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目的评价Bac TALERT3D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 TALERT3D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 TALERT3D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 as a surrogate method for sterility testing in specific injection products. Methods Three different types of aseptic preparations were collected. According to the Chinese Pharmacopoeia 2010 edition APPENDIX APPROACH TO GUIDELINES FOR DETERMINATION OF SUBSTITUTED METHODS OF MICROBIAL MICROSCOPY, the author investigated the relationship between specificity, detection limit, repeatability and durability in comparison with the current version of China Pharmacopoeia sterile check whether there are differences. Results For a single variety of potassium and magnesium aspartate injection, Bac TALERT3D microbial detection system and pharmacopoeia basically the same, and proprietary test results show that the detection system is not suitable for the other two kinds of sterile preparations of sterile examination. Conclusion The Bac TALERT3D microbial detection system can be used for the sterile quality control of the production process on the premise of verifying one by one.