能力验证非无菌药品微生物检查的不确定度评定

Evaluation of Uncertainty in Microbial Examination of Non Sterile Drugs for Capability Verification

目的:评定能力验证非无菌药品微生物检查的不确定度。方法:根据《中华人民共和国药典(2020年版)》、JJF 1059.1-2012《测量不确定度评定与表示》、SN/T 4091-2015《食品微生物学测量不确定度评估指南》,对不确定度来源进行分析与评定。结果:样品236需氧菌总数1.7×10^(3) cfu/mL,扩展不确定度U_(236)=0.0666log10(cfu/mL),反对数取值区间(1460,1980)cfu/mL;样品316霉菌和酵母菌总数9.5×10^(2) cfu/mL,扩展不确定度U_(316)=0.0744log10(cfu/mL),反对数取值区间(800,1120)cfu/mL,k=2。

Objective:To assess the uncertainty of the ability to validate microbiological tests for non-sterile drugs.Methods:The sources of uncertainty were analyzed and evaluated according to Pharmacopoeia of the People's Republic of China(2020 edition),JJF 10591-2012"Evaluation and Expression of Uncertainty in Measurement",and SN/T 4091-2015"Guide for the Evaluation of Uncertainty in Food Microbiological Measurement".Results:The total number of aerobic bacteria in the sample 236 was 1.7×10^(3) cfu/mL,the extended uncertainty U_(236)=0.0666log10(cfu/mL),and the value interval of the inverse number was(1460,1980)cfu/mL.The total number of molds and yeasts in sample 316 was 9.5×10^(2)cfu/mL,the extended uncertainty U_(316)=0.0744log_(10)(cfu/mL),and the value interval of the inverse number(800,1120)cfu/mL,k=2.