EP4100330B1 - Device and method for transferring a packaging unit into a barrier system for pharmaceuticals - Google Patents

Device and method for transferring a packaging unit into a barrier system for pharmaceuticals 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
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EP22708526.3A
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German (de)
French (fr)
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EP4100330A1 (en
Inventor
Albrecht Kühnle
Benjamin Hoffmann
Ulrich Krauss
Markus Ilgenfritz
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Syntegon Technology GmbH
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Syntegon Technology GmbH
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Publication of EP4100330A1 publication Critical patent/EP4100330A1/en
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    • 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.

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  • 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)

Description

Die Erfindung betrifft eine Vorrichtung zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika mit den Merkmalen des Oberbegriffs des Patentanspruchs 1 und ein Verfahren zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika mit den Merkmalen des Oberbegriffs des Patentanspruchs 11.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.

Vorrichtungen und Verfahren dieser Art dienen dazu, die Verpackungseinheit möglichst kontaminationsfrei in das Barrieresystem hinein überführen zu können, wobei die Verpackungseinheit einen sterilisierten Behälter und mindestens ein darin angeordnetes Sterilprodukt umfasst. Sofern nicht weitere Maßnahmen getroffen werden, würde ein einfaches Öffnen einer Umverpackung der Verpackungseinheit in der Umgebung des Barrieresystems dazu führen, dass die Außenseite des Behälters der Verpackungseinheit kontaminiert werden könnte, sodass ein Risiko besteht, dass Keime in das Barrieresystem eingeführt werden.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.

Es ist bekannt, außerhalb des Barrieresystems einen Zusatzbereich bereitzustellen, in welchem die Verpackungseinheit samt Umverpackung einer Luftströmung ausgesetzt und die Umverpackung innerhalb der Luftströmung aufgetrennt wird, um anschließend die Verpackungseinheit in das Barrieresystem zu transportieren. In dem Zusatzbereich kann alternativ oder zusätzlich auch eine Bestrahlung und/oder eine Behandlung mit Wasserstoffperoxid stattfinden. Schließlich ist es möglich, dass auch der gesamte Zusatzbereich steril gehalten wird und dass in dem Zusatzbereich die Umverpackung gegen eine - auch außenseitig -sterile Umverpackung ersetzt wird.It is known to provide an additional area outside the barrier system in which the packaging unit including the 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. Alternatively or additionally, irradiation and/or treatment with hydrogen peroxide can also take place in the additional area. Finally, it is possible for the entire additional area to be kept sterile and for the outer packaging in the additional area to be replaced by an outer packaging that is also sterile on the outside.

Ein System zum Einschleusen eines in einem Beutel verpackten und sterilisierten Gegenstands in einen Reinraum ist beispielsweise aus der EP 2 291 224 A1 bekannt.A system for introducing a bagged and sterilized object into a clean room is, for example, from the EP 2 291 224 A1 known.

Hiervon ausgehend liegt der vorliegenden Erfindung die Aufgabe zugrunde, eine Vorrichtung und ein Verfahren anzugeben, welche eine einfache, kontaminationsfreie Überführung der Verpackungseinheit in das Barrieresystem hinein ermöglichen.Proceeding from this, 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.

Diese Aufgabe wird durch eine Vorrichtung mit den Merkmalen des Patentanspruchs 1 gelöst.This task is solved by a device with the features of patent claim 1.

Diese Aufgabe wird durch ein Verfahren mit den Merkmalen des Patentanspruchs 11 gelöst.This task is solved by a method with the features of patent claim 11.

Erfindungsgemäß wird der sterile Innenraum des Barrieresystems in die Umgebung des Barrieresystems hinein verlängert, und zwar unter Zwischenschaltung der Zugangsöffnung zu dem Barrieresystem. Die Verlängerung dieses sterilen Innenraums ist durch einen Folienschlauch bereitgestellt, der endseitig geschlossen ist.According to the invention, 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.

Zur Überführung der Verpackungseinheit in den Innenraum des Folienschlauchs hinein wird zunächst, unter Verwendung einer Verbindungseinrichtung, eine sich über einen Verbindungsbereich erstreckende Verbindung zwischen einem Deckelabschnitt der Umverpackung und einem Überlappungsabschnitt einer Außenseite des Folienschlauchs hergestellt. Auf diese Weise sind die Außenseite des Deckelabschnitts der Umverpackung und die Außenseite des Folienschlauchs miteinander verbunden, wobei die Außenseiten in unmittelbarer Anlage miteinander stehen können oder zwischen den Außenseiten Verbindungsmaterial angeordnet ist.To transfer the packaging unit into the interior of the film tube, 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. 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.

