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.
134 Citations
182 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.
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13. An apparatus for the sterile connecting of a container and a drug 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;
a heat shield arranged to selectively shield the container holder and the reconstitution device from the sterilizing emitter assembly; and
wherein the connecting mechanism is configured to connect the container and reconstitution device within the sterilizing field. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. An apparatus for the sterile connecting of a container and a drug reconstitution device comprising:
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a container pallet;
a device loader for loading a reconstitution device onto the container pallet;
a container loader for loading a container onto the container pallet;
a first sterilization booth for the sterile connecting of the reconstitution device and container; and
,a container pallet conveyor on which the container pallet is conveyed between the device loader, the container loader, and the first sterilization booth. - View Dependent Claims (29, 30, 31, 32, 33, 34)
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35. 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 (36, 37)
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38. 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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39. 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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40. 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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41. An apparatus for assembling a reconstitution assembly having a reconstitution device having a first end connected to a flexible diluent container, the reconstitution device having a second end connected to a drug vial, the apparatus comprising:
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a vial pallet;
a vial/device pallet conveyor configured to convey the vial pallet between a device loading position, a vial loading position, a vial pallet stacking position, a first connecting position, and a transfer vial/device subassembly position;
a device loader positioned proximate the vial conveyor, the device loader configured to load a reconstitution device onto the vial pallet;
a vial loader positioned proximate the vial conveyor, the vial loader configured to load a drug vial onto the vial pallet;
a first sterilization booth positioned about the vial conveyor at the first connecting position, the first sterilization booth having a first sterilizing emitter assembly and having a first connector assembly configured to connect the drug vial to the second end of the reconstitution device within an electron beam, and adapted to define the vial/device subassembly;
a bag pallet;
a bag pallet conveyor configured to convey the bag pallet between a bag loading position, a palletize module for loading the vial/device subassembly, and a second connecting position;
a bag loader positioned proximate the bag pallet conveyor, the bag loader configured to load a bag onto the bag pallet;
a palletizing module positioned proximate the bag pallet conveyor, configured to transfer a vial/device assembly from the vial pallet at the transfer vial/device subassembly position and onto the bag pallet; and
a second sterilization booth positioned around the bag pallet conveyor at the second connecting position, the second sterilization booth having a second sterilizing emitter assembly and a second connector assembly configured to connect the bag to the first end of the reconstitution device within an electron beam.
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42. An apparatus for assembling a reconstitution assembly having a reconstitution device having a first end connected to a flexible diluent container, the reconstitution device having a second end connected to a drug vial, the apparatus comprising:
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a vial pallet conveyor providing conveyance between a device loading position, a vial loading position, a vial pallet stacking position, a first connecting position, a vial pallet unstacking position, and a transfer vial/device subassembly position;
a vial pallet positioned on the vial conveyor, the vial pallet having a base, a reconstitution device holder, and a vial holder;
a device loader positioned proximate the vial conveyor, the device loader configured to load a reconstitution device onto the reconstitution device holder of the vial pallet, the device loader having a reconstitution device receiver, a rotary dial index table, transport tracks, a device presentation nest, and a transport robot;
a vial loader positioned proximate the vial conveyor, the vial loader configured to load a drug vial onto the vial holder of the vial pallet, the vial loader having an accumulating conveyor, a container transfer robot, an inspection assembly, an uncap mechanism assembly, a pallet load robot, and a vial holder opener;
a vial holder placement module positioned proximate the vial conveyor, the vial holder placement module configured to stack the vial holder onto the reconstitution device holder, the vial holder placement module having a pick and place unit and a lift and locate unit;
a first sterilization booth positioned about the vial conveyor at the first connecting position, the first sterilization booth having a sterilizing emitter assembly having a first electron beam and a first connector assembly configured to connect the drug vial to the second end of the reconstitution device within the first electron beam;
a vial holder removal module positioned proximate the vial conveyor, the vial holder removal module configured to unstack the vial holder from the reconstitution device holder, the vial holder removal module having a pick and place unit and a lift and locate unit;
