Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity ...
There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary. A broad issue for single-use filter users ...
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 ...
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 ...
The new filter tester greatly improves the detectability of operator errors, improper test set-ups and out-of-tolerance environmental conditions. It is also more reliable and easier to use than ever ...
This 2-day course examines the downstream processing aspects of a typical biopharmaceutical production process used in the production of recombinant protein for human therapeutic use. This will ...