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

At different stages of the drug lifecycle, the minimum provision for parenteral products is a safety barrier against potential contaminants. This protection is guaranteed by selected container closure ...

The revised USP Chapter Sterile Product Packaging-Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic ...

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 ...