Case: Company X requested bioburden testing for their product (suture) which will be sterilized by EO. As is routine, the correction factor determination test using repetitive method was conducted first before bioburden testing can be performed. The results showed high correction factor (CF) value, >15.0 corresponding to a low bioburden recovery efficiency percentage. When this CF value was applied to their bioburden results, the bioburden level was higher than expected. This

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.