Method and manufacturing apparatus for sterilizing the interior of a package, and package having a sterilized interior

Abstract

The present invention relates to a method for sterilizing an interior (11) of a package (5), the package (5) comprising a top film (3) and a bottom part (1), in a sealed state of the package (5), the top film (3) and the bottom part (1) at least partially defining an interior (11), a sterilizing substance (15) is applied to a first side (13) of the top film (3), the sterilizing substance (15) comprising iodine, the top film (3) is arranged on the bottom part (1) such that the first side (13) of the top film (3) at least partially faces the interior (11) of the package (5), the sterilizing substance (15) is arranged on the interior of the package (5) and activated from the outside for a predefined activation time, such that an initial bacterial load in the package (5), in particular in the interior (11) of the package (5), is reduced to at least 10 6 It is reduced to one-fifth.

Description

[Technical Field]

[0001] The present invention relates to a method for sterilizing the interior of a package, a package having an interior sterilized by such a method, and a manufacturing apparatus for sterilizing the interior of a package. [Background technology]

[0002] Ethylene oxide sterilization is known to sterilize the interior of packaging, particularly filled medical primary packaging means or pharmaceutical primary packaging means disposed within the packaging. Such ethylene oxide sterilization is a complex and costly process and is typically performed exclusively by specialized service providers. The disadvantages are the increased complexity and limited choice of primary packaging materials.

[0003] U.S. Patent No. 4,381,380 discloses a thermoplastic material made of polyurethane containing an iodine compound. The inclusion of the iodine compound gives the plastic an antibacterial effect, particularly a sterilizing effect. The disadvantages of this method are that the synthesis of polyurethane containing iodine compounds is complicated and polyurethane as a plastic has limitations.

[0004] U.S. Patent Application Publication No. 2005 / 173270 discloses packaging for medical devices that has an antibacterial effect. The antibacterial effect is achieved by adding an antibacterial agent, specifically iodine. The disadvantage of this method is that sterility is not guaranteed. Summary of the Invention

[0005] The present invention is therefore based on the problem of providing a method and device for sterilizing the interior of a package, as well as a package having a correspondingly sterilized interior, whereby the above-mentioned disadvantages are at least partially overcome, in particular avoided.

[0006] The problem is solved by providing the teachings of the present technology, in particular the teachings of the embodiments disclosed in the independent and dependent claims and the specification.

[0007] This problem is solved by creating a method for sterilizing the interior of a package. The package includes an upper film and a lower portion, and in a sealed state of the package, the upper film and the lower portion at least partially define the interior. In a first step, a sterilizing substance is applied to a first side of the upper film, the sterilizing substance including iodine. In a second step, the upper film is placed on the lower portion so that the first side of the upper film at least partially faces the interior of the package. In a third step, the sterilizing substance is placed inside the package and activated from the outside for a predetermined activation time.

[0008] Advantageously, activation of the sterilizing substance, in particular iodine, sterilizes the interior of the package and, in particular, provides external sterilization for any products placed inside the package. In addition, the sterilization of the interior of the package with the sterilizing substance, in particular iodine, and the activation of the sterilizing substance, in particular iodine, are advantageously easy to integrate into existing processes and / or methods.

[0009] Particularly preferably, a film, in particular a plastic film, or a molded part, in particular a plastic molded part, is used as the lower part.

[0010] Preferably, the activation of the sterilizing substance corresponds to a kinetic activation. Particularly preferably, the activation of the sterilizing substance corresponds to the release of iodine from the solution.

[0011] Preferably, the sterilizing substance is a compound, in particular a compound containing iodine, or, particularly preferably, the sterilizing substance is a mixture of substances containing iodine.

