Barrier (pharmaceutical)
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Because people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the efficacy of the final drug product. In the mid 80's the industry began to employ barrier isolators and later in the 90's Restricted Access Barrier Systems (RABS, Stewart Davenport, Upjohn (now Pfizer) Kalamazoo, Michigan coined the acronym RABS in the early 1990’s.) to separate people from the process. As defined by the Food and Drug Administration FDA, a barrier isolator is "a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel."
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