate that is positioned in the lower portion 114 of compartment 102.
[0154] In some embodiments, the spores 115 can be positioned in a spore location or in a plurality of spore locations, all of which can be positioned in reservoir 103, in the lower 114 portion of compartment 102, and / or in the reservoir of spores 136. In some modalities, the fact that there are multiple spore sites can maximize spore exposure to sterilizer and liquid 122, can optimize preparation (for example, spore disposition can be facilitated by placing each spore site. spores in a depression within the biological sterilization indicator 100), and can optimize detection characteristics (for example, due to the fact that spores may not be so easily detected in the middle of a large spore site). In embodiments employing a plurality of spore sites, each spore site may include a different known number of spores, and / or each spore site may include different spores, so that a plurality of types of spores can be tested. When employing multiple types of spores, the biological sterilization indicator 100 can be used for a variety of sterilization processes and a specific spore location can be analyzed for a specific sterilization process, or multiple types of spores can be used to test additionally the effectiveness, or reliability, of a sterilization process.
[0155] In addition, in some embodiments, the biological sterilization indicator 100 may include a plurality of spore reservoirs 136, and each spore reservoir 136 may include one or more spore sites 115. In some embodiments, the use of a plurality of spore reservoirs 136, the plurality of spore reservoirs 136 can be positioned in fluid communication with reservoir 103.
[0156] In some embodiments, the spores 115 may be covered with a cover (not shown) adapted to fit on or over the spores 115 and / or the spore reservoir 136. This cover can help to keep the spores within a desired region of the biological sterilization indicator 100 during preparation, sterilization and / or use. The cover, if used, can be formed of a material that does not substantially impede a detection process, and / or that is at least partially transmissible to wavelengths of electromagnetic radiation of interest. In addition, depending on the composition of the covering material, in some embodiments, the covering may facilitate absorption by capillary effect of liquid 122 (for example, the nutrient medium) next to the spores 115. In some embodiments, the covering may also contain features to facilitate the flow of fluids within the spore reservoir 136 (or to the spores 115), such as capillary channels, hydrophilic microporous fibers or membranes, or the like, or a combination thereof. In addition, in some embodiments, coverage can isolate a signal, or improve the signal, which can facilitate detection. This cover can be used if the spores 115 are positioned inside the spore reservoir 136 or directly in the lower portion 114 of compartment 102. Furthermore, this cover can be used in modalities that employ a plurality of spore sites. The cover can include a variety of materials, including, but not limited to, paper, a polymer (for example, any of the polymers mentioned above in relation to compartment 102), an adhesive (for example, acrylate, natural or synthetic rubber , silicone, silicone polyurea, isocyanate, epoxy, or combinations thereof), a woven cloth, a non-woven cloth, a microporous material (for example, a microporous polymeric material), a glass, a porcelain, a ceramic, a forming material gel (for example, guar gum), or combinations thereof.
[0157] In some embodiments, the biological sterilization indicator 100 may also include a modified inner surface, such as a reflective surface, a white surface, a black surface, or other suitable surface modification to optimize the optical properties of the surface. A reflective surface (for example, provided by a foil) can be positioned to reflect a signal sent to the spore reservoir 136 from a test or detection device and / or to reflect any signal generated within the spore reservoir 136 back to the test device. As a result, the reflective surface can work to optimize (for example, optimize the intensity of) a signal from the sterilization biological indicator 100. This reflective surface can be provided by an internal surface of compartment 102; a material coupled to the internal surface of compartment 102; an internal surface of the spore reservoir 136; a material coupled to the internal surface of the spore reservoir 136; or similar; the reflective surface can form a portion of or be coupled to a spore substrate; or a combination of them.
[0158] Similarly, in some embodiments, the biological sterilization indicator 100 may also include a white and / or black surface positioned to increase and / or decrease a particular signal sent to the spore reservoir 136 from a device test and / or increase and / or decrease a particular signal generated within the spore reservoir 136. As an example only, a white surface can be used to improve the signal, and a black surface can be used to reduce the signal ( that is, noise).
[0159] In some embodiments, spores 115 can be positioned on a functionalized surface to promote immobilization of spores 115 on the desired surface. For example, such a functionalized surface can be provided by an internal surface of compartment 102, an internal surface of spore reservoir 136, can form a portion of or if coupled to a spore substrate, or the like, or a combination thereof.
[0160] In some embodiments, the 115 spores are positioned (for example, applied by coating or an application method) on a microstructured or microreplied surface (for example, as the microstructured surfaces presented in Halverson et al., PCT publication n WO 2007/070310, Hanschen et al., US publication No. 2003/0235677, and Graham et al., PCT publication No. WO 2004/000569, all of which are incorporated herein by reference). For example, this microstructured surface can be provided by an internal surface of compartment 102, it can be provided by an internal surface of spore reservoir 136, it can form a portion of or be coupled to a spore substrate, or the like, or a combination of the same.
[0161] In some embodiments, the biological sterilization indicator 100 may further include a gel-forming material positioned to be combined with spores 115 and liquid 122 when liquid 122 is released from container 120. For example, the material gel former can be positioned close to spores 115 (for example, in spore reservoir 136), in the lower portion 114 of compartment 102, it can form a portion to be coupled to a spore substrate, or similar, or a combination thereof . Such a gel-forming material can form a gel (for example, a hydrogel) or a matrix comprising spores and nutrients when the liquid 122 comes in contact with the spores. A gel-forming material (eg guar gum) can be particularly useful because it has the ability to form a gel upon hydration, and can assist in locating a signal (eg, fluorescence), can anchor spores 115 in place , can help to minimize spore diffusion 115 and / or a signal from spore reservoir 136 and / or can improve detection.
[0162] In some embodiments, the biological sterilization indicator 100 may also include an absorbent or material for absorption by capillary effect. For example, the material for absorption by capillary effect can be positioned close to spores 115 (for example, in spore reservoir 136), it can form at least a portion of, or be coupled to, a spore substrate, or the like, or combination thereof. This capillary absorption material includes a porous capillary absorption block, an immersion block, or the like, or a combination thereof, to facilitate placing the liquid 122 in close contact with the spores.
[0163] In some embodiments, the frangible container 120 can be configured to facilitate breaking the frangible container 120 in the desired manner. For example, in some embodiments, a lower portion of the frangible container 120 may be formed of a thinner and / or weaker material, so that the lower portion preferably breaks into another portion of the frangible container 120. In addition , in some embodiments, the frangible container 120 may include a variety of features positioned to facilitate breaking of the frangible container 120 in a desired manner, including, but not limited to, a thin and / or weakened area, a cut line, perforation, or the like, or combinations thereof.
[0164] The frangible container 120 may have a first closed state in which liquid 122 is contained within frangible container 120 and a second open state in which frangible container 120 has been broken and liquid 122 is released into reservoir 103 and / or spore reservoir 136, and in fluid communication with spores 115.
[0165] In some embodiments, the biological sterilization indicator 100 can be activated (for example, the second portion 106 can be moved to the second position 150) manually. In some embodiments, the biological sterilization indicator 100 can be activated by a reading device 12 (for example, how the biological sterilization indicator 100 is positioned on the reading device 12). In some embodiments, the biological sterilization indicator 100 can be activated with a device (for example, an activation device) independent of such a reading device 12, for example, by positioning the biological sterilization indicator 100 on the device before positioning of the biological sterilization indicator 100 in a cavity 14 of a reading device 12. In some embodiments, the biological sterilization indicator 100 can be activated by a combination of two or more of the reading device 12, a device independent of the reading device 12 and manual activation.
[0166] One or both, the biological sterilization indicator 100 and another device, such as a reading device 12, can be additionally configured to inhibit premature or accidental breakage of the frangible container 120. For example, in some embodiments, the biological indicator of sterilization 100, the activation device or reading apparatus 12 may include a lock or locking mechanism which is positioned to prevent the second portion 106 of compartment 102 from moving to the second position 150 as far as desired. In these modalities, the biological sterilization indicator 100 cannot be activated until the lock is moved, removed or unlocked. In addition, or alternatively, in some embodiments, the biological sterilization indicator 100, the activation device and / or the reading apparatus 12 may include a lock or locking mechanism that is positioned to prevent the second portion 106 of compartment 102 move from second position 150 back to first position 148 after activation.
[0167] In some embodiments, as shown in figures 2 to 4, at least a portion of the compartment can be flat (for example, the parallel walls 168), and can be substantially planar in relation to the spore reservoir 136, and one or both of the parallel walls 168 or a portion thereof (for example, the detection window 167) substantially match at least one dimension of the spore reservoir 136 and / or the spore location 115. In other words, the wall 168 or a portion thereof (for example, detection window 167) may include a cross-sectional view that is substantially the same size as the cross-sectional area of the spore reservoir 136 and / or the spore location 115. This Equal size testing between wall 168 / detection window 167 and spore reservoir 136 and / or spore site 115 can maximize the signal detected during a detection or testing process. Alternatively, or in addition, the wall 168 or detection window 167 can be dimensioned to match the reservoir 103 (for example, at least one dimension or the cross-sectional areas can be dimensioned to be equalized). This equal size test between detection zones can improve the spore detection test.
[0168] The biological sterilization indicator 100 shown in figures 2 to 4, at least the portion of the biological sterilization indicator 100 where the spores 115 are positioned, is relatively thin (that is, the “z dimension” is minimized), so that the optical path of the spores to the wall 168 (or detection window 167) is minimized and / or any effect of interference of substances in the liquid 122 (or nutrient medium) is minimized.
[0169] In use, the biological sterilization indicator 100 can be positioned together with a sterilization batch during a sterilization process. During sterilization, a sterilizer is in fluid communication with reservoir 103 (i.e., first chamber 109 and second chamber 111), spore reservoir 136, and spores 115 primarily through sterilizer path 164, so that the sterilizer can reach the spores to produce sterile spores. In addition, during sterilization, the frangible container 120 is in a closed state, kept intact at least partially by the carrier 132 of the insert 130. When the frangible container 120 is in a closed state, the liquid 122 is protected from the sterilizer and it is not in fluid communication with reservoir 103 (particularly, the second reservoir 111 formed at least partially by the lower portion 114 of compartment 102), spore reservoir 136, spores 115 or sterilizing path 164.
