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By Barb Jacobs

五月 23, 2017

Measuring container closure integrity (CCI) of polymer–based containers and syringes is a challenge. Tracer gas leak detection (i.e., Helium-leak)—the method endorsed by USP <1207> (Package Integrity Evaluation – Sterile Products)—cannot be used directly, because gases permeate polymers. Helium permeates at a very high rate, in part due to its small size. As such, direct use of Helium-leak with a polymer-based system will result in a leak rate above that measured with a glass-based system, that may be misinterpreted as resultant from a non-integral system, but is actually from Helium permeation.