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年产量2000万袋颗粒剂生产车间工艺设计 摘 要 本文依据国家食品药品监督管理局颁布的《药品生产管理规范》（2010年修订）、《医药工业洁净厂房设计规范》（GB50457-2008）、《洁净厂房设计规范》（GB50073-2001）和国家关于建筑、消防、环保、能源等方面的规范，主要从工艺路线、物料衡算、设备选型、净化空调系统和车间布局等方面进行探讨优化，合理规划布置年产量为2000万袋的颗粒剂车间及其工艺设计。目的是设计出在高效、低耗、低费用的原则上，符合GMP的现代化的颗粒剂车间。 关键词 颗粒剂；GMP；车间；工艺设计；洁净区 |
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fjtony163
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Silly_girl: 金币+10, 翻译EPI+1, ★★★★★最佳答案 2012-04-15 22:21:27
Silly_girl: 金币+10, 翻译EPI+1, ★★★★★最佳答案 2012-04-15 22:21:27
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Processes design for manufacturing shop of annual production of 20 million packs of granules. Abstract: this paper refers to Drug production Regulation Rule (2010, Revised) by SFDA, Medical industry salutation design rule (GB50457-2008), Salutation industrial shop design rule (GB50073-2001), and some national rules about architecture, fire control, environment, and energy. It discussed optimization of process routes, material feed calculation, devices selection, aircondition system, and production shop design and design the granules production shop with annual production of 20 millions packs and its process design. It is aimed at modern GMP-fit granule production shop based on high efficiency, low energy cost, and low financial cost. Key words: Granule, GMP, production shop, process design, salutation zone. |
2楼2012-04-15 15:14:09
YH_ChowF
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Silly_girl: 金币+10, ★★★很有帮助 2012-04-15 22:21:33
Silly_girl: 金币+10, ★★★很有帮助 2012-04-15 22:21:33
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The process design of granules workshop at annual output of 20 million bags Abstract Based on GMP issued by SFDA (revised in 2010), and" the design specifications of clean workshop of pharmaceutical industry "(GB50457-2008), and" the design specifications of clean workshop "(GB50073-2001) and the national specifications about building, fire protection, environmental protection, and energy, the article has discussed and optimized, mainly from the aspects such as process route, material balance, equipment selection, and purification air-conditioning system and workshop layout, to reasonablely plan granule workshop for the annual output of 20 million bags and process design. The aim is to design a modern granule workshop according with GMP, based on the principles such as high efficiency, low energy consumption and low cost. Key words: granules; GMP; workshop; process design; clean area |
3楼2012-04-15 15:49:36