EP4100330A1 - Dispositif et procédé de transfert d'une unité emballage dans un système de barrière pour produits pharmaceutiques - Google Patents

Dispositif et procédé de transfert d'une unité emballage dans un système de barrière pour produits pharmaceutiques

Info

Publication number
EP4100330A1
EP4100330A1 EP22708526.3A EP22708526A EP4100330A1 EP 4100330 A1 EP4100330 A1 EP 4100330A1 EP 22708526 A EP22708526 A EP 22708526A EP 4100330 A1 EP4100330 A1 EP 4100330A1
Authority
EP
European Patent Office
Prior art keywords
barrier system
packaging unit
film tube
interior
packaging
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.)
Granted
Application number
EP22708526.3A
Other languages
German (de)
English (en)
Other versions
EP4100330B1 (fr
Inventor
Albrecht Kühnle
Benjamin Hoffmann
Ulrich Krauss
Markus Ilgenfritz
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.)
Syntegon Technology GmbH
Original Assignee
Syntegon Technology GmbH
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
Application filed by Syntegon Technology GmbH filed Critical Syntegon Technology GmbH
Publication of EP4100330A1 publication Critical patent/EP4100330A1/fr
Application granted granted Critical
Publication of EP4100330B1 publication Critical patent/EP4100330B1/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
    • B65B69/0033—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
    • 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
    • B65B69/005—Unpacking of articles or materials, not otherwise provided for by expelling contents, e.g. by squeezing the container
    • B65B69/0058—Solid contents

