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By Candice Sun

December 07, 2020

For injectable drug products, coring and fragmentation of elastomer stoppers is a critical concern. This is caused by tearing or shearing a fragment of the stopper in a vial during insertion of a needle or a spike. The cores/fragments that enter the drug product may lead to harmful patient outcomes. Testing of stoppers is a must for many pharmacopeias. Coring and fragmentation is complex and influenced by many factors, in particular the stopper and the needle.