{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T01:42:30Z","timestamp":1776217350063,"version":"3.50.1"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2024,6,17]],"date-time":"2024-06-17T00:00:00Z","timestamp":1718582400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100001807","name":"Funda\u00e7\u00e3o de Amparo \u00e0 Pesquisa do Estado de S\u00e3o Paulo","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001807","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001871","name":"Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001871","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Institute of Molecular Sciences"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The control of the microbial contamination of pharmaceutical products (PP) is crucial to ensure their safety and efficacy. The validity of the monitoring of such contamination depends on the uncertainty of this quantification. Highly uncertain quantifications due to the variability of determinations or the magnitude of systematic effects affecting microbial growth or other analytical operations make analysis unfit for the intended use. The quantification of the measurement uncertainty expressing the combined effects of all random and systematic effects affecting the analysis allows for a sound decision about quantification adequacy for their intended use. The complexity of the quantification of microbial analysis uncertainty led to the development of simplified ways of performing this evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This work assesses the adequacy of the simplified quantification of the uncertainty of the determination of the microbial contamination of PP by log transforming microbial count and dilution factor of the test sample whose uncertainty is combined in a log scale using the uncertainty propagation law.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This assessment is performed by a parallel novel bottom-up and accurate evaluation of microbial analysis uncertainty involving the Monte Carlo method simulation of the Poisson log-normal distribution of counts and of the normally distributed measured volumes involved in the analysis. Systematic effects are assessed and corrected on results to compensate for their impact on the determinations. Poisson regression is used to predict precision affecting determinations on unknown test samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Result<\/jats:title>\n                    <jats:p>Simplified and detailed models of the uncertainty of the measurement of the microbial contamination of PP are provided, allowing objective comparisons of several determinations and those with a maximum contamination level.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This work concludes that triplicate determinations are required to produce results with adequately low uncertainty and that simplified uncertainty quantification underevaluates or overevaluates the uncertainty from determinations based on low or high colony numbers, respectively. Therefore, detailed uncertainty evaluations are advised for determinations between 50 and 200% of PP\u2019s maximum admissible contamination value<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Highlight<\/jats:title>\n                    <jats:p>User-friendly tools for detailed and simplified evaluations of the uncertainty of the measurement of microbial contamination of PP are provided together with the understanding of when simplifications are adequate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jaoacint\/qsae044","type":"journal-article","created":{"date-parts":[[2024,6,14]],"date-time":"2024-06-14T19:41:46Z","timestamp":1718394106000},"page":"856-866","source":"Crossref","is-referenced-by-count":0,"title":["Simplified and Detailed Evaluations of the Uncertainty of the Measurement of Microbiological Contamination of Pharmaceutical Products"],"prefix":"10.1093","volume":"107","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2630-151X","authenticated-orcid":false,"given":"Felipe Rebello","family":"Louren\u00e7o","sequence":"first","affiliation":[{"name":"Universidade de S\u00e3o Paulo, Faculdade