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