AAMI Releases New Guidance for Radiation Sterilization

AAMI recently published AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing.

The new guidance updates best practices and outlines acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems in pharmaceutical and biopharmaceutical manufacturing. AAMI CR513:2024 covers sterilization dose, sterile claim, dose application, risk assessment, and user verification for single-use systems. The guidance offers streamlined approaches for radiation sterilization validation and control, addressing outdated practices in the industry.

Further information is available at this link to the AAMI website: New Consensus on the Sterilization of Single-Use Systems for Manufacturing | AAMI News