Product family grouping, as discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013, titled ‘Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose,’ provides general requirements and guidance for establishing a product family for radiation sterilization. This approach allows manufacturers to group similar products together, so not every product type needs individual testing. This method is widely used in the industry to streamline the sterilization process and reduce testing redundancy.
AAMI’s Technical Information Report (TIR) 35 initially addressed alternative sampling plans for radiation sterilization using Method 1 and Method 2. Upon revision, the AAMI committee recognized an opportunity to offer additional guidance on various approaches for product family adoption. Consequently, in 2016, AAMI TIR35 was published under the title ‘Sterilization of Health Care Products—Radiation Sterilization—Product Adoption and Alternative Sampling Plans for Verification Dose Experiments and Sterilization Dose Audits.’ This updated TIR provides comprehensive information on adopting new products into an existing family, offering a broader range of strategies and considerations for manufacturers.
The webinar will delve into the key concepts outlined in this document, providing a thorough understanding of product family grouping and its practical applications. Participants will learn how to implement these guidelines to optimize their sterilization processes. The presentation will cover the steps required to establish a product family, including the criteria for grouping products and the benefits of this approach in terms of efficiency and compliance.
Furthermore, the webinar will explore the alternative sampling plans described in AAMI TIR35, explaining how these methods can be used to verify sterilization doses and conduct sterilization dose audits. Real-world examples will illustrate how these concepts can be applied, helping attendees to grasp the practical implications of the guidance provided.
By the end of the webinar, participants will have a clear understanding of how to adopt products into an existing family for radiation sterilization. They will be equipped with the knowledge to apply alternative sampling plans effectively, ensuring their sterilization processes are both efficient and compliant with current standards.