CN215196355U - Sterile filtration and filter membrane integrity test system - Google Patents
Sterile filtration and filter membrane integrity test system Download PDFInfo
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- CN215196355U CN215196355U CN202120531754.5U CN202120531754U CN215196355U CN 215196355 U CN215196355 U CN 215196355U CN 202120531754 U CN202120531754 U CN 202120531754U CN 215196355 U CN215196355 U CN 215196355U
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Abstract
The utility model relates to an aseptic filtration and filter membrane integrality test system, the system contains two systems of aseptic filtration and filter membrane integrality test. The sterile filtering system comprises a first pipeline, a three-way valve A, a third pipeline, a sterile filter membrane, a three-way valve B, a fourth pipeline and a receiving bottle; the filter membrane integrity test system comprises an air supply device, a second pipeline, a pressure gauge, a three-way valve A, a third pipeline, a sterile filter membrane, a three-way valve B, a fifth pipeline and a bubble detector. The two systems are combined together through a three-way valve A, a pipeline III, a sterile filter membrane and a three-way valve B. The utility model has the advantages of system operation is simple, only can realize filtering and the function switch of two systems of filter membrane integrality test through adjusting three-way valve A and three-way valve B.
Description
Technical Field
The utility model belongs to the technical field of detect, specifically speaking relates to a liquid medicine sterile filtration and filter membrane integrality test system.
Background
In the pharmaceutical industry, sterile filtration of a formulation is a critical step in the manufacturing process of the entire product. According to the regulations in appendix 1 'aseptic drugs' of Chinese drug production quality management specifications (2010): "sterile filters must be checked for integrity and recorded immediately after use by an appropriate method. Common methods are bubble point test, diffusion flow test or pressure retention test ". For radiopharmaceutical production, because of the low yields, radiopharmaceuticals are typically sterilized by sterile filtration. In the conventional operation, the radiopharmaceutical is filtered through aseptic filter membrane, needs the technical staff to dismantle the filter membrane manually, places and carries out the bubble point method inspection on filter membrane integrality test instrument, and this process is not only consuming time and wasting power, increases technical staff's radiation risk, dismantles the process moreover and probably leads to the filter membrane to damage, causes the test result inaccurate.
SUMMERY OF THE UTILITY MODEL
In order to solve the problem that the aseptic filter membrane needs manual dismantlement to carry out the integrality test in the above-mentioned radiopharmaceutical production process, the utility model aims to provide an online integrality test system of aseptic filter membrane, its simple easy operation of system.
In order to achieve the above object, the utility model discloses the technical scheme that the system adopted is:
a sterile filtration and filter membrane integrity test system, said system comprising two systems for sterile filtration and filter membrane integrity testing; the sterile filtering system consists of a first pipeline, a three-way valve A, a third pipeline, a sterile filter membrane, a three-way valve B, a fourth pipeline and a receiving bottle. The filter membrane integrity test system consists of a second pipeline, an air supply device, a pressure gauge, a three-way valve A, a third pipeline, a sterile filter membrane, a three-way valve B, a fifth pipeline and a bubble detector. The two systems of the sterile filtration and the filter membrane integrity test are combined together through a three-way valve A, a pipeline III, a sterile filter membrane and a three-way valve B.
Furthermore, the front end of the pipeline is a liquid medicine inlet; the front end of the second pipeline is connected with the gas supply equipment.
Furthermore, the first end of the pipeline, the second end of the pipeline and the third front end of the pipeline are connected through a three-way valve A.
Further, a pressure gauge is arranged on the second pipeline.
Furthermore, the three tail ends of the pipelines, the four front ends of the pipelines and the five front ends of the pipelines are connected through a three-way valve B.
Further, a sterile filter membrane is further mounted on the third pipeline.
Furthermore, the four tail ends of the pipeline are connected with a receiving bottle; the five tail ends of the pipelines are connected with the bubble detector.
Preferably, the gas supplied by the gas supply device is N2。
Preferably, the liquid contained in the bubble detector is water.
The utility model provides a sterile filtration and filter membrane integrality test system, its use is right through control three-way valve A and three-way valve B's case position the system carries out the function regulation, makes and need not manual dismantlement after the sterile filtration membrane filters and can carry out the integrality test. When the valve cores of the three-way valve A and the three-way valve B are in the I type, the system carries out sterile filtration of the liquid medicine; and when the valve cores of the three-way valve A and the three-way valve B are T-shaped, the system performs the integrity test of the sterile filter membrane.
