초록 ▼

This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a c

This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment; manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment; decontaminating the plunger cover and tip seal; lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal; assembling the barrel and tip seal to form a barrel/tip seal combination; assembling the plunger cover and plunger substrate to form a plunger; filling the barrel/tip seal combination with a predetermined amount of fluid; and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination. When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe.

대표청구항 ▼

[ We claim:] [1.] A process of manufacturing a syringe, the process comprising:molding a barrel and a plunger substrate within at least a class 100 environment, without subsequently washing the barrel and the plunger substrate;packaging the barrel and plunger substrate within at least a class 100 en

[ We claim:] [1.] A process of manufacturing a syringe, the process comprising:molding a barrel and a plunger substrate within at least a class 100 environment, without subsequently washing the barrel and the plunger substrate;packaging the barrel and plunger substrate within at least a class 100 environment, thereby maintaining the barrel and the plunger substrate substantially free of contaminants;molding a plunger cover and a tip seal within an environment less clean than a class 100 environment;packaging the plunger cover and the tip seal within at least a class 100 environment, thereby maintaining the plunger cover and the tip seal substantially free of contaminants;transporting the packaged barrel and the packaged tip seal to a first assembly site having at least a class 100 environment;unpackaging the barrel and the tip seal within the at least class 100 environment at the first assembly site;assembling the unpackaged tip seal to the unpackaged barrel within the at least class 100 environment at the first assembly site, thereby providing a barrel/tip seal combination;transporting the packaged plunger substrate and the packaged plunger cover to a second assembly site having at least a class 100 environment;unpackaging the plunger substrate and the plunger cover within the at least class 100 environment at the second assembly site;assembling the unpackaged plunger cover to the unpackaged plunger substrate within the at least class 100 environment at the second assembly site, thereby providing a plunger assembly;packaging the barrel/tip seal combination within at least a class 100 environment, thereby maintaining the barrel/tip seal combination substantially free of contaminants;packaging the plunger assembly within at least a class 100 environment, thereby maintaining the plunger assembly substantially free of contaminants;transporting the packaged barrel/tip seal combination and the packaged plunger assembly to a final assembly site having least a class 100 environment;unpackaging the barrel/tip seal combination and the plunger assembly within the at least class 100 environment at the final assembly site; andassembling the unpackaged plunger assembly to the unpackaged barrel/tip seal combination within the at least class 100 environment at the final assembly site.