Die vorstehend erörterte Verbindung ermöglicht eine kontaminationstechnische Isolierung der Außenseite des Deckelabschnitts der Umverpackung. Unter Beibehaltung dieser Isolierung ist es möglich, den Verbindungsbereich - und somit auch den Folienschlauch und die Umverpackung - lokal aufzutrennen, sodass die Verbindung zwischen dem Überlappungsabschnitt des Folienschlauchs und dem Deckelabschnitt der Umverpackung und die damit einhergehende Isolierung der Außenfläche des Deckelabschnitts des Behälters erhalten bleibt, gleichzeitig aber eine Durchtrittsöffnung geschaffen wird, welche es ermöglicht, die Verpackungseinheit aus der nun aufgetrennten Umverpackung heraus in den nun aufgetrennten Folienschlauch hinein zu überführen.The 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.

Solange im Zuge der lokalen Auftrennung des Verbindungsbereichs die zuvor hergestellte Verbindung zwischen dem Deckelabschnitt der Umverpackung und Überlappungsabschnitte des Folienschlauchs als Folienverbund beibehalten wird, ist es möglich, dass der Verbindungsbereich so aufgetrennt wird, dass der Deckelabschnitt der Umverpackung mit der übrigen Umverpackung und dass der Überlappungsabschnitt des Folienschlauchs mit dem übrigen Folienschlauch verbunden bleibt. Dies hat den Vorteil, dass der durch die Verbindung hergestellte Folienverbund sowohl mit der Umverpackung als auch mit dem Folienschlauch verbunden bleibt, sodass im Anschluss an die Überführung einer Verpackungseinheit in das Barrieresystem eine miteinander zusammenhängende Einheit entsorgt werden kann, welche einen Abschnitt des Folienschlauchs, den Folienverbunds und die übrige Umverpackung umfasst.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.

In diesem Zusammenhang ist es bevorzugt, dass ein erster Teil des Verbindungsbereichs aufgetrennt wird, wobei der Folienschlauch und die Umverpackung in einem von dem ersten Teil abweichenden zweiten Teil des Verbindungsbereichs miteinander verbunden bleiben, und dass die Verpackungseinheit - unter Verformung eines Folienverbunds aus Deckelabschnitt und Überlappungsabschnitt - in den Innenraum des Folienschlauchs verbracht wird.In this context, it is preferred that 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.

Besonders bevorzugt ist es, wenn die Verformung des Folienverbunds mit dessen Verlagerung in den Innenraum des Folienschlauchs hinein einhergeht. Insbesondere kann der Folienverbund scharnierartig in den Innenraum des Folienschlauchs hineinklappen.It is particularly preferred if the deformation of the film composite is accompanied by its displacement into the interior of the film tube. In particular, the film composite can fold like a hinge into the interior of the film tube.

Es ist möglich, dass der Verbindungsbereich sich über die gesamte Fläche des Deckelabschnitts und des Überlappungsabschnitts hinweg erstreckt. Besonders vorteilhaft ist es jedoch, wenn sich der Verbindungsbereich entlang einer umfangsseitig geschlossenen Bahn erstreckt. Das Auftrennen des Verbindungsbereichs erfolgt entlang zumindest eines Teils dieser Bahn, wobei über die Erstreckung des Verbindungsbereichs in der Fläche hinweg gesehen der Trennbereich schmaler ist als die Bahn.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.

Ferner ist vorzugsweise der Trennbereich so angeordnet, dass entlang des Verlaufs der Bahn gesehen, jeweils zu beiden Seiten ein Verbindungsbereichabschnitt ausgebildet bleibt, sodass der Deckelabschnitt und der Überlappungsabschnitt randseitig miteinander verbunden sind und sodass außerdem jeweils angrenzende Abschnitte der Umverpackung und des Folienschlauchs ebenfalls miteinander verbunden sind. Dies gilt unabhängig davon, ob die lokale Auftrennung des Verbindungsbereichs dem Verlauf einer umfangsseitig geschlossenen Bahn vollständig erfolgt oder ob Auftrennung des Verbindungsbereichs nur entlang eines Teils des Verlaufs der umfangsseitig geschlossenen Bahn erfolgt.Furthermore, 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.

