Primary packaging for pharmaceutical substances

Abstract

To provide a primary packaging material for a medicinal substance which reduces risks of mixture of particles or bacteria and minimizes manufacturing labor or costs of manufacture.SOLUTION: A primary packaging material includes a hollow body (1) and a closure (2). The hollow body (1) includes cycloolefin polymer or cycloolefin copolymer and has an opening (3). The closure (2) closes the opening (3), includes normal elastomers and / or thermoplastic elastomers, and has a piercing area (4) to be used in order to introduce a cannula in the hollow body (1). In the primary packaging material, the normal elastomers and / or thermoplastic elastomers of the closure (2) are inseparably connected to the hollow body (1) without being broken.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a primary packaging material used for containing a pharmaceutical substance and a method for manufacturing the primary packaging material.

Background Art

[0002] Primary pharmaceutical packaging materials, such as vials and cartridges, are used for the aseptic storage of pharmaceutical substances and, in some cases, may be used directly during subsequent administration. The removal of the pharmaceutical substance is usually carried out via a cannula. For this purpose, the corresponding piercing area provided in the closure of the primary packaging material is pierced. In the case of a vial, the pharmaceutical substance is usually first removed by a syringe, while from a cartridge, the pharmaceutical substance can be directly administered using a suitable injection device. Regardless of the subsequent use, for this type of primary packaging material, a tight closure that guarantees sterility and enables easy removal using a cannula is of utmost importance.

[0003] Primary pharmaceutical packaging, such as vials and cartridges, is conventionally formed as described below according to the prior art. The primary packaging generally consists of a hollow body having a body portion, a shoulder portion, a neck portion, a curled edge portion, and an opening. The hollow body can be manufactured from various different materials, especially glass, cycloolefin polymer, or cycloolefin copolymer. Additionally, in most cases, a closure is attached to the mouth after filling with the pharmaceutical substance. The closure consists of two elements, a septum and a crimp. The septum is conventionally made of rubber and has a piercing area. The crimp is generally made of an aluminum alloy and has a central notch for the piercing area. The closure is manufactured separately from both elements. Suitable closures for primary pharmaceutical packaging are well known in the prior art and are regulated, for example, by ISO 8872:2003. The septum is joined to the hollow body by crimping the edge of the crimp. In this process, the septum is pressed by the crimp, whereby the hollow body is joined to the closure in a form-fitting manner. The connection between the hollow body and the septum can be separated without destruction and without residue by removing the crimp. By re-crimping the crimp on the hollow body, it is possible to reform the connection with the same quality using the same septum.

[0004] The prior art has the following disadvantages. The closure has to be manufactured and assembled separately after manufacturing the hollow body. This requires multiple elements and manufacturing steps to produce the primary packaging, which increases the material consumption, prolongs the manufacturing process, makes it more laborious or costly, and ultimately makes automation difficult. Additionally, using various different elements and manufacturing steps has an adverse effect. On the one hand, it increases the possibility that the primary packaging will be contaminated by particles during individual manufacturing steps. On the other hand, assembling the closure separately poses a risk of bacteria contamination, so the sealing surface of the closure has to be sterilized laboriously or at cost. Furthermore, when crimping the edge of the closure, there is a risk that the primary packaging will not be tightly closed, allowing the contained pharmaceutical substance to leak or bacteria to enter from the outside.

[0005] The conventional method of attaching a closure to a hollow body is also disadvantageous. For the edge bending of the closure, the hollow body necessarily has to have an edge bending edge. The edge bending edge is standardized according to ISO 13926-1:2005-10 for, for example, a coupling. Therefore, changing the shape of the hollow body is either impossible or only possible to a limited extent. This makes it impossible or only possible to a limited extent to change the design of the primary packaging, for example in terms of shape, size adaptation or the addition of shape-coupling elements.

