Drug cartridge assembly and method of manufacture

• US 6,883,222 B2
• Filed: 10/16/2002
• Issued: 04/26/2005
• Est. Priority Date: 10/16/2002
• Status: Expired due to Term

• Current Assignee: Inovio Pharmaceuticals, Inc.
• Original Assignee: Bioject Incorporated
• Inventors: Landau, Sergio
• Primary Examiner(s): Bryant, David P.
• Assistant Examiner(s): Kenny, Stephen
• Application Number:
  US10/272,689
• Publication Number:
  US 20040074076A1
• Time in Patent Office: 923 Days
• Field of Search: 294/28, 294/29, 294/58, 294/69, 534/25, 534/26, 534/32, 535/11, 604/403
• US Class Current: 29/469
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 2005/2462 by displacing occluding plugs
• CPC Class Codes: A61M 2005/2488 via rotation, e.g. threads or bayonet
• CPC Class Codes: A61M 2005/287 by displacing occluding plugs
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: Y10T 29/49904 Assembling a subassembly, then assembling with a second subassembly

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.

Claims

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.

2. The method of claim 1, where preparing the nozzle sub-assembly includes providing a nozzle having a nozzle opening to accommodate ejection of liquid, and positioning a sealing mechanism adjacent the nozzle opening so that the sealing mechanism covers the nozzle opening.

3. The method of claim 1, where sterilizing the nozzle sub-assembly is performed with a radiation-based sterilization process.

4. The method of claim 3, where sterilizing the nozzle sub-assembly is performed using gamma radiation.

5. The method of claim 3, where sterilizing the drug cartridge is performed with a thermal sterilization process, and is performed separately from sterilization of the nozzle sub-assembly.

6. The method of claim 1, where sterilization of the nozzle sub-assembly and drug cartridge are performed separately using different sterilization processes.

7. The method of claim 1, further comprising washing the drug cartridge.

8. The method of claim 1, further comprising depyrogenizing the drug cartridge.

9. The method of claim 1, further comprising siliconizing the drug cartridge.

10. The method of claim 1, where sealing the drug cartridge includes securing a valve structure between an opening in the nozzle sub-assembly and an opening in the drug cartridge.

11. The method of claim 10, where sealing the drug cartridge further includes disposing a plunger within another opening of the drug cartridge.

12. The method of claim 1, where the first cleanroom is a class 10,000 cleanroom and the second cleanroom is a class 100 cleanroom.

13. A method of manufacturing a medical device, comprising:

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.

14. A method of manufacturing a sterile injection device, comprising:

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.