Connection device and virus purification system

Abstract

This utility model discloses a connection device and a virus purification system. The connection device, used to connect a purifier and a reservoir, includes a connector and a connector head. The connector includes a first interface, a second interface, and a third interface, and has switchable first and second states. In the first state, the first interface is connected to the second interface; in the second state, the first interface is connected to the third interface. The first interface is used to connect to the purifier, and the second interface is used to discharge waste liquid. The connector head is connected to the third interface and is used to connect to the reservoir. According to the connection device of this utility model embodiment, in the first state, the connector disinfects and cleans the collection pipeline of the purifier; in the second state, the connector inputs the purified sample into the reservoir through the connector head, which can optimize the cleaning and disinfection effect of the collection pipeline of the purifier.

Description

Technical Field

[0001] This utility model relates to the field of biopharmaceutical technology, and in particular to a connecting device and a virus purification system. Background Technology

[0002] Samples purified by the AKTA chromatography system need to be transported to a disposable storage bag via a collection line connected to the outlet valve. Technicians typically clean and disinfect this section of the line from the purifier's outlet valve to the collection line using a 0.5M NaOH solution before connecting it to the disposable storage bag. Finally, the purified virus solution is collected in the disposable storage bag. Before collecting the target virus, it is difficult to thoroughly disinfect this section of the line connecting the purifier's outlet valve to the collection line. Utility Model Content

[0003] One objective of this invention is to provide a connecting device and a virus purification system that can optimize the cleaning and disinfection of the collection pipeline of the purification instrument.

[0004] A connection device according to an embodiment of the present invention is used to connect a purifier and a liquid reservoir. It includes a connector and a connector head. The connector includes a first interface, a second interface, and a third interface. The connector has a switchable first state and a second state. In the first state, the first interface is connected to the second interface; in the second state, the first interface is connected to the third interface. The first interface is used to connect to the purifier, and the second interface is used to discharge waste liquid. The connector head is connected to the third interface and is used to connect to the liquid reservoir.

[0005] According to the connection device of this utility model embodiment, the connector disinfects and cleans the collection pipeline of the purifier in the first state, and inputs the purified sample into the reservoir through the connector head in the second state, which can optimize the cleaning and disinfection effect of the collection pipeline of the purifier.

[0006] In addition, the connecting device according to the above embodiments of the present invention may also have the following additional technical features: In some embodiments, the connector includes a mating valve and a coupling portion movably connected to the mating valve to control the first interface to selectively connect to either the second or third interface.

[0007] In some embodiments, the mating valve includes a connecting pipe, a first interface located on the side wall of the connecting pipe, a second interface located at the first end of the connecting pipe, a first end of the coupling portion being closed and inserted from the second end of the connecting pipe and sealingly mating with the inner wall surface of the connecting pipe, a third interface located at the second end of the coupling portion, and a communication port on the side wall of the coupling portion for connecting the third interface. In the first state, the first interface is connected to the second interface and is separated from the communication port. In the second state, the first interface is connected to the communication port and is separated from the second interface.

[0008] In some embodiments, the first end of the coupling portion is provided with a first sealing structure, which cooperates with the inner wall surface of the connecting pipe to seal the gap between the first end of the coupling portion and the inner wall surface of the connecting pipe. In the first state, the first sealing structure separates the first interface and the communication port, and in the second state, the first sealing structure separates the first interface and the second interface.

[0009] In some embodiments, the coupling portion is further provided with a second sealing structure, which cooperates with the inner wall surface of the connecting pipe to seal the gap between the coupling portion and the inner wall surface of the connecting pipe. The first sealing structure and the second sealing structure are provided on both sides of the communication port along the axial direction of the coupling portion.

[0010] In some embodiments, the outer wall surface of the coupling portion is provided with a first limiting groove and a second limiting groove, and the connector further includes a first locking portion for restricting the movement of the coupling portion along the mating valve. In the first state, the first locking portion is inserted into the first limiting groove, and in the second state, the first locking portion is inserted into the second limiting groove.

[0011] In some embodiments, the coupling portion is provided with a drive handle for driving the coupling portion to move, and the third interface is located on the side of the drive handle opposite to the mating valve; and / or, the mating valve includes a guide portion, and the coupling portion includes a sliding portion, the sliding portion being slidably engaged with the guide portion along the axis of the mating valve.

