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The integrity test of sterilized filter element is detailed
2024-11-15
Bacteria-grade filtration is often used to remove microorganisms such as bacteria and to ensure that the final product plays a key role in sterility.The integrity test of the terminal filter element is a necessary means.Through testing, it is possible to confirm whether the filter element is installed correctly, whether the filter element is damaged, and whether the filter element meets the manufacturing specifications to ensure that the filter performance is verified before and after the filter is used.
What is integrity?
Microporous filter membrane and microporous filter membrane folding filter integrity is a key issue in the production and use of filters, the so-called integrity of the filter membrane, generally speaking, is the filter membrane in the process of manufacturing defects, no defects of the filter membrane, that is, the integrity of the filter membrane can be a good interception of pollutants larger than the membrane hole, the downstream of the filter no pollutants exist;
The defective filter membrane is also an incomplete filter membrane. The damaged part of the defective membrane cannot intercept pollutants larger than the membrane hole, and there are pollutants downstream of its filtration.
The integrity of the so-called folding filter refers to whether the microporous filter membrane meets the regulations, whether there are defects, and whether there is leakage in the end seal and side seal of the filter element.
Types of integrity test
Filter integrity tests are classified into destructive tests (particle challenge tests, or bacterial challenge tests) and non-destructive tests (including bubble point, diffusion flow, water intrusion, pressure decay tests).
1, Destructive testing is generally done by the supplier, the purpose of which is to determine that the filter is a bacterial-grade filter, the test method is the FDA definition of bacterial-grade filter.
2. The main purpose of non-destructive integrity testing is to determine whether there are defects that may endanger the filter's retention ability without damaging the filter, which requires the supplier to operate at the factory and the customer at the site of use, and the user generally only needs to carry out non-destructive testing, in addition, the supplier also needs to carry out non-destructive testing.
Relevance of integrity testing
All non-destructive integrity test criteria must be associated with destructive integrity test results to be effective. Bacterial retention test is the most sensitive integrity test for bacteria-removing ability, and non-destructive integrity test is an alternative test associated with bacterial challenge test.
The challenge is that the experimental results are associated with the integrity test results, and the general user only needs to test the integrity data to judge the bacterial retention efficiency of the debacteria-grade filter element.