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The Scientific World Journal
Volume 2012, Article ID 234858, 10 pages
http://dx.doi.org/10.1100/2012/234858
Research Article

Fluorescence-Based Rapid Detection of Microbiological Contaminants in Water Samples

Merck Millipore, Lab Solutions, BioMonitoring, Research & Development, Applications Group, 39, Route industrielle de la Hardt, 67120 Molsheim, France

Received 8 December 2011; Accepted 25 December 2011

Academic Editors: A. P. Hudson and A. L. MacHado

Copyright © 2012 Hervé Meder et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Microbiological contamination of process waters is a current issue for pharmaceutical industries. Traditional methods require several days to obtain results; therefore, rapid microbiological methods are widely requested to shorten time-to-result. Milliflex Quantum was developed for the rapid detection and enumeration of microorganisms in filterable samples. It combines membrane filtration to universal fluorescent staining of viable microorganisms. This new alternative method was validated using European and United States Pharmacopeia definitions, with sterile water and/or sterile water artificially contaminated with microorganisms. The Milliflex Quantum method was demonstrated to be reliable, robust, specific, accurate, and linear over the whole range of assays following these guidelines. The Milliflex Quantum system was challenged to detect natural contaminants in different types of pharmaceutical purified process waters. Milliflex Quantum was demonstrated to detect accurately contaminants 3- to 7-fold faster than traditional membrane filtration method. The staining procedure is nondestructive allowing downstream identification following a positive result. The Milliflex Quantum offers a fast, sensitive, and robust alternative to the compendial membrane filtration method.