The utility model discloses beneficial effect:
the utility model has the advantages of simple and convenient device and simple operation. After the liquid medicine is aseptically filtered, the function conversion of two systems of filtering and aseptic filter membrane integrity testing can be realized only by changing the directions of the valve cores of the three-way valve A and the three-way valve B, the filter membrane is not required to be disassembled to be connected with a commercial integrity tester for integrity testing, the time for testing the integrity of the filter membrane is shortened, and the cost for testing the integrity of the aseptic filter membrane is reduced.
Drawings
Fig. 1 is a schematic diagram of the system of the present invention.
Wherein the reference numerals are represented as:
1-a first pipeline, 2-a three-way valve A, 3-a second pipeline, 4-an air supply device, 5-a pressure gauge, 6-a third pipeline, 7-a sterile filter membrane, 8-a three-way valve B, 9-a fourth pipeline, 10-a receiving bottle and 11-a fifth pipeline, 12-a bubble detector.
Detailed Description
In order that the present disclosure may be more readily and clearly understood, reference is now made to the following detailed description taken in conjunction with the accompanying drawings and specific examples, the scope of which is not limited in any way by the examples described herein. Based on the embodiments of the present invention, all other embodiments obtained by a person skilled in the art without any creative work belong to the protection scope of the present invention.
As shown in fig. 1, a sterile filtration and sterile filtration membrane integrity test system comprises two systems of sterile filtration and filtration membrane integrity test, wherein the sterile filtration system comprises a first pipeline (1), a three-way valve a (2), a third pipeline (6), a sterile filtration membrane (7), a three-way valve B (8), a fourth pipeline (9) and a receiving bottle (10); the filter membrane integrity test system comprises a second pipeline (3), an air supply device (4), a pressure gauge (5), a three-way valve A (2), a third pipeline (6), a sterile filter membrane (7), a three-way valve B (8), a fifth pipeline (11) and a bubble detector (12); the two systems of the sterile filtration and the filter membrane integrity test are combined together through a three-way valve A, a pipeline III, a sterile filter membrane and a three-way valve B.
The front end of the first pipeline (1) is a liquid medicine inlet, and the front end of the second pipeline (3) is connected with an air supply device (4); the tail end of the first pipeline (1) and the tail end of the second pipeline (3) are connected with the front end of the third pipeline (6) through a three-way valve A (2); a pressure gauge (5) is arranged on the second pipeline (3); the tail end of the pipeline III (6) and the front end of the pipeline IV (9) are connected with the front end of the pipeline V (11) through a three-way valve B (8); a sterile filter membrane (7) is also arranged on the pipeline III (6); the tail end of the pipeline four (9) is connected with the receiving bottle (10), and the tail end of the pipeline five (11) is connected with the bubble detector (12).
When the liquid medicine is subjected to sterile filtration, the three-way valve A (2) and the three-way valve B (8) are adjusted to be I-shaped, and even if the joint of the pipeline I (1) and the three-way valve A (2) is opened, the joint of the pipeline II (3) and the three-way valve A (2) is closed; the joint of the pipeline four (9) and the three-way valve B (8) is opened, and the joint of the pipeline five (11) and the three-way valve B (8) is closed. At the moment, the liquid medicine input from the liquid medicine inlet at the front end of the pipeline I (1) enters the three-way valve A (2) through positive pressure driving of gas, then flows through the pipeline III (6) and is filtered through the sterile filter membrane (7), and the obtained filtrate sequentially passes through the three-way valve B (8) and the pipeline IV (9) and is finally received by the receiving bottle (10).
