| 湿热灭菌工艺验证的探讨 |
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| 引用本文： | 莫凌,吴武.湿热灭菌工艺验证的探讨[J].医药工程设计,2012,33(4):23-25. |
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| 作者姓名： | 莫凌 吴武 |
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| 作者单位： | 1. 海南海灵化学制药有限公司,海南海口,570311
2. 海南通用三洋药业有限公司,海南海口,5703121 |
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| 摘 要： | 灭菌工艺是无菌药品生产中至关重要的技术.最成熟的灭菌技术为湿热灭菌；着重探讨湿热灭菌工艺的研究和验证,对验证工作中的微生物学和热力学的细节问题提出看法和建议.
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| 关 键 词： | 湿热灭菌工艺 验证 温度验证仪 生物指示剂 |
Discussion of Validation for Moisture Heat Sterilization Process |
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| Mo Ling,Wu wu.Discussion of Validation for Moisture Heat Sterilization Process[J].Pharmaceutical Engineering Design,2012,33(4):23-25. |
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| Authors: | Mo Ling Wu wu |
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| Institution: | 1.Hainan Hai Ling Chemical Pharmaceutical Co.,Ltd Haikou,570311;2.Hainan General Sanyo Pharmaceutical Co.,Ltd Haikou,570312) |
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| Abstract: | Sterilization is one of vitally important technologies.The most mature technique is moisture heat sterilization.In this article,the research and validation of moisture heat sterilization process were emphatically discussed and some viewpoints and proposals for microbiology and thermodynamics involved in validation were presented. |
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| Keywords: | moisture heat sterilization process validation temperature validator biological indicator |
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