EP4100330B1 - Vorrichtung und verfahren zur überführung einer verpackungseinheit in ein barrieresystem für pharmazeutika - Google Patents

Vorrichtung und verfahren zur überführung einer verpackungseinheit in ein barrieresystem für pharmazeutika Download PDF

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Publication number
EP4100330B1
EP4100330B1 EP22708526.3A EP22708526A EP4100330B1 EP 4100330 B1 EP4100330 B1 EP 4100330B1 EP 22708526 A EP22708526 A EP 22708526A EP 4100330 B1 EP4100330 B1 EP 4100330B1
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EP
European Patent Office
Prior art keywords
film tube
barrier system
packaging
packaging unit
interior
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
EP22708526.3A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP4100330A1 (de
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/de
Application granted granted Critical
Publication of EP4100330B1 publication Critical patent/EP4100330B1/de
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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
    • B65B69/0033—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 for transferring a packaging unit into a barrier system for pharmaceuticals with the features of the preamble of patent claim 1 and a method for transferring a packaging unit into a barrier system for pharmaceuticals with the features of the preamble of patent claim 11.
  • Devices and methods of this type serve to place the packaging unit in the container with as little contamination as possible Barrier system to be able to be transferred into it, the packaging unit comprising a sterilized container and at least one sterile product arranged therein. Unless further measures are taken, simply opening an outer packaging of the packaging unit in the vicinity of the barrier system would result in the outside of the container of the packaging unit being contaminated, so that there is a risk of germs being introduced into the barrier system.
  • a system for introducing a bagged and sterilized object into a clean room is, for example, from the EP 2 291 224 A1 known.
  • the present invention is based on the object of specifying a device and a method which provide a simple, contamination-free Enable the packaging unit to be transferred into the barrier system.
  • the sterile interior of the barrier system is extended into the surroundings of the barrier system, with the access opening to the barrier system 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 first established between a cover section of the outer packaging and an overlap section of an outside of the film tube using a connecting device.
  • a connecting device In this way, the outside of the cover section of the outer packaging and the outside of the film tube are connected to one another, with the outside sides being able to be in direct contact with one another or connecting material being arranged between the outside sides.
  • connection discussed above enables contamination-related isolation of the outside of the lid section of the outer packaging. While maintaining this insulation, it is possible to locally separate the connection area - and thus also the film tube and the outer packaging - so that the connection between the overlap 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 maintained, At the same time, however, a passage opening is created, which makes it possible to transfer the packaging unit from the now separated outer packaging into the now separated film tube.
  • connection area As long as the previously established connection between the cover section of the outer packaging and overlapping sections of the film tube is retained as a film composite in the course of the local separation of the connection area, it is possible for the connection area to be separated in such a way that the cover section of the outer packaging is connected to the remaining outer packaging and that the overlap 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 to both the outer packaging and the film tube, so that following the transfer of a packaging unit into the barrier system, an interconnected unit can be disposed of, which contains a section of the Film tube, the film composite and the rest of the outer packaging.
  • connection area a first part of the connection area is separated, with the film tube and the outer packaging remaining connected to one another in a second part of the connection area that deviates from the first part, and that the packaging unit - with deformation of a film composite consisting of the cover section and the overlap section - is placed in the interior of the film tube.
  • the deformation of the film composite is accompanied by its displacement into the interior of the film tube.
  • the film composite can fold like a hinge into the interior of the film tube.
  • connection area it is possible for the connection area to extend over the entire surface of the cover section and the overlap section. However, it is particularly advantageous if the connection area extends along a path that is closed on the circumference. The connection area is separated along at least part of this path, with the separation area being narrower than the path over the extent of the connection area in the surface.
  • the separation area is preferably arranged so that, viewed along the course of the web, in each case A connecting area section remains formed on both sides, so that the lid section and the overlap section are connected to one another at the edge and so that adjacent sections of the outer packaging and the film tube are also connected to one another. This applies regardless of whether the local separation of the connection area takes place completely along the course of a path that is closed on the circumference or whether the connection area is separated only along part of the path of the path that is closed on the circumference.
  • 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 disposing of a piece of film tube used in a previous transfer process together with the film composite and with the remaining outer packaging of the previous packaging unit and by using a new, unused piece of the film tube is provided, which is then connected in an overlap area to the cover section of the outer packaging of a further packaging unit.
  • the endless hose can preferably be unwound or removed from 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 film tube in an area spaced from the access opening of the barrier system.
  • the film closure can include winding rolls onto which used film tubes and possibly associated film composites and remaining sections of the outer packaging can be wound.
  • the outer packaging is preferably made from a thermoplastic film material and is preferably provided in the form of bags.
  • 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 additional outer packaging, in particular in the form of an outer bag.
  • the outer packaging here: the inner bag
  • the outer bag is removed in an additional area of the device mentioned above. This makes it possible to achieve even greater security against contamination of the packaging unit.
