Two-stage filter integrity sterility detection device

By designing a dual-stage filter integrity sterile detection device, using the self-weight inflow and pressurized heating steps, the problem of the asepticity of the dual-stage filter in the prior art is solved, and the sterility integrity detection of the filter is achieved, ensuring the safety of drug production.

CN120333791APending Publication Date: 2025-07-18SHANGHAI KYOWA VACUUM ENG CO LTD
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Patent Information

Application Number
CN202510489271.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-18
Publication Date
2025-07-18

AI Technical Summary

Technical Problem

The existing refrigeration vacuum dryer repression system cannot effectively detect the sterility of the dual-stage filter before and after production, resulting in risks in drug production.

Method used

A two-stage filter integrity sterile detection device is designed. Through the connection method of the water making tank, the first filter and the second filter, water is flowed into the filter by self-weight, and combined with steps such as pressurization and heating, the sterile integrity detection of the filter is achieved.

Benefits of technology

The sterile integrity detection of the dual-stage filter is achieved, the problem of sterile air detection is solved, and the safety of drug production is ensured.

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Abstract

The invention discloses a two-stage filter integrity sterility detection device which comprises a water production tank, a first filter and a second filter, the upper end of the water production tank is respectively connected with a filter steam inlet valve and a filter overflow valve, and the other end of the filter overflow valve is respectively connected with a first filter isolation valve and a second filter isolation valve through pipelines; the first filter isolation valve is communicated with the first filter, and the second filter isolation valve is communicated with the second filter; the lower end of the water production tank is respectively connected with a first water supply valve and a second water supply valve, the first water supply valve is communicated with the first filter, and the second water supply valve is communicated with the second filter. The invention aims to provide the integrity sterility detection device for the two-stage filter to overcome the existing defects, and sterility integrity detection is realized.
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Description

Technical Field

[0001] The present invention relates to a double - stage filter integrity aseptic detection device. Background Art

[0002] At present, for the repressurization systems of freeze - drying vacuum dryers produced by domestic and foreign manufacturers, it is necessary to detect the quality of the filter elements before and after production. Especially the detection before production, that is, the detection of the filter after SIP sterilization, cannot achieve the redundant filter of the double - stage filter, cannot realize the aseptic detection, and cannot achieve double protection, which poses a certain risk to drug production.

[0003] Therefore, a double - stage filter integrity aseptic detection device is proposed to solve the above problems. Summary of the Invention

[0004] The purpose of the present invention is to provide a double - stage filter integrity aseptic detection device to overcome the existing defects and achieve aseptic integrity detection.

[0005] To achieve the above purpose, the present invention provides the following technical solution: A double - stage filter integrity aseptic detection device includes a water - making tank, a first filter, and a second filter;

[0006] The upper end of the water - making tank is respectively connected to a filter inlet steam valve and a filter overflow valve, and the other end of the filter overflow valve is respectively connected to a first filter isolation valve and a second filter isolation valve through a pipeline;

[0007] The first filter isolation valve communicates with the first filter, and the second filter isolation valve communicates with the second filter;

[0008] The lower end of the water - making tank is respectively connected to a first water supply valve and a second water supply valve. The first water supply valve communicates with the first filter, and the second water supply valve communicates with the second filter;

[0009] A second filter pressurizing valve is connected to the second filter, a first filter pressurizing valve is connected to the first filter. A second filter pressurizing valve and a fourth filter isolation valve are connected between the second filter pressurizing valve and the first filter pressurizing valve, and one end of the second filter pressurizing valve is connected to a filter drying valve;

[0010] A through - valve is connected between the first filter isolation valve and the second filter isolation valve.

[0011] Preferably, a second air - release valve is connected between the first filter and the second filter.

[0012] Preferably, the first filter is connected to a first air release valve, the other end of the first air release valve is connected to a filter electric heater, the other end of the filter electric heater is connected to a filter drying valve, and the filter drying valve is communicated with clean and dry air.

[0013] Preferably, the lower end of the second filter is connected to a sterilization isolation valve, and the other end of the sterilization isolation valve is connected to a third air release valve.

[0014] Preferably, the filter drying valve and the filter electric heater are respectively connected to the first filter and the second filter through pipelines.

[0015] Preferably, a drying overflow valve is connected between the first water supply valve and the second water supply valve through a pipeline.

[0016] Preferably, the water production tank is respectively connected with a water production inlet valve, a water production drain valve and a water production exhaust valve.

[0017] Preferably, the water production tank is connected with a water production pressure relief valve.

