| 满足生物制药行业需求的高端灭菌器 |
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| 引用本文： | 姚如意,丁洪勇.满足生物制药行业需求的高端灭菌器[J].中国医疗器械信息,2012,18(2):28-32. |
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| 作者姓名： | 姚如意 丁洪勇 |
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| 作者单位： | 山东新华医疗器械股份有限公司,淄博,255086 |
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| 摘 要： | 新华医疗高端灭菌器,根据生物制药行业对高端灭菌器的需求,依据GAMP5指南进行设计,采用西门子S7-300+MP277作为控制核心,设计、制造、安装、调试过程同步生成GMP验证文件,具有能够满足FDA要求的电子签名、电子记录的功能,符合2011版GMP的要求。
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| 关 键 词： | 生物制药灭菌器 GAMP5 2011版GMP 电子签名 电子记录 FDA认证 |
Top Grade Sterilizer for Biological and Pharmaceutical Industry |
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| YAO Ru-yi,DONG Hong-yong.Top Grade Sterilizer for Biological and Pharmaceutical Industry[J].China Medical Devices Information,2012,18(2):28-32. |
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| Authors: | YAO Ru-yi DONG Hong-yong |
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| Institution: | YAO Ru-yi DONG Hong-yong S(handong Xinhua Medical Instrument Co.,Ltd Zibo 255086) |
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| Abstract: | Top grade sterilizer, manufactured by SHINVA, is designed, manufactured, assembled and tested for Biological and Pharmaceutical Industry. It adopts SIEMENS S7-300＋MP277 as critical control, in accordance of GAMP5. The whole process of design, manufacture, assembling and testing is recorded to generate GMP validation documents. This sterilizer has the function of electrical signature and electrical record required by FDA, in accordance of GMP regulations of 2011 edition. |
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| Keywords: | Sterilizer For Biological and Pharmaceutical Industry GAMP5 GMP of2011 edition ES （Electrical Signature） ER （Electrical Record） FDA |
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