When working as a microbiologist in an aseptic manufacturing facility, getting accurate results from the environmental monitoring regime in cleanrooms, specifically from contact plates and swabs, is always a concern. Similarly, the accuracy of sterility testing results is a concern, especially when the pharmaceutical product formulation could have anti-microbial properties. It can be both disastrous and extremely frustrating when a contamination event takes place, particularly one involving a sterile product, and one which cannot be linked to a specific reason or root cause.
As its name suggests growth media is designed to offer ideal conditions to encourage microbial growth; unfortunately, it does not take much to reduce the efficacy of the media. Generally, microbiological testing in the pharmaceutical industry consists of: environmental monitoring; sterility testing of final products, intermediates and active pharmaceutical ingredients (APIs), etc. and the testing for specific undesirable micro-organisms. In all of these situations, there will be chemicals present that inhibit microbial growth.
It is important to stress that some micro-organisms are extremely difficult to kill and can survive in extreme environments – the presence of a particular chemical may stop it growing, but the micro-organism is not dead. In the right conditions, when the inhibitory chemical has been neutralised, it will start to grow again.
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