Delivery window with through-wall system, sterile solution transfer system and operation method for solution cross-regional transfer

Abstract

The invention discloses a delivery window with a through-wall system, a sterile solution transfer system and an operation method of solution cross-regional transfer, and belongs to the technical field of sterile solution transfer. The sleeve penetrates through the wall, one end of the sleeve extends into the cavity of the VHP delivery window, and the other end of the sleeve is located on the outer side of the VHP delivery window; blind plates are arranged at the two ends of the sleeve, and chucks are arranged on the blind plates. Compared with a wall penetrating system installed on a solid wall of a clean area, the VHP delivery window is provided with a glass visual window, operators in the two areas can conveniently observe the solution delivery progress in real time, and personnel operation is better facilitated; vHP disinfection can be performed on the through-wall system after the operation is finished, so that the biological safety is further guaranteed.

Description

Technical Field

[0001] The present invention belongs to the technical field of aseptic solution transfer, and in particular relates to a transfer window with a wall-penetrating system, an aseptic solution transfer system and an operating method for solution cross-region transfer. Background Art

[0002] China GMP (2010 edition), WHO TRS 986 and EU GMP all stipulate that "validated processes should be used for virus removal or inactivation, and measures should be taken during the operation to prevent the treated products from being contaminated again." EU GMP and PIC / S GMP Appendix 2 also require that in addition to considering mixed cultures and inactivators during the inactivation process, all container contact surfaces exposed to live cultures should also be considered and transferred to a second inactivation container when necessary. Inactivating the produced virus liquid in different areas according to the results of virus inactivation kinetics is an effective measure to prevent the inactivated product from being contaminated again, that is, inactivation is carried out in the toxic area in the early stage and then transferred to another area for further inactivation in the later stage. During the inactivation process, filtering the virus inactivation liquid through the wall-penetrating system to the inactivation container in another area can effectively prevent the inactivated product from being contaminated again and reduce the risk of virus inactivation failure due to protein aggregation. For example, the Chinese Pharmacopoeia (2020 edition) and WHO TRS 993 both stipulate that the Sabin strain polio inactivated vaccine production should be re-filtered in a timely manner during the inactivation process. Compared with the hard pipe connection, the through-the-wall hose connection can reduce the waste when transferring the virus inactivation liquid.

[0003] Vaporized hydrogen peroxide (VHP) biological sterilization technology is a sterilization method that converts liquid hydrogen peroxide into gaseous hydrogen peroxide at room temperature. Its main characteristics are dryness, rapid action, non-toxicity and no residue. This sterilization technology is widely used in the fields of biotechnology, medicine and health, and pharmaceutical industries. VHP transfer windows are often used as channels for transferring items between different clean areas. The VHP transfer windows in the existing technology cannot be directly applied to the use environment of the wall. The modification work is cumbersome and complicated, and the airtightness of the transfer window cannot be guaranteed after the modification. Summary of the invention

[0004] In order to solve the above problems, the present invention adopts the following technical solutions:

[0005] A transfer window with a wall penetration system, comprising:

[0006] VHP transfer window;

[0007] A sleeve passes through the wall, one end of the sleeve extends into the cavity of the VHP transfer window, and the other end is located outside the VHP transfer window; both ends of the sleeve are provided with blind plates, and the blind plates are provided with chucks.

[0008] Furthermore, the inner diameter of the sleeve is 9 cm and the length is 28 cm.

[0009] A sterile solution transfer system, comprising a transfer window with a wall penetration system as described in any one of the above, and further comprising:

[0010] A pre-filtration solution holding container located outside the wall, the pre-filtration solution holding container is provided with a first siphon cover, the first siphon cover is provided with two first short tubes and one first long tube, one of the first short tubes is connected to two air filters; one end of the first long tube is located in the pre-filtration solution holding container and extends to the bottom, the other end is located outside the pre-filtration solution holding container and is connected to a Y-shaped or T-shaped first tee, the second end of the first tee is connected to a first sterile connector, and the third end is connected to a first sampling bottle through a connecting tube, and a sterile disconnection ring is installed on the connecting tube;

[0011] A solution receiving container located in the VHP transfer window, wherein the solution receiving container is provided with a second siphon cover, wherein the second siphon cover is provided with two second short tubes and one second long tube, wherein one of the second short tubes is connected to two air filters, and the other second short tube is sequentially provided with a sterile disconnection ring, two gaskets, a filter and a second sterile connector, wherein one end of the second long tube is located in the solution receiving container and extends to the bottom, and the other end is located outside the solution receiving container and connected to a Y-shaped or T-shaped second tee, wherein the second end of the second tee is connected to a third sterile connector, and the third end is connected to two second sampling bottles via a Y-shaped or T-shaped third tee;

[0012] When in use, the two gaskets are fixed on the two chucks respectively, the filter and the second sterile connector are both located on the side of the sleeve away from the VHP transfer window, and the second sterile connector is connected to the first sterile connector.

