EP3490893B1 - Öffnungsanordnung für behälteraufnehmende beutel zur pharmazeutischen verwendung - Google Patents

Öffnungsanordnung für behälteraufnehmende beutel zur pharmazeutischen verwendung Download PDF

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Publication number
EP3490893B1
EP3490893B1 EP17743339.8A EP17743339A EP3490893B1 EP 3490893 B1 EP3490893 B1 EP 3490893B1 EP 17743339 A EP17743339 A EP 17743339A EP 3490893 B1 EP3490893 B1 EP 3490893B1
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EP
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Prior art keywords
bag
clamping mechanism
opening assembly
zone
clamping
Prior art date
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EP17743339.8A
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English (en)
French (fr)
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EP3490893A1 (de
Inventor
Claudio Trebbi
Gabriele Gabusi
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IMA Industria Macchine Automatiche SpA
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IMA Industria Macchine Automatiche SpA
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    • 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 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).
  • 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 opening assembly for bags B housing containers A for pharmaceutical use.
  • 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 cutting element 2a is designed to separate the end flap D and is arranged between the gripping mechanisms 14 and the clamping mechanism 2.
  • manipulator 4 can advantageously move between at least two end configurations.
  • 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 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.
  • 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 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)

Claims (14)

  1. Öffnungsanordnung für Beutel (B), in denen Behälter (A) für pharmazeutische Zwecke untergebracht sind, umfassend mindestens einen Klemmmechanismus (2) zum Klemmen eines Teils (C) des Beutels (B) und mindestens ein Schneidelement (2a);
    wobei der Klemmmechanismus (2) angeordnet ist, um Abschnitte gegenüberliegender Bleche (E, F) des Beutels (B), die in Bezug auf eine Endklappe (D) des Beutels (B) voneinander beabstandet sind, zusammenzuklemmen;
    dadurch gekennzeichnet, dass mindestens ein Schneidelement (2a) zum Trimmen und Trennen der Endklappe (D) angeordnet und konfiguriert ist, wobei die Endklappe (D) in Bezug auf die Abschnitte der gegenüberliegenden Bleche (E, F) des Beutels (B), welche durch den Klemmmechanismus (2) miteinander zusammengeklemmt sind, hervorsteht.
  2. Öffnungsanordnung nach Anspruch 1, umfassend Greifmechanismen (14), die mit mindestens einer Klemmbacke (15) zum Greifen der Endklappe (D) des Beutels (B) ausgestattet sind, wobei der Beutel (B) an der mindestens einen Backe (15) des Greifmechanismus (14) hängt.
  3. Öffnungsanordnung nach Anspruch 2, wobei die Greifmechanismen (14) einer Transportvorrichtung (5) zugeordnet sind.
  4. Öffnungsanordnung nach Anspruch 3, wobei die Transportvorrichtung (5) einen proximalen Abschnitt (10), der in einer ersten Zone (9) angeordnet ist, und einen distalen Abschnitt (12), der in einer zweiten Zone (11) angeordnet ist, umfasst, wobei die erste Zone (9) eine höhere Verunreinigungsklasse und einen höheren Umgebungsdruck als die zweite Zone (11) aufweist.
  5. Öffnungsanordnung nach Anspruch 3 oder 4, wobei die Transportvorrichtung (5) eine Konfiguration mit geschlossenem Regelkreis aufweist und von einer automatischen Antriebseinheit, die mit einem Steuer- und Verwaltungsprozessor verbunden ist, angetrieben wird.
  6. Öffnungsanordnung nach einem der vorhergehenden Ansprüche 2 bis 5, wobei das Schneidelement (2a) zwischen den Greifmechanismen (14) und dem Klemmmechanismus (2) angeordnet ist, wenn die Endklappe (D) von den Abschnitten der gegenüberliegenden Bleche (E, F), die durch den Klemmmechanismus (2) geklemmt sind, getrennt ist.
  7. Öffnungsanordnung nach einem der vorhergehenden Ansprüche, wobei der Klemmmechanismus (2) in ein bewegliches Anschlussende (3) eines Manipulators (4) integriert ist.
  8. Öffnungsanordnung nach Anspruch 7, wobei der Manipulator (4) ein Roboter vom anthropomorphen Typ ist.
  9. Öffnungsanordnung nach Anspruch 7 oder 8, wobei der Manipulator (4) zwischen mindestens zwei Endkonfigurationen beweglich ist, nämlich eine erste Konfiguration, bei welcher der Beutel (B) von der Transportvorrichtung (5) zum Klemmen der gegenüberliegenden Bleche (E, F) mit dem Klemmmechanismus (2) entfernt wird, und eine zweite Konfiguration, bei welcher der Beutel (B) in die Nähe einer Öffnung (6) gebracht wird, die an einer Trennwand (7) definiert ist, die die erste Zone (9) von einem Fach (8) mit einer höheren Kontaminationsklasse und einem höheren Umgebungsdruck im Vergleich zu der ersten Zone (9) trennt.
  10. Öffnungsanordnung nach Anspruch 9, wobei in der ersten Zone (9) mindestens ein Spender eines Gasstroms angeordnet ist, der über den proximalen Abschnitt (10) der Transportvorrichtung (5) fließen soll, wobei der Beutel (B) entlang des Endabschnitts (10) und des in der ersten Zone (9) befindlichen Manipulators (4) transportiert wird.
  11. Öffnungsanordnung nach Anspruch 10, wobei der Gasstrom vom laminaren Typ ist.
  12. Verfahren zum Öffnen von Beuteln (B), in denen Behälter (A) für pharmazeutische Zwecke untergebracht sind, umfassend die Schritte:
    - Anordnen eines Teils (C) des Beutels (B), der in Bezug auf eine Endklappe (D) in einem Abstand mit einem Klemmmechanismus (2) beabstandet ist;
    - Zusammenklemmen von Abschnitten gegenüberliegender Bleche (E, F) des Beutels (B) mit dem Klemmmechanismus (2), gekennzeichnet durch den weiteren Schritt des:
    - Trimmens und Trennens der Endklappe (D) mittels eines Schneidelements (2a) in Bezug auf die Abschnitte der gegenüberliegenden Bleche (E, F) des Beutels (B), die durch den Klemmmechanismus (2) miteinander zusammengeklemmt sind.
  13. Verfahren nach Anspruch 12, ferner umfassend den Schritt des Ausrichtens des durch den Klemmmechanismus (2) geklemmten Teils des Beutels (B) an einer nachfolgenden Betriebsstation.
  14. Verfahren nach Anspruch 12 oder 13, wobei das Klemmen des Beutels (B) mit dem Klemmmechanismus (2) die Abschnitte der gegenüberliegenden Bleche (E, F) zusammengeklemmt hält, so dass die im Beutel (B) befindlichen Behälter (A) auch nach dem Zuschneiden von der Außenumgebung isoliert bleiben.
EP17743339.8A 2016-07-27 2017-07-26 Öffnungsanordnung für behälteraufnehmende beutel zur pharmazeutischen verwendung Active EP3490893B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000078609A IT201600078609A1 (it) 2016-07-27 2016-07-27 Gruppo di apertura per confezioni di contenitori ad uso farmaceutico
PCT/EP2017/068858 WO2018019874A1 (en) 2016-07-27 2017-07-26 Opening assembly for bags housing containers for pharmaceutical use

