Barrier (pharmaceutical)

Isolators (a.k.a. Barrier Isolators) are devices that provide a physical barrier between the laboratory technician and the work process. They are routinely found within the pharmaceutical industry, and with the recent implementation of USP797, are increasingly used in pharmacy applications. They are designed to provide an isolation of a process or the maintenance of an internal condition (sterile, aseptic). Isolators may operate at positive, negative, or ambient differential pressure. Isolators may provide personnel, product, or environmental protection (or any combination). They are used throughout industry from orange juice filling lines to cytotoxic drug compounding to electronics manufacturing.

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Regarding pharmacy applications, 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. Since this time the technology and applications of these systems has developed and broadened significantly.