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Ethylene Oxide (EO) Sterilization of Medical Products: The Basics
This will review how EO sterilizes, basic factors affecting sterilization, calculating the D value, Biological Indicators, the processing steps, EO residuals, and product release in a practical manner.
Many companies are using EO to achieve product sterility. Whether EO sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to how the process works.
ANSI/AAMI/ISO 11135 defines the requirements and standard practices for use of EO as an industrial sterilant. This presentation will review how EO sterilizes, basic factors affecting sterilization, calculating the D value, Biological Indicators, the processing steps, EO residuals, and product release in a practical manner so the product manufacturer can better understand the application of EO Sterilization and the ANSI/AAMI/ISO 11135.
Areas Covered in the Seminar:
- How does EO sterilize
- Basic factors affecting sterilization
- Calculating D Value
- Processing steps of an EO cycle
- EO Residuals
- Product release
Who Will Benefit:
This web seminar will provide valuable assistance to all regulated companies that are using or considering using EO as their method of sterlization, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologic fields. The employees who will benefit include:
- End-users responsible for sterility assurance
- QA Managers and personnel
- Validation Specialists
- Quality System Auditors
Ms. Foster began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Foster has held various quality assurance positions at both the facility and Corporate levels where she has served as Vice President of Quality Assurance responsible for Sterigenics’ worldwide network of sterilization facilities and is currently Vice President of the SteriPro Consulting and Labs division of Sterigenics. Ms. Foster is an Executive Committee Member of the AAMI Sterilization Standards Board, a member of the AAMI Sterilization Standards Committee, serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2 Radiation Sterilization Working Group, served as co-chair for the AAMI Radiation Process Control Task Group, which developed TIR 29, Guide for Process Control in Radiation Sterilization, and is an active member of several other AAMI Sterilization Working groups.
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