Sterilization is one of the most critical processes in the healthcare and medical device industry. It ensures that medical devices, pharmaceutical products, and healthcare materials are free from viable microorganisms before reaching patients and healthcare professionals. Among the many sterilization technologies available today, Ethylene Oxide Sterilization and Gamma Sterilization remain two of the most widely used methods globally. Although both methods achieve sterility as

After being involved in the medical device industry for more than 10 years, I found that despite newer technologies and sterilization methods that have come up to so call replace Ethylene Oxide as a sterilization agent, it still remains as the number one choice for sterilization of medical devices. This is of course mostly due to its unique compatibility with heat or moisture sensitive materials or with medical devices with complex geometries. The chemical structure of ethyle

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.