TR 2021/241: An Evaluation of Elastomeric Stopper Compatibility with Closed System Transfer Devices

This study investigates the performance of various West elastomeric stoppers used with five commercially available CSTDs in comparing system performance by means of attachment forces, residual volume and fragmentation.

The increased use of CSTDs in recent years has revealed a range of complications for both drug developers and end users. High forces, coring and fragmentation, device and vial leakage, high residual volume, and drug physicochemical incompatibilities with commercially available CSTDs are common complaints. Carefully evaluating the compatibility of components with CSTDs is therefore critical.

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