The Integritest 4 Was Assessed Using Oversize Volumes to Determine Accuracy of Results Sterilizing-grade filters are designed to reproducibly remove microorganisms from the process stream producing a ...

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 ...

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 ...

Understanding of the risks associated with FMEA is crucial in lot release testing. The quality assurance of lot release in the biopharmaceutical industry is based to a great extent on integrity ...