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CCI is an essential performance requirement of any container closure system. A holistic approach to achieving this has been published by F. DeGrazio: Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity. A key element is achieving CCI that meets the specific maximum allowable leakage limit (MALL) for the drug product and closure system.
USP guidance Chapter <1207> Package Integrity Evaluation – Sterile Products presents numerous types of CCI measurement methods with various sensitivities. West's Analytical Lab Services has the facilities, staff, and detailed procedures to perform all of them.
The most sensitive CCI method is tracer gas leak detection with helium. Sealed closure samples are prepared by flooding with 100% helium via a metal cannula inserted through the stopper. After cannula removal, the punctured stoppers are sealed with epoxy. Samples are placed in a vacuum chamber, then vacuum applied continuously, and chamber helium concentration measured by mass spectrometry. Literature has correlated helium leak rates to defect size*. Historically, leak rates lower than 6.0 x 10-6 cm3/s (sometimes called Kirsch level) are considered acceptable. West closure systems typically do far better, with rates lower than 2 x 10-7 cm3/s for 20 mm stoppers, and lower than 7 x 10-8 cm3/s for 13 mm stoppers. This method is also suitable to other container types, such as syringe systems, cartridges and blister packs.