AAMI Releases Alternative Guidance for Radiation Sterilization
29 Julio 2024 - 9:45AM
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rely on outdated best practices related to radiation sterilization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.