When Do I Really Need to Perform an Ethylene Oxide Requalification? скачать в хорошем качестве

When Do I Really Need to Perform an Ethylene Oxide Requalification?

Overview: One of the first questions that comes to mind after completing an EO sterilization qualification is, “When do I need to perform a requalification study, and what will that study entail?” Maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired SAL is of utmost importance. This presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification. Attendees will learn: • Regulatory background and industry expectation for annual requalification activities of an EO processes • Verifying and maintaining the effectiveness of an EO sterilization process • Proper routine assessment of process and equipment changes • Change assessment strategies with regards to product design, packaging design, and loading configurations