Apparatus for fabricating a reconstitution assembly

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;
• 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.

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;
• 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.

An apparatus for the sterile connecting of a container and a drug reconstitution device comprising:

• 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.