ABSTRACT
INTRODUCTION The Pierre Fabre Group is the third largest French pharmaceutical manufacturer and produces a number of essential medications. Pierre Fabre Medicament Production (Aquitaine Pharm International) is a pharmaceutical laboratory of the Pierre Fabre Group. A portion of the Pierre Fabre facility in Idron, South West of France, specializes in the production of sterile anticancer drugs. This facility offers contract manufacturing services to worldwide pharmaceutical business and has used isolation technology from the early 1990s. Pierre Fabre required a facility for the manufacture of its new anti-cancer injectable drug “Navelbine” and the ‘new’ technology of isolators was selected. This product (and other oncology drugs) presents unique challenges to manufacture because of its high toxicity, which requires that specific measures be undertaken to protect the production operators. The principle reasons for selection of isolators were to improve both aseptic processing and the protection of personnel and environment. The first stage of operation and the product it manufactured were FDA approved in 1993.
