巴西专利BR112012027616B1 device for a biological liquid treatment plant

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专利摘要:
DEVICE FOR A BIOLOGICAL LIQUID TREATMENT INSTALLATION. The invention relates to a device consisting of a base (2) and a door (20), said device having a closed door position in which the circuit (8) of the device consists of a bag (10) containing two flexible films (65.66) and guiding network connectors (11), and a press (9) consisting of a first housing (16) placed on the front face (5) of said base (2) and a second housing (17 ) placed on said door (20); and a hinge system that rotates the door (20) in relation to said base (2), and placed only on one side of said door (20) to form the lateral spaces between said door (20) and said base ( 2) over the rest of the perimeter of said door (20).
公开号:BR112012027616B1
申请号:R112012027616-6
申请日:2011-06-03
公开日:2020-10-27
发明作者:Sébastien Cirou；René Reinbigler；Virginie Buisson；Jean-Louis Weissenbach
申请人:Emd Millipore Corporation；
IPC主号:

专利说明:

[0001] The invention relates to a device for a biological liquid treatment plant, especially, but not exclusively, for the purification of a biopharmaceutical liquid, to obtain products, such as monoclonal antibodies, vaccines or recombinant proteins.
[0002] It is known that biopharmaceutical liquids in general are obtained by culture in a bioreactor and that they must be treated to obtain the required characteristics of purity, concentration, absence of viruses, etc.
[0003] Purification is carried out through a succession of treatments, such as clarification, to eliminate residues from the culture of the bioreactor, and viral filtration sometimes followed by diafiltration and concentration through tangential flow filtration (TFF). There are other operations related to purification, such as chromatography.
[0004] A number of types of containers containing liquids can be connected at the entrance of the circuit, such as the source container that contains the product to be treated, but also containers that contain a cleaning liquid, such as sodium hydroxide, rinsing, such as pure water or a buffer liquid, such as saline. In addition to the container for collecting the treated liquid, several other containers for collecting cleaning liquid, rinsing or buffer solution, or for collecting waste can be connected at the outlet of the circuit.
[0005] In a production context, liquid treatments can only be performed in sequence, the collection container for the first treatment potentially becoming the source container for the next treatment, and so on, until performed the last treatment.
[0006] These treatments are conventionally carried out in exclusive installations consisting of stainless steel pipes and other parts, such as tanks or filter housings, which require operations before and after the actual treatment, which are relatively expensive, especially in cleaning operations after use.
[0007] In recent years, these treatments have been performed alternatively in installations where the components in contact with the liquid are single-use components.
[0008] The invention aims to produce a device that allows simple, economical and convenient implementation of treatments for biological liquids.
[0009] For this purpose, the invention relates to a device for a biological liquid treatment installation consisting of: - a base having a front face; - a movable or removable door, said device having the door closed position; - in the closed door position, the circuit consists of a plurality of connectors and a network for directing the liquid between said connectors, whose circuit consists of a bag containing two flexible films and the said network connectors, whose the circuit also consists of a press containing a first housing placed on said front face of said base and a second housing placed on said door; and - a hinge system rotating said door in relation to said base, said hinge system being placed only on one side of said door to form, in the closed door position, lateral spaces between said door and said base to the along the rest of the perimeter of said door, to allow free access to the connectors of said bag.
[0010] Due to the invention, it is possible to connect the connectors of the circuit bag very simply and quickly to the treatment components around it.
[0011] To be exact, in addition to the device according to the invention, the biological liquid treatment installation consists, depending on the treatments performed, of one or more other devices, for example, superimposed on the device according to the invention.
[0012] This or these other devices are provided with those treatment components around them mentioned above, formed especially by one or more pumps, for example, of the diaphragm type, and / or by a source container containing the product to be treated and / or by a container for collecting the treated liquid and / or by a chromatography column, these treatment components around each being connected in the bag, directly or not.
[0013] Depending on the arrangement of the hinge system that allows the support of the door in relation to the base only on one side of the door, the lateral spaces are advantageously formed over most of the external perimeter of the door, between that door and the base .
[0014] Therefore, the circuit bag may contain connectors that come out of most of its external space with free access to it due to the lateral spaces, for the connection of pipes in it coming from the treatment components to its (pumps and / or containers and / or column).
[0015] In addition, due to the lateral spaces formed according to the invention, the routing of the pipes that connect the circuit to the treatment components around it is simplified, while preventing the pipes from passing in front of the door.
[0016] As a result of the invention, it is also possible to change the bag very simply and very quickly, and if necessary, the first carcass and the second carcass, to carry out a new treatment, of the same type or of a different type.
[0017] To be exact, for this purpose it is sufficient to activate the passage from the closed door position to the other position, that is, to open or remove the door of the device, to remove the bag, before or after disconnecting the tubes from the surrounding treatment components and which were previously connected to the connectors coming out of the bag, and then, if necessary, remove the first and second housings, respectively, from the base and the door. Finally, it is sufficient to install the first and second housings in the device, as well as a bag for the second treatment, to control the passage from the other position to the closed door position, and connect the tubes to the connectors that come out of the bag.
[0018] When the door is movable in relation to the base, it is sufficient to first open it and then close it again on the base.
[0019] When the door is removable, it is sufficient to first remove it and then place it back on the base.
[0020] In this way, it is possible to move from a first treatment, for example, a tangential filtration treatment, to a second treatment of another type, for example, a chromatography treatment, in a simple, economical, convenient and efficient.
[0021] It is clear that when the next treatment is different from the previous one, the bag and the first and the second carcasses for the second treatment have characteristics (ducts of the targeting network, connectors) that are different from the bag and the first and second carcasses previous treatment, to form a circuit adapted to the next treatment.
