title: Fluorescence-based rapid detection of microbiological contaminants in water samples.
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.
authors.affiliation: Merck Millipore, Lab Solutions, BioMonitoring, Research & Development, Applications Group, 39 Route industrielle de la Hardt, Molsheim, France. herve.meder@merckgroup.com
authors.forename: Hervé
authors.initials: H
authors.lastname: Meder
authors.forename: Anne
authors.initials: A
authors.lastname: Baumstummler
authors.forename: Renaud
authors.initials: R
authors.lastname: Chollet
authors.forename: Sophie
authors.initials: S
authors.lastname: Barrier
authors.forename: Monika
authors.initials: M
authors.lastname: Kukuczka
authors.forename: Frédéric
authors.initials: F
authors.lastname: Olivieri
authors.forename: Esther
authors.initials: E
authors.lastname: Welterlin
authors.forename: Vincent
authors.initials: V
authors.lastname: Beguin
authors.forename: Sébastien
authors.initials: S
authors.lastname: Ribault
mesh_terms: D015169:Colony Count, Microbial; D004345:Drug Industry; D005374:Filtration; D005453:Fluorescence; D057230:Limit of Detection; D013194:Staining and Labeling; D014871:Water Microbiology / Q000592:standards