Microbial identification strategies in the pharmaceutical industry.
A commonly discussed question amongst pharmaceutical microbiologists, and the quality assurance organizations they serve, is what microbial isolates from the many microbial monitoring programs at a manufacturing facility need to be characterized, identified to genus, identified to species, or strain-typed? This article discusses the overall strategies that may be successfully applied to microbial identification in support of microbial monitoring of utilities, pharmaceutical ingredients, the manufacturing environment, and finished products. Emphasis in the article is given to the justification of the microbial identification program, selection of identification methods, and use of speciation in successful product failure investigations.
Cundell
Anthony M
AM
Microbiological Consultant, 105 Lee Road, Scarsdale, NY 10583, USA.
D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000379:methods / Q000639:trends*; D004783:Environmental Microbiology; D015723:Gene Library; D005827:Genetics, Microbial; D007218:Industrial Microbiology / Q000379:methods / Q000639:trends*; D008828:Microbiological Techniques; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D013242:Sterilization / Q000379:methods; D013678:Technology, Pharmaceutical; D014481:United States