Apparatus for fabricating a reconstitution assembly

• US 7,358,505 B2
• Filed: 12/23/2003
• Issued: 04/15/2008
• Est. Priority Date: 09/15/1998
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Smith, Jeffery, Adams, David J., Reed, William, Steeber, Michael, Korzeniewski, Kim, Martine, John A. Jr., Woodworth, Archie
• Primary Examiner(s): MCKANE, ELIZABETH L
• Application Number:
  US10/744,946
• Publication Number:
  US 20040241041A1
• Time in Patent Office: 1,575 Days
• Field of Search: None
• US Class Current: 250/455.11
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61L 2/00 Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for contact lenses A61L12/00; atomisers for disinfecting agents A61M; sterilisation of packages or package contents in association with packaging B65B55/00; treatment of water, waste water, sewage or sludge C02F; disinfecting paper D21H21/36; disinfecting devices for water closets E03D; articles having provision for disinfection, see the relevant subclasses for these articles, e.g. H04R1/12
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking

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.

Claims

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.

2. The apparatus of claim 1 wherein the positioning assembly is a pallet.

3. The apparatus of claim 2 wherein the container is a vial.

4. The apparatus of claim 1 wherein the connecting mechanism comprises a snap-closure assembly.

5. The apparatus of claim 4 wherein the snap-closure assembly comprises a cylinder configured to move the positioning assembly into a connecting position such that the container and the reconstitution device are snap-fit together.

6. The apparatus of claim 5 wherein the snap-closure assembly comprises a cylinder configured to move the container or the reconstitution device into a connecting position such that the container and the reconstitution device are snap-fit together.

7. The apparatus of claim 1 fhrther comprising a conveyor assembly upon which a plurality of positioning assemblies are supported and moved from a loading position to a connecting position.

8. The apparatus of claim 7 further comprising a positioning assembly loader wherein the conveyor assembly is arranged to transport the positioning assembly from the loader to the connecting mechanism.

9. The apparatus of claim 8 wherein the positioning assembly loader includes a device loader and a vial loader.

10. The apparatus of claim 9 further comprising a positioning assembly unloader wherein the conveyor assembly is arranged to transport the positioning assembly from the connecting mechanism to the positioning assembly unloader.

11. The apparatus of claim 1 further comprising a housing which houses the sterilizing emitter assembly, the positioning assembly, and the connecting mechanism.

12. The apparatus of claim 11 wherein the housing comprises a pre-sterilization chamber, a sterilization chamber, and a post sterilization chamber.

13. The apparatus of claim 12 wherein the housing comprises entry doors and exit doors from each of the pre-sterilization chamber, the sterilization chamber, and the post sterilization chamber.

14. The apparatus of claim 13 wherein the housing further comprising individual conveyors within each of the pre-sterilization chamber, the sterilization chamber, and the post sterilization chamber.

15. 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.

16. 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.

17. 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.