BacTALERT^(■)3D微生物检测系统作为无菌检查替代方法可行性的探讨

Discussion on Feasibility of Alternative Sterility Test of BacTALERT^(■) 3D Microbial Detection System

目的评价Bac TALERT3D微生物检测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3种不同类型的无菌制剂,参照中国药典2010年版附录药品微生物检验替代方法验证指导原则的有关内容,考察在专属性、检测限、重复性以及耐用性这4个方面与现行版中国药典无菌检查法是否存在差异。结果对于单一品种门冬氨酸钾镁注射液,Bac TALERT3D微生物检测系统与药典方法基本相当,而专属性试验结果表明该检测系统不适用于其余2种无菌制剂的无菌检查。结论 Bac TALERT3D微生物检测系统在逐一验证的前提下,对特定注射剂产品可用于生产过程的无菌质量控制。

OBJECTIVE To evaluate the feasibility of Bac TALERT3D Microbial Detection System carrying out as an alternative method of sterility test in particular injection. METHODS According to the alternative method validation guiding principle in Appendix of Chinese Pharmacopoeia 2010, collecting three different types of injections to validate the specificity, limit of detection, reproducibility and durability which were experimental researched and statistical compared with the pharmacopoeia method. RESULTS No statistically substantial difference in test result was found between using the Bac TALERT3D Microbial Detection System and the pharmacopoeia method in testing Potassium Aspartate and Magnesium Aspartate injection. But specificity test results showed that Bac TALERT3D Detection System did not apply to other two injections. CONCLUSION For a specific product, Bac TALERT3D Microbial Detection System can be used to the production process control after validation.