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Microbiological Testing & Contamination Control

Published In: Contract Pharma

Contamination control for a non-sterile drug was first highlighted by Professor Kallings1 in Sweden in 1965. He detected strains of Salmonella in an oral drug, Thyroidinum, USP, a dry thyroid powder from domestic animals. At this time there were no microbial specifications for non-sterile drugs or cosmetics. Soon thereafter, bacteriologists from the USP, FDA and the pharmaceutical industry fashioned a ground-breaking protocol: the microbial limit test. The USP XVIII2 microbial limit test was used internationally for 38 years until 2009, when it was harmonized by an international committee called the Pharmacopeial Discussion Group.

The harmonized test first appeared in 2009 as two chapters dealing with enumeration and specified organisms USP <61> and USP <62>, respectively3. USP <62> is substantially different from the previous non-harmonized test; these changes are the subject of this article. The procedures in preparing the sample for testing, method suitability and growth promotion are an improvement. We also believe that elimination of the selective media is of unproven value and potentially error-prone. A case-study is presented with Salmonellae and E. coli on the shift from classical microbiology techniques to polymerase chain reaction [PCR].

Authors: Daniel L. Prince, Ph. D., Christopher J. Waskewich, M.S., Kristah J. Kohan, B.S. and Danina G. Rinaldi, B.S.


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