Microbial Detection Systems

An analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to 2006 showed that 48% of recalls were due to contamination by the bacteria Burkholderia cepacia, Pseudomonas spp., or Ralstonia picketti, while yeast and mold contamination were found in 23% of recalls.

Microbial Detection Systems perform an important role in assuring pharmaceutical products are free from unwanted bacteria, yeast, mold and other microbial contaminants before leaving the manufacturing facility. Recently, rapid and automated microbial detections systems have been developed to speed the detection process.

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Milliflex Quantum Rapid Detection System

MilliporeSigma

Type: Fluorescent Staining-based System
Pharmaceutical Application: Raw material (media, buffers, pharmaceutical ingredients and water), In-process samples (bioburden prior to sterilization, CIP/SIP samples, cell culture/fermentation samples, media for fermentation, buffers for manufacturing, and intermediate process samples), Final product, Environmental samples
Temperature Range: 15 – 40C (59F - 104F)

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