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 ...

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 authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined. Sterility assurance is critically ...