Filter integrity testing device and testing method

Abstract

The invention relates to a filter integrity testing device, which is used to test the integrity of a filter to be tested. The filter integrity testing device comprises an integrity tester, a connecting barrel and an isolator, wherein: the filter to be tested is arranged in a first cavity inside the isolator; the connecting barrel comprises a barrel body and a connecting pipe, a second cavity is formed inside the barrel body, one end of the barrel body is connected to the isolator, the connecting pipe is installed in the second cavity, one end of the connecting pipe is connected to the filter to be tested, and the other end of the connecting pipe is connected to the integrity tester; the integrity tester is used to transport compressed gas to the connecting pipe; the equipment required by the present application is simple, occupies a small area, and has a low investment cost, and the connecting barrel and the isolator can be reused, saving the use and processing costs of consumables, and the integrity tester is connected to the filter to be tested through the connecting pipe to perform the integrity test of the filter to be tested, the connection relationship is simple, and the gas leakage caused by the complex connection relationship is avoided, thereby improving the test accuracy.

Description

Technical Field

[0001] The present invention relates to the technical field of filter integrity testing, and in particular to a filter integrity testing device and a testing method. Background Art

[0002] In the production process of sterile products, sterile products can be divided into two categories according to the production process: the first category is the terminal sterilization type using the final sterilization process, and the second category is the non-terminal sterilization type using the aseptic production process in some or all processes. For products that cannot be terminally sterilized, filters are often required to filter and sterilize the products. In order to ensure the sterility of the final product, it is crucial to conduct integrity testing on the filter.

[0003] Currently, there are two main ways to conduct integrity testing on filters. One is online integrity testing, which means in-situ testing of sterilizing filters. The sterilizing filters do not need to be moved and integrity testing is performed at the filtration station. The other is integrity testing that integrates disposable consumables and filters, which means performing integrity testing on filters through disposable consumables.

[0004] However, the equipment required for online integrity testing is highly integrated and occupies a large amount of factory space, resulting in high investment costs. The integrity test of the integrated disposable consumables and filters uses a large number of disposable consumables, which has a high cost of using consumables. After use, the disposable consumables will be treated as hazardous chemicals, increasing the processing cost. In addition, the connection between the disposable consumables and the filter is complicated, which is prone to gas leakage leading to test failure, resulting in low test accuracy. Summary of the invention

[0005] Based on this, it is necessary to provide a sterilizing filter integrity testing device and testing method to address the current problems of high cost and low test accuracy of sterilizing filter integrity testing.

[0006] A filter integrity testing device is used to test the integrity of a filter to be tested. The filter integrity testing device comprises: an integrity tester, a connecting barrel and an isolator, wherein:

[0007] The filter to be tested is arranged in the first cavity inside the isolator;

[0008] The connecting barrel comprises a barrel body and a connecting pipe, a second cavity is formed inside the barrel body, one end of the barrel body is connected to the isolator, the connecting pipe is installed in the second cavity, one end of the connecting pipe is connected to the filter to be tested, and the other end of the connecting pipe is connected to the integrity tester;

[0009] The integrity tester is used to deliver compressed gas to the connecting pipe.

[0010] The above-mentioned filter integrity testing device connects the integrity tester with the filter to be tested by setting a connecting pipe to perform the integrity test of the filter to be tested. Compared with the prior art using online integrity testing, the equipment required by this application includes a connecting barrel, an integrity tester and an isolator. The equipment is simple, occupies a small area and has a low investment cost. Compared with the prior art using disposable consumables and filter integrated integrity testing, this application uses a connecting barrel and an isolator to replace the use of disposable consumables. The connecting barrel and the isolator can be reused, which greatly saves the use and processing costs of consumables. In addition, this application connects the integrity tester with the filter to be tested through a connecting pipe to perform the integrity test of the filter to be tested. The connection relationship is simple, which avoids gas leakage caused by complex connection relationship, reduces test failures, and thus improves test accuracy.

