Medrad, Inc.

Michelle Robinson

Eugene A Gelblum

Ralph E Wolstenholme

Mark Lawecki

Eugene B Wolstenholme

David M Reilly

Edward J Rhinehart

Mark W Hitchins

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.

Manufacture of prefilled syringes

An apparatus and method are provided for manufacturing articles, such as syringe barrels, substantially free from contaminants. The apparatus is an enclosure defining at least a class 100 and MCB-3 environment, and includes a molding isolation module and a packaging isolation module. Any contaminants that may exist within the enclosure are removed by the use of horizontal and vertical laminar airflows directed into air filter units. Further, the molding temperature may be selected such that it renders the fabricated articles substantially free from contaminants. The molding isolation module and packaging isolation module keep the fabricated articles substantially free from contaminants from the time the articles are molded to the time the articles are placed in sealed containers for shipment.

Molding and packaging articles substantially free from contaminants

Isolation module for molding and packaging articles substantially free

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Zelienople, PA, United States of America

Michelle Robinson