EP3490893B2 - Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique - Google Patents

Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique

Info

Publication number
EP3490893B2
EP3490893B2 EP17743339.8A EP17743339A EP3490893B2 EP 3490893 B2 EP3490893 B2 EP 3490893B2 EP 17743339 A EP17743339 A EP 17743339A EP 3490893 B2 EP3490893 B2 EP 3490893B2
Authority
EP
European Patent Office
Prior art keywords
bag
clamping mechanism
zone
opening assembly
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
Application number
EP17743339.8A
Other languages
German (de)
English (en)
Other versions
EP3490893A1 (fr
EP3490893B1 (fr
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 EP3490893A1 publication Critical patent/EP3490893A1/fr
Application granted granted Critical
Publication of EP3490893B1 publication Critical patent/EP3490893B1/fr
Publication of EP3490893B2 publication Critical patent/EP3490893B2/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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 (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).
  • the atmosphere inside the bag will also present a very low contamination class (such as, an ISO Class less than or equal to 5).
  • 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.
  • 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 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 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 advantageously moves 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)

Claims (10)

  1. Groupe de coupe pour sachets (B) de contenants (A) à usage pharmaceutique, comprenant au moins un organe de serrage (2) pour serrer une portion (C) dudit sachet (B) et au moins un élément de découpe (2a), dans lequel ledit organe de serrage (2) est configuré pour serrer entre elles des portions de feuilles opposées (E, F) dudit sachet (B), lesdites portions étant espacées par rapport à un bord terminal (D) du sachet, dans lequel ledit élément de découpe (2a) est conçu pour couper et séparer ledit bord terminal (D), qui dépasse des portions de feuilles opposées (E, F) du sachet (B), lesdites portions étant serrées l'une contre l'autre par ledit organe de serrage (2), caractérisé en ce que le groupe comprend en outre des organes de préhension (14) munis d'au moins une mâchoire de serrage (15) destinée à serrer ledit bord terminal (D) du sachet (B), le sachet (B) étant suspendu à ladite mâchoire (15) de l'organe de préhension (14).
  2. Groupe de coupe selon la revendication 1, dans lequel les organes de préhension (14) sont associés à un dispositif de transport (5).
  3. Groupe de coupe selon la revendication 2, dans lequel ledit dispositif de transport (5) comprend une section proximale (10) disposée dans une première zone (9) et une section distale (12) disposée dans une seconde zone (11), la première zone (9) présentant une classe de contamination et une pression ambiante supérieures à celles de la seconde zone (11).
  4. Groupe de coupe selon la revendication 2 ou 3, dans lequel ledit dispositif de transport (5) forme une boucle fermée et est entraîné par une unité de motorisation automatique pilotée par un processeur de commande et de gestion.
  5. Groupe de coupe selon l'une quelconque des revendications précédentes, dans lequel ledit élément de découpe (2a) est disposé entre lesdits organes de préhension (14) et ledit organe de serrage (2), lorsque ledit bord terminal (D) est séparé des portions de feuilles opposées (E, F) serrées entre elles par ledit organe de serrage (2).
  6. Groupe de coupe pour sachets (B) de contenants (A) à usage pharmaceutique, comprenant au moins un organe de serrage (2) pour serrer une portion (C) dudit sachet (B) et au moins un élément de découpe (2a) dans lequel ledit organe de serrage (2) est configuré pour serrer entre elles des portions de feuilles opposées (E, F) dudit sachet (B), lesdites portions étant espacées par rapport à un bord terminal (D) du sachet, dans lequel ledit élément de découpe (2a) est conçu pour couper et séparer ledit bord terminal (D), qui dépasse des portions de feuilles opposées (E, F) du sachet (B), lesdites portions étant serrées l'une contre l'autre par ledit organe de serrage (2), caractérisé en ce que ledit organe de serrage (2) est solidaire d'une extrémité terminale (3) mobile d'un manipulateur (4), lequel manipulateur (4) est orientable entre au moins deux configurations d'extrémité, une première configuration dans laquelle le sachet (B) est prélevé à partir d'un dispositif de transport (5) pour le serrage desdites feuilles (E, F) opposées à l'aide dudit organe de serrage (2), et une seconde configuration dans laquelle le sachet (B) est amené à proximité d'une ouverture (6) formée dans une paroi de séparation (7) qui sépare une première zone (9) d'un compartiment (8) présentant une classe de contamination et une pression ambiante supérieures à celles de ladite première zone (9).
  7. Groupe de coupe selon la revendication 6, dans lequel ledit manipulateur (4) est de type robot anthropomorphe.
  8. Groupe de coupe selon la revendication 6, dans lequel, dans ladite première zone (9), est disposé au moins un diffuseur destiné à émettre un flux de gaz sur ladite section proximale (10) du dispositif de transport (5), ledit sachet (B) transporté le long de ladite section proximale (10) et ledit manipulateur (4) disposé dans ladite première zone (9).
  9. Groupe de coupe selon la revendication 8, dans lequel ledit flux de gaz est un flux laminaire.
  10. Procédé de découpe de sachets (B) de contenants (A) à usage pharmaceutique, comprenant les étapes suivantes :
    - disposer une portion (C) dudit sachet (B), espacée par rapport à un bord terminal (D), en alignement avec un organe de serrage (2) ;
    - serrer entre elles des portions de feuilles opposées (E, F) dudit sachet (B) à l'aide dudit organe de serrage (2);
    - couper et séparer, au moyen d'un élément de découpe (2a), ledit bord terminal (D) par rapport aux portions de feuilles opposées (E, F) dudit sachet (B) serrées entre elles par ledit organe de serrage (2),
    le procédé étant caractérisé en ce qu'il comprend en outre l'étape consistant à:
    - aligner la portion du sachet (B) serrée par ledit organe de serrage (2) avec une station opératoire suivante,
    dans laquelle le serrage du sachet (B) à l'aide de l'organe de serrage (2) maintient lesdites portions de feuilles opposées (E, F) serrées entre elles, de sorte que les contenants (A) disposés à l'intérieur du sachet (B) restent isolés de l'environnement extérieur même après la découpe.
EP17743339.8A 2016-07-27 2017-07-26 Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique Active EP3490893B2 (fr)

