Device and method for transferring a packaging unit into a barrier system for pharmaceuticals

Abstract

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.

Claims

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 thatby 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).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further features and advantages of the invention form the subject matter of the following description and the illustrative representation of a preferred exemplary embodiment.

(2) In the drawing,

(3) FIG. 1 shows a side view of an embodiment of a device for transferring a packaging unit into a barrier system for pharmaceuticals;

(4) FIG. 2 shows a detail of the device according to FIG. 1, during the production of a connection region and during the subsequent separation of a part of the connection region;

(5) FIG. 3 shows a plan view of the partially separated connection region; and

(6) FIG. 4 shows a further detail of the device according to FIG. 1 during the transport of the packaging unit into the barrier system.

DETAILED DESCRIPTION

(7) A device which is denoted in the drawing as a whole by the reference sign 10 comprises a barrier system 12 in which pharmaceuticals are handled, in particular filled. The barrier system 12 has an interior 14 which is separate from the surroundings 16 of the barrier system 12. A division between the interior 14 of the barrier system 12 and the surroundings 16 of the barrier system 12 is illustrated in the drawing by a dashed-dotted line 18. This boundary is generally 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.

(8) The device 10 serves to convey a packaging unit 22 from the surroundings 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 material 26, for example an empty syringe 28 which is to be filled in the interior 14 of the barrier system with a pharmaceutical product, is arranged in the container 24.

(9) In an initial state or delivery state, the packaging unit 22 is surrounded by a sterilized outer packaging 30, for example a bag which is formed from film and which is optionally surrounded by an outer bag 32.

(10) The device 10 has an inlet region 34 with a bearing surface 36 for bearing at least the packaging unit 22 and the outer packaging 30.

(11) A station 38 adjoins the inlet region 34 with a set-up surface 40 which preferably can be adjusted flush with the bearing surface 36 and is also preferably height-adjustable by means of a transport device 42.

(12) A receiving surface 44 which preferably extends into the interior 14 of the barrier system 12 is arranged level with a lower boundary of the access opening 20. The receiving surface 44 has a through-passage 46 which is dimensioned such that a packaging unit 22 can be transferred from the station 38 through the through-passage 46.

(13) A support element 48 which extends parallel to the receiving surface 44 is provided level with an upper edge of the access opening 20. The receiving surface 44 and the support element 48 are encased by a film tube, denoted as a whole by the reference sign 50.

(14) The film tube 50 is configured as an endless tube and can be pulled off a tube material supply 58 arranged adjacent to the access opening 20. The film tube 50 defines an interior 52 and is closed on the end face in a region 54 which is spaced apart from the access opening 20. The region 54 can comprise, for example, at least one winding roller 56 onto which the used-up pieces of the film tube 50 are wound.

(15) The film tube 50 is supported at its upper end in cross section by the support element 48 and is fixed adjacent to the access opening 20. At the same time, a lower end of the film tube 50 in cross section encases the receiving surface 44 and the through-passage 46 thereof.

(16) 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, see FIG. 2.

(17) The connecting device 60 serves to produce a connection between an outer face 64 of the material 66 of the film tube 50 and an outer face 68 of a cover portion 70 of the outer packaging 30. The connection region is shown for clearer illustration in the two enlargements of FIG. 2 in the form of a connecting layer which is denoted by the reference sign 72. For example, it can be a bonding material or alternatively a region (graphically illustrated) in which the material of the cover portion 70 of the outer packaging 30 and an identically sized overlap portion 74 of the material 66 of the film tube 50 are connected together, in particular fused together.

(18) The connection region 72 preferably extends along a web 76 which is closed on the peripheral side, see FIG. 3. The web 76 defines a free space 78 which is defined between the cover portion 70 and the overlap portion 74, see FIG. 2. Germs arranged on the outer face 68 of the cover portion 70 of the outer packaging 30, therefore, are enclosed between the cover portion 70 and the overlap portion 74 of the film tube 50 and at the same time inside the web-shaped connection region 72.

(19) A width 80 of the web 76, which is measured in the extension plane of the connection region 72, is preferably at least 2 mm, in particular at least 4 mm.

(20) Proceeding from the production of the connection region 72, the separating device 62 serves to separate locally the connection region 72. This separation can take place along the entire web-shaped path of the connection region 72; but it is preferred if a separating region 82 extends only across a first part of the connection region 72. This is illustrated in FIG. 3 by a dashed line; the separating region 82 extends, for example, along opposing side edges 84 and 86 and along a front edge 88 of the connection region 72. A second part 90 of the connection region 72 remains unchanged, and thus in this second part 90 is not locally separated. In particular, this is a rear edge of the connection region 72.

(21) During the local separation of the connection region 72, the separating device 62 also cuts through the material of the film tube 50 and the material of the outer packaging 30, for example by using a blade 92, see FIG. 2. When viewed across the width 80 of the web 76, the separating region is arranged such that, after locally separating the connection region 72 and at the same time cutting through the material of the film tube 50 and the material of the outer packaging 30 on both sides of the separating region, the respective portions 72a and 72b of the connection region 72 are maintained.

(22) Proceeding from a state in which the cover portion 70, the overlap portion 74 and the connection region 72 are separated at least along a part of the web-shaped connection region 72, the packaging unit 22 is transported out of the station 38 into the interior 52 of the film tube 50, see FIG. 4. Preferably, the set-up surface 40 is lifted until it has reached the height of the receiving surface 44. The packaging unit 22 is inserted through the through-passage 46 of the bearing surface 44 into the interior 52. A film composite 94 consisting of the cover portion 70 and the overlap portion 74, which are connected together, is pushed into the interior 52 of the film tube 50. As a result of the connection in the region of the rear edge/in the region of the second part 90 of the connection region 72, the film composite 94 is folded back to the side so that the packaging unit 22 is transferred past the folded-back film composite 94 into the interior 52 of the film tube 50. The packaging unit 22 can be transferred therefrom in a manner known per se into the interior 14 of the barrier system 12, for example by means of transport elements known per se, for example slides or grippers.

(23) Following a transfer of a first packaging unit 22 into the interior 14 of the barrier system 12, the film tube 50 can be pulled off the supply 58, wherein at the same time the film composite 94 and the remaining constituent parts of the outer packaging 30 can be removed and collected. After a fresh piece of film tube has been provided, a further packaging unit 22 can be transferred in the manner described above into the interior 14 of the barrier system 12.

(24) It is possible that a flow device 96 is provided for further increasing the protection against contamination, (see FIG. 1), the flow device subjecting the surroundings 16 and/or the interior 14 of the barrier system 12 to a defined airflow which is oriented from top to bottom, for example.