[0011] In one of the embodiments, the connecting barrel further includes a first filter, which is disposed between the connecting pipe and the integrity tester and is in communication with both the connecting pipe and the integrity tester.

[0012] In one embodiment, the barrel body includes an end plate and a side wall connected to the end plate, the end plate and the side wall form the second cavity, and the end plate is provided with a first fixed through hole penetrating the thickness thereof, the side of the side wall facing away from the end plate is connected to the isolator, and the first filter is fixed in the first fixed through hole and connected to the connecting pipe.

[0013] In one embodiment, a split butterfly valve is further included, wherein the split butterfly valve includes an active valve and a passive valve, wherein:

[0014] The passive valve seal is installed on a side of the side surrounding wall away from the end plate;

[0015] The isolator comprises a working cabin with an opening at one end and a visual door sealedly connected to the open end of the working cabin, the first cavity is formed inside the working cabin, an operating port is opened on the visual door, a glove is sealedly arranged in the operating port, and the glove is used to install the filter to be tested on the connecting pipe;

[0016] The active valve is installed in the working cabin, and is used to connect the first cavity and the second cavity when docking with the passive valve.

[0017] In one embodiment, the central axis of the connecting tube is parallel to the central axis of the barrel body, and the length of the connecting tube from the end of the barrel body close to the separator is in the range of 2 cm to 3 cm.

[0018] In one embodiment, a connecting piece is further included, one end of which is detachably connected to the connecting tube, and the other end of which extends into the isolator and is detachably connected to the filter to be tested.

[0019] In one embodiment, the connecting member is a first installation pipe, and the filter to be tested is a capsule filter to be tested.

[0020] In one embodiment, the connecting member is a filter cartridge sleeve, and the filter to be tested is a filter cartridge to be tested.

[0021] The present invention also provides a method for testing the filter integrity testing device based on any one of the above embodiments, comprising the following steps:

[0022] S1. Provide integrity tester, connection barrel, isolator, initial filter and water for injection;

[0023] S2, connecting the connecting barrel to the isolator, and placing the initial filter and the water for injection in the isolator;

[0024] S3, wetting the initial filter with the injection water to obtain a filter to be tested, and connecting the filter to be tested with the connecting pipe of the connecting barrel;

[0025] S4, connecting the integrity tester to the end of the connecting tube away from the filter to be tested, and turning on the integrity tester to perform an integrity test on the filter to be tested.

[0026] The testing method of the above-mentioned filter integrity testing device first obtains the integrity tester, the connecting barrel, the isolator, the initial filter and the water for injection through step S1; then, the connecting barrel and the isolator are docked through step S2, and the initial filter and the water for injection are arranged in the isolator; then, the filter to be tested is obtained by wetting the initial filter with the water for injection through step S3, and the filter to be tested is connected with the connecting pipe of the connecting barrel; finally, the integrity tester is connected with the end of the connecting pipe barrel away from the filter to be tested through step S4, and the integrity tester is turned on to perform the integrity test of the filter to be tested. Through the above-mentioned arrangement, the integrity test of the filter to be tested is realized more conveniently. The whole process is simple and convenient to operate with strong operability. In addition, by setting a connecting pipe to connect the integrity tester with the filter to be tested to perform the integrity test of the filter to be tested, compared with the prior art using online integrity testing, the equipment required by the present application includes a connecting barrel, an integrity tester and an isolator. The equipment is simple, occupies a small area and has a low investment cost. Compared with the prior art using disposable consumables and filter integrated integrity testing, the present application uses connecting barrels and isolators to replace the use of disposable consumables. The connecting barrels and isolators can be reused, which greatly saves the use and processing costs of consumables. In addition, the present application connects the integrity tester with the filter to be tested through a connecting pipe to perform the integrity test of the filter to be tested. The connection relationship is simple, which avoids gas leakage caused by complex connection relationship, reduces test failures, and thus improves test accuracy.

