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Ethylene Oxide (EO) Sterilization of Medical Products: The Basics

  • Training

  • 60 Minutes
  • Compliance Online
  • ID: 5975980
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
  • BI’s
  • 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
  • Consulants
  • Quality System Auditors

Course Provider

  • Lisa Foster
  • Lisa Foster,