药品生产中需要注意的问题及对策 (8)

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一、注射剂剂型选择的合理性··········································2

二、注射剂无菌安全存在的问题········································2

（一）注射剂的剂型··················································2

（二）灭菌方法······················································2

（三）无菌检查方法验证的弱项········································2

三、不同灭菌方式的无菌保证水平······································2

（一）灭菌产品的无菌保证要求规定····································2

（二）过度杀灭法····················································3

（三）除菌过滤法····················································3

（四）加大安全生产执法力度··········································3

四、提高注射剂无菌安全水平的对策思考································3

（一）剂型的安全原则················································3

（二）过度杀灭法或残存概率法终端灭菌································3

（三）无菌检查方法的验证和无菌检验的结果····························4

（四）采用无菌制造工艺··············································4

五、总结····························································4

【摘要】目的完善注射剂的质量保证体系,确保其质量、疗效和用药安全。方法本文从剂型选择的合理性、无菌检查的局限性、不同灭菌方式的无菌保证水平、无菌安全的保证要素等方面,对国内注射剂的无菌安全问题进行了分析。结果根据无菌制剂的无菌保证的要求,提出了在现有条件下提高注射剂的无菌保证水平的可行对策。结论无菌安全实际上就是避免染菌。在生产过程中避免灭菌不完全和灭菌过程中的二次污染,就能够保证产品的无菌安全。

【关键词】注射剂;无菌;安全;问题;对策