Sterile connecting device and antigen harvesting device comprising same

Abstract

The utility model provides a sterile connecting device and an antigen harvesting device comprising the sterile connecting device, and relates to the technical field of antigen preparation, the sterile connecting device comprises a sealing cover, a telescopic sleeve assembly, a guide pipe and an adjusting pipe; the sealing cover comprises a cover body and a sterile isolation device arranged at the top of the cover body; one end of the telescopic sleeve assembly is arranged on the guide pipe and the adjusting pipe in a sleeving mode, and the other end of the telescopic sleeve assembly is connected with the sterile isolation device. The telescopic sleeve assembly comprises a telescopic sleeve, and the length of the telescopic sleeve changes along with the length of the guide pipe located in the telescopic sleeve. The sterile state is still maintained in the non-sterile environment, so that the requirement on the operation environment is reduced; the telescopic sleeve assembly protects the leading-in hard pipe and the adjusting hard pipe and is connected with different parts, and independent sterilization is achieved. The technical problem that in the prior art, when a sterile antigen is transported at-20 DEG C or 2-8 DEG C, a sterile connecting device is prone to pipeline damage to cause antigen pollution is solved.

Description

Technical Field

[0001] This utility model relates to the field of antigen preparation technology, and in particular to a sterile connecting device and an antigen harvesting device containing a sterile connecting device. Background Technology

[0002] Antigen harvesting is a crucial step in the biopharmaceutical and biotechnology fields, typically involving the isolation and purification of antigens from large-scale cultured cells or culture media. Currently, harvesting large volumes of antigens requires aseptic connection via thermoplastic tubing to prepared 50L sterile containers. These containers are then stored at 2–8°C or -20°C based on prior antigen preservation tests, and subsequently transported long distances by shipping companies. During transport, if transported at 2–8°C, protective devices and cold chain logistics are necessary, which is expensive. If transported at 2–8°C or -20°C, the tubing on the container lid is easily damaged during transport, leading to antigen contamination.

[0003] In view of the above, this utility model is hereby proposed. Utility Model Content

[0004] One of the objectives of this invention is to provide a sterile connection device to solve the technical problem that in the prior art, when transported under conditions of 2-8℃ or -20℃, the sterile connection device is prone to pipeline damage, resulting in antigen contamination.

[0005] The second objective of this invention is to provide an antigen harvesting device.

[0006] In order to achieve the above-mentioned objectives of this utility model, the following technical solution is adopted:

[0007] In a first aspect, this utility model provides a sterile connection device, including a sealing cap, a telescopic sleeve assembly, a catheter, and an adjustment tube;

[0008] The sealing cap includes a cap body and a sterile isolation device disposed on the top of the cap body;

[0009] One end of the telescopic sleeve assembly is fitted onto the catheter and the adjusting tube to provide a sealed space for the catheter and the adjusting tube located inside the telescopic sleeve assembly; the other end of the telescopic sleeve assembly is connected to the aseptic isolation device.

[0010] The telescopic sleeve assembly includes a telescopic sleeve, the length of which varies with the length of the conduit located within the telescopic sleeve.

[0011] Furthermore, the telescopic sleeve assembly also includes a sleeve bottom and a sleeve top connected to the telescopic sleeve, with the conduit and adjusting tube extending through the sleeve top and into the telescopic sleeve, respectively.

[0012] Preferably, the conduit and the regulating tube are respectively threaded to the top of the sleeve.

[0013] Furthermore, the bottom of the sleeve is provided with pre-set sealing holes corresponding to the guide tube and the regulating tube;

[0014] Preferably, the aseptic isolation device is provided with pre-set sealing holes corresponding to the conduit and the regulating tube.

[0015] Furthermore, the catheter includes a rigid catheter connected to a telescopic cannula assembly;

[0016] The regulating pipe includes a regulating rigid pipe connected to the telescopic sleeve assembly;

[0017] Preferably, the length of the rigid catheter is greater than or equal to the sum of the height of the telescopic sleeve in its contracted state and the depth of the container connected to the aseptic connection device.

[0018] Furthermore, the catheter also includes a soft catheter and a flexible connecting tube connected to the end of the rigid catheter that is away from the sterile isolation device;

[0019] Preferably, the flexible conduit is a silicone hose or a thermoplastic tube;

[0020] Preferably, the flexible connecting pipe is a thermoplastic pipe.

