Introduction/Definition

Abstract

The historical development of the isolator technology is shown in [1] and [3]. Isolators are now a part of the pharmaceutical industry [6], which cannot be imagined without. Since its beginnings in the nuclear industry, many isolator applications are new to the chemical and pharmaceutical industries and are used to separate the user, product, and environment consistently from each other. For the pharmaceutical industry of the twenty-first century, containment systems for aseptic processes and the handling of API's have become more important. A modern isolator as it is used in the pharmaceutical industry of today can be designed for the product and process protection and/or for the protection of operators and the environment. Additional safety features and operating costs savings versus conventional clean room approaches are driving the change to containment solutions. Containments can be glove boxes, isolators, or restricted access barrier systems (RABS) . Isolators have captured a firm position in the pharmaceutical industry during the past few years.