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Coring and Fragmentation

By Fran DeGrazio

六月 19, 2018

The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge, is it single- or multi-dose, could spikes, vial adapters or closed system transfer devices be used. Cores and fragments can be generated by needle penetration of the elastomer components. Cores are formed by the needle cannula cutting the elastomer – ordinarily they are cylindrical. Fragments are formed via an abrasion phenomenon of the needle penetration – shapes are irregular.