On-line wetting, sterilizing and integrity detecting device for injection microfilter

Abstract

The utility model relates to the technical field of detection devices, and discloses an online wetting, sterilizing and integrity detection device for an injection microporous filter, which comprises a main pipeline, a first branch pipe and a second branch pipe, a fifth valve, a second integrity detector, a fourth valve, a seventh valve, a microporous filter and an eleventh valve are sequentially arranged on the main pipeline; the first branch pipe and the second branch pipe are respectively communicated with the main pipeline between the fourth valve and the seventh valve; the first branch pipe is used for introducing injection water, the second branch pipe is used for introducing pure steam, and the main pipeline is used for introducing clean compressed air. The to-be-detected microporous filter is directly mounted on the main pipeline, so that the process of transferring the microporous filter to the integrity detection filter cartridge and the liquid medicine pipeline is reduced, and artificial pollution possibly caused in the transferring process and damage to the microporous filter due to frequent disassembly are avoided.

Description

Technical Field

[0001] The utility model relates to the technical field of detection devices, in particular to an online wetting, sterilization and integrity detection device for an injection microporous filter. Background Art

[0002] In the production process of injections, microporous filters are usually used to remove particles, visible foreign matter, microorganisms, etc. from the drug solution. There are usually two types of microporous filters used for sterilization filtration, one for sterilization filtration of drug solution terminals, and one for sterilization filtration of air; both types of microporous filters must undergo microporous filter integrity testing in accordance with the requirements of Good Manufacturing Practice for Pharmaceuticals (commonly known as GMP) to ensure the sterilization filtration effect.

[0003] In most companies, microporous filter integrity testing is usually done offline, which has the advantages of simple equipment and easy learning. However, it has many disadvantages, mainly including: each time the test needs to be done, the filter cartridge and filter element need to be disassembled and assembled, which can easily cause contamination of the filter element during the process; and problems such as poor sealing due to manual assembly affecting the accuracy of the test. Therefore, it is necessary to develop a new method or device for microporous filter integrity testing.

[0004] like Figure 1 The microporous filter integrity detection device in the prior art shown is composed of an air source filter, two air source control valves, a first integrity detector, an integrity detection filter cartridge and a discharge valve. The specific operation process of using the above microporous filter integrity detection device is: manually place the microporous filter in water for injection to fully wet it (the wetting time is generally more than 8 hours); manually install the microporous filter in the integrity detection filter cartridge; open the discharge valve; open the two air source control valves and adjust them to the pressure value required for the microporous filter detection (the pressure value is usually based on the value recommended by the microporous filter manufacturer); turn on the integrity detection instrument, start the integrity detection, and output the results.

[0005] There are the following technical problems in testing using the microporous filter integrity testing device in the above-mentioned prior art: the microporous filter relies on manual wetting, which takes a long time; it is easy to cause human pollution during the manual transportation process; the integrity test filter cartridge needs to be disassembled and assembled for each test, and the microporous filter is easily contaminated during the disassembly and assembly process; the connection of the integrity test filter cartridge is easily not sealed due to manual assembly, affecting the accuracy of the test; usually after the integrity test is completed, it is assembled into the liquid medicine pipeline and sterilized together with the liquid medicine pipeline. It is unknown whether the sterilization process will affect the integrity of the microporous filter, and there is a risk of affecting the integrity of the microporous filter itself. Utility Model Content

[0006] In view of the problems existing in the prior art, the purpose of the utility model is to provide an online wetting, sterilization and integrity testing device for an injection microporous filter, so as to solve the problem that the microporous filter integrity testing device in the prior art needs to be manually transported when performing integrity testing on the microporous filter, and the microporous filter needs to be disassembled multiple times, which easily causes contamination to the microporous filter.

[0007] An online wetting, sterilizing and integrity testing device for an injection microporous filter, comprising a main pipe, a first branch pipe and a second branch pipe;

[0008] The main pipe is provided with a fifth valve, a second integrity detector, a fourth valve, a seventh valve, a microporous filter and an eleventh valve in sequence; the first branch pipe and the second branch pipe are respectively connected to the main pipe between the fourth valve and the seventh valve; the first branch pipe is used for introducing water for injection, the second branch pipe is used for introducing pure steam, and the main pipe is used for introducing clean compressed air.

[0009] Furthermore, the first branch pipe is provided with a second valve for controlling the flow of injection water.

