Membranes and packages for gas or vapor permeable packaging and methods of using the same

Abstract

Membranes and packages for gas or vapor-permeable packaging applications and methods for manufacturing sterilized packages using the same are disclosed. These membranes are particularly suitable for the sterilized storage and transportation of articles for medical, pharmaceutical or cosmetic use, and are particularly suitable for primary sterilized pharmaceutical packaging tools such as vials, ampoules, syringes or cartridges. The membrane comprises at least a selectively permeable non-woven layer, a perforated membrane layer, and an adhesive that can be activated by energy transfer. Optionally, it further comprises other membrane layers. The method for manufacturing a sterilized package comprises the steps of hermetically sealing the package by activating the adhesive, thereby making the non-woven fabric impermeable.

Description

Technical Field

[0001] The present invention relates to membranes and packages for gas or vapor-permeable packaging applications and a method of manufacturing a purification package using the membranes and packages. These membranes are particularly suitable for sterile storage and transportation for medical, pharmaceutical or cosmetic uses, and are particularly suitable for primary packaging tools for sterile drugs, such as vials, ampoules, syringes or cartridges. Background Art

[0002] When manufacturing packages for sterile storage and transportation of objects, a basic requirement is that the package is sterilizable and capable of maintaining a sterile atmosphere inside the package. In particular, for primary packaging tools for sterile drugs such as vials, ampoules, syringes or cartridges, typical packages for transporting the primary packaging tools for drugs from the manufacturer to the pharmaceutical company using the primary packaging tools include a tub or tray containing a plurality of primary packaging tools, the tub or tray being sealed with a non-woven fabric and then enclosed in one or two bags. The non-woven fabric is usually a spunbonded fibrillation structure of flash-spun filaments made of high-density polyethylene (well-known as ) under the DuPont brand, or a spunbonded ultra-long filament non-woven fabric. After the package is sealed, these selectively permeable non-woven fabrics allow sterilization by means of gases or vapors (such as ethylene oxide, steam or hydrogen peroxide). Therefore, at least one wall of the outer closed bag also comprises or consists of such non-woven fabric. While the selectively permeable non-woven fabric is permeable to sterilizing gases or vapors, it is substantially impermeable to microorganisms, thus forming a microbial barrier. Microorganisms are trapped in the non-woven filament structure. Depending on the type and density of the non-woven fabric, different sterilization assurance levels can be achieved, but there will always be a certain amount of microorganisms passing through. Therefore, these non-woven fabrics should only be called substantially impermeable to microorganisms.

[0003] At the pharmaceutical company, under controlled sterilization conditions, the sterilized primary packaging tools are opened and filled. This involves so-called disinfection and / or purification steps when transitioning from a higher-level clean room to a lower-level clean room. For example, these steps can be biological purification using an electron beam, hydrogen peroxide or wiping with an alcohol solution. Before transferring the tub or tray to the sterile area, a further purification step is carried out, in which or other non-woven sealing films are removed, and the active pharmaceutical ingredient is filled into the primary packaging tools. This is necessary because the sterility of the outside of the tub or tray cannot be guaranteed.

[0004] In the context of the present application, decontamination is defined as the general term for reducing the amount of microorganisms and biological agents such as fungi, bacteria, viruses, spore forms, prions, single-celled eukaryotes, etc. The difference in the technical terms of disinfection and sterilization lies in the amount of reduction of these microorganisms and biological agents. However, disinfection only reduces the amount of the contaminants, but sterilization effectively kills, inactivates or eliminates all forms of life and other biological agents present, i.e., a 100% reduction. Therefore, disinfection is less effective than sterilization. The required reduction level is determined by the intended application.

[0005] Although the non-woven seal on the bucket or tray has been recognized as a sterilization barrier, the integrity of the package cannot currently be proven without damaging the package. There is a permanent gas exchange through the porous non-woven part of the package between the ambient atmosphere and the atmosphere inside the bag.