[0170] After sterilization, the effectiveness of the sterilization process can be determined using the biological sterilization indicator 100. The second portion 106 of compartment 102 can be unlocked, if previously locked in the first position 148, and moved from the first position 148 (see figure 3) to the second position 150 (see figure 4) to cause the activation of the sterilization biological indicator 100. Such movement of the second portion 106 can cause the frangible container 120 to move in compartment 102, for example, along the longitudinal direction DL from a position above the upper ends 159 of the projections 158 to a position within the projections 158, which can cause the frangible container 120 to break. Breaking the frangible container 120 can change the frangible container 120 from its closed state to its open state and release liquid 122 in reservoir 103, and in liquid communication with spore reservoir 136 and spores 115. Liquid 122 may include a nutrient medium (for example, germination medium) for the spores, or liquid 122 may contact the nutrient medium in a dry form (for example, in a powdered or tablet form) to form the nutrient medium, so that the mixture that includes the sterile spores and the nutrient medium is formed. The mixture can then be incubated before or during a detection or testing process, and the biological sterilization indicator 100 can be interrogated for signs of spore growth.
[0171] To detect a detectable change in spores 115, the sterilization biological indicator 100 can be tested immediately after liquid 122 and after spores 115 have been combined to achieve a baseline reading. After that, any detectable change in the baseline reading can be detected. The biological sterilization indicator 100 can be monitored and measured continuously or intermittently. In some embodiments, a portion of the incubation step, or the entire incubation step, can be performed before measuring the detectable change. In some embodiments, incubation can be performed at a temperature (for example, at 37 ° C, between 50 and 60 ° C, etc.), and the measurement of the detectable change can be performed at a different temperature (for example, at room temperature, 25 ° C, or 37 ° C).
[0172] The reading time of the biological sterilization indicator 100 (that is, the time to determine the effectiveness of the sterilization process) can be, in some modalities, less than 8 hours, in some modalities less than 1 hour, in some modalities modalities less than 30 minutes, in some modalities less than 15 minutes, in some modalities less than 5 minutes, and in some modalities less than 1 minute. Sterilization Biological Indicator System
[0173] The sterilization biological indicator system 10 will now be described with reference to figures 3 to 5. Figures 3 and 4 illustrate the sterilization biological indicator system 10 of figure 1 in cross section, taken along line 3- 3 of Figure 1, and Figure 5 illustrates a block diagram of an embodiment of the reading apparatus 12.
[0174] The phrase “reading device” generally refers to one or more devices that operate to “read” a biological sterilization indicator 100 to detect whether the spores 115 of the biological sterilization indicator 100 have survived a sterilization process, as a means of judging the effectiveness of a sterilization process. The phrase "reading device" is intended to cover any combination of mechanical and electronic components necessary to perform such detection. In addition, in the present disclosure, the reading apparatus 12, or a portion thereof, is configured to detect whether the biological sterilization indicator 100 has been activated. As a result, a first device, or portion of the reading device 12, can be dedicated to determining an activation state of the biological sterilization indicator 100, and a second device, or another portion of the reading device 12, can be dedicated determining the effectiveness of a sterilization process. When more than one device is used as the reading device 12, the devices need not be directly coupled. As a result, although the phrase “reading device” is used throughout the document as being configured to detect the effectiveness of activation and sterilization, it should be understood that such disclosure also includes when a first device, or reading device , is used to detect activation, and a second device, or reading device, is used to detect sterilization effectiveness. However, particular advantages can be found when a single device is used to detect both activation and sterilization efficacy.
[0175] As shown in figure 5, in some embodiments, the reading device 12 can process multiple biological sterilization indicators 100 in a synchronized manner without user intervention. In addition, the reading apparatus 12 can combine the incubation location and the location of the reader with a common location. The fluorescence values can be read for each well 14 independently, as shown in figures 3 to 5, in some embodiments, the reading device 12 may include an incubator block 21, which can maintain a stable and consistent temperature for incubating biological indicators sterilization tube 100 in multiple wells 14. Just as an example, the reading device 12 is illustrated as including ten wells 14 that can independently process a biological sterilization indicator 100. Each well 14 of the reading device 12 can include an area of corresponding display (for example, an LCD screen) on screen 16 of the reading device 12 to present results of sterilization biological indicator processing to a user, cavity 14 as number, time remaining, temperature, and / or other general information .
[0176] As shown in figures 3 and 4, in some embodiments, the incubator block 21 can be sized and shaped (for example, “registered”) to accommodate the shape of the sterilization biological indicator 100, or a portion of it (for example, example, the outer shape of the lower portion 114 of the sterilization biological indicator 100). Such a design of the incubator block 21 may allow for stable and consistent incubation of the biological sterilization indicator 100, which may allow stable interrogation or test results (for example, stable fluorescence readings), while still allowing the biological sterilization indicator 100 to show a unobstructed detection window 167 (for example, a flat detection window 167) for the detection / optical systems of the reading apparatus 12 (for example, the second sensor 54, described in more detail below).
[0177] In some embodiments, the incubator block 21 can be an integrally formed component, with an individual portion or section configured to interact independently with each cavity 14 of the reading device 12. In some embodiments, each cavity 14 can be equipped with its own separate and separate incubator block 21. Regardless of the mechanical configuration of incubator block 12 for the entire reading device 12, each incubator block 21 that corresponds to a cavity 14 of the reading device 12 can be operated independently of adjacent incubator blocks 21 and can be thermally isolated from such adjacent incubator blocks 21, as needed (for example, through an air gap).
[0178] In some embodiments, the reading device 12 may include three printed circuit board assemblies (MPCIs), namely, a main MPCI 45, a light-emitting diode (LED) MPCI 47 and an indicator detector MPCI biological sterilization (IBE) 49. Figure 5 shows a defect of the primary circuit modules within the main MPCI 45. The main MPCI 45 can provide the control functions for the MPCI LED 47 and the MPCI detector IBE 49, as well as screen 16 and the heater (for example, a flexible resistive heater), and can coordinate their interactions and dependencies. The heater can be thermally coupled to the incubator block 21, which can be thermally coupled to one or more wells 14 of the reading apparatus 12.
[0179] In modalities that employ ten cavities 14, the MPCI LED 47 can accommodate ten LEDs (for example, UV LEDs) - one for each cavity in the sample 14. The LEDs can serve as a source of excitation for a biological indicator sterilization unit 100. The IBE detector MPCI 49 can include first ten sensors 52, which can be used to detect the presence of a sterilization biological indicator 100 in a corresponding cavity 14, as well as the approximate position of the second portion 106 of the indicator sterilization biological 100, as described in more detail below.
[0180] As shown in figure 5, in some embodiments, the main MPCI 45 can include three microcontrollers: a main microcontroller 60, an optical microcontroller 62 and a screen microcontroller 64. The three microcontrollers 60, 62 and 63 can collectively be called “controller” 51 of the reading device 12.
[0181] Controller 51, shown schematically in figures 3 and 4, can be configured to control the various execution and processing portions of the reading device 12. Generally, controller 51 (or microcontrollers 60, 62 and 64) can be a suitable electronic device, such as a programmable logic controller (“PLC”), a microprocessor, a personal computer (“PC”), another industrial / personal computing device or combinations thereof. As such, controller 51 may include hardware and software components, and is intended to broadly cover the combination of such components. Controller 51 is only shown schematically in figures 3 and 4, but an element of common knowledge in the art will understand the various ways in which components of the reading device 12 can interact with controller 51, for example, through wired communication. or wireless. The defect of controller 51 shown in figure 5 is shown by way of example only.
[0182] The main microcontroller 60 can control an excitation driver circuit 66 to drive excitation sources, such as LEDs, in conjunction with the MPCI LED 47. The excitation driver circuit 66 can include a ten-channel constant current driver in that each channel is controlled individually, and can connect to a set of LEDs (for example, UV LEDs) on the MPCI LED 47. Each channel of the ten-channel current driver can be calibrated / normalized to accommodate channel variations to channel. The main microcontroller 60 can also detect the insertion and / or activation of biological sterilization indicators 100 by controlling IBE 73 detection circuits (for example, which may include ten circuits in modalities that employ ten cavities 14) together with the IBE 49 detector MPCI. The IBE 73 detection circuits may include a sensor, such as a proximity sensor (for example, the first 52 sensors, described in more detail below with reference to figures 3 and 4), which can allow the main microcontroller 60 to monitor the insertion or removal of biological sterilization indicators 100 in relation to a corresponding cavity 14, as well as the detection of activation of the biological sterilization indicators 100. The main microcontroller 60 can also obtain emission readings from the optical microcontroller 62; controlling the screen microcontroller 64 and communicating with a host computer 68 via Ethernet communication 69.
[0183] The optical microcontroller 62 can provide control of detection circuits 75 (for example, which can include ten circuits in modalities that employ ten cavities 14). Such detection circuits 75 can include a detector, such as a photodiode, (for example, a detector 74 of a second sensor 54, as described in greater detail below, with reference to figures 3 and 4). The optical microcontroller 62 can also provide temperature control of the incubation block 21 via a heater control 76. The heater control 76 can include a closed-loop system that monitors the temperature of the incubator block 21 and turns the block on and off incubator 21 accordingly.
[0184] Additionally, in some embodiments, the reading device 12 (for example, the optical microcontroller 62) can be adapted to minimize the effects of temperature variation on various electronic components of the reading device 12, such as the detection circuits 75 (for example, for fluorescence detection). That is, in some modalities, the temperature variations of various optical components can be determined and eliminated. In such modalities, the temperature of various optical components and / or ambient temperature can be monitored, a correction factor can be determined and the correction factor can be used to normalize the output of such optical components (for example, detectors 74 of detection circuits 75). Such adjustments can minimize the fluctuations in output that can be the result of temperature variation, and can improve the accuracy of the test results of the reading device 12 (for example, regarding sterilization efficiency).
[0185] Screen microcontroller 64 can receive information from main microcontroller 60, can generate character sets, and can display information and / or screen capture information and / or user interface 16. Screen 16 can display status information and can provide error codes for a user.
[0186] As additionally shown in figures 3 and 4, the reading apparatus 12 may include a dedicated detection system 55 associated with each of the cavities 14 of the reading apparatus 12. In some embodiments, a detection system 55 may be associated a (for example, receiving signals from, providing electromagnetic radiation to and / or generally interacting with) more than one cavity 14 of the reading apparatus 12; however, particular benefits have been observed when each cavity 14 of the reading device 12 is associated with a dedicated and independent detection system 55. The dedicated detection system 55 can include all or a portion of the IBE 73 detection circuits of the driver circuit excitation 66 and / or detection circuits 75.
