Isolatortechnik in der pharmazeutischen IndustrieStand der Technik 2002, ISO-Norm 14644 als Hilfsmittel zur Dimensionierung und Prüfung von Isolatoren Edgar C. Sirch Dießen Paul-Gerhard Schmidt, Concept Heidelberg, zum Gedenken Isolator Technology in the Pharmaceutical Industry / State of the art 2002, ISO standard 14644 / Separative Devices as a basis for the dimensioning and examination of isolators This paper presents state-of-the-art of isolator technology in the pharmaceutical industry. Essential components for all isolator technologies (aseptic production, biotech processes, handling of high potent and toxic substances, specific pathogen-free animal breeding in pharmaceutical research) are available in sufficient quality. Economic aspects of this technology in comparison to conventional cleanroom techniques are still evaluated, especially for aseptic production. The benefits of using the new ISO standard 14644-7 for the definition of user requirements, for specifications and qualification criteria are shown by examples.
Key Words Isolatortechnik · ISO 14644-7/abtrennende Reinraum-Module · Nutzen · Qualifizierung · Spezifizierung
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pharmind 2003, Nr. 3, Seite 265
