Method and apparatus for assembling and packaging medical devices

• US 6,164,044 A
• Filed: 03/12/1999
• Issued: 12/26/2000
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Odell, Robert B., Kropatsch, James C., Porfano, Donald J., German, Mark A.
• Primary Examiner(s): Vo, Peter
• Assistant Examiner(s): HUYNH, LOUIS K
• Application Number:
  US09/267,108
• Time in Patent Office: 655 Days
• Field of Search: 53/425, 53/420, 53/452, 53/471, 53/489, 53/490, 53/443, 65/36, 141/1, 422/28
• US Class Current: 53/471
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/344 using additional parts, e.g. clamping rings or collets
• CPC Class Codes: A61M 5/347 rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/348 snap lock, i.e. upon axial displacement of needle assembly A61M5/344 takes precedence
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/027 Packaging in aseptic chambers
• CPC Class Codes: B65B 55/10 by liquids or gases

Abstract

A housing assembly is provided to define a locally controlled environment to maintain a localized clean work area without the need to maintain cleanliness levels in an entire room as in conventional clean rooms. The housing assembly includes a HEPA filter coupled to an air inlet to filter all of the air entering the housing. An air blower is coupled to the air inlet to feed filtered air into the housing assembly and to maintain a positive air pressure in the housing assembly to prevent unfiltered outside air from entering. Prefillable medical containers, such as syringe barrels and syringe tip closures, are introduced into the housing assembly where the syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. A thin coating of a lubricant is applied to the inner surface of each of the syringe barrels. The syringe barrels can be filled with a substance. Alternatively, while still in the housing assembly the syringe barrels can be formed into an array and placed in a clean container. A cover is then attached to the tub to completely enclose the array of syringe barrels followed by an outer wrap. Thereafter, the syringe barrels either filled or packaged in the array can be sterilized. The syringe barrels may be prefillable plastic syringe barrels made of a cyclic polyolefin copolymer or polypropylene.

Claims

1. A method of producing a prefillable syringe barrel assembly comprising the steps of:

supplying a plurality of syringe barrels and a plurality of tip closures to at least one housing assembly having an air filtering device to maintain a predetermined cleanliness level,

coupling said tip closures to said syringe barrels within said housing assembly to form syringe barrel assemblies,

directing filtered air onto said syringe barrel assemblies to clean outer surfaces of said syringe barrel assemblies,

directing filtered air to loosen particulates from inner surfaces of said syringe barrel assemblies and applying a vacuum to remove loosened particulates, and applying a lubricant to said inner surfaces of said syringe barrel assemblies,

forming an array of said syringe barrel assemblies, and placing said array in a container having a closed bottom, side walls and an open top end applying a cover sheet to said container to entirely close said container, and sealing said cover sheet to said container, and

placing said containers in another container and sealing said another container while in said housing assembly.

2. The method of claim 1, further comprising supplying a plurality of closures, filling each of said syringe barrel assemblies with a substance and closing said syringe barrel assemblies with said closures.

3. The method of claim 2, wherein said substance includes either water, saline solutions, flush solutions, contrast agents, pharmaceutical agents or vaccines.

4. The method of claim 2, wherein said substance is in either a dry state or a liquid state.

5. The method of claim 1, wherein said housing assembly maintains a cleanliness level of Class 100.

6. The method of claim 1, wherein said housing assembly includes an air blower and a HEPA filter coupled to said air blower to filter air entering said housing assembly.

7. The method of claim 6, further comprising the step of operating said air blower so as to maintain a positive pressure in said housing assembly.

8. The method of claim 1, further comprising a plurality of housing assemblies coupled together.

9. The method of claim 8, wherein said coupling step is in a first housing assembly, said cleaning and lubricating steps are in a second housing assembly, said step of forming an array and placing said array in a container is in a third housing assembly, and said sealing step is in a fourth housing assembly.

10. The method of claim 9, further comprising the step of positioning a protective sheet over said array of syringe barrel assemblies in said container before applying said cover sheet to said container.

11. The method of claim 10, wherein said cover sheet is a heat sealable sheet material and said method comprises heat sealing said cover sheet to said container to close said container.

12. The method of claim 9, further comprising the step of sterilizing said array of syringe barrel assemblies in said container after applying said cover sheet and an outer wrap.

13. The method of claim 12, wherein said sterilizing step comprising exposing said container to either gamma radiation, beta radiation, ethylene oxide, hot air, steam or a sterilizing gas.

14. The method of claim 12, wherein said cover sheet is a gas permeable sheet material and said sterilizing step comprises exposing said container to a sterilizing gas.

15. The method of claim 14, wherein said cover sheet is a sheet of spun bonded polyolefin.

16. The method of claim 1, wherein said container is a prefilled syringe, said method further comprising:

filling said syringe barrel assemblies with a substance,

supplying a plurality of stoppers, and

applying the stopper to each syringe barrel assembly to close said syringe barrel assembly.

17. The method of claim 16, further comprising applying a lubricant to inner surfaces of said syringe barrels.

18. The method of claim 1, wherein said syringe barrel is a plastic or glass syringe barrel.

19. The method of claim 1, further comprising the steps of supplying a plurality of collars and snapping the collar onto each syringe barrel prior to forming said array of said syringe barrel assemblies.