[0018] Preferably, the first air release valve is communicated with a first steam and water discharge valve, and the other end of the first steam and water discharge valve is communicated with a first filter steam and water drain valve;

[0019] The second air release valve is respectively communicated with a second steam and water discharge valve and a third steam and water discharge valve, and the other end of the third steam and water discharge valve is communicated with a second filter steam and water drain valve;

[0020] The third air release valve is respectively communicated with a fourth steam and water discharge valve and a fifth steam and water discharge valve, the fourth steam and water discharge valve is communicated with the second steam and water discharge valve; the fifth steam and water discharge valve is communicated with a third filter steam and water drain valve;

[0021] The first filter steam and water drain valve, the second filter steam and water drain valve and the third filter steam and water drain valve are all communicated with a drain port.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows: for this double-stage filter integrity aseptic detection device, compared with other filter elements whose wetting is achieved by pressing water in under pressure, in this device, water flows into the filter by its own gravity, solving the problem of lack of aseptic air; at the same time, the detection air source of the second filter passes through the first filter, realizing the aseptic integrity detection of the whole detection process. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The drawings are used to provide a further understanding of the present invention, and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention, and do not constitute a limitation to the present invention. In the drawings:

[0024] Figure 1Schematic connection diagram of the integrity sterile detection device for the double-stage filter of the present invention.

[0025] In the figure: 1, water production tank; 2, first filter; 3, second filter; 4, filter steam inlet valve; 5, filter overflow valve; 6, first filter isolation valve; 7, second filter isolation valve; 8, first water supply valve; 9, second water supply valve; 10, second air release valve; 11, first air release valve; 12, filter electric heater; 13, filter drying valve; 14, sterilization isolation valve; 15, third air release valve; 16, drying overflow valve; 17, water production inlet valve; 18, water production drain valve; 19, water production exhaust valve; 20, water production pressure relief valve; 21, first steam and water discharge valve; 22, first filter steam and water drain valve; 23, second steam and water discharge valve; 24, third steam and water discharge valve; 25, second filter steam and water drain valve; 26, fourth steam and water discharge valve; 27, fifth steam and water discharge valve; 28, third filter steam and water drain valve; 29, second filter pressurizing valve; 30, fourth filter isolation valve; 31, first filter pressurizing valve; 32, second filter pressurizing valve; 33, communication valve. Specific embodiments

[0026] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0027] Please refer to Figure 1 , a double-stage filter integrity sterile detection device, including a water production tank 1, a first filter 2 and a second filter 3; the upper end of the water production tank 1 is respectively connected to a filter steam inlet valve 4 and a filter overflow valve 5, and the other end of the filter overflow valve 5 is respectively connected to a first filter isolation valve 6 and a second filter isolation valve 7 through a pipeline; the first filter isolation valve 6 communicates with the first filter 2, and the second filter isolation valve 7 communicates with the second filter 3; the lower end of the water production tank 1 is respectively connected to a first water supply valve 8 and a second water supply valve 9, the first water supply valve 8 communicates with the first filter 2, and the second water supply valve 9 communicates with the second filter 3.

[0028] The second filter 3 is connected with a second filter pressurizing valve 29, the first filter 2 is connected with a first filter pressurizing valve 31, and a second filter pressurizing valve 32 and a fourth filter isolation valve 30 are connected between the second filter pressurizing valve 29 and the first filter pressurizing valve 31, and one end of the second filter pressurizing valve 32 is connected to a filter drying valve 13.

[0029] A communication valve 33 is connected between the first filter isolation valve 6 and the second filter isolation valve 7.

[0030] Specifically, a second air release valve 10 is connected between the first filter 2 and the second filter 3.

[0031] Specifically, the first filter 2 is connected to a first air release valve 11, the other end of the first air release valve 11 is connected to a filter electric heater 12, the other end of the filter electric heater 12 is connected to a filter drying valve 13, and the filter drying valve 13 communicates with clean and dry air.

[0032] Specifically, the lower end of the second filter 3 is connected to a sterilization isolation valve 14, and the other end of the sterilization isolation valve 14 is connected to a third air release valve 15.

[0033] Specifically, the filter drying valve 13 and the filter electric heater 12 are respectively connected to the first filter 2 and the second filter 3 through pipelines.

[0034] Specifically, a drying overflow valve 16 is connected between the first water supply valve 8 and the second water supply valve 9 through a pipeline.

[0035] Specifically, the water production tank 1 is respectively connected with a water production inlet valve 17, a water production drain valve 18 and a water production exhaust valve 19. The water production tank 1 is connected with a water production pressure relief valve 20.

[0036] Specifically, the first air release valve 11 communicates with a first steam and water discharge valve 21, and the other end of the first steam and water discharge valve 21 communicates with a first filter steam and water discharge valve 22;

[0037] Specifically, the second air release valve 10 communicates with a second steam and water discharge valve 23 and a third steam and water discharge valve 24 respectively, the other end of the third steam and water discharge valve 24 communicates with a second filter steam and water discharge valve 25; the third air release valve 15 communicates with a fourth steam and water discharge valve 26 and a fifth steam and water discharge valve 27 respectively, the fourth steam and water discharge valve 26 communicates with the second steam and water discharge valve 23; the fifth steam and water discharge valve 27 communicates with a third filter steam and water discharge valve 28; the first filter steam and water discharge valve 22, the second filter steam and water discharge valve 25 and the third filter steam and water discharge valve 28 all communicate with a drain port.

[0038] The wetting process of the second filter 3 is as follows:

[0039] Open the second water supply valve 9, the second filter isolation valve 7 and the filter overflow valve 5, and the water in the water production tank 1 flows into the second filter 3 by its own weight.