[0027] In one embodiment, in step S2, the following steps are included:

[0028] S21, sterilizing the connecting barrel, the initial filter and the water for injection once;

[0029] S22, placing the primary filter and the water for injection after the primary sterilization in the isolator;

[0030] S23, the isolator performs secondary sterilization on the initial filter and the water for injection;

[0031] S24, aseptically connecting the sterilized connection barrel to the isolator. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A schematic diagram of a filter integrity testing device provided by the present invention;

[0033] Figure 2 A flowchart of a test method for a filter integrity test device provided by the present invention;

[0034] Figure 3 This is a schematic diagram of the interior of the isolator provided by the present invention when performing a hydrogen peroxide sterilization process.

[0035] in:

[0036] 10. filter integrity test device; 20. filter to be tested; a. capsule filter to be tested; 30. initial filter; b. capsule filter;

[0037] 100. Integrity tester; 110. First delivery pipe;

[0038] 200, isolator; 210, first cavity;

[0039] 300, connecting barrel; 310, barrel body; 311, second cavity; 320, connecting pipe; 330, first filter;

[0040] 400, fixing assembly; 410, second clamp;

[0041] 500, split butterfly valve; 510, active valve;

[0042] 600, connecting piece; c, first installation pipeline; d, filter element sleeve;

[0043] 700. Breathing bag. DETAILED DESCRIPTION

[0044] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0045] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0046] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0047] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0048] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0049] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for illustrative purposes only and are not intended to be the only implementation method.

[0050] Implementation Reference Figure 1 As shown, an embodiment of the present invention provides a filter integrity testing device 10 for testing the integrity of a filter 20 to be tested. The filter integrity testing device 10 comprises: an integrity tester 100, a connecting barrel 300 and an isolator 200, wherein:

[0051] The filter 20 to be tested is disposed in the first cavity 210 inside the isolator 200. In the specific configuration, the filter 20 to be tested refers to the initial filter 30 wetted with injection water;

[0052] The connecting barrel 300 includes a barrel body 310 and a connecting pipe 320. A second cavity 311 is formed inside the barrel body 310. One end of the barrel body 310 is connected to the isolator 200. The connecting pipe 320 is installed in the second cavity 311. One end of the connecting pipe 320 is connected to the filter 20 to be tested. The other end of the connecting pipe 320 is connected to the integrity tester 100. In the specific setting, the barrel body 310 and the connecting pipe 320 are made of stainless steel. The first delivery pipe 110 in the integrity tester 100 is connected to the connecting pipe 320.

[0053] The integrity tester 100 is used to deliver compressed gas to the connecting tube 320. In a specific setting, the compressed gas is sterile gas. In specific use, a corresponding test program is selected on the integrity tester 100 to start the integrity test of the filter 20 to be tested. The integrity tester 100 will deliver the compressed air to the connecting tube 320 through the first delivery tube 110, and the connecting tube 320 will deliver the compressed air to the filter 20 to be tested for its integrity test.

[0054] The above-mentioned filter integrity testing device 10 connects the integrity tester 100 with the filter 20 to be tested by setting a connecting tube 320 to perform an integrity test on the filter 20 to be tested. Compared with the prior art using online integrity testing, the equipment required by this application includes a connecting barrel 300, an integrity tester 100 and an isolator 200. The equipment is simple, occupies a small area and has a low investment cost. Compared with the prior art using disposable consumables and filter integrated integrity testing, this application uses a connecting barrel 300 and an isolator 200 to replace the use of disposable consumables. The connecting barrel 300 and the isolator 200 can be reused, which greatly saves the use and processing costs of consumables. In addition, this application connects the integrity tester 100 with the filter 20 to be tested through a connecting tube 320 to perform an integrity test on the filter 20 to be tested. The connection relationship is simple, which avoids gas leakage caused by a complex connection relationship, reduces the number of test failures, and thus improves the test accuracy.