[0021] Furthermore, the regulating pipe also includes a regulating hose, which is connected to the end of the regulating rigid pipe away from the telescopic sleeve assembly.

[0022] Furthermore, the open ends of the flexible connecting pipe and the regulating hose are respectively equipped with gas filtration devices.

[0023] Furthermore, the aseptic isolation device includes a aseptic connection / disconnection piece, a aseptic connector, a aseptic valve, or a aseptic filter, preferably an aseptic connection / disconnection piece.

[0024] Secondly, this utility model provides an antigen harvesting device, including a container and the aforementioned aseptic connection device;

[0025] The aseptic connection device is sealed to the container through one end of the sealing cap equipped with an aseptic isolation device.

[0026] This utility model provides a sterile connection device with a sterile isolation device on the sealing cap, enabling aseptic operation even in non-sterile environments, reducing the requirements for the operating environment and facilitating use. The telescopic sleeve serves two purposes: firstly, it protects the inlet and adjustment tubes, preventing damage; secondly, it connects different components, forming an integrated structure with the sealing cap, allowing for individual sterilization. This solves the technical problem in existing technologies where sterile connection devices are prone to tube breakage and antigen contamination during transportation at 2–8℃ or -20℃. Attached Figure Description

[0027] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the structure of a sterile connection device provided in Embodiment 1 of this utility model;

[0029] Figure 2 A schematic diagram of the installation structure of the sealing cap provided in Embodiment 2 of this utility model;

[0030] Figure 3 This is a schematic diagram of the installation structure of the sleeve bottom and sterile isolation device provided in Embodiment 2 of this utility model;

[0031] Figure 4 A schematic diagram of the installation structure of the conduit entering the container provided in Embodiment 2 of this utility model;

[0032] Figure 5 This is a schematic diagram of the aseptic connection device and container after installation according to Embodiment 2 of this utility model;

[0033] Figure 6 This is a three-dimensional structural diagram of the antigen harvesting device provided in Embodiment 2 of this utility model;

[0034] Figure 7 for Figure 6 Enlarged structural diagram at point A in the middle;

[0035] Figure 8 This is a schematic diagram of the antigen harvesting device provided in Comparative Example 1 of this utility model.

[0036] Icon: 10 - Container;

[0037] 11-Telescopic sleeve; 12-Bottom of sleeve; 13-Top of sleeve; 14-Cap; 15-Sterile isolation device;

[0038] 21- Rigid catheter; 22- Flexible catheter; 23- Flexible connecting tube;

[0039] 31-Adjusting rigid tube; 32-Adjusting flexible tube;

[0040] 41-Gas filtration device;

[0041] 5-Plug. Detailed Implementation

[0042] Unless otherwise defined herein, the scientific and technical terms used in connection with this utility model shall have the meanings commonly understood by one of ordinary skill in the art. The meaning and scope of terms shall be clear; however, in any case of potential ambiguity, the definitions provided herein shall prevail over any dictionary or foreign definitions. In this application, unless otherwise stated, the use of "or" means "and / or". Furthermore, the use of the term "comprising" and other forms is non-limiting.

[0043] Unless otherwise stated, the methods and techniques of this invention are generally carried out in accordance with conventional methods well known in the art and described in various general and more specific references, which are cited and discussed throughout this specification.

[0044] This utility model provides a sterile connection device, including a sealing cap, a telescopic sleeve assembly, a conduit, and an adjustment tube; the sealing cap includes a cap body 14 and a sterile isolation device 15 disposed on the top of the cap body 14;

[0045] One end of the telescopic sleeve assembly is fitted onto the catheter and the adjusting tube to provide a sealed space for the catheter and the adjusting tube located inside the telescopic sleeve assembly, and the other end of the telescopic sleeve assembly is connected to the sterile isolation device 15.

[0046] The telescopic sleeve assembly includes a telescopic sleeve 11, the length of which varies with the length of the conduit located within the telescopic sleeve 11.

