METHOD AND MANUFACTURING DEVICE FOR STERILISING AN INTERIOR OF A PACKAGING, AND PACKAGING WITH STERILISED INTERIOR

Abstract

The invention relates to a method for sterilising an interior of a packaging, wherein the packaging has an upper film and a lower part, wherein the upper film and the lower part, in the closed state of the packaging, delimit the interior at least in some regions, wherein a sterilising substance is applied to a first surface of the upper film, wherein the sterilising substance contains iodine, wherein the upper film is arranged on the lower part in such a way that the first surface of the upper film faces the interior of the packaging at least in some regions, wherein the sterilising substance is arranged within the packaging and is activated from outside for a predetermined activation time period, and wherein an initial germ load within the packaging, in particular in the interior of the packaging, is preferably reduced by a factor of at least 10.sup.6.

Claims

1. Method for sterilising an interior of a packaging, wherein the packaging comprising an upper film and a lower part, wherein the upper film and the lower part, in the closed state of the packaging, delimit the interior at least in regions, wherein a sterilising substance is applied to a first surface of the upper film, wherein the sterilising substance comprising iodine, wherein the upper film is arranged on the lower part in such a way that the first surface of the upper film faces the interior of the packaging at least in regions, wherein the sterilising substance is arranged inside the packaging and is activated from the outside for a predetermined activation time period.

2. The method according to claim 1, wherein the sterilising substance (15) comprises at least 40 wt % iodine.

3. The method according to claim 1, wherein the sterilising substance is dried for a predetermined drying time period after application to the first surface of the upper film.

4. The method according to claim 1, wherein the sterilising substance is applied as a layer, in particular as a homogeneous layer, to the first surface of the upper film.

5. The method according to claim 1, wherein the upper film and the lower part are firmly bonded.

6. The method according to claim 1, wherein the sterilising substance is activated before and/or after the packaging is closed.

7. The method according to claim 1, wherein the activation is carried out by evaporating with a predetermined activation temperature and/or a predetermined activation pressure for the predetermined activation time period.

8. The method according to claim 6, wherein the packaging, in particular the upper film, is evaporated with water vapour.

9. The method according to claim 1, wherein the sterilising substance is applied to the first surface of the upper film by means of a method selected from a group consisting of spraying, pressing on, vapour deposition and rolling on.

10. The method according to claim 1, wherein the closed packaging is dried for a predetermined storage time period, preferably in a vacuum chamber.

11. The method according to claim 1, wherein a compound or mixture of substances selected from a group consisting of a polymer-iodine complex and a solution of diethylene glycol monoethyl ether or diethylene glycol diethyl ether with at least 40 wt % iodine to at most 50 wt % iodine is used as the sterilising substance.

12. The method according to claim 1, wherein a transparent upper film is used as the upper film and a transparent lower part is used as the lower part.

13. The method according to claim 1, wherein a vapour-permeable film, in particular a Tyvek film, is used as the upper film.

14. The method according to claim 1, wherein an initial germ load within the packaging, in particular in the interior of the packaging, is reduced by a factor of at least 10.sup.6.

15. The method according to claim 1, wherein a medical device is arranged within the packaging, in particular between the upper film and the lower part.

16. The method according to claim 1, wherein a pharmaceutical container is arranged within the packaging, in particular between the upper film and the lower part.

17. Packaging, in particular bubble pack and/or blister, having an upper film and a lower part, wherein the upper film (3) and the lower part are firmly bonded, wherein an interior of the packaging, which is delimited at least in regions by the upper film and the lower part, is sterilised by means of a method according to one of the preceding claims.

18. The packaging according to claim 17, wherein a medical device and/or a pharmaceutical container is arranged in the interior of the packaging, in particular between the upper film and the lower part.

