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 ...

Guidelines on Reducing the Time Needed to Accurately Conduct a Bubble Point Test Integrity testing filters post-use is a regulatory requirement for products labeled sterile. The bubble point (BP) test ...

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 ...

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the ...

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 ...