A filtration assembly and filtration system

Abstract

The utility model discloses a filter assembly and filter system, wherein the filter assembly includes liquid module, liquid outlet module, main fluid filter and the main air filter of the upstream of main fluid filter, and is sealedly connected first waste container on liquid outlet module, sets up second waste container at the first downstream end of main air filter, and the inside of first waste container and second waste container is isolated with outside, has improved the internal sealing of filter assembly, first waste container and second waste container can respectively undertake wetting liquid and test gas, avoid wetting liquid and test gas direct emission to the environment, can guarantee the sealing of whole flow path inside and the sterility requirement of use environment, and wetting liquid and test gas flow into the corresponding container in waste module, also realize the end point indication of wetting and integrity tester.

Description

Technical Field

[0001] This utility model relates to the field of aseptic filtration technology, and in particular to a filtration component and filtration system. Background Technology

[0002] According to the manufacturing process, sterile drugs can be terminally sterilized products or non-terminally sterilized products.

[0003] For terminally sterilized products, packaging containers and equipment components should be cleaned using validated processes to ensure proper control of microbial, particulate, and bacterial endotoxin / pyrogen contamination. The interval between preparation and sterilization of the solution should be minimized as much as possible, and control standards for the interval between preparation, filling, and sterilization should be established based on the characteristics of the product and storage conditions.

[0004] For non-terminally sterilized products, aseptic operations should be minimized through engineering designs such as sterilization after complete assembly. Pipelines and equipment that come into direct contact with the product should be sterilized online as much as possible after assembly. For sterilization filtration processes of non-terminally sterilized products, measures should be taken to reduce the risks of filtration sterilization, and sterilization filter components should undergo integrity testing after sterilization before use. Gas filters used for sterilization of critical sterile gases (such as compressed air and nitrogen) should undergo integrity testing before being removed from the housing after use.

[0005] When sterilizing filters undergo integrity testing, the wetting liquid used to wet the sterilizing filter and the original exhaust gas in the sterilizing filter are both released into the environment. During this process, test gas or liquid may flow back and contaminate the sterilizing filter. Therefore, in filtration processes with high sterility requirements, the actual operating environment (Class C or Class B environment) and the entire filtration flow path need to take sterility requirements into account, thus requiring improved sealing requirements for the entire fluid filtration system. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the purpose of this utility model is to provide a filter component and filter system that solves the problem that the existing sterilization filter is prone to introducing external pollution during waste discharge.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: A filtration assembly includes an inlet module, an outlet module, a main fluid filter, and a main air filter located upstream of the main fluid filter; The main fluid filter includes a first upstream section and a first downstream section, the first downstream section being sealed to the liquid outlet module; the main air filter includes a first upstream end and a first downstream end. It also includes a waste discharge module, which includes a first waste discharge container that is sealed to the liquid discharge module and a second waste discharge container that is sealed to the first downstream end of the main air filter. The liquid inlet module is sealed to both the first upstream section and the first upstream end, and can communicate with the main fluid filter or the main air filter. The liquid inlet module has an inlet for connecting to a wetting liquid source or a feed liquid source. The first upstream end and / or the first upstream portion has an interface capable of sealingly communicating with a filter integrity testing device or a container integrity testing device, so as to allow the test gas passing through the filter integrity testing device or the container integrity testing device to pass only through the main air filter, or only through the main fluid filter and then into the first waste discharge container, or pass through the main air filter and the main fluid filter in sequence and then into the first waste discharge container.

[0008] In this utility model's filter assembly, to improve filtration accuracy and internal cleanliness, a main air filter is sealed upstream of the main fluid filter. The first upstream section refers to the pre-filtration area of ​​the main fluid filter, and the first downstream section refers to the post-filtration area of ​​the main fluid filter. The liquid outlet module is used to collect the filtrate, and it is crucial to maintain the sealing and sterility of the liquid outlet module to ensure that the sterility of the filtrate meets the usage requirements. The first upstream end refers to the pre-filtration area of ​​the main air filter, and the first downstream end refers to the post-filtration area of ​​the main air filter. The filtered sterile test gas is then introduced into the main fluid filter for integrity testing; therefore, the sealing and sterility of the first downstream section and the first downstream end must be ensured. During integrity testing, both the main fluid filter and the main air filter need to be wetted, and the test gas needs to be introduced. The wetting liquid and test gas are discharged from the first downstream section and the first downstream end, respectively. There is a risk of backflow contamination during the discharge process. Therefore, the filter assembly of this utility model has a first waste discharge container sealed to the liquid outlet module and a second waste discharge container set at the first downstream end of the main air filter. The interiors of both the first and second waste discharge containers are isolated from the outside, which improves the internal sealing of the filter assembly. The first and second waste discharge containers can respectively receive the wetting liquid and the test gas, avoiding the direct discharge of the wetting liquid and the test gas into the environment. This ensures the sealing of the entire flow path and the sterility requirements of the operating environment. At the same time, the wetting liquid and the test gas flow into the corresponding containers in the waste discharge module. The waste discharge module can be a device with or subsequently set with an endpoint indication function to realize the endpoint indication of the wetting and integrity tester.

[0009] Preferably, the waste discharge module further includes a third waste discharge container that is sealed and connected to the first upstream portion of the main fluid filter, the third waste discharge container being used at least to receive the waste gas discharged when the main fluid filter is wetted.

[0010] The main fluid filter has a large volume and a lot of internal air, which has a significant impact on the filter. Therefore, during the wetting process, the internal space of the main fluid filter will gradually be filled with wetting liquid, and exhaust gas will be discharged from the first upstream section. The third exhaust container is sealed to the first upstream section and can receive the exhaust gas and overflowing wetting liquid discharged during the wetting of the main fluid filter, serving as a warning and facilitating the complete removal of air from the main fluid filter, thus optimizing the filtration effect. In addition, the third exhaust container can also seal the first upstream section. Although the first upstream section is the pre-filtration area of ​​the main fluid filter and does not come into contact with the filtrate, sealing the first upstream section can improve the overall sealing and sterility of the main fluid filter in some processes with high sterility requirements, in order to meet the sterility requirements of the filtrate.

[0011] Preferably, the first, second, and third waste discharge containers are all containers with zero initial internal pressure and observable contents. This ensures that the wetting liquid and test gas will not be subjected to reverse pressure and cause backflow when discharged, guaranteeing smooth flow of the wetting liquid and test gas. In particular, the flow of test gas affects the results of the integrity test, and this setting can improve the accuracy and efficiency of the integrity test. The observable contents make the prompts of the waste discharge module more intuitive and faster.

[0012] Preferably, the first waste discharge container, the second waste discharge container, and the third waste discharge container are all transparent bags. The initial state of the transparent bags is that the inside is sealed and there is no air, so as to ensure that there is no negative pressure inside the container and that the indication is clear, making it easier to connect and operate each step of the filtration assembly, which is conducive to improving work efficiency.

[0013] Preferably, the filtration assembly further includes at least one set of auxiliary fluid filters, which are located upstream of the main fluid filter and are sealed in series according to the fluid flow sequence. The auxiliary fluid filters include a second upstream section and a second downstream section, and the second downstream section is sealed to the first upstream section or the second upstream section of another auxiliary fluid filter. The waste discharge module further includes a fourth waste discharge container sealed to the second upstream section, which is at least used to receive the waste gas discharged when the auxiliary fluid filters are wetted. The second upstream portion is sealed to the first downstream end, and the liquid inlet module is sealed to the second upstream portion and can communicate with the auxiliary fluid filter. The second upstream portion has an interface for sealing connection with the filter integrity testing device, so that the test gas passing through the filter integrity testing device can pass only through the auxiliary fluid filter, or sequentially through the main air filter and the auxiliary fluid filter. Alternatively, it also includes an auxiliary air filter corresponding to the auxiliary fluid filter, the auxiliary air filter including a second upstream end and a second downstream end, the second upstream portion and the second downstream end being sealed to each other, the waste discharge module also includes a fifth waste discharge container sealed to the second downstream end, the liquid inlet module being sealed to both the second upstream portion and the second upstream end, and can communicate with the auxiliary fluid filter or the auxiliary air filter, the second upstream portion and / or the second upstream end having an interface capable of sealing connection with the filter integrity testing device, so that the test gas passing through the filter integrity testing device can pass only through the auxiliary fluid filter, or sequentially through the auxiliary air filter and the auxiliary fluid filter, or only through the auxiliary air filter.

[0014] The auxiliary fluid filter pre-filters the liquid feed, working in conjunction with the main fluid filter to achieve multiple filtration, improving filtration accuracy and filtrate purity. Therefore, the auxiliary fluid filter is located upstream of the main fluid filter, and its quantity can be set to one or more as needed. The auxiliary fluid filter also requires integrity testing, and the filtered test gas must pass through a humidified auxiliary fluid filter. The auxiliary fluid filter can utilize the main air filter to filter the test gas, or a dedicated auxiliary air filter can be used. Therefore, both the auxiliary fluid filter and the auxiliary air filter need to be humidified and purged with test gas. Since another auxiliary air filter is located downstream of the auxiliary fluid filter... The auxiliary fluid filter, either a primary or secondary fluid filter, does not require an additional sealed exhaust container and can share the same exhaust container (first exhaust container) with the primary fluid filter. The fourth exhaust container functions similarly to the third. Because the fluid filter contains a significant amount of air, which greatly affects the auxiliary fluid filter, during wetting, the internal space of the auxiliary fluid filter gradually fills with wetting liquid, resulting in exhaust gas being discharged from the second upstream section. The fourth exhaust container, sealed to the second upstream section, collects the exhaust gas and overflowing wetting liquid during the wetting of the auxiliary fluid filter, serving as a warning and facilitating the complete removal of air from the auxiliary fluid filter, thus optimizing the filtration effect. The fifth exhaust container, sealed to the second downstream end of the auxiliary air filter, serves the same purpose as the second exhaust container: ensuring the sterility of the test gas filtered by the auxiliary air filter and preventing backflow contamination of the wetting liquid. Both the fourth and fifth exhaust containers are isolated from the outside environment, improving the internal sealing and sterility of the filter assembly. They also serve as a warning when wetting liquid and test gas flow into the corresponding exhaust module, guiding the next step.

[0015] Preferably, a topwash bag for receiving topwash liquid is provided between the first downstream section and the liquid outlet module; the interface at the first upstream end is also used for sealed communication with the container integrity testing device to allow test gas to enter the topwash bag.

