Selecting container closure components with confidence: A data-driven approach to Container Closure Integrity
By Bettine Boltres Director of Scientific Affairs & Technical Solutions, West Pharmaceutical Services- Glass Systems
Published in: Pharmaceutical Online Newsletter
Published on: August 11, 2023
One major potential point of friction on the approval journey is the need to specify and verify a compatible packaging combination for your drug product. Container closure integrity (CCI) is a critical aspect of drug development, and one that demands attention and investment early in the process to avoid complications and possible harm further down the line. This point is underlined by FDA data, which reveals that around a third (34%) of injectable product recalls in recent years can be linked to particulates or a lack of sterility attributable to the container closure combination.
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