Um mehrere Verpackungseinheiten, welche in einem Ausgangszustand jeweils von einer eigenen Umverpackung umgeben sind, nacheinander in das Barrieresystem zu überführen, ist es bevorzugt, wenn der Folienschlauch in Form eines Endlosschlauchs bereitgestellt ist. Dies ermöglicht die einfache Vorbereitung der Vorrichtung zur Überführung einer weiteren Verpackungseinheit in den Innenraum des Barrieresystems hinein, indem ein bei einem vorherigen Überführungsvorgang gebrauchtes Folienschlauchstück gemeinsam mit dem Folienverbund und mit der übrigen Umverpackung der vorherigen Verpackungseinheit entsorgt wird und indem ein neues, ungebrauchtes Stück des Folienschlauchs bereitgestellt wird, welches dann in einem Überlappungsbereich mit dem Deckelabschnitt der Umverpackung einer weiteren Verpackungseinheit verbunden wird.In order to transfer several packaging units, which in an initial state are each surrounded by their own outer packaging, one after the other into the barrier system, it is preferred if 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.

Der Endlosschlauch ist vorzugsweise von einem zur Zugangsöffnung des Barrieresystems benachbarten Schlauchmaterial-Vorrat abwickelbar oder abziehbar. Dies ermöglicht es, den endseitigen Verschluss des Folienschlauchs in einem zu der Zugangsöffnung des Barrieresystems beabstandeten Bereich anzuordnen.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.

Der Folienverschluss kann Aufwickelrollen umfassen, auf welchen verbrauchter Folienschlauch und ggf. damit verbundene Folienverbünde und übrige Abschnitte der Umverpackung aufgewickelt werden können.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.

Die Umverpackungen sind vorzugsweise aus einem thermoplastischen Folienmaterial hergestellt und sind vorzugsweise in Form von Beuteln bereitgestellt. Bevorzugte Materialien für solche Beutel sind Polyethylen, Polystyrol und "Tyvek" der Firma DuPont.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.

Es ist möglich, dass es sich bei den genannten beutelförmigen Umverpackungen um einen Innenbeutel handelt, der seinerseits von einer zusätzlichen Umverpackung, insbesondere in Form eines Außenbeutels, umgeben ist. Für den Fall, dass die Umverpackung (also hier: der Innenbeutel) auch an seiner Außenseite sterilisiert sein sollte und der Außenbeutel innenseitig sterilisiert ist, ist es bevorzugt, wenn die Entfernung des Außenbeutels in einem eingangs genannten Zusatzbereich der Vorrichtung erfolgt. Hierdurch kann eine noch höhere Sicherheit gegen eine Kontamination der Verpackungseinheit erzielt werden.It is possible that 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. In the event that the outer packaging (here: the inner bag) should also be sterilized on the outside and the outer bag is sterilized on the inside, it is preferred if 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.

Wie vorstehend erläutert, ist es möglich, dass die Verbindungseinrichtung den Deckelabschnitt und den Überlappungsabschnitt über dessen flächenmäßige Erstreckung hinweg miteinander verbinden. Bevorzugt ist es, wenn die Verbindungseinrichtung dazu ausgebildet ist, - zumindest oder nur - den Rand des Deckelabschnitts und - zumindest oder nur - den Rand des Überlappungsabschnitts miteinander zu verbinden.As explained above, 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.

Es ist möglich, dass die Verbindungseinrichtung eine Heizvorrichtung zum Verschmelzen des Materials des Deckelabschnitts und des Materials des Überlappungsabschnitts aufweist. Eine solche Heizvorrichtung ist beispielsweise so beschaffen, dass sie über den gesamten Verbindungsbereich hinweg wirkt und eine Verbindung durch einmalige Positionierung der Heizvorrichtung und/oder einmaliges Aktivieren der Heizvorrichtung hergestellt wird. Es ist auch möglich, dass die Heizvorrichtung bewegbar antreibbar ist, sodass unterschiedliche Abschnitt des Verbindungsbereichs hergestellt werden, indem die Heizvorrichtung jeweils Abschnitte des Verbindungsbereichs herstellt, wobei die Heizvorrichtung relativ zu dem Deckelabschnitt und dem Überlappungsabschnitt bewegt wird.It is possible for the connecting device to have 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. 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.

Es ist auch möglich, dass die Verbindungseinrichtung eine Austrageinrichtung zum Austrag eines Verklebungsmaterials aufweist. Auch der Austrag des Verklebungsmaterials kann gleichzeitig über den gesamten Verbindungsbereich hinweg oder aber - mit Bewegung/Antrieb der Austrageinrichtung - nacheinander über unterschiedliche Abschnitte des Verbindungsbereichs hinweg erfolgen.It is also possible for the connecting device to have 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.