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 (fr) 2016-07-27 2017-07-26 Ensemble ouverture pour sacs logeant des contenants à usage pharmaceutique

Publications (3)

Publication Number Publication Date
EP3490893A1 EP3490893A1 (fr) 2019-06-05
EP3490893B1 EP3490893B1 (fr) 2021-03-24
EP3490893B2 true EP3490893B2 (fr) 2025-09-10

Family

ID=57610180

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17743339.8A Active EP3490893B2 (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) EP3490893B2 (fr)
JP (1) JP6971305B2 (fr)
CN (1) CN109715505B (fr)
CA (1) CA3032037A1 (fr)
ES (1) ES2874645T5 (fr)
IT (1) IT201600078609A1 (fr)
WO (1) WO2018019874A1 (fr)

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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.
CN111513357A (zh) * 2019-12-02 2020-08-11 广州富港万嘉智能科技有限公司 一种含馅食物自动制作贩卖设备
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
IT202100004685A1 (it) * 2021-03-01 2022-09-01 Ima Spa Procedimento e apparato per il trattamento automatico di involucri.
GB2606021B (en) * 2021-04-23 2023-07-19 Mpac Group Plc Packaging removal apparatus
DE102022110051A1 (de) * 2022-04-26 2023-10-26 Syntegon Technology Gmbh Vorrichtung, Set, pharmazeutische Anlage und Verfahren zum Entpacken einer Vielzahl von Gegenständen
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
WO2022195572A2 (fr) * 2022-05-25 2022-09-22 Indian Institute of Technology Guwahati Appareil de coupe et de pressage de sachets/poches
DE102022118701A1 (de) * 2022-07-26 2024-02-01 Tt Innovation Ag Verfahren zum Ausbringen eines Behälters aus einem Beutel, Schneidvorrichtung, Entnahmevorrichtung und Entpackvorrichtung

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WO2011012658A1 (fr) † 2009-07-30 2011-02-03 Autefa Automation Gmbh Dispositif d'ouverture
EP2441692A1 (fr) † 2010-10-14 2012-04-18 CO.RI.M.A. S.r.l. Appareil et procédé pour retirer un produit stérile d'un paquet stérile contenant le produit

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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
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DE102010063892B4 (de) 2010-12-22 2023-10-19 Syntegon Technology Gmbh Vorrichtung und Verfahren zum Entnehmen eines Objekts aus einer Verpackung
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WO2011012658A1 (fr) † 2009-07-30 2011-02-03 Autefa Automation Gmbh Dispositif d'ouverture
EP2441692A1 (fr) † 2010-10-14 2012-04-18 CO.RI.M.A. S.r.l. Appareil et procédé pour retirer un produit stérile d'un paquet stérile contenant le produit

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Also Published As

Publication number Publication date
IT201600078609A1 (it) 2018-01-27
CN109715505A (zh) 2019-05-03
US20210292032A1 (en) 2021-09-23
CA3032037A1 (fr) 2018-02-01
JP6971305B2 (ja) 2021-11-24
WO2018019874A1 (fr) 2018-02-01
ES2874645T5 (en) 2026-01-02
CN109715505B (zh) 2021-02-26
ES2874645T3 (es) 2021-11-05
JP2019521927A (ja) 2019-08-08
EP3490893A1 (fr) 2019-06-05
EP3490893B1 (fr) 2021-03-24

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