[0012] Preferably, the predetermined activation time is at least 0.1 seconds and up to 300 seconds, more preferably at least 0.2 seconds and less than 60 seconds. Particularly preferably, the predetermined activation time is up to 55 seconds. Particularly preferably, the predetermined activation time is up to 50 seconds. Particularly preferably, the predetermined activation time is up to 45 seconds. Particularly preferably, the predetermined activation time is up to 40 seconds. Particularly preferably, the predetermined activation time is up to 35 seconds. Particularly preferably, the predetermined activation time is up to 30 seconds. Particularly preferably, the predetermined activation time is up to 25 seconds. Particularly preferably, the predetermined activation time is up to 20 seconds. Particularly preferably, the predetermined activation time is up to 15 seconds. Particularly preferably, the predetermined activation time is up to 10 seconds. Particularly preferably, the predetermined activation time is up to 9 seconds. Particularly preferably, the predetermined activation time is up to 8 seconds. Particularly preferably, the predetermined activation time is up to 7 seconds. Particularly preferably, the predetermined activation time is up to 6 seconds. Particularly preferably, the predetermined activation time is up to 5 seconds. Particularly preferably, the predetermined activation time is at least 0.5 seconds. Particularly preferably, the predetermined activation time is at least 1 second. Particularly preferably, the predetermined activation time is at least 1.5 seconds. Particularly preferably, the predetermined activation time is at least 2 seconds. Particularly preferably, the predetermined activation time is at least 2.5 seconds. Particularly preferably, the predetermined activation time is at least 3 seconds. Particularly preferably, the predetermined activation time is at least 3.5 seconds. Particularly preferably, the predetermined activation time is at least 4 seconds. Particularly preferably, the predetermined activation time is at least 4.5 seconds. Particularly preferably, the predetermined activation time is at least 5 seconds. Particularly preferably, the predetermined activation time is 5 seconds.

[0013] Preferably, the amount of sterilizing substance applied to the first surface of the top film is 1 cm 2 At least 0.001 mg of iodine per cm 2 Preferably, the sterilizing substance contains at least 0.01 mg of iodine per ml and up to 5 mg of iodine per ml, and preferably at least 10 mg of iodine per ml is present on the first surface of the top film. Alternatively or additionally, the sterilizing substance preferably contains at least 0.01 mg of iodine per ml and up to 5 mg of iodine per ml.

[0014] Preferably, the sterilizing substance comprises more than 30 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 31 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 32 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 33 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 34 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 35 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 36 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 37 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 38 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 39 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 40 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 41 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 42 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 43 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 44 wt% iodine. Particularly preferably, the sterilizing substance comprises at least 45 wt% iodine. Preferably, the sterilizing substance comprises at most 50 wt% iodine, preferably at most 49 wt% iodine, preferably at most 48 wt% iodine, preferably at most 47 wt% iodine, preferably at most 46 wt% iodine.

[0015] The amount wt% denotes a percentage by mass, in particular a mass fraction. According to a further development of the invention, it is provided that the sterilizing substance comprises at least 40 wt% iodine.

[0016] According to a further development of the invention, the sterilizing substance is dried for a predetermined drying time after application to the first side of the top film, which advantageously ensures optimal application of the sterilizing substance to the first side of the top film.

[0017] Preferably, the predetermined drying time is at least 5 seconds and up to 10 minutes. Particularly preferably, the predetermined drying time is at least 10 seconds. Particularly preferably, the predetermined drying time is at least 15 seconds. Particularly preferably, the predetermined drying time is at least 20 seconds. Particularly preferably, the predetermined drying time is at least 25 seconds. Particularly preferably, the predetermined drying time is at most 5 minutes. Particularly preferably, the predetermined drying time is at most 2 minutes. Particularly preferably, the predetermined drying time is at most 1 minute.

[0018] According to a further development of the invention, the sterilizing substance is applied as a layer, in particular as a homogeneous layer, to the first side of the top film. Advantageously, the layer of sterilizing substance, in particular the homogeneous layer, can be optimally activated from the outside.

[0019] According to a further development of the invention, the upper film and the lower part are firmly connected to one another. Preferably, the strong connection between the upper film and the lower part is constituted by gluing or welding. Advantageously, the strong connection of the upper film to the lower part ensures that fluids cannot leak from the interior of the package between the upper film and the lower part.

[0020] Preferably, the package is particularly tightly and / or tightly sealed by creating a strong bond between the upper film and the lower part.