19. Manufacturing device for sterilising an interior of a packaging, wherein the manufacturing device comprising a receiving unit, a positioning unit and an activation unit, wherein the receiving unit is adapted to receive an upper film comprising a sterilising substance on a first surface and a lower part, wherein the positioning unit is adapted to place the upper film on the lower part in such a way that the upper film and the lower part delimit the interior of the packaging at least in regions and that the first surface of the upper film faces the interior of the packaging at least in regions, wherein the activation unit is adapted to activate the sterilising substance from the outside.

20. The manufacturing device according to claim 19, wherein the manufacturing device comprises an application unit adapted to apply the sterilising substance to the first surface of the upper film.

21. The manufacturing device according to claim 19, wherein the manufacturing device comprises a sealing unit adapted to firmly bonded the upper film and the lower part.

22. The manufacturing device according to claim 19, wherein the activation unit comprises an evaporation unit which is adapted in particular to deliver a water vapour blow out.

Description

[0057] The invention is explained in more detail below with reference to the drawing. Thereby show:

[0058] FIG. 1 a schematic representation of a lower part and an upper film of a first embodiment of a packaging,

[0059] FIG. 2 a schematic representation of the first embodiment of a packaging,

[0060] FIG. 3 a schematic representation of a second embodiment of a packaging,

[0061] FIG. 4 a schematic representation of a third embodiment of a packaging, and

[0062] FIG. 5 a schematic representation of a first and a second embodiment of a manufacturing device.

[0063] FIG. 1 shows a schematic representation of a lower part 1 and an upper film 3 of a first embodiment of a packaging 5. The lower part 1 and the upper film 3 are both preferably configured to be transparent. A medical device 7 and/or a pharmaceutical container 9 is preferably arranged in the lower part 1. The upper film 3 is preferably a vapour-permeable film, in particular a Tyvek film.

[0064] In the closed state, the lower part 1 and the upper film 3 delimit an interior 11 of the packaging 5 at least in certain regions. In this case, a first surface 13 of the upper film 3 faces the interior 11 of the packaging 5 at least in certain regions.

[0065] In a method for sterilising the interior 11 of the packaging 5, in a first step a sterilising substance 15 is applied to the first surface 13 of the upper film 3, wherein the sterilising substance 15 comprises iodine. Preferably, the sterilising substance 15 comprises at least 40 wt % iodine.

[0066] Preferably, the sterilising substance 15 comprises a compound, in particular a chemical compound, selected from a group consisting of a polymer-iodine complex and a solution of diethylene glycol monoethyl ether or diethylene glycol diethyl ether having at least 40 wt % iodine to at most 50 wt % iodine, preferably 45 wt % iodine. Alternatively, a mixture of substances consisting of diethylene glycol monoethyl ether or diethylene glycol diethyl ether with at least 40 wt % iodine to at most 50 wt % iodine, preferably 45 wt % iodine, is used as the sterilising substance.

[0067] Preferably, the sterilising substance 15 is applied as a layer 17, in particular as a homogeneous layer, to the first surface 13 of the upper film 3.

[0068] Preferably, the sterilising substance 15 is applied to the first surface 13 of the upper film 3 by a method selected from a group consisting of spraying, pressing on, vapour deposition and rolling on.

[0069] Alternatively or additionally, after application to the first surface 13 of the upper film 3, the sterilising substance 15 is dried for a predetermined drying time period.

[0070] The upper film 3 is then arranged on the lower part 1 in such a way that the first surface 13 of the upper film 3 faces the interior 11 at least in certain areas.

[0071] FIG. 2 shows a schematic representation of the first embodiment of the packaging 5, which is composed of the lower part 1 and the upper film 3 from FIG. 1. In the interior 11 of the packaging 5, in particular between the lower part 1 and the upper film 3, the medical device 7 and/or the pharmaceutical container 9 is arranged.

[0072] Identical and functionally identical elements are provided with the same reference signs in all figures, so that reference is made in each case to the preceding description.

[0073] In a second step of the method for sterilising the interior 11 of the packaging 5, the sterilising substance 15 is activated externally for a predetermined activation time period.

