Magnus Stering is head of Application Services South Europe Filtration, Sartorius Stedim Biotech SA, Aubagne, France.
Failure Mode Effects Analysis for Filter Integrity Testing
Understanding of the risks associated with FMEA is crucial in lot release testing.
Improving the Integrity Test Assurance of Multiround Housings Assessments
The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.