[0022] The invention, in addition, makes it possible to have a device provided with a base and a single door for the execution of different types of treatments, through a modular circuit in which the modules (bag, first and second) second carcasses) are interchangeable, depending on the treatments to be performed.
[0023] Optionally, said hinge system consists of a single hinge placed in a corner of said door, and said hinge being constituted by a first hinge portion connected in said corner of said door and a second hinge portion connected on the side face of said device, whose side face is connected to said front face.
[0024] Also optionally, the axis of said hinge is compensated by a joint plane formed between said first housing and the second housing in the closed door position.
[0025] According to the preferred, simple, convenient and economical typical characteristics of the device according to the invention: - said base of said device is constituted, on its front face, of a console that forms an inclined chassis on the which the first housing is placed, whose chassis consists of clamping jaws, and the first housing contains pins placed on said clamping jaws; - said device contains a first locking system for fixing said second housing on a support of said door, whose first locking system consists of: - at least one lever device placed on said support; - at least one spring placed on said support; - at least one rod connected to at least said lever device by a first end and to at least one spring by a second end which is at an end opposite the first end, said at least one rod being constituted by at least one screw locking and having an unconnected position and an on position; and - at least one lock stop placed in a recess of said second housing; - said at least one lever device being configured to actuate the passage of said at least one rod between its closed position and its non-closed position; said at least one spring being configured to actuate the passage of said at least one rod between its unopened position and its closed position; and - said at least one locking screw being mounted on said at least one lock stop in the closed position of said rod and being removed from said at least one lock stop in the unopened position of said rod; - said device being constituted by a second locking system configured in such a way that it fixes said first frame and said second frame when said door is in the closed door position; - said second housing has a first orifice, said bag being constituted by at least a second opening in a treatment zone of said liquid, and said second locking system being constituted by at least one ball locking pin provided with a body, a head and spheres and having a state of not closed and a state of closed, said ball locking pin being pressed against said first housing, said head passing through said first housing and said second opening emerging in said first hole of said second housing in the closed door position, said balls entering said head in said unclosed state of said pin and being projected from said head in said closed state of said pin; - said circuit containing the necessary instruments for the treatment of said biological liquid, especially valves, to allow and prevent the passage of said liquid in said ducts, and / or sensors of physicochemical values of said liquid, and said instruments being integrated in said first housing; - said first housing being constituted by a first connector at the rear, and said base of said device being constituted by a second connector configured in such a way that it is connected in said first connector to drive said instruments integrated in said first housing ; - said front face of said base being constituted by a support provided with an opening, and said second connector is configured in such a way that it passes through said opening to connect to said first connector; - in the closed door position, said bag is attached between the first and the second carcasses in a state in which the ducts of the said network for directing the liquid are formed between said films. - said device has a position in addition to said closed door position, in which said bag is supported only by the first housing; - the two said flexible films of said bag are joined with each other and delimit an area for the treatment of said liquid according to a closed contour, said connectors of the targeting network emerging from the internal part and the external part at least one side of said closed contour; - said bag containing the first openings on one side of said bag for its installation, and said first housing containing charges for hanging said bag, which pass through said first openings of said bag; and - said bag containing at least a third opening on one side of said bag, said first housing containing at least one pin and said second housing containing at least a second hole, where, in the closed door position, said by at least one pin passes through said third opening of said bag and said at least one second orifice receives said pin from said first housing.
[0026] The presentation of the invention will now be continued with the description of the realizations, presented below for illustrative purposes and non-limiting example, with reference to the attached drawings, in which: - figure 1 is a perspective view of a device for an installation treatment of biological liquid according to a first example of carrying out the invention, without the bag: - figure 2 is a view similar to figure 1, with the bag; figure 3 is a view on the right side of the device, with a right side panel partially turned; figure 4 is a view from the left side of the device, in the closed door position; figure 5 is a sectional view showing a hinge system that connects the door to a base of the device; figure 6 is a view from inside the door, alone, without the second frame, and showing the locking system of that second frame on that door; - figures 7 and 8 are sectional views in VII-VII of figure 2, showing the locking system of the second frame on the door, respectively, in the closed and closed state; figures 9 and 3 are sectional views, respectively in IX-IX and X-X of figures 7 and 8, respectively; figure 11 is an isolated perspective view of the system for fixing the first and second housings together; figures 12 and 13 are sectional views showing partially the first and second housings, with the locking system in the non-closed and closed states respectively; figure 14 is a rear view of the first housing, with the rear panel removed; figure 15 is a view similar to figure 14, with the rear panel; figure 16 is a partial view of the front of the device, with the first housing removed; Figures 17 and 18 are partly sectioned views of the device, showing diagrammatically the male and female connectors in the unconnected and connected state respectively; figure 19 is a diagrammatic view of the biological liquid treatment circuit of the installation; and - figure 20 is a perspective view of the bag;
[0027] Figures 1 and 2 illustrate a device 1 for a biological liquid treatment installation (not shown).
[0028] Device 1 has a generally parallelepiped shape.
[0029] This device 1 is composed of a base 2 having a first side face 3, a second side face 4 that is opposite the first side face 3, a front face 5 that joins the first and second side faces 3 and 4, and a rear face 6 which is opposite the front face 5 and which joins the second side faces 3 and 4.
