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March 02, 2021

Understanding Risks of Coring and Fragmentation of Rubber Stoppers

When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
Bjoern Henze

Björn Henze

Manager, TCS. Commercial, EU


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