Method and apparatus for automatically producing a plurality of sterile liquid filled delivery devices

• US 5,884,457 A
• Filed: 02/05/1997
• Issued: 03/23/1999
• Est. Priority Date: 02/05/1997
• Status: Expired due to Term

• Current Assignee: Sterile-Rx, Inc.
• Original Assignee: Smithkline Beecham Corporation (GSK plc)
• Inventors: Ortiz, Jose A., Sylvester, Kenneth J.
• Primary Examiner(s): Moon, Daniel B.
• Application Number:
  US08/792,352
• Time in Patent Office: 776 Days
• Field of Search: 53/281, 53/282, 53/381.4, 53/468, 53/471, 53/492, 53/284.5, 53/381.2, 53/284.6, 53/425, 53/426, 53/167
• US Class Current: 53/468
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 7/2835 applying and rotating preformed threaded caps for bottles or jars B67B3/20

Abstract

A method of automatically producing a plurality of prefilled, sterile delivery devices with a desired quantity of fluid. The sterile delivery devices each include a hollow barrel with a dispensing nozzle at one end and an open opposite end. A piston plunger is positioned within the open end and is slidable in sealing engagement with the barrel to retain a fluid therein. A tip is secured to the dispensing nozzle. A plurality of the sterile delivery devices are automatically fed along a predetermined path. Tips are then removed from the dispensing nozzles of the sterile delivery devices. The hollow barrels of the sterile delivery devices are then filled through the dispensing nozzles with a desired is quantity of fluid. The dispensing nozzles of the sterile delivery devices are then closed and sealed after the filling step to provide sealed sterile delivery devices with sterile fluid contents.

Claims

1. A method of automatically producing a plurality of prefilled, sterile delivery devices, the sterile delivery devices each including a hollow barrel with a dispensing nozzle at one end and an open opposite end, a piston plunger positioned within the open end and slidable in sealing engagement with the barrel to retain a fluid therein and a tip secured to the dispensing nozzle, the method comprising the steps of:

(a) automatically feeding a plurality of the sterile delivery devices along a predetermined path;

(b) removing the tips from the dispensing nozzles of the sterile delivery devices;

(c) filling the hollow barrels of the sterile delivery devices through the dispensing nozzles with a desired quantity of fluid; and

(d) closing and sealing the dispensing nozzles of the sterile delivery devices after the filling step to provide sealed sterile delivery devices with sterile fluid contents.

2. The method as recited in claim 1 wherein steps (b), (c) and (d) are carried cut consecutively with respect to each individual sterile delivery device.

3. The method as recited in claim 2 wherein steps (b), (c) and (d) are carried out at least partially simultaneously with respect to at least three sterile delivery devices.

4. The method as recited in claim 1 wherein step (d) further comprises securing a cap to each dispensing nozzle of the sterile delivery devices.

5. The method as recited in claim 4 wherein the tip is secured to the nozzle using a twist on connection and step (d) further comprises securing a cap to each dispensing nozzle of the sterile delivery devices by rotating said cap onto the dispensing nozzle.

6. The method as recited in claim 1 wherein in step (c) the plunger moves within the hollow barrel as the hollow barrel is filled with the fluid.

7. The method as recited in claim 1 wherein the tip is secured to the nozzle using a twist on connection and step (b) comprises grasping and rotating each tip to remove the tips from the dispensing nozzles of the sterile delivery devices.

8. The method as recited in claim 1 wherein step (a) comprises feeding a magazine holding a plurality of the sterile delivery devices along a predetermined path and steps (b), (c) and (d) are carried out with the sterile delivery devices held by the magazine.

9. The method as recited in claim 1 further comprising feeding the sterile delivery devices to a filling station after step (b) and step (c) is carried out at said filling station.

10. The method as recited in claim 9 further comprising feeding the filled sterile delivery devices to a sealing station after step (c) and step (d) is carried out at said sealing station.

11. The method as recited in claim 1 wherein in step (c) the sterile delivery devices are in an inverted position such that as fluid flows into the hollow barrel the hollow barrel fills from the dispensing nozzle to the open end.

