Nanofiltration virus removal device

Abstract

The invention discloses a nanofiltration virus removal device, and relates to the technical field of pharmaceutical equipment, the nanofiltration virus removal device comprises a bubble trap, a bag type filter, a nano membrane filter and a nanofiltration pipeline, a first multi-channel valve and a second multi-channel valve are connected through a first bypass pipe, a third multi-channel valve and a fourth multi-channel valve are connected through a second bypass pipe, and the first bypass pipe is connected with the second bypass pipe. The nanofiltration pipeline at the inlet end of the bubble trap is connected with a compressed air pipe through a fifth multi-channel valve, the nanofiltration pipeline at the outlet end of the nano-membrane filter is connected with a waste liquid pipe through a sixth multi-channel valve and is provided with a first valve, an upper emptying port of the nano-membrane filter is connected with the fifth multi-channel valve through a third bypass pipe, and a second valve is arranged on the third bypass pipe; according to the device, switching of the procedures such as pipeline cleaning, nanometer film air tightness detection, rinsing and bubble discharging and product nanofiltration is rapidly achieved through switching of the multiple channels and the valves, switching of the pipelines and the valves during switching is reduced, and the operation process is optimized.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical equipment, in particular to a nanofiltration virus removal device. Background Art

[0002] Biological products can be divided into three categories based on their sources. The first category is products made from human or animal tissues. The second category is viral vaccines and viral vectors for gene therapy. The third category is biological products expressed from fully characterized animal cells. All biological products have the potential risk of viral contamination. Vaccines, blood, and plasma products have all been contaminated with viruses. The risk of viral contamination in products made from cell culture is relatively much lower. Due to the potential possibility of viral contamination in biological products or blood products, potential viral risks must be prevented during the production of biological products and blood products.

[0003] Virus removal nanofiltration is an important aspect of the biopharmaceutical production process, ensuring the safety of biopharmaceuticals. This filtration is based on a size exclusion mechanism, separating viruses (such as parvoviruses with a size of 18-26 nm) from biological products (such as monoclonal antibodies with a size of ~12 nm). Generally speaking, virus removal nanofiltration can remove 4 log10 of viruses and can ensure a good recovery rate. Nanofiltration is often used in the production process of biopharmaceuticals as a robust means of removing viruses.

[0004] Nanofiltration is an effective means to remove potential viruses from blood products. The nanofiltration process involves many processes, such as pipeline cleaning, nanomembrane air tightness testing, rinsing and bubble removal, product nanofiltration and other processes. The large number of processes leads to frequent switching of pipelines and valves when switching the nanofiltration process, resulting in low operating efficiency. Summary of the invention

[0005] In order to overcome the defects of frequent switching and low operating efficiency of the nanofiltration process in the prior art, the present invention provides a nanofiltration virus removal device.

[0006] The technical solution adopted by the present invention to solve the technical problem is: a nanofiltration virus removal device comprises a bubble trap, a capsule filter and a nano-membrane filter, the bubble trap, the capsule filter and the nano-membrane filter are connected in series once through a nanofiltration pipeline, a first multi-channel valve and a second multi-channel valve are respectively provided on the nanofiltration pipelines at both ends of the capsule filter, the first multi-channel valve and the second multi-channel valve are connected through a first bypass pipe, a third multi-channel valve and a fourth multi-channel valve are respectively provided on the nanofiltration pipelines at both ends of the nano-membrane filter, the third multi-channel valve and the fourth multi-channel valve are connected through a second bypass pipe, the nanofiltration pipeline at the inlet end of the bubble trap is connected to a compressed air pipe through a fifth multi-channel valve, the nanofiltration pipeline at the outlet end of the nano-membrane filter is connected to a waste liquid pipe through a sixth multi-channel valve, a first valve is provided on the nanofiltration pipeline at the outlet end of the nano-membrane filter, an upper emptying port of the nano-membrane filter is connected to the fifth multi-channel valve through a third bypass pipe, a second valve is provided on the third bypass pipe, and the sixth multi-channel valve is connected to the bubble trap through a fourth bypass pipe.

[0007] As a further improvement of the present invention, a first pressure sensor is provided on the nanofiltration pipeline at the outlet end of the nanomembrane filter.

[0008] As a further improvement of the present invention, a second pressure sensor is provided on the third bypass pipe.

[0009] As a further improvement of the present invention, the first pressure sensor and the second pressure sensor are both digital display sensors.

[0010] As a further improvement of the present invention, the nanofiltration pipeline is a polypropylene pipeline.

[0011] As a further improvement of the present invention, the nano-membrane filter is a cellulose membrane device.

[0012] As a further improvement of the present invention, the bubble trap is a double-buffer type bubble trap.

[0013] Compared with the prior art, the present invention has the following beneficial effects: in this solution, the switching of processes such as pipeline cleaning, nano-membrane air tightness detection, rinsing and bubble removal, and product nanofiltration is quickly achieved through multi-channel and valve switching, which reduces the conversion of pipelines and valves during switching and optimizes the operating process. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments.

