Background Sterility testing is one of the most critical steps in ensuring the safety and compliance of medical devices, pharmaceuticals, and other healthcare products. However, before sterility testing can be performed, regulatory guidelines such as USP <71> Sterility Tests and ISO 11737-2 require a preliminary check called the Sterility Method Suitability Test, commonly referred to as the Bacteriostasis and Fungistasis (B&F) Test. Why is this step so important? Because cert

The Bacteriostasis and Fungistasis (B&F) test is also known as the Sterility Suitability test. The test is performed on a sterile product for the purpose of finding if any inhibiting factors exist in the product which would invalidate a sterility test. The test method will therefore confirm the presence or absence of inhibitory substances in the medical devices that could affect the result of sterility test. The test is usually required during the course of validation