After the aseptic filtration of the liquid medicine is finished, starting the integrity test of the aseptic filter membrane, adjusting the three-way valve A (2) and the three-way valve B (8) at the moment, and adjusting the three-way valve A (2) and the three-way valve B (8) from the I type to the T type, so that the joint of the pipeline I (1) and the three-way valve A (2) is closed, and the joint of the pipeline II (3) and the three-way valve A (2) is opened; the joint of the pipeline four (9) and the three-way valve B (8) is closed, and the joint of the pipeline five (11) and the three-way valve B (8) is opened. Then, the gas supply equipment (4) is opened to introduce N into the second pipeline (3)2And observing the pressure indication of the pressure gauge (5) and the bubble condition in the bubble detector (12). If continuous small bubbles begin to appear in the bubble detector (12), the current pressure reading is the bubble point, and then the current pressure reading is compared with the standard bubble point value of the filter membrane, and the pressure reading must be more than or equal to the standard bubble point value, so that the aseptic filtration is qualified; if the reading of the pressure gauge (5) is slowly increased and a low pressure state is maintained, a large amount of bubbles are continuously generated in the bubble detector (12) from the beginning of ventilation, and the damage of the sterile filter membrane (7) for filtering the liquid medicine is proved, namely the sterile filtration is unqualified.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (7)
1. A sterile filtration and membrane integrity test system characterized in that: the system comprises two systems of sterile filtration and filter membrane integrity test, wherein the sterile filtration system comprises a pipeline I, a three-way valve A, a pipeline III, a sterile filter membrane, a three-way valve B, a pipeline IV and a receiving bottle; the filter membrane integrity test system comprises an air supply device, a second pipeline, a pressure gauge, a three-way valve A, a third pipeline, a sterile filter membrane, a three-way valve B, a fifth pipeline and a bubble detector; the two systems of the sterile filtration and the filter membrane integrity test are combined together through a three-way valve A, a pipeline III, a sterile filter membrane and a three-way valve B.
2. The sterile filtration and membrane integrity test system of claim 1, wherein: the front end of the first pipeline is a liquid medicine inlet, and the front end of the second pipeline is connected with an air supply device.
3. The sterile filtration and membrane integrity test system of claim 1, wherein: the first end of the pipeline, the second end of the pipeline and the third front end of the pipeline are connected through a three-way valve A.
4. The sterile filtration and membrane integrity test system of claim 2, wherein: and a pressure gauge is arranged on the second pipeline.
5. The sterile filtration and membrane integrity test system of claim 1, wherein: the three tail ends of the pipelines, the four front ends of the pipelines and the five front ends of the pipelines are connected through a three-way valve B.
6. The sterile filtration and membrane integrity test system of claim 5, wherein: and a sterile filter membrane is also arranged on the third pipeline.
7. The sterile filtration and membrane integrity test system of claim 5, wherein: the four tail ends of the pipeline are connected with the receiving bottle; the five tail ends of the pipelines are connected with the bubble detector.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202120531754.5U CN215196355U (en) | 2021-03-15 | 2021-03-15 | Sterile filtration and filter membrane integrity test system |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202120531754.5U CN215196355U (en) | 2021-03-15 | 2021-03-15 | Sterile filtration and filter membrane integrity test system |
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| CN215196355U true CN215196355U (en) | 2021-12-17 |
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| CN202120531754.5U Active CN215196355U (en) | 2021-03-15 | 2021-03-15 | Sterile filtration and filter membrane integrity test system |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114713036A (en) * | 2022-06-10 | 2022-07-08 | 北京先通国际医药科技股份有限公司 | Online filter membrane integrity testing device and method and application thereof |
| CN114713037A (en) * | 2022-06-10 | 2022-07-08 | 北京先通国际医药科技股份有限公司 | Online filter membrane integrity testing device and method and application thereof |
| CN114858650A (en) * | 2022-05-17 | 2022-08-05 | 合肥檀泰环保科技有限公司 | Filter membrane breakage detection device in filter |
-
2021
- 2021-03-15 CN CN202120531754.5U patent/CN215196355U/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114858650A (en) * | 2022-05-17 | 2022-08-05 | 合肥檀泰环保科技有限公司 | Filter membrane breakage detection device in filter |
| CN114858650B (en) * | 2022-05-17 | 2023-10-17 | 合肥檀泰环保科技有限公司 | Filter membrane breakage detection device in filter |
| CN114713036A (en) * | 2022-06-10 | 2022-07-08 | 北京先通国际医药科技股份有限公司 | Online filter membrane integrity testing device and method and application thereof |
| CN114713037A (en) * | 2022-06-10 | 2022-07-08 | 北京先通国际医药科技股份有限公司 | Online filter membrane integrity testing device and method and application thereof |
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