WO2014087247A3 - Validation techniques for fluid delivery systems - Google Patents

Validation techniques for fluid delivery systems Download PDF

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Publication number
WO2014087247A3
WO2014087247A3 PCT/IB2013/003163 IB2013003163W WO2014087247A3 WO 2014087247 A3 WO2014087247 A3 WO 2014087247A3 IB 2013003163 W IB2013003163 W IB 2013003163W WO 2014087247 A3 WO2014087247 A3 WO 2014087247A3
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
fluid delivery
delivery systems
container
delivery system
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.)
Ceased
Application number
PCT/IB2013/003163
Other languages
French (fr)
Other versions
WO2014087247A2 (en
Inventor
Robert C. Williams
Patrice Marchildon
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.)
Bracco Imaging SpA
Original Assignee
Bracco Imaging SpA
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
Priority to KR1020157017976A priority Critical patent/KR102177981B1/en
Priority to EP13861020.9A priority patent/EP2928521B1/en
Priority to ES13861020.9T priority patent/ES2663472T3/en
Priority to AU2013353762A priority patent/AU2013353762B2/en
Priority to PL13861020T priority patent/PL2928521T3/en
Priority to CA2893809A priority patent/CA2893809C/en
Application filed by Bracco Imaging SpA filed Critical Bracco Imaging SpA
Priority to CN201380071094.5A priority patent/CN104936636B/en
Publication of WO2014087247A2 publication Critical patent/WO2014087247A2/en
Publication of WO2014087247A3 publication Critical patent/WO2014087247A3/en
Anticipated expiration legal-status Critical
Priority to AU2017203853A priority patent/AU2017203853A1/en
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
    • G01M3/28—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds
    • G01M3/2853—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds for pipe joints or seals
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22—Testing for sterility conditions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/26—Accessories
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1413—Modular systems comprising interconnecting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14232—Roller pumps
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/18—Testing for antimicrobial activity of a material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
    • G01N31/226—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating the degree of sterilisation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
    • G01N2013/003—Diffusion; diffusivity between liquids
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/13—Tracers or tags

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • General Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Pathology (AREA)
  • Urology & Nephrology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Toxicology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross- contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.
PCT/IB2013/003163 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems Ceased WO2014087247A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP13861020.9A EP2928521B1 (en) 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems
ES13861020.9T ES2663472T3 (en) 2012-12-05 2013-12-05 Validation techniques for fluid management systems
AU2013353762A AU2013353762B2 (en) 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems
PL13861020T PL2928521T3 (en) 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems
CA2893809A CA2893809C (en) 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems
KR1020157017976A KR102177981B1 (en) 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems
CN201380071094.5A CN104936636B (en) 2012-12-05 2013-12-05 Verification technique for fluid delivery system
AU2017203853A AU2017203853A1 (en) 2012-12-05 2017-06-07 Validation techniques for fluid delivery systems

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261733825P 2012-12-05 2012-12-05
US61/733,825 2012-12-05

Publications (2)

Publication Number Publication Date
WO2014087247A2 WO2014087247A2 (en) 2014-06-12
WO2014087247A3 true WO2014087247A3 (en) 2015-01-08

Family

ID=50825786

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2013/003163 Ceased WO2014087247A2 (en) 2012-12-05 2013-12-05 Validation techniques for fluid delivery systems

Country Status (11)

Country Link
US (5) US9228220B2 (en)
EP (1) EP2928521B1 (en)
KR (1) KR102177981B1 (en)
CN (1) CN104936636B (en)
AU (2) AU2013353762B2 (en)
CA (2) CA2893809C (en)
ES (1) ES2663472T3 (en)
PL (1) PL2928521T3 (en)
PT (1) PT2928521T (en)
TR (1) TR201806688T4 (en)
WO (1) WO2014087247A2 (en)

