Arlington, Virginia, July 29, 2024 (GLOBE NEWSWIRE) — Right now, pharmaceutical and biopharmaceutical manufacturers often rely on outdated best practices related to radiation sterilization and routine control of single-use systems. But there is new industry guidance that will help streamline these processes.
The Association for the Advancement of Medical Instrumentation (AAMI) is pleased to announce the release of a new guidance document that updates best practices for manufacturers of pharmaceuticals and biopharmaceuticals.
The new guidance outlines acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems. It is a Consensus Report, a document type based on expert opinion that AAMI uses to provide quick and practical guidance on urgent issues.
AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing was produced by the AAMI Radiation Sterilization Working Group, a diverse team of sterilization and sterile processing professionals, regulators, and scientists. The group is co-chaired by Niki Fidopiastis, director of microbiology for Global Laboratory Services at Medtronic, and Kimberly Patton, sterilization staff engineer and auditor of the MedAccred Program at the Performance Review Institute.
AAMI CR513:2024 provides guidance on:
- Sterilization dose, addressing which products should be selected for testing, and best practices for testing.
- Sterile claim, providing 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.
According to Fidopiastis, AAMI CR513 is a much-needed stopgap, and its “simplified approaches for validation and routine control of single-use systems” will provide manufacturers with the clear guidance they need.
Patton agreed, stating, “The current practices as written for radiation sterilization validation and control testing can be difficult to implement for large, complicated single-use systems and are often cumbersome and can lead to contamination in the test vessels. They are also overly conservative in some cases where large equipment might not come into contact with the patient.”
Ultimately, AAMI CR513 is an ideal resource for manufacturers interested in improving their processes and continuing to produce safe products.
The document can be accessed or purchased on AAMI ARRAY. Journalists interested in a copy of the guidance are encouraged to reach out to the AAMI Media Team via dvisnovsky@aami.org.
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