[0006] Furthermore, when using a non-woven seal on a tray or bucket, if decontamination is carried out by hydrogen peroxide treatment, there is a risk of residual hydrogen peroxide inside the tray or bucket. This is particularly dangerous in the case of filling sensitive biopharmaceuticals into medical primary packaging tools that tolerate only extremely low traces of hydrogen peroxide. To avoid residual hydrogen peroxide, there has still been no satisfactory solution until now. Sometimes, an airtight film is sealed on the non-woven fabric. However, this brings the risk of enclosing a non-sterile surface between the non-woven fabric and the airtight film, as well as the risk of incomplete sealing. Moreover, these additional steps have to be carried out manually, thus hindering the fully automatic processing of the packaging tool while introducing the packaging tool into the clean room and bringing other contamination risks. Summary of the Invention

[0007] The object of the present invention is to provide a package that overcomes these disadvantages of the prior art. Specifically, one object is to provide a package that allows for non-destructive integrity inspection. Another object is to provide a package that can avoid hydrogen peroxide contamination of the items in the package when performing the hydrogen peroxide decontamination step.

[0008] In one embodiment, the present invention relates to a film for gas or vapor sterilizable packaging applications, which consists of or at least includes the following in sequence from the outside to the inside of the package:

[0009] a) A first film layer that is substantially impermeable to sterilizing gases or vapors and has a first pattern of needle punching, perforating, and / or cutting;

[0010] b) An adhesive layer that can be activated by energy transfer and covers the entire surface of the underlying layer or is arranged as a pattern, and

[0011] c) A selectively permeable nonwoven layer that is substantially impermeable to microorganisms.

[0012] In the present application, "selectively permeable nonwoven" should be understood as being permeable to gases or vapors, but substantially impermeable to microorganisms and microbial bodies, thereby forming a microbial barrier. In this context, the term "substantially impermeable to microorganisms" refers to a microbial barrier with a log reduction value (LRV) of 2 to 6 as measured according to ASTM F1608-16.

[0013] Typical packaging applications that aim to use the film according to the present invention include being a primary packaging tool for sterilized drugs for items to be packaged, such as vials, ampoules, syringes, or cartridges. These primary packaging tools are usually placed in trays or buckets and then sealed with a lid film according to the present invention. After that, the sealed buckets or trays are further enclosed in one or two bags.

[0014] Another application of the film according to the present invention is these other outer bags that at least partially comprise the film according to the present invention. It is also possible to combine the above two applications and use the film according to the present invention as the lid film for the tray or bucket and the surrounding bags.

[0015] It has been found that instead of sealing an airtight film to the nonwoven area of the packaging to hermetically seal the packaging after purification, sealing by an adhesive (which can be activated by energy transfer) is far more effective than sealing an additional film to these areas because it can be carried out immediately after purification without other manual handling. Specifically, there is no risk of trapping contaminated surfaces inside the packaging. The sealed packaging can be purified through the nonwoven area as usual. Once purification is completed, the adhesive is activated by energy transfer, and the needle-punched, perforated, and / or cut patterns of the sealing film and / or the holes of the nonwoven fabric. After this airtight seal, during the opening of the packaging, the step of purifying the tray or bucket with hydrogen peroxide can be carried out without contaminating the items in the packaging.

[0016] If the film according to the present invention is used as a component of a closed bag, the integrity of the packaging can be safely and nondestructively inspected.

[0017] An adhesive can be selected such that it is permeable to the purification gas or vapor in the non-activated state and becomes impermeable after activation. Then, the adhesive is applied to cover the entire area of the non-woven fabric and / or the membrane layer. However, this reduces the permeability of the non-woven fabric and / or the membrane layer, thus increasing the time required to be exposed to the purification atmosphere. For this reason, more preferably, the adhesive is not applied over the entire area but only applied in a pattern. In either case, the amount of the selected adhesive should be sufficient to reliably seal the needle-punched, perforated, and / or cut patterns of the membrane and / or the holes in the non-woven fabric layer. If the adhesive is applied in a pattern, its type and flow characteristics must also be selected so that it can spread over the entire surface during activation.

[0018] Other aspects relate to the bonding between the membrane and the non-woven fabric layer. To fix the non-woven fabric and the two membrane layers to each other, there are two options. On separate areas (e.g., in a grid shape or small pieces) between the layers, a standard laminating adhesive is applied to achieve bonding, while the remaining part of the surface is treated with an activatable adhesive, or only an activatable adhesive is used, and during the production of the layers, pre-defined composite areas are selectively activated. For example, the selective activation can be carried out by means of a mask, a screen, or a tool.

