| 注射剂灌装泵系统在线清洗及灭菌的研究 |
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| 引用本文： | 张丽丽,于颖,高春刚,程绍祥,卢存义.注射剂灌装泵系统在线清洗及灭菌的研究[J].医药工程设计,2012,33(1):40-44. |
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| 作者姓名： | 张丽丽 于颖 高春刚 程绍祥 卢存义 |
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| 作者单位： | 1. 中国药科大学药学院,江苏南京,210009
2. 南京博健科技有限公司,江苏南京,210039 |
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| 摘 要： | 最终灭菌注射剂灌装生产线中灌装头的清洗及灭菌采用手工清洗及灭菌,存在诸多隐患。为更好地满足新版《药品生产质量管理规范》(GMP)的要求,灌装头的在线清洗(CIP)及灭菌(SIP)是亟待解决的问题之一。针对应用最广泛的陶瓷计量泵灌装法,初步讨论灌装泵的在线清洗及灭菌方法。根据所选方法仅通过改进原有设备的灌装系统结构以适应新技术,并确定了过程操作的基本参数、可编程逻辑控制器(PLC)控制过程以及相应仪表的形式。
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| 关 键 词： | 最终灭菌注射剂 陶瓷灌装泵 在线清洗 在线灭菌 系统研究 |
Research of Cleaning and Sterilization in Process for Filling Pump System of Injection |
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| Zhang Lili
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Yu Ying
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Gao Chungang
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Cheng Shaoxiang
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Lu Cunyi.Research of Cleaning and Sterilization in Process for Filling Pump System of Injection[J].Pharmaceutical Engineering Design,2012,33(1):40-44. |
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| Authors: | Zhang Lili Yu Ying Gao Chungang Cheng Shaoxiang Lu Cunyi |
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| Institution: | 1.China Pharmaceutical University Nanjing,210009;2.Nanjing Bojian Science & Technology Co.,Ltd Nanjing,210039) |
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| Abstract: | There are many potential perils in hand cleaning of filling head in injection filling production line.To meet the requirements in new version GMP,cleaning in place(CIP) and sterilization in process(SIP) are two of the most urgent problems to be solved.In this paper,with respect to the filling method by using ceramic volume meter,the methods of CIP and SIP were discussed.With selected method,the structure of filling system in original equipment was reformed to adapt new technique,the basic parameters used in process,the control process in PLC and relevant instrument were determined. |
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| Keywords: | final sterilized injection agent ceramic filling pump cleaning in place sterilization in process system research |
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