[0021] According to a development of the invention, the sterilizing substance is activated before and / or after the packaging is sealed.

[0022] According to a development of the invention, activation is carried out by steam treatment at a defined activation temperature and / or a defined activation pressure for a defined activation time.

[0023] Preferably, the predetermined activation temperature is at least 60°C and at most 250°C, more preferably at least 100°C and less than 200°C. Particularly preferably, the predetermined activation temperature is at most 195°C. Particularly preferably, the predetermined activation temperature is at most 190°C. Particularly preferably, the predetermined activation temperature is at most 185°C. Particularly preferably, the predetermined activation temperature is at most 180°C. Particularly preferably, the predetermined activation temperature is at most 175°C. Particularly preferably, the predetermined activation temperature is at most 170°C. Particularly preferably, the predetermined activation temperature is at most 165°C. Particularly preferably, the predetermined activation temperature is at most 160°C. Particularly preferably, the predetermined activation temperature is at most 155°C. Particularly preferably, the predetermined activation temperature is at most 150°C. Particularly preferably, the predetermined activation temperature is at most 145°C. Particularly preferably, the predetermined activation temperature is at most 140°C. Particularly preferably, the predetermined activation temperature is at most 135°C. Particularly preferably, the predetermined activation temperature is at most 130°C. Particularly preferably, the predetermined activation temperature is at most 125°C. Particularly preferably, the predetermined activation temperature is at most 120°C. Particularly preferably, the predetermined activation temperature is at least 65°C. Particularly preferably, the predetermined activation temperature is at least 70°C. Particularly preferably, the predetermined activation temperature is at least 75°C. Particularly preferably, the predetermined activation temperature is at least 80°C. Particularly preferably, the predetermined activation temperature is at least 85°C. Particularly preferably, the predetermined activation temperature is at least 90°C. Particularly preferably, the predetermined activation temperature is at least 95°C. Particularly preferably, the predetermined activation temperature is at least 105°C. Particularly preferably, the predetermined activation temperature is at least 110°C. Particularly preferably, the predetermined activation temperature is at least 115°C. Particularly preferably, the predetermined activation temperature is at least 120°C. Particularly preferably, the predetermined activation temperature is 120°C.

[0024] Preferably, the predetermined activation pressure is at least 1 psi (0.069 bar) to a maximum of 350 psi (24 bar), more preferably at least 30 psi (2.1 bar) to a maximum of 340 bar. Particularly preferably, the predetermined activation pressure is a maximum of 320 psi (22 bar). Particularly preferably, the predetermined activation pressure is a maximum of 300 psi (21 bar). Particularly preferably, the predetermined activation pressure is a maximum of 280 psi (19 bar). Particularly preferably, the predetermined activation pressure is a maximum of 260 psi (18 bar). Particularly preferably, the predetermined activation pressure is a maximum of 240 psi (17 bar). Particularly preferably, the predetermined activation pressure is a maximum of 220 psi (15 bar). Particularly preferably, the predetermined activation pressure is a maximum of 200 psi (14 bar). Particularly preferably, the predetermined activation pressure is a maximum of 180 psi (12 bar). Particularly preferably, the predetermined activation pressure is a maximum of 160 psi (11 bar). Particularly preferably, the predetermined activation pressure is at most 140 psi (9.7 bar). Particularly preferably, the predetermined activation pressure is at most 120 psi (8.3 bar). Particularly preferably, the predetermined activation pressure is at most 100 psi (6.9 bar). Particularly preferably, the predetermined activation pressure is at least 2 psi (0.14 bar). Particularly preferably, the predetermined activation pressure is at least 3 psi (0.21 bar). Particularly preferably, the predetermined activation pressure is at least 4 psi (0.28 bar). Particularly preferably, the predetermined activation pressure is at least 5 psi (0.34 bar). Particularly preferably, the predetermined activation pressure is at least 6 psi (0.41 bar). Particularly preferably, the predetermined activation pressure is at least 7 psi (0.48 bar). Particularly preferably, the predetermined activation pressure is at least 8 psi (0.55 bar). Particularly preferably, the predetermined activation pressure is at least 9 psi (0.62 bar). Particularly preferably, the predetermined activation pressure is at least 10 psi (0.69 bar). Particularly preferably, the predetermined activation pressure is at least 15 psi (1.03 bar). Particularly preferably, the predetermined activation pressure is at least 20 psi (1.4 bar).Particularly preferably, the predetermined activation pressure is at least 25 psi (1.7 bar).

