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

This study found that after 6 days in the icebox with temperatures of roughly 20˚C, the EO recovery is still within an acceptable range. However, this does not extend to ECH and EG residues, which have a recovery rate of less than 80% after Day 1, possibly due to the increase in temperature above 10˚C.