Performance Testing of Pharmaceutical Isolators Based on USP 797 Requirements

This application note demonstrates the testing of two models of pharmaceutical isolators against the United States Pharmacopeia requirements laid out in an in-process revision to chapter 797 of their regulations. The SterilSHIELD and the ChemoSHIELD were tested according to CETA CAG 002-2006 and subjected to a simulated process-generated cross-contamination.