Abstract:
Disclosed are plunger assemblies including various convertible plungers and methods of making the same. Each plunger assembly is configured for disposition within a barrel of a medical container, e.g., a syringe, and displaced within the barrel from an engagement position to a release position. The engagement position is configured to provide a compression seal between a storage sealing section of the plunger and an inner wall of the syringe barrel. In the release position, the compression seal is reduced or eliminated. Also disclosed are methods for making convertible plungers and assembling them into syringes, e.g., pre-filled syringes.
Abstract:
A method is disclosed in which a vapor-deposited coating or layer is directly or indirectly applied to at least a portion of the internal wall of the barrel of a capped pre-assembly comprising a barrel, a dispensing portion, and a shield. The shield is secured to the barrel and at least substantially isolates the distal opening of the dispensing portion from pressure conditions outside the shield. A vapor-deposited coating or layer is applied directly or indirectly to at least a portion of the internal wall of the barrel while the pre-assembly is capped. The coating or layer is applied under conditions effective to maintain communication between the barrel lumen and the dispensing portion lumen via the proximal opening at the end of the applying step. The capped pre-assembly can be pressure tested easily and rapidly, for example with a test duration between 1 and 60 seconds, to determine whether it has container closure integrity.
Abstract:
Disclosed are plunger assemblies including various convertible plungers and methods of making the same. Each plunger assembly is configured for disposition within a barrel of a medical container, e.g., a syringe, and displaced within the barrel from an engagement position to a release position. The engagement position is configured to provide a compression seal between a storage sealing section of the plunger and an inner wall of the syringe barrel. In the release position, the compression seal is reduced or eliminated. Also disclosed are methods for making convertible plungers and assembling them into syringes, e.g., pre-filled syringes.
Abstract:
Disclosed are container and cap assemblies for cryogenic storage of materials at temperatures below negative 150° C. The container and cap assemblies disclosed maintain container closure integrity and fluid-tightness at ambient and cryogenic temperatures, optionally to preserve biologically active substances stored therein.