de Ci\u00eancias Farmac\u00eauticas, Departamento de F\u00e1rmacia , Av. Prof. Lineu Prestes, 580 , CEP 05508-000 S\u00e3o Paulo,","place":["Brazil"]}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1990-3472","authenticated-orcid":false,"given":"Ricardo J N","family":"Bettencourt da Silva","sequence":"additional","affiliation":[{"name":"Centro de Qu\u00edmica Estrutural - Institute of Molecular Sciences, Faculdade de Ci\u00eancias, Universidade de Lisboa , Campo Grande, 1749-016 Lisboa,","place":["Portugal"]}]}],"member":"286","published-online":{"date-parts":[[2024,6,17]]},"reference":[{"key":"2026041420220608800_qsae044-B1","author":"International Conference on Harmonisation","year":"2009"},{"key":"2026041420220608800_qsae044-B2","author":"International Conference on Harmonisation","year":"2023"},{"key":"2026041420220608800_qsae044-B3","author":"International Conference on Harmonisation","year":"2015"},{"key":"2026041420220608800_qsae044-B4","volume-title":"Guide to Microbiological Control in Pharmaceutical and Medical Devices","author":"Denyer","year":"2017","edition":"2nd Ed."},{"key":"2026041420220608800_qsae044-B5","volume-title":"Controle Biol\u00f3gico de Qualidade de Produtos Farmac\u00eauticos, Correlatos e Cosm\u00e9ticos","author":"Pinto","year":"2015","edition":"4th Ed."},{"key":"2026041420220608800_qsae044-B6","author":"United States Pharmacopeial Convention","year":"2018"},{"key":"2026041420220608800_qsae044-B7","volume-title":"Farmacopeia Brasileira","author":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria","year":"2019","edition":"6th Ed.,"},{"key":"2026041420220608800_qsae044-B8","author":"Ellison","year":"2012"},{"key":"2026041420220608800_qsae044-B9","author":"Ramsey","year":"2019"},{"key":"2026041420220608800_qsae044-B10","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1080\/10408347.2021.1940086","volume":"53","author":"Separovic","year":"2023","journal-title":"Crit. Rev. Anal. Chem"},{"key":"2026041420220608800_qsae044-B11","author":"Magnusson","year":"2023"},{"key":"2026041420220608800_qsae044-B12","author":"Williams","year":"2021"},{"key":"2026041420220608800_qsae044-B13","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1002\/j.1551-8833.2008.tb09584.x","volume":"100","author":"Emelko","year":"2008","journal-title":"J. Am. Water Work. Assoc"},{"key":"2026041420220608800_qsae044-B14","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1146\/annurev-food-022814-015546","volume":"6","author":"Jongenburger","year":"2015","journal-title":"Annu. Rev. Food Sci. Technol."},{"key":"2026041420220608800_qsae044-B15","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1007\/s007690100360","volume":"6","author":"Niemi","year":"2001","journal-title":"Accredit. Qual. Assur"},{"key":"2026041420220608800_qsae044-B16","doi-asserted-by":"publisher","first-page":"1073","DOI":"10.1016\/j.ijpharm.2015.10.022","volume":"496","author":"Gunar","year":"2015","journal-title":"Int. J. Pharm"},{"key":"2026041420220608800_qsae044-B17","doi-asserted-by":"publisher","first-page":"109871","DOI":"10.1016\/j.ijfoodmicro.2022.109871","volume":"380","author":"Garre","year":"2022","journal-title":"Int. J. Food Microbiol"},{"key":"2026041420220608800_qsae044-B18","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1016\/j.mran.2018.07.002","volume":"10","author":"Hern\u00e1ndez","year":"2018","journal-title":"Microb. Risk Anal"},{"key":"2026041420220608800_qsae044-B19","doi-asserted-by":"publisher","first-page":"106723","DOI":"10.1016\/j.mimet.2023.106723","volume":"208","author":"Sharp","year":"2023","journal-title":"J. Microbiol. Methods"},{"key":"2026041420220608800_qsae044-B20","doi-asserted-by":"publisher","first-page":"105864","DOI":"10.1016\/j.mimet.2020.105864","volume":"171","author":"Dias","year":"2020","journal-title":"J. Microbiol. Methods"},{"key":"2026041420220608800_qsae044-B21","doi-asserted-by":"publisher","first-page":"106312","DOI":"10.1016\/j.mimet.2021.106312","volume":"189","author":"Dias","year":"2021","journal-title":"J. Microbiol. Methods"},{"key":"2026041420220608800_qsae044-B22","doi-asserted-by":"publisher","first-page":"1268","DOI":"10.1016\/j.foodcont.2011.01.028","volume":"22","author":"Gonzales-Barron","year":"2011","journal-title":"Food