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 ...

Testing sterilizing grade filters using integrity testers has become a standard method in biopharmaceutical production and quality assurance. In accordance with international regulations and ...

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 ...