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 is a continuation of U.S. patent application Ser. No. 11 / 525,186 filed on Sep. 21, 2006, which is a Reissue of U.S. patent application Ser. No. 09 / 897,309 filed on Jul. 2, 2001 (now U.S. Pat. No. 6,792,743), which is a continuation of U.S. patent application Ser. No. 09 / 678,080 filed on Oct. 3, 2000 (now U.S. Pat. No. 6,263,641), which is a continuation of U.S. patent application Ser. No. 09 / 267,107 filed on Mar. 12, 1999 (now U.S. Pat. No. 6,189,292), which claims priority to U.S. Provisional Application Ser. No. 60 / 102,338 filed on Sep. 29, 1998 and U.S. Provisional Application Ser. No. 60 / 077,897, filed on Mar. 13, 1998, the entire disclosures of each of 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 ...

AI Technical Summary

Benefits of technology

This approach ensures that medical containers are produced with low bio-burden and sterility, reducing the need for additional cleaning steps and maintaining cleanliness standards throughout the manufacturing and assembly process, thereby minimizing contamination risks.

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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