Troubleshooting ethylene oxide (EO) processes - Webinar by GlobalCompliancePanel

15 September 2010, United States

Introduction

Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions may be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the course to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The rationales for both conventional and parametric release will be addressed.