  • the connecting device it is possible for the connecting device to connect the cover section and the overlap section to one another over their surface extent. It is preferred if the connecting device is designed to connect - at least or only - the edge of the cover section and - at least or only - the edge of the overlap section to one another.
  • the connecting device prefferably has a heating device for fusing the material of the lid section and the material of the overlap section.
  • a heating device for fusing the material of the lid section and the material of the overlap section.
  • Such a heating device is designed, for example, such 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.
  • the heating device it is also possible for the heating device to be movably drivable, so that different sections of the connection area are produced by the heating device respectively producing sections of the connection area, with the heating device being moved relative to the cover section and the overlap section.
  • the connecting device prefferably has a discharge device for discharging an adhesive material.
  • the bonding material can also be discharged simultaneously over the entire connection area or - with movement/drive of the discharge device - take place one after the other across different sections of the connection area.
  • the separating device locally separates the connection area 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 cutting through at least part of the connection area.
  • the device has a station for arranging the packaging unit and the outer packaging, in which 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 floor of the station serves to arrange the packaging unit and the outer packaging, the floor of the station being arranged below the film tube and can be raised so that the packaging unit can be raised to the height of the interior of the film tube.
  • a device designated overall by reference number 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 that 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 dash-dotted 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 transport 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, i.e. 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 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.
  • the device 10 has an entrance 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 adjoined by a station 38, with a support surface 40, which can preferably be adjusted flush with the support surface 36 and is further preferably adjustable in height by means of a transport device 42.
  • a receiving surface 44 is arranged, which 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 the station 38 through the opening 46.
  • a support element 48 extending parallel to the receiving surface 44 is provided.
  • the receiving surface 44 and the support element 48 are covered by a film tube, designated overall by the reference number 50.
  • the film tube 50 is designed as an endless tube and can be removed from a tube material supply 58 arranged adjacent to the access opening 20.
  • the film tube 50 delimits an interior 52 and is closed at the end in an area 54 spaced apart from the access opening 20.
  • the area 54 can, for example, include at least one winding roll 56 onto which used pieces of the film tube 50 are wound.
  • the film tube 50 is supported at its upper end in cross section by the support element 48 and fixed adjacent to the access opening 20. At the same time, a section below the end of the film tube 50 encloses the receiving surface 44 and its opening 46.
  • the device 10 further comprises a connecting device 60 and a separating device 62, which are preferably arranged in the interior 52 of the film tube 50, compare Figure 2 .
  • the connecting device 60 serves to establish a connection between an outside 64 of the material 66 of the film tube 50 and an outside 68 of a lid section 70 of the outer packaging 30.
  • the connection area is shown in the two enlargements for better visual representation Figure 2 shown in the form of a connecting layer, which is designated by the reference numeral 72.
  • This can be, for example, an adhesive material or (shown graphically) an area in which the material of the cover section 70 of the outer packaging 30 and an identically sized overlap section 74 of the material 66 of the film tube 50 are connected to one another, in particular fused together.
  • connection area 72 preferably extends along a circumferentially closed path 76, compare Figure 3 .
  • the track 76 delimits a free space 78 limited between the cover section 70 and the overlap section 74, compare Figure 2 .
  • Germs arranged on the outside 68 of the cover section 70 of the outer packaging 30 are therefore between the cover section 70 and the overlap section 74 of the film tube 50 and at the same time enclosed within the web-shaped connection area 72.
  • a width 80 of the web 76 measured in the plane of extension 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 connection area 72 locally. This separation can take place along the entire path of the connecting region 72; However, it is preferred that a separation area 82 only extends over a first part of the connection area 72. This is in Figure 3 illustrated with a dashed line; The separating region 82 extends, for example, along opposite side edges 84 and 86 and along a front edge 88 of the connecting region 72. A second part 90 of the connecting region 72 remains unchanged and is therefore not locally separated in this second part 90. This is in particular a rear edge of the connection area 72.
  • the separating device 62 cuts through, for example using a knife 92, compare Figure 2 , also 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 separation area is arranged so that after the local separation of the connection area 72 and simultaneous severing of the material of the film tube 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 are retained.
  • the packaging unit 22 is transported from the station 38 into the interior 52 of the film tube 50, compare Figure 4 .
  • the mounting surface 40 is raised until it has reached the height level of the receiving surface 44.
  • the packaging unit 22 is introduced into the interior 52 through the opening 46 in the support surface 44.
  • a film composite 94 made of interconnected cover section 70 and overlap section 74 is pushed into the interior 52 of the film tube 50.
  • the film composite 94 folds away laterally, so that the packaging unit 22 is transferred past the folded-away film composite 94 into the interior 52 of the film tube 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 sliders or grippers.
  • the film tube 50 can be removed from the supply 58, at the same time the film composite 94 and the remaining components of the outer packaging 30 can be removed and collected.
  • another packaging unit 22 can be transferred into the interior 14 of the barrier system 12 in the manner described above.
  • a flow device 96 (see Figure 1 ) is provided, which exposes the environment 16 and / or the interior 14 of the barrier system 12 to 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)
EP22708526.3A 2021-02-23 2022-02-17 Vorrichtung und verfahren zur überführung einer verpackungseinheit in ein barrieresystem für pharmazeutika Active EP4100330B1 (de)