[0016] The function of the top wash bag is to receive the feed liquid from the filter assembly during the top wash process. When the feed liquid is expensive, the wetting liquid and the feed liquid may be made of different materials. Therefore, before the filtration step, the wetting liquid needs to be drained first, that is, the wetting liquid in the flow path of the fluid filter assembly is used to top wash the feed liquid. In the process of draining the wetting liquid, the main fluid filter may also be connected to the outside world and become contaminated. The top wash bag also plays a role in isolating and sealing the main fluid filter from the external environment during the top wash process before filtration. The integrity of the top wash bag needs to be confirmed by the container integrity test device and test gas to ensure the sealing and sterility of the first downstream part of the main fluid filter.

[0017] Preferably, the filtration assembly further includes a micro-sampling bag, which is sealed to the first upstream section. The function of the micro-sampling bag is to sample the liquid that has not entered the fluid filter in order to measure the properties of the liquid, and thus set the process parameters for subsequent filtration based on the test results; when only the main fluid filter in the filtration assembly is used to filter the liquid, the micro-sampling bag is sealed to the first upstream section to ensure that the collected unfiltered liquid is filtered.

[0018] Preferably, the filtration assembly further includes a micro-sampling bag, which is sealed to a second upstream portion of the first auxiliary fluid filter in the fluid flow sequence. The micro-sampling bag serves to sample the liquid that has not yet entered the fluid filter to determine its properties, thereby setting the process parameters for subsequent filtration based on the test results. Generally, the micro-sampling bag is positioned upstream of the first fluid filter in the liquid flow direction to ensure that unfiltered liquid is collected. When the fluid filtration assembly includes one or more auxiliary fluid filters, the micro-sampling bag is sealed to a second upstream portion of the first auxiliary fluid filter in the fluid flow sequence.

[0019] Preferably, the liquid inlet module includes a first liquid inlet pump and a first liquid inlet flow path. The first liquid inlet flow path has an inlet connected to a wetting liquid source or a material liquid source. The first liquid inlet pump is disposed on the first liquid inlet flow path to control the fluid flow in the first liquid inlet flow path, and the first liquid inlet flow path is sealed to the first upstream part. The liquid inlet module further includes a second liquid inlet pump and a second liquid inlet flow path. The second liquid inlet flow path has an inlet for connecting to a wetting liquid source. The second liquid inlet pump is disposed on the second liquid inlet flow path to control the fluid flow in the second liquid inlet flow path, and the second liquid inlet flow path can be sealed and connected to the first upstream end.

[0020] Separating the inlet flow paths for the main fluid filter and the main air filter reduces the number of pipeline switching in the inlet module. The first inlet pump and the first inlet flow path for the main fluid filter can be used to transport wetting liquid and feed liquid, while the second inlet pump and the second inlet flow path for the main air filter are only used to transport wetting liquid. This makes the operation simpler and more efficient.

[0021] Preferably, the liquid inlet module includes a first liquid inlet pump and a first liquid inlet flow path. The first liquid inlet flow path has an inlet connected to a wetting liquid source or a material liquid source. The first liquid inlet pump is disposed on the first liquid inlet flow path to control the fluid flow in the first liquid inlet flow path. The first liquid inlet flow path is sealed to the second upstream part of the first auxiliary fluid filter located in the fluid flow sequence. The liquid inlet module further includes a second liquid inlet pump and a second liquid inlet flow path. The second liquid inlet flow path has an inlet for connecting to a wetting liquid source. The second liquid inlet pump is disposed on the second liquid inlet flow path to control the fluid flow in the second liquid inlet flow path, and the second liquid inlet flow path can be sealed and connected to the first upstream end. When each of the auxiliary fluid filters corresponds to an auxiliary air filter, the second liquid inlet flow path can be sealed and connected to the second upstream end.

[0022] Separating the inlet flow paths for the fluid filter and the air filter reduces the need for pipeline switching in the inlet module. The first inlet pump and the first inlet flow path corresponding to the main fluid filter and the auxiliary fluid filter can be used to transport wetting liquid and feed liquid, while the second inlet pump and the second inlet flow path corresponding to the main air filter and the auxiliary air filter are only used to transport wetting liquid. This makes the operation simpler and more efficient.

[0023] Preferably, a first pressure sensor is provided in the first liquid inlet flow path, and the first pressure sensor can communicate with the control module. The first pressure sensor can detect the fluid pressure in the first liquid inlet flow path. After the detection information is fed back to the control module, the fluid speed and pressure of the first liquid inlet pump, wetting liquid source, or feed liquid source can be adjusted to protect the various components in the filter assembly.

[0024] Preferably, the liquid outlet module includes a liquid outlet flow path connected to the first downstream section, and a second pressure sensor is provided on the liquid outlet flow path; both the first pressure sensor and the second pressure sensor are communicatively connected to the control module.

[0025] When only the main fluid filter is used to filter the liquid, the first pressure sensor and the second pressure sensor are located upstream and downstream of the main fluid filter, respectively. By comparing the difference in values ​​between the first and second pressure sensors, the pressure difference experienced by the main fluid filter can be determined. If the pressure difference is too large, it indicates that the main fluid filter is clogged, requiring immediate replacement of the entire assembly. Alternatively, the pressure difference can be used to control the liquid inflow rate and volume in the first inlet flow path, keeping the pressure difference within a reasonable range to protect the main fluid filter. When the filtration assembly filters the liquid through both the auxiliary fluid filter and the main fluid filter, the first pressure sensor and the second pressure sensor are located upstream of the auxiliary fluid filter and downstream of the main fluid filter, respectively. By comparing the difference in values ​​between the first and second pressure sensors, the pressure difference experienced by the main fluid filter and the auxiliary fluid filter can be determined, thereby controlling the liquid inflow rate and volume in the first inlet flow path, keeping the pressure difference within a reasonable range to protect both the main fluid filter and the auxiliary fluid filter.

[0026] Preferably, a third pressure sensor is provided between the second downstream section and the first upstream section, and the third pressure sensor is communicatively connected to the control module. By comparing the value of the third pressure sensor with that of the first pressure sensor, the pressure differential of the auxiliary fluid filter can be determined. By comparing the second pressure sensor with the third pressure sensor, the pressure differential of the main fluid filter can be determined. This ensures that pressure differential detection is performed on each fluid filter, resulting in higher accuracy and making it easier to identify faulty fluid filters.

[0027] Preferably, the liquid inlet includes a wetting liquid inlet and a feed liquid inlet that are independent of each other; when the liquid inlet module includes only one liquid inlet flow path, the liquid inlet flow path includes a wetting liquid inlet and a feed liquid inlet that are independent of each other, and also includes interfaces that are respectively connected to the fluid filter and the air filter; when the liquid inlet module includes a first liquid inlet flow path and a second liquid inlet flow path, the first liquid inlet flow path is used to deliver wetting liquid and feed liquid to the fluid filter, and therefore has a wetting liquid inlet and a feed liquid inlet that are independent of each other, and the second liquid inlet flow path is used to deliver wetting liquid to the air filter, and therefore has a separate wetting liquid inlet.

[0028] Preferably, the liquid outlet module includes an independent product outlet and a waste liquid outlet, the waste liquid outlet being sealed to the first waste discharge container. The product outlet is used to connect to a filtrate storage device to collect filtrate during the filtration process. The first waste discharge container is used to collect waste liquid from each stage of the fluid filtration assembly, including but not limited to wetting liquid, residual feed liquid from the previous filtration, or a mixture of wetting liquid and feed liquid, separating the two for ease of operation while ensuring the purity of the filtrate.

[0029] To achieve the above objectives, the present invention also adopts the following technical solution: A filtration system includes the aforementioned filtration components, and further includes a filter integrity testing device and a container integrity testing device; The filter integrity testing device can be connected to a test air source to perform integrity testing on the main fluid filter, main air filter, auxiliary fluid filter, or auxiliary air filter. The container integrity testing device can be connected to a test air source to perform integrity testing on the top wash bag or the first waste discharge container and to detect the sealing performance of the flow path from the main air filter to the top wash bag or the first waste discharge container.

[0030] The filtration system of this invention utilizes a filter integrity testing device to perform integrity tests on the main fluid filter, main air filter, auxiliary fluid filter, or auxiliary air filter, and a container integrity testing device to perform integrity tests on the top wash bag or first waste discharge container and to detect the sealing performance of the flow path from the main air filter to the top wash bag or the first waste discharge container. During this process, the exhaust gas and wetting liquid discharged from the main fluid filter or auxiliary fluid filter are input into the corresponding waste discharge container, and the wetting liquid discharged from the main air filter or auxiliary air filter is input into the corresponding waste discharge container. This avoids backflow contamination during the testing of each filter and also prevents the wetting liquid, exhaust gas, and test gas from being directly discharged into the external environment, thereby ensuring the sterility of the entire filtration system and the external environment.

[0031] Preferably, the filtration system further includes a control module and a weight sensor disposed on the top wash bag, the weight sensor being communicatively connected to the control module.

[0032] In summary, compared with the prior art, the present invention has at least the following beneficial effects: The filter assembly of this invention has a first waste discharge container sealed to the liquid outlet module, and a second waste discharge container set at the first downstream end of the main air filter. The interiors of both the first and second waste discharge containers are isolated from the outside, improving the internal sealing of the filter assembly. The first and second waste discharge containers can respectively receive wetting liquid and test gas, preventing the wetting liquid and test gas from being directly discharged into the environment. This ensures the sealing of the entire flow path and the sterility requirements of the operating environment. At the same time, the wetting liquid and test gas flow into the corresponding waste discharge modules, which also realizes the endpoint indication of the wetting and integrity tester.

[0033] The filtration system and online integrity testing method of this utility model utilize a filter integrity testing device to perform integrity testing on the main fluid filter, main air filter, auxiliary fluid filter, or auxiliary air filter, and a container integrity testing device to perform integrity testing on the top wash bag or first waste discharge container and detect the sealing performance of the flow path from the main air filter to the top wash bag or the first waste discharge container. During this process, the exhaust gas and wetting liquid discharged from the main fluid filter or auxiliary fluid filter are input into the corresponding waste discharge container, and the wetting liquid discharged from the main air filter or auxiliary air filter is input into the corresponding waste discharge container. This avoids backflow contamination during the testing of each filter and also prevents the wetting liquid, exhaust gas, and test gas from being directly discharged into the external environment, thereby ensuring the sterility of the entire filtration system and the external environment. Attached Figure Description

[0034] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0035] Figure 1 This is a schematic diagram of the filter assembly according to Embodiment 1 of this utility model.