Definitions

  • the invention relates to a device and a method for converting a packaging unit into a barrier system for pharmaceuticals, wherein the packaging unit comprises a sterilized container and at least one sterile product arranged therein and wherein the packaging unit is surrounded in an initial state by outer packaging that is sterilized at least on the inside, the barrier system having an access opening through which the packaging unit an area surrounding the barrier system can be transferred into an interior space of the barrier system.
  • Devices and methods of this type are used to be able to transfer the packaging unit into the barrier system with as little contamination as possible. Unless further measures are taken, simply opening the packaging unit's outer packaging in the vicinity of the barrier system would result in the outside of the packaging unit's container being contaminated, with the risk of introducing germs into the barrier system.
  • Packaging unit including outer packaging is exposed to an air flow and the outer packaging is separated within the air flow in order to then transport the packaging unit into the barrier system.
  • irradiation and/or treatment with hydrogen peroxide can also take place in the additional area.
  • the present invention has the object of specifying a device and a method which a simple, contamination-free Enable transfer of the packaging unit into the barrier system.
  • Overlapping section of an outside of the film tube is provided and that a separating device is provided for local separation of the connection area and production of a passage opening, which makes it possible to transfer the packaging unit from the outer packaging into the interior of the film tube.
  • a film tube closed at the end is or will be arranged in the area surrounding the barrier system, the interior of which communicates with the access opening, that a connection area between a flat cover section of the outer packaging and a cover section overlapping flat overlapping section of an outside of the film tube is produced, that then the connection area or a part of the connection area is separated locally, and that the Packaging unit is brought out of the outer packaging through the passage opening into the interior of the film tube and is transferred from there into the interior of the barrier system.
  • the sterile interior space of the barrier system is extended into the surroundings of the barrier system, with the access opening to the barrier system being interposed.
  • the extension of this sterile interior is provided by a film tube that is closed at the end.
  • a connection extending over a connection area is made between a cover section of the outer packaging and a
  • Overlap section made an outside of the film tube.
  • the outside of the lid section of the outer packaging and the outside of the tubular film are connected to one another, it being possible for the outsides to be in direct contact with one another or connecting material is arranged between the outsides.
  • connection discussed above allows for isolation of the outside of the lid portion of the overpack from contamination. While maintaining this insulation, it is possible to use the connection area - and thus also the film tube and the outer packaging - to be separated locally, so that the connection between the overlapping section of the film tube and the lid section of the outer packaging and the associated insulation of the outer surface of the lid section of the container is retained, but at the same time a passage opening is created which makes it possible to remove the packaging unit from the now separated outer packaging into to transfer the now separated film tube into it.
  • connection area As long as the previously created connection between the lid section of the outer packaging and overlapping sections of the film tube is retained as a film composite during the local separation of the connection area, it is possible for the connection area to be separated in such a way that the lid section of the outer packaging with the rest of the outer packaging and that the overlapping section of the film tube remains connected to the rest of the film tube.
  • This has the advantage that the film composite produced by the connection remains connected both to the outer packaging and to the film tube, so that after a packaging unit has been transferred to the barrier system, a coherent unit can be disposed of which has a section of the film tube, the Foil composite and the rest of the outer packaging includes.
  • connection area it is preferred that a first part of the connection area is separated, wherein the The film tube and the outer packaging remain connected to one another in a second part of the connection area that differs from the first part, and that the packaging unit is brought into the interior of the film tube - with deformation of a film composite made up of a cover section and an overlapping section.
  • the deformation of the film composite is accompanied by its displacement into the interior of the film tube.
  • the film composite can fold into the interior of the film tube like a hinge.
  • connection area extends over the entire area of the cover section and the overlapping section.
  • connection area extends along a path that is closed on the peripheral side. The separation of the connection area takes place along at least part of this path, with the separation area being narrower than the path over the extension of the connection area in the area.
  • the separating area is preferably arranged in such a way that, viewed along the course of the web, a connecting area section remains formed on both sides, so that the cover section and the
  • Overlap section are connected to each other at the edge and so that each adjacent sections of the outer packaging and the film tube also with each other are connected. This applies regardless of whether the local separation of the connection area occurs completely along the course of a path closed on the peripheral side or whether the separation of the connection area takes place only along part of the course of the path closed on the peripheral side.
  • the film tube is provided in the form of an endless tube. This enables the device to be easily prepared for transferring a further packaging unit into the interior of the barrier system by using a packaging unit used in a previous transfer process
  • Tubular film piece is disposed of together with the composite film and with the rest of the outer packaging of the previous packaging unit and by providing a new, unused piece of the tubular film which is then connected in an overlapping area to the cover section of the outer packaging of another packaging unit.
  • the endless hose can preferably be unwound or pulled off a supply of hose material adjacent to the access opening of the barrier system. This makes it possible to arrange the end closure of the tubular film in an area spaced apart from the access opening of the barrier system.
  • the film closure can include winding rollers, onto which used film tube and any film composites connected thereto and other sections of the outer packaging can be wound up.
  • the overwraps are preferably made from a thermoplastic film material and are preferably provided in the form of pouches.
  • Preferred materials for such bags are polyethylene, polystyrene and "Tyvek” from DuPont.
  • the bag-shaped outer packaging mentioned is an inner bag, which in turn is surrounded by an additional outer packaging, in particular in the form of an outer bag.
  • the outer packaging i.e. here: the inner bag
  • the outer bag is removed in an additional area of the device mentioned at the outset.
  • the connecting device it is possible for the connecting device to connect the cover section and the overlapping section to one another over their surface extent. It is preferred if the connecting device is designed to - at least or only - the edge of the cover section and - at least or only - to connect the edge of the overlapping section together.
  • the connecting device prefferably has a heating device for fusing the material of the cover section and the material of the overlapping section.
  • a heating device for fusing the material of the cover section and the material of the overlapping section.
  • Such a heating device is designed, for example, in such a way that it acts over the entire connection area and a connection is established by positioning the heating device once and/or activating the heating device once. It is also possible that the heating device can be driven to move so that different sections of the connection area are produced by the heating device producing sections of the connection area in each case, with the heating device being moved relative to the cover section and the overlapping section.
