Non-reclosable package for products that are hazardous to health

Description

[0001] The invention relates to non-resealable packaging for health hazardous products, in particular for pharmaceutical products. Furthermore, the invention relates to a method of making such packages and to packaging products with such packages.

[0002] Packaging of potentially hazardous products must meet increased protection requirements in order to prevent removal of these products or misuse by unauthorized persons, especially in the case of packaging of medicaments, appropriate measures must be provided so that the child cannot remove the product from packaging. For this purpose, various types of child-proof packaging have been developed and internationally valid, standardized test methods have been introduced to control such child-proofing (DIN EN 862 for non-resealable packaging for non-pharmaceutical products; DIN EN 14375 for non-resealable products). reseal pharmaceutical packaging).

[0003] However, the childproof lock must not lead to persons authorized to open the package for its intended purpose having extreme difficulties in opening it. A child-resistant package of the drug must be designed such that, for example, also elderly people are able to open the package on their own within a few minutes. Such a packaging is for example disclosed in DE 20 2004 003781 Ul.

[0004] For the packages of the present invention, these are non-reclosable packages with at least one releasable connection (e.g. a heat seal). The package is opened such that one or more of the detachable connections are torn manually, without the use of auxiliaries or tools, and the packed product can be taken out through the opening that is created.

[0005] The object of the present invention was to provide a package of the above-described type which is suitable for products potentially hazardous to health and which in particular is childproof, and allows the package to be easily handled as intended.

[0006] This object is achieved with a package according to claim 1, the use of such a package according to claim 15 and a method of production and packaging according to claim 16, and the embodiments described in the dependent claims.

[0007] According to claim 1, the non-reclosable package according to the invention for health hazardous products, in particular pharmaceutical products, has a first packaging material element and a second packaging material element, both overlapping. In addition, the package has at least one first surface area, on the rim or the edges of which the two packaging material elements are detachably connected to each other, wherein at least one empty space for receiving the packaged product is formed between these packaging material elements. . Furthermore, the package has at least one second surface area that is arranged external to or adjacent to the first surface area, and at a periphery or periphery both of the packaging material elements are releasably connected to each other. At least one of the two packaging material elements is provided with at least one structure which extends within the second surface area (12) and which allows the packaging material element (s) to be torn.

[0008] The package is generally opened such that one or both of the packaging material elements tears within the second surface area under the pressure of a finger, starting with said structure. Thus, there are two edges of the packaging material elements that are easy to grip or serve as gripping wings to separate the joints between the two packaging material elements. Then the joints in the first surface area are also separated, which allows access to the void containing the product to be packaged.

[0009] With these features, it is possible to shape the package such that it can be opened in defined successive at least four steps:

(i) folding or folding the package along a single line such that said structure is available for opening the package;

(ii) tearing the package at a location of said structure and continuing to tear along the structure;

(iii) catching the released edges of the elements of the packaging material as auxiliary elements (flaps) to facilitate its opening;

(iv) stretching and detachment of connections between elements of packaging material.

These manipulations are very difficult for children, especially young children, but an adult can easily open the package without the help of tools.

[0010] In general, the materials used to manufacture the packaging material elements must have a tear strength that is sufficiently high that the undamaged packaging cannot be damaged without the use of auxiliary means, e.g. tools. Suitable materials for this are known to those skilled in the art; for example, flexible materials in the form of plastic films, metal (e.g. aluminum) or composite materials made of the mentioned materials can be used. Single films as well as double or multi-layer laminates can be used as film materials. Suitable plastic materials are, in particular, individually or in combination: polyesters (e.g. polyethylene terephthalate), polyethylene (e.g. HDPE, LDPE), polypropylene, polyisobutylene, polystyrene, polyvinyl chloride, polyamides, polycarbonate, cellulose acetate. The film materials are preferably 5 to 300 µm thick, particularly preferably 50 to 200 µm.

[0011] Another preferred film material is Barex® (BP Chemicals), a copolymer of acrylonitrile and butadiene. Barex can be obtained by graft polymerization of 73-77 parts of acrylonitrile and 23-27 parts of methyl acrylate in the presence of 8-18 parts of acrylonitrile-butadiene copolymer, which contains about 70% butadiene. Barex is the heat-sealable part of the composite packaging material. It is a material with very high chemical resistance and it is a barrier to oxygen, but shows a certain permeability to water vapor.

