Integrity Testing

Ensuring Filter Integrity: Vital for Pharmaceutical Filtration

In the pharmaceutical industry, integrity testing of sterilizing filters is a fundamental requirement for critical process filtration. Compliance with FDA Guidelines is crucial, as filters used in sterile solutions like LVPs and SVPs must undergo integrity testing. Documentation of testing is essential and must be included in batch product records.

Integrity testing in Australia is classified into two types: destructive and non-destructive. At CoPure, we prioritize quality assurance by conducting destructive testing on samples from every manufacturing lot of sterilizing-grade filter products. Additionally, non-destructive testing is performed on each sterilizing-grade filter before sale to ensure its integrity.

Data Sheet, Certitest™20 Integrity Tester