Isolators: qualifications and maintenance. Clean rooms, controlled environments ans containment laboratories. ASPEC-GERPAC

The isolator is a barrier system, a close protection device, but also an air treatment device. In certain cases, it is also a containment enclosure. Isolators are now well established in many industrial sectors (pharmaceutical industry, fine chemistry, biotechnology, food-processing industry…), in hospital pharmacies, as well as in laboratories (specifically in biohazard containment zones). Isolators are used to protect employees and/or for aseptic production or microbiological tests. This publication will be of particular interest to isolator designers and those using isolators for the preparation of sterile medical products. However, the extensive content and the
proposed approach can be applied to isolators used for other activities.

This publication is an update of first French edition published in 2002 and the work of multidisciplinary team. This edition focuses on qualification operations and features new chapters on maintenance. Surface sterilisation (or bio-decontamination), not to be
confused with core sterilisation, are also addressed with a focus on the isolator qualification (DQ, IQ, OQ, and PQ).

This publication is a truly educational tool. It contains roughly 20 practical information sheets.
This second edition constitutes a reference tool for isolator technology professionals.

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