Measurement uncertainty evaluation and risk of false conformity assessment for microbial enumeration tests.

Microbial enumeration tests are widely used to assess the microbiological quality of non-sterile pharmaceutical products. Despite of all efforts to guarantee the reliability of microbial enumeration tests, there will always be an uncertainty associated with the measured values, which can lead to false conformity/non-conformity decisions. In this work, we evaluated the measurement uncertainty using a bottom-up approach and estimate the consumer's or producer's risk due to the measurement uncertainty.

Top-down evaluation of the matrix effects in microbial enumeration test uncertainty.

Microbial contamination may compromise the efficacy and safety of pharmaceutical products. Microbial enumeration tests are required by most of the pharmacopeial compendia and consist in conventional pour-plate inoculation of a sample aliquot followed by incubation under appropriate conditions. Despite of this, the measurement uncertainty evaluation for microbial enumeration tests is rarely considered.