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

Published Date: July 26, 2016

One of the first questions that comes to mind after completing an ethylene oxide (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 while continually delivering the desired Sterility Assurance Level (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.

The knowledge gained from this presentation will aid in the management of annual requalification and provide a logical approach to verifying change management. This presentation will help the manufacturer navigate through some of these considerations.

This webinar is appropriate for the Supplier Management personnel, Sterility Assurance personnel, and Sterilization Validation personnel, both on the manufacturer and contract sterilization side, as it provides a fundamental basis for ensuring a solid partnership between manufacturer and contract sterilization facility.

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