[0055] In order to ensure the sterility of the gas input into the filter 20 to be tested, in a preferred embodiment, the connecting barrel 300 also includes a first filter 330, and the first filter 330 is arranged between the connecting tube 320 and the integrity tester 100, and the first filter 330 is connected to both the connecting tube 320 and the integrity tester 100. In the specific setting, the first delivery pipe 110 in the integrity tester 100 is connected to the end of the first filter 330 away from the connecting pipe 320. In order to strengthen the connection between the first delivery pipe 110 and the first filter 330, the filter integrity test device 10 also includes a fixing assembly 400, and the fixing assembly 400 includes a first clamp. The first clamp is sleeved at the connection between the first delivery pipe 110 and the first filter 330. The integrity tester 100 inputs compressed air through the first delivery pipe 110 into the first filter 330 for filtration. The first filter 330 is arranged on the outside of the barrel body 310, and the first filter 330 is an air filter, which ensures that the gas input into the connecting pipe 320 after passing through the first filter 330 is sterile gas.

[0056] In order to conveniently seal and connect the first filter 330 with the connecting pipe 320, the first filter 330 is fixed to the barrel body 310. Specifically, the barrel body 310 includes an end plate and a side wall connected to the end plate, the end plate and the side wall form a second cavity 311, and a first fixed through hole running through the thickness of the end plate is provided on the end plate, and the side wall is connected to the isolator 200 on the side away from the end plate. The first filter 330 is fixed in the first fixed through hole and communicated with the connecting pipe 320. It is not difficult to understand that the first fixed through hole is connected to the second cavity 311. In the specific setting, in order to ensure that the first filter 330 smoothly transmits sterile gas to the connecting pipe 320, the first filter 330 is sealed and connected to the connecting pipe 320, and the barrel body 310 can also include a cylindrical docking piece, which is fixed to the inner wall of the first fixed through hole, one end of the docking piece is sealed and connected to the connecting pipe 320, and the other end of the docking piece is sealed and connected to the first filter 330.

[0057] It should be noted that the test of filter integrity in the prior art also includes offline integrity testing, that is, removing the filter and transferring it to a designated workstation for integrity testing, but the offline testing is performed before the filter is sterilized and after use, and the integrity of the sterilized filter before use cannot be directly confirmed. The present application can perform integrity tests on the filter before and after sterilization. In order to ensure that the integrity of the sterilized filter 20 to be tested is tested in a sterile environment, so that the sterilized filter 20 to be tested remains sterile after the test, specifically, the filter integrity testing device 10 also includes a split butterfly valve 500, and the split butterfly valve 500 includes an active valve 510 and a passive valve, wherein:

[0058] The passive valve is seal-mounted on the side of the side wall away from the end plate. In a specific configuration, the passive valve is seal-connected to the side wall. When the passive valve is opened, the outside can be connected to the second cavity 311.

[0059] The isolator 200 includes a working cabin with an opening at one end and a visual door sealedly connected to the open end of the working cabin. A first cavity 210 is formed inside the working cabin. An operating port is provided on the visual door. A glove is sealedly arranged in the operating port. The glove is used to install the filter 20 to be tested on the connecting pipe 320.

[0060] The active valve 510 is installed in the working cabin, and the active valve 510 is used to connect the first cavity 210 and the second cavity 311 when docking with the passive valve. In specific use, the active valve 510 is sealed and connected to the working cabin. When the active valve 510 is opened, the outside can be connected to the first cavity 210. When the isolator 200 is docked with the connecting barrel 300, that is, the active valve 510 and the passive valve are docked as one. At this time, opening the active valve 510 from the inside of the first cavity 210 through the glove can drive the passive valve to open, and the first cavity 210 is connected with the second cavity 311.

[0061] It should be noted that the filter 20 to be tested refers to the initial filter 30 moistened with injection water. It is not difficult to understand that in order to ensure the sterility of the entire test process, in specific use, the sterilized initial filter 30 and a bottle of sterilized injection water are placed in the first cavity 210, and the isolator 200 is used for secondary sterilization again, and then the sterilized connecting barrel 300 is aseptically docked with the isolator 200, and the initial filter 30 is moistened with injection water through gloves to obtain the filter 20 to be tested, and then the filter 20 to be tested is connected to the connecting tube 320 through gloves to start the integrity test, and the whole process ensures the sterility of the filter 20 to be tested. Through the above settings, the integrity test of the filter 20 to be tested is carried out in the isolator 200, so that the sterilized filter 20 to be tested remains sterile after the test.

