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  • General

    • Isolators: qualifications and maintenance

       

      • This guide is an updated version of a french document first published in 2002.

        It is the result of work by a group of multidisciplinary isolator technology experts.

        COORDINATOR

        Sylvie Vandriessche, Aspec

        PRESIDENTS OF THE COMMISSION

        Sylvie Crauste-Manciet, Présidente

        du GERPAC et PUPH CHU Bordeaux – Université de Bordeaux

        Didier Meyer, DM Compliance

        EDITORIAL COMMITTEE

        Bruno Aze, Steris

        Philippe Callegari, MSD Riom

        Françoise Durand, Laboratoires Anios

        Eric Gohier, JCE Biotechnology

        Cyril Mounier, Getinge La Calhène

        Cosmin Patrascu, INRS

        Alain Pineau, Bioquell

        REVISION COMMITTEE

        Vincent Barbier, NNE Pharmaplan

        Eric Caudron, Hôpital Européen Georges Pompidou

        Jon Nottingham, Cape Europe

        Pr Pascal Odou, CHRU Lille

        Franck Pavan, PIERRE FABRE

        Christian Poinsot, Groupe ICARE

        Emmanuelle Sansoe, TRB CHEMEDICA

        Patrick Vanhecke, GSK Belgique

        Michèle Vasseur, CHRU Lille

        ABSTRACT

        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.