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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

Full text
Author(s):
Dias, Francielle Regina Silva [1] ; Lourenco, Felipe Rebello [1]
Total Authors: 2
Affiliation:
[1] Univ Sao Paulo, Fac Pharmaceut Sci, Dept Pharm, Sao Paulo - Brazil
Total Affiliations: 1
Document type: Journal article
Source: Journal of Microbiological Methods; v. 189, OCT 2021.
Web of Science Citations: 0
Abstract

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. Three main sources of uncertainty were identified and quantified: dilution factor, plated volume, and microbial plate counts. The contribution of these sources of uncertainty depends on the measured value of microbial load in pharmaceutical products. The contribution of dilution factor and plated volume uncertainties increase with an increase of measured value, while the contribution of microbial plate count uncertainty decreases with an increase of measured value. The overall uncertainty values were expressed as uncertainty factors, which provide an asymmetric 95% level confidence level of microbial load in pharmaceutical products. In addition, the risk of false conformity/nonconformity decisions due to measurement uncertainty was assess using Monte Carlo method. When the measured value is close to the upper specification limit and/or the measurement uncertainty is large, the risk of false conformity/non-conformity decisions may be significantly high. Thus, we conclude that the use of uncertainty factor in the conformity/non-conformity assessment is important to guarantee the reliability of microbial enumeration test results and to support decision-making. (AU)

FAPESP's process: 19/16206-3 - Risks of false decisions due to the measurement uncertainties in the evaluation of pharmaceutical equivalence
Grantee:Felipe Rebello Lourenço
Support Opportunities: Regular Research Grants
FAPESP's process: 17/04539-2 - Using measurement uncertainty in performance evaluation of analytical methods
Grantee:Felipe Rebello Lourenço
Support Opportunities: Regular Research Grants