Integrity testing.
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.
Jornitz
Maik W
MW
Maik.Jornitz@Sartorius.com
D001419:Bacteria / Q000254:growth & development*; D004203:Disinfection / Q000295:instrumentation* / Q000379:methods / Q000592:standards* / Q000639:trends; D005374:Filtration / Q000592:standards*; D011786:Quality Control