Testing Requirements for a Successful Medical Device Sterilization Validation

Today there are a range of sterilization techniques used to terminally sterilize medical devices. This webinar will provide a general overview of the requirements for planning and executing sterilization validations. Using two of the more common sterilization techniques, ethylene oxide (ISO11135) and irradiation (ISO11137), we will review in detail the testing requirements underpinning their validation process and how to optimize your testing strategy utilizing case studies. In addition to the detailed review of these sterilization techniques, we will also discuss the importance of microbiological control, how this can be assessed throughout the production process and its impact on the sterilization outcome for devices.

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