Examination Of Non-Sterile Products

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 (details below) to request a copy of the article.

Company Overview
As a GMP/GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of our laboratory technicians and managers enables us to be fully conversant with global regulatory expectations.

We are committed to providing a quality testing service, combining high levels of client satisfaction together with the maintenance of appropriate accreditation. This and the continual pursuit of delivering excellence remain central to our business.

We are routinely inspected by the MHRA, FDA and Home Office, and offer the opportunity for clients to conduct audits on a regular basis.