[0013] Furthermore, the first short tube, the first long tube, the second short tube and the second long tube are all silicone tubes.

[0014] An operating method for transporting a solution across regions is an operating method for the sterile solution transport system described in any one of the above, and the operating method comprises the following steps:

[0015] S10, open the rear door in the rear door area of ​​the VHP transfer window, place the qualified pressure-maintaining solution receiving container in the VHP transfer window, put the short tube with the sterile connector of the solution receiving container into the wall sleeve, and fix a gasket with a chuck located in the VHP transfer window;

[0016] S20, open the blind plate outside the front door of the wall sleeve in the front door area of ​​the VHP transfer window, take out the sterile connector, the filter and another gasket from the sleeve, and fix the gasket with a chuck outside the sleeve, and then aseptically connect the first sterile connector on the first long tube of the pre-filtration solution container to the second sterile connector on the second short tube of the solution receiving container;

[0017] S30, after adjusting the pressure of the compressed air source, connect the air source to the air filter of the first short tube containing the solution, and start filtering after confirming that the passages of the first long tube and the second long tube are in an open state;

[0018] S40. After the filtration is completed, the solution transfer pipeline is clamped and the staff in the rear door area of ​​the VHP transfer window uses sterile disconnection forceps to disconnect the connection at the sterile disconnection ring, moves the filtered solution out of the VHP transfer window and closes the rear door of the VHP transfer window.

[0019] Furthermore, the method further comprises the following steps:

[0020] S50. After the transfer is completed, the staff in the front door area of ​​the VHP transfer window opens the front door of the transfer window, loosens the two chucks, and takes out the two gaskets and the silicone tube respectively, and then fixes the blind plate on the outside of the front door of the transfer window with the chuck on the outside of the sleeve, closes the front door of the transfer window and runs the VHP disinfection program to disinfect the cavity of the VHP transfer window and the inside of the wall sleeve.

[0021] Furthermore, before opening the back door of the VHP transfer window, you should first check the VHP disinfection data of the transfer window in the front door area of ​​the VHP transfer window to confirm that the VHP disinfection program is qualified, and then click to open the back door on the transfer window operation interface.

[0022] Beneficial effects:

[0023] The present invention organically combines the VHP transfer window and the wall penetration system to achieve functional complementarity, and has the following advantages:

[0024] (1) The VHP transfer window has a built-in leak test function for the entire chamber. After installing a through-wall system on the front door of the transfer window, this function can be used to verify the tightness of the entire system and the tightness of the system after the pipeline is connected during operation. The operation is simple and ensures that the air in the low-level area will not enter the high-level area. It is especially suitable for the transfer of solutions between non-sealed areas and sealed areas of the same level to ensure biological safety.

[0025] (2) Compared with installing a through-wall system on the solid wall of the clean area, the VHP transfer window has its own glass viewing window, which makes it easier for operators in both areas to observe the progress of solution transfer in real time, which is more conducive to personnel operation.

[0026] (3) After the operation, the through-the-wall system can be disinfected with VHP to further ensure biosafety. The disinfection process is fully automatic and the data is traceable.

[0027] (4) According to the sampling requirements, the required sampling bottles are connected to the solution container and sterilized together under high pressure. The pipeline is disconnected using sterile disconnection forceps + sterile disconnection ring. The sampling operation is performed in a closed system. When the solution is transferred, the pipeline connection is connected through a sterile connector to further ensure sterility. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A schematic diagram of the structure of a transfer window with a wall penetration system provided by the present invention;

[0029] Figure 2 It is a schematic diagram of the structure of the container for containing the solution before filtration;

[0030] Figure 3 is a schematic diagram of the structure of a solution receiving container;

[0031] Figure 4 A schematic diagram of a sterile solution transfer system provided by the present invention before connection;

[0032] Figure 5 A schematic diagram of a sterile solution transport system provided by the present invention after connection;

[0033] Among them, 1. sleeve; 2. blind plate; 3. chuck; 4. VHP transfer window; 5. container for solution before filtration; 6. first short tube I; 7. first short tube II; 8. air filter I; 9. first long tube; 10. first sterile connector; 11. first tee; 12. first sampling bottle; 13. solution receiving container; 14. gasket; 15. filter; 16. second sterile connector; 17. second short tube I; 18. second short tube II; 19. air filter II; 20. second long tube; 21. third sterile connector; 22. second tee; 23. third tee; 24. second sampling bottle. DETAILED DESCRIPTION

[0034] Example 1

[0035] refer to Figure 1 , a transfer window with a through-wall system, comprising:

[0036] VHP transfer window 4;

[0037] A sleeve 1 passes through the wall, one end of the sleeve 1 extends into the VHP transfer window 4, and the other end is located outside the VHP transfer window 4; blind plates 2 are provided at both ends of the sleeve 1, and a chuck 3 is provided on the blind plate 2.