[0025] In a preferred embodiment of the method, the steam treatment is carried out by means of a steam nozzle that is applied directly to the upper film or that is placed at a predetermined distance from the upper film and that is suitably aligned with the upper film, and all of the parameters, the predetermined activation temperature, the predetermined activation pressure, the predetermined activation time, and the distance of the steam nozzle to the upper film, are suitably adjusted to one another to ensure optimal activation of the sterilizing substance.

[0026] If the sterilizing substance is activated by steam treatment after the package has been sealed, it is advantageous if the top film and / or bottom portion is steam permeable.

[0027] According to a development of the invention, the packaging, in particular the top film, is steamed using water vapor.

[0028] According to a further development of the invention, the sterilizing substance is applied to the first side of the top film by a method selected from the group consisting of spraying, pressing, vapor deposition and rolling, which advantageously ensures optimal application of the sterilizing substance to the first side of the top film, in particular optimal application of the first side of the top film with the sterilizing substance.

[0029] According to a further development of the invention, the sealed package is dried for a predetermined storage time, preferably in a vacuum chamber. Particularly preferably, the sealed package is dried for a predetermined storage time after activation of the sterilizing substance.

[0030] According to a further development of the invention, a compound selected from the group consisting of a polymer-iodine complex and a solution of diethylene glycol monoethyl ether or diethylene glycol diethyl ether containing at least 40% to a maximum of 50% iodine by weight, preferably 45% iodine by weight, is used as the sterilizing substance, or a mixture of substances consisting of diethylene glycol monoethyl ether or diethylene glycol diethyl ether containing at least 40% to a maximum of 50% iodine by weight, preferably 45% iodine by weight, is used as the sterilizing substance.

[0031] According to a further development of the invention, a transparent upper film is used as the upper film and a transparent lower part is used as the lower part, which advantageously allows visual inspection of the product placed in the packaging.

[0032] According to a development of the invention, a vapor-permeable film, in particular a Tyvek film, is used as the top film, which advantageously allows particularly good activation of the sterilizing substance after the package has been sealed, in particular after the top film has been firmly joined to the bottom part.

[0033] According to a further development of the invention, the initial bacterial load in the packaging is at least 10 6 The initial bacterial load is reduced by 10 6 A 6-log reduction is also known as a 6-log reduction. A 6-log reduction in the initial bacterial load is required to ensure adequate sterility of the package.

[0034] In the context of the present technical teaching, bacteria is understood to mean in particular microorganisms, in particular prokaryotes, in particular bacteria and archaea, eukaryotes, in particular fungi, yeasts, plant and animal unicellular and / or multicellular organisms, prions, protists, viruses and spores.

[0035] According to a development of the invention, the medical device is arranged inside the packaging, in particular between the top film and the bottom part.

[0036] According to a development of the invention, the drug container is arranged inside the packaging, in particular between the top film and the bottom part.

[0037] In a preferred embodiment of the method, the primary packaging means, in particular a syringe or cartridge, is used as a medical device and / or pharmaceutical container.

[0038] This problem is also solved by creating a package comprising an upper film and a lower portion, the upper film and the lower portion being firmly joined together, the interior of the package being at least partially defined by the upper film and the lower portion being sterilized by the method of the present invention or by the method of one or more of the above-mentioned embodiments. In connection with the package, the advantages already mentioned in connection with the method arise in particular.

[0039] In one embodiment of the packaging, the lower part is configured as a film, in particular as a plastic film. The packaging is then configured in particular as a film bag. In another embodiment, the lower part is configured as a molded part, in particular a molded plastic part.