[0010] Furthermore, the second branch pipe is provided with a third valve for controlling the introduction of pure steam.

[0011] Furthermore, the main pipe between the fourth valve and the seventh valve is connected with a third branch pipe; the third branch pipe is located at the lower side of the second branch pipe; and a sixth valve is arranged on the third branch pipe.

[0012] Furthermore, the main pipeline between the microporous filter and the eleventh valve is connected with a fourth branch pipe, and the fourth branch pipe is provided with an eighth valve, an integrity test tank, a ninth valve and a steam trap in sequence from top to bottom; and a respirator is provided on the integrity test tank.

[0013] Furthermore, a fifth branch pipe is connected to the fourth branch pipe between the integrity test tank and the ninth valve, and a tenth valve is provided at the bottom end of the fifth branch pipe.

[0014] Furthermore, an air sterilizing filter is provided on the main pipe between the second integrity detector and the fourth valve.

[0015] Beneficial effects: The microporous filter to be tested is directly installed on the main pipe, which reduces the step of transporting the microporous filter to the integrity test cartridge and avoids the risk of contamination caused by disassembling the integrity test cartridge. The microporous filter is directly installed on the main pipe, the second valve, the seventh valve and the eleventh valve are opened, and injection water is introduced from the first branch pipe to clean and wet the microporous filter. The time required to wet the microporous filter to the integrity test is about 0.5 hours, which can effectively reduce the time required for manual wetting, and at the same time avoid the process of manually transporting the microporous filter to the integrity test cartridge after manual wetting, avoiding possible contamination during transportation; after the microporous filter is wetted with injection water, the second valve is closed, the third valve is opened, and pure steam is introduced from the second branch pipe to sterilize the microporous filter. Compared with the existing technology, During the operation, the microporous filter 29 needs to be transferred and installed in the drug pipeline for unified sterilization, which can reduce the process of installing and disassembling the microporous filter 29, and at the same time avoid the possibility of other substances in the drug pipeline causing contamination or damage to the microporous filter 29; after the microporous filter is sterilized with pure steam, the third valve is closed, the fifth valve and the fourth valve are opened, and clean compressed air is introduced into the main pipeline, and the integrity of the microporous filter is tested by the second integrity detector; the air sterilizing filter is used to ensure the quality of the pure compressed air passing through the microporous filter to avoid contamination of the microporous filter by impurities carried in the pure compressed air. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the specification will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0017] Figure 1 It is a microporous filter integrity detection device in the prior art;

[0018] Figure 2 It is a schematic diagram of the overall structure of an embodiment of the utility model.

[0019] In the figure: 11, first air source control valve; 12, first air source filter; 13, second air source control valve; 14, first integrity detector; 15, first valve; 16, integrity detection filter cartridge; 17, discharge valve;

[0020] 21. Second valve; 22. Third valve; 23. Fourth valve; 24. Air sterilizing filter; 25. Second integrity detector; 26. Fifth valve; 27. Sixth valve; 28. Seventh valve; 29. ​​Microporous filter; 210. Eighth valve; 211. Integrity test tank; 212. Respirator; 213. Ninth valve; 214. Steam trap; 215. Tenth valve; 216. Eleventh valve. DETAILED DESCRIPTION

[0021] The technical solutions in the embodiments of the present invention are described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. For ease of explanation, the terms "vertical", "horizontal", "left", "right", "upper", "lower", "inner", "outer", "bottom", etc. used in this specification indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as a limitation on the present application.

[0022] It should be noted that the embodiments of the present invention and the features involved in the embodiments can be combined with each other without conflict. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0023] like Figure 1 A microporous filter integrity detection device in the prior art shown in the figure includes a first air source control valve 11, a first air source filter 12, a second air source control valve 13, a first integrity detector 14, a first valve 15, a first integrity detection filter cartridge 16 and a discharge valve 17 which are installed on the same pipeline from top to bottom in sequence; the first integrity detection filter cartridge 16 is a detachable structure, and a cavity for installing a microporous filter 29 is provided in the first integrity detection filter cartridge 16; the first air source control valve 11 is connected to the air source of clean compressed air, and is used to control the input of clean compressed air in the pipeline; the microporous filter 29 is a prior art and will not be described in detail here.