[0074] In one embodiment of the method, the activation of the sterilising substance 15 is carried out before the packaging 5 is closed, in particular before the lower part 1 is firmly bonded to the upper film 3. Alternatively or additionally, the activation of the sterilising substance 15 is carried out after the packaging 5 has been closed, in particular after the lower part 1 has been firmly bonded to the upper film 3.

[0075] Preferably, the activation of the sterilising substance 15 is carried out by evaporation, preferably by evaporation by means of water vapour, with a predetermined activation temperature and/or a predetermined activation pressure for the predetermined activation time period.

[0076] In a preferred embodiment of the method, the packaging 5, in particular the upper film 3, is evaporated by means of a steam nozzle 19 which preferably emits water vapour.

[0077] In an optional third step of the method for sterilising the interior 11 of the packaging 5, the closed packaging 5 is dried for a predetermined storage time period. Preferably, this drying is carried out in a vacuum chamber.

[0078] In a particularly preferred embodiment of the method, the initial germ load within the packaging 5, in particular in the interior 11 of the packaging 5 and on a surface of the medical device 7 and/or a surface of the pharmaceutical container 9, is reduced by a factor of at least 10.sup.6.

[0079] FIG. 3 shows a schematic representation of a second embodiment of a packaging 5 with the upper film 3 and the lower part 1. The medical device 7 and/or the pharmaceutical container 9, in particular a syringe, is arranged in the interior 11 of the packaging 5. For sterilisation of the interior 11 of the packaging 5 and the surface of the medical device 7 and/or the surface of the pharmaceutical container 9, reference is made to the previous description.

[0080] FIG. 4 shows a schematic representation of a third embodiment of a packaging 5 with the upper film 3 and the lower part 1. The medical device 7 and/or the pharmaceutical container 9, in particular a syringe, is arranged in the interior 11 of the packaging 5. For sterilisation of the interior 11 of the packaging 5 and the surface of the medical device 7 and/or the surface of the pharmaceutical container 9, reference is made to the previous description.

[0081] FIG. 5 shows a schematic representation of a first and second embodiment of a manufacturing device 19.

[0082] FIG. 5 a) shows the first embodiment of the manufacturing device 19 for sterilising the interior 11 of a packaging 5. The manufacturing device 19 comprises a receiving unit 21, a positioning unit 23 and an activation unit 25.

[0083] The receiving unit 21 is adapted to receive an upper film 3 comprising a sterilising substance 15 on a first surface 13, and a lower part 1.

[0084] The positioning unit 23 is adapted to place the upper film 3 on the lower part 1 in such a way that the upper film 3 and the lower part 1 at least partially delimit the interior 11 of the packaging 5 and that the first surface 13 of the upper film 3 at least partially faces the interior 11 of the packaging 5.

[0085] The activation unit 25 is adapted to activate the sterilising substance 15 from the outside. Preferably, the activation device 25 comprises an evaporation unit 27 adapted in particular to deliver a water vapour blow out.

[0086] Optionally, the manufacturing device 19 comprises an application unit 29. The application unit 29 is adapted to apply the sterilising substance 15 to the first surface 13 of the upper film 3.

[0087] Optionally, the manufacturing device 19 comprises a sealing unit 31. The sealing unit 31 is adapted to firmly bond the upper film 3 and the lower part 1 after activation of the sterilising substance 15 by means of the activation device 25.

[0088] Identical and functionally identical elements are provided with the same reference signs in all figures, so that reference is made to the previous description in each case.

[0089] FIG. 5 b) shows the second embodiment of the manufacturing device 19 for sterilising the interior 11 of a packaging 5. Optionally, the manufacturing device 19 comprises the sealing unit 31. The sealing unit 31 is adapted to firmly bond the upper film 3 and the lower part 1 before the sterilising substance 15 is activated by means of the activation device 25.