| 冻干粉针剂无菌灌装验证方法的探讨 |
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| 引用本文： | 张玉莲,顾倩. 冻干粉针剂无菌灌装验证方法的探讨[J]. 医药工程设计, 2007, 28(2): 29-31 |
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| 作者姓名： | 张玉莲 顾倩 |
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| 作者单位： | 上海新先锋药业有限公司,上海,201203 |
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| 摘 要： | 对冷冻干燥粉针剂无菌灌装的验证方法进行了试验，确立了以硫乙醇酸盐液体培养基为模拟灌装液，对整个冻干生产线的全过程进行了验证。每次试验样本数均〉3000瓶，当可信度为95％时，取得了污染率均〈0.1％的良好效果。
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| 关 键 词： | 冻干粉针剂 无菌灌装 验证方法 液体培养基 模拟灌装 |
| 文章编号： | 1008-455X(2007)02-0029-03 |
| 修稿时间： | 2006-12-27 |
Discussion of Verification Method for Aseptic Filling Production of Lyophilisation Injection Agent |
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| Zhang Yulian,Gu Qian. Discussion of Verification Method for Aseptic Filling Production of Lyophilisation Injection Agent[J]. Pharmaceutical Engineering Design, 2007, 28(2): 29-31 |
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| Authors: | Zhang Yulian Gu Qian |
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| Abstract: | The test for the method of aseptically filling lyophilized powder injection agent was carried out. With thioglycollate liquor medium as analogous filled liquid, the whole process of freezing and drying production line was tested, and the sample of every test was greater than 3000 bottles, thus, the reliability reached 90%. The result that the pollution rate was less than 0.1% was satisfactory. |
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| Keywords: | lyophilized powder injection agent aseptic filling verification method liquor medium analogous filling |
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