[0024] The specific use process of the microporous filter integrity detection device in the prior art is as follows: first, the microporous filter 29 to be detected is placed in the injection water for manual soaking. To ensure that the microporous filter 29 is fully wetted, the soaking time is at least 8 hours; after the microporous filter 29 is fully wetted, the microporous filter 29 is installed in the first integrity detection filter cartridge 16; after the microporous filter 29 is installed, the first air source control valve 11, the second air source control valve 13 and the discharge valve 17 are opened, and the gas pressure in the pipeline is adjusted to the value recommended by the manufacturer of the microporous filter 29; then the first integrity detector 14 and the first valve 15 are opened to detect the integrity of the microporous filter 29 and output the result.

[0025] In the above process, the microporous filter 29 needs to be wetted in advance, which takes a long time; after wetting, the microporous filter 29 needs to be manually transported, which is easy to cause human contamination; each time the microporous filter 29 is tested, the integrity detection filter cartridge 16 and the microporous filter 29 need to be disassembled, and the disassembly process is easy to contaminate the microporous filter 29; when the microporous filter 29 is installed in the integrity detection filter cartridge 16, the accuracy of the integrity test result may be affected due to loose sealing; after the integrity test, the microporous filter 29 is assembled into the medicine pipeline and sterilized together with the medicine pipeline. The process of sterilizing the microporous filter 29 together with the medicine pipeline may involve the risk of affecting the integrity of the microporous filter 29.

[0026] like Figure 2 The figure shows an online wetting, sterilizing and integrity testing device for a microporous filter for injection provided by an embodiment of the utility model, which comprises a main pipe, a first branch pipe and a second branch pipe; the main pipe is provided with a fifth valve 26, a second integrity detector 25, an air sterilizing filter 24, a fourth valve 23, a seventh valve 28, a microporous filter 29 and an eleventh valve 216 in sequence from right to left; the main pipe is used to introduce clean compressed air, and the fifth valve 26 is used to control the introduction of clean compressed air;

[0027] One end of the first branch pipe and one end of the second branch pipe are respectively connected to the main pipe between the fourth valve 23 and the seventh valve 28. The first branch pipe is used to introduce water for injection into the main pipe, and the second branch pipe is used to introduce pure steam into the main pipe. The first branch pipe is provided with a second valve 21 for controlling the flow of water for injection, and the second branch pipe is provided with a third valve 22 for controlling the introduction of pure steam.

[0028] In this embodiment, the microporous filter 29 to be tested is directly installed on the main pipe, which reduces the step of installing the microporous filter 29 on the integrity detection filter cartridge 16, and avoids the risk of contamination caused by disassembling the integrity detection filter cartridge 16 and transporting the microporous filter 29. The microporous filter 29 is directly installed on the main pipe, the second valve 21, the seventh valve 28 and the eleventh valve 216 are opened, and injection water is introduced from the first branch pipe to clean and wet the microporous filter 29. The time required to wet the microporous filter 29 to the integrity test is about 0.5 hours, which can effectively reduce the time required for manual wetting, and at the same time avoid the process of manually transporting the microporous filter 29 after artificial wetting, avoiding possible contamination during transportation; after the microporous filter 29 is wetted with injection water, the second valve 21 is closed, the third valve 22 is opened, and pure steam is introduced from the second branch pipe to sterilize the microporous filter 29. Compared with the prior art The microporous filter 29 needs to be installed separately in the liquid medicine pipeline for unified sterilization process, which can reduce the process of transporting the microporous filter 29 and avoid the possibility of contamination or damage to the microporous filter 29 by other substances in the liquid medicine pipeline; after the microporous filter 29 is sterilized by pure steam, the third valve 22 is closed, the fifth valve 26 and the fourth valve 23 are opened, and clean compressed air is introduced into the main pipeline, and the integrity of the microporous filter 29 is tested by the second integrity detector 25; the air sterilizing filter 24 is used to ensure the quality of the pure compressed air passing through the microporous filter 29 to avoid contamination of the microporous filter 29 by impurities carried in the pure compressed air.

[0029] It also includes a third branch pipe, which is located at the lower side of the second branch pipe, and one end of the third branch pipe is connected to the main pipe between the fourth valve 23 and the seventh valve 28; the third branch pipe is provided with a sixth valve 27.

