WO2018019874A1 - Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique - Google Patents

Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique Download PDF

Info

Publication number
WO2018019874A1
WO2018019874A1 PCT/EP2017/068858 EP2017068858W WO2018019874A1 WO 2018019874 A1 WO2018019874 A1 WO 2018019874A1 EP 2017068858 W EP2017068858 W EP 2017068858W WO 2018019874 A1 WO2018019874 A1 WO 2018019874A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
clamping mechanism
opening assembly
zone
clamping
Prior art date
Application number
PCT/EP2017/068858
Other languages
English (en)
Inventor
Claudio Trebbi
Gabriele Gabusi
Original Assignee
I.M.A. Industria Macchine Automatiche 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57610180&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2018019874(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by I.M.A. Industria Macchine Automatiche S.P.A. filed Critical I.M.A. Industria Macchine Automatiche S.P.A.
Priority to CA3032037A priority Critical patent/CA3032037A1/fr
Priority to EP17743339.8A priority patent/EP3490893B1/fr
Priority to ES17743339T priority patent/ES2874645T3/es
Priority to JP2019504966A priority patent/JP6971305B2/ja
Priority to CN201780058439.1A priority patent/CN109715505B/zh
Priority to US16/321,435 priority patent/US20210292032A1/en
Publication of WO2018019874A1 publication Critical patent/WO2018019874A1/fr

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B69/00Unpacking of articles or materials, not otherwise provided for
    • B65B69/0008Opening and emptying bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B69/00Unpacking of articles or materials, not otherwise provided for
    • B65B69/0033Unpacking of articles or materials, not otherwise provided for by cutting
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B69/00Unpacking of articles or materials, not otherwise provided for
    • B65B69/005Unpacking of articles or materials, not otherwise provided for by expelling contents, e.g. by squeezing the container
    • B65B69/0058Solid contents

