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

Microorganism identification is the process of determining the species of microbes found during bioburden or environmental testing.

ISO 10993 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological...

What is Bioburden? Bioburden is the population of viable microorganisms present on or in a product. The bioburden of a product can come...