Troubleshooting ethylene oxide (EO) processes
This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification.
Why Should You Attend:
Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. Many anomalies occur during qualification or routine processing and may come in the form of sterilization cycle parameter that is not achieved or a positive biological indicator. Not knowing how to respond to these situations can result in a response that results in the release of product that might not meet the required sterility assurance level (SAL) or the needless re-sterilization of product. Regulatory action can result from the prior while additional expense to the company can result from the latter. But not every parameter in the EO sterilization process in critical for the determination of the SAL.
Areas Covered in the Seminar:
- What is a cycle anomaly.
- What cycle specifications are critical for sterilization.
- What cycle specifications are critical for product residuals.
- Actions to be taken for critical deviations/anomalies.
- Actions to be taken for non-critical deviations/anomalies.
- What testing can be performed to justify product release.
- Developing a specification to address actions.
- How to document your rationale.
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