Online integrity detection device for sterile filter
By designing an online integrity testing device for sterile filters, the device utilizes the filter and valve structure to ensure sterility, solving the problem that existing testing devices cannot guarantee sterility. This simplifies the testing process and ensures the integrity of the filter and the sterility of drug production.
Patent Information
- Application Number
- CN202422579956.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-24
- Publication Date
- 2025-11-14
- Estimated Expiration
- 2034-10-24
AI Technical Summary
In existing sterile filter integrity testing devices, the external compressed air and the conveyed liquid cannot guarantee a sterile state, and the testing process is complicated, affecting the integrity of the filter element and failing to guarantee a sterile environment.
An online integrity testing device for sterile filters was designed, including first, second, and third filters, multiple pipeline channels, and valves. By setting up filters and valves, the sterility of compressed gas and liquid is ensured, and the sterile sealing state is maintained by controlling the valve opening and closing, thus ensuring the sterility of the testing process.
It achieves sterility during the testing process, avoids affecting the performance of the filter element, simplifies the testing process, and meets the sterility requirements of pharmaceutical production.
Smart Images
Figure CN223551547U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of filter integrity testing technology, specifically to an online integrity testing device for sterile filters. Background Technology
[0002] The statements herein provide only background information related to this invention and do not necessarily constitute prior art.
[0003] With the continuous improvement and upgrading of the Good Manufacturing Practice (GMP) for pharmaceuticals, the aseptic standards in the pharmaceutical manufacturing process have become increasingly stringent. Furthermore, in the production of aseptic pharmaceutical preparations, sterilization is crucial; and within the sterilization process, filters are one of the most critical components. Therefore, according to the requirements of GMP, the integrity of filters must be tested before and after SIP (steam in-line sterilization) of the pharmaceutical solution to ensure the integrity and safety of the filter element before and after use. The latest EU GMP stipulates that the integrity of filters must be tested after SIP of the pharmaceutical solution.
[0004] In existing integrity testing devices, the filter element is typically impregnated with a feed solution while compressed air is supplied. The integrity of the filter is then tested using methods such as bubble point testing. However, this method cannot guarantee that the external compressed air and the supplied feed solution are sterile, which can easily affect the filter element. Furthermore, it cannot guarantee that the filter and piping will be sterile after the integrity test. Moreover, existing testing devices involve numerous connecting pipes and components, making the entire testing process quite complex. Utility Model Content
[0005] The technical problem to be solved by this utility model is to provide an online integrity testing device for sterile filters. By setting a first filter, a second filter and a third filter, it can ensure that the external compressed gas and the conveyed liquid are in a sterile state, and it can also ensure that the discharged gas and liquid are in a sterile state. Furthermore, by setting a valve, it can ensure that the entire device is in a sterile state during the integrity testing of the filter under test.
[0006] The purpose of this utility model is to provide an online integrity testing device for sterile filters, which is externally connected to the original pipeline channel on which the filter to be tested is installed. The online integrity testing device includes a first pipeline channel, a second pipeline channel, a third pipeline channel and a fourth pipeline channel. On the original pipeline channel, valves S1 and S2 are respectively provided on both sides of the filter to be tested.
[0007] One end of the first pipeline channel is connected to a bubble point detector, and starting from the bubble point detector, a first filter and an S3 valve are sequentially installed on the first pipeline channel. The other end of the first pipeline channel is connected to the original pipeline channel between the S1 valve and the filter to be tested.
[0008] The second pipeline channel is sequentially equipped with valve S4, a second filter, and valve S5. The third pipeline channel is sequentially equipped with valve S6, a third filter, and valve S7. One end of the second and third pipeline channels is connected to one end of the fourth pipeline channel. The other end of the fourth pipeline channel is connected to the original pipeline channel between valve S2 and the filter under test. Valve S8 is installed on the fourth pipeline channel.
[0009] As a further technical solution, the first filter and the third filter are air filters.
[0010] As a further technical solution, the second filter is a liquid filter.
[0011] As a further technical solution, pressure sensors are provided on the first filter, the second filter, and the third filter.
[0012] As a further technical solution, the first pipeline channel, the second pipeline channel, the third pipeline channel and the fourth pipeline channel are all sanitary grade pipelines.
[0013] As a further technical solution, the sanitary pipe is a stainless steel pipe.
[0014] As a further technical solution, the interior of the first, second, third, and fourth pipeline channels is coated with a waterproof layer.
[0015] As a further technical solution, pressure sensors are installed on the first pipeline channel, the second pipeline channel, the third pipeline channel and the fourth pipeline channel.
[0016] As a further technical solution, valves S1 to S8 are isolation valves.
[0017] As a further technical solution, valves S1 to S8 are electrically operated barrier valves.