[0187] In figures 3 and 4, a cavity 14, a biological sterilization indicator 100 and a detection system 55 are shown in cross section. As shown, in some embodiments, the detection system 55 may include a first sensor 52 positioned to be aligned with the signal modulation feature 153 of the first portion 104 and a second sensor 54. The first sensor 52 can be calibrated through zeroing of ambient light. In some embodiments, the first sensor 52 can be positioned to detect the presence of the biological sterilization indicator 100 in cavity 14, as well as the position of the second portion 106 of the biological sterilization indicator 100 (for example, to confirm the activation of the biological indicator of sterilization 100). In some embodiments, the second sensor 54 can be used to confirm that the sterilization biological indicator 100 has been properly positioned (for example, fully positioned) within cavity 14 (for example, to safely confirm activation), and / or for perform the detection or testing process by interrogating the lower portion 114 (or the second chamber 111 or a portion thereof) of compartment 102 for spore growth, for example, for a detectable change in the spores 115 or the liquid surrounding the spores 115. In some embodiments, the first sensor 52 alone is used to confirm activation of the biological sterilization indicator 100.
[0188] At least partially because of the design of the biological sterilization indicator 100, the cavity 14 of the reading device 12 and the second sensor 54, the entire lower portion 114 of the biological sterilization indicator 100 can be interrogated by the second sensor 54, which can result in a faster positive result (for example, spore viability failure and sterilization cycle) compared to existing systems. Each well 14 can be independently interrogated by its own corresponding dedicated detection system 55 (for example, an optical detection system). In some embodiments, the reading device 12 may include one or more dampers positioned to inhibit crosstalk between the cavities 14.
[0189] In some embodiments, the reading apparatus 12 may include a plurality of parts or elements that can be coupled to define at least a portion of the cavity 14 and / or to house the detection systems 55 (for example, which includes the first sensors 52, excitation sources 72 and detectors 74). As shown in figures 3 and 4 for example only, the reading apparatus 12 may include a first frame element 80 sized to receive the incubator block 21, and a second frame element 82 sized to receive the excitation source 72 and detector 74. As shown in figures 3, 4, 11 and 12, the first and second frame elements 80 and 82 can be configured to be coupled or to have cooperative, matching or interconnecting pieces. In addition, in some embodiments, the reading apparatus 12 may additionally include a third frame element 84, which may be coupled to at least one of the first and second frame elements 80 and 82, and particularly, which may form a cover for the second frame element 82.
[0190] As shown in figures 11 and 12, which show plans in horizontal and vertical cross section through the reading device 12 (with the biological sterilization indicator 100 not shown for clarity), in some modalities, one or more among the incubator block 21, the first frame element 80, the second frame element 82 and the third frame element 84 can include one or more protuberances, recesses or ribs that are configured to interact with a coupling part of an adjacent component (e.g. example, with one or more of the incubator 21 and the frame elements 80, 82 and 84) to form one or more dampers that are positioned between adjacent cavities 14 in order to inhibit the crosstalk of electromagnetic radiation (for example, ultraviolet light and / or visible) between the wells 14.
[0191] With reference to figures 11 and 12, in some embodiments, the incubator block 21 may include a plurality of channels 86 that extend along the upper surface, a lower surface and a lateral surface of the incubator block 21. In addition, the first frame member 80 may include a plurality of protrusions or ribs 88, each of which is sized to be received in a channel 86 of the incubator block 21. Although channel 86 and the corresponding rib 88 are shown in the illustrated embodiment as extending continuously along the three sides or edges of the incubator block 21 and the first frame member 80, it should be understood that in some embodiments, only one or more discontinuous channels 86 and ribs 88 may be required, which may be located on one or more sides or edges of the incubator block 21 and / or the first frame member 80.
[0192] Still with reference to figure 11, in some embodiments, the first frame member 80 may additionally include a plurality of channels 90 that are formed on a rear surface. The second first frame element 82 may include a plurality of protrusions or ribs 92, each of which is sized to be received in a channel 90 of the incubator block 80. The similar additional coupling between the second frame element 82 and the third element of frame 84 may also be present. Furthermore, as shown in figure 11, in some embodiments, the first frame element 80 and the incubator block 21 can at least partially define a plurality of cavities 14, and the second frame element 82 may include one or more recesses aligned with a cavity 14 that is configured to house an excitation source 72 and / or a detector 74 dedicated to the adjacent cavity 14. For example, as shown in figure 11, in some embodiments, the second frame element 82 may include a plurality of first recesses 94, each of which is adapted to accommodate at least a portion of an excitation source 72, and a plurality of second recesses 96, each of which is adapted to accommodate at least a portion of a detector 74.
[0193] Such coupling of the incubator block 21, the first frame element 80 and the second frame element 82 allows the three components to be coupled to at least partially define the cavities 14, to house at least partially the excitation sources 72 and detectors 74 in line with cavities 14, and to define a first series or plurality of dampers 85 (for example, defined by one or both channels 86 and ribs 88; see figures 11 and 12) and a second series or plurality of dampers 87 (for example, defined by one or both channels 90 and ribs 92) positioned between the cavities 14. The additional dampness can be used between the cavities 14 with corresponding structures between the second frame element 82 and the third frame element 84.
[0194] The reading apparatus 12 is shown in figures 3, 4, 11 and 12 as including an incubator block 21 and three frame elements 80, 82 and 84 to define at least partially the cavities 14 and the muffling structures between the cavities 14. However, it should be understood that only one frame element or incubator block and as many as necessary can be used to define cavities 14 and muffling structures. In addition, channels 86 and 90 and ribs 88 and 92 can be used interchangeably. For example, in some embodiments, the incubator block 21 may include a plurality of ribs 86 corresponding to channels 88 and so on. Any similar interconnecting structures can be employed to create one or more dampers 85, 87 to inhibit crosstalk between the cavities 14 without deviating from the character and scope of the present description. Additionally, in some embodiments, the reading apparatus 12 may include only a series of dampers, instead of at least two (i.e., dampers 85 and 87).
[0195] As described above, in some embodiments, sufficient closure of the second portion 106 in relation to the first portion 104 of the biological sterilization indicator (e.g., sufficient closure of the lid) may be indicative of a successful activation step. In such embodiments, the reading apparatus 12 may include means for detecting the position of the second portion 106. For example, the first sensor 52 may be positioned to detect at least one of the following: (i) when the cavity 14 corresponding to the first sensor 52 is empty, and emit a first signal; (ii) when the biological sterilization indicator 100 is positioned in cavity 14 and in the second portion 106 is in the first position 148, or at least is not in the second position 150, and emits a second signal; and (iii) when the biological sterilization indicator 100 is positioned in cavity 14 and in the second portion 106 is in the second position 150. The controller 51 of the reading apparatus 12 can receive the first signal, the second signal or the third signal, and perform various actions for signal reception.
[0196] As mentioned above, in some embodiments, the second position 150 of the second portion 106 can be any position where the seal 156, or a portion thereof, engages a portion (e.g., the upper end 157) of the first portion 104 of compartment 102. As a result, the reading apparatus 12 (for example, controller 51) may include a threshold value that the third signal would need to reach in order to align the second portion 106 as being in a “second position, ”For example, where the seal 156 is engaged and the interior of the biological sterilization indicator 100 is sealed from the environment. Such a threshold can accommodate different levels or degrees of closure of the second portion 106. For example, in some embodiments, only when only one edge (for example, a lower edge) of the second portion 106 is in line with the first sensor 52, or “ visible ”for the first sensor 52, the limit can be satisfied, the first sensor 52 can send the third signal to controller 51, and sufficient activation and seal of the sterilization biological indicator 100 can be confirmed. This could be the case, for example, when seal 156 is dimensioned (for example, it is long enough in the longitudinal direction DL of the biological sterilization indicator 100) and the limit value is controlled so that when the limit is satisfied, seal 156 is engaged. On the other hand, in modalities where the seal 156 is not engaged sufficiently when only one edge of the second portion 106 is in line with the first sensor 52, the limit value can be adjusted so that the third signal would not be sent to the controller 51 until the second portion 106 is moved further over the first portion 104 to generate a signal that meets or exceeds the limit value.
[0197] If controller 51 receives the first signal from the first sensor 52, controller 51 can output an error code or some output level to screen 16 to indicate to an operator that cavity 14 is empty. Similarly, if controller 51 receives the second signal from first sensor 52, controller 51 can issue an error code or some output level to screen 16 to indicate to an operator that a sterilizing biological indicator 100 is positioned on the respective cavity 14, but that the second portion 106 is not in the second position 150, or that the biological sterilization indicator 100 has not been activated. If controller 51 receives the third signal from first sensor 52, controller 51 may begin to initiate a spore detection and / or growth process, or the test result will be output to screen 16 without an error code.
[0198] In some embodiments, the reading device 12 can detect and generate (for example, controller 51 can emit) only the first signal (that is, cavity 14 is empty) and the third signal (that is, the indicator sterilization biological 100 is activated). In some embodiments, however, the reading apparatus 12 can generate the first signal, the second signal and the third signal. As a result, in some embodiments, the reading device 12 can generate at least two of the first signal, the second signal and the third signal.
[0199] As mentioned above, the biological sterilization indicator 100 can be activated while the biological sterilization indicator 100 is positioned in cavity 14 of the reading device 12; before being positioned in cavity 14; and / or as the biological sterilization indicator 100 is positioned in cavity 14 by lowering the second portion 106 as the biological sterilization indicator 100 becomes positioned in cavity 14. The biological sterilization indicator 100 can be activated manually (for example, before, during or after being inserted into the cavity 14 of the reading device 12), or through the use of an activation device (for example, by positioning the biological sterilization indicator 100 on a device separate from the reading device 12).
[0200] In some embodiments, if the biological sterilization indicator 100 is activated in cavity 14 or outside of cavity 14, the reading device 12 can be configured to determine whether the second portion 106 is in the second position 150, and does not start a growth process and spore test until the activation of the sterilization biological indicator 100 is confirmed. In some embodiments, however, the reading device 12 can perform the spore detection and / or growth process, but an error code or some output level can be given to a user to inform the user that the biological sterilization indicator 100 is not properly positioned in cavity 14, the biological sterilization indicator 100 has not been activated, that the spore detection and / or growth process could not be completed, that the spore detection and / or growth process could not be started , that the test result may be questionable or similar, or a combination thereof. Such error codes or outputs from the reading device 12 can be displayed on screen 16 of the reading device 12.