a depalletization module positioned proximate the vial conveyer, the depalletizaton module configured to remove the vial/device subassembly from the vial pallet, the depalletization module having a vial holder opener and a transport robot;
a shrinkband applicator positioned proximate the vial conveyor, the shrinkband applicator having a puck configured to receive the vial/device subassembly from the vial depalletize device wherein a shrinkband is applied around the vial and device;
a bag pallet conveyor providing conveyance between a palletize module for loading the vial/device subassembly, a bag loading position, a nozzle blow-off position, a second connecting position, and a second depalletize module for depalletizing the reconstitution assembly;
a bag pallet positioned on the bag pallet conveyor, the bag pallet having a base, a vial/device subassembly holder, a bag holder, and a frame;
a bag loader module positioned proximate the bag pallet conveyor, the bag loader module configured to load a bag onto the bag pallet, the bag loader having a pallet loader, a bag-offload station, a label application conveyor, and a bag transfer conveyor;
a palletizing module positioned proximate the bag pallet conveyor, the palletize module configured to transfer the vial/device subassembly from the shinkband applicator onto the bag pallet, the palletize module having a transfer robot and a bag pallet opener;
a nozzle blow-off module positioned proximate the bag pallet conveyor, the nozzle blow-off module configured to remove particulate contamination, the nozzle blow-off module having a housing and a blower mechanism assembly;
a second sterilization booth positioned about the bag pallet conveyor at the second connecting position, the second sterilization booth having a second sterilizing emitter assembly having a second electron beam and a second connector assembly configured to connect the bag to the first end of the reconstitution device within the second electron beam; and
,a depalletization module positioned proximate the bag pallet conveyor, the depalletize module configured to remove the reconstitution assembly from the bag pallet, the depalletize module having a pick and place assembly and a pallet release mechanism.
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43. 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 (44, 45, 46)
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47. 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 (48, 49, 50, 51, 52, 53, 54, 55, 56, 57)
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58. 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.
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59. 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, a first positioning assembly, and a second positioning device;
positioning the drug vial and drug reconstitution device in the first 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;
connecting the drug vial to the drug reconstitution device within the sterilizing field to form a device and vial subassembly;
positioning the device and vial subassembly and the flexible diluent container in the second positioning assembly;
providing a sterilizing field incident upon the second positioning assembly at a location contemplated for the formation of a connection between the device and vial subassembly and the flexible diluent container;
connecting the device and vial subassembly to the flexible diluent container to form a reconstitution assembly.
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60. An apparatus for positioning a container and a reconstitution device for forming a connection within a sterilizing field comprising:
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a reconstitution device holder and a container holder configured to position the reconstitution device and container for sterile connection; and
a shield for shielding a portion of at least one of the container and the reconstitution device. - View Dependent Claims (61, 62, 63, 64, 65)
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66. An apparatus for positioning a container and a reconstitution device for forming a connection within a sterilizing field comprising:
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a base;
a device holder mounted on the base and configured to hold the reconstitution device;
a container holder mounted on the base and configured to hold the container; and
wherein at least one of the container holder and device holder is movable from a loading position to a connecting position. - View Dependent Claims (67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78)
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79. An apparatus for positioning a container and a reconstitution device for connecting within a sterilizing field comprising:
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a base;
a first holder mounted on the base and configured to hold the reconstitution device;
a container holder mounted on the base and configured to hold the container;
wherein the container holder is movable from a loading position to a connecting position; and
,a container holder placement module for moving the container holder from the loading position to the connecting position. - View Dependent Claims (80, 81, 82, 83)
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84. An apparatus for positioning at least two components within a sterile field for connection, where one of the components contains a pharmaceutical agent or cosmetic agent which may degrade if exposed to the sterile field, the apparatus comprising:
a component holder configured to connect the at least two components, and having a sterilizeable portion and a protected portion, the sterilizeable portion configured to be positioned within the sterile field during connection such that the pharmaceutical agent or cosmetic agent is shielded by the protected portion and the safety and efficacy is not affected by the sterile field.
