Blogs

West’s Integrated Solutions program brings together all West’s products/services and industry knowledge into customer-focused solutions that Simplify the Journey™. One aspect of Integrated Solutions is wide-ranging analytical services, which includes state-of-the-art container closure integrity (CCI) capabilities. Understanding CCI as it relates to industry expectations, manufacturing, and regulations can be a challenge.

With the help of the FDA’s expedited programs for approval, a new wave of high-value biologic drugs is on the rise in the pharma industry.1 These drugs require cryogenic storage (-80oC to -180oC) to maintain stability. This presents a new challenge: how to measure and demonstrate container closure integrity (CCI) of storage and delivery systems at such low temperatures.