[0036] Figure 2 This is a schematic diagram of the framework of a filtration system based on the filtration component of Embodiment 1 of this utility model.

[0037] Figure 3 This is a schematic diagram of the filtration system according to Embodiment 2 of this utility model.

[0038] Figure 4 This is a schematic diagram of the filtration system according to Embodiment 2 of the present invention, specifically a schematic diagram of the system when performing wetting and integrity tests on the main fluid filter and the auxiliary fluid filter.

[0039] Figure 5 This is a schematic diagram of the filtration system according to Embodiment 2 of the present invention, specifically a schematic diagram of the filtration process during the wetting and integrity testing of the main air filter and the auxiliary air filter.

[0040] Figure 6 This is a schematic diagram of the filtration system according to Embodiment 2 of the present invention, specifically a schematic diagram of the system when performing an integrity check on the main fluid filter and the auxiliary fluid filter.

[0041] Explanation of reference numerals in the attached figures 10. Main fluid filter; 11. First upstream section; 12. First downstream section; 13. First valve; 14. Third waste discharge container; 15. Micro-sampling bag; 16. Top wash bag; 161. Weight sensing device; 17. Four-way connector; 171. Third valve; 172. Fourth valve; 173. Fifth valve; 18. Opening and closing element; 20. Main air filter; 21. First upstream end; 22. First downstream end; 23. Second waste discharge container; 24. Sixth valve; 30. Liquid inlet module; 31. First liquid inlet pump; 32. First liquid inlet flow path; 321. Wetting liquid inlet; 322. Feed liquid inlet; 323. Second valve; 33. Second liquid inlet pump; 34. Second liquid inlet flow path; 40. Liquid discharge module; 41. Product outlet; 42. First waste discharge container; 50. Auxiliary fluid filter; 51. Second upstream section; 52. Second downstream section; 53. Seventh valve; 54. Eighth valve; 55. Fourth waste discharge container; 60. Auxiliary air filter; 61. Second upstream end; 62. Second downstream end; 63. Ninth valve; 64. Fifth waste discharge container; 70. Filter integrity testing device; 71. First on / off valve; 72. Three-way solenoid valve; 80. Container integrity testing device; 81. Second on / off valve; 90. First pressure sensor; 91. Second pressure sensor; 92. Third pressure sensor. Detailed Implementation

[0042] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0043] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0044] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0045] like Figure 1As shown, the filtration assembly of this utility model embodiment includes a liquid inlet module 30, a liquid outlet module 40, a main fluid filter 10, and a main air filter 20 located upstream of the main fluid filter 10; the main fluid filter 10 includes a first upstream portion 11 and a first downstream portion 12, the first downstream portion 12 being sealed to the liquid outlet module 40; the main air filter 20 includes a first upstream end 21 and a first downstream end 22; it also includes a waste discharge module, the waste discharge module including a first waste discharge container 42 sealed to the liquid outlet module 40 and a second waste discharge container 23 sealed to the first downstream end 22 of the main air filter 20; the liquid inlet module 30 is connected to the first upstream portion 11 and the first downstream portion 12 of the main air filter 20; the main fluid filter 10 includes a first upstream portion 11 and a first downstream portion 12; the main fluid filter 10 includes a first upstream portion 11 and a first downstream portion 22; the main fluid filter 10 includes a first upstream portion 11 and a first downstream portion 22; the main fluid filter 20 includes a first upstream portion 11 and a first downstream portion 22; the main fluid filter 20 includes a first upstream portion 11 and a first downstream portion 22; the main fluid filter 20 includes a first upstream portion 11 and a first downstream portion 22; the main fluid filter 20 includes a first downstream ... The upstream end 21 is sealed and connected and can communicate with the main fluid filter 10 or the main air filter 20. The liquid inlet module 30 has a liquid inlet for connecting with the wetting liquid source or the material liquid source. The first upstream end 21 and / or the first upstream part 11 has an interface that can be sealed and communicated with the filter integrity test device 70 or the container integrity test device, so as to allow the test gas passing through the filter integrity test device or the container integrity test device to pass only through the main air filter 20, or only through the main fluid filter 10 and then into the first waste discharge container 42, or pass through the main air filter 20 and the main fluid filter 10 in sequence and then into the first waste discharge container 42.

[0046] The main fluid filter 10 plays a major filtering role in the entire filtration assembly and is used to generate filtrate; the first upstream part 11 refers to the pre-filtration area of ​​the main fluid filter 10, the first downstream part 12 refers to the post-filtration area of ​​the main fluid filter 10, and the filtrate outlet module 40 is used to collect the filtrate; in order to ensure the sterility of the filtrate, the main fluid filter 10 needs to maintain its integrity, and also needs to maintain the sealing and sterility of the filtrate outlet module 40.

[0047] To ensure the integrity of the main fluid filter 10, an integrity test is required. The integrity test method involves fully wetting the main fluid filter 10, then introducing test gas into it, and testing it using a filter integrity testing device 70. During this process, the sterility of the test gas must also be maintained. Therefore, a main air filter 20 is needed to filter the test gas. The first upstream end 21 refers to the pre-filtration area of ​​the main air filter 20, and the first downstream end 22 refers to the post-filtration area of ​​the main air filter 20. The filtered, sterile test gas is introduced into the main fluid filter 10 for integrity testing. Therefore, the sealing and sterility of the first downstream section 12 and the first downstream end 22 must be ensured. Simultaneously, the main air filter 20 also needs to be tested for integrity to ensure the sterility of the test gas and prevent damage to the main air filter 20 that could introduce contamination. Contaminated test gas introduced into the main fluid filter 10 and the piping in the fluid filtration assembly would also cause contamination, making it difficult to guarantee the sterility of the filtrate. Therefore, the main air filter 20 also needs to be tested for integrity.

[0048] In the present invention, the upstream part refers to the area that has not passed through the fluid filter, i.e., before the filter membrane; the downstream part refers to the area that has passed through the fluid filter, i.e. after the filter membrane; the upstream end refers to the area that has not passed through the air filter, i.e. before the filter membrane; and the downstream end refers to the area that has passed through the air filter, i.e. after the filter membrane.

[0049] During integrity testing, the main fluid filter 10 and the main air filter 20 need to be wetted and the test gas needs to be introduced. The wetting liquid and the test gas will be discharged from the first downstream section 12 and the first downstream end 22, respectively. There is a risk of backflow contamination during the discharge process. Therefore, the filter assembly of this utility model has a first waste discharge container 42 sealed to the liquid outlet module 40, and a second waste discharge container 23 is set at the first downstream end 22 of the main air filter 20. The interiors of the first waste discharge container 42 and the second waste discharge container 23 are isolated from the outside, which improves the internal sealing of the filter assembly. The first waste discharge container 42 and the second waste discharge container 23 can respectively receive the wetting liquid and the test gas, avoiding the direct discharge of the wetting liquid and the test gas into the environment. This can ensure the sealing of the overall flow path and the sterility requirements of the use environment. At the same time, the wetting liquid and the test gas flow into the corresponding waste discharge module. The waste discharge module can be a device with or subsequently set with an endpoint indication function to realize the endpoint indication of the wetting and integrity tester.

[0050] After confirming the integrity of the main fluid filter 10 and the main air filter 20, the liquid inlet module 30 can also be directly connected to the main fluid filter 10, so that the liquid can be filtered through the main fluid filter 10. At this time, the first waste container 42 is also used to receive the liquid flowing out from the first downstream part 12 of the main fluid filter 10, including wetting liquid, filtrate and mixture. It should be noted that the wetting liquid and mixture are placed separately from the filtrate to avoid affecting the purity of the collected filtrate.

[0051] The main fluid filter 10 has a large volume and a lot of internal air, which has a significant impact on it. During the wetting process, the internal space of the main fluid filter 10 will gradually be filled with wetting liquid, and exhaust gas will be discharged from the first upstream section 11. Figure 1As shown, the waste discharge module also includes a third waste discharge container 14 that is sealed to the first upstream portion 11 of the main fluid filter 10. The third waste discharge container 14 is used to receive the waste gas discharged and the overflowing wetting liquid when wetting the main fluid filter 10, which serves as an indicator and helps to confirm that the air in the main fluid filter 10 has been completely removed, thus optimizing the filtration effect. In addition, the third waste discharge container 14 can also seal the first upstream portion 11. Although the first upstream portion 11 is the pre-filtration area of ​​the main fluid filter 10 and does not come into contact with the filtrate, sealing the first upstream portion 11 can improve the overall sealing and sterility of the main fluid filter 10 in some processes with high sterility requirements, so as to meet the sterility requirements of the filtrate.

[0052] The first waste container 42, the second waste container 23, and the third waste container 14 are all containers with zero initial internal pressure and observable contents. This ensures that the wetting liquid and test gas will not be subject to backflow due to reverse pressure during discharge, guaranteeing smooth flow of the wetting liquid and test gas. The flow of the test gas, in particular, affects the integrity test results; this design improves the accuracy and efficiency of the integrity test. The observable contents also make the discharge module's prompts more intuitive and faster. Figure 1 In the first embodiment shown, the first waste discharge container 42, the second waste discharge container 23, and the third waste discharge container 14 are all transparent bags. The initial state of the transparent bags is that the inside is sealed and there is no air, so as to ensure that there is no negative pressure inside the container and that the indication is clear, making it easier to connect and operate each step of the filter assembly, which is conducive to improving work efficiency.

[0053] like Figure 1 As shown, the first upstream section 11 is also sealed with a micro-sampling bag 15. The function of the micro-sampling bag 15 is to sample the liquid that has not entered the fluid filter in order to measure the properties of the liquid, and then set the process parameters for subsequent filtration based on the test results. The pipelines connecting the third waste discharge container 14 and the micro-sampling bag 15 to the first upstream section 11 are respectively equipped with opening and closing elements 18 to control the opening and closing of the first upstream section 11 and the third waste discharge container 14 and the micro-sampling bag 15.

