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

• US 6,189,292 B1
• Filed: 03/12/1999
• Issued: 02/20/2001
• 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., German, Mark A., Odell, Robert B., Kropatsch, James C., Carre, Patrick G., Servin, Mario de Aguero, Porfano, Donald J.
• Primary Examiner(s): Vo, Peter
• Assistant Examiner(s): Huynh, Louis K.
• Application Number:
  US09/267,107
• Time in Patent Office: 711 Days
• Field of Search: 534/25, 534/26, 534/52, 534/71, 534/89, 534/90, 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

Glass medical devices such as medical containers are manufactured and annealed by heating in an oven which produces a clean device having a low bio-burden. Plastic medical devices and medical containers are formed by plastic molding devices which produce a clean device. The clean devices are immediately transferred to a controlled environment to maintain a clean work area. 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. The syringe barrels may be prefillable glass or plastic syringe barrels.

Claims

1. A method of producing prefillable glass syringe barrel assemblies 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 barrels;

annealing said glass syringe barrels

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

supplying a plurality of tip caps to said housing assembly;

coupling said tip caps to said syringe barrels within said housing assembly to form syringe barrel assemblies;

directing a filtered air stream to loosen particulates from at least one surface of said syringe barrel assemblies and applying a vacuum to remove loosened particulates from said syringe barrel assemblies; and

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.

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

enclosing said container in a second container; and

sterilizing said second container.

3. The method of claim 1, further comprising the steps of filling said syringe barrel assembly with a desired substance and coupling a closure member to said syringe barrel assembly to close said syringe barrel assembly.

4. The method of claim 1, further comprising the steps of applying said tip cap to close a first end of said syringe barrel, filling said syringe barrel with a substance, supplying a plurality of stoppers, and applying a stopper to a second end of said syringe barrel to form a prefilled syringe prior to forming said array of said syringe barrel assemblies.

5. The method of claim 4, wherein said substance includes either water, a saline solution, a flush solution, a contrast agent, pharmaceutical agent or a vaccine.

6. The method of claim 1, wherein said step of forming said syringe barrel comprises heating a first end of the cylindrical 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.

7. The method of claim 6, further comprising 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.

8. The method of claim 1, wherein said step of forming said syringe barrels comprises supplying a cylindrical glass tube to said forming device and heating a first 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 a second end of said glass tube to a temperature whereby said glass tube is pliable and forming a tip at said second end.

9. The method of claim 8, wherein said first and second ends of said glass tube are heated to a temperature of about 760°

C. to 1100°

C.

10. The method of claim 8, further comprising annealing said syringe barrels by heating to at least about 560°

C.

11. The method of claim 1, further comprising the step of cleaning said syringe barrels in said at least one housing assembly prior to forming said array.

12. The method of claim 11, wherein said cleaning step comprises directing a stream of filtered, ionized air onto said syringe barrels to remove particulates from surfaces thereof.

13. The method of claim 1, wherein said at least one housing assembly includes an air blower and a HEPA filter coupled to said air blower to filter air entering said housing assembly and maintain a cleanliness level of about Class 100.

14. The method of claim 1, wherein said at least one housing assembly is maintained at a positive internal pressure to prevent unfiltered air from entering said housing assembly.

15. The method of claim 1, further comprising the step of transferring said syringe barrels to a second housing assembly and applying a coating of a lubricant to an inner surface of said syringe barrels prior to forming said array.

16. The method of claim 15, wherein said steps of forming said array of said syringe barrel assemblies, placing said array in a container and sealing said container take place in a third housing assembly.

17. The method of claim 1, wherein said glass forming device is enclosed in a housing assembly for maintaining a predetermined cleanliness level.

18. The method of claim 17, wherein said housing assembly enclosing said forming device maintains a cleanliness level of about Class 100.

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 1, wherein said directed filtered air stream is ionized air.

21. The method of claim 1, 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.