[0030] The device 1 also consists of a circuit 8 provided with a press 9 and a bag 10, which contains a number of connectors 11 for liquid and a network 12 for directing the liquid between those connectors 11 of which can be seen ducts 13 in figure 2.
[0031] Press 9 contains two housings 16 and 17, each formed from a solid block of rigid material.
[0032] Here, housings 16 and 17 are made of polyoxymethylene (POM), also called acetal, and each of them, generally, has a parallelepiped shape.
[0033] The housing 16 is mounted on the front face 5 of the base 2.
[0034] The device 1 also consists of a port 20 connected to the base 2.
[0035] Frame 17 is mounted on that door 20.
[0036] Device 1 has a closed door position in which door 20 is closed and covers housing 16, and another position in which bag 10 is supported only by housing 16.
[0037] In this other position, frame 17 is separated from frame 16.
[0038] In the closed door position, bag 10 is inserted between the two housings 16 and 17.
[0039] Device 1 is placed on the bottom, with a closed receptacle 186 which is intended to receive one or more tanks (not shown) containing a sachet, whose tanks form, for example, a container to collect treated liquids, or a tailings container.
[0040] This receptacle 186 is closed by a sliding panel 7 placed on the front face 5 of the device 1, whose panel 7 is adapted to be moved in translation downwards and then towards the rear of the device 1 (see the arrows in the figure 1) to insert and remove the tanks.
[0041] A control panel 14 is placed on top of the front face 5 of device 1.
[0042] This control panel 14 is provided with a graphic touch interface 15 that allows the biological liquid treatment process to be checked and controlled.
[0043] This control panel 14 is therefore placed at a height that allows a user to use it.
[0044] To facilitate movement, device 1 is in the form of a cart mounted on four casters 18 (three of which can be seen in figure 1), with two casters located under the front face of the device 5 that constitute a brake 19 , and with the device 1 furthermore having two handles 21 on the respective opposite sides of the front face 5, in the vicinity of the respective side faces 3 and 4.
[0045] Device 1 consists of a chassis 25 on its front face 5.
[0046] As can be seen more specifically in figure 3, this chassis 25 is tilted.
[0047] The chassis 25 has an external perimeter and an internal perimeter that are delimited on four sides, of which the left side 140 (visible in figure 16) and a right side 141 which are opposite sides, and a top side 143 and a bottom side 142 (visible in figure 16) which are opposite sides.
[0048] The left sides 140 and right sides 141 each contain two claws 26 in the form of L that emerge from the respective side and extend upwards.
[0049] A support plate 27 is attached to the right side 141 of the chassis 25, between the two fixing claws 26.
[0050] This support plate 27 is placed in the immediate vicinity under the fixing claw 26 located higher on the right side 141, to allow free access to the hanging claw 26 which is located on that same right side 141.
[0051] The support plate 27 contains two fixation heads 28 on which a platform (not shown) is adapted to be fixed to be placed on it instruments that may be necessary for the treatment of the biological liquid.
[0052] These instruments, for example, may be optional sets, such as sensors for measuring pH or conductivity and are chosen by the user according to the type of treatment to be performed.
[0053] The base 2 of the device 1 is still constituted by the devices 29, which, with the complementary devices 40 of the door 20, allow the placement and fixation of that door 20 in the closed door position.
[0054] There are three of the devices 29, which are placed in the corners of the chassis 25, respectively on the top right side, on the right side of the bottom, and on the left side of the bottom, as can be seen especially in figures 1 and 2.
[0055] These devices 29, each one consists of a body, and an annular shoulder (not shown) a head connected to that annular shoulder, that head having the shape of a conical tube (figures 1 and 2) and being supplied internally with a rod 30 with a tapered tip. The body consists of a pneumatic chamber, a piston that is mechanically connected with the rod 30 with a conical tip, whose rod 30 is adapted to be extended inside the head.
[0056] As can be seen in figures 1 to 3, the door 20 consists of a support 35 having a generally rectangular configuration.
[0057] This support 35 has a first side 36, a second side 37 that is opposite the first 36, a third side 38 that joins the first and second sides 36 and 37 and a fourth side 39 that is an opposite side to the third side 38 and that joins the first and second sides 36 and 37.
[0058] The support 35 contains three complementary devices 40 adapted to cooperate with the devices 29 of the base 2, whose complementary devices 40 are located, respectively, in the upper left, bottom left, and right bottom, as seen in the figures 1 to 3.
These complementary devices 40 are provided with a first cylindrical portion 155 and a second cylindrical portion 156 which is hollow and is connected with the first portion 155 by a shoulder 157 (figure 16). This second portion 156 has a smaller diameter than the diameter of the first portion 155. In addition, the second portion 156 is provided with 3 openings 158 on its outer surface.
[0060] These complementary devices 40 are still constituted by 3 spheres (not shown) each one being able to be projected from the second portion 156, passing through a respective opening 158.
[0061] In the closed door position, each second portion 156 of a respective complementary device 40 of the door 20 is inserted in a respective head of a respective device 29 of the base 2.
[0062] The devices 29 and the complementary devices 40 form, in pairs, a system of ball clamping pins supplied with a pneumatic lever device of the type of double action with a spring (not shown), having an extended position and a stowed position, the operation for which it is well known.
[0063] The rod 30 of the device 29 is adapted to be inserted into the second hollow cylindrical portion 156 when the lever device is in its extended position.
[0064] In this position of the lever system, the rod 30 pushes the balls until each one passes through an opening 158, thereby blocking the movement of the door 20 in relation to the base 2.
[0065] The device 1 also consists of a hinge system through which the door 20 is rotated on the base 2.
[0066] This hinge system is provided with a single hinge 42 containing a first hinge portion 43 attached to the top right corner of the support 35 of the door 20, and a second hinge portion 44 fixed to the side face of the base 2 of the device 1.
[0067] The hinge portion 43 is fixed on the first side 36 of the support 35 by means of three fixing screws 158 (figure 6).
[0068] As can be seen in greater detail in figure 5, the hinge portions 43 and 44, respectively, of the door 20 and the base 2 are joined by a rod 45 forming a pivotal connection.
[0069] The hinge portion 44 of the base 2 is connected by six fixing screws 46 on the side face 3 of the base 2.
[0070] An adjustment pad (not shown) located behind that portion of hinge 44 allows it to be adjusted in the best possible way.