[0012] In some embodiments, the connection device further includes a disconnector connected between the connector and the connector head. The disconnector has a first and a second connector that can be connected and disconnected. One of the first and second connectors communicates with the third interface, and the other of the first and second connectors communicates with the connector head.

[0013] In some embodiments, a first flexible tube is connected between the first connector and the third interface, and a second flexible tube is connected between the second connector and the connector head.

[0014] In some embodiments, the length of the first hose is in the range of 5 cm to 50 cm; the length of the second hose is in the range of 5 cm to 50 cm.

[0015] In some embodiments, the first connector and the second connector are configured to be connected when mated and disconnected when disconnected.

[0016] In some embodiments, the first connector includes a first main body, a first sealing part, and a first elastic member. The first main body has a first opening, and the first elastic member elastically abuts against the first sealing part to close the first opening. The second connector includes a second main body, a second sealing part, and a second elastic member. The second main body has a second opening, and the second elastic member elastically abuts against the second sealing part to close the second opening. When the first connector and the second connector are mated, the first sealing part opens the first opening, the second sealing part opens the second opening, and the first opening and the second opening communicate with each other.

[0017] In some embodiments, the second body is detachably pluggable to the first body portion, and the disconnector further includes a second locking portion for locking and unlocking the connection between the first connector and the second connector; And / or, when the first connector and the second connector are mated, the first sealing part and the second sealing part abut against each other, driving the first sealing part to open the first opening and the second sealing part to open the second opening.

[0018] The virus purification system according to an embodiment of the present invention has a disinfection mode and a collection mode, including a purifier and the aforementioned connection device, wherein the first interface is connected to the purifier, the connector is in the first state in the disinfection mode, and the connector is in the second state in the collection mode. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of a connection device according to an embodiment of the present invention.

[0020] Figure 2 This is a schematic diagram of a connection device according to another embodiment of the present invention, wherein the connector is in a first state.

[0021] Figure 3 This is a schematic diagram of a connection device according to another embodiment of the present invention, wherein the connector is in a second state.

[0022] Figure 4 This is a schematic diagram of a connection device according to another embodiment of the present invention, wherein the connector is in a first state.

[0023] Figure 5 This is a schematic diagram of a connection device according to another embodiment of the present invention, wherein the connector is in a second state.

[0024] Figure 6 This is a schematic diagram of a connector according to an embodiment of the present invention, wherein the connector is in a first state.

[0025] Figure 7 This is a schematic diagram of a connector according to an embodiment of the present invention, wherein the connector is in a second state.

[0026] Figure 8 This is a schematic diagram of a disconnector according to an embodiment of the present invention, wherein the disconnector is in the ON state.

[0027] Figure 9 This is a schematic diagram of a disconnector according to an embodiment of the present invention, wherein the disconnector is in the disconnected state.

[0028] Figure 10 This is a schematic diagram of a virus purification system according to an embodiment of the present invention.

[0029] Figure label: Virus purification system 100, connecting device 10, connector 11, first interface 1101, second interface 1102, third interface 1103, connecting port 1104, mating valve 111, coupling part 112, first sealing structure 113, second sealing structure 114, drive handle 115, disconnector 12, first connector 121, first main body 1211, first sealing part 1212, first elastic element 1213, first opening 1214, second connector 122, second main body 1221, second sealing part 1222, second elastic element 1223, second opening 1224, connector 13, first hose 141, second hose 142, purifier 20, liquid reservoir 30, waste liquid collector 40. Detailed Implementation

[0030] More and more viral vector-based CGT drugs (cell and gene therapy drugs) are now designed with relatively large viral vectors, such as herpes simplex virus and poxvirus, in order to insert more target genes, such as IL-12 and PD-1. The smallest of these viruses are 180-260 nanometers. We use sterilization filters with a pore size of 0.2 micrometers for final filtration and sterilization. If the virus size is too large, it cannot be filtered and sterilized, which also means that the drug product cannot be ultimately filtered and sterilized.

