SGS has invested in a new Genotypic DNA sequencing MicroSeq Rapid Microbial Identification System from Applied Biosystems at its Chicago facility. The molecular identification system is undergoing validation and is expected to be fully implemented in 3Q16 to provide high speed microbiological testing for the identification of microorganisms.
 
According to the FDA’s 2004 guidance, “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice,” genotypic methods have been demonstrated to be more accurate and precise than traditional biochemical and phenotypic methods. With the installation, SGS clients will be able to offer minimized transit delays by consolidating testing requirements through a single lab, obtaining identification of bacterial and fungal isolates, and facilitating a more rapid response to the investigation of contamination.
 
“The accurate and speedy identification of bacteria and fungi using a built in library will assist our clients with investigations related to sterility contamination, media fill study failures, product bioburden testing, raw material testing and environmental monitoring excursions,” said Mark Rogers, vice president for Life Sciences, SGS USA. He added, “We will be able to build custom libraries for our clients so that they can identify and track specific microorganisms quickly and efficiently.”

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