[0030] In this embodiment, before the microporous filter 29 is sterilized by pure steam, the third valve 22 and the sixth valve 27 are opened, and the seventh valve 28 is closed, so that the condensed water formed after the pure steam in the second branch pipe is condensed can be easily discharged. The discharge of the condensed water can minimize the interference that the condensed water may cause to the subsequent integrity detection.

[0031] The main pipe between the microporous filter 29 and the eleventh valve 216 is connected to a fourth branch pipe, on which are arranged, from top to bottom, an eighth valve 210, an integrity test tank 211, a ninth valve 213 and a steam trap 214. A respirator 212 is arranged on the integrity test tank 211.

[0032] In this embodiment, when the microporous filter 29 is sterilized by pure steam, the third valve 22, the seventh valve 28, the eighth valve 210, the ninth valve 213 and the steam trap 214 are opened; the integrity test tank 211 is used as a buffer tank and can play a buffering role; the steam trap 214 is a valve that automatically discharges condensed water and non-condensable gases to block steam leakage. In the industrial industry, steam is often used to heat products or as a power for mechanical equipment. In this case, the steam trap 214 is required to ensure that there is no steam leakage. The setting of the buffer tank and the steam trap 214 can improve the sterilization effect.

[0033] The fourth branch pipe between the integrity test tank 211 and the ninth valve 213 is connected to a fifth branch pipe, and a tenth valve 215 is disposed at the bottom end of the fifth branch pipe.

[0034] In this embodiment, the tenth valve 215 is used to discharge the remaining pure compressed air after the integrity detection process.

[0035] Working principle: The injection water used to wet the microporous filter 29, the pure steam used to sterilize the microporous syringe, the pure compressed air required for the integrity test of the microporous filter 29 and related equipment are installed on a pipeline; the microporous filter 29 is wetted, sterilized and integrity tested in sequence by opening and closing different valves. The wetting, sterilization and integrity test processes are integrated on a pipeline, which reduces the need for frequent transportation of the microporous filter 29 in the prior art, reduces the pollution that may be caused by the process of repeatedly disassembling the integrity test filter cartridge 16 and the microporous filter 29, reduces the time required for the integrity test process, and avoids the damage to the integrity of the microporous filter 29 that may be caused when the microporous filter 29 is sterilized together with the liquid medicine pipeline.

[0036] Although preferred embodiments of the present invention have been described, those skilled in the art may make additional changes and modifications to these embodiments once they are aware of the basic creative concepts. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention. Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. An online wetting, sterilization and integrity detection device for injection microporous filters, characterized in that: It includes the main pipe, the first branch pipe and the second branch pipe; The main pipe is provided with a fifth valve, a second integrity detector, a fourth valve, a seventh valve, a microporous filter and an eleventh valve in sequence; the first branch pipe and the second branch pipe are respectively connected to the main pipe between the fourth valve and the seventh valve; the first branch pipe is used for introducing water for injection, the second branch pipe is used for introducing pure steam, and the main pipe is used for introducing clean compressed air.

2. The online wetting, sterilization and integrity detection device for injection microporous filter according to claim 1 is characterized in that: The first branch pipe is provided with a second valve for controlling the flow of injection water.

3. The online wetting, sterilization and integrity detection device for injection microporous filter according to claim 1 is characterized in that: The second branch pipe is provided with a third valve for controlling the introduction of pure steam.

4. The online wetting, sterilization and integrity detection device for injection microporous filter according to any one of claims 1 to 3, characterized in that: The main pipe between the fourth valve and the seventh valve is connected with a third branch pipe; the third branch pipe is located at the lower side of the second branch pipe; and the sixth valve is arranged on the third branch pipe.

5. The online wetting, sterilization and integrity detection device for injection microporous filter according to any one of claims 1 to 3, characterized in that: The main pipeline between the microporous filter and the eleventh valve is connected with a fourth branch pipe, and the fourth branch pipe is provided with an eighth valve, an integrity test tank, a ninth valve and a steam trap in sequence from top to bottom; and a respirator is provided on the integrity test tank.

6. The device for online wetting, sterilization and integrity detection of microporous filter for injection according to claim 5, characterized in that: The fourth branch pipe between the integrity test tank and the ninth valve is connected with a fifth branch pipe, and the bottom end of the fifth branch pipe is provided with a tenth valve.

7. The device for online wetting, sterilization and integrity detection of microporous filter for injection according to claim 1, characterized in that: An air sterilizing filter is arranged on the main pipe between the second integrity detector and the fourth valve.

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