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