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.
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
Instructor Profile:
Marisel Ortiz, is the founder and President of Sterilization Expert, a consulting company offering technical consultation services in microbiology and sterilization fields. With over twenty two (+22) years experience in management and the application of vanguard sterilization and microbiology technology in world-wide leader companies such as: Baxter, McGaw, Edwards Lifesciences, Cardinal Health and Teleflex Medical Marisel is now dedicated to share her knowledge and experience with the Industry. She has been recognized to be the sterilization expert driving competitive advantage through innovative solutions thus creating greater value while maintaining full regulatory compliance. Was renowned for uncompromisable ethics and integrity and for always honoring commitments.
Marisel has three Bachelor degrees in Science: Pre-medicine, Industrial Microbiology and Biology. She graduated with Cum Laude honors from the prestigious University of Puerto Rico, Mayaguez campus.
She is founder member of the Industrial Microbiology Society of Puerto Rico University and member of AAMI, Association for the advancement of Medical Instrumentation.
