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 ...

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 ...

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 ...

The authors describe a new assembly for bulk and final drug product filling operations. Increased regulatory expectations and the need to mitigate risk have popularised the use of redundant filtration ...