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 filled syringe made in accordance with a method 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 into an environmentally controlled area 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 syringe barrel to form a prefilled syringe; and   removing said prefilled syringe from said environmentally controlled area.   
     
     
         2 . The filled syringe of  claim 1 , wherein the method further comprises a step of packaging said prefilled syringe. 
     
     
         3 . The filled syringe of  claim 1 , wherein the method further comprises a step of sterilizing said prefilled syringe. 
     
     
         4 . The filled syringe of  claim 1 , wherein the method further includes a step of sterilizing said prefilled syringe followed by a step of packaging said prefilled syringe. 
     
     
         5 . A filled syringe made in accordance with a method 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 into an environmentally controlled area without exposing said syringe barrel to unfiltered air;   directing a stream of filtered are 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.   
     
     
         6 . The filled syringe of  claim 5 , wherein the method further comprises a step of packaging said prefilled syringe. 
     
     
         7 . The filled syringe of  claim 5 , wherein the method further comprises a step of sterilizing said prefilled syringe. 
     
     
         8 . The filled syringe of  claim 5 , wherein the method further includes a step of sterilizing said prefilled syringe followed by a step of packaging said prefilled syringe. 
     
     
         9 . A plastic drug or medical container made in accordance with a method comprising the steps of:
 forming said medical or drug 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.   
     
     
         10 . The drug or medical container of  claim 9 , wherein the method further comprises a step of filling said drug or medical container with a substance. 
     
     
         11 . The drug or medical container of  claim 10 , wherein the method further comprises a step of closing or sealing said substance within said drug or medical container. 
     
     
         12 . A plastic vial made in accordance with a method comprising the steps of:
 forming said 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.   
     
     
         13 . The vial of  claim 12 , wherein the method further comprises a step of filling said vial with a substance. 
     
     
         14 . The vial of  claim 13 , wherein the method further comprises a step of closing or sealing said substance within said vial. 
     
     
         15 . A plastic ampoule made in accordance with a method comprising the steps of:
 forming said 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.   
     
     
         16 . The ampoule of  claim 15 , wherein the method further comprises a step of filling said ampoule with a substance. 
     
     
         17 . The ampoule of  claim 16 , wherein the method further comprises a step of closing or sealing said substance within said ampoule.