🔬 Filter Integrity Test: Assurance of Sterility in Critical Processes
A Filter Integrity Test (FIT) is a crucial, non-destructive validation procedure used predominantly in the pharmaceutical, biotechnology, and food and beverage industries.
Its primary purpose is to confirm the structural integrity of a filter membrane and the entire filtration assembly (including housing and seals) after sterilization and/or production. This testing ensures that the filter is capable of consistently removing contaminants, particularly microorganisms like bacteria, down to the required level, thus guaranteeing the sterility and quality of the final product. Regulatory bodies, such as the FDA and EMA, mandate that sterilizing-grade filters must be tested post-use to confirm their performance during the batch run.
The Science: Correlating Physical Tests to Bacterial Retention
Since directly challenging a production filter with live bacteria is a destructive and impractical method, Filter Integrity Tests rely on validated non-destructive physical tests. These tests measure a physical parameter of the…