[0040] According to a development of the invention, the medical device and / or medicine container is arranged inside the packaging, in particular between the top film and the bottom part.

[0041] This problem is also solved by creating a manufacturing device for sterilizing the interior of a package, in particular by a method according to the present invention or one or more of the above-mentioned embodiments. The manufacturing device comprises a receiving unit, a positioning unit, and an activation unit. The receiving unit is configured to receive an upper film and a lower portion, the upper film containing a sterilizing substance on a first side thereof. The positioning unit is configured to place the upper film on the lower portion such that the upper film and the lower portion at least partially define the interior of the package and the first side of the upper film at least partially faces the interior of the package. The activation unit is configured to activate the sterilizing substance from the outside. In particular, the manufacturing device is configured to perform the method according to the present invention or one or more of the above-mentioned embodiments. The manufacturing device provides the advantages already described, in particular in relation to the method and the package.

[0042] Preferably, the receiving section, positioning section, and activation section are arranged so that the upper film and lower section first pass through the receiving section, then through the positioning section, and then through the activation section.

[0043] According to a development of the invention, the manufacturing device comprises an application unit, which is configured to apply a sterilizing substance to the first side of the top film.

[0044] According to a development of the invention, the manufacturing device comprises a sealing part, which is configured to firmly connect the upper film and the lower part.

[0045] According to a development of the invention, the activation section comprises a steam treatment section which is in particular designed to spray water vapor.

[0046] To demonstrate the sterilization effect of the method according to the present invention or one or more embodiments thereof, in particular the 6-log reduction in initial bacterial load, a series of experiments were carried out, as described below.

[0047] For all experiments, a Tyvek film was used as the top film and a cuvette, preferably a polystyrene cuvette, was used as the bottom part.

[0048] To demonstrate the sterilization effect, before applying the method, the cuvettes were inoculated with Bacillus subtilis. For this purpose, a strain of Bacillus subtilis was grown for 3 to 4 weeks on an agar medium containing manganese. Subsequently, the spores were collected in ultrapure water, in particular 2 ml of ultrapure water, and preferably washed twice. Furthermore, the presence of spores was confirmed by microscopic observation. Subsequently, the spores were stored in a 4% solution of ultrapure ethanol, and spore concentration was carried out by known methods, in particular by dilution series, growth in Petri dishes and counting of colony-forming units, so-called CFU counts (colony-forming units). To inoculate the cuvettes, 3 x 10 per ml of Bacillus subtilis was used. 9 A spore suspension exceeding CFU was prepared, thus making it possible to conclusively demonstrate a 6-log reduction in the initial bacterial load, even in the case of spontaneous reduction of spores due to drying and / or still present vegetative cells, which is usually in the range of a 1.5-log reduction.

[0049] Before inoculating the cuvettes with 100 μl of spore suspension, the cuvettes were sterilized with UV light. After inoculation, the cuvettes were stored at 37°C for at least 8 h to allow the liquid to evaporate and the spores to adhere to the inner walls of the cuvette.

[0050] After the completion of each experiment, a CFU count was performed. In each case, 1 ml of ultrapure water was filled into a cuvette, and the spores were separated from the inner wall of the cuvette using a sterile cotton swab and dissolved in the ultrapure water. The resulting suspension was transferred to another container. The process of forming a suspension in the cuvette was repeated until 5 ml of suspension was collected in another container. The 5 ml suspension was diluted in a six-step dilution series, and 1 ml subsamples of each were plated on agar plates, preferably casein-soy peptone agar plates. CFU counts were performed after 24 and 48 hours.

[0051] Experimental series 1: To sterilize the inoculated cuvettes, a solution of 45 wt% iodine in diethylene glycol monoethyl ether was pipetted onto the Tyvek film, preferably with a density of 1 cm. 2 Either 2.18 mg of I2 (iodine) was obtained per film or a 1:50 iodine ethanol solution was applied to the Tyvek film.