Due to its very good barrier properties and chemical resistance, it is particularly suitable for the packaging of drugs containing aggressive and / or volatile active substances, for example nicotine.

[0012] The two packaging material elements may be made of the same or different materials. Preferably, at least one of the packaging material elements is made of a transparent material (e.g. transparent plastic film). Moreover, the invention includes embodiments in which one or both of the packaging material elements have the same or different colors, which may be a transparent or opaque color.

For example, one of the two packaging material components may be made of an opaque composite of paper (or cardboard) with plastics (e.g. polyethylene or polyethylene terephthalate coated paper) and the other packaging material component may be transparent, colorless or colored plastic film. In order to reduce the air, light and water vapor transmission, it is advantageous if at least one surface of the support layer and / or the top layer is metallized (e.g. coated with aluminum).

[0014] Said detachable connections are preferably formed by welding seams or welding surfaces. As sealing agents, it is possible to use, in particular, peel-off foil varnishes (Peel-Lack) or hot melt adhesives. Suitable sealing compounds and sealing methods are known to the person skilled in the art, e.g. sands based on polyethylene-LD or ethylene-vinyl acetate copolymers. Hot welding methods as well as cold welding methods can be used. Preferably, the peelable bond is formed by heat welding at a temperature in the range of 50 ° C to 250 ° C, using hot melt materials.

The weld seams or sealing surfaces preferably have a width of 0.1 mm to 10 cm, in particular 1 mm to 2 cm, and preferably extend over the entire length or width of the packaging material elements. In order to make it even more difficult to open the package, at least one of the weld seams may be wider than the other seams.

The weld joints or surfaces to be welded preferably have a strength (seal strength) in the range from 1 N / 15 mm to 50 N / 15 mm, preferably 2 N / 15 mm to 20 N / 15 mm.

[0016] Said structure, which enables the tearing of the packaging material element (s), may be provided on one or two packaging material elements, the latter embodiment being preferred. In this case, the structure (s) on both packaging material elements is / are preferably shaped in the same or similar shape and are arranged to coincide with each other.

Suitable structures for tearing the packaging material element (s) are preferably: a straight incision; zigzag or wavy incision; perforations, in particular perforations from staggered points and / or cuts; material recesses; blanks, in particular arrow, triangular or diamond blanks; required breaking point.

Preferably, said structure (s) is / are located within said second surface area at the periphery, i.e. close to the junction of the two packaging material elements (e.g. a weld seam or a sealed surface). ), but not within this periphery. However, the invention also covers other embodiments, in which said structure sometimes extends as far as the sealed rim, but in no case extends to the outer edge of the package.

[0019] In order to facilitate said folding or bending of the package, it is preferably provided with a fold or fold line, made, for example, by boring or folding. Methods useful for this are known to those skilled in the art.

[0020] Said structure, or at least one of these structures, is preferably arranged such that, starting from the inside of the second packaging material element, it intersects the bevel or fold line, for example obliquely or at right angles, such that the structure runs along a slope. both sides of the kink or fold line. However, the tear structure should reach and contact at least this kink or fold line. By giving this structure the form described above, the opening of the package can be greatly facilitated without compromising the childproofing of the package.

This is especially important for older people who need to be able to open the package in a short time without the use of tools or other aids and without frustrating attempts.

[0021] In a further embodiment it is provided that at least the first packaging material element is formed of a single or multi-layer film and that this packaging material element is formed with one or more of the structures mentioned. The second packaging material element which is detachably connected to this foil can in this case be formed of another material (e.g. as a plastic molding).

[0022] According to an advantageous embodiment, the package according to the invention is in the form of an all round, preferably flat bag.

[0023] Furthermore, it is advantageous that the two packaging material elements are connected along its entire outer edge by a continuous weld layer or a weld seam.

[0024] In a further embodiment it is provided that the second packaging material element is formed as an open container, an open hollow element, in particular a bottle, or a deep drawn molding, depending on the shape and size of the product to be packaged. Again, the second packaging material element has a second surface area as described above. In particular, a thermoformable blister foil may be used as the second component of packaging material; such films are known to the person skilled in the art (e.g. hard PVC films, cellulose ester films or oriented polystyrene films; in each case with a thickness of 50 to 2000 µm, particularly preferably 100 to 1000 µm).

