Drug cartridge assembly and method of manufacture
First Claim
1. A method of preparing a sterile drug cartridge assembly, comprising:
- providing a drug cartridge;
providing a nozzle sub-assembly, where the drug cartridge and nozzle-sub-assembly are adapted to be engaged together to enable ejection of liquid from the drug cartridge out through the nozzle sub-assembly;
assembling the nozzle subassembly and otherwise preparing the nozzle sub-assembly for sterilization in a first cleanroom;
sterilizing the nozzle sub-assembly;
sterilizing the drug cartridge; and
positioning the drug cartridge in a ready-to-use position within the nozzle sub-assembly, and filling and sealing the drug cartridge, where the positioning, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate-per-volume rating which is at least ten times lower than that of the first cleanroom.
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Accused Products
Abstract
A method of manufacture for a drug cartridge assembly. The method includes providing a drug cartridge, providing a nozzle sub-assembly, and sterilizing the drug cartridge and nozzle sub-assembly. The method further includes assembling the drug cartridge and nozzle sub-assembly together in a configuration that enables ejection of liquid out of the drug cartridge through the nozzle sub-assembly. The method further includes filling the drug cartridge with a liquid, such as an injectable drug. The method may include separate sterilization of the drug cartridge and nozzle sub-assembly, using different sterilization processes. Portions of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom having a substantially lower particulate-per-volume rating than the first cleanroom.
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Citations
14 Claims
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1. A method of preparing a sterile drug cartridge assembly, comprising:
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providing a drug cartridge;
providing a nozzle sub-assembly, where the drug cartridge and nozzle-sub-assembly are adapted to be engaged together to enable ejection of liquid from the drug cartridge out through the nozzle sub-assembly;
assembling the nozzle subassembly and otherwise preparing the nozzle sub-assembly for sterilization in a first cleanroom;
sterilizing the nozzle sub-assembly;
sterilizing the drug cartridge; and
positioning the drug cartridge in a ready-to-use position within the nozzle sub-assembly, and filling and sealing the drug cartridge, where the positioning, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate-per-volume rating which is at least ten times lower than that of the first cleanroom. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of manufacturing a medical device, comprising:
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separating a glass drug container of the medical device from another component of the medical device;
sterilizing the glass drug container separately from the other component of the medical device, where the glass drug container is sterilized with a thermal-based sterilization process, and where the other component is sterilized using a radiation-based sterilization process;
filling the glass drug container with a metered dose of an injectable drug;
assembling the glass drug container with the other component of the medical device; and
disposing the glass drug container and the other component of the medical device within a sterile package.
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14. A method of manufacturing a sterile injection device, comprising:
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providing a liquid container;
providing a nozzle sub-assembly, where the liquid container and nozzle-sub-assembly are adapted to be engaged together to enable ejection of liquid from the liquid container out through the nozzle sub-assembly;
preparing the nozzle sub-assembly for sterilization, where such preparation is performed in a first cleanroom;
sterilizing the nozzle sub-assembly via irradiation;
sterilizing the liquid container separately from the nozzle sub-assembly using a thermal sterilization process; and
securing the liquid container and nozzle sub-assembly together, and filling and sealing the liquid container, where the securing, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate-per-volume rating which is at least ten times lower than that of the first cleanroom.
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Specification