活菌计数法测定布鲁氏菌病活疫苗活菌数含量不确定度评定OA

Live bacterial counting is a critical indicator for evaluating the immunological efficacy of brucellosis vaccines.Establishing a scientific uncertainty evaluation method not only helps vaccine manufacturers optimize production processes and control product quality,but also provides technical support for regulatory authorities to formulate more rational quality standards.In this study,the uncertainty associated with the determination of live bacterial count in brucellosis vaccines using the live bacterial counting was evaluated.The live bacterial count of brucellosis vaccine was determined in accordance with the Live Bacteria(Spore)Counting of the Veterinary Pharmacopoeia of the People's Republic of China(2020 Edition).Following the relevant provisions of the Conformity assessment—Application guide for evaluation and expression of uncertainty in biological sample measurement,various uncertainty factors potentially introduced during the determination process were analyzed,evaluated,and quantified.The calculated expanded uncertainty(U)for the determination was 5.6302(coverage factor k=2),and the main factors of uncertainty were identified as incubator temperature control and pipetting operation errors.