For the Sterile Compounding, does a barrier isolator have to be in a Clean Room?

PCAB submitted this question directly to staff members at USP. Please read the Important Note regarding questions submitted to USP. In accordance with the USP Communications policy, (see http://www.usp.org/aboutUSP/governance/policies/communications.html) USP cannot offer any official interpretations, and any answer given must be "regarded solely as a personal opinion of the individual providing the interpretation and not necessarily an official position of the USP."

USP: According to the official USP General Chapter , "An emerging alternative technology utilizes barrier isolator systems to minimize the extent of personnel contact and interaction, to separate the external environment from the critical site, and to provide an ISO Class 5 environment. A well-designed positive pressure barrier isolator supported by adequate procedures for its maintenance, monitoring, and control, may offer an acceptable alternative to the use of conventional LAFWs in clean rooms for aseptic ... more.

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