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

[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.

[0014]Another object of the invention is to provide a method and apparatus for producing clean medical containers and delivering the device

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 tha

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