[0031] For products that are not terminally sterilized (such as viral vector cell and gene therapy (CGT) drugs), aseptic requirements for the chromatography purification step are maintained throughout the entire process. The core is to ensure that the product is not contaminated by microorganisms during the purification stage through strict process control—due to the lack of a terminal sterilization step, contamination at any stage can directly lead to product non-compliance. According to the Good Manufacturing Practice (GMP) for pharmaceuticals and the Appendix to Cell Therapy Products, CGT products, because the final product cannot be sterilized, must ensure sterility through full-process control. The US FDA's "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing" states that critical production steps (including chromatography purification) for non-terminally sterilized products must be carried out in a Class A clean area (dynamic), and the background environment must reach Class B to minimize the risk of contamination. ICH Q5A, EU GMP Appendix 1, and other standards emphasize that viral purification processes must avoid contamination by exogenous factors, and critical steps (such as sample loading, chromatography, and collection) must be operated in a closed or strictly aseptic environment.

[0032] Samples purified by the AKTA chromatography system need to be transported to a disposable storage bag via a collection line connected to the outlet valve. This section of the line, from the purifier's outlet valve to the collection line, is cleaned and disinfected with alkali before being connected to the disposable storage bag. The purified virus solution is then collected in the disposable storage bag. Before collecting the target virus, it is difficult to thoroughly disinfect this section of the line connecting the purifier's outlet valve to the collection line. Generally, the line is first disinfected with alkali, and the alkali solution at the end of the line is rinsed with water for injection and discharged into a waste collection device (e.g., a waste bottle). The waste collection device is then disconnected from the line, and the collection line is connected to the disposable storage bag. However, in this case, using a sterile tube sealing machine, the high temperature during hot-melt welding causes submicron-sized particles in the tubing material to directly mix into the virus solution. Even without using a sterile tube sealing machine, using a "Y" connector, where one end of the "Y" connector drains the disinfectant alkali solution to the waste liquid collector and the other end connects to a disposable storage bag for the final collection of virus liquid, it is still difficult to clean the residual alkali solution in the dead corners of the connector. The alkali solution will cause contamination of the harvested virus liquid.

[0033] This utility model relates to the field of biopharmaceutical technology, specifically to the process of producing viral vector drugs. In the downstream virus purification process using a purification instrument, it is necessary to clean and disinfect the section where the collection pipeline of the purification instrument's outlet valve is connected to a disposable storage bag. This utility model can effectively solve this problem.

[0034] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model.

[0035] like Figures 1 to 3 According to an embodiment of the present invention, a connecting device 10 is used to connect a purifier 20 and a reservoir 30. The connecting device 10 includes a connector 11 and a connector head 13. The connector 11 includes a first interface 1101, a second interface 1102, and a third interface 1103. The connector 11 has a switchable first state and a second state. The first interface 1101 is used to connect to the purifier 20, and the second interface 1102 is used to discharge waste liquid. The connector head 13 is connected to the third interface 1103 and is used to connect to the reservoir 30. Figure 2 In the first state, the first interface 1101 is connected to the second interface 1102; for example... Figure 3 In the second state, the first interface 1101 is connected to the third interface 1103.

[0036] According to the connecting device 10 of this utility model embodiment, the connector 11 disinfects and cleans the collection pipeline of the purifier 20 in the first state, and in the second state, the connector 11 inputs the purified sample into the reservoir 30 through the connector 13, which can optimize the cleaning and disinfection effect of the collection pipeline of the purifier 20. The reservoir 30 can be a disposable reservoir bag.

[0037] like Figure 2 , Figure 3 , Figure 6 and Figure 7 In some embodiments, connector 11 includes a mating valve 111 and a coupling portion 112, the coupling portion 112 being movably connected to the mating valve 111 to control the first interface 1101 to selectively connect to either the second interface 1102 or the third interface 1103, wherein, for example... Figure 2 , Figure 4 and Figure 6 As shown, the coupling part 112 moves to the first position, at which time the first interface 1101 and the second interface 1102 are connected; as Figure 3 , Figure 5 and Figure 7 As shown, the coupling part 112 moves to the second position, at which time the first interface 1101 and the third interface 1103 are connected. The movement of the coupling part 112 can be used to control the working state of the connector 11, thereby simplifying the operation and control of the connector 11, facilitating the use of the connector 11, and enabling the conversion between disinfection and cleaning and sample transfer by quickly switching the state of the connector 11, thereby improving the efficiency and effect of disinfection and cleaning.