[0054] like Figure 1 As shown, a top-wash bag 16 for receiving top-wash liquid is provided between the first downstream section 12 and the liquid outlet module 40. The top-wash bag 16 also serves to isolate and seal the main fluid filter 10 from the external environment during the top-washing process before filtration. The liquid outlet module 40 includes a product outlet 41 or a first waste discharge container 42 that is sealed to the first downstream section 12. The product outlet 41 is used to connect to a filtrate storage device to collect filtrate during the filtration process. The first waste discharge container 42 is used to collect waste liquid from each stage of the fluid filtration assembly, including but not limited to wetting liquid, residual liquid from the previous filtration, or a mixture of wetting liquid and liquid.

[0055] like Figure 1 In the first embodiment shown, the filter assembly only has a main fluid filter 10 as a liquid filtration device. The main air filter 20 is located upstream of the main fluid filter 10. Both the liquid inlet module 30 and the liquid outlet module 40 include pipelines and valves for controlling the opening and closing of the pipelines. The pipelines of the liquid inlet module 30 are sealed and selectively connected to the upstream of the main air filter 20 and the main fluid filter 10, respectively. The pipelines of the liquid outlet module 40 are sealed and connected to the downstream of the main fluid filter 10 and can select the product outlet 41.

[0056] like Figure 1 As shown, a pipeline and a valve for controlling the opening and closing of the pipeline are provided between the main air filter 20 and the main fluid filter 10. Specifically, a first valve 13 is provided between the first downstream end 22 and the first upstream part 11. The first valve 13 can control the opening and closing of the two while maintaining a sealed connection between the first upstream part 11 and the first downstream end 22.

[0057] like Figure 1 As shown, the liquid inlet module 30 includes a first liquid inlet pump 31 and a first liquid inlet flow path 32. The first liquid inlet flow path 32 has an inlet port connected to a wetting liquid source or a feed liquid source. The first liquid inlet pump 31 is disposed on the first liquid inlet flow path 32 to control the flow rate and flow volume of the fluid in the first liquid inlet flow path 32. The first liquid inlet flow path 32 is sealed to the first upstream part 11. A second valve 323 is provided on the first liquid inlet flow path 32 to control the opening and closing of the first liquid inlet flow path 32. The first liquid inlet flow path 32 includes a first interface for connecting to a wetting liquid source and a second interface for connecting to a feed liquid source. Valves for controlling the opening and closing are respectively provided on the first interface and the second interface. The first liquid inlet pump 31 is located downstream of the connection between the first interface and the second interface. The liquid inlet module 30 also includes a second liquid inlet pump 33 and a second liquid inlet flow path 34. The second liquid inlet flow path 34 has an inlet for connecting to the wetting liquid source. The second liquid inlet pump 33 is installed on the second liquid inlet flow path 34 to control the flow rate and flow volume of the fluid in the second liquid inlet flow path 34. The second liquid inlet flow path 34 can be sealed and connected to the first upstream end 21. A valve for controlling the opening and closing of the second liquid inlet flow path 34 can also be installed on the second liquid inlet flow path 34.

[0058] Separating the inlet flow paths for the main fluid filter 10 and the main air filter 20 reduces the need for pipeline switching in the inlet module 30. The first inlet pump 31 and the first inlet flow path 32 corresponding to the main fluid filter 10 can be used to transport wetting fluid and feed liquid, while the second inlet pump 33 and the second inlet flow path 34 corresponding to the main air filter 20 are used only for transporting wetting fluid. This simplifies operation and increases efficiency. The first inlet pump 31 and the second inlet pump 33 can be peristaltic pumps.

[0059] Of course, in other embodiments, the liquid inlet flow path of the liquid inlet module 30 can be connected to the first upstream part 11 and the first upstream end 21 respectively, and the flow direction of the wetting liquid is controlled by the valve on the liquid inlet flow path, so as to achieve the sequential wetting of the main fluid filter 10 and the main air filter 20.

[0060] like Figure 1 As shown, a four-way interface 17 is connected between the liquid outlet module 40 and the first downstream section 12, which is connected to the first downstream section 12, the top washing bag 16, the first waste discharge container 42 and the product outlet 41 respectively. A third valve 171 is provided between the top washing bag 16 and the four-way interface 17, a fourth valve 172 is provided between the product outlet 41 and the four-way interface 17, and a fifth valve 173 is provided between the first waste discharge container 42 and the four-way interface 17. A sixth valve 24 is provided between the second waste discharge container 23 and the first downstream end 22.

[0061] In this embodiment, the first valve 13, the second valve 323, the third valve 171, the fourth valve 172, the fifth valve 173 and the sixth valve 24 can be pinch valves to ensure the sealing of the pipeline and control the opening and closing of the pipeline.

[0062] A first pressure sensor 90 is provided on the first inlet flow path 32. The first pressure sensor 90 can communicate with the control module and can detect the fluid pressure on the first inlet flow path 32. The outlet module 40 includes an outlet flow path connected to the first downstream section 12, and a second pressure sensor 91 is provided on the outlet flow path. Both the first pressure sensor 90 and the second pressure sensor 91 can communicate with the control module. When only the main fluid filter 10 is used to filter the liquid, the first pressure sensor 90 and the second pressure sensor 91 are located upstream and downstream of the main fluid filter 10, respectively. Therefore, by comparing the difference between the values ​​of the first pressure sensor 90 and the second pressure sensor 91, the pressure difference of the liquid under the main fluid filter 10 can be determined. If the pressure difference is too large, it indicates that the main fluid filter 10 is blocked and the entire component needs to be replaced in time. The pressure difference comparison can be realized by the logic circuit in the control module, and the control module will execute the next operation, as can be referred to in the prior art.

[0063] The liquid inlet includes a wetting liquid inlet 321 and a feed liquid inlet 322, which are independent of each other. When the liquid inlet module 30 includes only one liquid inlet flow path, the liquid inlet flow path includes a wetting liquid inlet 321 and a feed liquid inlet 322, and also includes interfaces that are connected to the fluid filter and the air filter respectively. When the liquid inlet module 30 includes a first liquid inlet flow path 32 and a second liquid inlet flow path 34, the first liquid inlet flow path 32 is used to deliver wetting liquid and feed liquid to the fluid filter, and therefore has a wetting liquid inlet 321 and a feed liquid inlet 322, and the second liquid inlet flow path 34 is used to deliver wetting liquid to the air filter, and therefore has a separate wetting liquid inlet 321.

[0064] Preferably, the liquid outlet module 40 includes an independent product outlet 41 and a waste liquid outlet, with the waste liquid outlet sealed to a first waste discharge container 42. The product outlet 41 is used to connect to a filtrate storage device to collect filtrate during the filtration process. The first waste discharge container 42 is used to collect waste liquid from each stage of the fluid filtration assembly, including but not limited to wetting liquid, residual liquid from the previous filtration, or a mixture of wetting liquid and liquid, separating the two for ease of operation while ensuring the purity of the filtrate.

[0065] The filtration system based on the filtration components of this embodiment, such as Figure 2 As shown, it also includes a filter integrity testing device 70 and a container integrity testing device 80; the filter integrity testing device 70 can be connected to a test air source to perform integrity testing on the main fluid filter 10 or the main air filter 20 or the auxiliary fluid filter 50 or the auxiliary air filter 60; the container integrity testing device 80 can be connected to a test air source to perform integrity testing on the top wash bag 16 or the first waste discharge container 42 and detect the sealing of the flow path from the main air filter 20 to the top wash bag 16 or the first waste discharge container 42.

[0066] The filter integrity testing device 70 has a first on / off valve 71 on its test line. This test line can be connected to the main fluid filter 10 or the main air filter 20, and its on / off state can be controlled by the first on / off valve 71. The first on / off valve 71 can be a double normally closed valve. The container integrity testing device 80 has a second on / off valve 81 on its test line. This test line can be connected to the main fluid filter 10 or the main air filter 20, and its on / off state can be controlled by the second on / off valve 81. The second on / off valve 81 can be a double normally closed valve.

[0067] Preferably, the filtration system further includes a control module and a weight sensor 161 disposed on the top washing bag 16. The weight sensor 161 is communicatively connected to the control module to transmit the amount of liquid in the top washing bag 16 to the control module. After the weight sensor 161 detects that the weight of the top washing bag 16 has reached the set value, it indicates that the flow path in the entire fluid filtration assembly has been completely wetted by the liquid and the next filtration step can be carried out. The weight sensor 161 can send a signal to the control module to notify the operator to perform the next operation, or the control module can automatically execute the next operation. Automatic control can be achieved through logic circuits, thereby improving the automation level of the fluid filtration assembly and reducing the waste of expensive liquid.

[0068] The online integrity testing method for the filtering system described in the above embodiments is as follows: Aseptically connect all components of the fluid filtration system and aseptically connect the filtrate storage bag at product outlet 41.

[0069] I. Container Integrity Testing Steps: 1.1 Integrity test procedure for the first waste discharge container 42: Keep the container integrity test device sealed and connected to the first upstream end 21, connect the main air filter 20 to the main fluid filter 10 to the first waste discharge container 42, and close the connection between the first upstream part 11, the first downstream part 12 and other components, so that the test gas passes through the container integrity test device in sequence and flows to the main air filter 20, the main fluid filter 10 and the first waste discharge container 42 to perform integrity test on the first waste discharge container 42; Specifically, the main fluid filter 10 and the main air filter 20 are kept connected, and the container integrity testing device 80 is kept in sealed connection with the first upstream end 21. The first on / off valve 71, the second valve 323, the third valve 171, the fourth valve 172 and the sixth valve 24 are closed, and the first valve 13 and the fifth valve 173 are opened. The main air filter 20 is connected to the main fluid filter 10 and then to the first waste discharge container 42. The test gas passes through the container integrity testing device 80 in sequence and flows to the main air filter 20, the main fluid filter 10 and the first waste discharge container 42. Then the test gas source is controlled to start pressurizing to the preset value. After reaching the preset value, the pressure is maintained, the pressure drop is detected and the pass / fail status is determined.

[0070] 1.2 Integrity test procedure for top wash bag 16: Maintain the connection between the main fluid filter 10 and the main air filter 20, and keep the container integrity testing device 80 sealed and connected to the first upstream end 21. Close the first on / off valve 71, the second valve 323, the fourth valve 172, the fifth valve 173, and the sixth valve 24. Open the first valve 13 and the third valve 171 to connect the main air filter 20 to the main fluid filter 10 to the top wash bag 16. The test gas passes through the container integrity testing device 80 in sequence and flows to the main air filter 20, the main fluid filter 10, and the top wash bag 16. Then, control the test gas source to start pressurizing to the preset value. After reaching the preset value, maintain the pressure, detect the pressure drop, and determine whether it is qualified.