[0019] In this embodiment where the layer sequence is a)-b)-c), the permeability of the overall package to the sterilization gas or vapor is achieved through the holes in the membrane, which are otherwise impermeable to the sterilization gas or vapor. Before activating the adhesive, the gas or vapor can enter the package through these holes and the porous non-woven fabric. After activating the adhesive, the membrane is bonded to the non-woven fabric layer, sealing the holes and voids. This basically corresponds to the currently applied process of manually sealing an additional membrane layer to the non-woven fabric layer or the outside of the packaging area. However, since the two layers have been combined before purification, the risk of trapping contaminants between the membrane and the non-woven fabric is minimized. Moreover, the activation of the adhesive can be carried out directly in the purification chamber.

[0020] Another embodiment with the layer sequence b)-a)-c) (i.e., the adhesive is located outside the package) is also considered. However, this alternative is less desirable because the adhesive cannot further bond the membrane layer to the non-woven fabric layer, thus closing the path of the sterilization gas within the two permeable layers. And with the external adhesive, it must be ensured that once activated, nothing touches the outside of the package before the adhesive cures.

[0021] In another embodiment, the membrane further includes:

[0022] d) A second membrane layer, which is substantially impermeable to the purification gas or vapor, has a second needle-punched, perforated, and / or cut pattern that does not coincide with the first pattern, and is arranged between the adhesive layer b) and the selectively permeable non-woven fabric layer c).

[0023] In this preferred embodiment with the layer sequence a)-b)-d)-c), an airtight seal of the structure is achieved by activating the adhesive between the two outer membrane layers. The same considerations as in the above-described embodiments apply to the choice of the adhesive and the surfaces it covers. Importantly, the first and second needle-punched, perforated, and / or cut patterns do not coincide. This can be achieved by using two different patterns or by using the same pattern but with a shift in the position of the pattern. Preferably, there is no intersecting pattern between the two layers to avoid a direct linear path from the outside to the inside of the membrane. Patterns that have proven useful for this purpose by themselves are, for example, a labyrinth pattern, a comb pattern, or a stripe pattern with sufficient spacing.

[0024] Regarding the needle-punched, perforated, and / or cut patterns used in the two membrane layers of this embodiment, there are various options for arranging them. As described above, when observed through the combined membrane, it is found that they can be arranged on the entire surface of the membrane in an intermeshing manner. This has the advantage that the travel path of the purifying gas or vapor between the two membrane layers is very short, thus improving the gas permeability of the package. However, the mechanical strength of the membrane layer decreases as the density of the pattern increases. For this variant, it is feasible to cover only a limited area of the membrane, thereby forming a window-like surface that allows the purifying gas and vapor to enter the package only in these predefined areas.

[0025] As an alternative, the needle-punched, perforated, and / or cut patterns can be arranged in separate areas of the combined membrane layer. For example, the pattern can be arranged in the first membrane to cover only the left side area of the package, and the pattern can be arranged in the second membrane to cover only the right side area of the package, while the middle of the package contains no pattern at all.

[0026] This embodiment has different advantages compared to other embodiments. Since an airtight seal of the structure is achieved between the two membranes that do not allow the passage of purifying gas or vapor, the reliability and durability of the seal are better compared to porous non-woven fabrics. Further, especially when using a cut pattern, the surface of the membrane is smoother than the rough non-woven fabric surface. As a result, it is easier to achieve an airtight seal. Finally, the gas exchange rate will be better because by applying the adhesive, there is no need to reduce the porosity of the non-woven fabric as much as in other embodiments. Just applying a sufficient standard laminating adhesive is sufficient to firmly fix the layers together, while in other embodiments, the amount of adhesive must be sufficient to cover the entire surface to achieve the seal.

[0027] In a variant of this embodiment, the first film layer a) and the second film layer d) form a laminated structure or are joined to each other only at their surface portions, in particular at their outer peripheral surface regions. While the films can be fixed on top of each other like laminated films, where gas and vapor permeability can be achieved by an activatable permeable adhesive or a standard laminating adhesive that only partially covers the surface, it is also possible to join the layers only at various parts of their surfaces, leaving most of the layer surfaces unbonded. The latter is preferably achieved by sealing the film layers together around the edges (such as in a sleeve).