[0038] In this embodiment, the inner diameter of the sleeve 1 is 9 cm and the length is 28 cm.

[0039] The sleeve 1 is preferably made of stainless steel. One to two stainless steel sleeves 1 can be installed on the front door of the VHP transfer window according to actual needs.

[0040] Example 2

[0041] refer to Figure 2 - Figure 5 , a sterile solution transfer system, comprising a transfer window with a wall-penetrating system provided in Example 1, and further comprising:

[0042] A pre-filtration solution container 5 is located outside the wall, and a first siphon cover is provided on the pre-filtration solution container 5. Two first short tubes and one first long tube 9 are provided on the first siphon cover. The two first short tubes are respectively set as a first short tube I6 and a first short tube II7, wherein two air filters I8 are connected to the first short tube II7; one end of the first long tube 9 is located inside the pre-filtration solution container 5 and extends to the bottom, and the other end is located outside the pre-filtration solution container 5 and connected to a Y-shaped or T-shaped first tee 11, the second end of the first tee 11 is connected to a first sterile connector 10, and the third end is connected to a first sampling bottle 12 through a connecting tube, and a sterile disconnection ring is installed on the connecting tube;

[0043] A solution receiving container 13 is located in the VHP transfer window 4, and a second siphon cover is provided on the solution receiving container 13. Two second short tubes and one second long tube 20 are provided on the second siphon cover. The two second short tubes are respectively set as a second short tube I 17 and a second short tube II 18, wherein two air filters II 19 are connected to the second short tube II 18, and a sterile disconnection ring, two gaskets 14, a filter 15 and a second sterile connector 16 are sequentially provided on the other second short tube I 17. One end of the second long tube 20 is located in the solution receiving container 13 and extends to the bottom, and the other end is located outside the solution receiving container 13 and connected to a Y-shaped or T-shaped second tee 22. The second end of the second tee 22 is connected to a third sterile connector 21, and the third end is connected to two second sampling bottles 24 through a Y-shaped or T-shaped third tee 23;

[0044] When in use, the two gaskets 14 are fixed on the two chucks 3 respectively, the filter 15 and the second sterile connector 16 are both located on the side of the sleeve 1 away from the VHP transfer window 4, and the second sterile connector 16 is aseptically connected to the first sterile connector 10.

[0045] In this embodiment, the pre-filtration solution container 5 and the solution receiving container 13 are preferably 20L borosilicate glass screw-neck bottles, the first sampling bottle 12 is preferably a 250mL bottle, the second sampling bottle 24 is preferably a 500mL bottle, and the filter 15 is a 0.2μm filter.

[0046] In this embodiment, the first short tube I6, the first short tube II7, the first long tube 9, the second short tube I17, the second short tube II18, the second long tube 20 and the connecting tube are all silicone tubes.

[0047] In this embodiment, a compressed air point is installed near the transfer window in the area where the sleeve is installed to provide the solution transfer gas source pressure.

[0048] Example 3

[0049] An operating method for transporting a solution across regions is an operating method for the sterile solution transport system provided in Example 2, and the operating method comprises the following steps:

[0050] S10, open the rear door in the rear door area of ​​the VHP transfer window, place the qualified pressure-maintaining solution receiving container in the VHP transfer window, put the short tube with the sterile connector of the solution receiving container into the wall sleeve, and fix a gasket with a chuck located in the VHP transfer window;

[0051] S20, open the blind plate outside the front door of the wall sleeve in the front door area of ​​the VHP transfer window, take out the sterile connector, the filter and another gasket from the sleeve, and fix the gasket with a chuck outside the sleeve, and then connect the first sterile connector on the first long tube of the pre-filtration solution container to the second sterile connector on the second short tube of the solution receiving container;

[0052] S30, after adjusting the pressure of the compressed air source, connect the air source to the air filter of the first short tube containing the solution, and start filtering after confirming that the passages of the first long tube and the second long tube are in an open state;

[0053] S40. After the filtration is completed, the solution transfer pipeline is clamped and the staff in the rear door area of ​​the VHP transfer window uses sterile disconnection forceps to disconnect the connection at the sterile disconnection ring, moves the filtered solution out of the VHP transfer window and closes the rear door of the VHP transfer window.

[0054] The method for transporting a solution across regions provided in this embodiment further comprises the following steps:

[0055] S50. After the transfer is completed, the staff in the front door area of ​​the VHP transfer window opens the front door of the transfer window, loosens the two chucks, and takes out the two gaskets and the silicone tube respectively, and then fixes the blind plate on the outside of the front door of the transfer window with the chuck on the outside of the sleeve, closes the front door of the transfer window and runs the VHP disinfection program to disinfect the cavity of the VHP transfer window and the inside of the wall sleeve.

