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FDA recommends alternatives to sterility testing

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 10, 2008

The FDA is recommending alternative methods for sterility testing of medical devices, biological products, and human and animal drugs. The FDA says products claiming to be sterile should be contamination free for their entire shelf life or dating period and the stability protocols performed must demonstrate that fact.

New guidance addresses stability protocols for devices labeled sterile. Sterility tests have limitations and are not the best method to demonstrate a product will remain sterile throughout its shelf life, the FDA says.

The guidance does not provde an exhaustive list of tests or recommend specific test methods. Those details depend on the actual container and closure system used for the sterile product.

The guidance does discuss container and closure system integrity testing as an alternative to sterility testing. Such tests look for leaks in the container system and other means of contamination. According to the FDA, the alternative tests:

• Reduce false positive results
• Take less time than sterility tests
• Can detect a problem in the container before contamination occurs

The FDA recommends manufacturers use container and closure system integrity tests when submitting marketing applications for sterile products. The application should describe the test method used and how it addresses "microbial integrity."

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