Section 12 of ISO 11135:2014 provides a pathway for adding new or modified (“candidate”) products to an already validated Ethylene Oxide (EO) sterilization process. This standard outlines that a candidate product can be incorporated if an evaluation demonstrates it is equivalent to or a lesser challenge than an existing product or Internal Process Challenge Device (IPCD). Achieving such an outcome can result in significant time and cost savings, streamlining the sterilization validation process.
This whitepaper is a comprehensive guide designed for Quality Assurance, Project Management, Sterility Assurance, and Validation personnel working within the medical device, pharmaceutical, commercial, and food industries. It details the necessary steps to evaluate a candidate product’s compatibility with an established EO sterilization process.
Readers will learn about the critical criteria for determining equivalence, including physical and biological indicators that ensure the candidate product does not present a greater challenge to the sterilization process than the existing validated product. The paper provides a thorough explanation of the evaluation process, from initial assessment through to documentation and reporting.
Key topics covered include the design and execution of comparative studies, data analysis techniques, and the importance of rigorous testing and validation protocols. The whitepaper also highlights common challenges and pitfalls in the evaluation process, offering practical solutions and best practices to overcome them.
By understanding and applying the guidelines outlined in ISO 11135:2014, professionals can efficiently and effectively evaluate candidate products, ensuring they meet the necessary sterility assurance standards. This knowledge not only aids in maintaining regulatory compliance but also optimizes operational efficiency and reduces validation costs. This whitepaper is an essential resource for those involved in the sterilization and validation processes, providing the tools and insights needed to successfully integrate new or modified products into established EO sterilization protocols.