[0201] In some embodiments, the detection process (for example, which can be controlled by the optical microcontroller 62 and may include the operation of the detection circuits 75) to check the effectiveness of a sterilization process may employ fluorescence detection at in order to interrogate the second chamber 111, or a portion thereof. For example, as shown in figures 3 and 4, in some embodiments, the second sensor 54 can be adapted for fluorescence detection and can include at least one emitter or excitation source (for example, a light-emitting diode (LED)) 72 configured and positioned to emit electromagnetic radiation at a specific frequency or frequency range, and a detector (for example, an emissions detector, such as a photodiode) 74 configured and positioned to detect certain frequencies of electromagnetic radiation emitted from the second chamber 111, or a portion thereof. The acute angle between excitation source 72 and detector 74 is shown by way of example only; however, it must be understood that other configurations are possible, which include, but are not limited to, a right angle, an obtuse angle and a trajectory configuration that crosses (for example, 180 degrees), etc., or combinations thereof. Various filters known to those of ordinary skill in the art can be employed to achieve the desired frequency emission and / or detection. The excitation source 72 can excite several fluorescent molecules with a first frequency of electromagnetic radiation which can cause the fluorescent molecules to fluoresce and emit electromagnetic radiation at a second frequency, which can then be detected by detector 74 of the second sensor 54. Other details of fluorescence detection generally known to those of ordinary skill in the art can be employed.
[0202] As mentioned above, in some embodiments, at least a portion of the second sensor 54 can be used to confirm that the sterilization biological indicator 100 has been properly positioned (for example, completely positioned) within cavity 14. That is, in In some embodiments, as shown in figures 3 and 4, the first sensor 52 can be positioned towards the top of the cavity 14 and adjacent to a location on the biological sterilization indicator 100 where the second portion 106 will remain when in the second position 150. In In such embodiments, the first sensor 52 can detect whether an upper portion (or region) 15 of the cavity 14 is empty, but when the upper portion 15 is not empty, the first sensor 52 may not be able to confirm that a lower portion (or 17) of cavity 14 is not empty. That is, as mentioned above, in some modalities, the biological sterilization indicator 100 and cavity 14 can be “registered” in relation to each other, so that the biological sterilization indicator 100 can be positioned in cavity 14 in just one guidance. If the biological sterilization indicator 100 is positioned in the cavity 14 in an incorrect orientation (for example, incorrectly turned around the longitudinal direction DL), the first sensor 52 can detect that the upper portion 15 of the cavity 14 is not empty, but the biological sterilization indicator 100 may not be completely positioned within cavity 14. In such embodiments, the first sensor 52 may not be correctly aligned with and capable of detecting any signal modulation features 153 of the first portion 104 or of the second portion 106. In In such cases, at least a portion of the second sensor 54 can be used to confirm that the biological sterilization indicator 100 is positioned in the lower portion 17 of cavity 14. As shown in figures 3 and 4, the second sensor 54 can be positioned towards to the bottom of the cavity 14 (i.e., adjacent to the lower portion 17 of the cavity 14) and can be positioned to detect whether the lower portion 17 of the cavity 14 is is empty.
[0203] In some embodiments, as shown in figures 3 and 4, the cavity 14 can be elongated and can include a longitudinal direction. The longitudinal direction DL of the biological sterilization indicator 100 can be oriented substantially along (or substantially aligned with) the longitudinal direction of the cavity 14 when the biological sterilization indicator 100 is positioned in the cavity 14. In such embodiments, the upper portion 15 of the cavity 14 can be a first portion or longitudinal region 15, and the lower portion 17 of cavity 14 can be a second portion or longitudinal region 17 that is spaced a longitudinal distance from the first portion or longitudinal region 15.
[0204] In such embodiments, the second sensor 54 can be configured to generate a fourth signal indicative of the lower portion 17 of the cavity 14 that is empty, and a fifth signal indicative of the lower portion 17 of the cavity 14 that is not empty. In some embodiments, the second sensor 54 can be configured to generate a sixth signal indicating the presence of liquid 122 in the lower portion 114 of the sterilization biological indicator 100. Examples of systems designed to detect the presence of fluid in a specific chamber or region of the biological sterilization indicator are described in copending US application No. 61 / 408,997. In some embodiments, the second sensor 54 can be configured to generate a sixth signal (or a seventh signal, if the liquid detection function is employed) indicative of spore viability (ie, sterilization cycle failure) and a seventh signal (or an eighth signal, if the liquid detection function is used) indicative of spore death (ie, sterilization cycle success).
[0205] In modalities that use the second sensor 54 to additionally confirm the proper positioning of the biological sterilization indicator 100 in the cavity 14 in order to depend on the signal from the first sensor 52 to confirm activation, in some modalities, the reading device 12 can start a spore growth procedure (or simply not report error codes when test results are displayed) when controller 51 receives the third signal from the first sensor 52 and the fifth signal from the second sensor 54. On the other hand, the Reading 12 can prevent a test process from starting or reporting error codes when test results are displayed, when controller 51 receives the first signal or second signal from the first sensor 52 and the fourth signal from the second sensor 54. The signals from the first sensor 52 are called the “first signal,” “second signal” and “third signal,” and the signals from the second sensor 54 are called “fourth signal” and “quint the signal, ”etc. for clarity purposes only; however, it should be understood that all signal references are for clarity and simplicity only, and other signal references can be used to describe the outputs generated by the first and second sensors 52 and 54 without deviating from the character and scope of this description.
[0206] As described above, the second sensor 54 can include an excitation source 72 and a detector 74 that can be employed for fluorescence detection, for example, when testing the biological sterilization indicator 100 for spore viability. In some embodiments, the same excitation source 72 and detector 74 can be used to generate the fourth and / or fifth signals for the purposes of confirming the position of the sterilizing biological indicator 100 in cavity 14, and / or confirming the activation of the biological sterilization indicator 100. Although this configuration of the second sensor 54 is shown and described, it should be observed by those elements of common knowledge in the art that other types and configurations of sensors (for example, any described below in relation to the first sensor 52) or components can be used in the second sensor 54 for the purpose of confirming the position and / or activating the biological sterilization indicator 100.
[0207] In some embodiments, the first sensor 52 may include at least one of a photo switch (for example, transmissive and / or reflective), a capacitive sensor, another suitable proximity sensor or a combination thereof. Photo switches can detect an object that interrupts a beam of light between a sensor and a reflector (that is, reflective) or between an emitter and a reservoir (that is, transmissive). As a result, in some embodiments, the first sensor 52 may include an excitation source and a detector, similar to those described above in relation to the second sensor 54. However, in some embodiments, the excitation source and detector of the first sensor 52 may be located next to each other, for example, in the same compartment. For example, in embodiments employing a reflective photo switch, the first sensor 52 can detect the position of the second portion 106 by emitting electromagnetic radiation in a portion of the adjacent cavity 14 and capturing the reflected signal. In some embodiments, the first portion 104 and / or the second portion 106 may include one or more signal modulation features that could modify the signal emitted by the first sensor 52, so that the modulation of the reflected signal would be detected by the first sensor 52 A variety of signal modulation features can be employed with the first portion 104, the second portion 106 and / or another component of the biological sterilization indicator 100. In the embodiment shown in figures 3 and 4, the first portion 104 may include signal modulation features 153 that can be used to change the signal received by the first sensor 52 when electromagnetic radiation is reflected back to the first sensor 52.
[0208] For example only, the signal modulation features 153 are shown in the form of figures 1 to 4 as being or including the transition from plane to round, or step, 152. In some modalities, particularly those that employ sensors reflective, if the first sensor 52 emits a signal in an empty cavity 14, the signal that is reflected back to the first sensor 52 will be low, in relation to the other received signals (for example, reflected). Additionally, if the first sensor 52 emits a signal over a smooth portion (for example, a smooth flat surface or a smooth round surface) of the first portion 104 or the second portion 106, the received signal (for example, reflected) will be loud, in relation to other signs. On the other hand, if the first sensor 52 detects the transition from plane to round 152, the reflected signal received by the first sensor 52 will be intermediate, since the relatively low signal and the relatively high signal, so that the substantially and significantly different signals will be received by the first sensor 52, and will be indicative of different scenarios.
[0209] With reference to the modality of figures 3 and 4, if the cavity 14 is empty, the first sensor 52 will receive a low signal and will send the first signal to the controller 51. If the sterilization biological indicator 100 is positioned in the cavity 14, but the second portion 106 is not in the second position 150, as shown in figure 3, the first sensor 52 will receive an intermediate signal due to the fact that at least a portion of the signal emitted by the first sensor 52 will be diverted by the resources of exposed signal modulation 153 (i.e., the transition from plane to round 152) of the first portion 104. The first sensor 52 will then send the second signal to controller 51. However, if the second portion 106 has been moved to the second position 150 (or when the second portion 106 is moved to the second position 150), as shown in figure 4, the first sensor 52 will receive a high signal due to the fact that the second portion 106 will have moved by an amount and sufficient to cover or obscure the signal modulation resources 153 of the first portion 104 from being detected by the first sensor 52. When the signal modulation resources 153 are obscured by the second portion 106 and are no longer exposed or aligned with the first sensor 52 , the signal from the first sensor 52 is not diverted by the signal modulation features 153. Preferably, the first sensor 52 would receive a relatively high signal from the smooth outer surface of the second portion 106 when the second portion 106 is in the second position 150. In In such modalities, the reading apparatus 12 can be configured so that the relatively high signal results in the first sensor 52 which sends the third signal to the controller 51, due to the fact that the sterilization biological indicator 100 is positioned in the cavity 14 and the second portion 106 has been moved to the second position 150.
[0210] That is, in the embodiment illustrated in figures 1 to 4, the first portion 104 of the biological sterilization indicator 100 includes a signal modulation feature 153 that can be exposed to, accessible by, readable by and / or detectable by the device readout 12 when second portion 106 is in first position 148 (or not in second position 150), but not when second portion 106 is in second position 150 (i.e., second portion 106 obscures signal modulation features 153 when in its second position 150). As a result, in the embodiment of figures 1 to 4, the first sensor 52 can generate: a first signal when the cavity 14 is empty; a second signal that is significantly different from the first signal, based on the exposed signal modulation features 153 of the first portion 104, when the biological sterilization indicator 100 is positioned in cavity 14 and the second portion 106 of the sterilization biological indicator 100 is not it is in the second position 150, for example, it is in the first position 148 (see figure 3); and a third signal that is significantly different from the first signal and the second signal, when the biological sterilization indicator 100 is positioned in cavity 14, the second portion 106 is in the second position 150, and the signal modulation features 153 are no longer exposed (see figure 4).
