Glossary
Filter Integrity Test
A non-destructive test confirming that a filter is undamaged and still delivers the required retention performance.
Details
Filter integrity testing confirms per batch that the physical soundness of a sterilising filter is linked to its microbial retention performance. Inspections cite weak correlation between the test value and validated microbial retention, inadequate retesting and investigation of failing results, and testing performed after the filter had been removed. Look at test method validation, pre-use and post-use raw data, the filter certificate, the batch record, and failure investigations.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, your firm performed HEPA filter integrity testing (b)(4) on your ISO- (b)(4) , despite the detection of a gross leak in the HEPA filter during (b)(4) testing.
FDA · FDA Warning Letter · 2024-10-22 -
Your operators obtained and printed a passing result after multiple production filter integrity tests failed.
FDA · FDA Warning Letter · 2025-03-18 -
You changed your manufacturing process for sterile products by including a re-filtration process of different products when the filters used in the aseptic filtration failed to meet the filter integrity test.
FDA · FDA 483 · 2024-01-17
