White Paper on Isolator Compliance The Baker Company recently concluded testing on their compounding aseptic isolators (CAIs) and compounding aseptic containment isolators (CACIs) to demonstrate compliance with the proposed USP <797> changes, which include a requirement for manufacturers to demonstrate that their CAIs and CACIs maintain ISO Class 5 internal cleanliness while located in an environment worse than ISO Class 7. Baker has prepared a white paper detailing the experimental process used to demonstrate compliance for its SterilSHIELD CAI and ChemoSHIELD CACI.

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