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 ...

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 ...

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories. Ensuring the performance of sterility filtration is essential in research and ...