Definitions

  • the present invention relates to an opening assembly for bags housing containers for pharmaceutical use.
  • the bag of specific interest is intended for containment and segregation with respect to the outside environment of containers such as vials, bottles, syringes, carpules and the like.
  • the nest is, in turn, placed inside a sterile tub with a protective film on top which has the purpose of preventing entrance into the containers (which have an upper opening open towards the outside) of dust or other particles.
  • the upper edges of the tub (containing protective film, nest and containers) are permanently joined to a sealing film in order to completely isolate the inside of the tub from the outside.
  • the sealed tub is placed within a bag (generally made of polymeric material) which constitutes a second protective barrier (since the outside of the tub and the sealing film must in any case be sterile).
  • a bag generally made of polymeric material which constitutes a second protective barrier (since the outside of the tub and the sealing film must in any case be sterile).
  • bag opening operations are such as to give rise to a risk of contamination (during the cutting step, particles may in fact detach and enter inside the bag, coming into contact with the protective film or the outside of the tub) .
  • the presence of particles on the protective film and/or the outer surface of the tub is particularly risky because removal of the film generally occurs when the tub is already in the environment with the highest contamination class (i.e., ISO 5 Class or lower, thus, with the least presence of contaminants) and could cause the diffusion of such particles (deposited on the film and/or tub) in that environment.
  • DE 10 2011 080289 discloses a device for opening a bag according to the prior art.
  • the main aim of the present invention is to solve the problems outlined above, by proposing an opening assembly for bags housing containers for pharmaceutical use capable of cutting the outer bag while preventing particles, in suspension and/or generated during the cutting step, from entering inside the bag.
  • an object of the invention is to propose an opening assembly for bags housing containers for pharmaceutical use that ensures isolation of the bag's content with respect to the outside environment even after opening the bag.
  • Another object of the invention is to propose an opening assembly for packaging of containers for pharmaceutical use capable of guaranteeing sterility of the containers transported in the nest present inside the tub, sealed by a protective film, and segregated inside the bag.
  • Figure 1 shows, in a schematic axonometric view, a portion of an opening assembly for bags housing containers for pharmaceutical use according to the invention
  • Figure 2 shows, in a schematic side view, the opening assembly for bags housing containers for pharmaceutical use according to the invention
  • an opening assembly for bags B housing containers A for pharmaceutical use.
  • the bag B is generally hermetically sealed and preferably made of polymeric material.
  • the assembly 1 comprises at least one clamping mechanism 2 to clamp a portion C of the bag B spaced apart (inwardly) with respect to an end flap D of the bag.
  • the clamping mechanism 2 is arranged so as to clamp together sections of opposing sheets E, F of the bag B.
  • the assembly 1 further comprises at least one cutting element 2a for the trimming of the end flap D with respect to the portion C defined by the sections of opposing sheets E, F of the bag B mutually clamped together by the clamping mechanism 2.
  • the bag B is in fact already opened (because it is without the end flap D) and thus subsequent access to its contents will not require any operation capable of generating contaminants and/or particles (which may in fact detach during the cutting step) thereby greatly improving the sterility and cleanliness of containers A transported inside the bag B.
  • the opening assembly further comprises gripping mechanisms 14 equipped with at least one clamping jaw
  • the cutting element 2a is designed to separate the end flap D and is arranged between the gripping mechanisms 14 and the clamping mechanism 2.
  • these gripping mechanisms 14 are associated with a transport device 5.
  • the transport device 5 in the illustrated example comprises a proximal section 10 arranged in a first zone 9 and a distal section 12 arranged in a second zone 11, wherein the first zone 9 has a higher contamination class and a higher ambient pressure than the second zone.
  • Said transport device 5 may be a closed loop design and driven by an automatic motor drive unit connected to a control and management processor.
  • the clamping mechanism 2 is integral with a moveable terminal end 3 of a manipulator 4.
  • manipulator 4 can advantageously move between at least two end configurations.
  • a first configuration whereby the bag B is removed from the transport device 5 for the clamping of said opposing sheets E, F with the clamping mechanism 2; and a second alignment configuration whereby the bag B is brought in proximity to an opening 6 defined on a separation wall 7 separating the first zone 9 from a compartment 8 with a higher contamination class and higher ambient pressure compared to the first zone 9.
  • the first zone 9 within which the manipulator 4 operates and in which the proximal section 10 of the transport device 5 is located has a higher contamination class and a higher ambient pressure compared to the second zone 11 in which the distal section 12 of the transport device 5 is located.
  • an operating condition will occur whereby the transport of packaging A will be carried out in ambient conditions with a less stringent contamination class (i.e, ISO Class 6 or ISO Class 7), the cutting of the end flap D and thus the opening of the bag B will occur in ambient conditions with an intermediate contamination class (according to the previous example, in ISO Class 6 or ISO Class 6+ or ISO Class 5 respectively), while the extraction of the contents of the bag B will only occur in the compartment 8 in which there is a higher contamination class (according to the previous example, ISO Class 5).
  • a less stringent contamination class i.e, ISO Class 6 or ISO Class 7
  • an intermediate contamination class accordinging to the previous example, in ISO Class 6 or ISO Class 6+ or ISO Class 5 respectively
  • the manipulator 4 can be an anthropomorphic-type robot.
  • the first zone 9 there is preferably arranged at least one dispenser of a gas flow intended to flow over the proximal section 10 of the transport device 5, the bag B transported along the end section 10 and the manipulator 4.
  • Such gas flow will provide the necessary overpressure in the first zone 9, with respect to the second zone 11 in which the distal section 12 of the transport device 5 is located so as to prevent access to the first zone 9 of particles and/or contaminants present in suspension in the air in the second zone 11.
  • the gas flow present in the first zone 9 will be of the laminar type.
  • the gas relating to such flow may be air (other types of gas such as inert gas, nitrogen and the like are not excluded).
  • the transport device 5 thus adopted allows all surfaces of each bag B to be invested by the gas, favoring the detachment of any particles accumulated thereupon, while hindering the deposit of any other particles present in suspension in the air of the particular environment in question.
  • a portion C of the bag B spaced apart (inwardly) relative to an end flap D, in alignment with a clamping mechanism 2.
  • a final step of the process involves trimming by means of a cutting element 2a the end flap D with respect to the portion C corresponding to the sections of opposing sheets E, F of the bag B mutually clamped together by the clamping mechanism 2.
  • the process involves aligning the portion C of bag B to the clamping mechanism 2, keeping it sealed by isolating the contents of the bag B from the outside environment, at a subsequent operating station, so that the containers A placed inside the bag B remain isolated from the outside environment even after the trimming.
  • the present invention solves the problems outlined above, by proposing an opening assembly 1 for bags housing containers for pharmaceutical use, preventing particles, in suspension and/or generated during the cutting step, from entering inside the bag B.
  • the opening assembly 1 guarantees the isolation of the contents of the bag B from the outside environment even after cutting the bag B.
  • the opening assembly 1 according to the invention is capable of guaranteeing the sterility of the containers transported in the nest inside the tub, sealed by a protective film, and segregated inside the bag B.
  • the opening assembly 1 according to the invention is relatively simple and practical to implement, and also entails contained costs: these features make the unit 1 an innovative and safe application.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Bag Frames (AREA)
  • Packages (AREA)

Abstract

L'invention concerne un ensemble ouverture pour des sacs (B) logeant des contenants (A) à usage pharmaceutique, comprenant au moins un mécanisme de serrage (2) pour serrer une partie (C) dudit sac (B) espacé par rapport à un volet extrémité (D) du sac, ledit mécanisme de serrage (2) étant agencé de façon à serrer ensemble des sections de feuilles opposées (E, F) dudit sac (B), et au moins un élément de coupe (2a) pour le détourage et la séparation dudit volet extrémité (D) par rapport auxdites sections desdites feuilles opposées (E, F) dudit sac (B) mutuellement serrées ensemble par ledit mécanisme de serrage (2).
PCT/EP2017/068858 2016-07-27 2017-07-26 Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique WO2018019874A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA3032037A CA3032037A1 (fr) 2016-07-27 2017-07-26 Ensemble ouverture pour sacs logeant des contenants a usage pharmaceutique
EP17743339.8A EP3490893B1 (fr) 2016-07-27 2017-07-26 Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique
ES17743339T ES2874645T3 (es) 2016-07-27 2017-07-26 Ensamble de apertura para bolsas que alojan recipientes para uso farmacéutico.
JP2019504966A JP6971305B2 (ja) 2016-07-27 2017-07-26 医薬用容器を収納する袋の開封ユニット
CN201780058439.1A CN109715505B (zh) 2016-07-27 2017-07-26 用于容纳医药用途的容器的袋子的开口组件
US16/321,435 US20210292032A1 (en) 2016-07-27 2017-07-26 Opening assembly for bags housing containers for pharmaceutical use

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000078609 2016-07-27
IT102016000078609A IT201600078609A1 (it) 2016-07-27 2016-07-27 Gruppo di apertura per confezioni di contenitori ad uso farmaceutico

Publications (1)

Publication Number Publication Date
WO2018019874A1 true WO2018019874A1 (fr) 2018-02-01

Family

ID=57610180

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2017/068858 WO2018019874A1 (fr) 2016-07-27 2017-07-26 Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique

Country Status (8)

Country Link
US (1) US20210292032A1 (fr)
EP (1) EP3490893B1 (fr)
JP (1) JP6971305B2 (fr)
CN (1) CN109715505B (fr)
CA (1) CA3032037A1 (fr)
ES (1) ES2874645T3 (fr)
IT (1) IT201600078609A1 (fr)
WO (1) WO2018019874A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109625500A (zh) * 2019-01-25 2019-04-16 格瑞果汁工业(天津)有限公司 一种果酱小袋拆袋机

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102018210747A1 (de) * 2018-06-29 2020-01-02 Robert Bosch Gmbh Vorrichtung und Verfahren zum Zuführen eines Gegenstandes
IT201900006552A1 (it) * 2019-05-06 2020-11-06 Ima Spa Apparato e metodo per la gestione automatizzata di una camera di lavorazione ad atmosfera controllata.
DE102021104221A1 (de) * 2021-02-23 2022-08-25 Syntegon Technology Gmbh Vorrichtung und Verfahren zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika
DE102022110826A1 (de) 2022-05-03 2023-11-09 Tt Innovation Ag Vorrichtung zum Manipulieren von Behälter enthaltenden Beuteln
CN115043051B (zh) * 2022-05-19 2023-08-04 玉林市第一人民医院 新冠病毒核酸检测标本密封袋拆包装置及方法
DE102022118701A1 (de) * 2022-07-26 2024-02-01 Tt Innovation Ag Verfahren zum Ausbringen eines Behälters aus einem Beutel, Schneidvorrichtung, Entnahmevorrichtung und Entpackvorrichtung

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011080289A1 (de) 2011-08-02 2013-02-07 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines sterilen Gegenstands aus einem Folienbeutel
US20130134068A1 (en) * 2007-08-02 2013-05-30 Fabiano Nicoletti Package structure for glass containers for pharmaceutical use

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITBO20060246A1 (it) 2006-04-05 2007-10-06 Ima Spa Apparato e metodo per alimentare con un prodotto una macchina confezionatrice.
WO2008016313A1 (fr) 2006-08-02 2008-02-07 J.M.P. Engineering Limited Séparateur de sac multicouche
CN201228095Y (zh) * 2008-05-20 2009-04-29 刘雪 开袋器
DE202009005086U1 (de) 2009-07-30 2010-12-16 Autefa Automation Gmbh Öffnungseinrichtung
DE102010039635A1 (de) 2010-08-23 2012-02-23 Robert Bosch Gmbh Verfahren zum Entsorgen von sterilem Verpackungsmaterial sowie Vorrichtung hierzu
IT1401846B1 (it) 2010-10-14 2013-08-28 Co Ri M A S R L Apparato e metodo per rimuovere un prodotto sterile da una confezione sterile che lo contiene
DE102010063892B4 (de) 2010-12-22 2023-10-19 Syntegon Technology Gmbh Vorrichtung und Verfahren zum Entnehmen eines Objekts aus einer Verpackung
DE102014201966A1 (de) 2014-02-04 2015-08-06 Robert Bosch Gmbh Vorrichtung und Verfahren zum Handling eines Trays
DE102014201967A1 (de) * 2014-02-04 2015-08-06 Robert Bosch Gmbh Vorrichtung und Verfahren zur Entnahme von Behältnissen aus einem Tray
JP6413053B2 (ja) * 2014-10-29 2018-10-31 ゼネラルパッカー株式会社 包装機
CN206871457U (zh) * 2017-07-11 2018-01-12 象山益精高分子材料有限公司 一种开袋装置

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130134068A1 (en) * 2007-08-02 2013-05-30 Fabiano Nicoletti Package structure for glass containers for pharmaceutical use
DE102011080289A1 (de) 2011-08-02 2013-02-07 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines sterilen Gegenstands aus einem Folienbeutel

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109625500A (zh) * 2019-01-25 2019-04-16 格瑞果汁工业(天津)有限公司 一种果酱小袋拆袋机

Also Published As

Publication number Publication date
EP3490893B1 (fr) 2021-03-24
ES2874645T3 (es) 2021-11-05
JP6971305B2 (ja) 2021-11-24
CN109715505A (zh) 2019-05-03
CA3032037A1 (fr) 2018-02-01
JP2019521927A (ja) 2019-08-08
CN109715505B (zh) 2021-02-26
IT201600078609A1 (it) 2018-01-27
EP3490893A1 (fr) 2019-06-05
US20210292032A1 (en) 2021-09-23

Similar Documents

Publication Publication Date Title
EP3490893B1 (fr) Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique
JP7030105B2 (ja) 医薬品及び化学分野における、袋から内容物を取り出すための取り出しユニット
CN107735321B (zh) 用于填充和密封瓶、筒、注射器及类似物的方法和机器
CN109789941B (zh) 用于包装的开启组件
US9718583B2 (en) Components packaging structure for pharmaceutical containers
KR102414349B1 (ko) 멸균 벌크 재료를 아이솔레이터로 운반 및 이송시키기 위한 방법 및 컨테이너
CN109789938B (zh) 用于医药用途的容器的包装的输送带组件
JP4329066B2 (ja) 無菌試験サンプリング方法及びその装置
JP7372307B2 (ja) 無菌の物体を容器からコンテインメント設備に汚染なく導入する構造体及びその方法
US20020041830A1 (en) System for multiple sterile sample collection and isolation
EP3774555B1 (fr) Machine pour remplir et fermer des récipients pharmaceutiques, tels que des seringues, des flacons et similaires
US20220227009A1 (en) Equipment for packaging products, and in particular for re-packaging products that have already been previously packaged
FR2853552A1 (fr) Procede et installation de traitement sterile de produits

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17743339

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2019504966

Country of ref document: JP

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 3032037

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2017743339

Country of ref document: EP

Effective date: 20190227