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

[0011]Accordingly, a primary object of the invention is to manufacture medical container devices immediately upstream of at least one housing assembly which defines a locally controlled environment. The medical containers are manufactured from glass or plastic under conditions which produce a substantially clean and sterile part. The housing assembly receives the medical containers directly from the manufacturing apparatus without a prior cleaning step so that the containers can be assembled within the housing assembly under controlled conditions to maintain predetermined cleanliness standards for medical containers and devices.

[0012]Another object of the invention is to provide a method for manufacturing a substantially clean and low bio-burden medical containers, such as a syringe barrel and assembling the syringe barrel with various components, such as a tip closure or Luer lock, in a locally controlled environment without the need for a water washing step.

[0013]A further object of the invention is to provide a method and apparatus for forming glass medical containers, such as drug delivery devices or components, annealing the glass medical containers, and then immediately capturing the annealed container in an environmentally controlled area to maintain a predetermined cleanliness and low bio-burden. The annealed glass medical containers are captured from the annealing oven in a manner to maintain the cleanliness and low bio-burden to avoid a mandatory cleaning step. The environmentally controlled area can be a clean room or a locally controlled environment.

[0015]In embodiments of the invention, the medical containers are glass syringe barrels, and particularly prefillable glass syringe barrels, manufactured by processes which produce substantially clean and low bio-burden or sterile syringe barrels. The glass syringe barrels are made from cylindrical glass tubes that are cut to a desired length. The tubes are then fed to a forming machine which in one embodiment heats the ends of the tubes and forms a flange at one end and a tip at the opposite end. The glass syringe barrels are annealed by heating in a Lehr or annealing oven to at least about 560° C. for an appropriate time to relieve stresses in the glass. The annealing produces a clean and low bio-burden syringe barrel which is then immediately transferred to an environmentally controlled area substantially without contamination.

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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