Im Prinzip ist es denkbar, dass die Trenneinrichtung den Verbindungsbereich berührungslos lokal auftrennt, beispielsweise mittels eines Energiestrahls. Besonders einfach und bevorzugt ist es jedoch, wenn die Trenneinrichtung mechanisch wirksam ist und ein Messer oder ein Stanzelement zum Durchtrennen zumindest eines Teils des Verbindungsbereichs aufweist.In principle, it is conceivable that the separating device locally separates the connection area without contact, for example by means of an energy beam. However, it is particularly simple and preferred if the separating device is mechanically effective and has a knife or a punching element for cutting through at least part of the connection area.

Zur weiteren Vereinfachung der Handhabung der Verpackungseinheit ist es bevorzugt, wenn die Vorrichtung eine Station zur Anordnung der Verpackungseinheit und der Umverpackung aufweist, in welcher die Verbindungseinrichtung und die Trenneinrichtung wirksam sind.To further simplify the handling of the packaging unit, it is preferred if 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.

Ferner ist es bevorzugt, wenn die Vorrichtung eine Transporteinrichtung zum Transport der Verpackungseinheit von der Station in den Innenraum des Folienschlauchs hinein umfasst. Bei einer besonders bevorzugten Ausführungsform dient der Boden der Station zur Anordnung der Verpackungseinheit und der Umverpackung, wobei der Boden der Station unterhalb des Folienschlauchs angeordnet ist und so angehoben werden kann, dass die Verpackungseinheit auf die Höhe des Innenraums des Folienschlauchs angehoben werden kann.Furthermore, it is preferred if the device comprises a transport device for transporting the packaging unit from the station into the interior of the film tube. In a particularly preferred embodiment, 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.

Weitere Merkmale und Vorteile der Erfindung sind Gegenstand der nachfolgenden Beschreibung und der zeichnerischen Darstellung eines bevorzugten Ausführungsbeispiels.Further features and advantages of the invention are the subject of the following description and the graphic representation of a preferred exemplary embodiment.

In der Zeichnung zeigenShow in the drawing

Fig. 1Fig. 1
eine Seitenansicht einer Ausführungsform einer Vorrichtung zur Überführung einer Verpackungseinheit in ein Barrieresystem für Pharmazeutika;a side view of an embodiment of a device for transferring a packaging unit into a barrier system for pharmaceuticals;
Fig. 2Fig. 2
einen Ausschnitt der Vorrichtung gemäß Fig. 1, während der Herstellung eines Verbindungsbereichs und während der anschließenden Auftrennung eines Teils des Verbindungsbereichs;a section of the device according to Fig. 1 , during the production of a connection area and during the subsequent separation of part of the connection area;
Fig. 3Fig. 3
eine Draufsicht auf den teilweise aufgetrennten Verbindungsbereich; unda top view of the partially separated connection area; and
Fig. 4Fig. 4
einen weiteren Ausschnitt der Vorrichtung gemäß Fig. 1, während eines Transports der Verpackungseinheit in das Barrieresystem.another section of the device according to Fig. 1 , during transport of the packaging unit into the barrier system.

Eine in der Zeichnung insgesamt mit dem Bezugszeichen 10 bezeichnete Vorrichtung umfasst ein Barrieresystem 12, in welchem Pharmazeutika gehandhabt, insbesondere abgefüllt, werden. Das Barrieresystem 12 weist einen Innenraum 14 auf, der von einer Umgebung 16 des Barrieresystems 12 getrennt ist. Eine Trennung zwischen dem Innenraum 14 des Barrieresystems 12 und der Umgebung 16 des Barrieresystems 12 ist in der Zeichnung durch eine strichpunktierte Linie 18 verdeutlicht. Diese Grenze ist üblicherweise durch eine Wand des Barrieresystems 12 gebildet, in der jedoch für einen Zugang zum Innenraum 14 des Barrieresystems 12 eine Zugangsöffnung 20 vorgesehen ist.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.

Die Vorrichtung 10 dient dazu, eine Verpackungseinheit 22 aus der Umgebung 16 in den Innenraum 14 des Barrieresystems zu befördern. Die Verpackungseinheit 22 weist einen sterilisierten Behälter 24 auf, der wannenförmig sein kann, also nach oben offen. In dem Behälter 24 ist mindestens ein Sterilgut 26 angeordnet, beispielsweise eine leere Spritze 28, die in dem Innenraum 14 des Barrieresystems mit einem Pharmazeutikum befüllt werden soll.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.

