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By Philomina Albanese

December 29, 2016

Integrity of a drug product container/delivery system is essential to guarantee safety and efficacy. USP has recently issued Chapter <1207> “Package Integrity Evaluation – Sterile Products”—a guidance for the pharmaceutical industry in measuring container closure integrity (CCI). In line with this guidance, West has just expanded its capability in measuring CCI by adding high-voltage leak detection (HVLD) –a method endorsed in Chapter <1207>.