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

Abstract

Medical devices such as medical containers can be formed of glass and annealed which produces a clean device having a low bio-burden, or formed by plastic molding which produces a clean device. The clean devices are immediately transferred to a controlled environment such as a clean room or localized area to avoid the need to maintain cleanliness levels in an entire room. 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. The syringe barrels can be filled with a substance and a closure member attached. While still in the housing assembly the syringe barrels can be formed into an array and placed in a clean outer container, which is then closed and sealed.

What is claimed is: 
     
       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 at a temperature of at least 500° C.; then,   immediately transferring said syringe barrels to at least one housing assembly for maintaining a predetermined cleanliness level, without any sterilization between said annealing and said transferring steps.   
     
     
       2. The method of  claim 1 , further comprising coupling at least one syringe component to said syringe barrels to form a plurality of syringe barrel assemblies, forming an array of syringe barrel assemblies in said at least one housing assembly, placing said array in a container and closing said container. 
     
     
       3. The method of  claim 2 , wherein said forming step 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. 
     
     
       4. The method of  claim 3 , wherein said first and second ends of said glass tube are heated to a temperature of about 760° C. to 1100° C. 
     
     
       5. The method of  claim 3 , further comprising annealing said syringe barrels by heating to at least about 560° C. 
     
     
       6. The method of  claim 2 , further comprising the step of cleaning said syringe barrels in said at least one housing assembly prior to forming said array. 
     
     
       7. The method of  claim 6 , wherein said cleaning step comprises directing a stream of filtered, ionized air onto said syringe barrels to remove particulates from surfaces thereof. 
     
     
       8. The method of  claim 2 , 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 . 
     
     
       9. The method of  claim 2 , further comprising 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. 
     
     
       10. The method of  claim 9 , further comprising transferring said syringe barrels to a third housing assembly and packaging said syringe barrels while in said third housing assembly. 
     
     
       11. 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. 
     
     
       12. 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 without exposing said syringe barrel to unfiltered air; 
 directing a stream of filtered air toward said syringe barrel in said environmentally controlled area to remove particles from surfaces thereof to clean said syringe barrel; 
 delivering a tip cap to said environmentally controlled area; 
 air washing said tip cap in 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. 
 
     
     
       13. The method of  claim 12 , further including the step of packaging said prefilled syringe. 
     
     
       14. The method of  claim 12 , further including the step of sterilizing said prefilled syringe. 
     
     
       15. The method of  claim 12 , further including the steps of sterilizing said prefilled syringe followed by the step of packaging said prefilled syringe. 
     
     
       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 without exposing said syringe barrel to unfiltered air; 
 directing a stream of filtered air toward said syringe barrel in said environmentally controlled area to remove particles from 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; 
 air washing said tip cap in 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 including the step of packaging said prefilled syringe. 
     
     
       18. The method of  claim 16 , further including the step of sterilizing said prefilled syringe. 
     
     
       19. The method of  claim 16 , further including the steps of sterilizing said prefilled syringe followed by the step of packaging said prefilled syringe. 
     
     
       20. A method of producing a plastic drug or medical container comprising the steps of:
 forming a drug or medical container,   transferring said drug or medical container to an environmentally controlled area without exposing said drug or medical container to unfiltered air,   directing a filtered air stream towards at least one surface of said drug or medical container in said environmentally controlled area, and   applying a vacuum to remove particulates loosened from said drug or medical container within said environmentally controlled area.   
     
     
       21. The method of claim 20 further comprising the step of filling said drug or medical container with a substance. 
     
     
       22. The method of claim 21 further comprising the step of closing or sealing said substance within said drug or medical container. 
     
     
       23. A method of producing a plastic vial comprising the steps of:
 forming a vial,   transferring said vial to an environmentally controlled area without exposing said vial to unfiltered air,   directing a filtered air stream towards at least one surface of said vial in said environmentally controlled area, and   applying a vacuum to remove loosened particulates from said vial within said environmentally controlled area.   
     
     
       24. The method of claim 23 further comprising the step of filling said vial with a substance. 
     
     
       25. The method of claim 24 further comprising the step of closing or sealing said substance within said vial. 
     
     
       26. A method of producing a plastic ampoule comprising the steps of:
 forming an ampoule,   transferring said ampoule to an environmentally controlled area without exposing said ampoule to unfiltered air,   directing a filtered air stream towards at least one surface of said ampoule in said environmentally controlled area, and   applying a vacuum to remove particulates loosened from said ampoule within said environmentally controlled area.   
     
     
       27. The method of claim 26 further comprising the step of filling said ampoule with a substance. 
     
     
       28. The method of claim 27 further comprising the step of closing or sealing said substance within said ampoule.