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Examination of Non-sterile Products: Application Note Published in EPR

Date of event 4th January 2018

Wickham Laboratories is pleased to announce our most recent Application Note, "Examination of Non-sterile Products: Tests for Specified Microorganisms” which is featured in the December 2017 issue of European Pharmaceutical Review.

Abstract:

For certain product types, there is a requirement for testing to determine the absence of certain microorganisms. These specified microorganisms include pathogens and are known as indicator microorganisms.

This is due to the fact that they may indicate the presence of other microorganisms from similar sources that are known to be hazardous for immunocompromised and other high-risk patients.

There are a number of microorganisms that are tested for, including the following:

Escherichia coli is a natural inhabitant of the gut flora and part of the Enterobacteriaceae family. Some species are pathogenic and cause diarrhoea. E. coli’s presence in water, raw material and products indicates faecal contamination and it is listed as an organism of concern for oral products.

If you are interested in reading this whitepaper in full please log on to the EPR website or contact us to request a copy of the article.

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