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应用无菌检验方法能够实现测定方法的全面掌握,使检测方法更为有效,且对检验试验样品同样适用,避免检验的假阳性或假阴性,为企业实现对药品有效的质量控制极为有利,为药品安全提供有效保障。本文取盐酸左氧氟沙星氯化钠注射液为本次试验样品,对其实施无菌方法验证,并通过实验确立的方法对实验加以证明,对药品生产企业中无菌检验方法的应用进行探讨。
The application of sterility test method can realize the overall control of the test method, make the test method more effective, and also apply to the test test sample to avoid the false positive or false negative test, which is very beneficial for the enterprise to realize the effective quality control of the drug. Drug safety to provide effective protection. In this paper, taking levofloxacin hydrochloride sodium chloride injection as the test sample, the implementation of aseptic method validation, and experimentally established methods to prove the experiment, to explore the application of sterile test methods in pharmaceutical manufacturing enterprises.