[0047] A sterile isolation device 15 is installed on the sealing cap, maintaining sterility even in non-sterile environments, reducing the requirements for the operating environment and facilitating use. A telescopic sleeve assembly is included, protecting the tubing and adjustment tube from damage while providing a sealed space for individual sterilization, facilitating sterility during non-operational periods. In use, the telescopic sleeve assembly connects to the sterile isolation device 15, allowing the tubing and adjustment tube to pass sequentially through the assembly and isolation device into the container 10 connected to the cap 14. Simultaneously, the telescopic sleeve 11 extends and retracts to facilitate tubing penetration, enabling aseptic operation even in non-sterile environments. During transportation, the sealing cap can be transported separately from the telescopic sleeve assembly, tubing, and adjustment tube, further reducing the risk of antigen contamination due to tubing damage. This solves the technical problem in existing technologies where sterile connection devices are prone to tubing damage and antigen contamination during transportation at 2–8℃ or -20℃.

[0048] In some specific embodiments, the telescopic sleeve assembly further includes a sleeve bottom 12 and a sleeve top 13 connected to the telescopic sleeve 11, with the conduit and adjusting tube extending through the sleeve top 13 into the telescopic sleeve 11. The telescopic sleeve 11, sleeve bottom 12, and sleeve top 13 cooperate to form a sealed environment.

[0049] The conduit and the regulating tube are respectively threaded to the top of the sleeve 13, such as a threaded structure, and the tube diameter can be matched with the diameter of the soft conduit 22.

[0050] In some specific embodiments, the cannula bottom 12 is connected to the aseptic isolation device 15. The connection method includes a snap-fit ​​or threaded connection to ensure a sealed connection, maintaining a sterile environment when the catheter is inserted into the container. In some specific embodiments, the cannula bottom 12 is provided with pre-set sealing holes corresponding to the catheter and the adjustment tube. In some specific embodiments, the aseptic isolation device 15 is provided with pre-set sealing holes corresponding to the catheter and the adjustment tube.

[0051] When not in use, the tube and regulating tube maintain a seal. When in use, the tube and regulating tube can penetrate the pre-sealed holes on the bottom of the sleeve 12 and the sterile isolation device 15 in sequence to enter the container 10 connected to the sealing cap.

[0052] In some specific embodiments, the conduit includes a rigid conduit 21 connected to a telescopic sleeve assembly; the adjusting tube includes an adjusting rigid tube 31 connected to the telescopic sleeve assembly.

[0053] The regulating rigid tube 31 can be made of a material that is resistant to low temperatures, such as stainless steel or a material that is resistant to high pressure.

[0054] In some specific embodiments, the length of the rigid catheter 21 is greater than or equal to the sum of the height of the telescopic sleeve 11 in its contracted state and the depth of the container connected to the aseptic connection device.

[0055] The catheter is used to connect the reactor pipeline so that the antigen can be smoothly introduced into the container connected to the sterile isolation device. In some specific embodiments, the catheter also includes a soft catheter 22 and a flexible connecting tube 23 connected to the end of the rigid catheter 21 away from the sterile isolation device 15.

[0056] The soft conduit 22 is connected to the hard conduit 21, and the flexible connecting pipe 23 is used to connect to the external reactor.

[0057] In some specific embodiments, the flexible conduit 22 is a silicone hose or a thermoplastic tube; the flexible connecting tube 23 is a thermoplastic tube.

[0058] The regulating tube is used to regulate pressure and avoid large pressure differences. In some specific embodiments, the regulating tube also includes a regulating hose 32 that is connected to the end of the regulating rigid tube 31 that is away from the sterile isolation device.

[0059] The regulating hose 32 is connected to the regulating rigid tube 31, so that the two sides of the sterile connection device are in a connected state to maintain pressure balance.

[0060] In order to maintain a sterile state during use, in some specific embodiments, the open ends of the flexible connecting tube 23 and the regulating hose 32 are respectively provided with gas filtering devices 41.

[0061] In some specific embodiments, the aseptic isolation device 15 includes a aseptic connection / disconnection piece, a aseptic connector, a aseptic valve, or a aseptic filter, preferably an aseptic connection / disconnection piece.

[0062] It should be noted that the above-mentioned aseptic connection device can be adjusted in size to match different container models according to the specific application container model.

[0063] According to another aspect of the present invention, an antigen harvesting device is also provided, comprising a container 10 and the aseptic connection device described above.