[0062] In order to more conveniently connect the filter 20 to be tested in the isolator 200 with the connecting pipe 320, in a preferred embodiment, the central axis of the connecting pipe 320 is parallel to the central axis of the barrel body 310, and the length of the connecting pipe 320 from the end of the barrel body 310 close to the isolator 200 ranges from 2 cm to 3 cm. In specific settings, the length of the connecting pipe 320 from the end of the barrel body 310 close to the isolator 200 can be any value of 2.2 cm, 2.4 cm, 2.6 cm, 2.8 cm and 2 cm to 3 cm. When the length of the connecting pipe 320 from the end of the barrel body 310 close to the isolator 200 is greater than 3 cm, it is difficult for the operator to connect the filter 20 to be tested with the connecting pipe 320 through the gloves. When the length of the connecting pipe 320 from the end of the barrel body 310 close to the isolator 200 is less than 2 cm, it is not conducive to the installation of the passive valve.

[0063] In order to more conveniently install and replace the filter 20 to be tested, in a preferred embodiment, the filter integrity test device 10 further includes a connector 600, one end of which is detachably connected to the connecting tube 320, and the other end of which extends into the isolator 200 and is detachably connected to the filter 20 to be tested. In specific operation, the connector 600 is placed in the first cavity 210 together with the sterilized initial filter 30 and the sterilized water for injection after sterilization. When installation is required, the operator installs the connector 600 between the connecting tube 320 and the filter 20 to be tested through gloves. By providing the connector 600 that acts as a bridge, the operator can conveniently connect the filter 20 to be tested in the isolator 200 with the connecting tube 320 in the connecting barrel 300 through the connector 600 through the gloves, and the filter 20 to be tested is detachably connected to the connector 600, so that after one filter 20 to be tested completes the integrity test, the next filter 20 to be tested can be quickly replaced for testing.

[0064] In order to conveniently realize the detachable connection between the connector 600, the connecting pipe 320 and the filter 20 to be tested, specifically, the connector 600 is the first installation pipe c, and the filter 20 to be tested is the capsule filter a to be tested. In the specific setting, the capsule filter a to be tested refers to the capsule filter b wetted with injection water, the first installation pipe c can be a hose, or a hard pipe, one end of the first installation pipe c is sleeved on the filter element to be tested, and the other end of the first installation pipe c is connected to the connecting pipe 320. In order to strengthen the connection between the first installation pipe c and the connecting pipe 320, the fixing assembly 400 includes a second clamp 410 and a first sealing gasket, the second clamp 410 is sleeved on the connection between the first installation pipe c and the connecting pipe 320, the first sealing gasket is arranged in the second clamp 410, and the side of the first sealing gasket facing away from the second clamp 410 abuts against the connection between the first installation pipe c and the connecting pipe 320. During specific use, the second clamp 410, the first sealing gasket, the first installation pipe c, the capsule filter b and the injection water are placed together in the first cavity 210 after sterilization. When installation is required, the operator uses gloves to install the first installation pipe c, the first sealing gasket, the second clamp 410 and the capsule filter b moistened with the injection water.

[0065] It should be noted that, currently, the integrity test of the integrated disposable consumables and filters can only test the capsule filter b, and the online integrity test is only applicable to the filter element. In addition to testing the capsule filter b, the present application can also test the filter element. The present application can be used for testing filters of any specifications and models, and has strong practicality and applicability. Specifically, the connector 600 is the filter element sleeve d, and the filter to be tested 20 is the filter element to be tested. It is not difficult to understand that the filter element to be tested refers to the filter element wetted with injection water. In the specific setting, the material of the filter element sleeve d is stainless steel. The filter element sleeve d includes a first sleeve and a second sleeve connected to the first sleeve. The second sleeve is sleeved on the filter element to be tested, and the first sleeve is connected to the connecting pipe 320. In order to strengthen the connection between the filter element sleeve d, i.e., the first sleeve and the connecting pipe 320, the fixing assembly 400 includes a third clamp and a second sealing gasket. The third clamp is sleeved at the connection between the first sleeve and the connecting pipe 320, and the side of the second sealing gasket facing away from the third clamp abuts against the connection between the first sleeve and the connecting pipe 320. In specific use, the third clamp, the second sealing gasket, the filter element sleeve d, the filter element and the injection water are placed together in the first cavity 210 after sterilization. When installation is required, the operator installs the third clamp, the second sealing gasket, the filter element sleeve d and the filter element wetted with injection water through gloves.