[0018] The beneficial effects of one or more of the above technical solutions:
[0019] This invention, through its various pipeline channels, valves, filters, and bubble point detector, ensures that the external compressed air and the transported liquid are sterile, thus avoiding any impact on the filtration performance of the filter under test. By controlling the opening and closing of each valve, the system remains sterile and sealed throughout the integrity testing process of the filter under test, ensuring that the entire pipeline system remains sterile after the filter element has completed the integrity test, thereby enabling the production of sterile pharmaceutical preparations. Furthermore, the entire online integrity testing device has a simple structure, reducing the difficulty of operation. Attached Figure Description
[0020] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. For ease of understanding, the proportions between the various structural parts have been adjusted. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute a limitation of this application.
[0021] Figure 1 This is a schematic diagram of the structure of an online integrity testing device for a sterile filter according to the present invention.
[0022] Among them, 1. Filter to be tested, 2. Original pipeline channel, 3. First pipeline channel, 4. Second pipeline channel, 5. Third pipeline channel, 6. Fourth pipeline channel, 7. S1 valve, 8. S2 valve, 9. S3 valve, 10. S4 valve, 11. S5 valve, 12. S6 valve, 13. S7 valve, 14. S8 valve, 15. First filter, 16. Second filter, 17. Third filter, 18. Bubble point detector. Detailed Implementation
[0023] The following is in conjunction with the appendix Figure 1 The technical solutions in the embodiments of this utility model will be clearly and completely described.
[0024] Example 1
[0025] An online integrity testing device for sterile filters is provided, and is used to connect externally to the original pipeline channel 2 on which the filter to be tested 1 is installed.
[0026] Reference Figure 1 The online integrity detection device includes a first pipeline channel 3, a second pipeline channel 4, a third pipeline channel 5 and a fourth pipeline channel 6. Meanwhile, S1 valve 7 and S2 valve 8 are respectively installed on both sides of the filter to be tested on the original pipeline channel 2.
[0027] Specifically, one end of the first pipeline channel 3 is connected to a bubble point detector 18, and starting from the bubble point detector 18, a first filter 15 and an S3 valve 9 are sequentially installed on the first pipeline channel 3. The other end of the first pipeline channel 3 is connected to the original pipeline channel 2 between the S1 valve 7 and the filter to be tested 1.
[0028] In this embodiment, the first filter 15 is an air filter, and the bubble point detector 18 is connected to compressed air during use and is transmitted along the first pipeline channel 3. During the transmission process, the first filter 15 filters the compressed air to obtain sterile compressed air. At the same time, pressure sensors are also provided on the first pipeline channel 3 and the first filter 15 to obtain the pressure value during the delivery of compressed air, which is convenient for regulation.
[0029] S4 valve 10, second filter 16 and S5 valve 11 are sequentially installed on the second pipeline channel 4, while S6 valve 12, third filter 17 and S7 valve 13 are sequentially installed on the third pipeline channel 5. One end of the second pipeline channel 4 and the third pipeline channel 5 are connected to one end of the fourth pipeline channel 6. At the same time, the other end of the fourth pipeline channel 6 is connected to the original pipeline channel 2 between S2 valve 8 and the filter under test 1, and S8 valve 14 is installed on the fourth pipeline channel 6.
[0030] In this embodiment, the second filter 16 is a liquid filter used to filter the delivered liquid to obtain sterile liquid, thereby achieving sterile impregnation of the filter element in the filter under test 1, avoiding any impact on the filter element, and enabling integrity testing of the filter element. The third filter 17 is an air filter used to filter the air output from the entire pipeline, ensuring that the output air is also sterile. During use, the opening of the second pipeline channel 4 near valve 10 is connected to a liquid delivery device to deliver the liquid to the filter under test 1, completing the impregnation of the filter element.
[0031] Meanwhile, pressure sensors are installed on the second filter 16, the third filter 17, the second pipeline channel 4, the third pipeline channel 5, and the fourth pipeline channel 6. The purpose is to ensure that the working status of each pipeline or sensor can be understood in real time during the gas or liquid transportation process, so as to regulate the gas or liquid transportation and thus successfully complete the integrity test of the filter element in the filter under test 1.
[0032] By setting up the above-mentioned devices and adjusting the opening and closing of each valve, the entire device can be isolated from the outside world, thereby ensuring that the entire safety testing process is aseptic.
[0033] How to use the device:
[0034] Step 1: After sterilizing the filter element in the filter to be tested 1, close valve S2 8 (before the device is running, valves S1 7 and S2 8 are normally open, and the other valves are normally closed).
[0035] Step 2: At this time, open valves S4 10, S5 11 and S8 14, and supply liquid to the filter to be tested 1 through the second pipeline channel 4 and the fourth pipeline channel 6; during the supply process, the second filter 16 filters and sterilizes the liquid, thereby impregnating the filter element in the filter to be tested 1 with sterile liquid.
