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Optimal conditions for the recovery of bioburden from pharmaceutical processes: A case study

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Abstract

Bioburden testing is an important part of pharmaceutical microbiology and provides data in relation to the quality of pharmaceutical products during manufacture. Little guidance is provided in relation to test methodology, culture media and incubation parameters. The quality control laboratory, therefore, needs to establish the most appropriate method. This paper outlines a case study for the selection of incubation parameters for the bioburden assessment of in-process samples using the Total Viable Count technique and pour plate method. While the outcome of the experiment contained within the paper relates to a specific set of processes, the approach taken can be used by other laboratories to compare or to develop their test methods and techniques for bioburden determinations.
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