[0071] Furthermore, at the bottom of figure 5 it can be seen that the support 21 is fixed indirectly to that portion of the hinge 44 through an inclined plate 41 and fixing screws 185.
[0072] At the top of the hinge portion 44, a mechanical spring 48 is mounted, assembled with a plastic lock 160 to facilitate opening and locking the door 20.
[0073] The device also includes a position sensor 162 to check and provide security for opening and locking door 20, by detecting the closed door position and the other position.
[0074] A pneumatic system 49 is also placed at the top of the hinge portion 44 to produce a system (described below) for fixing the housing 17 and which is located on the door 20.
[0075] To that end, that system 49 consists of a connector 50 that is connected to both, the pneumatic power supply (not shown) and an opening 51 formed on the stem 45, whose opening 51 extends on the stem 45 from the connector 50 for the hinge portion 43 that is in port 20.
[0076] In the closed door position, as shown more especially in figure 4, the axis of rotation X around which the hinge portion 43 of the door 20 rotates, is counterbalanced in relation to a partition surface P formed between the housings 16 and 17 when they hold bag 10 between them.
[0077] This axial compensation towards the front of the device 1 of the X axis in relation to the partition surface P allows the lateral spaces 53 to be formed between the door 20 and the base 2 of the external perimeter of the door 20.
[0078] Therefore, it is greatly facilitated the access, for example, to the connector 11 of the bag 10 which is illustrated in figure 4.
[0079] The door 20 is still constituted, in its support 35, by a system 55 for fixing the frame 17 (figure 6).
[0080] This system 55 contains two lever devices 56 placed on the respective opposite sides of the support 35, in its top portion, and the rods 57 that extend over a large portion of the height of the support 35.
[0081] The lever devices 56 are of the single-acting pneumatic type with a spring, which is not integrated in the lever device 56, and are provided by the connector 50 which can be seen in figure 5.
[0082] These lever devices 56, as will be seen in greater detail below, are each connected to a rod 57 and each of them is adapted to push that rod 57 between a closed position and an unclosed position of the system 55.
[0083] Each rod 57 contains two fixing screws 58.
[0084] The system 55 also consists of two springs 59 placed on the bottom of the support 35, each spring 59 being connected to a stem 57 to push that respective stem 57 into its closed position and, therefore, advance the corresponding fixing screws 58.
[0085] The bag 10 contains two flexible films 65 and 66 connected with each other through a seal that delimits a closed contour, and the connectors 11 of the targeting network 12 (figures 2 and 20).
[0086] Therefore, each of the 65 and 66 films is a PureFlex® film from the applicant.
[0087] This is a coextruded film containing four layers, respectively, from the inside to the outside, a layer of ultra low density polyethylene (ULDPE) forming the material for contact with liquid, a copolymer of ethylene and vinyl alcohol (EVOH) ) forming a gas barrier, a layer of ethylene copolymer and vinyl acetate (EVA) and a layer of ultra low density polyethylene (ULDPE) forming the outer layers.
[0088] The seal is a welded bead formed on the periphery of films 65 and 66.
[0089] In addition to films 65 and 66 and connectors 11 for liquid, bag 10 contains a connector for the pneumatic agent (not shown) to form ducts 13 (13A to 13F in figure 20).
[0090] The closed contour of the bag 10 forms a liquid treatment zone 67, in which the ducts 13 extend.
[0091] The closed contour has a first side 68, a second side 69 that is opposite the first 68, a third side 70 that joins the first and second sides 68 and 69 and a fourth side 71 that is an opposite side to the third side 70 and that joins the first and second sides 68 and 69. The connectors of the directing network 12 emerge in and out of the first, second, and third sides 68, 69, and 70, as can be seen more especially in figure 20 .
[0092] The dimensions of the bag 10 correspond to those of the surfaces of the carcasses 16 and 17.
[0093] As can be seen below, the bag 10 is provided to be attached between the carcasses 16 and 17 with one side of the bag 10 in contact with the face of the carcass 16 and with the other face of the bag 10 being in contact with the face of the carcass 17.
[0094] On its fourth side 71, the bag 10 is still made up of three openings 73 for its fixation.
[0095] These fixing openings 73 are aligned and spaced regularly, two of the openings 73 being located on respective opposite sides of the fourth side 71 of the bag 10, and the other opening 73 being located in the center of the fourth side 71 of the bag 10.
[0096] These fixing openings 73, as will be seen below, are used to fix the bag 10 in the housing 16.
[0097] The bag 10 is still constituted, in its treatment zone 67, by two openings 75 for the union of the carcasses 16 and 17, these fixing openings 75 having a larger diameter than the fixing openings 73.
[0098] These fixation openings 75 are located in the treatment zone 67 in the places where most of the ducts are 13, because it is in these places that the pressure force is greatest during treatment. The fixing openings 75 are therefore at least partially surrounded by the ducts 13.
[0099] It will be seen below how the means for fixing the carcasses 16 and 17 carry out this fixation and at the same time fix the bag 10 in circuit 8 between them.
[0100] The bag 10 also consists of other fixation openings 77.
[0101] One of the fixing openings 77 is placed on the fourth side 71 of the bag 10 in the vicinity of the fixing opening 73 located on the left side of the top of the bag 10, and the other fixing opening 77 is placed on the opposite end, that is , towards the bottom of the bag 10, in the treatment area 67.
[0102] These fixing openings 77, as will be seen below, serve to fix the door 20 in the closed door position of the device.
[0103] As can be seen in figures 1 to 3, housing 17 has a reference surface 80, which is flat here, and a number of format channels 81 with a recession into that reference surface 80. This housing 17 has a first side 82 and a second side 83 which is a side opposite the first side 82, a third side 84 and a fourth side 85 which is a side opposite the third side 84, these third and fourth sides 84 and 85, each of them connected on the first and second sides 82 and 83.
[0104] On its fourth side 85, the housing 17 is provided with three fixing holes 86 for fixing the bag 10, which are placed, as shown below, facing the fixing openings 73 of the bag 10 in the position of closed door, with bag 10 fixed between housings 16 and 17.
[0105] In addition, housing 17 is provided with two other fixing holes 87 for fixing door 20 in the closed door position, one of which is placed on the first side 82 of the housing 17, and the other on the other end, towards the bottom of the housing 17.
[0106] As will be seen below, these two fixing holes 87 are placed in front of the fixing openings 77 of the bag 10 in the closed door position, with the bag 10 fixed between the housings 16 and 17.
[0107] In a central area, the housing 17 also consists of two other locking holes 88 with a larger diameter than the fixing holes 86 and 87 of that housing 17, whose fixing holes 88 serve to join the frames 16 and 17 , as will be seen below.