[0006] In the case of a primary packaging suitable for the direct administration of substances in a suitable injection device, such as a coupling in particular, the design limitation in terms of the shape surface leads to an undesirable dead volume in the mouth region. The plunger can only advance up to where the taper starts, and thus the remaining substance cannot be expelled from the primary packaging. A reduction in the dead volume cannot be achieved or can only be achieved to a limited extent based on the above-mentioned constraints on the shape surface. Summary of the Invention Problems to be Solved by the Invention

[0007] The object of the present invention is to overcome the disadvantages of the prior art, in particular to provide a primary packaging for pharmaceutical substances that reduces the risk of particle or bacteria contamination and minimizes the manufacturing effort or manufacturing costs, and to provide a corresponding manufacturing method for the primary packaging. Furthermore, an object of the present invention is to achieve an increased degree of design freedom in terms of the shape and size of the primary packaging. Means for Solving the Problems

[0008] The above problems are solved by the independent claims. Preferred embodiments are described in the dependent claims.

[0009] The primary packaging according to the present invention, preferably pharmaceutical primary packaging, particularly preferably a vial or a cartridge, used for containing a substance, preferably a pharmaceutical product, comprises a hollow body and a closure. The hollow body contains a cycloolefin polymer or a cycloolefin copolymer, has an opening, and the closure closes the opening, contains a normal elastomer and / or a thermoplastic elastomer, and has a piercing area used for introducing a cannula into the hollow body. The normal elastomer and / or the thermoplastic elastomer of the closure is characterized in that it is inseparably bonded to the hollow body without being destroyed.

[0010] The hollow body may be formed in the form of a vial or a cartridge. Vials and cartridges typically form a body, a shoulder, a neck, a curled edge and an opening. The hollow body may have a bottom. The hollow body may contain another material in addition to the cycloolefin polymer or the cycloolefin copolymer. In that case, the cycloolefin polymer or the cycloolefin copolymer may contain additives. Preferably, a dye is used as the additive. Furthermore, the hollow body may be made of another material. A multilayer structure of the hollow body made of various different materials is also possible and is manufactured, for example, by sandwich injection molding. The wall thickness of the hollow body is preferably 0.5 mm to 3 mm, but other wall thicknesses are also possible. The shape of the hollow body is limited only in that it forms an opening.

[0011] Through the opening, the contained substance can be taken out of the hollow body. Additionally, the hollow body may have a second opening, for example, a second opening for filling. Cartridges usually have a second opening. Hereinafter, no further entry into the second opening will be made. The concept of the opening relates to the extraction opening closed by the closure.

[0012] The closure is arranged on the opening. At this time, the closure and the hollow body are firmly and self-supportingly bonded to each other without auxiliary means. A crimped or equivalent mounting device can be omitted.

[0013] A normal elastomer should be understood as a chemically cross-linked polymer that cannot be re-separated from each other without decomposition. A normal elastomer is elastically deformable under tensile and compressive loads, but returns to its initial shape upon unloading. Furthermore, a normal elastomer does not exhibit thermoplastic behavior under heat supply, and thus cannot be manufactured or molded by injection molding.

[0014] A thermoplastic elastomer should be understood as a cross-linked polymer that exhibits elastic deformation behavior equivalent to that of a normal elastomer at room temperature. However, upon heat supply, the thermoplastic elastomer is plastically deformable. This process is reversible and can be repeated by cooling and reheating. Therefore, in the context of this application, a normal elastomer and a thermoplastic elastomer should be distinguished. The thermoplastic elastomer may be, for example, a thermoplastic polyolefin elastomer, such as a cycloolefin polymer elastomer or a cycloolefin copolymer elastomer. This type of thermoplastic elastomer is available under the trade name TOPAS® Elastomer E-140.

[0015] The piercing region corresponds to a part of the total volume of the closure. In this case, the piercing region is preferably arranged in the form of a vertically oriented cylinder at the central position within the closure. More preferably, the transition to the piercing region within the closure is homogeneous and not characterized by a distinct boundary surface.