20. The method of claim 19, wherein said collar is a luer locking collar.

21. The method of claim 1, wherein said filtered air directed onto said syringe barrel assemblies to clean the outer surfaces of said syringe barrel assemblies is ionized air.

22. The method of claim 1, wherein said directed filtered air stream is ionized air.

23. A method of producing a prefilled medical container comprising the steps of:

supplying a plurality of medical containers to a first housing assembly having an air filtering device to maintain a predetermined cleanliness level,

directing a filtered air stream to loosen particulates from inner surfaces of said medical containers and applying a vacuum to remove loosened particulates from said medical containers prior to filling, and

filling said medical containers with a substance and closing said containers.

24. The method of claim 23, further comprising forming an array of said filled medical containers, and placing said array in a container package and closing said container package.

25. The method of claim 23, wherein said prefilled medical container is a plastic or glass syringe barrel.

26. The method of claim 25, further comprising the steps of:

supplying plurality of tip caps to said housing assembly, and

coupling said tip caps to said syringe barrels before filling.

27. The method of claim 26, further comprising supplying a plurality of stoppers to assembly said housing and coupling said stoppers to said syringe barrels after filling.

28. The method of claim 26, further comprising the steps of supplying a plurality of collars and snapping the collar onto each syringe barrel prior to forming said array of said syringe barrel assemblies.

29. The method of claim 23, wherein said housing assembly includes an air blower and a HEPA filter coupled to said air blower to filter air entering said housing assembly to maintain a cleanliness level of Class 100.

30. The method of claim 29, further comprising the step of operating said air blower to maintain a positive pressure in said housing assembly.

31. The method of claim 23, further comprising the step of sterilizing said filled medical containers.

32. The method of claim 31, wherein said sterilizing step comprising exposing said filled medical containers to either gamma radiation, beta radiation, hot air, steam or a sterilizing gas.

33. A method of producing packaged prefillable syringe barrel assemblies comprising the steps of:

supplying a plurality of syringe barrels and a plurality of tip caps to a first housing assembly for maintaining a locally controlled environment, said first housing assembly having an air filtering device for introducing filtered air into said first housing assembly and maintaining a predetermined cleanliness level in said first housing assembly,

coupling said tip caps to said syringe barrels to form syringe barrel assemblies,

cleaning at least one surface of said syringe barrel assemblies,

conveying said syringe barrel assemblies to a second housing assembly and applying a coating of a lubricant to inner surfaces of said syringe barrel assemblies in said second housing assembly, and

forming an array of said syringe barrel assemblies, placing said array in a container, and closing and sealing said container to form said packaged refillable syringe barrel assemblies.

34. The method of claim 33, comprising conveying said lubricated syringe barrel assemblies to a third housing assembly and forming said array in said third housing assembly.

35. The method of claim 33, wherein said syringe barrels are plastic or glass prefillable syringe barrels.

36. The method of claim 33, wherein said first housing assembly includes an air blower and a HEPA filter coupled to said air blower to filter air entering said first housing assembly and to maintain a cleanliness level of Class 100.

37. The method of claim 36, further comprising the step of operating said air blower to maintain a positive pressure in said housing assembly.

38. The method of claim 33, further comprising the steps of supplying a plurality of collars and snapping the collar onto each syringe barrel prior to forming said array of said syringe barrel assemblies.

39. A method of producing packaged prefillable syringe barrel assemblies comprising the steps of:

supplying a plurality of syringe barrels and a plurality of tip caps to at least one housing assembly for maintaining a locally controlled environment, said at least one housing assembly having an air filtering device for introducing filtered air into said at least one housing assembly and maintaining a predetermined cleanliness level in said at least one housing assembly,

coupling said tip caps to said syringe barrels to form syringe barrel assemblies,

cleaning at least one surface of said syringe barrel assemblies,

forming an array of said syringe barrel assemblies, placing said array in a container, positioning a protective sheet over said array of syringe barrel assemblies in said container and applying a cover sheet to said container and thereafter sealing said cover sheet to said container to form said packaged prefillable syringe barrel assemblies, said steps of coupling, cleaning, forming and sealing being carried out in said at least one housing assembly.

40. The method of claim 39, wherein said cover sheet is a heat sealable sheet material and said method further comprises heat sealing said cover sheet to said container to close said container.

41. The method of claim 39, further comprising the step of sterilizing said array of syringe barrel assemblies in said container after applying said cover sheet and an outer wrap.

42. The method of claim 41, wherein said sterilizing step comprises exposing said container to either gamma radiation, beta radiation, hot air, steam or a sterilizing gas.

43. The method of claim 39, further comprising the steps of supplying a plurality of collars and snapping the collar onto each syringe barrel prior to forming said array of said syringe barrel assemblies.

44. The method of claim 39, wherein the step of cleaning at least one surface of said syringe barrel assemblies includes directing ionized air to loosen particulates from said surface and applying a vacuum to remove loosened particulates from said syringe barrel assemblies.