[0064] The aseptic connection device is sealed to the container through one end of the sealing cap which is equipped with an aseptic isolation device 15.

[0065] Specifically, the sealed connection is a CPC connector connection.

[0066] The technical solution of this utility model will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0067] Example 1

[0068] Combination Figure 1 The present invention describes a sterile connection device, comprising a sealing cap, a telescopic sleeve assembly, a catheter, and an adjustment tube.

[0069] The sealing cap includes a cap body 14 and a sterile isolation device 15 disposed on top of the cap body 14.

[0070] One end of the telescopic cannula assembly is fitted onto the catheter and adjusting tube to provide a sealed space for the catheter and adjusting tube located inside the telescopic cannula assembly. The other end of the telescopic cannula assembly is connected to the aseptic isolation device 15. The telescopic cannula assembly includes a telescopic cannula 11, a cannula bottom 12 connected to the telescopic cannula 11, and a cannula top 13. The length of the telescopic cannula 11 varies with the length of the catheter located inside the telescopic cannula 11. The catheter and adjusting tube extend through the cannula top 13 into the telescopic cannula 11. The cannula bottom 12 is provided with pre-set sealing holes corresponding to the catheter and adjusting tube, respectively. The aseptic isolation device 15 is provided with pre-set sealing holes corresponding to the catheter and adjusting tube, respectively.

[0071] The catheter includes a rigid catheter 21 connected to the telescopic sleeve assembly, a flexible catheter 22 communicating with the rigid catheter 21, and a flexible connecting tube 23. The adjustment tube includes an adjusting rigid tube 31 connected to the telescopic sleeve assembly and an adjusting flexible tube 32 communicating with the end of the adjusting rigid tube 31 away from the aseptic isolation device. The rigid catheter 21 and the adjusting rigid tube 31 are threaded to the top 13 of the sleeve, and are made of stainless steel with a diameter matching that of a 25# silicone flexible tube. The length of the rigid catheter 21 is greater than or equal to the sum of the height of the telescopic sleeve 11 in its retracted state and the depth of the container connected to the aseptic connection device. Both the flexible catheter 22 and the adjusting flexible tube 32 are made of 25# silicone flexible tube. The flexible connecting tube 23 is made of thermoplastic tubing matching the size of the 25# silicone flexible tube. The open ends of the flexible connecting tube 23 and the adjusting flexible tube 32 are respectively equipped with gas filtering devices 41.

[0072] Example 2

[0073] Combination Figures 2-7To illustrate, an antigen harvesting device is used, with a 50L bucket as the container. The sealing cap of the aseptic connection device provided in Example 1 is installed at the bucket opening. The telescopic sleeve assembly, the conduit, and the adjustment tube are separate components, which are sterilized and ready for use. When in use, they are connected to the container with the sealing cap. The conduit and the adjustment tube are inserted into the corresponding pre-set sealing holes on the sealing cap, and the telescopic sleeve 11 is compressed until the bottom of the conduit reaches the bottom of the container.

[0074] Comparative Example 1

[0075] Combination Figure 8 The connection device and container are an integrated structure commonly used in existing technologies and require sterilization together during use. The top of the container cap 14 is equipped with a conduit consisting of a flexible conduit 22 and an adjusting hose 32. The portions of the flexible conduit 22 and the adjusting hose 32 that contact the container cap 14 are made of stainless steel rigid tubing, and the bottom of the flexible conduit 22 contacts the bottom of the container. A plug 5 is provided at the free end of the flexible conduit 22 for sealing the pipeline. A gas filter 41 is provided at the free end of the adjusting hose.

[0076] Simulation test

[0077] Five antigen harvesting devices from both Example 2 and Comparative Example 1 were used. Sterile water was introduced into the antigen harvesting devices instead of antigen, simulating a -20°C transport condition. The specific operation is as follows:

[0078] 1. Harvesting antigens

[0079] (1) Preparation: Sterilize the container and aseptic connection device, assemble and set aside.

[0080] (2) Connect the flexible connecting tube to the outlet of the antigen production system. During the connection process, ensure that all interfaces and connections are sterile. Specifically, maintain a sterile environment through a gas filter.

