Method and apparatus for manufacturing, filling and packaging medical devices and medical containers

Abstract

Medical devices such as medical containers can be formed of glass and annealed which produces a clean device having a low bio-burden, or formed by plastic molding which produces a clean device. The clean devices are immediately transferred to a controlled environment such as a clean room or localized area to avoid the need to maintain cleanliness levels in an entire room. Syringe tip closures can be introduced into the housing assembly, where syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. The syringe barrels can be filled with a substance and a closure member attached. While still in the housing assembly the syringe barrels can be formed into an array and placed in a clean outer container, which is then closed and sealed.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of U.S. Provisional Patent application U.S. Ser. No. 60 / 077,897 filed Mar. 13, 1998, U.S. Provisional Patent application U.S. Ser. No. 60 / 102,338 filed Sep. 29, 1998, is continue of U.S. patent application Ser. No. 09 / 267,107 filed Mar. 12, 1999, now U.S. Pat. No. 6,189,292, and is a continuation of U.S. patent application Ser. No. 09 / 678,080 filed Oct. 3, 2000, now U.S. Pat. No. 6,263,641, which are hereby incorporated by reference in their respective entireties.FIELD OF THE INVENTION[0002]The present invention relates generally to a method of manufacturing drug delivery and drug container devices, such as syringe components, and packaging the components in a clean, substantially particulate-free area. More particularly, the invention is directed to a method for manufacturing glass or plastic syringe barrels and assembling and packaging the syringe barrels in a clean room or locally controlled environme...

AI Technical Summary

Benefits of technology

The invention is a method and apparatus for manufacturing medical containers, such as syringes, in a way that ensures they are clean and free of bacteria. The containers are made from glass or plastic under controlled conditions to maintain their cleanliness standards. The method and apparatus involve manufacturing the containers, annealing them to remove any stresses, and then capturing them in an environmentally controlled area to prevent contamination. This allows for the production of medical containers that meet high standards of cleanliness and low bio-burden without the need for a water washing step.

Problems solved by technology

These syringes have the disadvantage of increasing the time and difficulty of filling the syringe at the point of use with increased possibility of contamination of the syringe and / or drug solution.

There is a further risk of glass particles from the ampoules contaminating the drug solution when the ampoules are opened.

A difficulty in producing prefilled syringes, if they are made of plastic rather than glass, is selecting suitable materials that maintain their clarity for extended periods of time and do not contaminate or react with the drug solution.

As people and equipment enter and leave the clean room, the risk of contamination and introduction of foreign particulates and pyrogens increases.

However, subsequent handling, filling and printing of the drug delivery device can contaminate the device.

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