SYRINGE SYSTEMS FOR LYOPHILIZED DRUGS AND METHODS FOR MAKINGTHE SAME

摘要

A syringe system requires a decreased vertical travel for sealing during a lyophilization process and therefore provides for increased utilization of space in a lyophilization chamber. The syringe system is provided with a sterility maintenance sleeve including a stopper affixed thereto for sealing ly engaging the syringe barrel to define a drug chamber. The sterility maintenance sleeve is provided with a venting passage to permit egress of vapor from the drug chamber during lyophilization. A plug cap cooperating wi th the sterility maintenance sleeve includes an occluding tip whigh is adapted to occupy the venting passage and seal the drug chamber after lyophilization. T he plug cap is provided with a support structure in the form of flexible fins f or supporting the plug cap in a venting position in which the occluding tip is removed from the venting passage to permit egress of drug solution vapor fro m the drug chamber during lyophilization. After lyophilization, the plug cap i s moved into a sealing position in which the drug chamber is sealed against contamination.