Method and apparatus for assembling and packaging medical devices

• US 6,250,052 B1
• Filed: 10/03/2000
• Issued: 06/26/2001
• 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:
  US09/678,084
• Time in Patent Office: 266 Days
• Field of Search: 534/25, 534/20, 534/52, 534/71, 534/89, 534/90, 534/43, 65/36, 141/1, 422/28, 422/25, 422/26, 604/199
• 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 filled syringe comprising the steps of:

forming a plastic syringe barrel in an injection molding machine, said syringe barrel having a cylindrical wall, an open proximal receiving end and a frustoconically shaped outlet nozzle at its distal end;

transferring said syringe barrel, without any additional cleaning or sterilization, into an environmentally controlled area to maintain a predetermined cleanliness level;

directing a stream of filtered air toward said syringe barrel in said environmentally controlled area to loosen particulates from surfaces of said syringe barrel and applying a vacuum to remove said loosened particulates from said surfaces thereof to clean said syringe barrel;

delivering a tip cap to said environmentally controlled area;

assembling said tip cap to said outlet nozzle of said syringe barrel to close said outlet nozzle;

filling said syringe barrel with a substance through its open proximal end;

delivering a stopper to said environmentally controlled area;

inserting said stopper into said open proximal end of said barrel to form a prefilled syringe; and

removing said prefilled syringe from said environmentally controlled area.

2. The method of claim 1, further comprising the step of applying a coating of a lubricant to inner surfaces of said syringe barrels.

3. The method of claim 1, wherein said environmentally controlled area includes an air blower and a HEPA filter coupled to said air blower to filter air entering said environmentally controlled area and to maintain a cleanliness level of Class 100.

4. The method of claim 3, further comprising the step of operating said air blower to maintain a positive pressure in said environmentally controlled area.

5. The method of claim 1, further comprising the step of forming an array of said prefilled syringes, placing said array in a container, positioning a protective sheet over said array of prefilled syringes in said container and applying a cover sheet to said container and thereafter sealing said cover sheet to said container.

6. The method of claim 5, wherein said cover sheet is a heat sealable sheet material and wherein sealing said cover sheet comprises heat sealing said cover sheet to said container to close said container.

7. The method of claim 5, further comprising the step of sterilizing said array of said prefilled syringes in said container after applying said cover sheet and an outer wrap.

8. The method of claim 7, wherein said sterilizing step comprises exposing said container to either gamma radiation, beta radiation, hot air, steam or a sterilizing gas.

9. The method of claim 1, further comprising the step of packaging said prefilled syringe.

10. The method of claim 1, further comprising the step of sterilizing said prefilled syringe.

11. The method of claim 1, further comprising the steps of sterilizing said prefilled syringe followed by the step of packaging said prefilled syringe.

12. The method of claim 1, further including the step of air cleaning said tip cap in said environmentally controlled area.

13. The method of claim 1, further including the steps of forming an array of said syringe barrel assemblies, placing said array in a container, and closing and sealing said container to form packaged syringe barrel assemblies in said environmentally controlled area placing said array in a container, and closing and sealing said container to form packaged syringe barrel assemblies.

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

15. The method of claim 1, wherein said syringe barrel formed in said injection molding machine includes a collar encircling said outlet nozzle to define an annular space surrounding said outlet nozzle.

16. A method of producing a filled syringe comprising the steps of:

forming a plastic syringe barrel in an injection molding machine, said syringe barrel having a cylindrical side wall, an open proximal receiving end and a frustoconically shaped outlet nozzle at its distal end;

transferring said syringe barrel, without any additional cleaning or sterilization, into an environmentally controlled area to maintain a predetermined cleanliness level;

directing a stream of filtered air toward said syringe barrel in said environmentally controlled area to loosen particulates from surfaces of said syringe barrel and applying a vacuum to remove said loosened particulates from said surfaces thereof to clean said syringe barrel;

delivering a stopper in said environmentally controlled area;

inserting said stopper into said open proximal end of said syringe barrel to close said proximal end;

filling said syringe barrel with a substance through its outlet nozzle;

delivering a tip cap to said environmentally controlled area;

assembling said tip cap to said outlet nozzle of said syringe barrel to form a prefilled syringe; and

removing said prefilled syringe from said environmentally controlled area.

17. The method of claim 16, further comprising the step of packaging said prefilled syringe in said environmentally controlled area.

18. The method of claim 16, further comprising the step of sterilizing said prefilled syringe in said environmentally controlled area.

19. The method of claims 16, further comprising the steps of sterilizing said prefilled syringe followed by the step of packaging said prefilled syringe in said environmentally controlled area.

20. The method of claims 19, wherein said step of packaging said prefilled syringe includes forming an array of said prefilled syringes, placing said array in a container, and closing and sealing said container to form said packaged prefilled syringe.

21. The method of claim 20, wherein said sterilizing step comprises exposing said container to either gamma radiation, beta radiation, hot air, steam or a sterilizing gas.

22. The method of claim 16, further comprising the step of air cleaning said tip cap in said environmentally controlled area.

23. The method of claim 16, wherein said directed filtered air stream is ionized air.

24. The method of claim 16, wherein said syringe barrel formed in said injection molding machine includes a collar encircling said outlet nozzle to define an annular space surrounding said outlet nozzle.