[0025] The primary surface of the packages may vary in size and shape depending on the size and shape of the packaged product; rectangular or square shape is preferred. The package can also have a round, elliptical or irregular shape. Preferably, the edges of the package are detachably connected to each other on at least two, in particular at least three, edges.

Moreover, both of the said packaging material elements may be of the same or different size. The void space for receiving the packaged product may be divided into several compartments; also each package may have two or more voids for receiving the product to be packaged.

According to a further embodiment, the two packaging material elements are made of the same material. For example, both of these packaging material elements can be made of transparent or opaque materials.

[0027] A further embodiment provides that the two packaging material elements are made of different materials. For example, one of the elements may be of a transparent material and the other of an opaque material.

Preferably, at least one of the two packaging material elements, preferably the first packaging material element, has a high tear strength and at the same time a low resistance to further tearing. In this way, good protection against unauthorized opening is achieved and the handling is easier when opening the package for its intended purpose.

[0029] In order to allow or facilitate further tearing of said structure, the tear strength is advantageously many times greater than the tear strength further. Preferably, the ratio of the tear strength to the tear strength is from 2 to 200, in particular from 50 to 150. The indicated values ​​relate to the strength of the two packaging material elements joined together.

[0030] The tearing strength and the further tearing strength can be determined with the aid of known tearers (e.g. available from FRANK Priifgerate GmbH, D69488 Birkenau). For example, during such measurements, a tear strength of 70 N and a further tear strength of 0.5 N were found; otherwise, values ​​of 95 N and 1.5 N, respectively, were obtained, measured in each case on the two pieces of packaging material connected to one another. Measurements were made on a FRANK tear tester using a tear test specimen holder (type no. 00740).

[0031] On the other hand, care must be taken that the tear strength is not too low, since then sufficient protection of the packaged product cannot be ensured and the said auxiliary handles may become detached when the package is opened. This can be determined by simple trials.

[0032] The materials having the mentioned properties (tear strength, tear strength) are known to the person skilled in the art; polyester films are especially useful.

Packaging materials, in particular plastic films, which have different tear resistance in their longitudinal direction or also in the transverse direction, are particularly preferred. Said structures which allow tearing and further tearing of the packaging material element (s) are preferably arranged along the direction of the film in which the resistance to further tearing is lowest. The tearing and further tearing aids can also be positioned in a direction other than that described above, depending on the desired form of the packaging and the confectioning device.

[0034] In particular, plastic films which have been stretched in one direction only or which have been stretched more strongly in the longitudinal direction than in the transverse direction or vice versa can be used for this purpose. The films so treated are known to those skilled in the art, for example polyester films, polystyrene, polyamide, polyethylene or polycarbonate films. In this way, the tearing of the packaging material as intended is facilitated without compromising the mechanical durability of the gripping wings.

[0035] The packages according to the invention are preferably characterized in that children cannot access the packaged product without using a tool. In a particularly preferred embodiment, the packages are child resistant in accordance with DIN EN 14375 and / or ASTM D3475-03a.

[0036] The package according to the invention may exist as a single package, but it is also possible to associate two or more such packages together so that a tape or card-like packing unit is formed. These interconnected packages can advantageously be in a rolled up or accordion-like form. In this connection, perforation lines can be provided between the individual packages to be joined, which make it possible to separate a single package. For example, about 50 to 500 of such packages may be wound on the winding core in the form of a dosing roll. The interconnected, separable packages each contain one dose of the pharmaceutical active ingredient, and each package has the features of a child resistant package as described above.

[0037] Moreover, two or more individual packages may be connected to each other in a radially symmetrical arrangement, whereby a roller-type package unit is formed from which the individual packages can be separated in succession. Again, each of the interconnected, separable packages contains a single dose of active ingredient, and each package has the features of the child resistant package described above.

Preferably, the packing units described above are used together with dispensers therefor which allow or facilitate the separation and removal of individual packages.

[0039] Furthermore, the invention includes the use of the above-described packages for packaging pharmaceutical or cosmetic preparations or items or substances hazardous to health, preferably for packing said preparations or objects in a manner not accessible to children.