[0211] Additionally or alternatively, in some embodiments, the second portion 106 may include a signal modulation feature. Figure 6 illustrates a second portion 206 of the sterilization biological indicator compartment according to another embodiment of the present description. As shown in figure 6, the second portion 206 may be similar to the second portion 106 of figures 2 to 4, except that the second portion 206 may include a signal modulation feature 253. As an example, the signal modulation 253 includes an angled inwardly extending surface, wall or deflection zone 252 located adjacent to the bottom edge of the second portion 206. That is, the angled surface 252 can be adapted to deviate slightly differently from the adjacent portions of the surface second portion 206. In some embodiments, the angled surface 252 may be called a recess. Such signal modulation feature 253 can be positioned to be picked up by the first sensor 52, for example, when the second portion 206 is in its second position.
[0212] Similarly, figure 7 illustrates a second portion 306 of the sterilization biological indicator compartment according to another embodiment of the present description. As shown in figure 7, the second portion 306 may be similar to the second portions 106 and 206, except that the second portion 306 of figure 7 may include a signal modulation feature 353. As an example, the signal modulation 353 includes an outwardly extending surface, wall or deflection zone 352 located adjacent to the bottom edge of the second portion 306. the angled surface 352 can be adapted to deviate slightly differently from the adjacent portions of the outer surface of the second portion 306. In some embodiments, the angled surface 352 may be called a protuberance, flange or protrusion. Again, such a signal modulation feature 353 can be positioned to be picked up by the first sensor 52, for example, when the second portion 306 is in its second position.
[0213] Figure 8 shows a second portion 406 of the sterilization biological indicator compartment according to another embodiment of the present description. As shown in Figure 8, in some embodiments, the second portion 406 may include a signal modulation feature 453. As an example, signal modulation features 453 include a marker 452 or other color or surface modification that has a signal that is exclusive for second portion 406, for example, an exclusively high signal or exclusively low signal (i.e., in relation to an empty cavity or a first portion of a biological sterilization indicator) for the first sensor 52 when the second portion 406 is in its second position. The marker 452 can include a color, dye and / or surface finish that produces the signal exclusively high or exclusively low, for example, in relation to a first portion of the compartment of a biological sterilization indicator. In addition or alternatively, marker 452 may include a standard, barcode, other unique identification feature for second portion 406, so that marker 452, or a portion thereof, produces the unique signal, for example, with respect to to a first portion of the biological sterilization indicator compartment. In such embodiments, a sensor (for example, the first sensor 52 of the reading device 12 of figures 1 to 5) can be configured to align with the marker 452, or a desired portion thereof, when the second portion 406 in its second closed position, so that the sensor can confirm (that is, through the signal that is exclusive to marker 452) that the second portion 406 has moved by an amount sufficient to cause a container to break, and to cause activation ( and / or sealing) of the biological sterilization indicator. In other embodiments, a first portion of the biological sterilization indicator may include such a marker that provides a unique signal when the second portion 406 is in its first position, but is obscured by the second portion 406 when the second portion 406 is in its second position .
[0214] In embodiments such as those shown in Figures 6 to 8, the second portion 206, 306, 406 may include a signal modulation feature 253, 353, 453 instead of the first portion 104 which includes a signal modulation feature, and the signal modulation feature 253, 353, 453 can be positioned on the second portion 206, 306, 406 so that the signal modulation feature 253, 353, 453 is aligned with the first sensor 52 when the second portion 206, 306, 406 is in the second position 150. In such embodiments, the first sensor 52 can generate: a first signal when the cavity 14 is empty; a second signal that is significantly different from the first signal when the biological sterilization indicator 100 is positioned in cavity 14 and the second portion 206, 306, 406 is not in the second position 150 (for example, it is in the first position 148); and a third signal that is significantly different from the first signal and the second signal, based on the signal modulation capabilities 253, 353, 453 exposed from the second portion 206, 306, 406, when the sterilization biological indicator 100 is positioned in the cavity 14 and the second portion 206, 306, 406 of the biological sterilization indicator 100 is in the second position 150. In some embodiments, as described below with reference to figure 10, both the first portion 104 and the second portion 106 may include a signal modulation, and in such embodiments, more than one first sensor 52 can be employed.
[0215] As illustrated by figures 6 to 8, the second portion 106, 206, 306, 406 can include a variety of signal modulation features (such as signal modulation features 253, 353 and 453). That is, the second portion 106, 206, 306, 406 can include any of the signal modulation features described above in relation to the signal modulation features 153 of the first portion 104 of figures 2 to 4, or a combination thereof.
[0216] The reading device 12 (for example, the first sensor 52) can be configured to capture a variety of signal modulation features of the biological sterilization indicator 100. As mentioned above, in some embodiments, the first portion 104 and / or the second portion 106 of the biological sterilization indicator 100 may include a signal modulation feature that can be detected or picked up by the reading apparatus 12, for example, to indicate whether the biological sterilization indicator 100 has been activated. However, in some embodiments, another portion of the biological sterilization indicator 100 may include a signal modulation feature that can generate a second signal and an uniquely different third signal. For example, in some embodiments, the container 120, the insert 130 and / or another portion of the biological sterilization indicator 100 may include one or more signal modulation features. Other examples of signal modulation features that can be employed are described in more detail below with reference to figures 9 and 10.
[0217] The signal modulation features 153 and, in particular, the transition from plane to round 152, which is illustrated in figures 2 to 4 is shown only as an example; however, it should be understood that a variety of signal modulation features 153 can be employed instead, or in addition to the signal modulation features 153 shown in figures 2 to 4. For example, in some embodiments, the signal modulation 153, regardless of which component of the sterilization biological indicator 100 includes, provides or is coupled with signal modulation features 153, may include, but is not limited to, a protrusion, flange, protrusion, recess, other shape change of surface or region or deflection zone, such as the transition from plane to round 152 of figures 2 to 4, an angled surface, such as angled surfaces 252 and 352 of figures 6 and 7, etc .; a marker or change in color or surface that provides an exclusively high signal or an exclusively low signal in reflection, such as marker 452 in figure 8; a surface modification, as shown in figure 9 and described below; the constitution of material or additive (for example, a metal-filled resin) that provides a unique signal; another suitable signal modulation feature; or a combination of them. A surface modification can provide deflection, absorbance, diffraction and / or diffusion of a signal, similar to other signal modulation features, and may include, but is not limited to, one or more of the engraved surfaces (for example, formed by a chemical etching process, such as plasma etching, for example, corona etching or the like), a scraped surface (for example, formed by a mechanical process (for example, an abrasion process, sandblasting, etc.), or combinations thereof) or optical (for example, laser)), a microstructured or microreplaced surface (for example, formed by a micro-replication process), a otherwise textured surface or surface finish (for example, formed by a molding or fabrication), another suitable surface modification or a combination thereof. In some embodiments, signal modulation features 153 may include an optical property (e.g., color, opacity / translucency, refractive index, etc.) that is different from adjacent regions of the biological sterilization indicator 100.
[0218] Figures 9 illustrates biological indicator of sterilization 500 according to another embodiment of the present description. The elements and characteristics corresponding to the elements and characteristics in the illustrated mode of figures 2 to 4 are provided with the same reference numbers in the 500 series. Reference is made to the description above of figures 2 and 4 in the annex for a more complete description of the characteristics and elements (and alternatives to said features and elements) of the modality illustrated in figure 9.
[0219] The biological sterilization indicator 500 includes a compartment 502 formed of a first portion 504 and a second portion 506 that are mobile relative to each other, for example, to activate (and seal) the biological sterilization indicator 500 after sterilization. The biological sterilization indicator 500 is similar to the biological sterilization indicator 100 of figures 2 to 4, except that the biological sterilization indicator 500 includes a first signal modulation feature 553 in the form of a transition from plane to round 552 and a second signal modulation feature 553 'in the form of a surface modification 552'. In particular, a modifying surface 552 'is in the form of a textured surface, but it should be understood that a variety of other signal modulation features, such as those mentioned above, can be employed as the second signal modulation feature 553' . Only as an example, the textured surface of the modality illustrated in figure 9 can be formed by a texture that is called by a molding guide, for example, MT 11010 with a D-2 finish, so that the texture is formed during the manufacturing process (e.g., molding) used to form compartment 502 and, in particular, to form the first portion 504 of compartment 502.
[0220] Such combination or multiplication of signal modulation features 553, 553 'in the first portion 504 of the sterilization biological indicator 500 can be used, for example, to ensure that the first sensor 52 receives a signal from the first portion 504 when the second portion 506 is in its first position 548 which is significantly different from the signal received from second portion 506 when second portion 506 is in its second position (not shown). In addition, in some embodiments, a modifying surface 552 'can generate a more reliable failure mode when the biological sterilization indicator 100 is incorrectly oriented in cavity 14, for example, due to the fact that the rear part of the biological sterilization indicator 100 would not generate a similar signal as the second smooth portion 106. As a result, a first sensor (for example, the first sensor 52 of the reading apparatus 12 of figures 1 to 5) would receive an intermediate signal unique to surface modification 552 '( for example, if the biological sterilization indicator 100 was incorrectly turned over in cavity 14), and a loud signal unique to the second smooth portion 106. As a result, a wrongly oriented biological sterilization indicator 100 would not generate the same signal on the first sensor as the second portion 106 in its second position, and it would be clear when the biological sterilization indicator 100 was simply incorrectly oriented in cavity 14.
[0221] Surface modification 552 'can also provide a means to minimize or inhibit the reach of ambient light in a detection chamber or region to be interrogated, from the sterilization biological indicator 500 (for example, a second chamber, such as second chamber 111 of figures 2 to 4). The surface modification 552 'is illustrated and described above only by way of example as a textured surface. However, other surface modifications that include one or more of any of the above signal modulation features can also be employed to inhibit the reaching of ambient light in certain portions of the sterilization biological indicator 500. For example, the surface modification could additionally or alternatively include a color (e.g., a dye), a reflective surface, it could be opaque, it could include other optical properties suitable to inhibit the reaching of ambient light at the entrance of the sterilization biological indicator 500, or combinations thereof.
