Sopheak Srun, a principal sterilization specialist at
QTS, recently worked with other sterilization experts across the medical device industry to publish the article, “The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results.” This article appears in the AAMI publication,
Industrial Sterilization: Challenging the Status Quo, Driving for Continuous Improvement, which is a peer-reviewed supplement to AAMI’s
BI&T journal.
Product tests of sterility are performed as part of sterilization validation activities to demonstrate the appropriateness of the biological indicator that is used to develop and qualify an EO sterilization process. It is recognized that practices around the use of the product test of sterility vary widely across the industry, which leads to a significant amount of confusion and practices that are often unnecessary. This article summarizes limitations of the product test of sterility, including experimental design attributes, to provide recommendations for designing scientifically valid studies and for the interpretation of results.
Publication of this article is part of QTS’s continuous efforts to collaborate with other industry experts in the science of sterilization, thereby sharing knowledge and driving innovation and best practices at QTS and across the industry. QTS’s subject matter experts in sterilization, cleaning, and packaging are also involved in various other industry groups, including ISO, AAMI, ASTM, IoPP, and Kilmer Innovations in Packaging (KIiP).
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