[0108] These fixing holes 88 are located in places where most of the channels 81 are used to form the ducts 13, because it is in these places that the pressure force is greatest during the treatment. The fixing holes 88 are therefore at least partially surrounded by channels 81.
[0109] As will be seen below, these fixing holes 88 are placed facing the fixing openings 75 of the bag 10 in the closed door position, with the bag 10 fixed between the frames 16 and 17.
[0110] As shown by figures 7 and 10, the housing 17 is provided with four lock stops 89, each formed in a recess of the housing body 17.
[0111] These lock stops 89 are placed along the first side 82 of the housing 17, and two other lock stops 89 are placed along the second side 83 of the housing 17, that is to say, that the four lock stops 89 are in opposite pairs.
[0112] As previously mentioned, the housing 17 is fixed on the support 35 of the door 20, and the fixing of that housing 17 on the door 20 will be described with reference to figures 7 to 10.
[0113] Each lever device 56 is provided with a body 90 consisting of a pneumatic chamber 91 and a movable piston 92 which extends by means of a rod, the lever device 56 of which is contained in support 35 of port 20, each piston 92 having an extended position and a retracted position in which the piston 92 has been moved through a predetermined space in relation to its extended position.
[0114] Each scoring system 56 is connected pneumatically to the opening 51 formed in the rod 45 that connects the hinge portions 43 and 44.
[0115] Lever devices 56 are shown in the extended position in figure 7 and in the retracted position in figure 8.
[0116] Each piston rod 92 is connected to a rod 57, whose rod 57 is also connected to a spring 59.
[0117] The pneumatic chamber 91, when under pressure, tilts piston 92 against spring 59. When piston 92 is at the end of travel spring 59 is in the stowed position (figures 7 and 9) and piston 92 is in extended position.
[0118] The rods 57 were therefore moved down translationally, the housing 17 was inserted against the sides 36 and 37 of the support 35 of the door 20, with its reference surface 80 facing outwards, and the fixing screws 58 of each rod 57 were inserted into the corresponding recesses of frame 17.
[0119] When the pneumatic chamber 91 of each lever device 56 is at atmospheric pressure, spring 59 causes piston 92 to move through stem 57 towards the other end of the displacement position of that piston 92. When that position is reached, spring 59 is in the extended position, and the piston is in the stowed position.
[0120] The rods 57 were therefore moved translationally upward with their locking screws 58 each having entered a lock stop 89 of the housing 17 to fix that housing 17 on the door 20.
[0121] Frame 16 has a flat reference surface 95 and formatting channels 96 in recession with respect to reference surface 95, each facing a corresponding formatting channel 81.
[0122] Generally, surfaces 80 and 95 have similar dimensions and the arrangement of format channels 96 is the mirror image of the set of format channels 81.
[0123] Format channels 81 and 96 have a semi-elliptical section.
[0124] Surfaces 80 and 95 can be applied against each other with channels 81 and 96 according to each other to delimit a network of cavities that are each generally tubular.
[0125] Housing 16 has a first side 145 and a second side 146 which is opposite the first side 145, a third side 147 and a fourth side 148 which is opposite the third side 147, the third and fourth sides of which 147 and 148 each of them meets the first and second sides 145 and 146.
[0126] In addition, the housing 16, on the opposite side walls 98 and 99, has the pins 100 adapted to be fitted, as a result of a vertical translation movement from the top to the bottom when the housing 16 is against the chassis 25, on the suspension clamps 26 placed on that chassis 25.
[0127] Furthermore, in those same opposite side walls 98 and 99, the housing 16 has rods 101 for handling housing 16, whose rods 101 are longer than pins 100.
[0128] This manipulation is performed by the user of device 1, or with the aid of a winch, which, for example, may be electric.
[0129] Thanks to the slope and the weight of the housing 16, and thanks to the fitting of the pins 100 in the clamping jaws 26, the housing 16 is fixed firmly on the chassis 25.
[0130] On its reference surface 95, the housing 16, moreover, has a recess portion 102 which extends downwards through an inclined surface 103, the inclination of which is directly into the device 1.
[0131] This inclined surface 103 allows access to the recess 6 that contains the containers.
[0132] The tubes (not shown) connected to the connectors 11 of the circuit 8, and specially placed in place of the third side 147 of the housing 16, can also be connected in the containers.
[0133] On a bottom face 97, the housing 16 also contains a channel 104 in the form of an inverted chute emerging from the inclined surface 103 (figures 1 and 14).
[0134] This channel 104 serves as an error-proof device when installing housing 16 on chassis 25 of base 2, so that the reference surface 95 is turned inwards.
[0135] The housing 16 also contains, at the location of its fourth side 148, three fastening rates 106, two of which are placed on opposite sides of the housing 16, the third being placed substantially in the center of the fourth side 148 of the housing 16, with those three ratios 106 being spaced evenly from each other.
[0136] As can be seen in figure 2, these rates 106 are adapted to pass through the fixing openings 73 of the bag 10 for the suspension of the last one on the housing 16.
[0137] Furthermore, the end furthest from these same fastening rates 106 is adapted to be inserted into the fastening holes 86 of the housing 17 in the closed door position.
[0138] The housing 16 contains two fixing pins 107 to fix the door 20, one of which is placed on the fourth side 148 of the housing 16 near the fixing rate 106 placed on the top left of that housing 16, the other fixing pin 107 being placed at the other end, that is, at the bottom of the housing 16, between two formatting channels 96 at the location of the third side 147.
[0139] These fixing pins 107 are adapted to pass through the openings 77 of the bag 10, and the furthest end of these fixing pins 107 is adapted to be inserted into the fixing holes 87 of the housing 17.
[0140] The housing 16 also contains two fixing holes 108 which are placed in the places where most of the channels 96 are used to form the ducts 13, and it is in these places that the pressure force is greatest during the treatment. The fixing holes 108 are therefore at least partially surrounded by channels 96.
[0141] These fixing holes 108 are placed facing the openings 75 of the bag 10 when it is placed in the housing 16, and also facing the corresponding fixing holes 88 of the housing 17 in the closed door position.
[0142] The fixing holes 108 of the housing 16 are passed through the ball locking pins 110, details of which will be shown below, for the joint fixing of the frames 16 and 17 when the door 20 is in its closed position, and for attaching bag 10 to circuit 8.
[0143] As can be seen more especially in Figures 11 to 13, each ball fixing pin 110 corresponds to a body 111, and an annular shoulder 112 provided with a transverse face 113 and connected to a head 114.
