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-carregadoInfo
- 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
Links
- 230000001954 sterilising effect Effects 0.000 title abstract 8
- 238000000034 method Methods 0.000 title abstract 5
- 229940071643 prefilled syringe Drugs 0.000 title 1
- 238000004659 sterilization and disinfection Methods 0.000 abstract 4
- 238000012414 sterilization procedure Methods 0.000 abstract 4
- 239000000463 material Substances 0.000 abstract 3
- 238000005406 washing Methods 0.000 abstract 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 abstract 1
- 230000003750 conditioning effect Effects 0.000 abstract 1
- 238000007781 pre-processing Methods 0.000 abstract 1
- 238000007789 sealing Methods 0.000 abstract 1
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.
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) |
Families Citing this family (8)
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US10780228B2 (en) | 2012-05-07 | 2020-09-22 | Medline Industries, Inc. | Prefilled container systems |
MX2021012557A (es) | 2019-04-24 | 2021-11-12 | Amgen Inc | Conjuntos y metodos de verificacion de esterilizacion de jeringuillas. |
CN110025850A (zh) * | 2019-05-07 | 2019-07-19 | 中国人民解放军第四军医大学 | 一种预充式冲管注射器 |
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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-
2016
- 2016-06-01 US US15/169,962 patent/US20170349313A1/en not_active Abandoned
-
2017
- 2017-05-22 MX MX2018014633A patent/MX2018014633A/es unknown
- 2017-05-22 BR BR112018074925-7A patent/BR112018074925B1/pt active IP Right Grant
- 2017-05-22 AU AU2017273335A patent/AU2017273335B2/en active Active
- 2017-05-22 CA CA3026404A patent/CA3026404A1/en active Pending
- 2017-05-22 EP EP17807234.4A patent/EP3463490A4/en active Pending
- 2017-05-22 JP JP2018563068A patent/JP7187321B2/ja active Active
- 2017-05-22 CN CN201780033848.6A patent/CN109414518A/zh active Pending
- 2017-05-22 WO PCT/US2017/033719 patent/WO2017209998A1/en unknown
-
2022
- 2022-06-22 AU AU2022204394A patent/AU2022204394B2/en active Active
- 2022-07-01 US US17/855,912 patent/US11958647B2/en active Active
-
2024
- 2024-05-22 AU AU2024203424A patent/AU2024203424A1/en active Pending
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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