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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.
Why you should attend: Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. It is not uncommon for anomalies to occur during qualification or routine processing. These anomalies 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 resterilization of product. Regulatory action can result from the prior while additional expense to the company can result from the latter. Neither of these situations is of benefit to a manufacturer.
Areas Covered in the Session:
- 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
Who Will Benefit:
- This webinar will provide valuable information to all companies that produce sterile products
- QA personnel
- Validation specialists
- Manufacturing personnel involved in validations
- R&D specialists