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 (de) 2021-02-23 2022-02-17 Vorrichtung und verfahren zur überführung einer verpackungseinheit in ein barrieresystem für pharmazeutika

Publications (2)

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

Family

ID=80682667

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22708526.3A Active EP4100330B1 (de) 2021-02-23 2022-02-17 Vorrichtung und verfahren zur überführung einer verpackungseinheit in ein barrieresystem für pharmazeutika

Country Status (6)

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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2291244B1 (de) * 2008-06-17 2012-04-25 Lugaia Sts Sterile Transfer Solutions Ag Verfahren zum einschleusen eines gegenstandes in einen reinraum

Family Cites Families (9)

* 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
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
DE102017012236B4 (de) * 2017-10-06 2023-10-19 Groninger & Co. Gmbh Verbessertes Entpackungssystem für ein in einer Verpackung, insbesondere einem Beutel, eingepacktes Objekt, insbesondere ein pharmazeutisches oder kosmetisches Objekt
DE102017124908A1 (de) * 2017-10-24 2019-04-25 Schott Ag Verfahren und Vorrichtung zur flexiblen Behandlung von Pharma-Packmitteln

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2291244B1 (de) * 2008-06-17 2012-04-25 Lugaia Sts Sterile Transfer Solutions Ag Verfahren zum einschleusen eines gegenstandes in einen reinraum

Also Published As

Publication number Publication date
US11897651B1 (en) 2024-02-13
CN116867710B (zh) 2024-05-28
EP4100330A1 (de) 2022-12-14
DE102021104221A1 (de) 2022-08-25
CN116867710A (zh) 2023-10-10
US20240034506A1 (en) 2024-02-01
ES2966850T3 (es) 2024-04-24
WO2022179922A1 (de) 2022-09-01

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