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May 23, 2017

New Methods in Measuring CCI – Part 1: Helium-Leak for Polymer Systems

Measuring container closure integrity (CCI) of polymer&ndash;based containers and syringes is a challenge. Tracer gas leak detection (i.e., Helium-leak)&mdash;the method endorsed by USP &lt;1207&gt; (<em>Package Integrity Evaluation &ndash; Sterile Products</em>)&mdash;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.
Barb Jacobs

Barb Jacobs

Scientist, Analytical Lab Services

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