JP2024516113A - 自動化シリンジ品質評価のための方法及びシステム - Google Patents

自動化シリンジ品質評価のための方法及びシステム Download PDF

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Publication number
JP2024516113A
JP2024516113A JP2023562211A JP2023562211A JP2024516113A JP 2024516113 A JP2024516113 A JP 2024516113A JP 2023562211 A JP2023562211 A JP 2023562211A JP 2023562211 A JP2023562211 A JP 2023562211A JP 2024516113 A JP2024516113 A JP 2024516113A
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JP
Japan
Prior art keywords
syringe
syringes
rack
plunger
container
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.)
Pending
Application number
JP2023562211A
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English (en)
Japanese (ja)
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JP2024516113A5 (enExample
Inventor
パドマクマール,ビカシュニ
クルチョーイー,エバン
コラー,ダニエル
ババトラ,オペイエミ
ロサス,オスカー
エバンス,グレゴリー
フロレス,スティーブン
Original Assignee
アムジエン・インコーポレーテツド
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Publication of JP2024516113A publication Critical patent/JP2024516113A/ja
Publication of JP2024516113A5 publication Critical patent/JP2024516113A5/ja
Pending legal-status Critical Current

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F22/00Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F11/00Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
    • G01F11/02Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement
    • G01F11/021Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type
    • G01F11/025Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type with manually operated pistons
    • G01F11/027Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type with manually operated pistons of the syringe type
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00594Quality control, including calibration or testing of components of the analyser
    • G01N35/00613Quality control
    • G01N35/00623Quality control of instruments
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01BMEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B11/00Measuring arrangements characterised by the use of optical techniques
    • G01B11/02Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness
    • G01B11/022Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness by means of tv-camera scanning
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00594Quality control, including calibration or testing of components of the analyser
    • G01N35/00613Quality control
    • G01N35/00663Quality control of consumables
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • GPHYSICS
    • G06COMPUTING OR CALCULATING; COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00Image analysis
    • G06T7/0002Inspection of images, e.g. flaw detection
    • G06T7/0004Industrial image inspection
    • GPHYSICS
    • G06COMPUTING OR CALCULATING; COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00Image analysis
    • G06T7/50Depth or shape recovery
    • 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
    • A61M2209/00Ancillary equipment
    • A61M2209/04Tools for specific apparatus
    • A61M2209/045Tools for specific apparatus for filling, e.g. for filling reservoirs
    • 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
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F23/00Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm
    • G01F23/22Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm by measuring physical variables, other than linear dimensions, pressure or weight, dependent on the level to be measured, e.g. by difference of heat transfer of steam or water
    • G01F23/28Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm by measuring physical variables, other than linear dimensions, pressure or weight, dependent on the level to be measured, e.g. by difference of heat transfer of steam or water by measuring the variations of parameters of electromagnetic or acoustic waves applied directly to the liquid or fluent solid material
    • G01F23/284Electromagnetic waves
    • G01F23/292Light, e.g. infrared or ultraviolet
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F25/00Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume
    • G01F25/0092Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume for metering by volume
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00594Quality control, including calibration or testing of components of the analyser
    • G01N35/00613Quality control
    • G01N35/00663Quality control of consumables
    • G01N2035/00673Quality control of consumables of reagents
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0474Details of actuating means for conveyors or pipettes
    • G01N2035/0491Position sensing, encoding; closed-loop control
    • GPHYSICS
    • G06COMPUTING OR CALCULATING; COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00Indexing scheme for image analysis or image enhancement
    • G06T2207/30Subject of image; Context of image processing
    • G06T2207/30108Industrial image inspection

Landscapes

  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Fluid Mechanics (AREA)
  • Quality & Reliability (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Electromagnetism (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Theoretical Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Thermal Sciences (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Manipulator (AREA)
JP2023562211A 2021-04-22 2022-04-12 自動化シリンジ品質評価のための方法及びシステム Pending JP2024516113A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163178339P 2021-04-22 2021-04-22
US63/178,339 2021-04-22
PCT/US2022/024331 WO2022225736A1 (en) 2021-04-22 2022-04-12 Methods and systems for automated syringe quality evaluation

Publications (2)

Publication Number Publication Date
JP2024516113A true JP2024516113A (ja) 2024-04-12
JP2024516113A5 JP2024516113A5 (enExample) 2025-04-02

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JP2023562211A Pending JP2024516113A (ja) 2021-04-22 2022-04-12 自動化シリンジ品質評価のための方法及びシステム

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EP (1) EP4327056A1 (enExample)
JP (1) JP2024516113A (enExample)
KR (1) KR20230171939A (enExample)
CN (1) CN117178172A (enExample)
AU (1) AU2022261835B2 (enExample)
BR (1) BR112023021779A2 (enExample)
CA (1) CA3211664A1 (enExample)
CL (3) CL2023003135A1 (enExample)
IL (1) IL305562A (enExample)
MX (1) MX2023011513A (enExample)
WO (1) WO2022225736A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4408504A1 (en) * 2021-09-29 2024-08-07 Amgen Inc. Apparatuses, systems and methods for plunger-stopper depth measurement in pre-filled syringes

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9881367B1 (en) * 2017-08-09 2018-01-30 Amgen Inc. Image processing techniques for plunger depth measurement
WO2019032101A1 (en) * 2017-08-09 2019-02-14 Amgen Inc. IMAGE PROCESSING TECHNIQUES FOR PISTON DEPTH MEASUREMENT
JP2021503976A (ja) * 2017-11-23 2021-02-15 オムニセル, インコーポレイテッド Iv調合用のマルチカメラ撮影

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS51829B (sr) 2001-08-23 2012-02-29 Genmab A/S. Ljudska antitela specifična za interleukin 15 (il-15)
US7499581B2 (en) * 2005-02-10 2009-03-03 Forhealth Technologies, Inc. Vision system to calculate a fluid volume in a container
US8161810B2 (en) * 2008-01-29 2012-04-24 Carefusion 303, Inc. Syringe imaging systems
US20180154088A1 (en) * 2016-12-01 2018-06-07 Ebroselow, Llc Method of verifying and logging syringe drug dosages in real time

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9881367B1 (en) * 2017-08-09 2018-01-30 Amgen Inc. Image processing techniques for plunger depth measurement
WO2019032101A1 (en) * 2017-08-09 2019-02-14 Amgen Inc. IMAGE PROCESSING TECHNIQUES FOR PISTON DEPTH MEASUREMENT
JP2021503976A (ja) * 2017-11-23 2021-02-15 オムニセル, インコーポレイテッド Iv調合用のマルチカメラ撮影

Also Published As

Publication number Publication date
AU2022261835B2 (en) 2026-03-12
CA3211664A1 (en) 2022-10-27
EP4327056A1 (en) 2024-02-28
IL305562A (en) 2023-10-01
KR20230171939A (ko) 2023-12-21
MX2023011513A (es) 2023-10-05
WO2022225736A1 (en) 2022-10-27
CN117178172A (zh) 2023-12-05
CL2023003135A1 (es) 2024-02-23
CL2025003266A1 (es) 2025-12-12
BR112023021779A2 (pt) 2023-12-26
CL2025003271A1 (es) 2026-01-09
US20240210428A1 (en) 2024-06-27
AU2022261835A1 (en) 2023-08-31

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