[0071] The integrity test procedures for the first waste container 42 and the top wash bag 16 can be performed in any order.

[0072] Based on the above test flow, a low-pressure leakage test step can also be performed, which precedes the container integrity test step. Maintain the connection between the main fluid filter 10 and the main air filter 20, and keep the container integrity testing device 80 sealed and connected to the first upstream end 21. Close the first on / off valve 71, the second valve 323, the fourth valve 172, and the sixth valve 24. Open the first valve 13, the third valve 171, and the fifth valve 173. Connect the main air filter 20 to the main fluid filter 10, then to the first waste discharge container 42, and the top washing bag 16. The test gas passes through the container integrity testing device 80 in sequence and flows to the main air filter 20, the main fluid filter 10, the first waste discharge container 42, and the top washing bag 16. Then, control the test gas source to start pressurizing to the preset value. After reaching the preset value, maintain the pressure, detect the pressure drop, and determine whether it is qualified (i.e., test the leakage of the bag body joint).

[0073] The high-pressure leakage test may be performed before the low-pressure leakage test, or the low-pressure leakage test may be omitted and the high-pressure leakage test may be performed directly before the container integrity test. Maintain the connection between the main fluid filter 10 and the main air filter 20, and keep the filter integrity testing device 70 sealed and connected to the first upstream end 21. Close the connections between the first upstream part 11, the first downstream part 12, the first upstream end 21, the first downstream end 22 and other components. Specifically, close the second valve 323, the third valve 171, the fourth valve 172, the fifth valve 173 and the sixth valve 24, close the opening and closing element 18 on the pipeline connecting the third waste discharge container 14 and the micro-limit sampling bag 15 to the first upstream part 11, open the first on / off valve 71, and close the second on / off valve 81. Allow the test gas to flow through the filter integrity testing device 70 to the main air filter 20 and the main fluid filter 10. Then, control the test gas source to start pressurizing to the preset value. After reaching the preset value, maintain the pressure, detect the pressure drop, and determine whether it is qualified (i.e., test the leakage of the filter joint).

[0074] II. Main Fluid Filter 10 Integrity Test Procedure: 2.1 Wet the main fluid filter 10 and keep the filter integrity test device 70 connected to the main air filter 20 and the main fluid filter 10 to perform an integrity test on the main fluid filter 10; Specifically, the wetting liquid source and the wetting liquid inlet 321 of the liquid inlet module 30 are connected. The second valve 323 is opened, and the first valve 13 is closed (if the pipeline between the main fluid filter 10 and the main air filter 20 is long, the first valve 13 may not be closed). The third valve 171, the fourth valve 172, and the fifth valve 173 are closed. The first liquid inlet pump 31 is started, so that the wetting liquid only wets the main fluid filter 10 and not the main air filter 20. At the same time, the opening and closing element 18 between the first upstream part 11 and the third waste discharge container 14 is opened to connect the two. The main fluid flows through... The exhaust gas inside the filter 10 is discharged into the third waste container 14. When the main fluid filter 10 has a wetting liquid flowing out of the exhaust port and the third waste container 14 has a wetting liquid, the opening and closing element 18 between the first upstream part 11 and the third waste container 14 is closed, and the first inlet pump 31 is turned off. After standing for 2 minutes, the first inlet pump 31 is restarted and the fifth valve 173 is opened at the same time. The first inlet pump 31 starts to dynamically flush the main fluid filter for 10 minutes at the preset speed. The excess wetting liquid is discharged into the first waste container 42. The main fluid filter 10 is fully wetted.

[0075] 2.2 Test procedure for main fluid filter 10: Connect the main fluid filter 10 and the main air filter 20, and keep the filter integrity test device 70 connected to the first upstream end 21. The test gas passes through the filter integrity test device 70, the main air filter 20 and the main fluid filter 10 in sequence to perform an integrity test on the main fluid filter 10. Specifically, the filter integrity testing device 70 is connected to the main air filter 20 and the first on / off valve 71 is opened, the first valve 13 and the fifth valve 173 are opened, and the second valve 323, the third valve 171, the fourth valve 172 and the sixth valve 24 are closed. The test gas passes through the filter integrity testing device 70, the main air filter 20 and the main fluid filter 10 in sequence. Excess test gas is discharged into the first waste discharge container 42. The integrity of the main fluid filter 10 is tested by the diffusion flow method. After the filter integrity testing device 70 outputs the result, if it passes, the next step is performed. If it fails, the main fluid filter 10 wetting step is repeated, and then the main fluid filter 10 testing step is performed again. If the integrity problem of the main fluid filter 10 is finally confirmed, the process is stopped.

[0076] III. Main Air Filter 20 Integrity Test Procedure: 3.1 Wet the main air filter 20 until the wetting liquid appears in the second waste container 23, and then keep the filter integrity test device 70 connected to the main air filter 20 to perform an integrity test on the main air filter 20. Specifically, disconnect the connection between the main fluid filter 10 and the main air filter 20, open the sixth valve 24, close the first on / off valve 71 and the second on / off valve 81, connect the wetting liquid source to the second inlet flow path 34, start the second inlet pump 33, and the wetting liquid enters from the first upstream end 21 of the main air filter 20 and flows out from the first downstream end 22 to wet the main air filter 20. When the wetting liquid appears in the second waste discharge container 23, it indicates that the main air filter 20 is fully wetted.

[0077] 3.2. Test procedure for main air filter 20: Disconnect the connection between main fluid filter 10 and main air filter 20, keep the filter integrity test device 70 sealed and connected to the first upstream end 21, and test gas passes through the filter integrity test device 70 and main air filter 20 in sequence to perform integrity test on main air filter 20. Specifically, the filter integrity testing device 70 is connected to the main air filter 20 and the first on / off valve 71 is opened, the sixth valve 24 is opened, the second on / off valve 81 is closed, and the connection between the first downstream end 22 and the first upstream part 11 is disconnected, so that the test gas passes through the filter integrity testing device 70 and the main air filter 20 in sequence to perform an integrity test on the main air filter 20. Excess test gas is discharged into the second waste discharge container 23. After the filter integrity testing device 70 outputs the result, if it passes, the next step is performed; if it fails, the main air filter 20 wetting step is repeated, and then the main air filter 20 testing step is performed again; if it is finally confirmed that the main air filter 20 has an integrity problem, the process is stopped.

[0078] IV. Filtering steps: Keep the inlet module 30 connected to the main fluid filter 10. The liquid to be filtered passes through the main fluid filter 10 to the outlet module 40 to achieve filtration, and the filtrate is collected in the outlet module 40. Specifically, disconnect the connection between the main fluid filter 10 and the main air filter 20, connect the liquid source to the liquid inlet 322 of the liquid inlet module 30, open the second valve 323, close the first valve 13, the third valve 171, the fourth valve 172 and the fifth valve 173, open the opening and closing element 18 between the first upstream part 11 and the micro-sampling bag 15 to connect the two, start the first liquid inlet pump 31 and make it pump the liquid into the micro-sampling bag 15 at a preset speed until the preset value is reached, and then stop the first liquid inlet pump. 31. The properties of the liquid are sampled and measured, and the process parameters for subsequent filtration are set according to the test results. Then, the third valve 171 is opened, the first inlet pump 31 is started and runs at the preset speed until the liquid in the top washing bag 16 reaches the preset value, and then the first inlet pump 31 is stopped. Then, the fourth valve 172 is opened, the third valve 171 is closed, the first inlet pump 31 is started and runs at the speed set by the process parameters to pump the liquid into the main fluid filter 10 to start filtration, and the filtrate is collected at the product outlet 41.

[0079] V. Main Fluid Filter 10 Integrity Retest Procedure: The filter integrity test device 70 is directly connected to the main fluid filter 10 to perform an integrity test on the main fluid filter 10.

[0080] Specifically, the entire main air filter 20 is removed, and the test pipeline of the filter integrity testing device 70 is connected to the first upstream part 11. The first on / off valve 71, the first valve 13, and the fifth valve 173 are opened, and the second valve 323, the third valve 171, and the fourth valve 172 are closed. The opening and closing elements 18 on the pipeline connecting the third waste discharge container 14 and the micro-limit sampling bag 15 to the first upstream part 11 are closed, so that the test gas passes through the filter integrity testing device 70 and the main fluid filter 10 in sequence. The integrity of the main fluid filter 10 is tested by the diffusion flow method. After the filter integrity testing device 70 outputs the result, if it passes, the process ends. If it fails, the main fluid filter 10 wetting step is repeated, and then the integrity retesting step of the main fluid filter 10 is performed again.

[0081] This utility model's online integrity testing method prioritizes container integrity testing of the filtration system to determine the sealing and integrity of the bag, preventing contamination of the filtration system due to bag damage. Then, integrity testing of the main fluid filter 10 and main air filter 20 is performed to ensure the sealing and sterility of each component before filtering the liquid, thus meeting the sterility requirements of the filtrate, avoiding costly waste of filtrate, and improving production efficiency. Finally, the integrity of the main fluid filter 10 is verified to confirm the integrity of the entire filtration system during the filtration process, proving the sterility of the filtrate. During this process, the exhaust gas and wetting liquid discharged from the main fluid filter 10 or auxiliary fluid filter 50 are input into the corresponding waste discharge container, and the wetting liquid discharged from the main air filter 20 or auxiliary air filter 60 is input into the corresponding waste discharge container. This prevents backflow contamination during testing of the filters and avoids the direct discharge of wetting liquid, exhaust gas, and test gas into the external environment, thereby ensuring the sterility of the entire filtration system and the external environment.