In einem Ausgangs- oder Anlieferungszustand ist die Verpackungseinheit 22 von einer sterilisierten Umverpackung 30 umgeben, beispielsweise einem aus Folie gebildeten Beutel, der optional von einem Außenbeutel 32 umgegeben ist.In an initial or delivery state, 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.

Die Vorrichtung 10 weist einen Eingangsbereich 34 auf mit einer Auflagefläche 36 zur Auflage zumindest der Verpackungseinheit 22 und der Umverpackung 30.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.

An den Eingangsbereich 34 schließt sich eine Station 38 an, mit einer Aufstellfläche 40, welche vorzugsweise mit der Auflagefläche 36 bündig einstellbar ist und weiter vorzugsweise mittels einer Transporteinrichtung 42 höheneinstellbar ist.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.

Auf Höhe einer unteren Begrenzung der Zugangsöffnung 20 ist eine Aufnahmefläche 44 angeordnet, die sich vorzugsweise bis in den Innenraum 14 des Barrieresystems 12 hinein erstreckt. Die Aufnahmefläche 44 weist einen Durchbruch 46 auf, der so bemessen ist, dass eine Verpackungseinheit 22 von der Station 38 ausgehend durch den Durchbruch 46 hindurch überführbar ist.At the level of a lower boundary of the access opening 20, 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.

Auf Höhe einer oberen Berandung der Zugangsöffnung 20 ist ein sich parallel zu der Aufnahmefläche 44 erstreckendes Abstützelement 48 vorgesehen. Die Aufnahmefläche 44 und das Abstützelement 48 sind von einem insgesamt mit dem Bezugszeichen 50 bezeichneten Folienschlauch umhüllt.At the level of an upper edge of the access opening 20, 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.

Der Folienschlauch 50 ist als Endlosschlauch ausgebildet und von einem benachbart zu der Zugangsöffnung 20 angeordneten Schlauchmaterial-Vorrat 58 abziehbar. Der Folienschlauch 50 begrenzt einen Innenraum 52 und ist in einem zu der Zugangsöffnung 20 beabstandeten Bereich 54 endseitig geschlossen. Der Bereich 54 kann beispielsweise mindestens eine Aufwickelrolle 56 umfassen, auf welche verbrauchte Stücke des Folienschlauchs 50 aufgewickelt werden.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.

Der Folienschlauch 50 ist an seinem im Querschnitt oberen Ende durch das Abstützelement 48 abgestützt und benachbart zu der Zugangsöffnung 20 fixiert. Gleichzeitig umhüllt ein im Querschnitt unters Ende des Folienschlauchs 50 die Aufnahmefläche 44 und dessen Durchbruch 46.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.

Die Vorrichtung 10 umfasst ferner eine Verbindungseinrichtung 60 und eine Trenneinrichtung 62, welche vorzugsweise in dem Innenraum 52 des Folienschlauchs 50 angeordnet sind, vergleiche Figur 2.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 .

Die Verbindungseinrichtung 60 dient dazu, eine Verbindung zwischen einer Außenseite 64 des Materials 66 des Folienschlauchs 50 und einer Außenseite 68 eines Deckelabschnitts 70 der Umverpackung 30 herzustellen. Der Verbindungsbereich ist zur besseren bildlichen Darstellung in den beiden Vergrößerungen der Figur 2 in Form einer Verbindungsschicht dargestellt, die mit dem Bezugszeichen 72 bezeichnet ist. Hierbei kann es sich beispielsweise um ein Verklebungsmaterial handeln oder aber (grafisch dargestellt) um einen Bereich, in welchem das Material des Deckelabschnitts 70 der Umverpackung 30 und eines identisch großen Überlappungsabschnitts 74 des Materials 66 des Folienschlauchs 50 miteinander verbunden sind, insbesondere miteinander verschmolzen sind.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.

Der Verbindungsbereich 72 erstreckt sich vorzugsweise entlang einer umfangsseitig geschlossenen Bahn 76, vergleiche Figur 3. Die Bahn 76 umgrenzt einen zwischen dem Deckelabschnitt 70 und dem Überlappungsabschnitt 74 begrenzten Freiraum 78, vergleiche Figur 2. Auf der Außenseite 68 des Deckelabschnitts 70 der Umverpackung 30 angeordnete Keime sind somit zwischen dem Deckelabschnitt 70 und dem Überlappungsabschnitt 74 des Folienschlauchs 50 und gleichzeitig innerhalb des bahnförmigen Verbindungsbereichs 72 eingeschlossen.The 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.

