Neues Verfahren zur Bestimmung der Inaktivierung von Endotoxin bei der Trocken-Hitze-Sterilisation Rainald Forberta, Lothar Gailb und Ulrich Pflugmacherc Siemens AG, A&D SPa,b, Frankfurt/Main, Aventis Pharma Deutschland GmbHc, QODP/QCDP, Frankfurt/Main New Procedure for Determining Dry-Heat Inactivation of Endotoxin The dry-heat inactivation of endotoxin can be determined either by using biological indicators or by temperature measurement and calculation using a previously modelled inactivation process. Most of the modelling procedures are based upon a) local temperature measurement of the sterilising object and b) isothermal inactivation measurement within the relevant temperature range. Key words Entpyrogenisierung • Inaktivierung, Endotoxininaktivierung, Kinetik • Sterilisation, Trocken-Hitze Sterilisation • Sterilisationstunnel • Validierung |
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pharmind 2005, Nr. 5, Seite 592