Conclusion: The established sterility test method for Imipenem monohydrate may be practical.

结论: 建立的亚胺培南一水合物无菌检查法可供实用.

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Conclusion The sterility test reassured by verification test is feasible and reliable.

方法采用直接接种法,通过无菌验证试验确定无菌检查方法的有效性.

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Conclusion: The sterility test reassured by validation test is feasible and reliable.

方法: 采用薄膜过滤法,通过无菌验证试验确定无菌检查方法的有效性.

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Methods: The method was based on the membrane filtration of sterility test of Chinese Pharmacopoeia 2005.

方法按《中国药典》2005年版附录无菌检查法项下薄膜过滤法.

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Objective: To determine the validity of membrane filtration method in the sterility test of little capacity injection.

目的探讨薄膜过滤法在小容量注射剂无菌检查中应用的可行性.

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Conclusion: This method is accurate, It can be used for sterility test of Oxaliplatin for Injection.

结论: 注射用奥沙利铂的无菌检查通过验证.

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Methods: The validation for sterility test includes inhibition test for bacteria and fungi and irrigation test.

方法: 无菌检查法的验证试验——抑细菌和抑真菌试验及冲洗量试验.

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