| 小容量注射剂联动生产线布局模式发展趋势 |
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| 引用本文： | 王善春.小容量注射剂联动生产线布局模式发展趋势[J].医药工程设计,2012,33(2):46-48. |
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| 作者姓名： | 王善春 |
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| 作者单位： | 江苏正大天晴药业股份有限公司,江苏连云港,222006 |
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| 摘 要： | 介绍国内小容量注射剂联动线的生产现状与问题,结合新版GMP规范要求和实施案例,阐述L型小容量针剂联动线的技术优势与发展趋势,有效的避免了人流与物流、操作区与维护区之间的交叉污染的可能性,降低了无茵区内悬浮粒子与微生物产生的风险.
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| 关 键 词： | 新版GMP L型安瓿联动线 人流与物流、操作区与维护区分开 风险控制 发展趋势 |
Development Trend of Layout Mode of Production Line for Small Volume Injection Agent |
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| Wang Shanchun.Development Trend of Layout Mode of Production Line for Small Volume Injection Agent[J].Pharmaceutical Engineering Design,2012,33(2):46-48. |
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| Authors: | Wang Shanchun |
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| Institution: | Wang Shanchun(Jiangsu Zhengda Tianqing Pharmaceutical Share Co.,Ltd Lanyungang,222006) |
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| Abstract: | Current situation of production line for small volume injection and the problems existed were introduced in this article.Combined with the requirements in new version GMP code and practical examples,the technical advantages of L mode production line for small volume injection and its development trend were stated.By using this production line,the possibility of cross contamination between people flow and matter flow and between operation zone and holding zone can be avoided,and the risk of existence of suspended particle and microbial can be decreased. |
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| Keywords: | new version GMP L mode ampoule production line people flow and matter flow separation of operation zone and holding zone risk control development trend |
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