[0028] Activation of the adhesive layer by energy transfer can be achieved by heating, UV radiation, IR radiation, induction, and / or microwave radiation. The type of energy transfer is selected to suit the type of adhesive. The adhesive can be, for example, a hot-melt adhesive or a reactive system such as a polyurethane or poly(meth)acrylate adhesive. Reactive systems typically contain additives such as photoinitiators or free-radical initiators and can thus be activated by UV radiation or IR radiation or heating. Systems that can be activated by induction typically contain nanoscale ferromagnetic additives. Heat-sealable adhesives can be, for example, based on ethylene-vinyl acetate copolymers or ionomers.

[0029] In a particularly preferred embodiment, the adhesive is a hot-melt heat-sealable adhesive system that contains additives responsive to energy transfer.

[0030] In one embodiment, the selectively permeable nonwoven fabric is a spunbonded nanofiber film fibril structure or a spunbonded ultra-fine fiber nonwoven fabric. Preferably, in either case, the diameter of the ultra-fine fibers is in the range of 0.5 - 10 μm. An example of such a nonwoven fabric material is The type particularly suitable for this application is 1073B.

[0031] Preferably, the selectively permeable nonwoven fabric is made of high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET).

[0032] In some embodiments, the adhesive can be arranged in a positive dot pattern, negative dot pattern, dotted line pattern, and / or linear pattern that does not coincide with the first and second needling, perforating, and / or cutting patterns. The positive and negative patterns should be understood as the adhesive pattern being composed of the said dots, dotted lines, and / or lines (positive pattern) or the adhesive pattern being composed of the adhesive layer in the entire area not covered by the dots, dotted lines, and / or lines (negative pattern). This allows customization of the relationship between adhesiveness and the ability to seal the permeation structure and the permeability of the nonwoven fabric layer and / or film layer before adhesive activation.

[0033] The patterns can be produced by different methods. Preferably, they are generated by printing techniques such as (rotogravure, offset or screen printing). For linear patterns, coating techniques such as Mayer rod coating or reverse roll coating can also be applied.

[0034] Preferably, the first film layer and / or the second film layer comprises polyethylene, polypropylene, polyamide 6, polyethylene terephthalate or a blend and / or copolymer thereof, or is made therefrom. In particular, polyamide 6 and polyethylene terephthalate films further improve the durability of the packaging and provide an oxygen barrier. In cases where transparency of the packaging is not required, the film can also consist of an aluminum composite film in order to provide an excellent oxygen barrier.

[0035] In an embodiment, the first and / or second stabbing, perforating and / or cutting pattern is selected from a maze pattern, a comb pattern and a stripe pattern. These patterns can be arranged efficiently, with no intersecting holes in the two layers, and when arranged with a suitable offset or negative layout, these patterns have good gas and vapor permeability and can be hermetically sealed very reliably.

[0036] The present invention also relates to a packaging for a sterile packaging of an article for medical, pharmaceutical or cosmetic use, the packaging at least partly comprising a film according to the present invention. Preferably, these articles are primary packaging tools for sterile drugs, such as vials, ampoules, syringes or cartridges.

[0037] In an embodiment, the packaging comprises a bucket or a tray, which optionally comprises a nesting member and is sealed by a film at least partly comprising a film according to the present invention. Preferably, the sealed bucket or tray is further packaged in at least one bag or overwrap at least partly comprising a film according to the present invention.

[0038] In other embodiments, the packaging comprises a bucket or a tray, which optionally comprises a nesting member, and the bucket or tray is enclosed by at least one bag or overwrap at least partly comprising a film according to the present invention.

[0039] The packaging according to the present invention does not have to be made entirely of the film according to the present invention. Similar to the prior art, for example, in the case where one side of a bag is made of a non-woven fabric layer and the other side is made of an impermeable film layer, one side of the packaging according to the present invention can use the film according to the present invention instead of the non-woven fabric layer, while the other side uses a common film layer. Moreover, a window-like structure known in the prior art with only a limited permeable area can also be replicated with the film according to the present invention. The film according to the present invention simply replaces the pure non-woven fabric layer so that the packaging has the ability to be hermetically sealed after sterilization.

