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 ...
False positives can occur when performing sterile integrity testing. Understanding how to identify them can help minimize their occurrence in future package designs. By Curtis L. Larsen Some medical ...
Identify components to test: casing head, tubing head, tree body, master/swab/wing valves, chokes, flanged connections, annulus outlets, VR plug threads. Define barriers: primary (tree + tubing hanger ...
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