TAN-MALECKI, Francisca,FORSTER, Ron,NUNN, Scott,HOLT, Mark D.,TRAN, Son,MOBERG, Sheldon
申请号：
ES16156580
公开号：
ES2675035T3
申请日:
2012.10.11
申请国别(地区):
ES
年份:
2018
代理人:
摘要：
An injector comprising: a container (452, 602, 650, 720) that includes a wall (460, 604, 652, 722) with an inner surface (462, 668, 738) and a seal assembly with an inner surface ( 494, 658, 728), the inner surface of the wall (460, 604, 652, 722) and the seal assembly defining a closed sterile tank (510, 670, 740), in which the wall (460, 604, 652, 722) of the container (452, 602, 650, 720) defines a perforation (480, 606) that includes the sterile tank (510, 670, 740)； a volume of a drug product (520, 680, 750) disposed in the sterile reservoir (510, 670, 740), the drug product (520, 680, 750) comprising a granulocyte colony stimulation factor (G-CSF )； a fluid delivery system (454, 700) comprising a container needle (550, 702, 772) having a tip (552, 704, 774), the tip (552, 704, 774) only partially arranged through of the seal assembly in a storage state, and disposed through the seal assembly and within the sterile reservoir (510, 670, 740) in a delivery state； and an actuator (456) that is adapted to move the container needle (550, 702, 772) from the storage state to the delivery state； characterized in that the seal assembly comprises a flexible wall (490, 608, 654, 724) with an inner surface that defines the inner surface (494, 658, 728) of the seal assembly, and a clean barrier (492, 610, 656, 726) arranged outside the flexible wall (490, 608, 654, 724) to define a clean space (530, 690, 760) enclosed between the flexible wall (490, 608, 654, 724) and the barrier clean (492, 610, 656, 726), the tip (552, 704, 774) of the container needle (550, 702, 772) arranged through the clean barrier (492, 610, 656, 726) on the clean space (530, 690, 760) in the storage state and arranged through the flexible wall (490, 608, 654, 724) in the sterile tank (510, 670, 740) in the delivery state, in the that the plug (540) or the flexible wall as a plug (608, 654, 724) is disposed within the perforation (480, 606) and is mobile along the perforation (480, 606).Un inyector q
