Method and apparatus for manufacturing, filling and packaging medical devices and medical containers

• US 6,263,641 B1
• Filed: 10/03/2000
• Issued: 07/24/2001
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Campos, Jorge J., Odell, Robert B., Kropatsch, James C., Carre, Patrick G., Servin, Mario de Aguero, Porfano, Donald J., German, Mark A.
• Primary Examiner(s): Vo, Peter
• Assistant Examiner(s): Huynh, Louis K.
• Application Number:
  US09/678,080
• Time in Patent Office: 294 Days
• Field of Search: 534/25, 534/20, 534/52, 534/71, 534/87, 534/90, 534/43, 65/36, 141/1, 422/28
• US Class Current: 53/425
• 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

Clean syringe barrels from forming device immediately transferred to a controlled environment to maintain a clean work area. The work area can be a clean room or localized area to avoid the need to maintain cleanliness levels in an entire room. A localized area uses a housing assembly having a HEPA filter coupled to an air inlet to filter 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. Syringe tip closures can be introduced into the housing assembly, where syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. A thin coating of lubricant is applied to the inner surfaces of the syringe barrels. The syringe barrels or medical container can be filled with a substance and a closure member is attached. While still in the housing assembly the syringe barrels can be formed into an array and placed in a clean outer container. The outer container is then closed and sealed. The outer container and syringe barrels can be sterilized with heat, radiation or by exposure to a sterilizing gas.

Claims

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

forming a plurality of clean syringe barrels in a glass forming device for shaping a cylindrical glass tube into syringe barrels having a first open end for receiving a syringe plunger and a second open end for discharging contents from said syringe barrel,

transferring said syringe barrels to an environmentally controlled area to maintain a predetermined cleanliness level, and

cleaning said syringe barrels by directing a filtered air stream to loosen particulates from at least one surface of said syringe barrels and applying a vacuum to remove said loosened particulates from said syringe barrels within said environmentally controlled area.

2. The method of claim 1, further comprising the steps of:

enclosing said syringe barrels in a container, and sterilizing said container.

3. The method of claim 2, wherein said sterilizing step comprises exposing said container to either gamma radiation, beta radiation, ethylene oxide, hot air, steam or a sterilizing gas.

4. The method of claim 1, wherein said method comprises heating said syringe barrels to an annealing temperature to simultaneously anneal and clean said syringe barrels.

5. The method of claim 1, further comprising the step of enclosing said forming device in a locally controlled area to maintain a predetermined cleanliness level.

6. The method of claim 1, further comprising the steps of forming an array of said syringe barrels, placing said array in a container, and closing and sealing said container to form packaged syringe barrels.

7. The method of claim 6, further comprising the step of positioning a protective sheet over said array of syringe barrels in said container before applying a cover sheet to said container to seal said container.

8. The method of claim 6, further comprising the step of applying a coating of a lubricant to an inner surface of said syringe barrel.

9. The method of claim 1, further comprising the steps of applying a tip cap to close said second open end of said syringe barrel, filling said syringe barrel with a substance, applying a stopper to said first open end of said syringe barrel to form a prefilled syringe.

10. The method of claim 9, wherein the step of filling said syringe barrel with the substance including a substance selected from the group consisting of saline solutions, flush solutions or contrast agents, pharmaceutical agents and vaccines, in either a dry or liquid state.

11. The method of claim 1, wherein said air stream comprises ionized air.

12. The method of claim 1, wherein said forming step includes forming said syringe barrel by heating a glass tube to a temperature of about 760°

C. to 1100°

C.

13. The method of claim 12, further comprising the step of annealing said syringe barrel at a temperature of at least about 560°

C.

14. The method of claim 12, wherein said forming step comprises heating a first end of said glass tube to a temperature whereby said glass tube is pliable and shaping said first end to form a flange extending substantially radially outward from a center axis of said glass tube.

15. The method of claim 14, further comprising the steps of heating a second end of said glass tube to a temperature whereby said glass tube is in a pliable state and shaping said second end for receiving a cannula needle.

16. The method of claim 14, wherein said forming step includes heating a second end of said glass tube to a temperature whereby said glass tube is in a pliable state and shaping said second end into a nozzle tip for receiving a needle, and further comprising the step of securing a needle in the nozzle tip by an adhesive.

17. The method of claim 16, further comprising the step of coupling a protective plastic needle sheath having an open end with said nozzle tip, said protective plastic needle sheath having a hollow, substantially cylindrical shape and being dimensioned to receive said needle so that said protective plastic needle sheath contacts and closes off a tip of the needle to prevent leakage.

18. The method of claim 1, wherein said environmentally controlled area maintains a cleanliness level of about Class 100.

19. The method of claim 1, wherein said environmentally controlled area comprises at least one housing assembly having an air blower and a HEPA filter coupled to said air blower to filter air entering said at least one housing assembly.

20. The method of claim 13, wherein said at least one housing assembly is maintained at a positive internal pressure to prevent unfiltered air from entering said housing assemblies.

21. The method of claim 1, further comprising the steps of providing a plurality of collars to said environmentally controlled area;

and snapping each said collar to said second open end of each syringe barrel.

22. A method of producing prefillable syringe barrel assemblies in one or more housing assembly for maintaining a predetermined cleanliness level comprising the steps of:

forming a plurality of clean syringe barrels in a forming device, said syringe barrels each having a first open end for receiving a syringe plunger and a second open end for discharging contents from said syringe barrels, with the second open end being formed into a nozzle tip for receiving a needle;

supplying a plurality of needles and securing said needles in the nozzle tips of said syringe barrels by an adhesive;

supplying a plurality of protective plastic needle sheaths and coupling the protective plastic needle sheaths to said nozzle tips of said syringe barrels to form syringe barrel assemblies;

transferring said syringe barrel assemblies to at least one housing assembly for maintaining a predetermined cleanliness level;

directing a filtered air stream to loosen any particulates from at least one surface of said syringe barrels assemblies and applying a vacuum to remove loosened particulates from said syringe barrel in said at least one housing assembly transferring said syringe barrel assemblies to at least another housing assembly; and

packaging at least one or more of said syringe barrel assemblies in a package in said at least another housing assembly.

23. The method of claim 22, wherein said step of forming said syringe barrels comprises supplying a cylindrical glass tube to said forming device and heating said first open end of said glass tube to a temperature whereby said glass tube is pliable and forming a flange about said first open end and heating said second open end of said glass tube to a temperature whereby said glass tube is pliable and forming said nozzle tip at said second open end.

24. The method of claim 23, wherein said protective plastic needle sheaths each have a hollow, substantially cylindrical shape and are dimensioned to receive said needle, and said coupling step includes contacting protective plastic needle sheaths with said needle so that said protective plastic needle sheath closes off a tip of each of the needles to prevent leakage.

25. The method of claim 23, further comprising the step of filling said syringe barrels with a desired substance and coupling a closure member to said syringe barrels to close said first open ends of said syringe barrels.

26. The method of claim 22, wherein said air stream comprises ionized air.

27. The method of claim 22, further comprising the steps of filling each said syringe barrel with a substance selected from the group consisting of saline solutions, flush solutions or contrast agents, or pharmaceutical agents and vaccines, in either a dry or liquid state and coupling a closure member to said syringe barrels to close the first open ends of said syringe barrels.

28. The method of claim 22, further comprising the step of sterilizing said package in at least another housing assembly.

29. The method of claim 45, wherein said packaging step includes 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.