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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.
Properties of both elastomer and needle affect coring and fragmentation. Based upon West experience, risk factors are:
Elastomer
Needle
To select the right elastomer component, based upon performance and function, reach out to West Technical Customer Support (TCS) for assistance.