[0082] like Figure 3 In the illustrated embodiment two, the filter components in the filtration system differ from those in embodiment one in that an auxiliary fluid filter 50 and an auxiliary air filter 60 are added, along with other adaptive modifications. Specifically, such as... Figure 3 As shown, the auxiliary fluid filter 50 is located upstream of the main fluid filter 10 and is sealed in series according to the fluid flow sequence. The auxiliary fluid filter 50 includes a second upstream section 51 and a second downstream section 52. The second downstream section 52 is sealed to the first upstream section 11 or the second upstream section 51 of another auxiliary fluid filter 50. The waste discharge module also includes a fourth waste discharge container 55 sealed to the second upstream section 51. The fourth waste discharge container is used at least to receive the waste gas discharged when the auxiliary fluid filter 50 is wetted. The auxiliary fluid filter 50 also needs to undergo integrity testing, and the filtered test gas also needs to pass through the wetted auxiliary fluid filter 50. Therefore, the filter assembly also includes components that correspond one-to-one with the auxiliary fluid filters 50. The auxiliary air filter 60 includes a second upstream end 61 and a second downstream end 62. The second upstream part 51 is sealed to the second downstream end 62. The waste discharge module also includes a fifth waste discharge container 64 sealed to the second downstream end 62. The liquid inlet module 30 is sealed to both the second upstream part 51 and the second upstream end 61 and can communicate with the auxiliary fluid filter 50 or the auxiliary air filter 60. The second upstream part 51 and the second upstream end 61 have interfaces that can be sealed to the filter integrity testing device 70 to allow the test gas to pass only through the auxiliary fluid filter 50, or sequentially through the auxiliary air filter 60 and the auxiliary fluid filter 50, or only through the auxiliary air filter 60.

[0083] The test pipeline of the filter integrity test device 70 is connected to the first upstream end 21 and the second upstream end 61 respectively through a three-way solenoid valve 72, and the flow direction of the test gas is controlled by the three-way solenoid valve 72.

[0084] Since the auxiliary fluid filter 50 and the auxiliary air filter 60 need to be wetted and test gas needs to be introduced, and the downstream of the auxiliary fluid filter 50 is another auxiliary fluid filter 50 or the main fluid filter 10, there is no need to set up an additional sealed exhaust container. It can share the same exhaust container (first exhaust container 42) with the main fluid filter 10. The function of the fourth exhaust container 55 is similar to that of the third exhaust container 14. Because there is more air in the auxiliary fluid filter 50, the amount of air inside it has a greater impact on the auxiliary fluid filter 50. Therefore, during the wetting process, the internal space of the auxiliary fluid filter 50 will gradually be filled with wetting liquid and exhaust gas will be discharged from the second upstream part 51. The fourth exhaust container 55 is sealed to the second upstream part 51 and can receive the exhaust gas discharged and the overflowing wetting liquid when wetting the auxiliary fluid filter 50. It serves as an indicator and helps to confirm that the air in the auxiliary fluid filter 50 has been completely removed, thus optimizing the filtration effect. The fifth waste discharge container 64, which is sealed to the second downstream end 62 of the auxiliary air filter 60, serves the same purpose as the second waste discharge container 23: to ensure the sterility of the test gas filtered by the auxiliary air filter 60 and to prevent backflow contamination of the wetting liquid. The interiors of both the fourth waste discharge container 55 and the fifth waste discharge container 64 are isolated from the outside environment, improving the internal sealing and sterility of the filter assembly. They also serve as a warning when the wetting liquid and test gas flow into the corresponding waste discharge module, guiding the next step. In this embodiment, both the fourth waste discharge container 55 and the fifth waste discharge container 64 are transparent bags.

[0085] The filtration assembly also includes a micro-sampling bag 15, which is sealed to the second upstream section 51 of the first auxiliary fluid filter 50 in the fluid flow sequence. The function of the micro-sampling bag 15 is to sample the liquid that has not entered the fluid filter to measure the properties of the liquid, thereby setting the process parameters for subsequent filtration based on the test results. Generally, the micro-sampling bag 15 is located upstream of the first fluid filter in the liquid flow direction to ensure that the collected unfiltered liquid is collected. When the fluid filtration assembly includes one or more auxiliary fluid filters 50, the micro-sampling bag 15 is sealed to the second upstream section 51 of the first auxiliary fluid filter 50 in the fluid flow sequence. The first upstream section 11 does not have a micro-sampling bag 15. The pipes connecting the fourth waste container 55 and the micro-sampling bag 15 to the second upstream section 51 are respectively equipped with opening and closing elements 18 to control the opening and closing of the second upstream section 51 and the fourth waste container 55 and the micro-sampling bag 15.

[0086] Preferably, the liquid inlet module 30 includes a first liquid inlet pump 31 and a first liquid inlet flow path 32. The first liquid inlet flow path 32 has an inlet connected to a wetting liquid source or a material liquid source. The first liquid inlet pump 31 is disposed on the first liquid inlet flow path 32 to control the fluid flow in the first liquid inlet flow path 32. The first liquid inlet flow path 32 is sealed to the second upstream portion 51 of the first auxiliary fluid filter 50 located in the fluid flow sequence. The liquid inlet module 30 also includes a second liquid inlet pump 33 and a second liquid inlet flow path 34. The second liquid inlet flow path 34 has an inlet connected to a wetting liquid source. The second liquid inlet pump 33 is disposed on the second liquid inlet flow path 34 to control the fluid flow in the second liquid inlet flow path 34. The second liquid inlet flow path 34 can be sealed to the first upstream end 21. When each auxiliary fluid filter 50 corresponds to an auxiliary air filter 60, the second liquid inlet flow path 34 can be sealed to the second upstream end 61.

[0087] Specifically, the liquid inlet module 30 is connected to the second upstream section 51, thereby sequentially passing liquid through the auxiliary fluid filter 50 and the main fluid filter 10; a seventh valve 53 is provided between the first upstream section 11 and the second downstream section 52, and an eighth valve 54 is provided between the second upstream section 51 and the second downstream end 62; a ninth valve 63 is provided between the fifth waste discharge container 64 connected to the second downstream end 62 and the second downstream end 62.

[0088] Preferably, the liquid inlet includes a wetting liquid inlet 321 and a feed liquid inlet 322, which are independent of each other. When the liquid inlet module 30 includes only one liquid inlet flow path, the liquid inlet flow path includes a wetting liquid inlet 321 and a feed liquid inlet 322, and also includes interfaces that are respectively connected to the main fluid filter 10, the auxiliary fluid filter 50, the main air filter 20, and the auxiliary air filter 60. When the liquid inlet module 30 includes a first liquid inlet flow path 32 and a second liquid inlet flow path 34, the first liquid inlet flow path 32 is used to deliver wetting liquid and feed liquid to the main fluid filter 10 and the auxiliary fluid filter 50, and therefore has a wetting liquid inlet 321 and a feed liquid inlet 322, and the second liquid inlet flow path 34 is used to deliver wetting liquid to the main air filter 20 and the auxiliary air filter 60, and therefore has a separate wetting liquid inlet 321.

[0089] Preferably, a first pressure sensor 90 is provided on the first inlet flow path 32, and the first pressure sensor 90 can communicate with the control module. The first pressure sensor 90 can detect the fluid pressure on the first inlet flow path 32. The outlet module 40 includes an outlet flow path connected to the first downstream part 12, and a second pressure sensor 91 is provided on the outlet flow path. Both the first pressure sensor 90 and the second pressure sensor 91 can communicate with the control module. When the filter assembly filters the material liquid through the auxiliary fluid filter 50 and the main fluid filter 10, the first pressure sensor 90 and the second pressure sensor 91 are located upstream of the auxiliary fluid filter 50 and downstream of the main fluid filter 10, respectively. Therefore, by comparing the difference in values ​​of the first pressure sensor 90 and the second pressure sensor 91, the pressure difference between the main fluid filter 10 and the auxiliary fluid filter 50 can be determined, thereby determining whether the main fluid filter 10 and the auxiliary fluid filter 50 are blocked. If blocked, the staff will be notified in time to replace the entire filter assembly. The pressure difference comparison can be implemented by the logic circuit in the control module, and the control module will execute the next operation, as can be referred to in the prior art.

[0090] Furthermore, a third pressure sensor 92 is provided between the second downstream section 52 and the first upstream section 11. This third pressure sensor 92 is communicatively connected to the control module. By comparing the value of the third pressure sensor 92 with that of the first pressure sensor 90, the pressure differential of the auxiliary fluid filter 50 can be determined. Similarly, by comparing the second pressure sensor 91 with the third pressure sensor 92, the pressure differential of the main fluid filter 10 can be determined. This ensures higher accuracy in pressure differential detection for each fluid filter and makes it easier to identify faulty fluid filters. The pressure differential comparison can be implemented through logic circuitry in the control module, and the control module will then execute the next operation, as per existing technology.

[0091] Of course, in other embodiments, if the number of auxiliary fluid filters 50 is greater than 1, a pressure sensor may be installed on the pipeline between the two auxiliary fluid filters 50 to protect each fluid filter and to promptly determine the blockage of the fluid filter.

[0092] Based on the filtering system of this embodiment two, the online integrity testing method includes the following steps: The fluid filtration system in this embodiment requires aseptic installation, as shown in the connections between various components. Figure 3 As shown, a filtrate storage bag is aseptically connected at product outlet 41; The testing method is as follows: I. Container integrity testing procedures: Integrity testing is only required for the top wash bag 16 and the first waste container 42. 1.1 Integrity test procedure for the first waste discharge container 42: Keep the container integrity test device sealed and connected to the first upstream end 21, connect the main air filter 20 to the main fluid filter 10 to the first waste discharge container 42, and close the connection between the first upstream part 11, the first downstream part 12 and other components, so that the test gas passes through the container integrity test device 80 in sequence and flows to the main air filter 20, the main fluid filter 10 and the first waste discharge container 42 to perform integrity test on the first waste discharge container 42; Specifically, the main fluid filter 10 and the main air filter 20 are kept connected, and the container integrity testing device 80 is kept in sealed connection with the first upstream end 21. The first on / off valve 71, the seventh valve 53, the third valve 171, the fourth valve 172 and the sixth valve 24 are closed, and the first valve 13 and the fifth valve 173 are opened. The main air filter 20 is connected to the main fluid filter 10 and then to the first waste discharge container 42. The test gas passes through the container integrity testing device 80 in sequence and flows to the main air filter 20, the main fluid filter 10 and the first waste discharge container 42. Then the test gas source is pressurized to the preset value. After reaching the preset value, the pressure is maintained, the pressure drop is detected and the pass / fail status is determined.

[0093] 1.2 Integrity test procedure for top wash bag 16: Maintain the connection between the main fluid filter 10 and the main air filter 20, and keep the container integrity testing device 80 sealed and connected to the first upstream end 21. Close the first on / off valve 71, the seventh valve 53, the fourth valve 172, the fifth valve 173, and the sixth valve 24. Open the first valve 13 and the third valve 171 to connect the main air filter 20 to the main fluid filter 10 and then to the top wash bag 16. The test gas passes through the container integrity testing device 80 in sequence and flows to the main air filter 20, the main fluid filter 10, and then to the top wash bag 16. Then, control the test gas source to start pressurizing to the preset value. After reaching the preset value, maintain the pressure, detect the pressure drop, and determine whether it is qualified.

