March 22, 2017
A New Approach for Understanding Container Closure Integrity over Shelf Life
Container systems must protect parenteral drug products through the entire shelf life. To accomplish this, container components (vial, elastomer stopper, and metal seal) must fit together well, and maintain an impervious seal. In a sealed system, elastomers are under compression, and it is well known that under compression they undergo relaxation. This raises the question whether such relaxation will affect the seal performance over time, and thus container closure integrity (CCI).