[0144] Four rods 115 are projected from the transverse face 113 to be inserted in the openings (not shown) formed in the body of the housing 16 to fix the body 111 in the housing 16.
[0145] The body 111 contains a pneumatic chamber 116 and a piston 117, the piston 117 being mechanically connected to a rod 118 with a conical tip.
[0146] That rod 118 extends into the head 114 of pin 110.
[0147] Three spheres 119 are placed to be projected from the head 114 passing through the openings formed in that head 114.
[0148] Pin 110 is similar to a double action type lever device and these pins 110 contain two pneumatic connectors 120.
[0149] The head 114 of each pin 110 passes through the corresponding fixing hole 108 of the housing 16, the head 114 also passes through the corresponding fixing opening 75 of the bag, and the head 114 finally emerges in a corresponding fixing hole 88 frame 17 in the closed door position.
[0150] One of the connectors 120 of the pin 110 allows a first portion of the pneumatic chamber 116 to be pressurized, to act on the piston 117. When the piston 117 is at the end of its displacement, the balls 119 are in the extended position, that is to say say that they protrude from the head 114 to be extended into the fixing hole 88 of the housing 17 (figure 13).
[0151] The fixing holes 88 are configured in such a way that, when the balls 119 are extended, the housings 16 and 17 are firmly fixed.
[0152] For this purpose, the fixing holes 88 contain a first portion having a first diameter, the first portion of which is adapted to face bag 10 when that bag is attached between housings 16 and 17, and then a recess , and finally a second portion having a second diameter larger than the first diameter.
[0153] Therefore, in the extended position of pin 110, the balls 119 of each pin 110 are projected into the second portion of the corresponding fixing hole 88, the first portion of that fixing hole 88 preventing the pin from being released by the lock of spheres 119.
[0154] The other connector 120 allows a second portion of the pneumatic chamber 116 to be pressurized, this second portion being opposite the first portion, to move piston 117 towards the other end of the displacement position. When that position is reached, the spheres 119 are in the retracted position, that is, they return into the head 114 (figure 12).
[0155] In addition to frames 16 and 17, circuit 8 contains, installed at the rear of frame 16, as shown in figure 14, the instruments required for the treatment of biological liquid.
[0156] For example, blocking valves 125 are illustrated containing actuators for blocking a duct 13 to prevent or allow the passage of liquid in that duct 13, and sensors 126 of physical-chemical value, for example, pressure.
[0157] Also illustrated is a pneumatic distributor 128 and means for checking and controlling the execution of various treatments of that liquid, the means of which are formed, for example, by a control and control unit 127.
[0158] In the example illustrated in figure 14, the actuators of the valves 125, each of them, for example, consists of a body connected to the housing 16 and a movable fixing finger having a retracted position when the valve 125 is in the open position and an extended position when valve 125 is in the closed position (not shown).
[0159] In the extended position, the movable finger is projected on one of the 96 channels (not shown).
[0160] Each sensor 126 is connected to the housing 16 according to a channel 96, with the furthest end of sensor 126 emerging into that channel 96, without actually having to touch the fluid (not shown).
[0161] Such sensors are well known and consist, for example, of pressure sensors that measure pressure across the outer surface of the bag 10.
[0162] The housing 16 is still constituted, installed behind that housing 16, by a female connector 130 that allows energy to be supplied to the valves 125, sensors 126, the distributor 128 and the verification and control unit 127, which are integrated on that carcass 16.
[0163] The supply is therefore electric (for power supply and control) and pneumatic.
[0164] This female connector 130 is placed on the right side of the bottom of the housing 16 (seen from behind).
[0165] As shown in figure 15, when the rear of the housing 16 is covered by a rear panel 132, only access to the female connector 130 is possible.
[0166] A male connector 135 placed on base 2 of device 1 can be connected to female connector 130 of circuit 8.
[0167] As shown in figures 16 and 17, the male connector 135 is movable, by the action of a pneumatic lever device 136 that carries the male connector 135 at its end, and this male connector 135 is adapted to pass through a opening 138 formed on the third side 142 of the chassis 25 for its connection with the female connector 130 (figures 18).
[0168] A description of the assembly of circuit 8 will now be made.
[0169] The housing 16 is attached to the chassis 25 of the base 2, by means of the pins 100 located on the fixing claws 26.
[0170] The male and female connectors 135 and 130 are connected together through the pneumatic lever device 136 that makes that male connector 135 mobile, for the electrical and pneumatic supply of circuit 8.
[0171] The bag 10, next, is fixed by suspension in the case 16, through the fixing openings 73 of that bag 10 which are passed through the rates 106 of the case 16.
[0172] In the other position of the device in which the casing 17 is far from the casing 16, the casing 17 is mounted on the support 35 of the port 20 and is then fixed by means of the system 55 of rods 57 of the port 20.
[0173] Door 20 is then closed to secure bag 10 between housings 16 and 17. The device is therefore in the closed door position.
[0174] When the door 20 is closed, its fixation, especially, is made by the pins 107 of the housing 16, through the fixing openings 77 of the bag 10 and through the fixing holes 87 of the housing 17.
[0175] The door 20 is fixed on the front face 5 of the base 2 using the devices 29 and 40, respectively, of the chassis 35 and door 20.
[0176] The housings 16 and 17, below, are fixed by the ball fixing pins 110 which furthermore allow the bag 10 to be secured between the housings 16 and 17.
[0177] The connection of the surrounding treatment components (not shown) with the connectors 11 of the bag 10 is then carried out (if not done before the assembly of the bag 10), through tubes, especially flexible tubes.
[0178] These treatment components around them are formed especially by one or more pumps, for example, of the diaphragm type, and / or by a source container containing the product to be treated and / or through a collection container of treated liquid and / or through a chromatography column.
[0179] These surrounding treatment components are placed on one or more devices, for example, juxtaposed to device 1.
[0180] These other devices are advantageously trolleys like device 1.
[0181] These connections are greatly facilitated by the lateral spaces formed around the bag 10.
[0182] It is clear that these connections may be formed before fixing the bag 10 by suspension on the housing 16, without being harmed later, that is, simultaneously with the suspension of that bag 10 on the housing 16, by the hinge system.
[0183] The bag 10 is then inflated: the connectors 11 for liquid are filled and a pneumatic agent is injected through the connector that is provided for that purpose (not shown).