Eine in der Erstreckungsebene des Verbindungsbereichs 72 gemessene Breite 80 der Bahn 76 beträgt vorzugsweise mindestens 2 mm, insbesondere mindestens 4 mm.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.

Ausgehend von der Herstellung des Verbindungsbereichs 72 dient die Trenneinrichtung 62 dazu, den Verbindungsbereich 72 lokal aufzutrennen. Diese Auftrennung kann entlang des gesamten bahnförmigen Verlaufs des Verbindungsbereichs 72 erfolgen; bevorzugt ist es aber, dass sich ein Trennbereich 82 nur über einen ersten Teil des Verbindungsbereichs 72 hinwegerstreckt. Dies ist in Figur 3 mit einer gestrichelten Linie verdeutlicht; der Trennbereich 82 erstreckt sich beispielsweise entlang einander gegenüberliegenden Seitenkanten 84 und 86 und entlang einer Vorderkante 88 des Verbindungsbereichs 72. Ein zweiter Teil 90 des Verbindungsbereichs 72 bleibt unverändert erhalten, wird also in diesem zweiten Teil 90 nicht lokal aufgetrennt. Hierbei handelt es sich insbesondere um eine Hinterkante des Verbindungsbereichs 72.Starting from the production of the connection area 72, 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.

Während der lokalen Auftrennung des Verbindungsbereichs 72 durchtrennt die Trenneinrichtung 62, beispielsweise unter Verwendung eines Messers 92, vergleiche Figur 2, auch das Material des Folienschlauchs 50 und das Material der Umverpackung 30. Über die Breite 80 der Bahn 76 hinweg gesehen ist der Trennbereich so angeordnet, dass nach der lokalen Auftrennung des Verbindungsbereichs 72 und gleichzeitiger Durchtrennung des Materials des Folienschlauchs 50 und des Materials der Umverpackung 30 beidseits des Trennbereichs jeweilige Abschnitte 72a und 72b des Verbindungsbereichs 72 erhalten bleiben.During the local separation 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.

Ausgehend von einem Zustand, in welchem der Deckelabschnitt 70, der Überlappungsabschnitt 74 und der Verbindungsbereich 72 zumindest entlang eines Teils des bahnförmigen Verbindungsbereichs 72 aufgetrennt sind, wird die Verpackungseinheit 22 aus der Station 38 in den Innenraum 52 des Folienschlauchs 50 transportiert, vergleiche Figur 4. Vorzugsweise wird dabei die Aufstellfläche 40 angehoben, bis sie das Höhenniveau der Aufnahmefläche 44 erreicht hat. Hierbei wird die Verpackungseinheit 22 durch den Durchbruch 46 der Auflagefläche 44 hindurch in den Innenraum 52 eingeführt. Dabei wird ein Folienverbund 94 aus miteinander verbundenem Deckelabschnitt 70 und Überlappungsabschnitt 74 in den Innenraum 52 des Folienschlauchs 50 hinein gedrängt. Durch die Verbindung im Bereich der Hinterkante / im Bereich des zweiten Teils 90 des Verbindungsbereichs 72 klappt der Folienverbund 94 seitlich weg, sodass die Verpackungseinheit 22 an dem weggeklappten Folienverbund 94 vorbei in den Innenraum 52 des Folienschlauchs 50 überführt wird. Von dort aus kann die Verpackungseinheit 22 in an sich bekannter Art und Weise in den Innenraum 14 des Barrieresystems 12 überführt werden, beispielsweise mittels an sich bekannten Transportelementen, beispielsweise Schiebern oder Greifern.Starting from a state in which the cover section 70, the overlap section 74 and the connection area 72 are separated at least along a part of the web-shaped connection area 72, the packaging unit 22 is transported from the station 38 into the interior 52 of the film tube 50, compare Figure 4 . Preferably, the mounting surface 40 is raised until it has reached the height level of the receiving surface 44. Here, 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. Due to the connection in the area of the rear edge / in the area of the second part 90 of the connection area 72, 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.

