US20210292032A1 - Opening assembly for bags housing containers for pharmaceutical use - Google Patents

Opening assembly for bags housing containers for pharmaceutical use Download PDF

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Publication number
US20210292032A1
US20210292032A1 US16/321,435 US201716321435A US2021292032A1 US 20210292032 A1 US20210292032 A1 US 20210292032A1 US 201716321435 A US201716321435 A US 201716321435A US 2021292032 A1 US2021292032 A1 US 2021292032A1
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US
United States
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.)
Abandoned
Application number
US16/321,435
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English (en)
Inventor
Claudio Trebbi
Gabriele Gabusi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
IMA Industria Macchine Automatiche SpA
Original Assignee
IMA Industria Macchine Automatiche SpA
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
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Application filed by IMA Industria Macchine Automatiche SpA filed Critical IMA Industria Macchine Automatiche SpA
Publication of US20210292032A1 publication Critical patent/US20210292032A1/en
Abandoned legal-status Critical Current

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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 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 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).
  • contamination i.e., ISO 5 Class or lower, thus, with the least presence of contaminants
  • 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.
  • the highest contamination class i.e., ISO 5 Class or lower
  • 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.
  • FIG. 1 shows, in a schematic axonometric view, a portion of an opening assembly for bags housing containers for pharmaceutical use according to the invention
  • FIG. 2 shows, in a schematic side view, the opening assembly for bags housing containers for pharmaceutical use according to the invention
  • 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 2 a 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 end flap D of the bag B (thus, the opening of the bag B) can then be removed.
  • the transfer to subsequent operating stations where it may be necessary to access the contents of the bag B will occur while the sections of opposing sheets E and F (portion C) are clamped together sealed by the clamping mechanism 2 and thus under such conditions as to prevent contamination of the contents of the bag B.
  • 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 15 for gripping the end flap D of the bag B when the bag B hangs from the at least one said jaw 15 of the gripping mechanism 14 .
  • the cutting element 2 a 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 .
  • an ISO contamination class of “5” or lower, more “safe” compared to the one in the first zone 9 could be established.
  • 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 2 a 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)
US16/321,435 2016-07-27 2017-07-26 Opening assembly for bags housing containers for pharmaceutical use Abandoned US20210292032A1 (en)

Applications Claiming Priority (3)

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
PCT/EP2017/068858 WO2018019874A1 (en) 2016-07-27 2017-07-26 Opening assembly for bags housing containers for pharmaceutical use

Publications (1)

Publication Number Publication Date
US20210292032A1 true US20210292032A1 (en) 2021-09-23

Family

ID=57610180

Family Applications (1)

Application Number Title Priority Date Filing Date
US16/321,435 Abandoned US20210292032A1 (en) 2016-07-27 2017-07-26 Opening assembly for bags housing containers for pharmaceutical use

Country Status (8)

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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102022110826A1 (de) 2022-05-03 2023-11-09 Tt Innovation Ag Vorrichtung zum Manipulieren von Behälter enthaltenden Beuteln
US20240034506A1 (en) * 2021-02-23 2024-02-01 Syntegon Technology Gmbh Device and method for transferring a packaging unit into a barrier system for pharmaceuticals

Families Citing this family (5)

* 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
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.
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

Family Cites Families (13)

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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 (en) 2006-08-02 2008-02-07 J.M.P. Engineering Limited A multi layer bag separator
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
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
DE102011080289B4 (de) * 2011-08-02 2021-07-08 Syntegon Technology 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
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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240034506A1 (en) * 2021-02-23 2024-02-01 Syntegon Technology Gmbh Device and method for transferring a packaging unit into a barrier system for pharmaceuticals
US11897651B1 (en) * 2021-02-23 2024-02-13 Syntegon Technology Gmbh Device and method for transferring a packaging unit into a barrier system for pharmaceuticals
DE102022110826A1 (de) 2022-05-03 2023-11-09 Tt Innovation Ag Vorrichtung zum Manipulieren von Behälter enthaltenden Beuteln

Also Published As

Publication number Publication date
EP3490893B1 (en) 2021-03-24
ES2874645T3 (es) 2021-11-05
WO2018019874A1 (en) 2018-02-01
JP6971305B2 (ja) 2021-11-24
CN109715505A (zh) 2019-05-03
CA3032037A1 (en) 2018-02-01
JP2019521927A (ja) 2019-08-08
CN109715505B (zh) 2021-02-26
IT201600078609A1 (it) 2018-01-27
EP3490893A1 (en) 2019-06-05

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