BR112015003534B1 - estrutura de embalagem de componentes para recipientes farmacêuticos - Google Patents

estrutura de embalagem de componentes para recipientes farmacêuticos Download PDF

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Publication number
BR112015003534B1
BR112015003534B1 BR112015003534-5A BR112015003534A BR112015003534B1 BR 112015003534 B1 BR112015003534 B1 BR 112015003534B1 BR 112015003534 A BR112015003534 A BR 112015003534A BR 112015003534 B1 BR112015003534 B1 BR 112015003534B1
Authority
BR
Brazil
Prior art keywords
cavities
supports
packaging structure
tray
support shelf
Prior art date
Application number
BR112015003534-5A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112015003534A2 (pt
Inventor
Fabiano Nicoletti
Giuseppe Fedegari
Original Assignee
Stevanato Group International A.S.
Fedegari Autoclavi S.P.A
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 Stevanato Group International A.S., Fedegari Autoclavi S.P.A filed Critical Stevanato Group International A.S.
Publication of BR112015003534A2 publication Critical patent/BR112015003534A2/pt
Publication of BR112015003534B1 publication Critical patent/BR112015003534B1/pt

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/10—Devices to locate articles in containers
    • B65D25/108—Devices, e.g. plates, presenting apertures through which the articles project
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/33—Trays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • 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
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2807—Feeding closures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
    • B65D39/0023—Plastic cap-shaped hollow plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
    • B65D65/02—Wrappers or flexible covers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3007—Stackable casings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1425—Snap-fit type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0069—Trays for holding or distributing medicines

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Stackable Containers (AREA)
  • Packaging Of Annular Or Rod-Shaped Articles, Wearing Apparel, Cassettes, Or The Like (AREA)
BR112015003534-5A 2012-08-30 2013-08-28 estrutura de embalagem de componentes para recipientes farmacêuticos BR112015003534B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT000215A ITVI20120215A1 (it) 2012-08-30 2012-08-30 Struttura per il confezionamento di componenti per contenitori ad uso farmaceutico
ITVI2012A000215 2012-08-30
PCT/IT2013/000230 WO2014033766A1 (en) 2012-08-30 2013-08-28 Components packaging structure for pharmaceutical containers

Publications (2)

Publication Number Publication Date
BR112015003534A2 BR112015003534A2 (pt) 2017-07-04
BR112015003534B1 true BR112015003534B1 (pt) 2021-05-11

Family

ID=46939904

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015003534-5A BR112015003534B1 (pt) 2012-08-30 2013-08-28 estrutura de embalagem de componentes para recipientes farmacêuticos

Country Status (11)

Country Link
US (1) US9718583B2 (enExample)
EP (1) EP2890423B1 (enExample)
JP (1) JP6347783B2 (enExample)
CN (1) CN104755115B (enExample)
BR (1) BR112015003534B1 (enExample)
CA (1) CA2882689C (enExample)
ES (1) ES2599552T3 (enExample)
IN (1) IN2015DN01399A (enExample)
IT (1) ITVI20120215A1 (enExample)
MX (1) MX353118B (enExample)
WO (1) WO2014033766A1 (enExample)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105501503B (zh) 2012-05-03 2018-01-12 肖特公开股份有限公司 用于处理或加工容器的方法和设备
KR101655726B1 (ko) 2012-05-03 2016-09-07 쇼오트 아게 의료, 제약 또는 화장품 어플리케이션들을 위한 물질들을 저장하기 위한 컨테이너들을 처리하기 위한 방법 및 장치
DE102013111600B4 (de) 2013-10-21 2018-04-05 Schott Ag Haltestruktur zum Halten von Behältern für Substanzen für medizinische, pharmazeutische oder kosmetische Anwendungen, sowie Transport- und Verpackungsbehälter mit selbiger
US10872313B2 (en) 2015-06-02 2020-12-22 ROCA Medical Ltd. Method for repurposing NDC codes in a pharmaceutical database for venom derived allergens involved in venom immunotherapy
US10639238B2 (en) * 2015-03-13 2020-05-05 Fisher Clinical Services, Inc. Passive cold storage container systems with packaging tray and retention plate
USD804052S1 (en) * 2015-04-17 2017-11-28 Schott Kaisha Pvt., Ltd. Nest for precrimped presterilized cartridges
US10548974B2 (en) 2015-06-02 2020-02-04 ROCA Medical Ltd. Therapeutic treatment kit for allergies based on DNA profiles
US10369215B2 (en) * 2015-06-02 2019-08-06 ROCA Medical Ltd. Predilution sets for distributing antigens
ES3034903T3 (en) 2016-01-27 2025-08-27 West Pharmaceutical Services Inc Syringe nest with hexagonal chimneys and center offset
DE102016123147A1 (de) * 2016-11-30 2018-05-30 Schott Ag Haltestruktur zum gleichzeitigen Halten einer Mehrzahl von Vials, Verwendung hiervon sowie Verfahren zur Behandlung solcher Vials
USD864385S1 (en) * 2017-07-13 2019-10-22 iMed Technology, Inc. Medical site cover mounting device
CN114889956B (zh) * 2017-10-02 2024-10-29 贝克顿迪金森法国公司 用以支承医用容器的包装装置和用于从所述包装装置移除医用容器的方法
WO2019094547A1 (en) * 2017-11-08 2019-05-16 Windgap Medical, Inc. A system and method for providing and assembling an auto-injector
CN111655593B (zh) * 2017-12-22 2022-06-14 西氏医药服务公司 用于无菌填充小容量瓶的包装系统
JP6694900B2 (ja) * 2018-02-08 2020-05-20 株式会社大協精工 保持部材、及び注射器用ピストンのパッケージング構造
ES2982563T3 (es) * 2018-05-02 2024-10-16 Becton Dickinson France Dispositivo de sujeción para soportar una pluralidad de contenedores médicos, paquete de contenedores médicos que comprende este dispositivo de sujeción, y método para fabricar un contenedor médico
DE102018111491A1 (de) * 2018-05-14 2019-11-14 Schott Schweiz Ag Haltestruktur zum gleichzeitigen Halten einer Mehrzahl von Behältern für Substanzen für pharmazeutische, medizinische oder kosmetische Anwendungen, Transportgebilde und Transport- oder Verpackungsbehälter mit selbiger
USD905267S1 (en) * 2019-03-27 2020-12-15 Avidien Technologies, Inc. Pipette tip adapter
IT201900011982A1 (it) * 2019-07-17 2021-01-17 Nuova Ompi Srl Struttura per il confezionamento di contenitori primari ad uso farmaceutico
IT201900022554A1 (it) * 2019-11-29 2021-05-29 Fedegari Autoclavi Apparato per il riempimento di contenitori in ambiente sterile
WO2021126676A1 (en) * 2019-12-16 2021-06-24 Merck Sharp & Dohme Corp. Pre-filled syringe stopper retainer and methods of using same
WO2021259964A1 (en) * 2020-06-25 2021-12-30 Sanofi Workpiece carrier
FR3114087B1 (fr) * 2020-09-11 2023-07-14 A Raymond Et Cie Systeme et procede d’emballage de bouchons medicaux compose d’une coiffe et d’un obturateur
FR3114086B1 (fr) * 2020-09-11 2023-11-10 A Raymond Et Cie Systeme et procede d’emballage de contenants medicaux
EP3974337B1 (en) * 2020-09-25 2024-11-06 SCHOTT Pharma Schweiz AG Holding device which restricts movement of primary packaging containers at first and further longitudinal positions
US20240067387A1 (en) * 2020-12-28 2024-02-29 West Pharmaceutical Services, Inc. Tray-based sterile packaging of pharmaceutical vials and vial closures
US12098018B2 (en) 2021-01-15 2024-09-24 Oyster Point Pharma, Inc. Nesting structures for storage, transport, and assembly of drug dispensers and containers
CA3231033A1 (en) * 2021-09-15 2023-03-23 Becton, Dickinson And Company Sustainable and recyclable pulp tray for blood collection tubes
US20250114514A1 (en) * 2022-01-28 2025-04-10 Becton, Dickinson And Company Honeycomb Cell Packaging
EP4486661A1 (en) * 2022-03-02 2025-01-08 Medisca Pharmaceutique Inc. Methods and assemblies for packaging containers for compositions containing active ingredients
USD1054056S1 (en) * 2022-05-27 2024-12-10 Beckman Coulter, Inc. Pipette rack
IT202300021390A1 (it) * 2023-10-13 2025-04-13 Biopap S R L Metodo e gruppo di assemblaggio per la realizzazione di vassoi
CN117141791A (zh) * 2023-10-27 2023-12-01 焦作福瑞堂制药有限公司新乡分公司 一种安瓿热熔灌封机

Family Cites Families (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2523877A (en) * 1949-09-26 1950-09-26 Pestolesi August Carrier and container for hypodermic syringes
US2655283A (en) * 1951-07-26 1953-10-13 St Regis Paper Co Box construction
US3491894A (en) * 1968-01-30 1970-01-27 Brunswick Corp Sterile tray
US4130978A (en) * 1975-11-12 1978-12-26 Medical Laboratory Automation, Inc. Method of assembling disposable pipette tips for shipment to users thereof
US4349109A (en) * 1980-10-20 1982-09-14 Medical Laboratory Automation, Inc. Disposable pipette tips and trays therefor
US4599314A (en) * 1983-06-14 1986-07-08 Hsc Research Development Corporation Multiple vessel specimen tray with lid for releasably adhering vessel covers
US5004103A (en) * 1989-09-11 1991-04-02 Remcon Plastics, Inc. Tool storage box
US5112574A (en) * 1991-04-26 1992-05-12 Imanigation, Ltd. Multititer stopper array for multititer plate or tray
US5827745A (en) * 1993-03-29 1998-10-27 Astle; Thomas W. Micropipette tip loading and unloading device and method and tip package
US5366088A (en) * 1993-09-01 1994-11-22 Larcon, North America Stackable pipette tip rack
US6007779A (en) * 1993-09-21 1999-12-28 Rainin Instrument Co., Inc. Refill pack for pipette tip racks
US5392914A (en) * 1993-09-21 1995-02-28 Rainin Instrument Co., Inc. Refill pack for pipette tip racks
US5441702A (en) * 1993-09-21 1995-08-15 Rainin Instrument Co., Inc. Refill pack for pipette tip racks
US5893618A (en) * 1997-07-21 1999-04-13 Poly Vac, Inc. Stacking sterilizing tray system
US7060226B1 (en) * 1997-11-24 2006-06-13 Medax International, Inc. Pipette tip packaging and transfer system
US6189292B1 (en) * 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
FR2784076B1 (fr) * 1998-10-06 2000-12-22 Gilson Sa Ensemble comprenant des recharges de cones de pipette empilees
US6286678B1 (en) * 1999-03-05 2001-09-11 Rainin Instruments Co., Inc. Refill pack for pipette tip racks and improved pipette tip support plate for use in such packs and racks
US6328933B1 (en) * 2000-03-16 2001-12-11 Corning Incorporated Double density pipette tip storage rack
US6566144B1 (en) * 2000-03-27 2003-05-20 Atrix Laboratories Cover plate for use in lyophilization
FR2816924B1 (fr) * 2000-11-20 2003-02-14 Becton Dickinson France Emballage pour produits steriles
FR2839497B1 (fr) * 2002-05-07 2005-04-15 Becton Dickinson France Emballage destine a etre utilise pour transporter des objets steriles ou a stereliser
USD506833S1 (en) * 2004-01-23 2005-06-28 Wescott, Iii Harvey M. Test platform
USD507658S1 (en) * 2004-01-27 2005-07-19 Wescott, Iii Harvey M. 8GC platform
US7232038B2 (en) * 2004-04-27 2007-06-19 Whitney Steven G Disposable test tube rack
US20060016156A1 (en) * 2004-07-01 2006-01-26 West Pharmaceutical Services, Inc. Vacuum package system and method
US8100263B2 (en) * 2004-07-01 2012-01-24 West Pharmaceutical Services, Inc. Vacuum package system
US7963396B2 (en) * 2004-07-01 2011-06-21 West Pharmaceutical Services, Inc. Vacuum package system
FR2911072B1 (fr) * 2007-01-09 2010-10-22 Becton Dickinson France Emballage pour produits qui doit etre decontamine par rayonnement
US8118167B2 (en) * 2007-03-05 2012-02-21 Daikyo Seiko, Ltd. Medical container
US20090026107A1 (en) * 2007-07-24 2009-01-29 Michelle Ross Insulin Syringe Storage Rack
CH702317B1 (it) * 2007-08-02 2011-06-15 Stevanato Group Internat As Struttura di confezione di flaconi in vetro ad uso farmaceutico.
JP4616363B2 (ja) * 2008-03-05 2011-01-19 株式会社椿本チエイン 創薬用マイクロチューブのキャップ
JP5470369B2 (ja) * 2008-04-11 2014-04-16 バイオティクス， インコーポレイテッド ピペットチップを取り扱うデバイスおよび方法
USD699859S1 (en) * 2009-04-11 2014-02-18 Biotix, Inc. Pipette tip handling device assembly
JP5559880B2 (ja) * 2009-07-15 2014-07-23 ベクトン ディキンソン フランス 細長い物体、特にシリンジ本体あるいはシリンジを位置決めするためのトレイ
IT1399750B1 (it) * 2010-04-30 2013-05-03 Stevanato Group Internat As Struttura di imballaggio per contenitori ad uso farmaceutico

Also Published As

Publication number Publication date
WO2014033766A1 (en) 2014-03-06
JP2015528344A (ja) 2015-09-28
CA2882689A1 (en) 2014-03-06
CA2882689C (en) 2020-04-28
JP6347783B2 (ja) 2018-06-27
MX353118B (es) 2017-12-20
CN104755115B (zh) 2017-12-12
ES2599552T3 (es) 2017-02-02
CN104755115A (zh) 2015-07-01
MX2015002143A (es) 2015-07-06
US20150238263A1 (en) 2015-08-27
EP2890423A1 (en) 2015-07-08
US9718583B2 (en) 2017-08-01
EP2890423B1 (en) 2016-08-24
IN2015DN01399A (enExample) 2015-07-03
BR112015003534A2 (pt) 2017-07-04
ITVI20120215A1 (it) 2014-03-01

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/08/2013, OBSERVADAS AS CONDICOES LEGAIS.