Isolator systems can provide an alternative to the standard International Organization for Standardization (ISO) Class 5 cleanrooms used in aseptic filling applications.
An isolator can be installed in a Class 6 or 7 cleanroom, precluding the need to build a Class 5 facility to provide an aseptic work environment and without compromising sterility and contaminant protection levels. Isolators are usually easier to decontaminate, monitor, and offer a high degree of sterility assurance.
However, isolators have limited flexibility and their physical requirements can call for significant planning. The enclosed machinery in an isolator system needs to be highly reliable in order to avoid frequent maintenance and the isolator design should provide easy access through glove ports or half-suits to enable adjustments during production. In addition, isolators used in continuous manual operations usually need to be configured to allow for worker comfort.
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