US 6,263,641 B1 · Method and apparatus for manufacturing, filling and packaging medical devices and medical containers

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.

Claims29

Dependent claims

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.

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.

4 more elements

Dependencies are inferred from the claim text.

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

Life of this patent

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

Life of this patent

Abstract

Claims29