| 新版GMP规范下卫生级脉动真空双扉灭菌柜URS |
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| 引用本文： | 史云.新版GMP规范下卫生级脉动真空双扉灭菌柜URS[J].医药工程设计,2012,33(4):15-18. |
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| 作者姓名： | 史云 |
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| 作者单位： | 中国医学科学院医学生物学研究所,云南昆明,650118 |
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| 摘 要： | URS是设备采购的重要技术资料,针对新版GMP规范要求,结合某企业灭菌柜工艺特点制定相关URS.
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| 关 键 词： | URS 灭菌柜 GMP |
USR of Sanitary Pulsation Vacuum Double-doors Sterilizing Cabinet Complying with New GMP |
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| Shi Yun.USR of Sanitary Pulsation Vacuum Double-doors Sterilizing Cabinet Complying with New GMP[J].Pharmaceutical Engineering Design,2012,33(4):15-18. |
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| Authors: | Shi Yun |
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| Institution: | Shi Yun(Research Institute of Medical Biology,ChineseAcademy of Medical Science Kunming,650118) |
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| Abstract: | User Requirement Specification(URS) is important technical document.With respect to the requirements in new version GMP,and combined with the process characteristics for sterilizer used in one enterprise,the making process of URS was stated in this article. |
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| Keywords: | URS sterilizer GMP |
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