[0038] like Figures 4 to 7 The valve 111 includes a connecting pipe, a first interface 1101 located on the side wall of the connecting pipe, and a second interface 1102 located at the first end of the connecting pipe (see attached diagram). Figure 6 (Left end of the connecting tube), the first end of the coupling part 112 (see attached) Figure 6 The left end of the coupling part 112 is closed, and the first end of the coupling part 112 is connected to the second end of the connecting tube (see Appendix). Figure 6 The right end of the connecting tube is inserted, the first end of the coupling part 112 is sealed to the inner wall of the connecting tube, and the third interface 1103 is located at the second end of the coupling part 112 (see attached diagram). Figure 6 The right end of the coupling part 112 has a connecting port 1104 on its side wall, which connects to the third interface 1103. In the first state, the first interface 1101 is connected to the second interface 1102 and separated from the connecting port 1104. In the second state, the first interface 1101 is connected to the connecting port 1104 and separated from the second interface 1102. This design allows for convenient and rapid movement of the coupler, facilitates automatic or manual driving of the coupler, simplifies the structure of the connection device 10, and allows the connector 11 to quickly switch between the first and second states.

[0039] like Figures 4 to 7 The first end of the coupling part 112 is provided with a first sealing structure 113, which mates with the inner wall surface of the connecting pipe to seal the gap between the first end of the coupling part 112 and the inner wall surface of the connecting pipe. Figure 6 In the first state, the first sealing structure 113 separates the first interface 1101 and the connecting port 1104; as Figure 7 In the second state, the first sealing structure 113 separates the first interface 1101 and the second interface 1102. The first sealing structure 113 can be used to separate the first interface 1101 and the second interface 1102 or to separate the first interface 1101 and the third interface 1103, and facilitate the connection of the first interface 1101 to the second interface 1102 or to the connecting port 1104, so as to realize the connector 11 quickly and stably switch between the first state and the second state, and reduce or avoid liquid retention in the disinfection or cleaning pipeline.

[0040] like Figures 4 to 7 The coupling part 112 is also provided with a second sealing structure 114, which mates with the inner wall surface of the connecting tube to seal the gap between the coupling part 112 and the inner wall surface of the connecting tube. The first sealing structure 113 and the second sealing structure 114 are arranged on both sides of the communication port 1104 along the axial direction of the coupling part 112. Using the second sealing structure 114, an effective seal can be achieved between the internal space of the connecting tube and the external space of the connecting device 10, preventing leakage of purified samples, improving the stability and safety of the connecting device 10, and avoiding environmental pollution.

[0041] The coupling part 112 has a first limiting groove (not shown) and a second limiting groove (not shown) on its outer wall surface. The connector 11 also includes a first locking part (not shown) for restricting the movement of the coupling part 112 along the mating valve 111. In the first state, the first locking part is inserted into the first limiting groove, and in the second state, the first locking part is inserted into the second limiting groove. This allows the coupling part 112 to be stably maintained in the first and second positions, facilitating stable disinfection and cleaning operations and sample transport operations.

[0042] The first locking part may include a first locking pin and a first elastic part. The first locking pin can be inserted into the first limiting groove and the second limiting groove, and can also be withdrawn from the first limiting groove and the second limiting groove. When the first locking pin is inserted into the first limiting groove or the second limiting groove, the coupling part 112 can be easily positioned. When the first locking pin is withdrawn from the first limiting groove and the second limiting groove, the coupler can easily move between the first position and the second position. The first elastic part may be configured to have an elastic force that drives the first locking pin to be inserted into the first limiting groove or the second limiting groove. In this way, when the locking part moves between the first position and the second position, the first locking pin can be quickly inserted into the first limiting groove or the second limiting groove to complete the positioning. In addition, the elastic force of the first elastic part is also configured to make a sound (e.g., a clicking sound) when the first locking pin is inserted into the first limiting groove or the second limiting groove, so as to remind the user that the coupling part 112 has moved into place.

[0043] The first locking pin can be configured to have a first groove (not shown in the figure) surrounding the coupling part 112. In the locked state, the edge of the first groove can be inserted into the first limiting groove or the second limiting groove. The first locking pin can be unlocked by pressing the pressing end of the first locking pin to overcome the elastic force of the first elastic part.