[0036] Step 3: After the soaking is completed, the liquid in the filter to be tested 1 is discharged through the original pipeline channel 2 on the side equipped with valve S1 7; during this process, it is ensured that the discharged liquid is also in a sterile state.
[0037] Step 4: After the liquid is discharged, close valves S1 7, S4 10 and S5 11, and open valves S3 9, S6 12 and S7 13.
[0038] Step 5: The bubble point detector 18 connects to compressed air and performs an integrity test on the filter element in the filter to be tested 1 through the first pipeline channel 3, while simultaneously discharging the air through the third pipeline channel 5. During this process, the first filter 15 filters and sterilizes the compressed air, ensuring that the compressed air does not affect the filtration performance of the filter element, and ultimately completing the filter element test; while the third filter 17 filters the output air, ensuring that the output air is also sterile.
[0039] Step 6: After completing the integrity test of the filter element in the filter to be tested 1, close valve S3 9 and open valve S1 7 to completely purge the air from the filter to be tested 1.
[0040] Step 7: After the air has been purged, close valves S6 12, S7 13 and S8 14, and open valve S2 8 to begin drug production.
[0041] All pipelines will be sterilized and dried during the next SIP cycle.
[0042] Through the above steps, the integrity of the filter element in the filter to be tested 1 can be tested, and the entire device can be kept in a sterile state.
[0043] To ensure the device does not affect the pharmaceutical manufacturing process, the first pipeline channel 3, the second pipeline channel 4, the third pipeline channel 5, and the fourth pipeline channel 6 are all sanitary-grade pipes, specifically sanitary-grade stainless steel pipes. Furthermore, to extend the device's lifespan, the interiors of these pipelines are coated with a sanitary-grade waterproof layer. Finally, for convenient control of the entire device, valves S1 7 to S8 14 (i.e., all eight valves) can be isolation valves or electrically operated isolation valves.
[0044] The above setup is based on the latest EU Good Manufacturing Practice (GMP) regulations for pharmaceuticals, ensuring that the integrity of the filter is tested after the drug solution is subjected to SIP (steam in-line sterilization) through the filter.
[0045] Although the specific embodiments of the present utility model have been described above in conjunction with the accompanying drawings, this is not intended to limit the scope of protection of the present utility model. Those skilled in the art should understand that various modifications or variations that can be made by those skilled in the art without creative effort based on the technical solution of the present utility model are still within the scope of protection of the present utility model.
Claims
1. An online integrity testing device for sterile filters, used for external connection to the original pipeline channel where the filter to be tested is installed, characterized in that, The online integrity detection device includes a first pipeline channel, a second pipeline channel, a third pipeline channel, and a fourth pipeline channel. S1 valve and S2 valve are respectively installed on both sides of the filter to be tested on the original pipeline channel. One end of the first pipeline channel is connected to a bubble point detector, and starting from the bubble point detector, a first filter and an S3 valve are sequentially installed on the first pipeline channel. The other end of the first pipeline channel is connected to the original pipeline channel between the S1 valve and the filter to be tested. The second pipeline channel is sequentially equipped with valve S4, a second filter, and valve S5. The third pipeline channel is sequentially equipped with valve S6, a third filter, and valve S7. One end of the second and third pipeline channels is connected to one end of the fourth pipeline channel. The other end of the fourth pipeline channel is connected to the original pipeline channel between valve S2 and the filter under test. Valve S8 is installed on the fourth pipeline channel.
2. The online integrity detection device for a sterile filter as described in claim 1, characterized in that, The first and third filters are air filters.
3. The online integrity testing device for a sterile filter as described in claim 1, characterized in that, The second filter is a liquid filter.
4. The online integrity testing device for a sterile filter as described in claim 1, characterized in that, Pressure sensors are installed on the first filter, the second filter, and the third filter.
5. The online integrity testing device for a sterile filter as described in claim 1, characterized in that, The first, second, third, and fourth pipeline channels are all sanitary grade pipelines.
6. The online integrity detection device for a sterile filter as described in claim 5, characterized in that, The sanitary-grade pipe is made of stainless steel.
7. The online integrity testing device for a sterile filter as described in claim 1, characterized in that, The interior of the first, second, third, and fourth pipeline channels is coated with a waterproof layer.
8. The online integrity detection device for a sterile filter as described in claim 1, characterized in that, Pressure sensors are installed on the first, second, third, and fourth pipeline channels.
9. The online integrity detection device for a sterile filter as described in claim 1, characterized in that, Valves S1 through S8 are isolation valves.
10. The online integrity testing device for a sterile filter as described in claim 1, characterized in that, The valves S1 to S8 are electrically operated isolation valves.