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85. An apparatus for positioning a container containing a pharmaceutical or cosmetic agent and a reconstitution device within a sterile field for connection, wherein the agent may degrade if exposed to the sterile field, the apparatus comprising:
a holder having a sterilizeable portion and a protected portion, the sterilizeable portion being configured to be positioned within the sterile field such that the pharmaceutical agent or cosmetic agent in the container is shielded by the protected portion of the holder.
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86. An apparatus for sterilizing an element within a sterile field, the apparatus comprising:
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a sterilization source which creates a sterile field;
at least two components configured to be connected within the sterile field;
means for exposing a first portion of the at least two components within the sterile field; and
means for shielding a second portion of the at least two components from the sterile field.
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87. An apparatus for sterilizing an element within a sterile field, the apparatus comprising:
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a sterilization source which creates a sterile field;
a first component adapted to be exposed to the sterile field;
a second component configured to be connected to the first component;
means for exposing a portion of the two components within the sterile field; and
means for shielding a portion of the two components from the sterile field.
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88. An apparatus for sterilizing an element within a sterile field, the apparatus comprising:
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a sterilization source which creates a sterile field;
a vial containing a pharmaceutical agent or cosmetic agent;
a reconstitution device configured to be connected to the vial;
means for exposing a portion of the vial and reconstitution device within the sterile field; and
means for shielding the pharmaceutical agent or cosmetic agent of the vial and the reconstitution device from the sterile field.
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89. An apparatus for positioning a flexible diluent container and a reconstitution device for forming a connection within a sterilizing field comprising:
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a reconstitution device holder and a flexible diluent container holder configured to position the reconstitution device and the flexible diluent container for sterile connection; and
a shield for shielding a portion of at least one of the flexible diluent container and the reconstitution device. - View Dependent Claims (90, 91, 92)
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93. An apparatus for positioning a container and a reconstitution device for connecting within a sterile field comprising;
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a base;
a frame mounted to the base;
a reconstitution device holder mounted to the frame;
a container holder mounted to the frame and configured to hold a bag; and
wherein at least one of the container holder and reconstitution device are movable from a loading position to a connecting position. - View Dependent Claims (94, 95, 96, 97, 98, 99, 100, 101, 102, 103)
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104. An apparatus for positioning a container and a reconstitution device for connecting within a sterile field comprising;
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a base having a top surface;
a frame mounted to the top surface of the base;
a reconstitution device holder mounted to the frame;
a container holder mounted to the frame and configured to hold a bag; and
wherein moving at least one of the container holder and the reconstitution device holder from a loading position to a connecting position when a reconstitution device is positioned in the reconstitution holder and a container is positioned in the container holder connects the container to the reconstitution device. - View Dependent Claims (105, 106, 107, 108, 109, 110, 111, 112, 113, 114)
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115. An apparatus for positioning at least two components within a sterile field for connection, where one of the components contains a pharmaceutical agent or cosmetic agent which may degrade if exposed to the sterile field, the apparatus comprising:
a component holder configured to connect the at least two components, and having a sterilizeable portion and a protected portion, the sterilizeable portion configured to be positioned within the sterile field during connection such that the pharmaceutical agent or cosmetic agent is shielded by the protected portion and the safety and efficacy is not affected by the sterile field.
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116. An apparatus for positioning a container containing a pharmaceutical or cosmetic agent and a reconstitution device within a sterile field for connection, wherein the agent may degrade if exposed to the sterile field, the apparatus comprising:
a holder having a sterilizeable portion and a protected portion, the sterilizeable portion being configured to be positioned within the sterile field such that the pharmaceutical agent or cosmetic agent in the container is shielded by the protected portion of the holder.
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117. An apparatus for sterilizing an element within a sterile field, the apparatus comprising:
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a sterilization source which creates a sterile field;
at least two components configured to be connected within the sterile field;
means for exposing a first portion of the at least two components within the sterile field; and
means for shielding a second portion of the at least two components from the sterile field.