[0040] The present invention also relates to a method for manufacturing a sterile packaging according to the present invention, the method comprising the following steps:

[0041] a) Provide a film according to the present invention;

[0042] b) Form a package that includes the film and contains an article for medical, pharmaceutical, or cosmetic use;

[0043] c) Seal the package hermetically by means of sealing and / or an adhesive;

[0044] d) Expose the sealed package to an atmosphere containing a purifying gas and / or vapor, and optionally subsequently purge the purged package with a gas in order to remove the purifying gas and / or vapor; and

[0045] e) Activate the adhesive layer in the film by means of energy transfer to hermetically seal the package.

[0046] The method according to the present invention differs from the prior art in two key points. Instead of the pure non-woven fabric layer used in the prior art, the present invention uses a film according to the present invention to prepare the package. Then, the package is purified in a gas or vapor chamber as usual, and optionally, subsequently purged with a gas to remove the purification medium. For example, when using ethylene oxide for purification, the toxic ethylene oxide is usually purged with nitrogen. Thus, the equipment and workflow can remain unchanged until the purification is completed. Additional purge cycles may be required to reduce ethylene oxide and ethylene chlorohydrin residues. Once the purification is completed, the method according to the present invention adds the step of hermetically sealing the package by activating the adhesive layer.

[0047] Contrary to the prior art, the package produced by the present invention has an airtight seal, and thus there is no gas exchange with the environment. This allows for a non-destructive integrity check of the package by means of laser gas analysis techniques such as, for example, TDLAS (Tunable Diode Laser Absorption Spectroscopy). Without opening the package, TDLAS can detect gas components such as oxygen, which would enter the package if there is a perforation, or TDLAS can measure the gas components inside the package to distinguish them from the defined atmosphere used before sealing it. Even if there is some degree of diffusion through a bag foil film such as LDPE / PET or the like, the flux over time can be calculated based on the material properties. Compared with the inherent diffusion, any difference can be manifested as a significant increase in oxygen concentration. Thus, before introducing each package into a sterile area subsequently, the integrity of each package can be checked and indirectly its sterility can be checked. 2 Moreover, the airtight seal of the package prevents hydrogen peroxide from entering the package during the hydrogen peroxide purification step and contaminating the articles in the package. Thus, there is no risk of, for example, the biopharmaceuticals filled in vials or syringes deteriorating during transportation within the package.

[0048]

[0049] ​In one embodiment, the method further includes a step between step d) and step e):

[0050] f) exposing the sanitized package to an atmosphere containing a protective gas.

[0051] This further step has two benefits. In addition to forming a protective atmosphere within the package, it also simplifies the detection of package integrity. By purging the package and creating a well-defined atmosphere within the package, the integrity check can be simplified to a measurement of the gas composition or even a single component of the gas within the package. If there is a perforation in the package, the gas composition will change, and this change can be detected very precisely. For example, the presence of oxygen can be effectively detected by means of TDLAS. Thus, detecting the presence of oxygen can indicate that the package has lost its integrity without having to open the package. Preferably, the protective gas is selected from nitrogen and argon, which can be used alone or as a predetermined mixture. Description of the Drawings

[0052] Figure 1 is a cross-sectional view of an embodiment before activation of the adhesive layer.

[0053] Figure 2 is after activation of the adhesive layer Figure 1 of the cross-sectional view of the embodiment. Detailed Description

[0054] Examples

[0055] Typical packages for vials were prepared according to examples of different embodiments of the membranes of the present invention presented below. The vials were placed in a bucket with a nesting piece that had been sealed with the corresponding membrane of the example. Thereafter, the sealed bucket was continuously wrapped in two identical bags that had been sealed, one side of each bag consisting of the corresponding membrane of the example and the other side consisting of a high-density polyethylene membrane. The bagged bucket could be sterilized by exposure to ethylene oxide for 6 hours at a temperature of 45 - 60 °C in a vacuum chamber. After sterilization, the chamber was purged with nitrogen, and as a final step, the package was exposed to an atmosphere of a mixture of nitrogen and argon. Thereafter, the adhesive was activated to hermetically seal the sterilized package. An integrity check was performed by measuring the oxygen content within the package using TDLAS.