The inventive method for producing a package and for packaging items comprises the following steps:

- providing a first element of packaging material;

- providing a second element of packaging material;

- placing the packaged product on one of the two pieces of packaging material;

- overlapping and joining the two packaging material elements in such a way that at least one first surface area is formed, on the periphery or edges of which the two packaging material elements are detachably joined together, and between two packaging material elements creating a void which is closed on all sides to receive the packaged product, and in such a way that at least one second surface area is formed, which is located external to or adjacent to the first surface region, and at the rim or the edges the two packaging material elements are releasably connected to each other;

- arranging at least one structure on at least one of the two packaging material elements, the structure extending within the second surface area (12) and allowing the packaging material element (s) to be torn.

[0040] It is not necessary to carry out these steps in the above-indicated order; for example, the structure may already be placed after the first or second step mentioned above.

Nor is it necessary that the first packaging material element and the second packaging material element are formed of different webs of packaging material. For example, by breaking a single web of material, two packaging material elements can be provided between which the product to be packaged can be placed.

[0041] Preferred embodiments of the package according to the invention are three edge seal bags and four heat seal bags.

Features, details and advantages of the invention are explained below on the basis of exemplary embodiments shown schematically in the drawing.

FIG. 1 shows a package according to the invention in a top view,

FIG. 2 shows a sectional view in plane (a) of Fig. 1,

FIG. 3 as in fig. 2, but in a different embodiment,

FIG. 4 is a sectional view in plane (b) of Fig. 1,

FIG. 5 as in fig. 4, but in a different embodiment,

FIG. 6 is a sectional view in plane (c) of Fig. 1,

FIG. 7 as Fig. 6, but in a different embodiment,

FIG. 8 as Fig. 1; shows the packaging when torn,

Fig. 9 as Fig. 8; shows the packaging when tearing open (continuation of opening),

Fig. 10 shows a further embodiment of the package according to the invention, in top view,

FIG. 11 shows various exemplary tearing structures in a top view of FIG. 12 shows a further embodiment of the package according to the invention, in a top view,

FIG. 13 shows a further embodiment of the package according to the invention, in a top view,

FIG. 14 shows a variant of the embodiment shown in Fig. 13.

[0043] FIG. 1 shows a package (10) which, as seen in sectional views in FIG. 2 to 7 - is formed by a first element (1) of packaging material and a second member (2) of packaging material. The package has a first surface area (11) at the rim of which (21) the two packaging material elements (1, 2) are detachably connected to each other; see also FIG. 7. Within this first surface area, the superimposed two packaging material elements form a void (4) for receiving the packaged product (5) (see also FIGS. 7 and 8). The package (10) has a second surface area (12) which is outside or adjacent to said first surface area (11), at the rim or rims (22) of which the two elements (1, 2) are detachably connected to each other. packaging material, preferably by a heat seal (see FIGS. 2 to 5). The surface area (12) is simply formed by the projecting packaging material (1, 2) of the first surface area.

There is a web (23) between the first surface area (11) and the second surface area (12) on which the two packaging material elements are also detachably connected to each other. Within the second surface area (12), the package is provided with at least one structure - here in the form of a score - which allows the packaging material element (s) (1, 2) to be torn off.

[0044] The structure (s) may / may be positioned in the direction of the line (a) as seen in FIG. 1; but alternatively, the structure may also be perpendicular, i.e. in the direction of line (d), or be oblique.

[0045] The length and width of the structure (3), as well as its location on the surface of the package, may differ from the example of FIG. 1.

[0046] In FIG. In one embodiment, the package is folded approximately along line (d) to open the package. The structure (3) intersects this line at right angles and runs on both sides of the fold line (d).

[0047] As seen in FIG. 2, the two packaging material elements (1, 2) within the second surface area (12) are connected to each other at their periphery (22). The structure (3) is located on the first packaging material element (1) close to the seal (22).

[0048] FIG. 3 shows an alternative embodiment of the package of FIG. 1, wherein the structure (3) - here in the form of a cut - is provided both on the first packaging material element (1) and on the second packaging material element (2), namely having the same length and position.