Publications (2)

Publication Number Publication Date
EP3490893A1 EP3490893A1 (de) 2019-06-05
EP3490893B1 true EP3490893B1 (de) 2021-03-24

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EP17743339.8A Active EP3490893B1 (de) 2016-07-27 2017-07-26 Öffnungsanordnung für behälteraufnehmende beutel zur pharmazeutischen verwendung

Country Status (8)

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

Cited By (1)

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WO2024022841A3 (de) * 2022-07-26 2024-04-04 Tt Innovation Ag Verfahren zum ausbringen eines behälters aus einem beutel, schneidvorrichtung, entnahmevorrichtung und entpackvorrichtung

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DE102018210747A1 (de) * 2018-06-29 2020-01-02 Robert Bosch Gmbh Vorrichtung und Verfahren zum Zuführen eines Gegenstandes
CN109625500B (zh) * 2019-01-25 2020-11-06 格瑞果汁工业(天津)有限公司 一种果酱小袋拆袋机
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.
US12030688B1 (en) * 2020-08-27 2024-07-09 Express Scripts Strategic Development, Inc. Systems and methods for pharmaceutical container processing
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

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WO2008016313A1 (en) 2006-08-02 2008-02-07 J.M.P. Engineering Limited A multi layer bag separator
WO2011012658A1 (de) 2009-07-30 2011-02-03 Autefa Automation Gmbh Öffnungseinrichtung
EP2441692A1 (de) 2010-10-14 2012-04-18 CO.RI.M.A. S.r.l. Vorrichtung und Verfahren zum Entfernen eines sterilen Produkts aus einer sterilen Verpackung mit dem Produkt darin
DE102010063892A1 (de) 2010-12-22 2012-06-28 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines Objekts aus einer Verpackung
DE102011080289A1 (de) 2011-08-02 2013-02-07 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines sterilen Gegenstands aus einem Folienbeutel
DE102014201966A1 (de) 2014-02-04 2015-08-06 Robert Bosch Gmbh Vorrichtung und Verfahren zum Handling eines Trays
EP2609015B1 (de) 2010-08-23 2015-12-09 Robert Bosch GmbH Verfahren zum entsorgen von sterilem verpackungsmaterial sowie vorrichtung hierzu

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CH702317B1 (it) * 2007-08-02 2011-06-15 Stevanato Group Internat As Struttura di confezione di flaconi in vetro ad uso farmaceutico.
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WO2008016313A1 (en) 2006-08-02 2008-02-07 J.M.P. Engineering Limited A multi layer bag separator
WO2011012658A1 (de) 2009-07-30 2011-02-03 Autefa Automation Gmbh Öffnungseinrichtung
EP2609015B1 (de) 2010-08-23 2015-12-09 Robert Bosch GmbH Verfahren zum entsorgen von sterilem verpackungsmaterial sowie vorrichtung hierzu
EP2441692A1 (de) 2010-10-14 2012-04-18 CO.RI.M.A. S.r.l. Vorrichtung und Verfahren zum Entfernen eines sterilen Produkts aus einer sterilen Verpackung mit dem Produkt darin
DE102010063892A1 (de) 2010-12-22 2012-06-28 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines Objekts aus einer Verpackung
DE102011080289A1 (de) 2011-08-02 2013-02-07 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines sterilen Gegenstands aus einem Folienbeutel
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Publication number Priority date Publication date Assignee Title
WO2024022841A3 (de) * 2022-07-26 2024-04-04 Tt Innovation Ag Verfahren zum ausbringen eines behälters aus einem beutel, schneidvorrichtung, entnahmevorrichtung und entpackvorrichtung

Also Published As

Publication number Publication date
JP2019521927A (ja) 2019-08-08
CN109715505B (zh) 2021-02-26
IT201600078609A1 (it) 2018-01-27
ES2874645T3 (es) 2021-11-05
US20210292032A1 (en) 2021-09-23
CA3032037A1 (en) 2018-02-01
JP6971305B2 (ja) 2021-11-24
EP3490893A1 (de) 2019-06-05
CN109715505A (zh) 2019-05-03
WO2018019874A1 (en) 2018-02-01

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