CA2502888A1 - Drug cartridge assembly and method of manufacture - Google Patents

Drug cartridge assembly and method of manufacture Download PDF

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Publication number
CA2502888A1
CA2502888A1 CA002502888A CA2502888A CA2502888A1 CA 2502888 A1 CA2502888 A1 CA 2502888A1 CA 002502888 A CA002502888 A CA 002502888A CA 2502888 A CA2502888 A CA 2502888A CA 2502888 A1 CA2502888 A1 CA 2502888A1
Authority
CA
Canada
Prior art keywords
assembly
drug cartridge
nozzle
cleanroom
nozzle sub
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002502888A
Other languages
French (fr)
Other versions
CA2502888C (en
Inventor
Sergio Landau
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bioject Inc
Original Assignee
Bioject, Inc.
Sergio Landau
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bioject, Inc., Sergio Landau filed Critical Bioject, Inc.
Publication of CA2502888A1 publication Critical patent/CA2502888A1/en
Application granted granted Critical
Publication of CA2502888C publication Critical patent/CA2502888C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • A61L2/081Gamma radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A61M2005/2462Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485Ampoule holder connected to rest of syringe
    • A61M2005/2488Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A61M2005/287Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104Caps for syringes without needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M2005/3132Syringe barrels 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00Methods of manufacture, assembly or production
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/1782Devices aiding filling of syringes in situ
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • Y10T29/49904Assembling 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 (27)

1. A method of manufacturing a drug cartridge assembly, where the drug cartridge assembly includes a pre-filled drug cartridge connected with a nozzle sub-assembly that is configured to facilitate injection of liquid from the drug cartridge through an opening in the nozzle sub-assembly, the method comprising:
pre-assembling the nozzle sub-assembly;
sterilizing the pre-assembled nozzle sub-assembly with a radiation-based sterilization process;
sterilizing the drug cartridge with a separate, thermal-based sterilization process;
filling the drug cartridge; and disposing the drug cartridge in a ready-to-use position within the nozzle sub-assembly.
2. The method of claim 1, further comprising sealing the drug cartridge.
3. The method of claim 2, where sealing the drug cartridge includes securing a valve structure to one opening of the drug cartridge, and disposing a plunger within another opening of the drug cartridge.
4. The method of claim 2, where sealing the drug cartridge includes:
positioning a sealing structure adjacent the opening in the nozzle sub-assembly so that the sealing structure covers the opening; and engaging an open end of the drug cartridge with the sealing structure after the sealing structure is positioned over the opening in the nozzle sub-assembly.
5. The method of claim 1, further comprising placing the drug cartridge and nozzle sub-assembly within a sterile package after the drug cartridge has been filled and positioned within the nozzle sub-assembly.
6. The method of claim 1, wherein the step of pre-assembling the nozzle sub-assembly is performed within a first cleanroom.
7. The method of claim 6, where filling the drug cartridge and positioning the drug cartridge -within the nozzle sub-assembly is 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.
8. The method of claim 7, where the first cleanroom is a class 10,000 cleanroom, and where the second cleanroom is a class 100 cleanroom.
9. The method of claim 1, where the nozzle sub-assembly is sterilized using gamma radiation.
10. The method of claim 1, further comprising assembling the nozzle sub-assembly prior to sterilization of the nozzle sub-assembly.
11. The method of claim 10, where assembling the nozzle sub-assembly includes providing a nozzle having a nozzle opening adapted to accommodate passage of liquid, and positioning a sealing structure adjacent the nozzle opening so that the sealing structure covers the opening.
12. The method of claim 11, further comprising engaging the drug cartridge with the sealing structure so that the sealing structure seals between an opening of the drug cartridge and the nozzle opening of the nozzle.
13. The method of claim 12, where the filling of the drug cartridge occurs after the drug cartridge has been engaged with the sealing structure.
14. 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.
15. The method of claim 14, 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.
16. The method of claim 14, where sterilizing the nozzle sub-assembly is performed with a radiation-based sterilization process.
17. The method of claim 16, where sterilizing the nozzle sub-assembly is performed using gamma radiation.
18. The method of claim 16, where sterilizing the drug cartridge is performed with a thermal sterilization process, and is performed separately from sterilization of the nozzle sub-assembly.
19. The method of claim 14, where sterilization of the nozzle sub-assembly and drug cartridge are performed separately using different sterilization processes.
20. The method of claim 14, further comprising washing the drug cartridge.
21. The method of claim 14, further comprising depyrogenizing the drug cartridge.
22. The method of claim 14, further comprising siliconizing the drug cartridge.
23. The method of claim 14, 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.
24. The method of claim 23, where sealing the drug cartridge further includes disposing a plunger within another opening of the drug cartridge.
25. The method of claim 14, where the first cleanroom is a class 10,000 cleanroom and the second cleanroom is a class 100 cleanroom.
26. 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.
27. 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.
CA2502888A 2002-10-16 2003-08-28 Drug cartridge assembly and method of manufacture Expired - Fee Related CA2502888C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/272,689 2002-10-16
US10/272,689 US6883222B2 (en) 2002-10-16 2002-10-16 Drug cartridge assembly and method of manufacture
PCT/US2003/027192 WO2004035107A2 (en) 2002-10-16 2003-08-28 Drug cartridge assembly and method of manufacture

Publications (2)

Publication Number Publication Date
CA2502888A1 true CA2502888A1 (en) 2004-04-29
CA2502888C CA2502888C (en) 2012-07-10

Family

ID=32092638

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2502888A Expired - Fee Related CA2502888C (en) 2002-10-16 2003-08-28 Drug cartridge assembly and method of manufacture

Country Status (8)

Country Link
US (1) US6883222B2 (en)
EP (1) EP1551476B1 (en)
JP (1) JP2006502803A (en)
AT (1) ATE491545T1 (en)
AU (1) AU2003273259A1 (en)
CA (1) CA2502888C (en)
DE (1) DE60335395D1 (en)
WO (1) WO2004035107A2 (en)

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ATE491545T1 (en) 2011-01-15
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WO2004035107A2 (en) 2004-04-29
AU2003273259A1 (en) 2004-05-04

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