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US9228220B2 (en) 2012-12-05 2016-01-05 Bracco Imaging S.P.A. Validation techniques for fluid delivery systems
JP6219760B2 (en) * 2014-03-26 2017-10-25 株式会社日立ハイテクサイエンス ICP emission spectrometer
US9546933B2 (en) 2014-07-30 2017-01-17 The Boeing Company Determining aerosol material compatibility
US9987416B2 (en) 2015-01-09 2018-06-05 BioQuiddity Inc. Sterile assembled liquid medicament dosage control and delivery device
EP3509953A1 (en) 2016-09-09 2019-07-17 The Procter and Gamble Company System and method for simultaneously filling containers of different shapes and/or sizes
CN109661623A (en) 2016-09-09 2019-04-19 宝洁公司 Method for the simultaneous production of different products on a single production line
US10996232B2 (en) 2016-09-09 2021-05-04 The Procter & Gamble Company System and method for independently routing container-loaded vehicles to create different finished products
US11584628B2 (en) 2016-09-09 2023-02-21 The Procter & Gamble Company System and method for independently routing vehicles and delivering containers and closures to unit operation systems
JP6810253B2 (en) 2016-09-09 2021-01-06 ザ プロクター アンド ギャンブル カンパニーＴｈｅ Ｐｒｏｃｔｅｒ ＆ Ｇａｍｂｌｅ Ｃｏｍｐａｎｙ Systems and methods for producing products on demand
US10640249B2 (en) 2016-09-09 2020-05-05 The Procter & Gamble Company Track system for creating finished products
EP3509795B1 (en) 2016-09-09 2020-07-29 The Procter and Gamble Company Vacuum holder with extensible skirt gasket
CA3035965C (en) 2016-09-09 2022-01-11 The Procter & Gamble Company System and method for simultaneously filling containers with different fluent compositions
JP7022767B2 (en) 2017-05-11 2022-02-18 イー・エム・デイー・ミリポア・コーポレイシヨン How to maintain a narrow residence time distribution in a continuous flow system
EP3621715A4 (en) * 2017-05-11 2021-01-27 EMD Millipore Corporation MECHANICAL PROCESS FOR MAINTAINING THE DISTRIBUTION OF RESIDENTIAL TIME LIMITED IN CONTINUOUS FLOW SYSTEMS
WO2019199622A1 (en) 2018-04-10 2019-10-17 The Procter & Gamble Company Method and apparatus for flexibly assembling packages of absorbent articles
CN110384875B (en) * 2018-04-23 2021-02-19 刘泽英 Implantable ultrasonic conduction and drug delivery device
US10994116B2 (en) 2018-06-30 2021-05-04 Bioq Pharma Incorporated Drug cartridge-based infusion pump
DK3823693T3 (en) * 2018-07-17 2025-08-18 Acist Medical Sys Inc IMPROVED INJECTION SYSTEM AND PATIENT SEATING DEVICE THEREFOR
US11338082B2 (en) 2019-09-04 2022-05-24 BloQ Pharma, Inc. Variable rate dispenser with aseptic spike connector assembly
JP2026511247A (en) * 2023-03-28 2026-04-10 バイエル・ヘルスケア・エルエルシー Convenient single-dose MR contrast agent package and accurate delivery system

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US20120179130A1 (en) * 2011-01-06 2012-07-12 Carefusion 303, Inc. Integrated infusion pump and container

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US20120179130A1 (en) * 2011-01-06 2012-07-12 Carefusion 303, Inc. Integrated infusion pump and container

Also Published As

Publication number Publication date
CA2982031C (en) 2019-06-11
US9228222B2 (en) 2016-01-05
KR102177981B1 (en) 2020-11-13
KR20150095744A (en) 2015-08-21
ES2663472T3 (en) 2018-04-12
US20140154671A1 (en) 2014-06-05
TR201806688T4 (en) 2018-06-21
CA2982031A1 (en) 2014-06-12
AU2017203853A1 (en) 2017-06-22
EP2928521A2 (en) 2015-10-14
AU2013353762A1 (en) 2015-06-18
US20140301912A1 (en) 2014-10-09
EP2928521B1 (en) 2018-02-14
CN104936636A (en) 2015-09-23
CN104936636B (en) 2017-12-15
US9228220B2 (en) 2016-01-05
CA2893809C (en) 2017-11-28
US9260741B2 (en) 2016-02-16
PL2928521T3 (en) 2018-07-31
PT2928521T (en) 2018-03-29
US9228221B2 (en) 2016-01-05
US20140154670A1 (en) 2014-06-05
US20140301913A1 (en) 2014-10-09
US20160161358A1 (en) 2016-06-09
AU2013353762B2 (en) 2017-05-25
CA2893809A1 (en) 2014-06-12
WO2014087247A2 (en) 2014-06-12

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