Reducing Ethylene Oxide (EO) Sterilization Costs While Maintaining Regulatory Compliance

Why Should You Attend:

Many medical device manufacturers are not taking 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 or belief that changes to the sterilization process are too complex or risky.

In this session, you will acquire the knowledge to evaluate your sterilization process for cost reduction, and learn how to implement such changes without jeopardizing product safety and regulatory compliance. Analyzing the microbiological and EO residual 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
  • BI Incubation reduction
  • Parametric Release
  • PCD/Packaging/Pallet modification
  • Lethality curve development
  • Aeration modification
• References.