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Reinräume für die aseptische Arzneimittelherstellung nach der neuen Norm ISO 14644

Integration von Planung, Qualifizierung und Betrieb

Lothar Gail

Siemens Axiva, Frankfurt/Main

Paul-Gerhard Schmidt, Concept Heidelberg, zum Gedenken

Cleanrooms for Aseptic Drug Manufacture According to the New Guideline ISO 14644 / Integration of design, qualification and operation

The requirements that cleanrooms for aseptic drug manufacture have to meet are laid down in various GMP (Good Manufacturing Practice) documents, which are aimed at linking design and operating activities by suitable qualification procedures. From a contamination control standpoint, such requirements are justified by the numerous critical contamination factors that may influence product quality. In the case of aseptic processing, such requirements include contamination by airborne microparticles, and especially by microorganisms, as well as ensuring continued compliance. The design process is divided into the definition of requirements and concepts, detail design, construction and qualification. To ensure applicability to different cleanroom conditions, particular attention is paid to the definition of requirements. For the same reason a detailed analysis of critical parameters is also required for cleanroom operation. The annexes to the standard present a variety of possible techniques, enabling operators to select the best option according to the results of risk analyses. Based on GMP concepts, the combination of cleanroom design and operation constitutes a major potential for progress in aseptic drug manufacture - a potential that is, however, available only insofar as the required depth of cooperation between designers, service providers and operators is achieved.

Key words Arzneimittelherstellung, aseptische · Reinraumtechnik