[0044] like Figure 6 and Figure 7 The coupling part 112 is provided with a drive handle 115 for driving the coupling part 112 to move, and the third interface 1103 is located on the side of the drive handle 115 away from the mating valve 111. The drive handle 115 can be used to manually drive the coupling part 112 to facilitate manual switching of the state of the connector 11, and the drive handle 115 can also have a limiting function, so that the pipeline connected to the third interface 1103 can be limited by the drive handle 115.

[0045] Additionally, the mating valve 111 may also include a guide portion, and the coupling portion 112 may also include a sliding portion, the sliding portion being slidably engaged with the guide portion along the axis of the mating valve 111. The guide portion may include a groove, and the sliding portion may include a slider; alternatively, the guide portion may include a guide rail, and the sliding portion may include a slider. Of course, the guide portion and the sliding portion can also be configured in other mating forms. By utilizing the guide portion and the sliding portion, the rotation of the coupling portion 112 relative to the mating valve 111 can be restricted, improving the sealing effect between the coupling portion 112 and the mating valve 111.

[0046] like Figure 4 and Figure 5 The third interface 1103 of connector 11 is a 1 / 2-inch tubing barbed connector, which connects to the 1 / 2-inch first tubing 141 (a silicone tubing approximately 10cm long, intended for connection to the aseptic disconnector 12). Connector 11 has a latch; when the latch is engaged, connector 11 is locked in the first state. The flow of alkali solution and water for injection used for cleaning and disinfection flows from the first interface 1101 to the second interface 1102. After cleaning and disinfection are completed, the latch is removed, the button on the first locking part is pressed, and the coupling part 112 pushes the connector from the third interface 1103 to the second interface 1102, sealing the second interface 1102, while the flow of the first interface 1101 can still pass through the third interface 1103. The first interface 1101 is connected to the outlet valve pipeline of the purifier 20, and can be connected to the outlet valve pipeline of the purifier 20 via a 3 / 4-inch to 1 / 8-inch adapter. The second interface 1102 is connected to the waste liquid collector 40, and can be connected via a 3 / 4-inch to 1 / 8-inch adapter. An inch-to-1 / 4-inch adapter can connect the second interface 1102 to the waste liquid collector 40.

[0047] like Figure 4 , Figure 5 , Figure 8 and Figure 9 In some embodiments, the connecting device 10 further includes a disconnector 12 connected between the connector 11 and the connector head 13. The disconnector 12 has a first connector 121 and a second connector 122 that can be connected and disconnected. One of the first connector 121 and the second connector 122 is connected to a third interface 1103, and the other of the first connector 121 and the second connector 122 is connected to the connector head 13. The third interface 1103 and the connector head 13 can be connected through the disconnector 12. When it is necessary to disconnect the connector 11 and the connector head 13, the first connector 121 and the second connector 122 can be disconnected, which facilitates the use of the connecting device 10.

[0048] like Figure 4 and Figure 5Optionally, a first flexible hose 141 is connected between the first connector 121 and the third interface 1103. Optionally, a second flexible hose 142 is connected between the second connector 122 and the connector 13. The disconnector 12 and the connector 11, as well as the disconnector 12 and the connector 13, are connected by flexible hoses, which simplifies the structure of the connection device 10 and facilitates the adjustment of the positions of the connector 13 and the connector 11.

[0049] The length of the first flexible tube 141 can be in the range of 5 cm to 50 cm; the length of the second flexible tube 142 can also be in the range of 5 cm to 50 cm. The length of the first flexible tube 141 can be set to 10 cm, 5 cm, 7.4 cm, 14 cm, 36 cm or 50 cm, etc., and the length of the second flexible tube 142 can be set to 10 cm, 5 cm, 7.4 cm, 14 cm, 36 cm or 50 cm, etc.

[0050] like Figure 8 and Figure 9 The first connector 121 and the second connector 122 are configured to be connected when mated and disconnected when disconnected. Specifically, the first connector 121 and the second connector 122 are connected when mated; when the first connector 121 and the second connector 122 are disconnected, both the first connector 121 and the second connector 122 are disconnected.