[0052] A Tyvek film pre-coated with iodine was adhered to the inoculated cuvette, ensuring that the iodine solution was completely positioned inside the cuvette. The cuvette and Tyvek film were pressed firmly together for 30 seconds and then allowed to stand for 10 minutes to allow for complete adhesive bonding between the cuvette and Tyvek film. As a control experiment, a comparison cuvette inoculated in the same manner was bonded to Tyvek film without iodine.

[0053] The inoculated cuvettes sealed with Tyvek film were then steamed by placing a steam nozzle in the center of the Tyvek film, followed by a 5-second burst of steam at 120°C and 36 psi (2.5 bar) pressure.

[0054] Each of these experiments was performed using multiple cuvettes and a control cuvette.

[0055] The cuvettes sealed with Tyvek film and the reference cuvette were then stored at 23°C for 72 hours, after which the Tyvek film was removed and a CFU count was performed. In a control experiment using a comparison cuvette in which iodine was not suspended on the Tyvek film, a 1.7-log reduction in the initial bacterial load was observed compared to the inoculum. The 1.7-log reduction in the control experiment was due to the dehydration process. In all experiments in which iodine was applied to the Tyvek film, no colony-forming units were found in the CFU count. This demonstrates that sterilization using the aforementioned methods, specifically applying iodine to Tyvek film and activating the iodine with a burst of steam, can result in at least a 6.9-log reduction in the initial bacterial load compared to the control experiment. [Brief explanation of the drawings]

[0056] The invention will be explained in more detail below with reference to the drawings. [Figure 1] 1 is a schematic diagram of the bottom portion and top film of a first embodiment of packaging. FIG. [Figure 2] 1 is a schematic diagram of a first embodiment of packaging; FIG. [Figure 3] FIG. 1 is a schematic view of a second embodiment of the packaging. [Figure 4] FIG. 10 is a schematic view of a third embodiment of the packaging. [Figure 5] 1A and 1B are schematic diagrams of first and second embodiments of a manufacturing apparatus. DETAILED DESCRIPTION OF THE INVENTION

[0057] 1 shows a schematic view of the lower part 1 and upper film 3 of a first embodiment of packaging 5. The lower part 1 and upper film 3 are preferably both constructed to be transparent. A medical device 7 and / or pharmaceutical container 9 is preferably placed in the lower part 1. The upper film 3 is preferably a vapor-permeable film, in particular a Tyvek film.

[0058] In the sealed state, the lower part 1 and the upper film 3 define, at least in a specific area, an interior 11 of the package 5. In this case, the first surface 13 of the upper film 3 faces the interior 11 of the package 5, at least in a specific area.

[0059] In a method for sterilizing the interior 11 of a package 5, in a first step, a sterilizing substance 15 is applied to the first surface 13 of the top film 3, where the sterilizing substance 15 comprises iodine. Preferably, the sterilizing substance 15 comprises at least 40 wt% iodine.

[0060] Preferably, the sterilizing substance 15 comprises a compound, in particular a compound selected from the 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 and up to 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 and up to 50 wt% iodine, preferably 45 wt% iodine, is used as the sterilizing substance.

[0061] Preferably, the sterilizing substance 15 is applied to the first side 13 of the top film 3 as a layer 17, in particular as a homogeneous layer.

[0062] Preferably, the sterilizing substance 15 is applied to the first surface 13 of the top film 3 by a method selected from the group consisting of spraying, pressing, vapor deposition, and rolling.

[0063] Alternatively or additionally, after application to the first side 13 of the top film 3, the sterilizing substance 15 is allowed to dry for a predetermined drying time.

[0064] The top film 3 is then placed on the bottom portion 1 so that the first surface 13 of the top film 3 faces the interior 11 at least in certain areas.

[0065] Figure 2 shows a schematic view of a first embodiment of a package 5 consisting of the lower part 1 and upper film 3 of Figure 1. In the interior 11 of the package 5, in particular between the lower part 1 and the upper film 3, a medical device 7 and / or a medicine container 9 is arranged.

[0066] In all figures, identical and functionally identical components are given the same reference numerals and in all cases reference is made to the above description.

[0067] In a second step of the method for sterilizing the interior 11 of the package 5, the sterilizing substance 15 is activated from the outside for a predetermined activation time.

[0068] In one embodiment of the method, activation of the sterilizing substance 15 is carried out before the package 5 is sealed, in particular before the lower part 1 is firmly bonded to the upper film 3. Alternatively or additionally, activation of the sterilizing substance 15 is carried out after the package 5 is sealed, in particular after the lower part 1 is firmly bonded to the upper film 3.

[0069] Preferably, activation of the sterilizing material 15 is carried out by steam treatment, preferably with water vapor, at a predetermined activation temperature and / or a predetermined activation pressure for a predetermined activation time.

[0070] In a preferred embodiment of the method, the packaging 5, in particular the top film 3, is steamed, preferably by means of a steam nozzle 19 which emits water vapor.

[0071] In an optional third step of the method for sterilizing the interior 11 of the package 5, the sealed package 5 is dried for a predetermined storage time. Preferably, this drying is carried out in a vacuum chamber.

[0072] In a particularly preferred embodiment of the method, the initial bacterial load in the packaging 5, in particular on the interior 11 of the packaging 5 and on the surface of the medical device 7 and / or on the surface of the pharmaceutical container 9, is at least 10 6 It is reduced to one-fifth.

[0073] 3 shows a schematic view of a second embodiment of packaging 5 having an upper film 3 and a lower part 1. A medical device 7 and / or a pharmaceutical container 9, in particular a syringe, is arranged in the interior 11 of packaging 5. For sterilization of the interior 11 of packaging 5 and the surface of the medical device 7 and / or pharmaceutical container 9, see the above explanations.

[0074] 4 shows a schematic view of a third embodiment of packaging 5 having an upper film 3 and a lower part 1. A medical device 7 and / or a pharmaceutical container 9, in particular a syringe, is arranged in the interior 11 of packaging 5. For sterilization of the interior 11 of packaging 5 and the surface of the medical device 7 and / or pharmaceutical container 9, see the above explanations.

[0075] FIG. 5 shows a schematic diagram of a first and second embodiment of the manufacturing apparatus 19.

[0076] 5(a) shows a first embodiment of a manufacturing apparatus 19 for sterilizing the interior 11 of a package 5. The manufacturing apparatus 19 includes a receiving section 21, a positioning section 23, and an activation section 25.

[0077] The receptacle 21 is configured to receive the upper film 3 and the lower portion 1 which contain the sterilizing substance 15 on the first side 13 .

[0078] The positioning portion 23 is configured to place the upper film 3 on the lower portion 1 so that the upper film 3 and the lower portion 1 at least partially define the interior 11 of the package 5 and the first surface 13 of the upper film 3 at least partially faces the interior 11 of the package 5.

[0079] The activation unit 25 is configured to activate the sterilizing substance 15 from the outside. Preferably, the activation device 25 includes a steam treatment unit 27, which is particularly configured to spray water steam.

[0080] Optionally, the manufacturing apparatus 19 includes an applicator 29. The applicator 29 is configured to apply a sterilizing substance 15 to the first surface 13 of the top film 3.

[0081] Optionally, the manufacturing apparatus 19 includes a sealing portion 31 configured to firmly bond the top film 3 and the bottom portion 1 together after the sterilizing substance 15 is activated by the activation device 25.

[0082] In all figures, identical and functionally identical components are given the same reference numerals and in all cases reference is made to the above description.

[0083] 5(b) shows a second embodiment of a manufacturing apparatus 19 for sterilizing the interior 11 of the package 5. Optionally, the manufacturing apparatus 19 includes a sealing portion 31 configured to tightly bond the top film 3 and the bottom portion 1 together before the sterilizing substance 15 is activated by the activation device 25.

Claims

1. A method for sterilizing the interior (11) of a package (5), comprising: The package (5) comprises an upper film (3) and a lower part (1), In the sealed state of the package (5), the upper film (3) and the lower part (1) at least partially define the interior (11), A sterilizing substance (15) is applied to the first surface (13) of the top film (3); the sterilizing substance (15) contains iodine, the upper film (3) is placed on the lower part (1) so that the first surface (13) of the upper film (3) at least partially faces the interior (11) of the package (5); the sterilizing substance (15) is placed inside the packaging (5) and activated from the outside for a predetermined activation time; A method wherein said activation is carried out by steam treatment at a predetermined activation temperature and / or a predetermined activation pressure for a predetermined activation time.

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

3. 3. The method according to claim 1 or 2, wherein the sterilizing substance (15) is applied to the first surface (13) of the top film (3) and then dried for a predetermined drying time.

4. 4. The method according to any one of claims 1 to 3, wherein the sterilizing substance (15) is applied as a layer (17) to the first side (13) of the top film (3).

5. 5. The method according to any one of claims 1 to 4, wherein the upper film (3) and the lower part (1) are firmly bonded together.

6. 6. The method according to any one of claims 1 to 5, wherein the sterilizing substance (15) is activated before and / or after the package (5) is sealed.

7. 7. The method according to any one of claims 1 to 6, wherein the packaging (5) is steamed using water vapor.

8. 8. The method according to any one of claims 1 to 7, wherein the sterilizing substance (15) is applied to the first surface (13) of the top film (3) by a method selected from the group consisting of spraying, pressing, vapor deposition, and rolling.

9. 9. A method according to any one of claims 1 to 8, wherein the sealed package (5) is dried for a predetermined storage time.

10. 10. The method according to any one of claims 1 to 9, wherein a compound or mixture of substances selected from the group consisting of a polymer-iodine complex and a solution of diethylene glycol monoethyl ether or diethylene glycol diethyl ether containing at least 40 wt% iodine and up to 50 wt% iodine is used as the sterilizing substance (15).

11. 11. The method according to any one of claims 1 to 10, wherein a transparent upper film is used as the upper film (3) and a transparent lower part is used as the lower part (1).

12. 12. The method according to any one of claims 1 to 11, wherein a vapor-permeable film is used as the top film (3).

13. The initial bacterial load in the package (5) is at least 10 ６ 13. The method of claim 1, wherein the amount of oxygen in the atmosphere is reduced by a factor of 1.

14. 14. The method according to any one of claims 1 to 13, wherein a medical device (7) is placed inside the packaging (5).

15. 15. The method according to any one of claims 1 to 14, wherein a pharmaceutical container (9) is placed inside the packaging (5).

16. A package (5), It comprises an upper film (3) and a lower part (1), A package (5) in which the upper film (3) and the lower part (1) are firmly bonded together and an interior (11) of the package (5) defined at least in part by the upper film (3) and the lower part (1) is sterilized by a method according to any one of claims 1 to 15.

17. 17. The packaging (5) of claim 16, wherein a medical device (7) and / or a pharmaceutical container (9) is arranged in the interior (11) of the packaging (5).

18. A manufacturing device (19) for sterilizing the interior (11) of a package (5), comprising: The manufacturing device (19) includes a receiving section (21), a positioning section (23), and an activation section (25); The receiving portion (21) is configured to receive an upper film (3) having a first surface (13) and a lower portion (1); the positioning portion (23) is configured to place the upper film (3) on the lower portion (1) such that the upper film (3) and the lower portion (1) at least partially define the interior (11) of the package (5) and the first surface (13) of the upper film (3) at least partially faces the interior (11) of the package (5); The activation section (25) includes a steam treatment section (27), The activation section (25) is configured to activate the sterilizing substance (15) applied from the outside onto the first surface (13) by steam treatment at a predetermined activation temperature and / or a predetermined activation pressure for a predetermined activation time.

19. The manufacturing apparatus (19) according to claim 18, further comprising an application section (29) configured to apply the sterilizing substance (15) to the first surface (13) of the upper film (3).

20. 20. The manufacturing device (19) according to claim 18 or 19, further comprising a sealing portion (31) configured to firmly bond the upper film (3) and the lower portion (1).

21. 21. The manufacturing apparatus (19) according to any one of claims 18 to 20, wherein the steam treatment section (27) is configured to spray water steam.

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