By Bettine Boltres West Pharmaceutical Services- Glass Systems

Published in: Pharmaceutical Online Newsletter

Published on: August 1, 2023

Bringing a new drug to market can undoubtedly deliver great rewards for patients and patent-holders alike, but whether in the case of biologics or small molecules, it is an undertaking that also carries well-documented risks. One major potential point of friction on this 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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