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目的探讨药品生产企业无菌检验方法验证。方法对左氧氟沙星氯化钠注射液的无菌方法验证进行总结汇报。结果通过实验建立的方法验证试验,可作为盐酸左氧氟沙星氯化钠注射液的无菌检查法。结论无菌检验方法验证能够全面掌握测定方法和能够准确检测方法达到能够全面适用于该供试品的检验,避免产生假阴性和假阳性,更有利于对药品质量的控制保证药品安全。
Objective To investigate the method of aseptic testing of drug manufacturers. Methods The levofloxacin sodium chloride injection aseptic method validation summary report. The results of the experiment established by the method validation test can be used as sterile levofloxacin hydrochloride injection injection. Conclusion The validation of the aseptic test method can fully grasp the measuring method and can accurately detect the test method so as to be fully applicable to the test of the test product, to avoid false negatives and false positives, and to be more conducive to the control of drug quality to ensure drug safety.