  • the connecting device prefferably has a discharge device for discharging a bonding material.
  • the adhesive material can also be discharged simultaneously over the entire connection area or—with movement/drive of the discharge device—successively over different sections of the connection area.
  • the separating device separates the connection area locally without contact, for example by means of an energy beam.
  • the separating device is mechanically effective and has a knife or a punching element for severing at least part of the connection area.
  • the device has a station for arranging the packaging unit and the outer packaging, in which station the connecting device and the separating device are effective.
  • the device comprises a transport device for transporting the packaging unit from the station into the interior of the film tube.
  • the base of the station is used for arranging the packaging unit and the outer packaging, with the base of the station being arranged below the film tube and being able to be raised in such a way that the packaging unit can be raised to the level of the interior of the film tube.
  • Show in the drawing 1 shows a side view of an embodiment of a device for transferring a packaging unit into a barrier system for pharmaceuticals
  • FIG. 2 shows a section of the device according to FIG. 1 during the production of a connection area and during the subsequent separation of a part of the connection area;
  • FIG. 4 shows a further section of the device according to FIG. 1 during transport of the packaging unit into the barrier system.
  • a device denoted overall by the reference numeral 10 in the drawing comprises a barrier system 12 in which pharmaceuticals are handled, in particular filled.
  • the barrier system 12 has an interior 14 which is separated from an environment 16 of the barrier system 12 .
  • a separation between the interior 14 of the barrier system 12 and the environment 16 of the barrier system 12 is illustrated in the drawing by a dot-dash line 18 .
  • This boundary is usually formed by a wall of the barrier system 12 in which, however, an access opening 20 is provided for access to the interior 14 of the barrier system 12 .
  • the device 10 serves to convey a packaging unit 22 from the environment 16 into the interior 14 of the barrier system.
  • the packaging unit 22 has a sterilized container 24, which can be trough-shaped, ie open at the top. At least one sterile item 26 is arranged in the container 24, for example an empty syringe 28, which is to be filled with a pharmaceutical in the interior space 14 of the barrier system.
  • the packaging unit 22 is surrounded by a sterilized outer packaging 30 , for example a bag made of film, which is optionally surrounded by an outer bag 32 .
  • a sterilized outer packaging 30 for example a bag made of film, which is optionally surrounded by an outer bag 32 .
  • the device 10 has an entry area 34 with a support surface 36 for supporting at least the packaging unit 22 and the outer packaging 30.
  • the entrance area 34 is followed by a station 38 with a set-up surface 40 which can preferably be adjusted flush with the support surface 36 and more preferably can be adjusted in height by means of a transport device 42 .
  • a receiving surface 44 is arranged at the height of a lower boundary of the access opening 20 and preferably extends into the interior 14 of the barrier system 12 .
  • the receiving surface 44 has an opening 46, which is dimensioned such that a packaging unit 22 can be transferred from station 38 through opening 46 .
  • a support element 48 extending parallel to the receiving surface 44 is provided at the height of an upper edge of the access opening 20 .
  • the receiving surface 44 and the support element 48 are encased by a tubular film which is designated overall by the reference number 50 .
  • the film tube 50 is designed as an endless tube and can be pulled off a tube material supply 58 arranged adjacent to the access opening 20 .
  • the tubular film 50 delimits an interior space 52 and is closed at the end in a region 54 spaced apart from the access opening 20 .
  • the area 54 can, for example, comprise at least one take-up roll 56 onto which used pieces of the tubular film 50 are wound.
  • the film tube 50 is supported at its upper end in cross-section by the support element 48 and is fixed adjacent to the access opening 20 . At the same time, a lower end of the film tube 50 in cross section encloses the receiving surface 44 and its opening 46.
  • the device 10 further includes a
  • Connecting device 60 and a separating device 62 which are preferably arranged in the interior 52 of the film tube 50, see Figure 2.
  • the connecting device 60 serves to create a connection between an outside 64 of the material 66 of the film tube 50 and an outside 68 of a cover section 70 of the outer packaging 30 .
  • the connection area is shown in the two enlargements of FIG. This can be, for example, an adhesive material or (represented graphically) an area in which the material of the lid section 70 of the outer packaging 30 and an identically sized overlapping section 74 of the material 66 of the film tube 50 are connected to one another, in particular fused to one another.
  • the connecting area 72 preferably extends along a circumferentially closed path 76, see Figure 3.
  • the path 76 delimits a space 78 defined between the lid section 70 and the overlapping section 74, see Figure 2.
  • germs are thus enclosed between the cover section 70 and the overlapping section 74 of the film tube 50 and at the same time within the web-shaped connecting area 72 .
  • a width 80 of the web 76 measured in the extension plane of the connection region 72 is preferably at least 2 mm, in particular at least 4 mm.
  • the separating device 62 serves to separate the connecting area 72 locally. This separation can take place along the entire web-like course of the connection region 72; however, it is preferred that a separating area 82 only extends over a first part of the connecting area 72 . This is illustrated in Figure 3 with a dashed line; the separating area 82 extends, for example, along mutually opposite side edges 84 and 86 and along a front edge 88 of the connecting area 72.
  • a second part 90 of the connecting area 72 remains unchanged, ie is not locally separated in this second part 90. This is in particular a rear edge of the connection area 72.
  • the separating device 62 for example using a knife 92, see Figure 2, also cuts through the material of the film tube 50 and the material of the outer packaging 30. Seen across the width 80 of the web 76, the separating area is arranged in this way that after the local separation of the connection area 72 and simultaneous separation of the material of the tubular film 50 and the material of the outer packaging 30 on both sides of the separation area, respective sections 72a and 72b of the connection area 72 remain intact.
  • the packaging unit 22 is transported from the station 38 into the interior 52 of the film tube 50, see Figure 4.
  • the installation surface 40 is preferably raised until it has reached the level of the receiving surface 44 .
  • the packaging unit 22 is inserted through the opening 46 in the support surface 44 and into the interior space 52 .
  • a composite film 94 made up of the cover section 70 and overlapping section 74 connected to one another is pushed into the interior space 52 of the film tube 50 .
  • the composite film 94 folds away laterally, so that the packaging unit 22 is transferred past the folded-away composite film 94 into the interior 52 of the tubular film 50. From there, the packaging unit 22 can be transferred into the interior 14 of the barrier system 12 in a manner known per se, for example by means of transport elements known per se, for example slides or grippers.
  • the film tube 50 can be pulled off the supply 58, with the film composite 94 and the other components of the outer packaging 30 being able to be removed and collected at the same time.
  • another packaging unit 22 in above described manner in the interior 14 of the barrier system 12 are transferred.
  • FIG. 1 See Figure 1 is provided, which exposes the environment 16 and / or the interior 14 of the barrier system 12 of a defined air flow, which is directed, for example, from top to bottom.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)