[0049] As seen in FIG. 3 and 4, both packaging material elements in this case are of materials of different thickness.

[0050] Fig. 5 shows an alternative embodiment of the package of FIG. 1, wherein the first packaging material element (1) and the second packaging material element (2) are formed of a single web of material, for example a film-like material, the material being folded at a location (24) and releasably connected. on the rim (22), for example by a weld seam.

[0051] FIG. 6 shows a packaged product (5) which is enclosed in a void (4) of the package. The first packaging material element is releasably connected at the edges or seals (21) to the second packaging material element (2).

[0052] FIG. 7 shows an alternative embodiment of the package of FIG. 1, wherein a deep drawn molding is used as the second packaging material element (2). Alternatively, also the first packaging material element (1) may be a deep drawn molding or both of the packaging material elements (1, 2) may be such moldings.

[0053] FIG. 8 and 9 show the intended procedure for opening the package of Fig. 1. The package is first folded along line (d) as indicated by the semicircular arrow. Line (d) runs transversely (i.e., approximately vertical) to the direction of structure (3) (line (a) in FIG. 1), which is cut here on both members (1,2). When the structure (3) runs in a direction other than in FIG. 1, the deflection direction can in any case be chosen such that it runs almost perpendicular to the direction of the structure (3) or oblique to it.

[0054] The folding along line (d) produces an open notch (25) in the cut zone (3). Due to the low resistance to further tearing of the material of the packaging material element (1, 2), the cut (3) may elongate during tearing in the direction of the arrow (e) marked in FIG. 8. Preferably, the tear strength in direction (d) is greater than in the direction of the tear structure (3) or in the direction of line (a) in FIG. 1.

[0055] In this way, the seal (22) in FIG. 2 can be largely or even completely separated. 8 at the top edge of the package. Such a state is shown in FIG. 9. After separating the seam, two free edges of the elements (1, 2) are formed from the packaging material, which can serve as flaps to facilitate opening of the package by stretching in the direction of both arrows. Thus, the two elements (1, 2) can be completely separated from the packaging material, or at least into the area of ​​the packaged product (5), which enables its removal from the packaging.

[0056] FIG. 10 shows a further embodiment of the package according to the invention, in which the packaging material elements (1, 2) are detachably connected to each other by means of a welding (22) within the second surface area (12) along the outer edge. The seam (22) is separated as described above, so that the packaging material elements (1, 2) in the area (12) are no longer connected to each other, but constitute separate gripping flaps by which the elements (1) can be completely separated. 2) from packaging material.

[0057] Fig. 11 shows the structures (3) in the form of perforation (3a) as a series of successive V-shaped blanks (3b) in the form of a diamond-shaped pattern (3c); disposed in each case in the direction of line (a) marked in FIG. 1, and a structure (3) in the form of a cut (3d) or perforation (3e); in each case along the line (d) marked in FIG. 1. For structures (3d, 3e), the package is folded when opened, for example in the direction of the line (a) shown in FIG. 1 (similar to the procedure of FIGS. 8 and 9; see above).

[0058] FIG. 12 shows a variation of the embodiment of FIG. 1, wherein the fold line (d) extends along the outer edge of the second surface area (12) but within the surface area. The tearable structure (3) intersects the line (d) at right angles and extends from the inside of the second surface area (12) to the weld rim (22 '). After folding the package along line (d), the tear structure (3) is accessible and the package can be opened as described in connection with FIG. 8.

[0059] FIG. 13 shows a variation of the embodiment of FIG. The apparatus of claim 1, wherein the web (23) extends into the region of the second surface area (12). As you can see, this tab can have a trapezoidal shape, but it can also be rounded or convex (for example, in the form of a segment of a circle or parabola), or it can have the shape of a triangle. This projection - as can be seen - can be axially symmetrical, but as an alternative, asymmetrical or irregular shapes are also possible.

[0060] As a result, tearing the package, i.e. detaching and stretching of the two packaging material elements (1, 2), is facilitated. The width of the web (23) in the opening direction is initially small and then increases gradually, so that less force is required for tearing than in embodiments where the web has a constant width.

Moreover, by such a design of the web, the overall length of the package can be reduced or the size of the first surface area (11) can be increased, which allows for a larger void space (4) to receive the packaged product (FIG. 14).