Ethylene oxide sterilization requirements have changed What you need to know

Tuesday, May 8, 2018
2 p.m. Eastern time / 11 a.m. Pacific time

ANSI/AAMI/ISO 11135:2014 Annex E recently underwent a revision expanding on the requirements for the release of healthcare 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 medical device 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.

Attending this webinar, you 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

Featured Speakers:

Paul Littley
Consulting Manager
Nelson Laboratories, LLC