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.
Sylvie Vandriessche, Aspec
PRESIDENTS OF THE COMMISSION
Sylvie Crauste-Manciet, Présidente
du GERPAC et PUPH CHU Bordeaux – Université de Bordeaux
Didier Meyer, DM Compliance
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
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
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.