[0015] Figure 1 This is a schematic structural diagram of a nanofiltration virus removal device of the present invention.

[0016] In the figure: 1. bubble trap; 2. capsule filter; 3. nano membrane filter; 4. nanofiltration pipeline; 5. first multi-channel valve; 6. second multi-channel valve; 7. first bypass pipe; 8. third multi-channel valve; 9. fourth multi-channel valve; 10. second bypass pipe; 11. compressed air pipe; 12. fifth multi-channel valve; 13. sixth multi-channel valve; 14. waste liquid pipe; 15. first valve; 16. third bypass pipe; 17. second valve; 18. fourth bypass pipe; 19. storage container; 20. first pressure sensor; 21. second pressure sensor. DETAILED DESCRIPTION

[0017] In order to make the technical solution and beneficial effects of the present invention more clearly understood, the present invention is further described in detail below in conjunction with specific embodiments.

[0018] Reference Figure 1 The embodiment of the present invention discloses a nanofiltration virus removal device, comprising a bubble trap 1, a capsule filter 2 and a nano-membrane filter 3. The bubble trap 1, the capsule filter 2 and the nano-membrane filter 3 are connected in series through a nanofiltration pipeline 4. The nanofiltration pipeline 4 at both ends of the capsule filter 2 is provided with a first multi-channel valve 5 and a second multi-channel valve 6, respectively. The first multi-channel valve 5 and the second multi-channel valve 6 are connected through a first bypass pipe 7. The nanofiltration pipeline 4 at both ends of the nano-membrane filter 3 is provided with a third multi-channel valve 8 and a fourth multi-channel valve 9, respectively. The third multi-channel valve 8 and the fourth multi-channel valve 9 are connected to each other. The channel valve 9 is connected through the second bypass pipe 10, the nanofiltration pipeline 4 at the inlet end of the bubble trap 1 is connected to the compressed air pipe 11 through the fifth multi-channel valve 12, the nanofiltration pipeline 4 at the outlet end of the nanomembrane filter 3 is connected to the waste liquid pipe 14 through the sixth multi-channel valve 13, the nanofiltration pipeline 4 at the outlet end of the nanomembrane filter 3 is provided with a first valve 15, the upper emptying port of the nanomembrane filter 3 is connected to the fifth multi-channel valve 12 through the third bypass pipe 16, the third bypass pipe 16 is provided with a second valve 17, and the sixth multi-channel valve 13 is connected to the bubble trap 1 through the fourth bypass pipe 18.

[0019] The lower drain pipe of the nano-membrane filter 3 is connected to the storage container 19. A first pressure sensor 20 is provided on the nanofiltration pipeline 4 at the outlet end of the nano-membrane filter 3. A second pressure sensor 21 is provided on the third bypass pipe 16. Both the first pressure sensor 20 and the second pressure sensor 21 are digital display sensors.

[0020] The nanofiltration pipeline is cleaned with the pipeline process as follows: injection water quick connector → bubble trap 1 → first multi-channel valve 5 → first bypass pipe 7 → second multi-channel valve 6 → third multi-channel valve 8 → second bypass pipe 10 → fourth multi-channel valve 9 → first valve 15 → sixth multi-channel valve 13 → waste liquid pipe 14. The first valve 15 is initially closed. After the passage is completed, open the first valve 15 and continue flushing with injection water until it is neutral.

[0021] Air tightness test, the pipeline process is as follows: clean compressed air → compressed air pipe 11 → fifth multi-channel valve 12 → bubble trap 1 → first multi-channel valve 5 → first bypass pipe 7 → second multi-channel valve 6 → third multi-channel valve 8 → nano-membrane filter 3 → fourth multi-channel valve 9 → first valve 15 → sixth multi-channel valve 13 → waste liquid pipe 14. The first valve 15 is initially closed. After the passage is completed, the bubble trap 1 is emptied, the first valve 15 is opened, so that the clean compressed air pressure is ≥ 0.01MPa, the water inside the nano-membrane filter 3 is emptied, the first valve 15 is closed, the nano-membrane filter 3 is kept horizontal, the nano-membrane filter 3 is filled with injection water, and the pressure is slowly increased to 0.1MPa. The pressure increase process takes at least 30s, the air pressure is stable for 10s, and no bubbles are generated for 30s, then the air tightness is qualified.

[0022] The nano-membrane is cleaned and the bubbles are discharged. The pipeline process is as follows: clean compressed air → compressed air pipe 11 → fifth multi-channel valve 12 → bubble trap 1 → first multi-channel valve 5 → first bypass pipe 7 → second multi-channel valve 6 → third multi-channel valve 8 → nano-membrane filter 3 → fourth multi-channel valve 9 → first valve 15 → sixth multi-channel valve 13 → waste liquid pipe 14. When injection water is added to the bubble trap 1 and the outlet of the nano-membrane filter 3 is cleaned, the first valve 15 is opened to adjust the compressed air pressure, the nano-membrane filter 3 is discharged, and the flushing volume is ≥300ml; through cleaning, the first valve 15 is closed, and the compressed air pressure is adjusted to make the pressure ≤0.1MPa, and the flushing volume is ≥900ml.