[0066] Combination Figure 2 As shown, the second embodiment of the present invention further provides a testing method based on the filter integrity testing device 10 described in any of the above embodiments, comprising the following steps:

[0067] Step S1, providing an integrity tester 100, a connecting barrel 300, an isolator 200, an initial filter 30 and water for injection. In a specific setting, the initial filter 30 may be a filter element, or may be a capsule filter b. When the initial filter 30 is a capsule filter b, in order to facilitate the connection between the capsule filter b and the connecting pipe 320, a first installation pipe c, a first sealing gasket and a second clamp 410 are also required to be provided. When the initial filter 30 is a filter element, in order to facilitate the connection between the filter element and the connecting pipe 320, a third clamp, a second sealing gasket and a filter element sleeve d are also required to be provided.

[0068] Step S2, connecting the connecting barrel 300 and the isolator 200, and the initial filter 30 and the water for injection are arranged in the isolator 200. In the specific arrangement, the initial filters 30 to be tested are generally multiple, and the amount of water for injection is adapted to the number of the initial filters 30. The water for injection and the multiple initial filters 30 are all placed in the isolator 200. The initial filters 30 to be tested include both the capsule filter b and the filter element. The first installation pipe c, the first sealing gasket, the second clamp 410, the third clamp, the second sealing gasket and the filter element sleeve d are all arranged in the isolator 200 together with the initial filter 30 to be tested;

[0069] Step S3, wet the initial filter 30 with injection water to obtain the filter 20 to be tested, and connect the filter 20 to be tested with the connecting pipe 320 of the connecting barrel 300. In the specific operation, the worker uses gloves to wet the initial filter 30 in the isolator 200 with injection water to obtain the filter 20 to be tested, and then uses the gloves to open the active valve 510 of the isolator 200 to drive the passive valve to open so that the first cavity 210 is connected with the second cavity 311. If the filter 20 to be tested is a capsule filter a to be tested, select the first installation pipe c, the first sealing gasket and the second clamp 410 to connect the capsule filter a to be tested with the connecting pipe 320. If the filter 20 to be tested is a filter element to be tested, select the third clamp, the second sealing gasket and the filter element sleeve d to connect the filter element to be tested with the connecting pipe 320.

[0070] Step S4, connect the integrity tester 100 to the end of the connecting tube 320 away from the filter 20 to be tested, and start the integrity tester 100 to test the integrity of the filter 20 to be tested. In specific settings, the integrity tester 100 is connected to the first filter 330 of the connecting barrel 300.

[0071] The testing method of the above-mentioned filter integrity testing device 10 is to first obtain the integrity tester 100, the connecting barrel 300, the isolator 200, the initial filter 30 and the water for injection through step S1; then, the connecting barrel 300 and the isolator 200 are docked through step S2, and the initial filter 30 and the water for injection are arranged in the isolator 200; then, the filter 20 to be tested is obtained by wetting the initial filter 30 with the water for injection through step S3, and the filter 20 to be tested is connected with the connecting pipe 320 of the connecting barrel 300; finally, the integrity tester 100 is connected with the end of the connecting pipe 320 barrel facing away from the filter 20 to be tested through step S4, and the integrity tester 100 is turned on to perform the integrity test of the filter 20 to be tested. Through the above-mentioned arrangement, the integrity test of the filter 20 to be tested is realized more conveniently. The whole process is simple and convenient to operate with strong operability. In addition, by setting the connecting tube 320, the integrity tester 100 is connected with the filter 20 to be tested to perform the integrity test of the filter 20 to be tested. Compared with the online integrity test adopted in the prior art, the equipment required by the present application includes the connecting barrel 300, the integrity tester 100 and the isolator 200. The equipment is simple, occupies a small area and has a low investment cost. Compared with the integrity test of the prior art which adopts the integration of disposable consumables and filters, the present application adopts the connecting barrel 300 and the isolator 200 to replace the use of disposable consumables. The connecting barrel 300 and the isolator 200 can be reused, which greatly saves the use and processing costs of consumables. In addition, the present application connects the integrity tester 100 with the filter 20 to be tested through the connecting tube 320 to perform the integrity test of the filter 20 to be tested. The connection relationship is simple, which avoids the gas leakage caused by the complicated connection relationship, reduces the test failure and improves the test accuracy.