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118. An apparatus for sterilizing an element within a sterile field, the apparatus comprising:
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a sterilization source which creates a sterile field;
a first component adapted to be exposed to the sterile field;
a second component configured to be connected to the first component;
means for exposing a portion of the two components within the sterile field; and
means for shielding a portion of the two components from the sterile field.
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119. An apparatus for sterilizing an element within a sterile field, the apparatus comprising:
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a sterilization source which creates a sterile field;
a flexible bag containing a pharmaceutical agent or cosmetic agent;
a reconstitution device configured to be connected to the flexible bag;
means for exposing a portion of the flexible bag and reconstitution device within the sterile field; and
means for shielding the pharmaceutical agent or cosmetic agent of the flexible bag and the reconstitution device from the sterile field.
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120. An apparatus for the loading of a reconstitution device onto a positioning assembly comprising:
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means for receiving a reconstitution device;
means for inspecting the reconstitution device for defects; and
means for loading the inspected reconstitution device onto a positioning assembly. - View Dependent Claims (121, 122, 123, 124, 125, 126, 145)
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127. An apparatus for the loading of a reconstitution device onto a positioning assembly comprising:
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means for receiving a reconstitution device;
means for orientating the reconstitution device;
means for rotating the reconstitution device;
means for inspecting the reconstitution device during rotation for defects; and
means for loading the inspected reconstitution device onto a positioning assembly. - View Dependent Claims (128)
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129. An apparatus for the loading of a reconstitution device onto a positioning assembly comprising:
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a reconstitution device receiver configured to receive reconstitution devices;
an index table proximate the reconstitution device receiver configured to move reconstitution devices;
transport tracks having a first end and a second end, and wherein the first end extends from the index table and is configured to transport reconstitution devices from the index table;
a device presentation nest located proximate to the second end of the transport tracks and configured to receive reconstitution devices from the transport tracks; and
,a transfer robot configured to transfer reconstitution devices onto a positioning assembly. - View Dependent Claims (130, 131, 132, 133, 134, 135, 136, 137, 138, 139)
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140. A method for the loading of a reconstitution device onto a positioning assembly comprising the steps of:
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loading a reconstitution device into a receiver;
inspecting the reconstitution device for defects; and
transferring the inspected reconstitution device onto a positioning assembly. - View Dependent Claims (141, 142, 143, 144)
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146. An apparatus for the loading of a container onto a positioning assembly comprising:
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an accumulating conveyor configured to circulate containers;
a container transfer robot located proximate to the accumulating conveyor and configured to remove containers from the accumulating conveyor;
an inspection assembly located proximate to the container transfer robot configured to inspect the containers;
an uncap mechanism assembly located proximate to the container transfer robot and configured to receive and uncap containers;
a pallet load robot located proximate to the uncap mechanism assembly and configured to transfer containers from the uncap mechanism to a positioning assembly. - View Dependent Claims (147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158)
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159. An apparatus for the loading of a container onto a positioning assembly comprising:
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an accumulating conveyor configured to circulate containers;
an inspection load robot configured to remove containers from the accumulating conveyor;
an inspection assembly located proximate to the inspection load robot and configured to inspect the containers;
a container transfer robot located proximate to the inspection assembly and configured to remove containers from the inspection assembly;
an uncap mechanism assembly located proximate to the container transfer robot and configured to receive and uncap containers; and
a pallet load robot located proximate to the uncap mechanism assembly and configured to transfer containers from the uncap mechanism to a positioning assembly. - View Dependent Claims (160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171)
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172. An apparatus for the loading of a drug vial onto a positioning assembly comprising:
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means for receiving a drug vial having a cap;
means for inspecting the drug vial for defects;
means for removing the cap from the drug vial;
means for transferring the drug vial to a positioning assembly. - View Dependent Claims (173, 174, 175, 176)
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177. A method for the loading of a drug vial onto a positioning assembly comprising the steps of:
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loading a drug vial having a cap onto a drug vial conveyor;
inspecting the drug vial for defects;
removing the cap from the drug vial;
transferring the drug vial to a positioning assembly. - View Dependent Claims (178, 179, 180, 181, 182)
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Specification