A barrier isolator, or simply an isolator, is a device that provides a physical barrier between a laboratory technician and a work process. Isolators are routinely found within the pharmaceutical industry, and with the recent implementation of USP 797 ("Pharmaceutical Compounding: Sterile Preparations", a set of sterile compounding standards issued by the United States Pharmacopeia), are increasingly used in pharmacy applications. They are designed to provide an isolation of a process or the maintenance of an internal condition (e.g., sterile or aseptic). Isolators may operate at positive, negative, or ambient differential pressure. Isolators may provide personnel, product, or environmental protection, or any combination thereof. They are used throughout industry, from orange juice filling lines to cytotoxic drug compounding to electronics manufacturing.
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-1980s, the industry began to employ barrier isolators, and later, in the 1990s, Restricted Access Barrier Systems, or RABS, to separate people from the process. The acronym RABS was coined by Stewart Davenport of Upjohn (now Pfizer). Since that time, the technology and applications of these systems has developed and broadened significantly.
Major manufacturers of barrier isolators include Powder Systems Limited, GETINGE, Envair Limited, Mach-Aire Ltd, Walker Barrier Systems, Howorth Air Technology, Amercare Ltd, The Baker Company, Esco Global, and Thermo-Electron Corporation. A world leader in Aseptic Pharmaceutical Production Isolators with integrated H2O2 Decontamination capabilities is SKAN, based out of Basel, Switzerland.
- Manufacturing High-Potency Drugs Using Isolators
- Sandle, T. The use of a risk assessment in the pharmaceutical industry – the application of FMEA to a sterility testing isolator: a case study, European Journal of Parenteral and Pharmaceutical Sciences, 2003; 8(2): 43-49
- Bässler, H.-J., Lehmann, F., Containment Technology: Progress in the Pharmaceutical and Food Processing Industry, 2013; Springer Heidelberg
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