VITEK®MS: The most rapid solution for identification of microorganisms – bioMérieux
Posted on March 21, 2014
Microorganisms found in pharmaceutical settings can require rapid and accurate identifications to assist in manufacturing processes and product failure investigations. Environmental monitoring samples with microbial growth for identification testing usually originate from surface and air controls, water for injection or quality controls of clean rooms. Protein profiling by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) has been embraced by the pharmaceutical microbiology community as state-of-the-art for the most rapid identification of microorganisms. The VITEK® MS protocols provide identification of bacteria, yeast and molds at the species level.
The success of the VITEK®MS is due to the robustness of the spectral database and algorithms embedded in the proprietary interpretive system. VITEK®MS received de novo FDA clearance August 2013.
Data formats and export are simplified by user-friendly software. Importantly for cGMP labs, three key features are available for every system: 1) full traceability from the agar plate to the VITEK®MS microbial identification through barcode recognition, 2) security hierarchy, electronic signature and an audit trail to support 21CFR11 compliance, and 3) tools with IQ, OQ and PQ protocols to accelerate the installation and routine use in an industry laboratory.
http://www.biomerieux-industry.com/biopharma/vitek-ms-0?dest=view&utm_source=BiopharmAsia&utm_medium=textImage&utm_campaign=VMS
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