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Measurement uncertainty evaluation and risk of false conformity assessment for microbial enumeration tests.
Dias, Francielle Regina Silva; Lourenço, Felipe Rebello.
Afiliação
  • Dias FRS; Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil.
  • Lourenço FR; Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil. Electronic address: feliperl@usp.br.
J Microbiol Methods ; 189: 106312, 2021 10.
Article em En | MEDLINE | ID: mdl-34428497
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/non-conformity 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Contagem de Colônia Microbiana / Carga Bacteriana Tipo de estudo: Etiology_studies / Health_economic_evaluation / Prognostic_studies / Risk_factors_studies Idioma: En Revista: J Microbiol Methods Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Contagem de Colônia Microbiana / Carga Bacteriana Tipo de estudo: Etiology_studies / Health_economic_evaluation / Prognostic_studies / Risk_factors_studies Idioma: En Revista: J Microbiol Methods Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda