BR112018074925A2 - método para esterilizar por eto uma seringa pré-carregada, método para esterilizar um kit cirúrgico, e método para esterilizar um recipiente pré-carregado - Google Patents

método para esterilizar por eto uma seringa pré-carregada, método para esterilizar um kit cirúrgico, e método para esterilizar um recipiente pré-carregado

Info

Publication number
BR112018074925A2
BR112018074925A2 BR112018074925-7A BR112018074925A BR112018074925A2 BR 112018074925 A2 BR112018074925 A2 BR 112018074925A2 BR 112018074925 A BR112018074925 A BR 112018074925A BR 112018074925 A2 BR112018074925 A2 BR 112018074925A2
Authority
BR
Brazil
Prior art keywords
sterilizing
sterilization
container
eto
stage
Prior art date
Application number
BR112018074925-7A
Other languages
English (en)
Other versions
BR112018074925B1 (pt
Inventor
Kuehne Kelley
Carpenter Curt
Leginski Jessica
Original Assignee
Centurion Medical Products Corporation
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 Centurion Medical Products Corporation filed Critical Centurion Medical Products Corporation
Publication of BR112018074925A2 publication Critical patent/BR112018074925A2/pt
Publication of BR112018074925B1 publication Critical patent/BR112018074925B1/pt

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet radiation
    • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • 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
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/027—Packaging in aseptic chambers

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Mechanical Engineering (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

trata-se de um método para esterilizar um recipiente pré-carregado que compreende montar um recipiente não vítreo e realizar pelo menos um ciclo de procedimento de esterilização por óxido de etileno (eto). a etapa de montagem inclui preencher o recipiente não vítreo com material sensível à esterilização e vedar o material sensível à esterilização dento do recipiente. o ciclo de procedimento de esterilização por eto compreende passar por um estágio de pré-processamento, um estágio de lavagem e condicionamento, um estágio de esterilização por eto e um estágio de lavagem e pós-exposição. mediante conclusão do ciclo de procedimento de esterilização por eto, um ph resultante do material sensível à esterilização não excede uma faixa de ph aceitável conforme definido pela farmacopeia norte-americana. a revelação também discute a inserção de um recipiente pré-carregado montado em uma bandeja de procedimento antes de realizar o ciclo de procedimento de esterilização por eto.
BR112018074925-7A 2016-06-01 2017-05-22 Método de empregar óxido de etileno (eto) para esterilizar uma montagem de seringa pré- preenchida BR112018074925B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15/169,962 2016-06-01
US15/169,962 US20170349313A1 (en) 2016-06-01 2016-06-01 Methods for manufacturing non-glass prefilled syringes
PCT/US2017/033719 WO2017209998A1 (en) 2016-06-01 2017-05-22 Methods for manufacturing non-glass prefilled containers

Publications (2)

Publication Number Publication Date
BR112018074925A2 true BR112018074925A2 (pt) 2019-03-12
BR112018074925B1 BR112018074925B1 (pt) 2022-10-18

Family

ID=60477844

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018074925-7A BR112018074925B1 (pt) 2016-06-01 2017-05-22 Método de empregar óxido de etileno (eto) para esterilizar uma montagem de seringa pré- preenchida

Country Status (9)

Country Link
US (2) US20170349313A1 (pt)
EP (1) EP3463490A4 (pt)
JP (1) JP7187321B2 (pt)
CN (1) CN109414518A (pt)
AU (3) AU2017273335B2 (pt)
BR (1) BR112018074925B1 (pt)
CA (1) CA3026404A1 (pt)
MX (1) MX2018014633A (pt)
WO (1) WO2017209998A1 (pt)

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US20220219842A1 (en) * 2020-02-06 2022-07-14 Thorne Intellectual Property Holdings, Llc Closed convenience kits for sterilized medicine preparation
CN113491784A (zh) * 2020-04-03 2021-10-12 清华大学 一种利用环氧乙烷对医疗防护用品进行高效灭菌及强化解析的方法
CN113306880A (zh) * 2020-08-25 2021-08-27 美昕医疗器械(昆山)有限公司 一种组合包装及其灭菌方法
CN112773918A (zh) * 2020-12-23 2021-05-11 北京伏尔特技术有限公司 一种环氧乙烷灭菌后快速解析工艺
CN112999388B (zh) * 2021-02-08 2023-02-10 厦门博创中安医疗技术有限公司 一种可吸收植入物及配套器械组合产品的灭菌方法

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Also Published As

Publication number Publication date
US20170349313A1 (en) 2017-12-07
AU2022204394B2 (en) 2024-02-22
EP3463490A1 (en) 2019-04-10
BR112018074925B1 (pt) 2022-10-18
US11958647B2 (en) 2024-04-16
MX2018014633A (es) 2019-07-18
US20220332453A1 (en) 2022-10-20
JP2019519298A (ja) 2019-07-11
AU2017273335A1 (en) 2018-12-13
EP3463490A4 (en) 2020-10-14
AU2022204394A1 (en) 2022-07-14
AU2024203424A1 (en) 2024-06-13
CA3026404A1 (en) 2017-12-07
AU2017273335B2 (en) 2022-03-24
CN109414518A (zh) 2019-03-01
JP7187321B2 (ja) 2022-12-12
WO2017209998A1 (en) 2017-12-07

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