Evaluation of Uncertainty in Microbial Examination of Non Sterile Drugs for Capability Verification
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 × 103 cfu/mL,the extended uncertainty U236=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 × 102cfu/mL,the extended uncertainty U316=0.07441og10(cfu/mL),and the value interval of the inverse number(800,1120)cfu/mL,k=2.
evaluation of uncertaintycapability verificationtotal number of aerobic bacteriatotal number of molds and yeasts
万方数据
维普
