Integrity testing

被引:3
|
作者
Jornitz, MW
机构
[1] Manorville, NY 11949
来源
STERILE FILTRATION | 2006年 / 98卷
关键词
membrane filter; FDA; EMEA; bacteria challenge test; bubble point test; diffusion test; pressure drop test; water intrusion test; multipoint diffusion test; automatic integrity tester;
D O I
10.1007/b104248
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
To ensure that sterilizing grade filters in aseptic processing worked as required, such filters are integrity tested. Integrity tests, like the bubble point, diffusive flow or pressure hold test, are non-destructive tests, which are correlated to a destructive bacteria challenge test. This correlation verifies the integrity test limits the filters have to pass. integrity tests are required by regulatory authorities. The post filtration integrity test is a must, pre filtration integrity testing is recommended. The different tests have specific limitations therefore there is no overall, best integrity test, which can be utilized for every filtration system.
引用
收藏
页码:143 / 180
页数:38
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