[0072] Combination Figure 3 As shown, in order to perform integrity testing on the initial filter 30 after sterilization and ensure sterility after the test, a preferred embodiment, in step S2, includes the following steps:

[0073] S21, sterilize the connection barrel 300, the initial filter 30 and the water for injection once. In the specific setting, the primary sterilization is moist heat sterilization. Put the water for injection, the filter element, the capsule filter b, the first installation pipe c, the first sealing gasket, the second clamp 410, the third clamp, the second sealing gasket, the filter element sleeve d and the connection barrel 300 after tightening the passive valve into the sterilization cabinet for moist heat sterilization, wherein the filter element, the capsule filter b, the first installation pipe c, the first sealing gasket, the second clamp 410, the third clamp, the second sealing gasket and the filter element sleeve d are all provided with two layers of breathing bags 700 outside;

[0074] S22, placing the initial filter 30 after one sterilization and the water for injection after one sterilization in the isolator 200. In the specific setting, the water for injection after moist heat sterilization, the filter element after moist heat sterilization, the capsule filter b after moist heat sterilization, the first installation pipe c after moist heat sterilization, the first sealing gasket after moist heat sterilization, the second clamp 410 after moist heat sterilization, the third clamp after moist heat sterilization, the second sealing gasket after moist heat sterilization and the filter element sleeve d after moist heat sterilization are generally placed in the isolator 200 through the visual door, and then the visual door is closed and sealed;

[0075] S23, the isolator 200 performs secondary sterilization on the initial filter 30 and the water for injection. In a specific setting, the secondary sterilization is hydrogen peroxide sterilization. The isolator 200 performs hydrogen peroxide sterilization on the water for injection, the filter element, the capsule filter b, the first installation pipe c, the first sealing gasket, the second clamp 410, the third clamp, the second sealing gasket and the filter element sleeve d located inside the isolator 200;

[0076] S24, connect the connection barrel 300 sterilized once to the isolator 200 in a sterile manner. In the specific setting, the connection barrel 300 sterilized by moist heat is connected to the active valve 510 on the isolator 200 through a passive valve. Then, the worker uses gloves to moisten the initial filter 30 in the isolator 200 with injection water to obtain the filter 20 to be tested, and then opens the split butterfly valve 500 to connect the first cavity 210 of the isolator 200 with the second cavity 311 of the connection barrel 300 in a sterile manner, and then selects the appropriate connector 600 and fixing assembly 400 for installation according to the type of the filter 20 to be tested; finally, the integrity tester 100 is connected to the first filter 330, and the corresponding test program is selected according to the model of the filter 20 to be tested, and the test is started. After the test passes, the filter 20 to be tested is replaced in the isolator 200, and the next one is tested.