[0222] In some embodiments, ambient light can affect testing or detection techniques, such as fluorescence detection, which are used to test the growth or viability of a source of biological activity. By modifying at least a portion of a surface (for example, an outer surface or an inner surface) of compartment 502, such ambient light can be spread and inhibited from being transmitted along the sterilization biological indicator 500 to a region that may affect test results. The configuration and location of the surface modification 552 'is shown by way of example only, and could be employed, so that when the second portion 506 of compartment 502 is in a second closed position, any ambient light around the biological indicator of sterilization 500 would find surface modification 552 'in the first portion 504 of compartment 502, and would be sufficiently spread by surface modification 552', so that ambient light is inhibited from entering the biological sterilization indicator 500 and reaches a lower portion (for example, the lower portion 114 of figures 2 to 4) or detection chamber (for example, the second chamber 111 of figures 2 to 4) of the biological sterilization indicator 500. In some embodiments, such as the embodiment shown in figure 9 , the surface modification 552 'can be positioned in the first portion 504. In such embodiments, any ambient light entering the biological sterilization indicator 500, until through any trajectory, would be spread by surface modification 552 '; for example, the light that passes through the second portion 506 (for example, if the second portion 506 is not completely opaque); the light that passes through the openings in the second portion 506, like the openings 107 of figure 2 (for example, through a barrier or filter positioned over the openings); light that passes just below the second portion 206 (for example, between the biological sterilization indicator 500 and a cavity of a reading device that the biological sterilization indicator 500 is positioned during detection); or combinations thereof.
[0223] Other similar surface modification means can be employed to inhibit the reach of ambient light in certain portions of the biological sterilization indicator 500 where such ambient light can interfere with the testing or detection processes. A method for testing whether ambient light is reaching certain portions of the biological sterilization indicator 500 may include turning off any excitation sources, such as excitation source 72 in figures 3 to 4 (for example, LEDs) from a reading device, and use a detector, such as detector 74 in figures 3 to 4, to see if any ambient light is being detected by the detector (for example, if the detector is level with a non-zero lighting condition) at a frequency (for example, the 450 nm) that can correspond and interfere with the detection process.
[0224] Figures 10 illustrates a sterilization biological indicator system 10 'in accordance with another embodiment of the present description. The sterilization biological indicator system 10 'includes a reading device 12' and a biological sterilization indicator 600. The reading device 12 'is similar to the reading device 12 of figures 1 to 4 and therefore the reading device 12 'is provided with substantially the same reference numbers as the reading device 12, with additional or different elements called the "main" symbol after the number. The elements and resources of the biological sterilization indicator 600 that correspond to elements and resources illustrated in the form of figures 1 to 4 are provided with the same reference numbers in the 600 series. Reference is made to the description above of figures 1 and 4 in annex for a more complete description of the characteristics and elements (and alternatives to said characteristics and elements) of the modality illustrated in figure 10.
[0225] The biological sterilization indicator 600 includes a compartment 602 formed of a first portion 604 and a second portion 606 that are mobile relative to each other (for example, to activate (and seal) the biological sterilization indicator 600 after sterilization) between a first position 648 (shown in dashed line) and a second position 650 (shown in solid lines). As shown in figure 10, the second portion 606 includes a signal modulation feature 653 in the form of an inwardly extending surface 652 adjacent to a bottom edge of the second portion 606 (similar to the second portion 306 of figure 6) . In addition, first portion 604 includes a signal modulation feature 653 'in the form of a transition from plane to round 652', similar to the biological sterilization indicator 100 of figures 2 to 4 described above.
[0226] The sterilization biological indicator system 10 'in figure 10 can function similarly to the biological sterilization indicator system 10 in figures 1 to 5, and may include similar components, except that the reading device 12 'includes a third sensor (or “first” additional sensor) 52'. As shown in figure 10, in some embodiments, the first sensor 52 can be positioned adjacent to the signal modulation feature 653 of the second portion 606 when the second portion 606 is in the second position 650, so that when the second portion 606 is in the first position 648, the smooth outer wall (that is, not in the region of the transition from plane to round 652 ') of the first portion 604 will show an exclusively high signal for the first sensor 52, but when the second portion 606 is in the second position 650 , the second portion 606 will obscure such an exclusively loud signal and present an exclusive signal (for example, an exclusively intermediate signal) for the first sensor 52. The third sensor 52 ', on the other hand, can be positioned to be adjacent to the modulation of signal 653 'of the first portion 604 when the biological sterilization indicator 600 is completely positioned in the cavity 14 of the reading apparatus 12', so that the modified signal the exclusive of the signal modulation feature 653 'can be detected by the third sensor 52' when the second portion 606 is in the first position 648 or in the second position 650.
[0227] In such modalities, the first sensor 52 can generate (and the controller 51 can receive): a first signal (for example, relatively low) when the cavity 14 is empty; a second signal, based on the smooth outer wall / surface of the first exposed portion 604, which is significantly different from the first signal, when the biological sterilization indicator 600 is positioned in cavity 14 and the second portion 606 is not in the second position 650 ( for example, it is in the first position 648); and a third signal, based on the signal modulation feature 653 of the second portion 206, which is significantly different from the first signal and the second signal, when the biological sterilization indicator 600 is positioned in cavity 14 and the second portion 606 is at second position 650.
[0228] In addition, the third sensor 52 'can generate (and the controller 51 can receive) a first signal (for example, relatively low) when the cavity 14 is empty; and a second signal that is significantly different from the first signal, based on the signal modulation feature 653 'of the first portion 604. In addition, the third sensor 52' will indicate when the sterilization biological indicator 600 is incorrectly positioned in cavity 14 , due to the fact that, in some embodiments, the third sensor 52 'can generate a third signal that is significantly different from the first signal and the second signal when the biological sterilization indicator 600 is turned (that is, positioned incorrectly) in the cavity 14. For example, if the biological sterilization indicator 600 was incorrectly oriented in cavity 14, the third sensor 52 'would no longer align with the signal modulation feature 653' of the first portion 604 to confirm that the biological sterilization indicator 600 is completely positioned in cavity 14, but preferably the third sensor 52 'would line up with a portion of the biological sterilizer indicator different action 600 (for example, the smooth outer wall opposite the signal modulation feature 653 ') and would produce a relatively high signal, compared to the exclusive signal of the signal modulation feature 653'. As a result, when the third sensor 52 'sends the second signal and the first sensor 52 sends the third signal to a controller 51, controller 51 can begin to initiate a spore detection and / or growth process, or the test result will be output to screen 16 without an error code.
[0229] The first sensor 52 and the third sensor 52 'can form a portion of a dedicated detection system 55' which is dedicated to the cavity 14 shown in figure 10, and which can additionally include the second sensor 54. As described above, the second sensor 54 can include excitation source 72 and detector 74, and can be used to confirm that the biological sterilization indicator 600 is fully positioned in cavity 14 (for example, to safely confirm the activation of the biological sterilization indicator 600), and / or to perform the detection or test process by interrogating the biological sterilization indicator 600 in relation to spore growth.
[0230] Although the biological sterilization indicator systems 10 and 10 ', the biological sterilization indicators 100, 500 and 600 and the second portions 106, 206, 306, 406, 506 and 606 are described above as individual modalities, it is understood that a sterilization biological indicator system of the present description can include any combination of the various features and elements described above and shown in figures 1 to 10 that put into practice the desired functions of the sterilization biological indicator system.
[0231] Additionally, although only a first sensor 52 is shown and described in relation to the reading device 12 and the biological sterilization indicator system 10, and two first sensors 52, 52 'are shown and described in relation to the reading device reading 12 'and the sterilization biological indicator system 10', it should be understood from the present disclosure that many first sensors 52 as needed can be employed to detect a variety of signal modulation features in various components of a biological indicator sterilization 100, 600 in order to confirm that the second portion 106, 606 of the sterilization biological indicator 100, 600 has moved by a sufficient amount, and to confirm the activation of the sterilization biological indicator 100, 600.
[0232] Modalities
[0233] Mode 1 is a biological sterilization indicator system, in which the system comprises:
[0234] Biological sterilization indicator comprising:
[0235] a compartment that includes
[0236] a first portion, and
[0237] a second portion adapted to be coupled to the first portion, the second portion is movable in relation to the first portion, when coupled to the first portion, between a first position and a second position; and
[0238] a container that contains a liquid and that is sized to be positioned in the compartment, at least a portion of the container is frangible, the container is positioned in at least the first portion of the compartment, the container has a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when the second portion of the compartment is in the second position; and
[0239] a reading apparatus comprising a cavity, in which the cavity is sized to receive at least a portion of the biological sterilization indicator, in which the reading apparatus is adapted to generate at least one of:
[0240] a first sign indicating that the cavity is empty,
[0241] a second sign indicating that the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position, and
[0242] a third sign indicating that the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position.
[0243] Mode 2 is a method for detecting a state of activation of a biological indicator of sterilization, in which the method comprises:
[0244] provide a biological sterilization indicator comprising:
[0245] a compartment that includes
[0246] a first portion, and
[0247] a second portion adapted to be coupled to the first portion, the second portion being movable with respect to the first portion between a first position and a second position; and
[0248] a container that contains a liquid and that is sized to be positioned in the compartment, at least a portion of the container is frangible, the container is positioned in at least the first portion of the compartment, the container has a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when the second portion of the compartment is in the second position;
[0249] providing a reading device that comprises a cavity sized to receive at least a portion of the biological sterilization indicator;
[0250] generate a first signal when the cavity is empty;
[0251] position the biological sterilization indicator in the cavity of the reading device; and
[0252] generate at least one of the following signals:
[0253] a second signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position, and
[0254] a third signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position.
[0255] Mode 3 is a biological sterilization indicator system, in which the system comprises:
[0256] a biological sterilization indicator comprising:
[0257] a compartment that includes
[0258] a first portion, and
[0259] a second portion adapted to be coupled to the first portion, the second portion is movable in relation to the first portion, when coupled to the first portion, between a first position and a second position; and
[0260] a container that contains a liquid and that is sized to be positioned in the compartment, at least a portion of the container is frangible, the container is positioned in at least the first portion of the compartment, the container has a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when the second portion of the compartment is in the second position; and
[0261] a reading apparatus comprising a cavity, in which the cavity is sized to receive at least a portion of the biological sterilization indicator, the reading apparatus is configured to detect at least one of the following conditions:
[0262] when the cavity is empty,
[0263] when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position, and
[0264] when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the second position.
[0265] Mode 4 is a method for detecting a state of activation of a biological indicator of sterilization, in which the method comprises:
[0266] provide a biological sterilization indicator comprising:
[0267] a compartment that includes
[0268] a first portion, and
[0269] a second portion adapted to be coupled to the first portion, the second portion being movable with respect to the first portion between a first position and a second position; and
[0270] a container that contains a liquid and that is sized to be positioned in the compartment, at least a portion of the container is frangible, the container is positioned in at least the first portion of the compartment, the container has a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is broken when the second portion of the compartment is in the second position;
[0271] provide a reading device that comprises a cavity sized to receive at least a portion of the biological sterilization indicator; and
[0272] detecting at least one of the following conditions:
[0273] when the cavity is empty;
[0274] when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position, and
[0275] when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position.
[0276] Mode 5 is the system or method of any mode above, wherein the first portion of the compartment includes an open end and a closed end, and where the second portion of the compartment is adapted to be coupled to the open end of the first portion of the compartment.
[0277] Mode 6 is the system or method of any mode above, in which the second position is located closer to the closed end of the first portion of the compartment than the first position.
[0278] Mode 7 is the system or method of any mode above, in which the biological indicator of sterilization is opened to the environment when the second portion of the compartment is in the first position, and in which the biological indicator of sterilization is prohibited from environment when the second portion of the compartment is in the second position.
[0279] Mode 8 is the system or method of any mode above, in which the compartment includes a longitudinal direction, and in which the second portion of the compartment is movable in the longitudinal direction in relation to the first portion between the first position and the second position.
[0280] Mode 9 is the system or method of any of the above modes, in which the container is in the first state when the second portion of the compartment is in the first position, and in which the container is in the second state when the second portion of the compartment is is in the second position.
[0281] Mode 10 is the system or method of any mode above, in which the reading device is configured to incubate the biological sterilization indicator.
[0282] Modality 11 is the system or method of any modality above, in which the second portion of the compartment is movable in relation to the first portion of the compartment when the biological sterilization indicator is positioned in the cavity of the reading device, and when the biological sterilization indicator is located outside the reading device cavity.
[0283] Mode 12 is the system or method of any mode above, in which the biological indicator of sterilization and the cavity are registered in relation to each other, so that the biological indicator of sterilization is positioned completely inside the cavity in just an orientation.
[0284] Mode 13 is the system or method of any mode above, in which the compartment includes a longitudinal direction, and in which the container is movable in the longitudinal direction of the compartment in response to the movement of the second portion of the compartment between the first position and the second position.
[0285] Mode 14 is the system or method of any mode above, in which the second portion of the compartment is in the first position during sterilization, and in which the second portion of the compartment is in the second position after activation.
[0286] Mode 15 is the system or method of any of modes 3 to 14, in which the reading device is configured to generate at least one of:
[0287] a first signal when the cavity is empty;
[0288] a second signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position; and
[0289] a third signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position.
[0290] Mode 16 is the system of any of modes 3 to 15, in which the reading device is configured to generate at least one signal, where each signal is indicative of one of the conditions detected.
[0291] Mode 17 is the method of any of the 4-16 modalities, which additionally comprises positioning the biological sterilization indicator in the cavity of the reading device.
[0292] Modality 18 is the method of any of modalities 4 to 17, which additionally comprises:
[0293] generate a first signal when the cavity is empty;
[0294] position the biological sterilization indicator in the cavity of the reading device; and
[0295] generate at least one of:
[0296] a first sign indicating when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position, and
[0297] a second sign indicating when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the second position.
[0298] Mode 19 is the system of mode 15 or the method of mode 18, in which the reading device is configured to generate an error code when the first signal or the second signal is generated.
[0299] Mode 20 is the system or method of any of the above modes, in which the reading device includes a first sensor positioned adjacent to a signal modulation feature of at least one of the first portion of the compartment and the second portion of the compartment .
[0300] Mode 21 is the system or method of any mode above, in which the reading device includes a first sensor configured to capture a signal modulation feature of the biological sterilization indicator.
[0301] Mode 22 is the system or method of Mode 21, in which at least one of the first portion of the compartment and the second portion of the biological indicator sterilization compartment includes the signal modulation feature.
[0302] Mode 23 is the system of any of the modalities 15 and 19 or the method of any of the modalities 18 to 19, in which the first portion of the biological sterilization indicator compartment includes a signal modulation feature, and wherein the second signal is at least partially determined by the signal modulation feature of the first portion of the compartment.
[0303] Modality 24 is the system of any one of the modalities 19 and 23 or the method of any one 23 of the modalities 18 to 19, in which the first portion of the biological sterilization indicator compartment includes a modulation feature of signal, and where the third signal is at least partially determined by the signal modulation feature of the first portion of the compartment.
[0304] Mode 25 is the system or method of any of the above modes, in which the first portion of the sterilization biological indicator compartment includes a signal modulation feature that is exposed to the reading device when the second portion of the compartment is in the first position and is not exposed to the reading device when the second portion of the compartment is in the second position.
[0305] Mode 26 is the system or method of any mode above, in which the reading device includes a first sensor configured to generate a first signal when a cavity is empty, and in which the first portion of the biological indicator compartment Sterilization includes a signal modulation feature that is exposed to the first sensor when the second portion of the compartment is in the first position and obscured by the second portion when the second portion is in the second position, so that the first sensor generates:
[0306] a second signal, based on the signal modulation feature, when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position, which is different from the first signal, and
[0307] a third signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position, which is different from the first signal and the second signal.
[0308] Mode 27 is the system or method of mode 25 or 26, where the signal modulation feature in the first portion of the sterilization biological indicator compartment includes a transition area from plane to round on an external surface of the first portion of the compartment.
[0309] Modality 28 is the system or method of any of the modalities 25 to 27, in which the signal modulation feature in the first portion of the sterilization biological indicator compartment includes at least one protrusion and a recess.
[0310] Mode 29 is the system or method of any of modes 25 to 28, in which the signal modulation feature in the first portion of the biological sterilization indicator compartment includes a marker attached to an external surface of the first portion the compartment.
[0311] Mode 30 is the system or method of any of modes 25 to 29, in which the signal modulation feature in the first portion of the sterilization biological indicator compartment includes a surface modification on an external surface of the first portion of the compartment.
[0312] Modality 31 is the system or method of any of the modalities 25 to 30, in which the signal modulation feature in the first portion of the compartment is a first signal modulation feature, and in which the second portion of the compartment includes a second signal modulation feature that is exposed when the second portion of the compartment is in the second position.
[0313] Mode 32 is the system or method of mode 29, in which the first signal modulation feature is different from the second signal modulation feature.
[0314] Modality 33 is the system or method of any modality above, in which the second portion of the sterilization biological indicator compartment includes a signal modulation feature that is exposed to the reading device when the second portion of the compartment is in the second position and is not exposed to the reading device when the second portion of the compartment is in the first position.
[0315] Mode 34 is the system or method of any mode above, in which the reading device includes a first sensor configured to generate a first signal when a cavity is empty, and in which the second portion of the biological indicator compartment Sterilization includes a signal modulation feature that is exposed when the second portion of the compartment is in the second position, so that the first sensor generates:
[0316] a second signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position which is different from the first signal, and
[0317] a third signal, based on the exposed signal modulation feature, when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position, which is different from the first signal and the second signal.
[0318] Modality 35 is the system or method of modality 33 or 34, in which the signal modulation feature in the second portion of the sterilization biological indicator compartment includes at least one protrusion and a recess.
[0319] Modality 36 is the system or method of any of the modalities 33 to 35, in which the signal modulation feature in the second portion of the sterilization biological indicator compartment includes a marker.
[0320] Mode 37 is the system or method of any of modes 33 to 36, in which the signal modulation feature in the second portion of the sterilization biological indicator compartment includes an optical property.
[0321] Modality 38 is the system or method of any of the modalities 33 to 37, in which the signal modulation feature in the second portion of the biological sterilization indicator compartment includes a surface modification.
[0322] Mode 39 is the system or method of any mode above, in which the reading device includes a first sensor positioned adjacent to the cavity, in which the first sensor is configured to generate at least one of the first signal, the second signal and the third signal.
[0323] Mode 40 is the system or method of mode 39, in which the reading device includes a second sensor configured to generate at least one signal indicating whether the biological sterilization indicator is completely positioned in the cavity.
[0324] Mode 41 is the system or method of any mode above, in which the reading device includes:
[0325] a first sensor positioned adjacent to a first region of the cavity, in which the first sensor is configured to generate at least one of:
[0326] a first sign indicating the first region of the cavity is empty,
[0327] a second sign indicating that the biological sterilization indicator is positioned in the first region of the cavity with the second portion of the compartment in the first position, and
[0328] a third sign indicating that the biological sterilization indicator is positioned in the first region of the cavity with the second portion of the compartment in the second position; and
[0329] a second sensor positioned adjacent to a second region of the cavity, in which the second sensor is configured to generate at least one of:
[0330] a fourth sign indicating that the second region of the cavity is empty, and
[0331] a fifth sign indicating that the biological sterilization indicator is positioned in the second region of the cavity.
[0332] Mode 42 is the system or method of mode 41, in which the reading device is configured to generate an error code when the second sensor generates the fourth signal.
[0333] Mode 43 is the system or method of mode 41 or 42, in which the reading device is configured to generate an error code when the first sensor generates the first signal or the second signal, and the second sensor generates the fifth sign.
[0334] Mode 44 is the system or method of any of modes 41 to 43, where the first region of the cavity is an upper region, and where the second region of the cavity is a lower region.
[0335] Mode 45 is the system or method of any of modes 41 to 44, where the first region of the cavity is a first longitudinal region of the cavity, and where the second region of the cavity is a second longitudinal region of the cavity, spaced by a longitudinal distance from the first region.
[0336] Mode 46 is the system or method of any of modes 20, 21 and 26 to 45, in which the first sensor includes a photo switch.
[0337] Mode 47 is the system or method of any of modes 40 to 46, wherein the second sensor comprises a fluorescence detection system that includes an excitation light source and a detector.
[0338] Mode 48 is the system or method of any of modes 40 to 46, in which the second sensor includes a photo switch.
[0339] Mode 49 is the method of any of the modes 2, 4 to 14 and 17 to 48, which additionally comprises moving the second portion of the compartment from the first position to the second position to activate the biological sterilization indicator.
[0340] Mode 50 is the method of mode 49, in which the movement of the second portion of the compartment from the first position to the second position occurs before the positioning of the biological sterilization indicator in the cavity, so that the first signal is generated before if the biological sterilization indicator is positioned in the cavity, and when the biological sterilization indicator is positioned in the cavity, the third signal is generated and the second signal is not generated.
[0341] Mode 51 is the method of mode 49, in which the movement of the second portion of the compartment from the first position to the second position occurs after the positioning of the biological sterilization indicator in the cavity, so that the first signal is generated before if the biological sterilization indicator is positioned in the cavity, and when the biological sterilization indicator is positioned in the cavity, the second signal is generated, and when the second portion of the compartment is moved to the second position, the third signal is generated.
