AAMI updates guidelines on radiation sterilization validation, single-use systems control

Editor's Note

In a new guidance document for manufacturers of pharmaceuticals and biopharmaceuticals, The Association for the Advancement of Medical Instrumentation (AAMI) has released a new guidance document updating best practices for radiation sterilization validation and routine control of single-use systems.

The document, AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing, outlines “acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems,” according to a July 29 press release.  A consensus report produced by the AAMI Radiation Sterilization Working Group, the guidance aims to streamline the following:

• sterilization dose, by addressing which products should be selected for testing, and best practices for testing.
• sterile claim, with guidance on estimating sterility assurance level and selecting sterile claims.
• dose application, including information on the proper delivery of a verification dose and sterility testing.
• risk assessment, establishing the components of risk assessment for single-use systems, considering each system’s needs.
• user verification, focusing on how to independently verify the sterility assurance level of a single-use system.