Herstellung von Wasser für den pharmazeutischen Gebrauch Teil 1: Stand der Technik und wichtige Betriebsparameter Tom Jünemanna, Peter Czermakb und Frank Runkelb Engelhard Arzneimittel GmbH & Co. KG, Qualitätssicherunga, Niederdorfelden, und Institut für Biopharmazeutische Technologie, Fachhochschule Gießen-Friedbergb, Gießen Preparation of Water for Pharmaceutical Use / Part 1: State of the art and important technical parameters Key words Destillation • Ionenaustauscher • Membranen • Reinstwasser • Trinkwasser • UmkehrosmosePharmaceutical water is mostly produced by well-proven methods like ion exchange, distillation and membrane applications such as reverse osmose, ultrafiltration and electrodeionization. Physical or chemical methods ensure disinfection and sanitation. Commonly used is the combination of ultraviolet light and ozone treatment. The following article describes the state of the art of pharmaceutical water production including the most important technical parameters. The first paragraph of Part 1 is concentrated in the pre-paration of drinking-water due to the fact that pharmaceutical water has to be made by drinking-water. Part 2 compares two different purified water systems with regard to microbiological and chemical quality of the produced water. |
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pharmind 2005, Nr. 8, Seite 958