[0094] The integrity test procedures for the first waste container 42 and the top wash bag 16 can be performed in any order.

[0095] Based on the above test flow, a low-pressure leakage test step can also be performed, which precedes the container integrity test step. Maintain the connection between the main fluid filter 10 and the main air filter 20, and keep the container integrity testing device 80 sealed and connected to the first upstream end 21. Close the first on / off valve 71, the seventh valve 53, the fourth valve 172, and the sixth valve 24. Open the first valve 13, the third valve 171, and the fifth valve 173. Connect the main air filter 20 to the main fluid filter 10, then to the first waste discharge container 42, and the top washing bag 16. The test gas passes through the container integrity testing device 80 in sequence and flows to the main air filter 20, the main fluid filter 10, the first waste discharge container 42, and the top washing bag 16. Then, control the test gas source to start pressurizing to the preset value. After reaching the preset value, maintain the pressure, detect the pressure drop, and determine whether it is qualified (i.e., test the leakage of the bag body joint).

[0096] Based on the above test flow, a high-pressure leakage test can be performed before the low-pressure leakage test, or the low-pressure leakage test can be skipped and the high-pressure leakage test can be performed directly before the container integrity test. like Figure 4 As shown, the main fluid filter 10 and main air filter 20 are kept connected, the auxiliary fluid filter 50 and auxiliary air filter 60 are kept connected, the filter integrity test device 70 is kept in sealed communication with the second upstream end 61, and the communication between the first upstream part 11, the first downstream part 12, the first upstream end 21, the first downstream end 22, the second upstream part 51, the second downstream part 52, the second upstream end 61 and the second downstream end 62 and other components is closed, that is, the first on / off valve 71, the second on / off valve 81, the second valve 323, the third valve 171, the fourth valve 172, the fifth valve 173, the sixth valve 24 and the ninth valve 63 are closed, and the third waste discharge container 14 is closed. The opening and closing element 18 on the pipeline connected to the first upstream section 11 closes the opening and closing element 18 on the pipeline connected to the fourth waste container 55 and the micro-limit sampling bag 15 and the second upstream section 51, opens the connection between the three-way solenoid valve 72 and the second upstream end 61, opens the first valve 13, the seventh valve 53 and the eighth valve 54, and the test gas passes through the filter integrity test device 70, the auxiliary air filter 60 and the auxiliary fluid filter 50 in sequence and flows to the main air filter 20 and the main fluid filter 10 respectively. Then the test gas source is controlled to start pressurizing to the preset value. After reaching the preset value, the pressure is maintained, the pressure drop is detected, and it is determined whether it is qualified (i.e., the leakage of the filter joint is tested).

[0097] II. Fluid Filter Integrity Test Procedure like Figure 4As shown, the process specifically includes a fluid filter wetting step. Since the liquid inlet module 30 is connected to the main fluid filter 10 through the auxiliary fluid filter 50, there is an auxiliary fluid filter 50 wetting step before the main fluid filter 10 wetting step: the connection between the auxiliary fluid filter 50 and the auxiliary air filter 60 is disconnected, the wetting liquid enters from the second upstream part 51 of the auxiliary fluid filter 50 and flows out from the second downstream part 52 to wet the auxiliary fluid filter 50; after confirming that the auxiliary fluid filter 50 is wetted, the flow path from the second downstream part 52 to the first upstream part 11 of the main fluid filter 10 is opened to perform the main fluid filter 10 wetting step.

[0098] Specifically, the wetting liquid source and the wetting liquid inlet 321 of the liquid inlet module 30 are connected. The second valve 323 is opened, the eighth valve 54 is closed (if the pipeline between the auxiliary fluid filter 50 and the auxiliary air filter 60 is long, the eighth valve 54 may not be closed), the seventh valve 53 is closed, and the first liquid inlet pump 31 is started, so that the wetting liquid only wets the auxiliary fluid filter 50 and not the auxiliary air filter 60. At the same time, the opening and closing element 18 between the second upstream part 51 and the fourth waste discharge container 55 is opened to connect the two. The exhaust gas inside the auxiliary fluid filter 50 is discharged into the fourth waste discharge container 55. When the wetting liquid flows out of the exhaust port of the auxiliary fluid filter 50, the second valve 323 is opened. When wetting liquid appears in the fourth waste container 55, the opening and closing element 18 between the second upstream part 51 and the fourth waste container 55 is closed, and the first inlet pump 31 is shut down. After standing for 2 minutes, the first inlet pump 31 is restarted, the seventh valve 53 is opened, and the main fluid filter 10 is wetted. For details, please refer to Embodiment 1. It should be noted that in this embodiment, based on the connection method of the inlet module 30, the first inlet pump 31 dynamically flushes both the main fluid filter 10 and the auxiliary fluid filter 50. If in other embodiments, the number of auxiliary fluid filters 50 is greater than 1, the above-mentioned wetting steps are also used to wet each auxiliary fluid filter 50 step by step.

[0099] After wetting the auxiliary fluid filter 50 and the main fluid filter 10, the main fluid filter 10 is tested first. The seventh valve 53 is closed, and the three-way solenoid valve 72 is opened to connect with the first upstream end 21. Other specific steps can be referred to in Embodiment 1. After the integrity of the main fluid filter 10 is passed, the auxiliary fluid filter 50 is tested. The flow path from the second downstream part 52 to the first upstream part 11 of the main fluid filter 10 is opened, connecting the main fluid filter 10 and the main air filter 20, and connecting the auxiliary fluid filter 50 and the auxiliary air filter 60. The filter integrity testing device 70 is kept in sealed connection with the second upstream end 61. The test gas passes through the filter integrity testing device 70, the auxiliary air filter 60, and the auxiliary fluid filter 50 in sequence to test the integrity of the auxiliary fluid filter 50.

[0100] Specifically, the filter integrity testing device 70 is connected and energized with the auxiliary air filter 60. The three-way solenoid valve 72 is opened to connect with the second upstream end 61. The eighth valve 54, seventh valve 53, first valve 13, and sixth valve 24 are opened, while the first on / off valve 71, second on / off valve 81, ninth valve 63, second valve 323, third valve 171, fourth valve 172, and fifth valve 173 are closed. The test gas passes sequentially through the filter integrity testing device 70, auxiliary air filter 60, and auxiliary fluid filter 50. Since the gas mainly flows upwards, the test gas passes through the filter integrity testing device 70, auxiliary air filter 60, and auxiliary fluid filter 50 after the third valve 171 and fourth valve 172 are closed. With both valve 2 and valve 173 closed, the test gas will not pass through the main fluid filter 10, but will instead flow through valve 24 to the second waste container 23 at the first downstream end 22, thereby completing the integrity test of the auxiliary fluid filter 50. The integrity of the auxiliary fluid filter 50 is tested using the diffusion flow method. After the filter integrity test device 70 outputs the result, if it passes, proceed to the next step; if it fails, repeat the auxiliary fluid filter 50 wetting step, and then perform the auxiliary fluid filter 50 test step again. If it is finally confirmed that the auxiliary fluid filter 50 has an integrity problem, the process is stopped.

[0101] III. Air Filter Integrity Test Procedure like Figure 5 As shown, the specific steps include the air filter wetting process: disconnecting the connection between the auxiliary fluid filter 50 and the auxiliary air filter 60, opening the sixth valve 24 and the ninth valve 63, closing the first on / off valve 71 and the second on / off valve 81, connecting the wetting liquid source with the second inlet flow path 34, starting the second inlet pump 33, the wetting liquid entering from the second upstream end 61 of the auxiliary air filter 60 and entering the fifth waste discharge container 64 from the second downstream end 62, the wetting liquid entering from the first upstream end 21 of the main air filter 20 and entering the second waste discharge container 23 from the first downstream end 22, the presence of a preset amount of wetting liquid in the fifth waste discharge container 64 and the second waste discharge container 23 respectively indicates that the auxiliary air filter 60 and the main air filter 20 are fully wetted; Specifically, the air filter testing steps include: a three-way solenoid valve 72 is provided on the test pipeline of the filter integrity testing device 70 to connect the first upstream end 21 and the second upstream end 61 respectively. The testing steps of the main air filter 20 and the auxiliary air filter 60 are not sequential. The testing steps of the main air filter 20 are as described in Embodiment 1. The testing steps of the auxiliary air filter 60 are as follows: disconnect the connection between the auxiliary fluid filter 50 and the auxiliary air filter 60, close the first on-off valve 71 and the second on-off valve 81, keep the filter integrity testing device 70 sealed and connected to the second upstream end 61, open the ninth valve 63, and the test gas passes through the filter integrity testing device 70 and the auxiliary air filter 60 in sequence to perform an integrity test on the auxiliary air filter 60.

[0102] IV. Filtration Steps like Figure 5 As shown, the connection between the main fluid filter 10 and the main air filter 20 is disconnected, and the connection between the auxiliary fluid filter 50 and the auxiliary air filter 60 is disconnected. The feed liquid passes through the auxiliary fluid filter 50 and the main fluid filter 10 in sequence to the liquid outlet module 40 to achieve filtration, and the filtrate is collected in the liquid outlet module 40.

[0103] Specifically, disconnect the connection between the first downstream end 22 and the first upstream part 11, disconnect the connection between the second downstream end 62 and the second upstream part 51, connect the liquid source to the liquid inlet 322 of the liquid inlet module 30, open the second valve 323, close the seventh valve 53, the eighth valve 54, the first valve 13, the third valve 171, the fourth valve 172, and the fifth valve 173, open the opening and closing element 18 between the second upstream part 51 and the micro-sampling bag 15 to connect the two, start the first liquid inlet pump 31 and make it pump the liquid into the micro-sampling bag 15 at a preset speed until the preset value is reached, and then stop the first liquid inlet. Pump 31 samples and measures the properties of the liquid material, and sets the process parameters for subsequent filtration based on the test results. Then, the seventh valve 53 and the third valve 171 are opened, while other valves are not operated. The first inlet pump 31 is started and runs at the preset speed until the liquid material in the top washing bag 16 reaches the preset value, and then the first inlet pump 31 is stopped. Then, the fourth valve 172 is opened, the third valve 171 is closed, while other valves are not operated. The first inlet pump 31 is started and runs at the speed set by the process parameters, pumping the liquid material into the auxiliary fluid filter 50 and the main fluid filter 10 in sequence to start filtration, and collecting the filtrate at the product outlet 41.

