Apparatus and method for fabricating a reconstitution assembly
First Claim
1. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
- a sterilization source configured to emit radiation the bounds of which define a sterilizing field;
a connecting mechanism positioned proximate the sterilization source, the connecting mechanism configured to hold a container and a reconstitution device in a connection area, the connecting mechanism having a movable member configured to provide relative motion between the container and reconstitution device to connect the same in the sterilizing field.
1 Assignment
0 Petitions
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.
136 Citations
74 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 sterilization source configured to emit radiation the bounds of which define a sterilizing field;
a connecting mechanism positioned proximate the sterilization source, the connecting mechanism configured to hold a container and a reconstitution device in a connection area, the connecting mechanism having a movable member configured to provide relative motion between the container and reconstitution device to connect the same in the sterilizing field. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a sterilization source configured to form a sterilizing field within a connection area;
a connecting mechanism positioned proximate the radiation source, the connecting mechanism having a positioning assembly configured to hold a container and a reconstitution device in the connection area, the positioning assembly configured to allow a movable member of the connecting mechanism to provide relative motion between the container and reconstitution device to connect the same in the sterilizing field.
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10. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a radiation emitting sterilization source the radiation defining a sterilizing field;
a connecting mechanism positioned proximate the sterilization source, the connecting mechanism having a movable member;
a container;
a reconstitution device;
wherein the container and reconstitution device are positioned by the connecting mechanism and wherein the movable member is configured to provide relative motion between the container and reconstitution device to connect the same in the sterilizing field.
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11. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a sterilizing emitter assembly configured to emit radiation to define a sterilizing field;
a connecting mechanism positioned proximate the sterilizing emitter assembly, the connecting mechanism configured to hold the container and reconstitution device in a connection area, the connecting mechanism having a movable member configured to provide relative motion between the container and reconstitution device to connect the same in the sterilizing field.
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12. 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. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. An apparatus for the sterile connecting of a container and a drug reconstitution device comprising:
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a 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; and
,means for providing relative motion between the first container and the reconstitution device to connect the same within the sterilizing field. - View Dependent Claims (32, 33)
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34. 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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35. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a sterilization source configured to create a sterilizing field; and
a connecting mechanism positioned proximate the sterilization source, the connecting mechanism configured to hold a container and a reconstitution device in a connection area, the connecting mechanism having a movable member configured to provide relative motion between the container and reconstitution device to connect the same within the sterilizing field.
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36. An apparatus for the sterile connecting of a container and a reconstitution device comprising:
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a connecting mechanism configured to hold a container and a reconstitution device in a connection area, the connecting mechanism having a movable member configured to provide relative motion between the container and reconstitution device to connect the same; and
means for sterilizing at least a portion of both the container and the reconstitution device at the connection area.
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37. A method for the sterile connecting of a container and a drug reconstitution device comprising the steps of:
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providing a container, a drug reconstitution device and a positioning assembly;
positioning the container and the drug reconstitution device in the positioning assembly;
conveying the positioning assembly to a connection area;
creating a sterilizing field within the connection area; and
connecting the container to the drug reconstitution device within the sterilizing field. - View Dependent Claims (38, 39, 40)
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41. A method for the sterile connecting of a container and a drug reconstitution device comprising the steps of:
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providing a container and a reconstitution device having first and second sleeves;
providing a sterilizing field; and
connecting the container and the reconstitution device within the sterilizing field. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
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52. A method for the sterile connecting of a container and a drug reconstitution device comprising the steps of:
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providing a drug vial, a drug reconstitution device, and a positioning assembly;
loading the drug vial and drug reconstitution device onto the positioning assembly;
providing a sterilizing field incident upon the positioning assembly at a location contemplated for the formation of a connection between the drug vial and the drug reconstitution device; and
connecting the drug vial to the drug reconstitution device within the sterilizing field. - View Dependent Claims (53, 54, 55, 56, 57, 58, 59)
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60. A method for the sterile connecting of a container and a drug reconstitution device comprising the steps of:
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providing a flexible diluent container and a reconstitution device;
providing a sterilizing field; and
connecting the flexible diluent container and the reconstitution device within the sterilizing field. - View Dependent Claims (61, 62, 63, 64, 65)
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66. A method for the sterile connecting of a container and a drug reconstitution device comprising the steps of:
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providing a flexible diluent container, a drug reconstitution device, and a positioning assembly;
loading the flexible diluent container and drug reconstitution device in the positioning assembly;
providing a sterilizing field incident upon the positioning assembly at a location contemplated for the formation of a connection between the flexible diluent container and the drug reconstitution device; and
connecting the flexible diluent container to the drug reconstitution device within the sterilizing field. - View Dependent Claims (67)
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68. A method for the sterile connecting of a container and a drug reconstitution device comprising the steps of:
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providing a container, a drug reconstitution device and a positioning assembly;
positioning the container and the drug reconstitution device in the positioning assembly;
conveying the positioning assembly to a connection area;
moving the container or the drug reconstitution device relative to each other such that the container and drug reconstitution form a sterile connection. - View Dependent Claims (69, 70, 71, 72, 73, 74)
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Specification