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Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release

Published Date: May 8, 2018

ANSI/AAMI/ISO 11135:2014 Annex E recently underwent revision expanding on the requirements for the release of product from a single batch Ethylene Oxide (EO) sterilization process. This addendum builds on the current allowances and requirements for the release of product from a single lot sterilization batch to demonstrate that the process delivered the desired Sterility Assurance Level (SAL) to the exposed product. This presentation takes a comprehensive look at the single lot release approach, the factors that determine what testing is necessary, and how the requirements in Annex E of ANSI/AAMI/ISO 11135 have changed.

This presentation will help the manufacturer navigate through some of the considerations for execution of a single batch release process. The training will assist in the development of a test plan, including sample size requirements, for performing a single batch sterilization process.

The webinar is appropriate for Sterility Assurance and R&D personnel, as it provides a fundamental basis for creating an accurate and robust test plan—which will allow the manufacturer to rapidly sterilize products for clinical trials or to market.

Attendees will learn:

  • Regulatory background and industry expectation for single batch release from EO processes
  • Pre-evaluation of product design, packaging design, and loading configurations
  • Establishing a compliant test plan for single batch release from EO processes
  • Proper assessment of process and test results, including required documentation to support single batch release from EO processes