[0077] In order to verify the effectiveness of the above-mentioned filter integrity test method, the filter integrity test method described in this application and the traditional integrity test method were used to test the same capsule filter a and the filter element to be tested respectively. The same test procedure was selected for both. The traditional integrity test method was to directly connect the integrity tester to the filter to be tested via a clamp. The test results are as follows: After testing the capsule filter a by the filter integrity test method described in this application, the test result showed 3800mbar, which was within the qualified range of 3450mbar-5000mbar. At this time, the capsule filter a to be tested was connected to the connecting tube 320 through the first connecting tube 320, and the second clamp 410 was used to clamp the joint between the first connecting tube 320 and the connecting tube 320. The integrity result of the capsule filter to be tested by the traditional method was 3750mbar, and the same Within the qualified range; and after the filter element to be tested is tested by the filter integrity testing device 10 described in the present application, the test result is shown to be 0.13ml / min, which is within the qualified range of not more than 0.16ml / min. At this time, a filter element sleeve d is provided on the outside of the filter element to be tested, and the filter element sleeve d is connected to the connecting pipe 320 through a third clamp. The integrity result of the filter element to be tested by the traditional method is 0.10ml / min, which is also within the qualified range. In summary, the filter integrity testing method described in the present application is feasible.

[0078] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0079] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A filter integrity testing device, used to test the integrity of a filter to be tested, It is characterized in that include: Integrity tester, connection barrel and isolator, including: The filter to be tested is arranged in the first cavity inside the isolator; The connecting barrel comprises a barrel body, a connecting pipe and a first filter, the barrel body comprises an end plate and a side wall connected to the end plate, the end plate and the side wall form a second cavity, the end plate is provided with a first fixing through hole penetrating the thickness thereof, the side of the side wall away from the end plate is connected to the isolator, the connecting pipe is installed in the second cavity, one end of the connecting pipe is connected to the filter to be tested, and the other end of the connecting pipe is connected to the integrity tester, the first filter is arranged between the connecting pipe and the integrity tester, the first filter is fixed to the first fixing through hole, and the first filter is connected to both the connecting pipe and the integrity tester; The integrity tester is used to deliver compressed gas to the connecting pipe; The filter integrity testing device further comprises a split butterfly valve, the split butterfly valve comprises an active valve and a passive valve, the passive valve is sealingly installed on the side of the side wall away from the end plate; the isolator comprises a working cabin with an opening at one end and a visual door sealedly connected to the open end of the working cabin, the first cavity is formed inside the working cabin, an operating port is opened on the visual door, a glove is sealingly arranged in the operating port, and the glove is used to install the filter to be tested on the connecting pipe; The active valve is installed in the working cabin, and is used to connect the first cavity and the second cavity when the active valve is docked with the passive valve.

2. The filter integrity test device according to claim 1, It is characterized in that The central axis of the connecting pipe is parallel to the central axis of the barrel body, and the length of the connecting pipe from the end of the barrel body close to the separator is in the range of 2 cm to 3 cm.

3. The filter integrity testing device according to claim 1, It is characterized in that It also includes a connecting piece, one end of which is detachably connected to the connecting pipe, and the other end of which extends into the isolator and is detachably connected to the filter to be tested.

4. The filter integrity test device according to claim 3, It is characterized in that The connecting piece is a first installation pipe, and the filter to be tested is a capsule filter to be tested.

5. The filter integrity testing device according to claim 3, It is characterized in that The connecting piece is a filter element sleeve, and the filter to be tested is a filter element to be tested.

6. A testing method based on the filter integrity testing device according to any one of claims 1 to 5, It is characterized in that The steps include: S1. Provide integrity tester, connection barrel, isolator, initial filter and water for injection; S2, connecting the connecting barrel to the isolator, and placing the initial filter and the water for injection in the isolator; S3, wetting the initial filter with the injection water to obtain a filter to be tested, and connecting the filter to be tested with the connecting pipe of the connecting barrel; S4, connecting the integrity tester to the end of the connecting tube away from the filter to be tested, and turning on the integrity tester to perform an integrity test on the filter to be tested.

7. The test method of the filter integrity test device according to claim 6, It is characterized in that In step S2, the following steps are included: S21, sterilizing the connecting barrel, the initial filter and the water for injection once; S22, placing the primary filter and the water for injection after the primary sterilization in the isolator; S23, the isolator performs secondary sterilization on the initial filter and the water for injection; S24, aseptically connecting the sterilized connection barrel to the isolator.

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