Simplified and Detailed Evaluation of the Uncertainty of the Measurement of Microbiological Contamination of Pharmaceutical Products.

This work concludes that triplicate determinations are required to produce results with adequately low uncertainty and that simplified uncertainty quantification underevaluate or overevaluate the uncertainty from determinations based on low or high colonies numbers, respectively. Therefore, detailed uncertainty evaluations are advised for determinations between 50% and 200% of PP's maximum admissible contamination value.