01-31-2018 02:16 PM
For a CSA, USP 797 says Surface sampling has to be done in all ISO classified areas. Is it correct to say that surface sampling is not required outside of the PEC in a segregated compounding area? It says viable air samples need to be done in the 'close proximity' but I don't read that in the section on surface sampling.
I have an ISO 5 certified PEC in an ISO 7 certified room sealed by doors. All of our air samples passed the criteria. A surface sample from a counter outside of the room with the PEC grew 1 count of staph (organism of concern). Can we still do compounding with a BUD of 12hrs per the rules for segregated compounding areas?