[0184] The effect of bag 10 inflation is that films 65 and 66, respectively, are suitable for the face of the carcass 16 with the surface 95 and the channels 96, and the face of the carcass 17 with the surface 80 and the channels 81.
[0185] Ducts 13 of elliptical section are formed at the location of channels 81 and 96.
[0186] Press 9 and bag 10 thus form a circuit 8 for treatment of biological liquid that is ready to be put into service.
[0187] As the biological liquid is treated in the circuit formed by the press 9 and the bag 10, which must be protected against contamination, the bag 10 is supplied with plugs placed in each of the connectors 11 for liquid and in the connector for the pneumatic agent (not shown) and is sterilized, for example, by gamma irradiation. The pneumatic agent injected into bag 11 is purified.
[0188] For example, the pneumatic agent is compressed air purified by a hydrophobic filter, such as an AERVENT® available from Millipore, connected to the filling connector (not shown).
[0189] Figure 19 shows in diagram the circuit 8 produced by a press 9 and a bag 10. In this circuit the valves 125A to 125G are formed respectively by an actuator, and by the portion of the housing 17 against which the duct 13 is pressed. when he is caught by the finger.
[0190] The connector 11B is used to inject the liquid to be treated in a circuit formed by the duct 13E, by the feed container connected to the 11C connector, by the feed pump, from which the inlet side is connected to another connector of the feed container. supply and from which the discharge side is connected to connector 11 A, through duct 13A and the filter.
[0191] When the liquid to be treated by connector 11B is injected, all valves are open, except valves 125E and 125A.
[0192] As soon as the product to be treated is transferred to the feed container, valves 125F and 125C are closed, while the other valves are opened and the feed pump is put into operation, such that the liquid to be treated treated flows in the circuit mentioned above.
[0193] When it is passed through the filter, the product to be treated is purified, with the retentate passing into the duct 13E and the filtrate being passed to the duct 13D, and then being evacuated to the drain.
[0194] When the liquid has been circulated enough in the circuit and has reached the required characteristics of purity and concentration, it is evacuated to the collection container connected to connector 11E, placing valve 125B in the closed position and valve 125C in the open position, the treated liquid then arrives at connector 11E through the passage through filter 151 where the liquid undergoes final filtration.
[0195] It should be noted that, in addition to the operations described above, the circuit is capable of implementing several other operations through the direction network 12 formed by ducts 13A to 13F and valves125A to 125G.
[0196] The sensors 126A to 126B are all pressure sensors here. They allow the proper operation of the installation to be checked, and especially, the detection of any occurrence of excess pressure (sensor 126 A) and ensure the proper operation of the filter (sensors 126B to 126D).
[0197] In a variation not illustrated, the hinge system consists of a door having a horizontal flexing axis instead of a single hinge located in a corner. This door having a horizontal axis of the hinge is fixed to the top or bottom of the front face of the base of the device. Similar to a single hinge, this door having a horizontal flexing axis allows lateral spaces to be created over most of the bag structure.
[0198] In a variation not illustrated, the door is removable, that is to say, it is independent of the base, and it is mounted on the base to be fixed in it.
[0199] In a variation not illustrated, the lever devices of the rod system are of the double action type, or are electric or hydraulic, instead of pneumatic.
[0200] In a variation not shown, the ball fixing pins are of the single acting type, or are electric or hydraulic, instead of pneumatic.
[0201] In other variations not shown, other mechanisms may be used instead of the rod system, ball locking pins and fixing claws.
[0202] In variations not shown, bag inflation is performed before the bag is attached, or partially before and partially after the bag is attached.
[0203] In yet another variation not illustrated, there is no such previous inflation of the bag, because the bag's ducts are formed directly by directing the fluid into the bag at the time of treatment.
[0204] In a variation not illustrated, instead of being dispersed over the same frame, the sensor or sensors of physical-chemical value are placed in different frames; and / or no sensor is provided. The instrumentation, of course, is different, depending on the treatment of the biological liquid to be performed.
[0205] In a variation not shown, the bag is triangular or circular, instead of being rectangular, and the box formed by the carcasses is adapted to the shape of the bag, as well as, if desired, the door and the base. For example, in the case of a triangular bag, the door has only three sides, and the hinge system is configured in such a way that it forms lateral spaces at least at the location of the remaining two sides.
[0206] In another variation not shown: - instead of being a single piece, the carcasses are formed by a set of modulated members associated with each other to delimit the different portions of the circuit, whose members are provided with marks or markings to ensure that they are placed correctly in the relationship between them. The marks and markings consist, for example, of numbers or reference codes and may be of the RFID type; - the housings are of a material other than polyoxymethylene, for example, stainless steel, or aluminum, or of another plastic material, especially having a high density, or of ceramic or wood; - housing 16 contains only two fixing rates, or more than three, and in this case, bag 10 contains only two or more and then three fixing openings 73, and for housing 17 it contains two or more and then three holes fixture 86, those rates, openings and holes being spaced or not evenly spaced: - housing 16 contains more than two fixing pins 107 and in a specific case, bag 10 contains more than two fixing openings 77, and housing 17 contains more than two fixing holes 87, those rates, openings and holes whether or not they are evenly spaced; - the housing 16 contains more than two fixing holes 108 and in one case, the bag 10 contains more than two fixing holes 75, and the housing 17 contains more than two fixing holes 88; - the bags' films are of a different material than PureFlex® film, for example, another multi-layer film compatible with biological liquids, such as the HyQ® CX5-14 film available from the Hyclone industries company, or the Platinum UltraPac film available from Lonza company: - the physical-chemical value measured by sensors 126 is temperature and / or pH and / or conductivity, in combination or as an alternative to pressure; - the formatting channels have a circular section instead of a semi-elliptical section; - the pump or pumps of the other devices are of the peristaltic type instead of the diaphragm type; and - the device is not in the form of a cart but is placed on another support, for example, on a table, and / or - all surrounding treatment components are placed with the device on the same cart, or on the same support, which is different from a cart.
[0207] It should be noted, more generally, that the invention is not limited to the described and represented examples.