[0023] Rinse and remove bubbles. The pipeline process is as follows: clean compressed air → compressed air pipe 11 → fifth multi-channel valve 12 → bubble trap 1 → first multi-channel valve 5 → capsule filter 2 → second multi-channel valve 6 → third multi-channel valve 8 → nano-membrane filter 3 → fourth multi-channel valve 9 → first valve 15 → sixth multi-channel valve 13 → waste liquid pipe 14 / bubble trap 1. During rinsing, confirm that the first valve 15 is open, adjust the compressed air pressure, and after filling the capsule filter 2, discharge 200ml of injection water in the replacement pipeline. After the replacement is completed, switch the sixth multi-channel valve 13 to the bubble trap 1, circulate the rinsing to remove the bubbles in the nano-membrane filter 3, and close the first valve 15 after completion.

[0024] The product nanofiltration, the pipeline flow is as follows: clean compressed air → compressed air pipe 11 → bubble trap 1 → first multi-channel valve 5 → capsule filter 2 → second multi-channel valve 6 → third multi-channel valve 8 → nano-membrane filter 3 → storage container 19. During nanofiltration, confirm that the first valve 15 is closed, adjust the compressed air pressure, control the transmembrane pressure of the nanofiltration process to meet the requirements, and after nanofiltration until there is no product in the capsule filter 2, switch the first multi-channel valve 5 to the first bypass pipe 7, blow out the product in the pipeline, switch the fifth multi-channel valve 12, and make the pipeline flow as follows: fifth multi-channel valve 12 → second valve 17 → nano-membrane filter 3 → storage container 19, open the second valve 17, adjust the compressed air pressure, blow out the product in the nano-membrane, and the nanofiltration ends.

[0025] The nanofiltration pipeline 4 is a polypropylene pipeline. The nano-membrane filter 3 is a cellulose membrane device, and the bubble trap 1 is a double-buffered bubble trap.

[0026] It should be understood that the specific embodiments described herein are only used to understand the present invention and are not used to limit the present invention. All other embodiments obtained by those skilled in the art without making any creative work are within the scope of protection of the present invention.

Claims

1. A nanofiltration virus removal device, characterized in that: The invention comprises a bubble trap (1), a capsule filter (2) and a nano-membrane filter (3); the bubble trap (1), the capsule filter (2) and the nano-membrane filter (3) are connected in series via a nano-filtration pipeline (4); a first multi-channel valve (5) and a second multi-channel valve (6) are respectively provided on the nano-filtration pipeline (4) at both ends of the capsule filter (2); the first multi-channel valve (5) and the second multi-channel valve (6) are connected via a first bypass pipe (7); a third multi-channel valve (8) and a fourth multi-channel valve (9) are respectively provided on the nano-filtration pipeline (4) at both ends of the nano-membrane filter (3); the third multi-channel valve (8) and the fourth multi-channel valve (9) are connected via a second bypass pipe (7); The nanofiltration pipeline (4) at the inlet end of the bubble trap (1) is connected to the compressed air pipeline (11) through a fifth multi-channel valve (12); the nanofiltration pipeline (4) at the outlet end of the nanomembrane filter (3) is connected to the waste liquid pipeline (14) through a sixth multi-channel valve (13); the nanofiltration pipeline (4) at the outlet end of the nanomembrane filter (3) is provided with a first valve (15); the upper drain port of the nanomembrane filter (3) is connected to the fifth multi-channel valve (12) through a third bypass pipe (16); the third bypass pipe (16) is provided with a second valve (17); and the sixth multi-channel valve (13) is connected to the bubble trap (1) through a fourth bypass pipe (18).

2. A nanofiltration virus removal device according to claim 1, characterized in that: The lower drain pipe of the nano-membrane filter (3) is connected to the storage container (19).

3. A nanofiltration virus removal device according to claim 1, characterized in that: A first pressure sensor (20) is provided on the nanofiltration pipeline (4) at the outlet end of the nanomembrane filter (3).

4. A nanofiltration virus removal device according to claim 3, characterized in that: A second pressure sensor (21) is provided on the third bypass pipe (16).

5. A nanofiltration virus removal device according to claim 4, characterized in that: The first pressure sensor (20) and the second pressure sensor (21) are both digital display sensors.

6. The nanofiltration virus removal device according to claim 1, characterized in that: The nanofiltration pipeline (4) is a polypropylene pipeline.

7. A nanofiltration virus removal device according to claim 6, characterized in that: The nano-membrane filter (3) is a cellulose membrane device.

8. A nanofiltration virus removal device according to claim 7, characterized in that: The bubble trap (1) is a double buffer type bubble trap.

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