This webinar was presented live on Tuesday, May 8, 2018. Click below to watch on demand.
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