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MerkenEnzyme indicators for H2O2 biodecontamination
Rubrik: Reinigung & Desinfektion
(Treffer aus cleanroom & processes, Nr. 03, Seite 156 (2024))
Riekert D | Schmid A | Demmler A | Bernhard L
Enzyme indicators for H2O2 biodecontamination / Influence of temperature and humidity · Riekert D1,2, Schmid A2, Demmler A1, Bernhard L1 · 1Optima pharma containment GmbH, Radolfzell-Stahringen und Hochschule Albstadt-Sigmaringen, Sigmaringen
Biodecontamination Isolator Enzyme Indicators Biological Indicators Aseptic Processing The aim of manufacturing sterile pharmaceuticals is to ensure the absence of viable microorganisms through reproducible process design. Both the European [ 1 ] and the United States Pharmacopoeia (USP) [ 2 ] as well as recommendations of the European Medicines Agency (EMA) [ 3 ] call for terminal sterilization in the final container as the method of choice, combined with a sterility assurance level (SAL) of 10 -6 or lower as a recognized acceptance criteria. The SAL value defines the probability of viable microorganisms remaining in the product batch after the ...