[0056] Example 1

[0057] The spunbonded ultra-long and thin filament non-woven fabric of polypropylene was laminated layer by layer onto a polypropylene film. Through needling, holes were provided in the polypropylene film. By offset printing, first a linear pattern of an adhesive in the form of a hot-melt methacrylate resin was coated onto the film, and then a thick rectangular grid of a polyurethane laminating adhesive containing a UV photoinitiator was coated. Then, the two layers were laminated under UV irradiation. To activate the adhesive, the package was irradiated with an IR lamp to heat it so as to melt the hot-melt adhesive.

[0058] Example 2

[0059] The structure of Example 2 is shown in Figure 1 in the unactivated state. The innermost layer is the non-woven fabric layer 1. By means of a standard laminating adhesive (not shown in the figure), this layer of the non-woven fabric 1 was bonded to the second layer, and this second film layer 4 is impermeable to sterilizing gas or vapor. The third layer is the activatable adhesive layer 2. The outermost layer is the first film layer 3, which is also impermeable to sterilizing gas or vapor.

[0060] To prepare this film, the first film layer 3 and the second film layer 4 were provided with incisions in a comb-like pattern as indicated by the holes 5 Figure 1 . In the finished film, these patterns of the two layers were arranged such that the combs meshed with each other. Thus, there is no path for the sterilizing agent to directly enter the package. In this way, the sterilizing agent has to follow a double-bent path as shown in Figure 1 . And the holes 5 always face the uncut film areas, which can seal the holes 5 once the activatable adhesive 2 has been activated, thus achieving an airtight seal of the package. This situation after the adhesive is activated is shown in Figure 2 .

[0061] By gravure printing, a hot-melt adhesive based on ethylene-vinyl acetate was coated in a thick dot pattern on the first surface of the first film layer 3 made of high-density polyethylene. Then, in a standard laminating process, the non-woven fabric layer 1073B was bonded to the first film layer 3 using heat. Thereafter, in a direction perpendicular to the linear pattern of the comb-like cutting pattern, the second surface of the first film layer 3 was gravure printed with an activatable adhesive 2 in the form of a reactive polyurethane resin containing a UV photoinitiator. Using a solvent-based standard laminating adhesive, a grid pattern was gravure printed on the second film layer 4 (which can also be made of high-density polyethylene), and the grid pattern has dimensions such that it matches and surrounds the comb-like cutting pattern. Then, using a standard wet laminating process, the second film layer 4 was laminated onto the first film layer 3.

[0062] Therefore, to activate the adhesive, the package has been irradiated with a UV lamp.

[0063] Alternatively, using the same structure, the film can also be made of a spunbonded ultra-fine polypropylene non-woven fabric layer and two polypropylene film layers.

[0064] List of Reference Numerals

[0065] 1 Non-woven fabric;

[0066] 2 Activable adhesive;

[0067] 3 First film layer;

[0068] 4 Second film layer;

[0069] 5 Hole.

Claims

1. A membrane for use in a gas-purifiable packaging application, said membrane consisting of or at least comprising, in order from the outside to the inside of the packaging: Layer a) A first membrane layer (3) that is substantially impermeable to the purifying gas and has a first pattern that includes a first needle-punched pattern, a first perforated pattern, and / or a first cut pattern. Layer b) An adhesive (2) layer that can be activated by energy transfer, said adhesive (2) layer covering the entire surface of the underlying layer or being arranged as a pattern. Layer c) A selectively permeable nonwoven fabric (1) layer that is substantially impermeable to microorganisms.

2. The membrane according to claim 1, further comprising: Layer d) A second membrane layer (4) that is substantially impermeable to the purifying gas and has a second pattern that is inconsistent with the first pattern, said second pattern including a second needle-punched pattern, a second perforated pattern, and / or a second cut pattern, and being arranged between the adhesive (2) layer b) and the selectively permeable nonwoven fabric (1) layer c).

3. The membrane according to claim 2, wherein, Layers a) and d) form a laminated structure.

4. The membrane according to claim 2, wherein, Layers a) and d) are joined to each other only at the surface portions of layers a) and d).