[0051] like Figure 8 and Figure 9 The first connector 121 includes a first main body 1211, a first sealing part 1212, and a first elastic member 1213. The first main body 1211 has a first opening 1214, and the first elastic member 1213 elastically abuts against the first sealing part 1212 towards the first opening 1214 to close the first opening 1214. The second connector 122 includes a second main body 1221, a second sealing part 1222, and a second elastic member 1223. The second main body 1221 has a second opening 1224, and the second elastic member 1223 elastically abuts against the second sealing part 1222 towards the second opening 1224 to close the second opening 1224. When the first connector 121 and the second connector 122 are connected, the first sealing part 1212 opens the first opening 1214, and the second sealing part 1222 opens the second opening 1224, thus connecting the first opening 1214 and the second opening 1224. It can quickly connect when the first connector 121 and the second connector 122 are mated, and quickly close the first opening 1214 and the second opening 1224 when the first connector 121 and the second connector 122 are separated.

[0052] like Figure 8 and Figure 9The second body is detachably plugged into the first body 1211. The disconnector 12 also includes a second locking part, which is used to lock and unlock the connection between the first connector 121 and the second connector 122. This facilitates the connection and disconnection of the first connector 121 and the second connector 122, and allows the locking state of the first connector 121 and the second connector 122 to be determined by the position of the second locking part.

[0053] The outer wall of the second main body is provided with a third limiting groove. The second locking part can be inserted into the third limiting groove to lock the first connector 121 and the second connector 122. The second locking part can be removed from the third limiting groove to unlock the first connector 121 and the second connector 122. This ensures that the first connector 121 and the second connector 122 are stably maintained in a connected state.

[0054] The second locking part may include a second locking pin and a second elastic part. The second locking pin can be inserted into the third limiting groove or withdrawn from the third limiting groove. When the second locking pin is inserted into the third limiting groove, it can facilitate the positioning of the first connector 121 and the second connector 122, and facilitate the separation of the first connector 121 and the second connector 122. In addition, the elastic force of the second elastic part is also configured to make an audible sound (e.g., a click) when the second locking pin is inserted into the third limiting groove, so as to remind the user that the first connector 121 and the second connector 122 are connected.

[0055] The second locking pin can be configured to have a second groove around the second body. In the locked state, the edge of the second groove can be inserted into the third limiting groove. The first connector 121 and the second connector 122 can be unlocked by pressing the pressing end of the second locking pin to overcome the elastic force of the second elastic part.

[0056] like Figure 8 When the first connector 121 and the second connector 122 are mated, the first sealing part 1212 and the second sealing part 1222 abut against each other, driving the first sealing part 1212 to open the first opening 1214 and the second sealing part 1222 to open the second opening 1224. This facilitates communication between the first connector 121 and the second connector 122 when they are mated. Figure 9 When the first connector 121 and the second connector 122 are separated, the first sealing part 1212 quickly closes the first opening 1214, and the second sealing part 1222 quickly closes the second opening 1224.

[0057] In the disconnector 12, one of the first connector 121 and the other of the second connector 122 is a male disconnector, and the other is a female disconnector. The male disconnector is a valved inline hose barbed connector insert, and the female disconnector is a valved inline hose barbed connector body. The male and female disconnectors together constitute the aseptic disconnector 12. Figure 2As shown. The first connector 121 can be connected to the third interface 1103 of the connector 11 via a first flexible tube 141 with a length of 10cm; the second connector 122 is interlocked with the first connector 121. After overall irradiation sterilization and before the virus collection is completed, the first connector 121 and the second connector 122 are always connected. Its function is to achieve aseptic disconnection after the purified virus is collected into the disposable storage bag; the connection between the first connector 121 and the second connector 122 can be aseptically disconnected by pressing the pressing part of the second locking part; the second connector 122 is connected to the connector 13 via a second flexible tube 142 with a length of 10cm.

[0058] Connector 13 is a sterile connector with a 1 / 4-inch tubing barb. It is a high-temperature type connector, as shown in the figure. Connector 13 is connected to the second connector 122 of disconnector 12 via a 10cm long silicone tube. Connector 13 is also connected to a sterile connector on a disposable storage bag for collecting virus fluid. This connector is not male or female; sterile connectors of the same model can be used for sterile connection.