12. An apparatus for automatically producing a plurality of prefilled, sterile delivery devices, the sterile delivery devices each including a hollow barrel with a dispensing nozzle at one end and an open opposite end, a piston plunger positioned within the open end and slidable in sealing engagement with the barrel to retain a fluid therein and a tip secured to the dispensing nozzle, the apparatus comprising:

(a) a predetermined feeding path configured to receive and move a plurality of the sterile delivery devices along said predetermined feeding path;

(b) a tip removing station positioned proximate said predetermined feeding path for removing the tips from the dispensing nozzles of the sterile delivery devices by engaging and removing a tip from a sterile delivery device as the sterile delivery devices move along said predetermined feeding path;

(c) a fluid filling station positioned proximate said predetermined feeding path for filling the hollow barrels of the sterile delivery devices through the dispensing nozzles with a desired quantity of fluid, said fluid filling station including a discharge end in fluid communication with a pump and being configured for complementary sealed engagement with the dispensing nozzles of the sterile delivery devices, said discharge end being movable between a first position wherein said discharge end is spaced from said sterile delivery devices and a second position wherein said discharge end is in complementary sealed engagement with a dispensing nozzle of a sterile delivery device for passing fluid to the hollow barrel of the sterile delivery device as the sterile delivery devices move along said predetermined feeding path; and

(d) a sealing station positioned proximate said predetermined feeding path for closing and sealing a dispensing nozzle of the sterile delivery device having fluid located in the hollow barrel to provide sealed sterile delivery devices with sterile fluid contents, said sealing station including a plurality of caps each being complementarily sized to seal the dispensing nozzle of the sterile dispensing devices, said sealing station securing said caps in complementary sealed engagement with the dispensing nozzles of the sterile dispensing devices to seal the fluid within the hollow barrel of the sterile dispensing device as said sterile delivery devices move along said predetermined feeding path.

13. The apparatus as recited in claim 12 further comprising a magazine for holding a plurality of the sterile delivery devices, said magazine being disposed on and moveable along said predetermined feeding path.

14. The apparatus as recited in claim 13 further including a motor operably associated with said magazine for moving said magazine along said predetermined feeding path with respect to the tip removing station, fluid filling station and sealing station in an indexed manner to pass each sterile delivery device in the magazine through said tip removing station, fluid filling station and sealing station whereby sealed sterile delivery devices with sterile fluid contents are located within said magazine after said magazine moves along said predetermined feeding path past said tip removing station, fluid filling station and sealing station.

15. The apparatus as recited in claim 12 wherein said tip removing station includes a movable gripping arm which engages and removes the tip from the sterile delivery device.

16. The apparatus as recited in claim 15 wherein the tip is secured to the nozzle using a twist on connection and said gripping arm grasps and rotates each tip to remove the tips from the dispensing nozzles of the sterile delivery devices.

17. The apparatus as recited in claim 12 wherein said fluid filling station further comprises a filling tube having a first end in fluid communication with said pump such that fluid dispensed by said pump flows into said filling tube and a second end which forms said discharge end of said pump.

18. The apparatus as recited in claim 12 wherein said sealing station further includes a movable pick up rod having a terminal end with a cap thereon, said pick up rod being movable between a first position wherein said terminal end is spaced from the said sterile delivery devices and a second position wherein said terminal end positions said cap in complementary sealed engagement with a dispensing nozzle of a sterile dispensing device to seal the fluid within the hollow barrel of the sterile dispensing device as said sterile delivery devices move along said predetermined feeding path.

19. The apparatus as recited in claim 18 wherein the tip is secured to the nozzle using a twist on connection and said pick up rod rotates said cap onto each dispensing nozzle of the sterile delivery devices.

20. The apparatus as recited in claim 12 wherein the sterile delivery devices are in an inverted position on said predetermined feeding path such that as fluid flows into the hollow barrel the hollow barrel fills from the dispensing nozzle to the open end.

21. A method of automatically mass producing prefilled, sterile delivery devices and distributing the filled sterile delivery devices to dispensing stations, the sterile delivery devices each including a hollow barrel with a dispensing nozzle at one end and an open opposite end, a piston plunger positioned within the open end and slidable in sealing engagement with the barrel to retain a fluid therein and a tip secured to the dispensing nozzle, the method comprising the steps of:

(a) providing a parenteral medical material in powder form;

(b) mixing said medical material with a diluent to form a parenteral fluid;

(c) automatically feeding a plurality of the sterile delivery devices along a predetermined path;

(d) removing the tips from the dispensing nozzles of the sterile delivery devices as the sterile delivery devices move along a predetermined path;

(e) filling the hollow barrels of the sterile delivery devices through the dispensing nozzles with a desired quantity of said parenteral fluid as the sterile delivery devices move along a predetermined path;

(f) closing and sealing the dispensing nozzles of the sterile delivery devices after the filling step to provide sealed sterile delivery devices with sterile fluid contents; and

(g) shipping said sealed sterile delivery devices with sterile fluid contents to one or more dispensing stations.