Im Anschluss an eine Überführung einer ersten Verpackungseinheit 22 in den Innenraum 14 des Barrieresystems 12 kann der Folienschlauch 50 von dem Vorrat 58 abgezogen werden, wobei gleichzeitig der Folienverbund 94 und die übrigen Bestandteile der Umverpackung 30 entfernt und gesammelt werden können. Nach Bereitstellung eines "frischen" Stücks Folienschlauch kann eine weitere Verpackungseinheit 22 in vorstehend beschriebener Art und Weise in den Innenraum 14 des Barrieresystems 12 überführt werden.Following a transfer of a first packaging unit 22 into the interior 14 of the barrier system 12, 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. After providing a “fresh” piece of film tube, another packaging unit 22 can be transferred into the interior 14 of the barrier system 12 in the manner described above.

Es ist möglich, dass zur weiteren Erhöhung der Kontaminationssicherheit eine Strömungseinrichtung 96 (vergleiche Figur 1) vorgesehen ist, welche die Umgebung 16 und/oder den Innenraum 14 des Barrieresystems 12 einer definierten Luftströmung aussetzt, welche beispielsweise von oben nach unten gerichtet ist.It is possible for 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.

Claims (13)

  1. A device (10) for transferring a packaging unit (22) into a barrier system (12) for pharmaceuticals, wherein the packaging unit (22) comprises a sterilized container (24) and at least one sterile product (26) arranged therein and wherein the packaging unit (22), in an initial state, is surrounded by an outer packaging (30) sterilized at least on the inside, wherein the barrier system (12) has an access opening (20) through which the packaging unit can be transferred from a surrounding region (16) of the barrier system (12) into an interior (14) of the barrier system (12), wherein a film tube (50) which is closed on the end side is arranged in the surrounding region (16) of the barrier system (12), the interior (52) of the film tube communicating with the access opening (20), characterized in that a connecting device (60) is provided for producing a connection region (72) between an outer face (68) of a planar cover portion (70) of the outer packaging (30) and a planar overlap portion (74) of an outer face (64) of the film tube (50) overlapping the cover portion (70), and in that a separating device (62) is provided for locally separating the connection region (72) and cutting through the material (66) of the film tube (50) and the material of the outer packaging (30), wherein the connection between the overlap portion (74) of the film tube (50) and the cover portion (70) of the outer packaging (30) and the isolation associated therewith of the outer face (68) of the cover portion (70) of the container (24) is maintained, but at the same time producing a through-opening which makes it possible to transfer the packaging unit (22) out of the outer packaging (30) into the interior (52) of the film tube (50).
  2. The device (10) as claimed in claim 1, characterized in that the connection region (72) extends along a web (76) which is closed on the peripheral side.
  3. The device (10) as claimed in one of the preceding claims, characterized in that the film tube (50) is provided in the form of an endless tube.
  4. The device (10) as claimed in claim 3, characterized in that the endless tube can be unwound from or pulled off a tube material supply (58) which is adjacent to the access opening (20) .
  5. The device (10) as claimed in one of the preceding claims, characterized in that the connecting device (60) is configured to connect together the edge of the cover portion (70) and the edge of the overlap portion (74).
  6. The device (10) as claimed in one of the preceding claims, characterized in that the connecting device (60) has a heating device for fusing the material of the cover portion (70) and the material of the overlap portion (74).
  7. The device (10) as claimed in one of the preceding claims, characterized in that the connecting device (60) has a dispensing device for dispensing a bonding material.
  8. The device (10) as claimed in one of the preceding claims, characterized in that the separating device (62) has a blade (92) or a punching element for cutting through at least a part of the connection region (72).
  9. The device (10) as claimed in one of the preceding claims, characterized in that the device (10) has a station (38) for arranging the packaging unit (22) and the outer packaging (30) and in which the connecting device (60) and the separating device (62) are operational.
  10. The device (10) as claimed in claim 9, characterized in that the device (10) comprises a transport device (42) for transporting the packaging unit from the station (38) into the interior (52) of the film tube.
  11. A method for transferring a packaging unit (22) into a barrier system (12) for pharmaceuticals, wherein the packaging unit (22) comprises a sterilized container (24) and at least one sterile product (26) arranged therein and wherein the packaging unit (22), in an initial state, is surrounded by an outer packaging (30) sterilized at least on the inside, wherein the barrier system (12) has an access opening (20) through which the packaging unit (22) can be transferred from a surrounding region (16) of the barrier system (12) into an interior (14) of the barrier system (12), wherein a film tube (50) which is closed on the end side is arranged or is to be arranged in the surrounding region (16) of the barrier system (12), the interior (52) of the film tube communicating with the access opening (20), characterized in that a connection region (72) is produced between an outer face (68) of a planar cover portion (70) of the outer packaging (30) and a planar overlap portion (74) of an outer face (64) of the film tube (50) overlapping the cover portion (70), in that subsequently the connection region (72) or a part of the connection region (72) is locally separated and at the same time the material (66) of the film tube (50) and the material of the outer packaging (30) is cut through, wherein the connection between the overlap portion (74) of the film tube (50) and the cover portion (70) of the outer packaging (30) and the isolation associated therewith of the outer face (68) of the cover portion (70) of the container (24) is maintained, but at the same time a through-opening is produced, and in that the packaging unit (22) is moved out of the outer packaging (30) through the through-opening into the interior (52) of the film tube (50) and is transferred therefrom into the interior (14) of the barrier system (12).
  12. The method as claimed in claim 11, characterized in that a first part (84, 86, 88) of the connection region (72) is separated, wherein the film tube (50) and the outer packaging (30) remain connected together in a second part (90) of the connection region (72) which differs from the first part, and in that - by deforming a film composite (94) consisting of the cover portion (70) and the overlap portion (74) - the packaging unit (22) is moved into the interior (14) of the film tube (52).
  13. The method as claimed in claim 12, characterized in that the deformation of the film composite (94) is associated with the displacement thereof into the interior (52) of the film tube (50).
EP22708526.3A 2021-02-23 2022-02-17 Device and method for transferring a packaging unit into a barrier system for pharmaceuticals Active EP4100330B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021104221.6A DE102021104221A1 (en) 2021-02-23 2021-02-23 Device and method for converting a packaging unit into a barrier system for pharmaceuticals
PCT/EP2022/053884 WO2022179922A1 (en) 2021-02-23 2022-02-17 Device and method for transferring a packaging unit into a barrier system for pharmaceuticals