Control"},{"key":"2026041420220608800_qsae044-B23","doi-asserted-by":"publisher","first-page":"1279","DOI":"10.1016\/j.foodcont.2011.01.029","volume":"22","author":"Gonzales-Barron","year":"2011","journal-title":"Food Control"},{"key":"2026041420220608800_qsae044-B24","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1016\/j.foodcont.2012.03.007","volume":"27","author":"Williams","year":"2012","journal-title":"Food Control"},{"key":"2026041420220608800_qsae044-B25","doi-asserted-by":"publisher","first-page":"11080","DOI":"10.1021\/acs.est.2c01828","volume":"56","author":"Morgado","year":"2022","journal-title":"Environ. Sci. Technol"},{"key":"2026041420220608800_qsae044-B26","author":"BIPM","year":"2007","edition":"3rd Ed."},{"key":"2026041420220608800_qsae044-B27","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1016\/j.ijfoodmicro.2010.07.025","volume":"143","author":"Jongenburger","year":"2010","journal-title":"Int. J. Food Microbiol"},{"key":"2026041420220608800_qsae044-B28","volume":"101","author":"BIPM","year":"2008","journal-title":"JCGM"},{"key":"2026041420220608800_qsae044-B29","doi-asserted-by":"publisher","first-page":"338","DOI":"10.1007\/s00769-005-0008-5","volume":"10","author":"Ellison","year":"2005","journal-title":"Accred. Qual. Assur"},{"key":"2026041420220608800_qsae044-B30","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1007\/s00769-003-0615-y","volume":"8","author":"Hibbert","year":"2003","journal-title":"Accred. Qual. Assur"},{"key":"2026041420220608800_qsae044-B31","author":"Bettencourt da Silva","year":"2015"},{"key":"2026041420220608800_qsae044-B32","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1016\/j.ijfoodmicro.2014.11.023","volume":"196","author":"Duarte","year":"2015","journal-title":"Int. J. Food Microbiol"},{"key":"2026041420220608800_qsae044-B33","doi-asserted-by":"publisher","first-page":"2304","DOI":"10.3389\/fmicb.2018.02304","volume":"9","author":"Chik","year":"2018","journal-title":"Front. Microbiol"},{"key":"2026041420220608800_qsae044-B34","doi-asserted-by":"publisher","first-page":"76","DOI":"10.1016\/j.foodres.2019.01.059","volume":"119","author":"Garre","year":"2019","journal-title":"Food Res. Int"},{"key":"2026041420220608800_qsae044-B35","doi-asserted-by":"publisher","first-page":"789","DOI":"10.1016\/j.talanta.2017.06.073","volume":"174","author":"Kuselman","year":"2017","journal-title":"Talanta"},{"key":"2026041420220608800_qsae044-B36","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1016\/j.chemolab.2018.09.004","volume":"182","author":"Bettencourt da Silva","year":"2018","journal-title":"Chemometr. Intell. Lab. Syst"},{"key":"2026041420220608800_qsae044-B37","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1016\/j.talanta.2018.12.021","volume":"196","author":"Louren\u00e7o","year":"2019","journal-title":"Talanta"},{"key":"2026041420220608800_qsae044-B38","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.chemolab.2019.02.010","volume":"188","author":"Bettencourt da Silva","year":"2019","journal-title":"Chemometr. Intell. Lab. Syst"}],"container-title":["Journal of AOAC International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jaoac\/advance-article-pdf\/doi\/10.1093\/jaoacint\/qsae044\/58306434\/qsae044.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jaoac\/article-pdf\/107\/5\/856\/59063726\/qsae044.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jaoac\/article-pdf\/107\/5\/856\/59063726\/qsae044.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T00:44:10Z","timestamp":1776213850000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jaoac\/article\/107\/5\/856\/7695244"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,17]]},"references-count":38,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2024,6,17]]},"published-print":{"date-parts":[[2024,10,1]]}},"URL":"https:\/\/doi.org\/10.1093\/jaoacint\/qsae044","relation":{},"ISSN":["1060-3271","1944-7922"],"issn-type":[{"value":"1060-3271","type":"print"},{"value":"1944-7922","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,9]]},"published":{"date-parts":[[2024,6,17]]}}}