[0040] The detection process of the second filter 3 is as follows:

[0041] In the first step, first open the second filter isolation valve 7, the through valve 33 and the third filter steam and water discharge valve 28 to drain the excess water;

[0042] Step 2: Open the filter drying valve 13, the first air release valve 11, the second filter pressurizing valve 29, the fourth filter isolation valve 30, and open the sterilization isolation valve 14, the third air release valve 15, and the DC air release valve downstream of the second filter 3.

[0043] The wetting process of the first filter 2 is as follows:

[0044] Open the first water supply valve 8, the first filter isolation valve 6, and the filter overflow valve 5, and the water in the water production tank 1 flows into the first filter 2 by its own weight.

[0045] The detection process of the first filter 2 is as follows:

[0046] Step 1: First, open the first filter isolation valve 6, the through valve 33, and the first filter steam and drain valve 22 to drain the excess water;

[0047] Step 2: Open the filter drying valve 13, the first filter pressurizing valve 31, the second filter pressurizing valve 32, and the DC air release valve.

[0048] Compared with other filter elements where wetting is achieved by pressing water in under pressure, in this double-stage filter integrity and sterility detection device, water flows into the filter by its own weight, solving the problem of lack of sterile air. At the same time, the detection air source of the second filter passes through the first filter, realizing the whole detection process of sterility and integrity detection.

[0049] Finally, it should be noted that the above are only the preferred embodiments of the present invention and are not used to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, for those skilled in the art, they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A double-stage filter integrity aseptic detection device, characterized in that, It includes a water production tank (1), a first filter (2) and a second filter (3); The upper end of the water production tank (1) is respectively connected to a filter inlet steam valve (4) and a filter overflow valve (5), and the other end of the filter overflow valve (5) is respectively connected to a first filter isolation valve (6) and a second filter isolation valve (7) through a pipeline; The first filter isolation valve (6) communicates with the first filter (2), and the second filter isolation valve (7) communicates with the second filter (3); The lower end of the water production tank (1) is respectively connected to a first water supply valve (8) and a second water supply valve (9), the first water supply valve (8) communicates with the first filter (2), and the second water supply valve (9) communicates with the second filter (3); A second filter pressurizing valve (29) is connected to the second filter (3), a first filter pressurizing valve (31) is connected to the first filter (2), a second filter pressurizing valve (32) and a fourth filter isolation valve (30) are connected between the second filter pressurizing valve (29) and the first filter pressurizing valve (31), and one end of the second filter pressurizing valve (32) is connected to a filter drying valve (13); A through valve (33) is connected between the first filter isolation valve (6) and the second filter isolation valve (7).

2. The double-stage filter integrity aseptic detection device according to claim 1, characterized in that, A second air release valve (10) is connected between the first filter (2) and the second filter (3).

3. The integrity sterility detection device for the two-stage filter according to claim 2, wherein, The first filter (2) is connected to a first air release valve (11), the other end of the first air release valve (11) is connected to a filter electric heater (12), the other end of the filter electric heater (12) is connected to a filter drying valve (13), and the filter drying valve (13) communicates with clean and dry air.

4. The double-stage filter integrity aseptic detection device according to claim 3, characterized in that The lower end of the second filter (3) is connected to a sterilization isolation valve (14), and the other end of the sterilization isolation valve (14) is connected to a third air release valve (15).

5. The integrity aseptic detection device for the two-stage filter according to claim 3, characterized in that, The filter drying valve (13) and the filter electric heater (12) are respectively connected to the first filter (2) and the second filter (3) through pipelines.

6. The integrity sterile detection device for the two-stage filter according to claim 1, wherein, A drying overflow valve (16) is connected between the first water supply valve (8) and the second water supply valve (9) through a pipeline.

7. The integrity sterile detection device for the two-stage filter according to claim 1, characterized in that The water production tank (1) is respectively connected to a water production inlet valve (17), a water production drain valve (18) and a water production exhaust valve (19).

8. The double-stage filter integrity aseptic detection device according to claim 1, wherein, The water production tank (1) is connected to a water production pressure relief valve (20).

9. The integrity sterile detection device of the two-stage filter according to claim 4, characterized in that, The first air release valve (11) communicates with a first steam and water discharge valve (21), and the other end of the first steam and water discharge valve (21) communicates with a first filter steam and water discharge valve (22); The second air release valve (10) communicates with a second steam and water discharge valve (23) and a third steam and water discharge valve (24) respectively, and the other end of the third steam and water discharge valve (24) communicates with a second filter steam and water discharge valve (25); The third air release valve (15) is respectively communicated with a fourth steam and water drain valve (26) and a fifth steam and water drain valve (27), and the fourth steam and water drain valve (26) is communicated with the second steam and water drain valve (23); the fifth steam and water drain valve (27) is communicated with the third filter steam and water drain valve (28). The first filter steam and water drain valve (22), the second filter steam and water drain valve (25) and the third filter steam and water drain valve (28) are all communicated with a drain port.