[0059] like Figure 10 The virus purification system 100 according to an embodiment of the present invention has a disinfection mode and a collection mode, including a purifier 20 and the aforementioned connecting device 10. The first interface 1101 is connected to the purifier 20. In the disinfection mode, the connector 11 is in a first state, and in the collection mode, the connector 11 is in a second state.

[0060] Combination Figure 10 , Figure 4 and Figure 5 The method of using the virus purification system 100 may include the following steps.

[0061] Step 1: As Figure 4 With connector 11 in the first state, the alkaline solution used for cleaning and disinfection flows out from the outlet valve of the purifier 20 through the collection pipeline and the second outlet of connector 11, rinsing the "purifier 20 outlet valve - collection pipeline" and "collection pipeline - connector 11" for 5 CV (Column Volume, where 5 CV refers to the fluid volume passing through the entire rinsing flow path, meaning the flow path is rinsed 5 times), and then flows out through the second interface 1102 of connector 11 to the waste bottle, completing the disinfection process; Step 2: Rinse the flow path of the purifier 20, the outlet valve-collection line of the purifier 20, and the collection line-connector 11 with water for injection for 5 cycles. The water will flow out through the second port 1102 of the connector 11 and be discharged into the waste bottle. Rinse the outlet valve-collection line of the purifier 20 and the collection line-connector 11 until neutral. Step 3: Once the purification process reaches the target viral peak, begin virus collection. Switch connector 11 to the second state and seal the second interface 1102. At this point, the second interface 1102 has completed its cleaning, disinfection, and waste liquid discharge functions and will not be used again. The collected viral fluid flows from... Figure 5 The first interface 1101 flows towards the connector 13, that is, the collection pipe is connected to the rightmost connector 13. Step 4: We aseptically connect connector 13 to the sterile connector on the storage bag (using aseptic connection can eliminate the need for a sterile tube connection machine and a sterile tube sealing machine, because heating the sterile tube connection machine to 400℃ will cause the thermoplastic tube material to produce submicron particles, which will directly mix into the virus solution and contaminate our products). The virus solution is collected into a disposable storage bag. Step 5: After the virus fluid collection is complete, press the spring button on the disconnector 12 to... Figure 8 The first connector 121 and the second connector 122 are disconnected, and the second connector 122, connector 13 and reservoir 30 can be removed.

[0062] After using this device, the collection pipeline connected to the purifier's outlet valve 20 can be thoroughly cleaned and disinfected with alkaline solution, leaving no blind spots. After discharging the waste alkaline solution into a waste bottle and rinsing it with water for injection until neutral, the discharge port can be sealed to ensure a clean and disinfected environment. Its thorough design ensures no alkaline residue. The design of the aseptic connection to the disposable storage bag and the aseptic disconnector 12 at the rear end also solves the problem of submicron particles being generated in the pipeline material due to the 400℃ high temperature of the aseptic sealing machine, which directly mixes into the virus solution. The collection of virus solution in the purification step is a weak link in the production of non-terminal sterilized products, and the use of this device meets the regulatory requirements for the aseptic production of non-terminal sterilized products throughout the entire process.

[0063] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0064] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this utility model, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0065] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0066] In this utility model, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0067] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0068] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A connecting device (10) for connecting a purifier (20) and a reservoir (30), characterized in that, include: A connector (11) includes a first interface (1101), a second interface (1102), and a third interface (1103). The connector (11) has a switchable first state and a second state. In the first state, the first interface (1101) is connected to the second interface (1102), and in the second state, the first interface (1101) is connected to the third interface (1103). The first interface (1101) is used to connect to the purifier (20), and the second interface (1102) is used to discharge waste liquid. Connector (13), which connects to the third interface (1103), is used to connect to the reservoir (30).

2. The connecting device (10) according to claim 1, characterized in that, The connector (11) includes a mating valve (111) and a coupling part (112), the coupling part (112) being movably connected to the mating valve (111) to control the first interface (1101) to selectively connect to the second interface (1102) or the third interface (1103).

3. The connecting device (10) according to claim 2, characterized in that, The valve (111) includes a connecting pipe, a first interface (1101) located on the side wall of the connecting pipe, a second interface (1102) located at the first end of the connecting pipe, a first end of a coupling part (112) closed and inserted from the second end of the connecting pipe and sealed with the inner wall surface of the connecting pipe, a third interface (1103) located at the second end of the coupling part (112), and a connecting port (1104) connected to the third interface (1103) on the side wall of the coupling part (112). In the first state, the first interface (1101) is connected to the second interface (1102) and separated from the connecting port (1104). In the second state, the first interface (1101) is connected to the connecting port (1104) and separated from the second interface (1102).