[0081] (3) Transfer antigen: Start the antigen production system, and let the antigen flow into the container through the conduit. After the transfer is completed, turn off the antigen production system and disconnect the flexible connecting tube from the antigen production system.

[0082] The antigen harvesting device containing the antigen should be stored at 2–8°C or -20°C, depending on the characteristics of the antigen and its use.

[0083] 2. Simulated Transportation

[0084] Under conditions of 2–8℃ or -20℃, the antigen harvesting devices were placed on a shaker and shaken at 50 rpm for 6 hours. Five antigen harvesting devices from the same group were then transported for 3 km on a non-cement road surface using a transport trolley to simulate the shaking or collisions caused by the shaking during transport. The breakage rate was statistically analyzed. Example 2 showed no breakage, while in Comparative Example 1, one barrel had a breakage at the connection between the flexible conduit 22 and the top of the cap; one barrel had a loose plug 5 on the flexible conduit 22; and one barrel had a loose connection between the regulating hose 32 and the top of the cap 14. Therefore, the breakage rate of Comparative Example 1 was 60%, while the improved Example 2 achieved zero breakage. Upon arrival at the destination, the antigen can be conveniently and reliably exported using a separate assembly consisting of a telescopic sleeve assembly, a conduit, and a regulating hose, connected to the sealing cap.

[0085] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. A sterile connection device, characterized in that, Includes sealing cap, telescopic sleeve assembly, conduit and regulating tube; The sealing cap includes a cap body (14) and a sterile isolation device (15) disposed on the top of the cap body (14); One end of the telescopic sleeve assembly is fitted onto the catheter and the regulating tube to provide a sealed space for the catheter and the regulating tube located inside the telescopic sleeve assembly. The other end of the telescopic sleeve assembly is connected to the sterile isolation device (15). The telescopic sleeve assembly includes a telescopic sleeve (11), the length of which varies with the length of the conduit located within the telescopic sleeve (11).

2. The aseptic connection device according to claim 1, characterized in that, The telescopic sleeve assembly also includes a sleeve bottom (12) and a sleeve top (13) connected to the telescopic sleeve (11), and the conduit and the adjusting tube extend through the sleeve top (13) and into the telescopic sleeve (11); The conduit and the regulating tube are respectively threaded to the top of the sleeve (13).

3. The aseptic connection device according to claim 2, characterized in that, The bottom (12) of the sleeve is provided with pre-set sealing holes corresponding to the guide tube and the regulating tube respectively; The sterile isolation device (15) is provided with pre-set sealing holes corresponding to the conduit and the regulating tube, respectively.

4. The aseptic connection device according to claim 1, characterized in that, The catheter includes a rigid catheter (21) connected to a telescopic sleeve assembly; The regulating pipe includes a regulating rigid pipe (31) connected to the telescopic sleeve assembly; The length of the rigid catheter (21) is greater than or equal to the sum of the height of the telescopic sleeve (11) in its contracted state and the depth of the container connected to the aseptic connection device.

5. The aseptic connection device according to claim 4, characterized in that, The catheter also includes a soft catheter (22) and a flexible connecting tube (23) connected to one end of the rigid catheter (21) away from the sterile isolation device (15); The flexible conduit (22) is a silicone hose or a thermoplastic tube; The flexible connecting pipe (23) is a thermoplastic pipe.

6. The aseptic connection device according to claim 5, characterized in that, The regulating pipe also includes a regulating hose (32), which is connected to the end of the regulating rigid pipe (31) away from the telescopic sleeve assembly.

7. The aseptic connection device according to claim 6, characterized in that, The open ends of the flexible connecting pipe (23) and the regulating hose (32) are respectively provided with gas filtration devices (41).

8. The aseptic connection device according to claim 1, characterized in that, The sterile isolation device (15) includes a sterile connection / disconnection piece, a sterile connector, a sterile valve, or a sterile filter.

9. The aseptic connection device according to claim 8, characterized in that, The aseptic isolation device (15) is an aseptic connection / disconnection piece.

10. An antigen harvesting device, characterized in that, Includes a container (10) and the aseptic connection device according to any one of claims 1 to 8; The aseptic connection device is sealed to the container through one end of the sealing cap which is equipped with an aseptic isolation device (15).

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