How to reduce EO residuals in medical devices
This Ethylene Oxide Sterilization Residuals regulation based webinar will provide a practical approach to fulfill requirements of the new ISO EO residual limits revised regulation.
Why Should You Attend:
The revision to ISO 10993-7:2008 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals, significantly reduced the amount of residual EO or its by-products allowed to be left on Medical devices. The transition period defined to reach compliance with the new EO residual limits ends on October 2011. The new EO residual limits impose a tremendous challenge as it’s requires a significant investment of time, effort and capital in middle of a tough economic climate.
This webinar will offer ways to re-evaluate, re-design, or re-engineer your products, test methods and/or sterilization process to find opportunities for the simplest, fastest and most economical solutions to the problem. Additionally this webinar will offer ideas to transform a challenge into a potential opportunity for cost reduction. We will also discuss the practical approach to fulfill the regulation requirements.
Areas Covered in the Seminar:
- EO residual limits comparison
- Factors influencing EO residuals
- Product/Process Evaluation
- Initial validation evaluation
- Product /packaging/pallet configuration Evaluation
- Process Re-engineering.
- PCD/packaging/pallet modification
- Lethality curve development
- Aeration/Degassing Modification
- Application of assumed transfer reduction factors
Who Will Benefit:This seminar is designed for professionals with responsibility for validating or making decisions related to the EO sterilization process
- Sterilization/Quality Managers
- Directors or VP
- Quality or laboratory personnel
- Chemistry laboratory Managers
- Validation specialists
Marisel Ortiz, Over 24 years of management experience in the application of vanguard sterilization and microbiology technology. Experienced in: Quality System audits, CAPA, Ethylene Oxide (EO), Gamma Radiation, Steam autoclave, Biocompatibility program, Environmental controls, critical systems and laboratory operations, Cleaning/Disinfection/