[0056] In this embodiment, before opening the back door of the VHP transfer window, the VHP disinfection data of the transfer window should be checked in the front door area of ​​the VHP transfer window to confirm that the VHP disinfection program is qualified, and then click to open the back door on the transfer window operation interface.

[0057] In this embodiment, the virus inactivation liquid is stored in the solution container for 6 days before filtration, and the solution receiving container is a virus inactivation liquid receiving bottle.

[0058] The above description is only a preferred embodiment of the present invention and does not limit the technical scope of the present invention. Therefore, any slight modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A transfer window with a wall penetration system, characterized in that: include: VHP transfer window; A sleeve passes through the wall, one end of the sleeve extends into the cavity of the VHP transfer window, and the other end is located outside the VHP transfer window; both ends of the sleeve are provided with blind plates, and the blind plates are provided with chucks.

2. The transfer window with a wall penetration system according to claim 1, characterized in that: The inner diameter of the sleeve is 9 cm and the length is 28 cm.

3. A sterile solution transport system, characterized in that: The transfer window with the wall penetration system according to any one of claims 1 to 2 further comprises: A pre-filtration solution holding container located outside the wall, the pre-filtration solution holding container is provided with a first siphon cover, the first siphon cover is provided with two first short tubes and one first long tube, one of the first short tubes is connected to two air filters; one end of the first long tube is located in the pre-filtration solution holding container and extends to the bottom, the other end is located outside the pre-filtration solution holding container and is connected to a Y-shaped or T-shaped first tee, the second end of the first tee is connected to a first sterile connector, and the third end is connected to a first sampling bottle through a connecting tube, and a sterile disconnection ring is installed on the connecting tube; A solution receiving container located in the VHP transfer window, wherein the solution receiving container is provided with a second siphon cover, wherein the second siphon cover is provided with two second short tubes and one second long tube, wherein one of the second short tubes is connected to two air filters, and the other second short tube is sequentially provided with a sterile disconnection ring, two gaskets, a filter and a second sterile connector, wherein one end of the second long tube is located in the solution receiving container and extends to the bottom, and the other end is located outside the solution receiving container and connected to a Y-shaped or T-shaped second tee, wherein the second end of the second tee is connected to a third sterile connector, and the third end is connected to two second sampling bottles via a Y-shaped or T-shaped third tee; When in use, the two gaskets are fixed on the two chucks respectively, the filter and the second sterile connector are both located on the side of the sleeve away from the VHP transfer window, and the second sterile connector is aseptically connected to the first sterile connector.

4. The transfer window with a wall penetration system according to claim 3, characterized in that: The first short tube, the first long tube, the second short tube, the second long tube and the connecting tube are all silicone tubes.

5. A method for transporting a solution across regions, characterized in that: The method for operating the sterile solution transport system according to any one of claims 3 to 4 comprises the following steps: S10, open the rear door in the rear door area of ​​the VHP transfer window, place the qualified pressure-maintaining solution receiving container in the VHP transfer window, put the short tube with the sterile connector of the solution receiving container into the wall sleeve, and fix a gasket with a chuck located in the VHP transfer window; S20, open the blind plate outside the front door of the wall sleeve in the front door area of ​​the VHP transfer window, take out the sterile connector, the filter and another gasket from the sleeve, and fix the gasket with a chuck outside the sleeve, and then connect the first sterile connector on the first long tube of the pre-filtration solution container to the second sterile connector on the second short tube of the solution receiving container; S30, after adjusting the pressure of the compressed air source, connect the air source to the air filter of the first short tube containing the solution, and start filtering after confirming that the passages of the first long tube and the second long tube are in an open state; S40. After the filtration is completed, the solution transfer pipeline is clamped and the staff in the rear door area of ​​the VHP transfer window uses sterile disconnection forceps to disconnect the connection at the sterile disconnection ring, moves the filtered solution out of the VHP transfer window and closes the rear door of the VHP transfer window.

6. The method for cross-regional solution transport according to claim 5, characterized in that: The following steps are also included: S50. After the transfer is completed, the staff in the front door area of ​​the VHP transfer window opens the front door of the transfer window, loosens the two chucks, and takes out the two gaskets and the silicone tube respectively, and then fixes the blind plate on the outside of the front door of the transfer window with the chuck on the outside of the sleeve, closes the front door of the transfer window and runs the VHP disinfection program to disinfect the cavity of the VHP transfer window and the inside of the wall sleeve.

7. The method for cross-regional solution transport according to claim 5, characterized in that: Before opening the back door of the VHP transfer window, you should also check the VHP disinfection data of the transfer window in the front door area of ​​the VHP transfer window to confirm that the VHP disinfection program is qualified, and then click to open the back door on the transfer window operation interface.

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