Method and apparatus for assembling and packaging medical devices

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.