Michelle Robinson

US Patent:

61891959, Feb 20, 2001

Filed:

Aug 22, 1995

Appl. No.:

8/517645

Inventors:

David M. Reilly - Glenshaw PA
Edward J. Rhinehart - Monroeville PA
Eugene A. Gelblum - Mt. Lebanon PA
Mark W. Hitchins - Sewickley PA
Michelle Robinson - Zelienople PA

Assignee:

Medrad, Inc. - Indianola PA

International Classification:

B23P 1500

US Classification:

29434

Abstract:

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.