5. The membrane according to claim 4, wherein, Layers a) and d) are joined to each other at the outer peripheral surface regions of layers a) and d).

6. The membrane according to any one of claims 1-5, wherein, Activating the adhesive (2) layer by energy transfer can be achieved by UV radiation, IR radiation, induction, and / or microwave radiation.

7. The membrane according to any one of claims 1-5, wherein, The adhesive (2) is a hot-melt heat-sealable adhesive system that contains additives responsive to the energy transfer.

8. The membrane according to any one of claims 1-5, wherein, The adhesive is a hot-melt adhesive or a reactive system.

9. The membrane according to claim 8, wherein, The adhesive is a polyurethane or poly(meth)acrylate adhesive.

10. The membrane according to any one of claims 2-5, wherein, The first pattern and / or the second pattern are arranged on the entire surface of the membrane or in separate regions of the membrane.

11. The membrane according to any one of claims 1-5, wherein, The selectively permeable nonwoven fabric (1) is a spunbonded nanofiber film fibril structure or a spunbonded superfine fiber nonwoven fabric.

12. The membrane according to claim 11, wherein, In either case, the diameter of the superfine fibers is in the range of 0.5 - 10 μm.

13. The membrane according to any one of claims 1-5, wherein, The selectively permeable nonwoven fabric (1) is made of high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET).

14. The membrane according to any one of claims 2-5, wherein, The adhesive (2) is arranged as a positive dot pattern or a negative dot pattern and / or a linear pattern that does not coincide with the first pattern of the first film layer (3) and / or the second pattern of the second film layer (4), where the positive dot pattern means that the adhesive pattern consists of dots and / or lines, and the negative dot pattern means that the adhesive pattern consists of an adhesive layer in the entire area not covered by dots and / or lines.

15. The film according to claim 14, wherein, the linear pattern includes a dotted line pattern.

16. The film according to any one of claims 2 - 5, wherein, the first film layer (3) and / or the second film layer (4) is made of or comprises polyethylene, polypropylene, polyamide 6, polyethylene terephthalate or a blend and / or copolymer thereof.

17. The film according to any one of claims 2 - 5, wherein, the first pattern and / or the second pattern is selected from a labyrinth pattern, a comb pattern and a stripe pattern.

18. The film according to claim 14, wherein, the lines include dotted lines.

19. The film according to any one of claims 1 - 5, wherein, activation of the adhesive (2) layer by energy transfer can be achieved by heating.

20. The film according to any one of claims 1 - 5, wherein, the gas is vapor.

21. A package for the purification packaging of an article for medical, pharmaceutical or cosmetic use, the package at least partially comprising the film according to any one of claims 1 to 20.

22. The package according to claim 21, which comprises a vial, an ampoule, a syringe or a cartridge.

23. The package according to claim 21 or 22, which comprises a drum or a tray, the drum or the tray being sealed with a film that at least partially comprises the film according to any one of claims 1 to 20.

24. The package according to claim 23, wherein the sealed drum or tray is further enclosed by at least one bag, the at least one bag at least partially comprising the film according to any one of claims 1 to 20.

25. The package according to claim 24, wherein the bag comprises an overwrap.

26. The package according to claim 21 or 22, which comprises a drum or a tray, the drum or the tray being enclosed by at least one bag, the at least one bag at least partially comprising the film according to any one of claims 1 to 20.

27. The package according to claim 26, wherein the bag comprises an overwrap.

28. The package according to claim 21 or 22, which comprises a drum, the drum comprising a nesting member.

29. A method for manufacturing a package according to any one of claims 21 to 28, the method comprises the following steps: a) providing the film according to any one of claims 1 to 20, b) forming a package that comprises the film and contains an article for medical, pharmaceutical or cosmetic use, c) sealing and / or closing the package with an adhesive, d) exposing the sealed package to an atmosphere containing a purifying gas, e) activating an adhesive layer in the membrane by energy transfer to hermetically seal the package.

30. The method according to claim 29, wherein in step d), the sealed package is exposed to an atmosphere containing a purifying gas and subsequently the purged package is purged with a gas to remove the purifying gas.

31. The method according to claim 29 or 30, further comprising a step between step d) and step e): f) exposing the purged package to an atmosphere containing a protective gas.

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