This EO sterilization training will discuss the Cycle validation and other requirements for Implementation of parametric release in EO sterilization as per EN/ISO 11135.
Why Should You Attend:
Even though many companies are utilizing the advantage of parametric released for their EO sterilized products, there are some which still thinks is too complex or risky to be implemented. Latest EN/ISO 11135 and TIR 20 revisions clearly defines the validation requirements but since it does not provides guidance on how to establish the parameters many sterilization experts has doubts regarding this critical aspect.
We developed this training utilizing not only the ISO guidance's but the hands-on experience acquired while successfully establishing parametric release for several medical device manufacturing companies. Learn the use of this practical approach which will allow for a simple, straight-forward implementation of parametric release which has been evaluated by the FDA and found in compliance in all of these companies. We will discuss the validation and other requirements along with monitoring methods.
Areas Covered in the Seminar:
- Introduction.
- Cycle Validation for parametric release.
- Microbiology requirements.
- Equipment Requirements
- Pre-conditioning
- Sterilization
- Aeration
- Product considerations
- Pallet configuration
- Product density
- Parameter Establishment for routine monitoring
- Humidity
- EO concentration
- Product temperature
- Routine EO cycle monitoring.
- Equipment requirements
- Processing requirements
- 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.
