Complianceonline, Online Web Event
2010-04-14
In this Ethylene Oxide (EO) Sterilization training learn how to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance. Why Should You Attend: Many medical device manufacturer companies are not taking the advantage of latest sterilization technologies and knowledge to effectively reduce the sterilization process cost. This is due mainly to: lack of knowledge of latest technologies fear of getting out of regulatory compliance believes that changes to the sterilization process are too complex or risky. The application of vanguard sterilization technologies will allow you to reduce sterilization costs with programs such as : reducing or eliminating preconditioning, reducing or eliminating aeration, BI elimination, EO gas consumption reduction and chamber utilization maximization. In this seminar you will acquire the knowledge to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance. Analyzing the microbiological and EO residues aspects of your cycle with a different approach will result in re-engineering it for cost reduction and avoidance while complying with EN/ISO11135. Areas Covered in the Seminar: - Introduction.
- Factors Influencing Lethality and Aeration.
- Finding Opportunities for Cycle Optimization.
- Negotiate cost reduction
- Initial Validation Evaluation
-
- Microbiological Method
- Cycle Parameters Evaluation
- EO residues dissipation curves
- Product Evaluation
- Cycle/Process Re-engineering
- Parametric Release
- PCD/Packaging/Pallet modification
- Lethality curve development
- Aeration modification
- References.
|