Abstract

L'invention concerne un dispositif (10) et un procédé de transfert d'une unité emballage (22) dans un système de barrière (12) destinés à des produits pharmaceutiques, l'unité emballage comprenant un récipient stérilisé (24) et au moins un produit stérile (26) agencé dans ce dernier, et l'unité emballage, dans un état initial, étant entourée par un emballage extérieur (30) stérilisé au moins sur l'intérieur. Le système de barrière présente une ouverture d'accès (20) par laquelle l'unité emballage peut être transférée d'une zone environnante (16) du système de barrière à un espace intérieur (14) du système de barrière, un film tubulaire (50), fermé à une extrémité, étant agencé dans la zone environnante du système de barrière, l'intérieur (52) du film tubulaire (50) communiquant avec l'ouverture d'accès, un dispositif de liaison étant conçu pour créer une zone de liaison entre une partie couvercle de l'emballage externe et une partie de chevauchement d'une face externe du film tubulaire empiétant sur la partie couvercle, et un dispositif de séparation étant conçu pour la séparation locale de la zone de liaison.
EP22708526.3A 2021-02-23 2022-02-17 Dispositif et procede de transfert d'une unite de conditionnement dans un systeme barriere pour produits pharmaceutiques Active EP4100330B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021104221.6A DE102021104221A1 (de) 2021-02-23 2021-02-23 Vorrichtung und Verfahren zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika
PCT/EP2022/053884 WO2022179922A1 (fr) 2021-02-23 2022-02-17 Dispositif et procédé de transfert d'une unité emballage dans un système de barrière pour produits pharmaceutiques

Publications (2)

Publication Number Publication Date
EP4100330A1 true EP4100330A1 (fr) 2022-12-14
EP4100330B1 EP4100330B1 (fr) 2023-09-27

Family

ID=80682667

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22708526.3A Active EP4100330B1 (fr) 2021-02-23 2022-02-17 Dispositif et procede de transfert d'une unite de conditionnement dans un systeme barriere pour produits pharmaceutiques

Country Status (6)

Country Link
US (1) US11897651B1 (fr)
EP (1) EP4100330B1 (fr)
CN (1) CN116867710B (fr)
DE (1) DE102021104221A1 (fr)
ES (1) ES2966850T3 (fr)
WO (1) WO2022179922A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2606021B (en) * 2021-04-23 2023-07-19 Mpac Group Plc Packaging removal apparatus

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000095221A (ja) * 1998-09-25 2000-04-04 Yokohama Rubber Co Ltd:The フィルムパック端末部切断用の切断治具
DE102007027878A1 (de) * 2007-06-18 2008-12-24 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines sterilen Gegenstands aus einer Sterilverpackung
EP2291244B1 (fr) 2008-06-17 2012-04-25 Lugaia Sts Sterile Transfer Solutions Ag Procédé pour introduire un objet dans une chambre propre
DE102009027600A1 (de) * 2009-07-10 2011-01-13 Robert Bosch Gmbh Vorrichtung und Verfahren zum Öffnen einer Verpackung
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
DE102011084302A1 (de) * 2011-10-11 2013-04-11 Robert Bosch Gmbh Vorrichtung und Verfahren zum Entnehmen eines sterilen Gegenstands aus einem Folienbeutel
DE102016103404A1 (de) * 2016-02-26 2017-08-31 Schott Ag Verfahren zum Überführen einer Mehrzahl von Behältern zur Aufbewahrung von Substanzen für medizinische, pharmazeutische oder kosmetische Zwecke in einen Reinraum, Transport- und Verpackungsbehälter und Verpackungsgebilde hierfür sowie Verwendung
IT201600078609A1 (it) * 2016-07-27 2018-01-27 I M A Industria Macch Automatiche S P A In Sigla Ima S P A Gruppo di apertura per confezioni di contenitori ad uso farmaceutico
DE102017123387B4 (de) * 2017-10-06 2023-03-09 Groninger & Co. Gmbh Entpackungssystem für ein in einer Verpackung, Füllanlage mit Entpackungssystem und Verfahren zum Entpacken eines Objektes
DE102017124908A1 (de) * 2017-10-24 2019-04-25 Schott Ag Verfahren und Vorrichtung zur flexiblen Behandlung von Pharma-Packmitteln

Also Published As

Publication number Publication date
US11897651B1 (en) 2024-02-13
DE102021104221A1 (de) 2022-08-25
WO2022179922A1 (fr) 2022-09-01
ES2966850T3 (es) 2024-04-24
CN116867710A (zh) 2023-10-10
US20240034506A1 (en) 2024-02-01
CN116867710B (zh) 2024-05-28
EP4100330B1 (fr) 2023-09-27

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