Apparatus for fabricating a reconstitution assembly
First Claim
1. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
- a sterilizing emitter assembly for emitting radiation to define a sterilizing field;
a connecting mechanism comprising a positioning assembly including a container holder configured to hold a container, and a reconstitution device holder configured to hold a reconstitution device; and
wherein the connecting mechanism is configured to connect the container and reconstitution device in the sterilizing field; and
wherein the sterilizing emitter assembly comprises a low energy electron beam tube, a container pallet shielding configured to shield the positioning assembly from electron beam radiation during a connecting process, wherein the container pallet shielding includes movable shutters configured to shield the positioning assembly to the sterilizing field in a first closed position and to expose the positioning assembly to the sterilizing field in a second open position and a vial back-up mechanism configured to position the container within the positioning assembly.
1 Assignment
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Accused Products
Abstract
What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.
503 Citations
17 Claims
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1. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a sterilizing emitter assembly for emitting radiation to define a sterilizing field; a connecting mechanism comprising a positioning assembly including a container holder configured to hold a container, and a reconstitution device holder configured to hold a reconstitution device; and wherein the connecting mechanism is configured to connect the container and reconstitution device in the sterilizing field; and wherein the sterilizing emitter assembly comprises a low energy electron beam tube, a container pallet shielding configured to shield the positioning assembly from electron beam radiation during a connecting process, wherein the container pallet shielding includes movable shutters configured to shield the positioning assembly to the sterilizing field in a first closed position and to expose the positioning assembly to the sterilizing field in a second open position and a vial back-up mechanism configured to position the container within the positioning assembly. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a sterilizing emitter assembly for emitting radiation to define a sterilizing field; a connecting mechanism comprising a positioning assembly including a container holder configured to hold a container, and a reconstitution device holder configured to hold a reconstitution device; wherein the connecting mechanism is configured to connect the container and reconstitution device in the sterilizing field; and the sterilizing emitter assembly comprising a container pallet shielding configured to shield the positioning assembly from electron beam radiation during a connecting process, wherein the container pallet shielding includes a vial back-up mechanism configured to position the container within the positioning assembly.
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16. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a sterilizing emitter assembly for emitting radiation to define a sterilizing field; a connecting mechanism comprising a positioning assembly including a container holder configured to hold a container, and a reconstitution device holder configured to hold a reconstitution device; and wherein the connecting mechanism is configured to connect the container and reconstitution device in the sterilizing field; a second sterilizing emitter assembly; a second positioning assembly; a second connecting mechanism cooperatively engageable with the second positioning assembly; a heat shield arranged to selectively shield a portion of the second positioning assembly configured to hold a container from the second sterilizing emitter assembly; a second housing which houses the second sterilizing emitter assembly, the heat shield, and the second positioning assembly; and wherein the second housing is operably connected to the first housing such that a container and a reconstitution device sterilely connected in the first housing are transported to the second housing and sterilely connected to a second container.
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17. An apparatus for the sterile connecting of a container and a drug reconstitution device comprising:
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a first sterilization source configured to emit radiation the bounds of which define a sterilizing field; means for positioning a first container and a reconstitution device within a connection area; means for providing relative motion between the first container and the reconstitution device to connect the same within the sterilizing field; a second sterilization source configured to emit radiation the bounds of which define a second sterilizing field; means for positioning the reconstitution device and a second container within a second connection area; means for providing relative motion between the second container and the reconstitution device to connect the same within the sterilizing field; and conveyance means for conveying the reconstitution device between the first sterilization source and the second sterilization source.
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Specification