4. The connecting device (10) according to claim 3, characterized in that, The first end of the coupling part (112) is provided with a first sealing structure (113). The first sealing structure (113) cooperates with the inner wall surface of the connecting pipe to seal the gap between the first end of the coupling part (112) and the inner wall surface of the connecting pipe. In the first state, the first sealing structure (113) separates the first interface (1101) and the communication port (1104). In the second state, the first sealing structure (113) separates the first interface (1101) and the second interface (1102). The coupling part (112) is further provided with a second sealing structure (114), which cooperates with the inner wall surface of the connecting pipe to seal the gap between the coupling part (112) and the inner wall surface of the connecting pipe. The first sealing structure (113) and the second sealing structure (114) are provided on both sides of the communication port (1104) along the axial direction of the coupling part (112).

5. The connecting device (10) according to any one of claims 2-4, characterized in that, The outer wall surface of the coupling part (112) is provided with a first limiting groove and a second limiting groove. The connector (11) also includes a first locking part for restricting the movement of the coupling part (112) along the mating valve (111). In the first state, the first locking part is inserted into the first limiting groove, and in the second state, the first locking part is inserted into the second limiting groove. And / or, the coupling part (112) is provided with a drive handle (115) for driving the coupling part (112) to move, and the third interface (1103) is provided on the side of the drive handle (115) away from the mating valve (111); And / or, the mating valve (111) includes a guide portion, and the coupling portion (112) includes a sliding portion that slidably engages with the guide portion along the axis of the mating valve (111).

6. The connecting device (10) according to any one of claims 1-4, characterized in that, The connecting device (10) further includes: A disconnector (12) is connected between the connector (11) and the connector head (13). The disconnector (12) has a first connector (121) and a second connector (122) that can be connected and disconnected. One of the first connector (121) and the second connector (122) communicates with the third interface (1103), and the other of the first connector (121) and the second connector (122) communicates with the connector head (13). The first connector (121) and the second connector (122) are configured to be connected when docked and disconnected when disconnected.

7. The connecting device (10) according to claim 6, characterized in that, A first flexible tube (141) is connected between the first connector (121) and the third interface (1103), and a second flexible tube (142) is connected between the second connector (122) and the connector (13). The length of the first hose (141) is in the range of 5 cm to 50 cm; the length of the second hose (142) is in the range of 5 cm to 50 cm.

8. The connecting device (10) according to claim 6, characterized in that, The first connector (121) includes a first main body (1211), a first sealing part (1212) and a first elastic member (1213). The first main body (1211) is provided with a first opening (1214). The first elastic member (1213) elastically abuts against the first sealing part (1212) toward the first opening (1214) to close the first opening (1214). The second connector (122) includes a second main body (1221), a second sealing part (1222), and a second elastic member (1223). The second main body (1221) is provided with a second opening (1224). The second elastic member (1223) elastically abuts against the second sealing part (1222) toward the second opening (1224) to close the second opening (1224). When the first connector (121) and the second connector (122) are mated, the first sealing part (1212) opens the first opening (1214), the second sealing part (1222) opens the second opening (1224), and the first opening (1214) and the second opening (1224) are connected.

9. The connecting device (10) according to claim 8, characterized in that, The second body is detachably plugged into the first body part (1211), and the disconnector (12) further includes a second locking part for locking and unlocking the connection between the first connector (121) and the second connector (122); And / or, when the first connector (121) and the second connector (122) are mated, the first sealing part (1212) and the second sealing part (1222) abut against each other, and drive the first sealing part (1212) to open the first opening (1214) and the second sealing part (1222) to open the second opening (1224).

10. A virus purification system (100), comprising a disinfection mode and a collection mode, characterized in that, include: Purification instrument (20); The connecting device (10) according to any one of claims 1-9, wherein the first interface (1101) is connected to the purifier (20), the connector (11) is in the first state in the sterilization condition, and the connector (11) is in the second state in the collection condition.

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