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Mikrobiologische Aspekte von Reinstwasseranlagen in der Pharmaindustrie

Eine aktuelle Literaturbetrachtung

Ralph G. Weyandt

Institut Fresenius GmbH, Taunusstein

Microbiological Aspects of Ultra Pure Water Units in the Pharmaceutical Industry / An up-to-date literature review

The absence of microorganisms and their degradation products is of the greatest importance for the water quality WfI in the pharmaceutical industry. In the distillation with subsequent hot water partition required in the production, a microbiological contamination will be reliably detected with the parameters colony count and endotoxin content, defined in the Ph.Eur. With the introduction of membrane bound technologies such as reverse osmosis, the suitability of these processes and their application in “cold water systems” must again be scrutinized. The present literature study includes the description of microbiological phenomena in pure water including important metabolic physiological adaptions to habitats poor in nutrients, and attempts to investigate the current analytical possibilities for an adequate microbiological detection in technical ultra pure water units.

Key words Reinstwasser · Umkehrosmose · Mikroorganismen · Biofilm