Method and apparatus for assembling and packaging medical devices
First Claim
1. A method of producing a prefillable syringe barrel assembly comprising the steps of:
- supplying a plurality of syringe barrels and a plurality of tip closures to at least one housing assembly having an air filtering device to maintain a predetermined cleanliness level,coupling said tip closures to said syringe barrels within said housing assembly to form syringe barrel assemblies,directing filtered air onto said syringe barrel assemblies to clean outer surfaces of said syringe barrel assemblies,directing filtered air to loosen particulates from inner surfaces of said syringe barrel assemblies and applying a vacuum to remove loosened particulates, and applying a lubricant to said inner surfaces of said syringe barrel assemblies,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, andplacing said containers in another container and sealing said another container while in said housing assembly.
1 Assignment
0 Petitions
Accused Products
Abstract
A housing assembly is provided to define a locally controlled environment to maintain a localized clean work area without the need to maintain cleanliness levels in an entire room as in conventional clean rooms. The housing assembly includes a HEPA filter coupled to an air inlet to filter all of 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. Prefillable medical containers, such as syringe barrels and syringe tip closures, are introduced into the housing assembly where the syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. A thin coating of a lubricant is applied to the inner surface of each of the syringe barrels. The syringe barrels can be filled with a substance. Alternatively, while still in the housing assembly the syringe barrels can be formed into an array and placed in a clean container. A cover is then attached to the tub to completely enclose the array of syringe barrels followed by an outer wrap. Thereafter, the syringe barrels either filled or packaged in the array can be sterilized. The syringe barrels may be prefillable plastic syringe barrels made of a cyclic polyolefin copolymer or polypropylene.
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Citations
44 Claims
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1. A method of producing a prefillable syringe barrel assembly comprising the steps of:
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supplying a plurality of syringe barrels and a plurality of tip closures to at least one housing assembly having an air filtering device to maintain a predetermined cleanliness level, coupling said tip closures to said syringe barrels within said housing assembly to form syringe barrel assemblies, directing filtered air onto said syringe barrel assemblies to clean outer surfaces of said syringe barrel assemblies, directing filtered air to loosen particulates from inner surfaces of said syringe barrel assemblies and applying a vacuum to remove loosened particulates, and applying a lubricant to said inner surfaces of said syringe barrel assemblies, 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, and placing said containers in another container and sealing said another container while in said housing assembly. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of producing a prefilled medical container comprising the steps of:
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supplying a plurality of medical containers to a first housing assembly having an air filtering device to maintain a predetermined cleanliness level, directing a filtered air stream to loosen particulates from inner surfaces of said medical containers and applying a vacuum to remove loosened particulates from said medical containers prior to filling, and filling said medical containers with a substance and closing said containers. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A method of producing packaged prefillable syringe barrel assemblies comprising the steps of:
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supplying a plurality of syringe barrels and a plurality of tip caps to a first housing assembly for maintaining a locally controlled environment, said first housing assembly having an air filtering device for introducing filtered air into said first housing assembly and maintaining a predetermined cleanliness level in said first housing assembly, coupling said tip caps to said syringe barrels to form syringe barrel assemblies, cleaning at least one surface of said syringe barrel assemblies, conveying said syringe barrel assemblies to a second housing assembly and applying a coating of a lubricant to inner surfaces of said syringe barrel assemblies in said second housing assembly, and forming an array of said syringe barrel assemblies, placing said array in a container, and closing and sealing said container to form said packaged refillable syringe barrel assemblies. - View Dependent Claims (34, 35, 36, 37, 38)
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39. A method of producing packaged prefillable syringe barrel assemblies comprising the steps of:
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supplying a plurality of syringe barrels and a plurality of tip caps to at least one housing assembly for maintaining a locally controlled environment, said at least one housing assembly having an air filtering device for introducing filtered air into said at least one housing assembly and maintaining a predetermined cleanliness level in said at least one housing assembly, coupling said tip caps to said syringe barrels to form syringe barrel assemblies, cleaning at least one surface of said syringe barrel assemblies, forming an array of said syringe barrel assemblies, placing said array in a container, positioning a protective sheet over said array of syringe barrel assemblies in said container and applying a cover sheet to said container and thereafter sealing said cover sheet to said container to form said packaged prefillable syringe barrel assemblies, said steps of coupling, cleaning, forming and sealing being carried out in said at least one housing assembly. - View Dependent Claims (40, 41, 42, 43, 44)
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Specification