EP3490893B1 - Öffnungsanordnung für behälteraufnehmende beutel zur pharmazeutischen verwendung - Google Patents
Öffnungsanordnung für behälteraufnehmende beutel zur pharmazeutischen verwendung Download PDFInfo
- 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
- Authority
- EP
- European Patent Office
- Prior art keywords
- bag
- clamping mechanism
- opening assembly
- zone
- clamping
- Prior art date
- Legal status (The legal status 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 status listed.)
- Active
Links
- 230000007246 mechanism Effects 0.000 claims description 35
- 238000011109 contamination Methods 0.000 claims description 22
- 238000009966 trimming Methods 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 238000000926 separation method Methods 0.000 claims description 3
- 239000002245 particle Substances 0.000 description 16
- 230000001681 protective effect Effects 0.000 description 9
- 239000007789 gas Substances 0.000 description 6
- 239000000356 contaminant Substances 0.000 description 4
- 239000000725 suspension Substances 0.000 description 4
- 230000036512 infertility Effects 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 239000000428 dust Substances 0.000 description 2
- 238000002955 isolation Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- 230000035508 accumulation Effects 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000003749 cleanliness Effects 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000005204 segregation Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Images
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
- B65B69/00—Unpacking of articles or materials, not otherwise provided for
- B65B69/0008—Opening and emptying bags
-
- 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
- B65B69/00—Unpacking of articles or materials, not otherwise provided for
- B65B69/0033—Unpacking of articles or materials, not otherwise provided for by cutting
-
- 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
- B65B69/00—Unpacking of articles or materials, not otherwise provided for
- B65B69/005—Unpacking of articles or materials, not otherwise provided for by expelling contents, e.g. by squeezing the container
- B65B69/0058—Solid 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)
- 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. - 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.
- Öffnungsanordnung nach Anspruch 2, wobei die Greifmechanismen (14) einer Transportvorrichtung (5) zugeordnet sind.
- 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.
- 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.
- 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.
- Öffnungsanordnung nach einem der vorhergehenden Ansprüche, wobei der Klemmmechanismus (2) in ein bewegliches Anschlussende (3) eines Manipulators (4) integriert ist.
- Öffnungsanordnung nach Anspruch 7, wobei der Manipulator (4) ein Roboter vom anthropomorphen Typ ist.
- 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.
- 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.
- Öffnungsanordnung nach Anspruch 10, wobei der Gasstrom vom laminaren Typ ist.
- 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.
- Verfahren nach Anspruch 12, ferner umfassend den Schritt des Ausrichtens des durch den Klemmmechanismus (2) geklemmten Teils des Beutels (B) an einer nachfolgenden Betriebsstation.
- 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.
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 |
Family
ID=57610180
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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)
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 |
Families Citing this family (7)
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 |
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 |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007113661A2 (en) | 2006-04-05 | 2007-10-11 | Ima Industria Macchine Automatiche S.P.A. | Apparatus and method for feeding a packaging machine with a product |
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 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CH702317B1 (it) * | 2007-08-02 | 2011-06-15 | Stevanato Group Internat As | Struttura di confezione di flaconi in vetro ad uso farmaceutico. |
CN201228095Y (zh) * | 2008-05-20 | 2009-04-29 | 刘雪 | 开袋器 |
DE102014201967B4 (de) * | 2014-02-04 | 2024-09-26 | Syntegon Technology 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 |
-
2016
- 2016-07-27 IT IT102016000078609A patent/IT201600078609A1/it unknown
-
2017
- 2017-07-26 ES ES17743339T patent/ES2874645T3/es active Active
- 2017-07-26 JP JP2019504966A patent/JP6971305B2/ja active Active
- 2017-07-26 CN CN201780058439.1A patent/CN109715505B/zh active Active
- 2017-07-26 EP EP17743339.8A patent/EP3490893B1/de active Active
- 2017-07-26 US US16/321,435 patent/US20210292032A1/en not_active Abandoned
- 2017-07-26 CA CA3032037A patent/CA3032037A1/en active Pending
- 2017-07-26 WO PCT/EP2017/068858 patent/WO2018019874A1/en unknown
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007113661A2 (en) | 2006-04-05 | 2007-10-11 | Ima Industria Macchine Automatiche S.P.A. | Apparatus and method for feeding a packaging machine with a product |
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 |
DE102014201966A1 (de) | 2014-02-04 | 2015-08-06 | Robert Bosch Gmbh | Vorrichtung und Verfahren zum Handling eines Trays |
Non-Patent Citations (2)
Title |
---|
JAMES L DRINKWATER, MARC VAN LAERE: "Risk-based environmental control and process monitoring in aseptic processing", EUROPEAN JOURNAL OF PARENTERAL & PHARMACEUTICAL SCIENCES, vol. 20, no. 4, 1 January 2015 (2015-01-01), pages 133 - 142, XP055909917 |
VON BENGT LJUNGQVIST ET AL.: "Contamination transfer research, Study of airborne and surface contamination transfer through a process of pre-sterilised container Tub transfer into a Filling Isolator via a De-Bagging No-Touch -Transfer - NTT Process step", CHALLENGES IN STERILE PRODUCT MANUFACTURING, 9 June 2016 (2016-06-09), XP055909931 |
Cited By (1)
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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