Device and method for transferring a packaging unit into a barrier system for pharmaceuticals
The invention relates to a device ( 10 ) and a method for transferring a packaging unit ( 22 ) into a barrier system ( 12 ) for pharmaceuticals, wherein the packaging unit comprises a sterilized container ( 24 ) and at least one sterile product ( 26 ) arranged in the latter, and wherein the packaging unit, in an initial state, is surrounded by an outer packaging ( 30 ) sterilized at least on the inside, wherein the barrier system has an access opening ( 20 ) through which the packaging unit can be transferred from a surrounding region ( 16 ) of the barrier system into an interior ( 14 ) of the barrier system, wherein a film tube ( 50 ), closed at one end, is arranged in the surrounding region of the barrier system, the interior ( 52 ) of the film tube ( 50 ) communicating with the access opening, wherein a connecting device is provided for producing a connection region between a cover portion of the outer packaging and an overlap portion of an outer face of the film tube overlapping the cover portion, and wherein a separating device is provided for local separation of the connection region.
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 for 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 an 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, 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 claim 1 , 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 claim 1 , 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 claim 1 , 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 claim 1 , characterized in that the connecting device ( 60 ) has a dispensing device for dispensing a bonding material.
8. The device ( 10 ) as claimed in claim 1 , characterized in that the separating device ( 62 ) has a blade ( 92 ) or a punching element for cutting through at least one part of the connection region ( 72 ).
9. The device ( 10 ) as claimed in claim 1 , 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 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 an 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 ).