目的:评价BACTEC FX全自动系统用于无菌快速检查的可行性。方法:选择15种不同类型的无菌制剂,参照2015年及2020年版《中华人民共和国药典》(简称《中国药典》)四部药品微生物检验替代方法验证指导原则,以《中国药典》无菌检查法为参考,考察该方法的专属性、检测限、重复性及耐用性。结果:专属性试验结果表明该系统适用于部分无菌制剂的无菌检查,其中,对于丙泊酚注射液,该系统的无菌检查结果与药典方法基本相当。结论:BACTEC FX全自动系统用于药品无菌检查具有快速且灵敏度高的优势,有望为常规无菌检查法带来有效的补充。
Objective: To evaluate the feasibility of BACTEC FX automated culture systems for rapid sterility test. Methods: According to the sterility test and alternative method validation guidancee in Chinese Pharmacopoeia 2015 and 2020, fifteen different types of sterility products were collected to validate the specificity, detection limit, repeatability and robustness. Results: The results of specificity test showed that the BACTEC FX system was suitable for some sterile products. The results indicated that there were no significant differences between the methods regarding the ability to detect microbial contamination in propofol injection. Conclusion: BACTEC FX automated culture systems have the advantages of high speed and sensitivity. Therefore, the BACTEC FX system is expected to bring effective supplement to pharmacopoeia sterility test.
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