Microbiological Control – How Much is Enough?

The microbiology department of a manufacturing facility for non-sterile products can be extremely busy carrying out extensive tests on incoming materials, intermediates, water systems, production equipment, and environmental monitoring.

Ten years ago, seeing a settle plate in a tablet packing area would have been a cause for consternation, but now it is relatively commonplace. This leads to questions of whether this is all necessary and how it is benefitting the patient.

Approaches to microbiological control of non-sterile products should be essentially the same as to all other products and strategies in the industry. It should be based upon an objective evaluation of risk. However, much of what is currently done, and much of what regulators ask to be done, is not based on risk and does not represent good science.

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