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 ...

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 ...

These tips can help you reduce false failures and improve robustness and reliability. A filter integrity test is a critical unit operation commonly employed in the bioprocessing industry designed to ...

Three key options are available for carrying out filter integrity testing and the chosen option is dependant on the filter membrane material. Test procedures for filters with hydrophilic membranes ...