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 ...
Understanding of the risks associated with FMEA is crucial in lot release testing. The quality assurance of lot release in the biopharmaceutical industry is based to a great extent on integrity ...
The Integritest 4 Was Assessed Using Oversize Volumes to Determine Accuracy of Results Sterilizing-grade filters are designed to reproducibly remove microorganisms from the process stream producing a ...
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