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By Lloyd Waxman and Vinod Vilivalam

May 29, 2012

Lloyd Waxman, Harold Murray and Vinod Vilivalam

 
ABSTRACT
 
Purpose: The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.