Publications (2)

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

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EP22708526.3A Active EP4100330B1 (en) 2021-02-23 2022-02-17 Device and method for transferring a packaging unit into a barrier system for pharmaceuticals

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US (1) US11897651B1 (en)
EP (1) EP4100330B1 (en)
CN (1) CN116867710B (en)
DE (1) DE102021104221A1 (en)
ES (1) ES2966850T3 (en)
WO (1) WO2022179922A1 (en)

Citations (1)

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EP2291244B1 (en) * 2008-06-17 2012-04-25 Lugaia Sts Sterile Transfer Solutions Ag Method for conveying an object into a clean room

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JP2000095221A (en) * 1998-09-25 2000-04-04 Yokohama Rubber Co Ltd:The Cutting jig for cutting film pack end part
DE102007027878A1 (en) 2007-06-18 2008-12-24 Robert Bosch Gmbh Apparatus and method for removing a sterile article from a sterile package
DE102009027600A1 (en) * 2009-07-10 2011-01-13 Robert Bosch Gmbh Apparatus and method for opening a package
IT1401846B1 (en) * 2010-10-14 2013-08-28 Co Ri M A S R L APPARATUS AND METHOD TO REMOVE A STERILE PRODUCT FROM A STERILE PACKAGE THAT CONTAINS IT
DE102011084302A1 (en) * 2011-10-11 2013-04-11 Robert Bosch Gmbh Device for removing sterile article from foil bag, has holding unit for holding foil bag and ultrasonic-cutting unit for cutting foil bag with ultrasonic knife, where removing unit is provided to remove article from foil bag
DE102016103404A1 (en) * 2016-02-26 2017-08-31 Schott Ag A method for transferring a plurality of containers for storing substances for medical, pharmaceutical or cosmetic purposes in a clean room, transport and packaging containers and packaging structures therefor, and use
IT201600078609A1 (en) * 2016-07-27 2018-01-27 I M A Industria Macch Automatiche S P A In Sigla Ima S P A OPENING GROUP FOR PHARMACEUTICAL CONTAINER PACKAGES
DE102017012236B4 (en) * 2017-10-06 2023-10-19 Groninger & Co. Gmbh Improved unpacking system for an object packed in a packaging, in particular a bag, in particular a pharmaceutical or cosmetic object
DE102017124908A1 (en) * 2017-10-24 2019-04-25 Schott Ag Method and device for flexible treatment of pharmaceutical packaging

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
EP2291244B1 (en) * 2008-06-17 2012-04-25 Lugaia Sts Sterile Transfer Solutions Ag Method for conveying an object into a clean room

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

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