title: Uncertainty of quantitative microbiological methods of pharmaceutical analysis.
abstract: The total uncertainty of quantitative microbiological methods, used in pharmaceutical analysis, consists of several components. The analysis of the most important sources of the quantitative microbiological methods variability demonstrated no effect of culture media and plate-count techniques in the estimation of microbial count while the highly significant effect of other factors (type of microorganism, pharmaceutical product and individual reading and interpreting errors) was established. The most appropriate method of statistical analysis of such data was ANOVA which enabled not only the effect of individual factors to be estimated but also their interactions. Considering all the elements of uncertainty and combining them mathematically the combined relative uncertainty of the test results was estimated both for method of quantitative examination of non-sterile pharmaceuticals and microbial count technique without any product. These data did not exceed 35%, appropriated for a traditional plate count methods.
authors.affiliation: Scientific Centre for Expert Evaluation of Medicinal Products, The Ministry of health of Russia. Petrovsky Boulevard 8, 127051 Moscow, Russia.
authors.forename: O V
authors.initials: OV
authors.lastname: Gunar
authors.affiliation: Scientific Centre for Expert Evaluation of Medicinal Products, The Ministry of health of Russia. Petrovsky Boulevard 8, 127051 Moscow, Russia. Electronic address: nadine87@inbox.ru.
authors.forename: N G
authors.initials: NG
authors.lastname: Sakhno
mesh_terms: D058491:Bacterial Load; D003470:Culture Media; D008828:Microbiological Techniques / Q000379:methods*; D035501:Uncertainty
chemical_list: D003470:Culture Media
keywords: Pharmaceutical analysis; Quantitative microbiological method; Uncertainty