权利要求:
Claims (17)
[0001]
1. Device for a biological liquid treatment installation, comprising: - a base (2) having a front face (5); - a movable or removable door (20), said device having a closed door position; - in the closed door position, a circuit (8) comprising a plurality of connectors (11) and a network (12) for directing the liquid between said connectors (11), whose circuit (8) comprises a bag (10) comprising two flexible films (65, 66) and the referred connectors of the targeting network (11), whose circuit (8) is still characterized by the fact that it comprises a press (9) comprising a first housing (16) placed on said front face ( 5) of said base (2) and a second housing (17) placed on said door (20); and - a hinge system that rotates said door (20) in relation to said base (2), said hinge system being placed only on one side of said door (20) to form, in the closed door position, spaces lateral between said door (20) and said base (2) over the rest of the perimeter of said door (20), to allow free access to the connectors (11) of said bag (8).
[0002]
Device according to claim 1, characterized by the fact that said hinge system comprises a single hinge (42) placed in the corner of said door (20), and said hinge (42) comprises a first hinge portion ( 43) attached to said corner of said door (20) and a second hinge portion (44) attached to a side face (3) of said device (2), whose side face (3) is connected to said front face (5 ).
[0003]
Device according to claim 2, characterized by the fact that said axis (42) of said hinge is counterbalanced by a joint plane (P) formed between said first housing (16) and the second housing (17) in the position of closed door.
[0004]
4. Device according to claim 1, characterized by the fact that said base (2) of said device (1) comprises, on its front face (5) an inclined chassis forming a console (25) on which is placed the first frame (16), whose chassis (25) comprises clamping claws (26), and the first frame (16) comprises pins (100) inserted in said clamping claws (26).
[0005]
5. Device according to claim 1, characterized by the fact that it also comprises a first locking system (55) for fixing said second housing (17) on the support (35) of said door (20), whose first locking system (55) comprises: - at least one lever device (56) placed on said support (35); - at least one spring (59) placed on said support (35); - at least one rod (57) connected to at least one lever device (56) by a first end, and at least one spring (59) by a second end which is at an end opposite the first end, said at least one rod (57) comprising at least one locking screw (58) and having an unopened and a closed position; and - at least one lock stop (89) placed in a recess of said second housing (17); said at least one lever device (56) being configured to drive the passage of said at least one rod (57) between its closed position and its non-closed position; said at least one spring (59) being configured to drive the passage of at least one rod (57) between its unopened position and its closed position; and said at least one locking screw (58) being engaged in said at least one lock stop (89) in the closed position of said rod (57) and being detached from said at least one lock stop (89) in the closed position. not closed of said rod (57).
[0006]
6. Device according to claim 1, characterized by the fact that it further comprises a second locking system configured in such a way that it simultaneously locks said first frame (16) and said second frame (17) when said door (20 ) is in the closed door position.
[0007]
Device according to claim 6, characterized in that said second housing (17) has a first hole (88), said bag (10) contains at least one first opening (75) in a treatment zone (67 ) of said liquid, and said second locking system comprises at least one ball locking pin (110) provided with a body (111), a head (114) and balls (119) and having an unclosed state and a in a closed state, said ball locking pin (110) being fixed on said first housing (16), said head (114) passing through said first housing (16) and said first opening (75) and emerging in said first hole (88) of said second housing (17) in the closed door position, said balls (119) entering said head (114) in said unclosed state of said pin (110) and being projected from said head (114 ) in said closed state of said pin (110).
[0008]
Device according to claim 1, characterized in that said circuit (8) comprises instruments (125, 126) necessary for the treatment of said biological liquid, comprising valves (125) to allow or prevent the passage of said liquid, in said ducts, and / or sensors (126) of physicochemical values of said liquid, and said instruments (125, 126) being integrated in said first housing (16).
[0009]
Device according to claim 8, characterized in that said first housing (16) comprises a first connector (130) at the rear, and said base (2) of said device (1) comprises a second connector (135 ) configured in such a way that it is connected to said first connector (130) to drive said instruments (125, 126) integrated in said first housing (16).
[0010]
Device according to claim 9, characterized in that said front face (5) of said base (2) comprises a support (35) provided with an opening (138), and said second connector (135) being configured such that it passes through said opening (138) to be connected to said first connector (130).
[0011]
Device according to claim 1, characterized in that, in the closed door position, said bag (10) is fixed between the first and the second housing (16, 17) in a state in which the ducts (13 ) of said network (12) for directing the liquid are placed between said films (65, 66).
[0012]
Device according to claim 11, characterized in that the two said flexible films (65, 66) of said bag (10) are joined together and delimit a zone (67) for the treatment of said liquid according to with a closed contour, said guiding network connectors (11) emerging on the internal side and on the external side of at least one side (68, 69, 70) of said contour.
[0013]
Device according to claim 12, characterized in that said bag (10) comprises side openings on one side (71) of said bag (10) for its attachment, and said first housing (16) comprises charges ( 106) for securing said bag (10) which passes through said side openings of said bag (10).
[0014]
Device according to claim 11, characterized in that said bag (10) comprises at least one side opening on one side (70, 71) of said bag (10), said first housing (16) comprises at least a pin (107), and said second housing (17) comprises at least a second hole (87), where, in the closed door position, said at least one pin (107) passes through said opening of said bag ( 10) and said at least one second orifice (87) receives said pin (107) from said first housing (16).
[0015]
Device according to claim 1, characterized by the fact that it has a position in addition to said closed door position, in which said bag (10) is supported only by the first housing (16).
[0016]
16. Device according to claim 1, characterized by the fact that the two said flexible films (65, 66) of said bag (10) are joined together and delimit a zone (67) for the treatment of said liquid according to a closed contour, said guiding network connectors (11) emerging from the inside and outside of at least one side (68, 69, 70) of said closed contour.
[0017]
17. Device according to claim 1, characterized in that said bag (10) contains side openings (73) on one side (71) of said bag (10) for its installation, and said first housing ( 16) contains fees (106) for hanging said bag (10), which pass through said side openings (73) of said bag (10).

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同族专利:

公开号 | 公开日

EP2579965B1|2018-07-18|

KR20130050950A|2013-05-16|

FR2960795B1|2012-07-27|

US20150008184A1|2015-01-08|

EP2579965A1|2013-04-17|

CN102933285A|2013-02-13|

US8900454B2|2014-12-02|

ES2863900T3|2021-10-13|

BR112012027616A2|2016-08-09|

JP2013530751A|2013-08-01|

JP5798622B2|2015-10-21|

SG184973A1|2012-11-29|

WO2011154885A1|2011-12-15|

KR101484422B1|2015-01-19|

EP3372303B1|2021-02-17|

ES2687789T3|2018-10-29|

CN102933285B|2015-12-09|

EP3372303A1|2018-09-12|

FR2960795A1|2011-12-09|

US9744487B2|2017-08-29|

US20120138173A1|2012-06-07|

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