| 新建头孢无菌原料药生产设施如何符合2010版GMP要求的关键几个问题讨论 |
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| 引用本文： | 柯华东. 新建头孢无菌原料药生产设施如何符合2010版GMP要求的关键几个问题讨论[J]. 医药工程设计, 2012, 33(1): 27-31 |
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| 作者姓名： | 柯华东 |
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| 作者单位： | 广州白云山化学制药厂,广州,510515 |
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| 摘 要： | 从洁净区区域划分设计、洁净级别设置、厂房立面和平面布局选择、关键工艺设备选用、注射用水系统的使用及设计、隔离操作技术的使用、循环经济和清洁生产设计等方面探讨新建头孢无菌原料药生产设施如何符合2010版GMP要求。
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| 关 键 词： | 无菌原料药 无菌原料药厂设计和厂房改造 头孢生产 |
Discussion of Several Key Points in Reaching Requirements in 2010 Edition GMP for Facilities for Production of Cephalosporins Sterile API |
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| Ke Huadong. Discussion of Several Key Points in Reaching Requirements in 2010 Edition GMP for Facilities for Production of Cephalosporins Sterile API[J]. Pharmaceutical Engineering Design, 2012, 33(1): 27-31 |
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| Authors: | Ke Huadong |
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| Affiliation: | Ke Huadong(Guangzhou Baiyunshan Chemical Pharmaceutical Factory Guangzhou,510515) |
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| Abstract: | From the respects of cleaning area division,cleaning level classification,3D and 2D layout of workshop,selection of key equipment,design and application of injection water system,use of isolation technique,circular economy and design of clean production,the way to meet the requirement in 2010 edition GMP in the production of sterile cephalosporins API was discussed in this article. |
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| Keywords: | sterile API design of sterile API factory and reform of workshop building production of cephalosporins |
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