| 除菌过滤器验证(四):兼容性验证 |
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| 引用本文： | 唐燕,洪海燕,谢婷,董巍,蔡清波,黄晓龙.除菌过滤器验证(四):兼容性验证[J].中国新药杂志,2011(18). |
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| 作者姓名： | 唐燕 洪海燕 谢婷 董巍 蔡清波 黄晓龙 |
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| 作者单位： | 颇尔中国生命科学部;国家食品药品监督管理局药品审评中心; |
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| 摘 要： | 兼容性验证是过滤器工艺验证项目之一,以证实工艺及工艺条件对过滤器的特定性能没有产生负面影响。文中介绍了兼容性的概念、兼容性验证的目的和除菌过滤器兼容性验证实验的方法,同时介绍了重复使用过滤器的兼容性验证和同系列药品在兼容性验证中的分组原则。
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| 关 键 词： | 兼容性 验证 除菌 过滤 重复使用 |
Validation of sterilizing grade filters(IV):compatibility |
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| TANG Yan,HONG Hai-yan,XIE Ting,DONG Wei,CAI Qing-bo,HUANG Xiao-long.Validation of sterilizing grade filters(IV):compatibility[J].Chinese Journal of New Drugs,2011(18). |
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| Authors: | TANG Yan HONG Hai-yan XIE Ting DONG Wei CAI Qing-bo HUANG Xiao-long |
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| Institution: | TANG Yan1,HONG Hai-yan1,XIE Ting1,DONG Wei1,CAI Qing-bo1,HUANG Xiao-long2(1 Pall China,Life Science Division,Shanghai 201203,China,2 Center for Drug Evaluation,State Food and Drug Administration,Beijing 100038,China) |
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| Abstract: | Compatibility is one of the projects in filtration process validation,which provides a proof that the filter performance is not affected by the fluid and conditions in the process.This article introduced compatibility conception,the purpose of compatibility validation and the compatibility method of sterilizing filter,and also discussed compatibility validation for re-use of filters and grouping principle for products in compatibility validation. |
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| Keywords: | compatibility validation aseptic filtration re-use |
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