BC120全自动血培养系统作为药品无菌检查替代方法的可行性研究

Feasibility Study on BC120 Blood Culture System as an Alternative Method for Sterility Test of Drug

摘要: 目的：评价基于呼吸信号检测原理的BC120全自动血培养系统在特定注射剂产品中作为替代方法开展无菌检查的可行性。方法：收集2种不同类型的无菌制剂，考察在专属性、检测限和方法适用性等方面与中国药典无菌检查法是否存在差异。结果：在严格按照BC120全自动血培养系统使用说明操作的前提下，该系统在专属性和检测限参数上与药典方法无显著差异，多数情况下比药典方法更快地报告阳性结果。结论：BC120全自动血培养系统在风险管理的前提下，经过验证，可作为药典无菌检查的替代方法用于特定注射剂产品的生产过程控制和快速放行。

Abstract: Objective: To evaluate the feasibility of BC120 blood culture system as an alternative method for sterility test. Methods: Two aseptic preparations were collected, to examine the differences between them and pharmacopoeia method in specificity, detection limit and method applicability. Results: According to the instructions of BC120 blood culture system, there is no significant difference between the system and the pharmacopoeia method in specificity and detection limit parameters, and in most cases, the positive results are reported faster than the pharmacopoeia method. Conclusions: Under the premise of risk management, BC120 blood culture system can be used as an alternative method for sterile testing in the production process of specific injection products for sterile quality control and rapid release after validation.