[0104] V. Fluid Filter Integrity Verification Steps like Figure 6 As shown, the connection between the main fluid filter 10 and the main air filter 20 is disconnected, while the filter integrity test device 70 is kept in sealed connection with the first upstream part 11. The test gas passes through the filter integrity test device 70 and the main fluid filter 10 in sequence to retest the integrity of the main fluid filter 10. Specifically, the entire main air filter 20 is removed, and the test pipeline of the filter integrity testing device 70 is connected to the first upstream section 11. That is, the three-way solenoid valve 72 is opened to connect with the first upstream section 11, the first on-off valve 71, the first valve 13 and the fifth valve 173 are opened, the second on-off valve 81, the second valve 323, the third valve 171, the fourth valve 172, the seventh valve 53 and the eighth valve 54 are closed, and the opening and closing elements 18 on the pipeline connecting the third waste discharge container 14 and the micro-limit sampling bag 15 to the first upstream section 11 are closed. The test gas is then passed through the filter integrity testing device 70 and the main fluid filter 10 in sequence. The integrity of the main fluid filter 10 is tested by the diffusion flow method. After the filter integrity testing device 70 outputs the result, if it passes, the process ends. If it fails, the integrity of the auxiliary fluid filter 50 is tested. Remove the entire auxiliary air filter 60 and connect the test line of the filter integrity testing device 70 to the second upstream section 51. That is, open the connection between the three-way solenoid valve 72 and the second upstream section 51, close the first on-off valve 71, the second on-off valve 81, the second valve 323, the third valve 171, the fourth valve 172 and the fifth valve 173, open the eighth valve 54, the seventh valve 53 and the first valve 13, and open the opening and closing element 18 between the first upstream section 11 of the main fluid filter 10 and the third waste discharge container 14, so that the test gas passes through the filter integrity testing device 70 and the auxiliary fluid filter 50 in sequence and flows into the third waste discharge container 14. Test the integrity of the auxiliary fluid filter 50 by diffusion flow method. If it passes, the process ends. If it fails, the fluid filter wetting step is repeated, and then the integrity of the main fluid filter 10 and the auxiliary fluid filter 50 is checked again.

[0105] In other embodiments, the auxiliary fluid filter 50 can use the main air filter 20 to filter the test gas. That is, compared with the filter assembly of Embodiment 1, only the auxiliary fluid filter 50 is added. The second upstream part 51 is sealed to the first downstream end 22, the liquid inlet module 30 is sealed to the second upstream part 51, and can communicate with the auxiliary fluid filter 50. The second upstream part 51 has an interface for sealing connection with the filter integrity test device 70, so that the test gas can pass through the auxiliary fluid filter 50 alone, or pass through the main air filter 20 and the auxiliary fluid filter 50 in sequence. The integrity test method and filtration steps of the auxiliary fluid filter 50, the main fluid filter 10 and the main air filter 20 in this embodiment can refer to Embodiment 1 and Embodiment 2, and will not be repeated here.

[0106] The above embodiments are merely preferred embodiments of this utility model and should not be construed as limiting the scope of protection of this utility model. Any non-substantial changes and substitutions made by those skilled in the art based on this utility model shall fall within the scope of protection claimed by this utility model.

Claims

1. A filtration assembly, comprising an inlet module, an outlet module, a main fluid filter, and a main air filter located upstream of the main fluid filter; The main fluid filter includes a first upstream section and a first downstream section, the first downstream section being sealed to the liquid outlet module; the main air filter includes a first upstream end and a first downstream end. Its features are, It also includes a waste discharge module, which includes a first waste discharge container that is sealed to the liquid discharge module and a second waste discharge container that is sealed to the first downstream end of the main air filter. The liquid inlet module is sealed to both the first upstream section and the first upstream end, and can communicate with the main fluid filter or the main air filter. The liquid inlet module has an inlet for connecting to a wetting liquid source or a feed liquid source. The first upstream end and / or the first upstream portion has an interface capable of sealingly communicating with a filter integrity testing device or a container integrity testing device, so as to allow the test gas passing through the filter integrity testing device or the container integrity testing device to pass only through the main air filter, or only through the main fluid filter and then into the first waste discharge container, or pass through the main air filter and the main fluid filter in sequence and then into the first waste discharge container.

2. The filter assembly as described in claim 1, characterized in that, The waste discharge module also includes a third waste discharge container that is sealed and connected to the first upstream part of the main fluid filter. The third waste discharge container is at least used to receive the waste gas discharged when the main fluid filter is wetted.

3. The filter assembly as described in claim 2, characterized in that, The first waste discharge container, the second waste discharge container, and the third waste discharge container are all containers with zero initial internal air pressure and observable contents.

4. The filter assembly as described in claim 3, characterized in that, The first waste discharge container, the second waste discharge container, and the third waste discharge container are all transparent bags.

5. The filter assembly as described in any one of claims 1 to 4, characterized in that, It also includes at least one set of auxiliary fluid filters, which are located upstream of the main fluid filter and are sealed in series according to the fluid flow sequence. The auxiliary fluid filter includes a second upstream section and a second downstream section, and the second downstream section is sealed to the first upstream section or the second upstream section of another auxiliary fluid filter. The waste discharge module also includes a fourth waste discharge container sealed to the second upstream section, which is at least used to receive the waste gas discharged when the auxiliary fluid filter is wetted. The second upstream portion is sealed to the first downstream end, and the liquid inlet module is sealed to the second upstream portion and can communicate with the auxiliary fluid filter. The second upstream portion has an interface for sealing connection with the filter integrity testing device, so that the test gas passing through the filter integrity testing device can pass only through the auxiliary fluid filter, or sequentially through the main air filter and the auxiliary fluid filter. Alternatively, it also includes an auxiliary air filter corresponding to the auxiliary fluid filter, the auxiliary air filter including a second upstream end and a second downstream end, the second upstream portion and the second downstream end being sealed to each other, the waste discharge module also includes a fifth waste discharge container sealed to the second downstream end, the liquid inlet module being sealed to both the second upstream portion and the second upstream end, and can communicate with the auxiliary fluid filter or the auxiliary air filter, the second upstream portion and / or the second upstream end having an interface capable of sealing connection with the filter integrity testing device, so that the test gas passing through the filter integrity testing device can pass only through the auxiliary fluid filter, or sequentially through the auxiliary air filter and the auxiliary fluid filter, or only through the auxiliary air filter.

6. The filter assembly as claimed in claim 1, characterized in that, A topwash bag for receiving topwash liquid is provided between the first downstream section and the liquid outlet module; the interface of the first upstream end is also used for sealed communication with the container integrity testing device to allow test gas to enter the topwash bag.

7. The filter assembly as claimed in claim 1, characterized in that, It also includes a micro-sampling bag, which is sealed to the first upstream portion.

8. The filter assembly as described in claim 5, characterized in that, It also includes a micro-sampling bag, which is sealed to a second upstream portion of the first auxiliary fluid filter in the fluid flow sequence.

9. The filter assembly as claimed in claim 1, characterized in that, The liquid inlet module includes a first liquid inlet pump and a first liquid inlet flow path. The first liquid inlet flow path has an inlet connected to a wetting liquid source or a material liquid source. The first liquid inlet pump is disposed on the first liquid inlet flow path to control the fluid flow in the first liquid inlet flow path, and the first liquid inlet flow path is sealed to the first upstream part. The liquid inlet module further includes a second liquid inlet pump and a second liquid inlet flow path. The second liquid inlet flow path has an inlet for connecting to a wetting liquid source. The second liquid inlet pump is disposed on the second liquid inlet flow path to control the fluid flow in the second liquid inlet flow path, and the second liquid inlet flow path can be sealed and connected to the first upstream end.

10. The filter assembly as claimed in claim 5, characterized in that, The liquid inlet module includes a first liquid inlet pump and a first liquid inlet flow path. The first liquid inlet flow path has an inlet connected to a wetting liquid source or a material liquid source. The first liquid inlet pump is disposed on the first liquid inlet flow path to control the fluid flow in the first liquid inlet flow path. The first liquid inlet flow path is sealed to the second upstream part of the first auxiliary fluid filter located in the fluid flow sequence. The liquid inlet module further includes a second liquid inlet pump and a second liquid inlet flow path. The second liquid inlet flow path has an inlet for connecting to a wetting liquid source. The second liquid inlet pump is disposed on the second liquid inlet flow path to control the fluid flow in the second liquid inlet flow path, and the second liquid inlet flow path can be sealed and connected to the first upstream end. When each of the auxiliary fluid filters corresponds to an auxiliary air filter, the second liquid inlet flow path can be sealed and connected to the second upstream end.

11. The filter assembly as claimed in claim 9 or 10, characterized in that, A first pressure sensor is provided on the first liquid inlet flow path, and the first pressure sensor can communicate with the control module.

12. The filter assembly as claimed in claim 11, characterized in that, The liquid outlet module includes a liquid outlet flow path connected to the first downstream section, and a second pressure sensor is provided on the liquid outlet flow path; both the first pressure sensor and the second pressure sensor can communicate with the control module.

13. The filter assembly as claimed in claim 5, characterized in that, A third pressure sensor is provided between the second downstream section and the first upstream section, and the third pressure sensor can communicate with the control module.

14. The filter assembly as claimed in claim 1, 9, or 10, characterized in that, The inlet includes a wetting liquid inlet and a feed liquid inlet, which are independent of each other; and / or The liquid discharge module includes a product outlet and a waste liquid outlet that are independent of each other, and the waste liquid outlet is sealed to the first waste discharge container.

15. A filtration system, characterized in that, The filter assembly includes the filter integrity testing device and the container integrity testing device as described in any one of claims 1 to 14. The filter integrity testing device can be connected to a test air source to perform integrity testing on the main fluid filter, main air filter, auxiliary fluid filter, or auxiliary air filter. The container integrity testing device can be connected to a test air source to perform integrity testing on the top wash bag or the first waste discharge container and to detect the sealing performance of the flow path from the main air filter to the top wash bag or the first waste discharge container.

16. The filtration system as claimed in claim 15, characterized in that, It also includes a control module and a weight sensor installed on the top washing bag, the weight sensor being communicatively connected to the control module.

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