ANSI/AAMI/ISO 11135:2014 Annex E has recently undergone significant revisions, expanding the requirements for the release of products from a single batch Ethylene Oxide (EO) sterilization process. This addendum builds upon the existing guidelines and requirements, ensuring that the process effectively delivers the desired Sterility Assurance Level (SAL) to the exposed product. This presentation offers a comprehensive examination of the single lot release approach, discussing the various factors that determine the necessary testing and how the requirements in Annex E of ANSI/AAMI/ISO 11135 have evolved.
The revised Annex E introduces more detailed requirements for demonstrating that a single lot sterilization batch meets the necessary SAL. This change emphasizes the importance of rigorous testing and documentation to confirm the efficacy of the sterilization process. Manufacturers must navigate these expanded requirements to ensure compliance and maintain the sterility of their products.
This presentation aims to guide manufacturers through the considerations involved in executing a single batch release process. It will cover the development of a test plan, including determining the appropriate sample size for performing a single batch sterilization. Attendees will gain valuable insights into the regulatory background and industry expectations for single batch releases from EO processes.
Key topics include pre-evaluation of product design, packaging design, and loading configurations. Understanding these factors is crucial for establishing a compliant test plan that meets the updated requirements. The presentation will also discuss the proper assessment of process and test results, highlighting the necessary documentation to support single batch releases from EO processes.
Attendees will learn how to develop a robust test plan that aligns with the revised Annex E requirements. This includes understanding the specific regulatory expectations and the industry standards that guide single batch EO sterilization processes. By gaining a thorough understanding of these elements, manufacturers can ensure their processes are compliant and effective.
This training will equip manufacturers with the knowledge needed to navigate the complexities of the revised Annex E, helping them to develop effective test plans and properly assess their sterilization processes. With this information, manufacturers can ensure they meet regulatory requirements and maintain high standards of product sterility.