The Product Sterility – Isolator test protects test articles from contamination by eliminating direct contact between the analyst and the test articles. This test is required on medical devices, pharmaceuticals, preparations, tissue materials, and any other materials that claim to be sterile or free from viable microorganisms.
Testing is done in conformance with criteria from USP General Chapter 71, ANSI/AAMI/ISO 11737-2, EP 2.6.1, JP and 21 CFR 610.12. To optimize aseptic transfer of samples into test material, sterility testing is performed in a state-of-the-art isolator. Vaporized hydrogen peroxide is used to sterilize the contents of the isolator and the inside of the enclosure prior to testing. Isolator sterility tests must be validated by performing a Method Suitability study (Bacteriostasis/Fungistasis (B/F), Sterility and MPN Method Suitability) test. Isolator sterility tests must also have isolator package validation testing performed.
Applicable Standards
- USP 71
- USP 161
- USP 797
- EP 2.6.1
- JP 14 54
- ANSI/AAMI/ISO 1137
- AAMI TIR33