[0342] Mode 52 is the method of any of the modes 18 to 19, 23 to 24 and 39 to 40 in which the generation of the first signal, the second signal and the third signal is performed by a first sensor of the reading positioned adjacent to a first region of the cavity, wherein the reading apparatus additionally includes a second sensor positioned adjacent to a second region of the cavity, and which further comprises generating at least one of the following signals with the second sensor:
[0343] a fourth sign indicating that the second region of the cavity is empty, and
[0344] a fifth sign indicating that the biological sterilization indicator is present in the second region of the cavity.
[0345] Mode 53 is the system of any of modes 15, 19, 23 to 24 and 39 to 40, in which the reading device is configured to generate the first signal and the third signal only.
[0346] Mode 54 is the system of any of modes 15, 19, 23 to 24 and 39 to 40, in which the reading device is configured to generate at least two of the first signal, the second signal and the third signal.
[0347] Mode 55 is the system or method of any of the above modes, in which at least a portion of the biological sterilization indicator compartment includes a surface modification.
[0348] Mode 56 is a biological sterilization indicator system in which the system comprises:
[0349] an office;
[0350] a container that contains a liquid and that is sized to be positioned in the compartment, at least a portion of the container is frangible, the container has a first state in which the container is intact and the liquid is not in fluid communication with a interior of the compartment and a second state in which the container is broken and the liquid is in fluid communication with the interior of the compartment;
[0351] a first chamber in the compartment in which the container is positioned when the container is in the first state; and
[0352] a second chamber in the compartment in which the container and liquid are not positioned when the container is in the first state, the second chamber comprises a source of biological activity that is not in fluid communication with the liquid when the container is in the first state and that is in fluid communication with the liquid when the container is in the second state; and
[0353] in which at least a portion of the compartment includes a surface modification positioned to inhibit the reaching of ambient light in the second chamber of the biological sterilization indicator.
[0354] Modality 57 is the biological indicator of sterilization of modality 56, in which the surface modification includes a textured surface.
[0355] Mode 58 is the biological indicator of sterilization of mode 56 or 57, where the compartment of the biological indicator of sterilization includes:
[0356] a first portion, and
[0357] a second portion adapted to be coupled to the first portion, the second portion is movable in relation to the first portion, when coupled to the first portion, between a first position and a second position; and
[0358] wherein the first portion of the compartment includes the surface modification.
[0359] Modality 59 is the biological indicator of sterilization of modality 58, in which the surface modification is located in an upper portion of the first portion of the compartment.
[0360] Modality 60 is the biological indicator of sterilization of any of the modalities 56 to 59, in which the surface modification is configured to spread ambient light.
[0361] Mode 61 is the biological indicator of sterilization of any of the modalities 56 to 60, in which the surface modification is positioned to inhibit the reach of ambient light in the second chamber of the biological sterilization indicator when the biological sterilization indicator is positioned in a cavity of a reading device.
[0362] The modalities described above and illustrated in the figures are presented by way of example only, and are not intended to limit the concepts and principles of this description. Consequently, it will be appreciated by one skilled in the art that various changes to the elements and their configurations and arrangements are possible without departing from the spirit and scope of this description. Various features and aspects of the present description are set out in the following claims.

权利要求:
Claims (15)
[0001]
1. Biological sterilization indicator system CHARACTERIZED by the fact that the system comprises: a biological sterilization indicator comprising: a compartment that includes a first portion, and a second portion adapted to be coupled to the first portion, the second portion being movable in in relation to the first portion, when coupled to the first portion, between a first position and a second position; and a container containing a liquid and being sized to be positioned in the compartment, at least a portion of the container being frangible, the container positioned in the at least first portion of the compartment, the container having a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is fractured when the second portion of the compartment is in the second position; and at least one signal modulation feature located in at least one of the first and second portion of the compartment, at least one signal modulation characteristic positioned to be detectable to indicate when the second portion of the compartment is in the first position or in the second position; and a reading device comprising: a cavity, the cavity sized to receive at least a portion of the biological sterilization indicator, a first sensor located adjacent to the cavity and positioned to detect when the cavity is empty and to detect at least one modulation feature signal from the biological sterilization indicator to determine the position of the second portion of the compartment in relation to the first portion of the compartment when the biological sterilization indicator is positioned in the cavity.
[0002]
2. Method for detecting an activation state of a biological sterilization indicator CHARACTERIZED by the fact that the method comprises: providing a biological sterilization indicator comprising: a compartment that includes a first portion, and a second portion adapted to be coupled to the first portion, the second portion being movable with respect to the first portion between a first position and a second position; and a container containing a liquid, at least a portion of the container being frangible, the container positioned in at least the first portion of the compartment, the container having a first state in which the container is intact when the second portion of the compartment is in the first position, and a second state in which the container is fractured when the second portion of the compartment is in the second position; at least one signal modulation feature located in at least one of the first and second portion of the compartment, at least one signal modulation characteristic positioned to be detectable to indicate when the second portion of the compartment is in the first position or the second position; and providing a reading apparatus comprising a cavity sized to receive at least a portion of the biological sterilization indicator; and detecting, with the reading device, when the cavity is empty, and detecting at least one signal modulation characteristic of the biological sterilization indicator with the first reading device sensor to determine the position of the second portion of the compartment in relation to the first portion of the compartment when the biological sterilization indicator is positioned in the cavity.
[0003]
3. System, according to claim 1, CHARACTERIZED by the fact that the biological sterilization indicator and the cavity are combined in relation to each other, so that the biological sterilization indicator is positioned completely inside the cavity in just one orientation .
[0004]
4. System, according to claim 1 or 3, CHARACTERIZED by the fact that the reading device is configured to generate: a first signal when the cavity is empty, and at least one among: a second signal when the biological indicator of sterilization is positioned in the cavity and the second portion of the compartment is in the first position; and a third signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position.
[0005]
5. Method, according to claim 2, CHARACTERIZED by the fact that it also comprises: generating a first signal when the cavity is empty; position the biological sterilization indicator in the cavity of the reading device; and generate at least one of them: a second signal indicating when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the first position, and a third signal indicating when the biological sterilization indicator is positioned in the cavity with the second portion of the compartment in the second position.
[0006]
6. System, according to claim 4, CHARACTERIZED by the fact that the reading device is configured to generate an error code when the first signal or the second signal is generated.
[0007]
7. System according to claim 1, 3, 4 or 6, CHARACTERIZED by the fact that the first portion of the sterilization biological indicator compartment includes a signal modulation feature that is exposed to the reading device when the second portion the compartment is in the first position and is not exposed to the reading device when the second portion of the compartment is in the second position.
[0008]
8. System according to claim 1, 3, 4, 6 or 7, CHARACTERIZED by the fact that the reading device includes a first sensor configured to generate a first signal when the cavity is empty, and in which the first portion The sterilization biological indicator compartment includes a signal modulation feature that is exposed to the first sensor when the second portion of the compartment is in the first position and obscured by the second portion when the second portion is in the second position, so that the first sensor generate: a second signal, based on the signal modulation characteristic, when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position, which is different from the first signal, and a third signal when the indicator sterilization biological is positioned in the cavity and the second portion of the compartment is in the second position, which is different from the first signal and the second signal l.
[0009]
9. System according to claim 7 or 8, CHARACTERIZED by the fact that the signal modulation feature in the first portion of the sterilization biological indicator compartment includes a transition area from plane to round on an external surface of the first portion the compartment.
[0010]
10. System according to any one of claims 7 to 9, CHARACTERIZED by the fact that the signal modulation characteristic in the first portion of the sterilization biological indicator compartment includes at least one of: a protuberance, a recess, a marker coupled to an external surface of the first portion of the compartment, and a surface modification on an external surface of the first portion of the compartment.
[0011]
11. System according to any one of claims 7 to 10, CHARACTERIZED by the fact that the signal modulation feature in the first portion of the compartment is a first signal modulation characteristic, and in which the second portion of the compartment includes a second signal modulation feature that is exposed when the second portion of the compartment is in the second position.
[0012]
12. System according to claim 1, 3, 4, 6, 7, 8, 9, 10 or 11, CHARACTERIZED by the fact that the second portion of the biological sterilization indicator compartment includes a signal modulation feature that it is exposed to the reading device when the second portion of the compartment is in the second position and is not exposed to the reading device when the second portion of the compartment is in the first position.
[0013]
13. System according to claim 1, 3, 4, 6, 7, 8, 9, 10 or 11, CHARACTERIZED by the fact that the reading device includes a first sensor configured to generate a first signal when a cavity is empty, and the second portion of the compartment includes a signal modulation feature that is exposed when the second portion of the compartment is in the second position, so that the first sensor generates: a second signal when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the first position which is different from the first signal, and a third signal, based on the exposed signal modulation characteristic, when the biological sterilization indicator is positioned in the cavity and the second portion of the compartment is in the second position, which is different from the first sign and the second sign.
[0014]
14. System according to claim 12 or 13, CHARACTERIZED by the fact that the signal modulation characteristic in the second portion of the sterilization biological indicator compartment includes at least one of: a protuberance, a recess, a marker, a optical property, and a surface modification.
[0015]
15. System, according to claim 1,3,4,6,7,8,9,10,11,12,13 or 14, CHARACTERIZED by the fact that the reading device includes: a first sensor positioned adjacent to a first region of the cavity, the first sensor configured to generate at least one of: a first signal indicating the first region of the cavity that is empty, a second signal indicating that the biological sterilization indicator is positioned in the first region of the cavity with the second portion of the compartment in the first position, and a third sign indicating that the biological sterilization indicator is positioned in the first region of the cavity with the second portion of the compartment in the second position; and a second sensor positioned adjacent to a second region of the cavity, the second sensor configured to generate at least one of: a fourth signal indicating that the second region of the cavity is empty, and a fifth signal indicating that the biological sterilization indicator is positioned in the second region of the cavity.

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同族专利:

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JP2014502856A|2014-02-06|

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US9410180B2|2016-08-09|

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BR112013008703A2|2016-06-21|

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CA2816085C|2019-03-05|

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法律状态:
2018-04-03| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-05-28| B06T| Formal requirements before examination|

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2019-12-17| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

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2020-04-14| B09A| Decision: intention to grant|

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2020-10-27| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/10/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US40904210P| true| 2010-11-01|2010-11-01|

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US61/409,042|2010-11-01|

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PCT/US2011/058262|WO2012061229A1|2010-11-01|2011-10-28|Biological sterilization indicator system and method|

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