[0016] The bond between the normal elastomer and / or thermoplastic elastomer of the closure and the cycloolefin polymer or cycloolefin copolymer of the hollow body is inseparable without breaking according to the present invention. "Inseparable without breaking" should be understood to mean that once the hollow body and the closure are separated, it is impossible to re-bond the same closure with the same quality according to the original bond. Further, the closure cannot be separated from the hollow body without residue. When separating, the hollow body and the closure are damaged, so that residues of the material remain on the other component respectively.

[0017] The pharmaceutical product to be contained may be, for example, liquid or solid. Further, for easy administration or other uses as prescribed, it is possible to contain the substance with the active ingredient metered in a predetermined amount.

[0018] The degree of freedom in design on the shaped surfaces of the hollow body and the closure is significantly improved in the primary packaging material according to the present invention. Thereby, flexible and individual use in various different devices and methods is possible. Further, design problems, such as dead volume when taking out the substance, can be eliminated or at least reduced. The primary packaging material according to the present invention can be manufactured by a single method. For this reason, material consumption and manufacturing time can be minimized. Further, by simplifying the manufacturing, contamination or bacterial contamination of the primary packaging material is prevented or at least reduced.

[0019] In a preferred embodiment of the primary packaging material, the normal elastomer and / or thermoplastic elastomer of the closure is bonded to the hollow body in a material-bonded (stoffschluessig) and / or micro-shape-bonded (mikroformschluessig) manner.

[0020] Material bonding should be understood to mean a bond that holds the components to be bonded by interatomic and / or intermolecular forces. Interatomic and intermolecular forces include non-covalent interactions, such as van der Waals interactions. Material bonding is separated only by breaking.

[0021] Microscopic shape coupling means that the constituent members to be coupled should be understood to engage with each other in a microscopic length region. At this time, the constituent members cannot be disengaged even when there is no external or mutual force transmission. The coupling of the constituent members is performed based particularly on the microscopic properties of their surfaces. The surface structure may have pores, increased roughness, or appropriate material irregularities or material structuring. Microscopic shape coupling is separated only by destruction.

[0022] In a preferred embodiment of the primary packaging, the closure tightly, preferably liquid-tightly, particularly preferably air-tightly closes the hollow body, and preferably, the tightness remains after the introduction and withdrawal of the cannula through the puncture region.

[0023] The tight closure prevents substances or bacteria from reaching the inner chamber of the primary packaging. Thereby, contamination of the inner chamber and / or the contained substance is prevented, and the sterility of the primary packaging is guaranteed. Furthermore, the tighter closure prevents the contained substance from leaking out of the inner chamber of the primary packaging and realizes inert storage. The primary packaging retains these properties even after the introduction of the cannula and contains only the substance introduced through the cannula. The tight closure can be manufactured by the application of a material-bonding type and / or microscopic shape-bonding type and / or macro shape-bonding type (makroformschluessig) of a normal elastomer and / or thermoplastic elastomer to the opening of the hollow body.

[0024] In a preferred embodiment of the primary packaging, the hollow body and the closure are shaped such that both are macro shape-bonded to each other.

[0025] Macroscopic shape coupling should be understood as the engagement of the constituent members to be joined with each other in a macroscopic length region. In this case, the constituent members cannot be disengaged even when there is no external or mutual force transmission. The coupling of the constituent members is carried out based particularly on the macroscopic structural features of the constituent members. The constituent members may have notches or ridges that spatially prevent the separation of the coupling between the constituent members. Macroscopic shape coupling may supplement material coupling and / or microscopic shape coupling in order to ensure a sufficient aseptic barrier.

[0026] In a preferred embodiment of the primary packaging, at least a part of the closure is under compressive stress at least in a part of the contact surface between the hollow body and the closure.

[0027] The compressive stress on the closure may be caused as a result of the compression of the closure during the manufacture of the primary packaging. Based on the elastic deformability of the closure, the compressive stress thus occurs at the contact surface between the hollow body and the closure. Thereby, the coupling and the sealing property between the hollow body and the closure can be enhanced.

[0028] In a preferred embodiment of the primary packaging, the closure has a Shore hardness (Shore A) of 20 to 70 in the piercing region, and the load is at most 30 N, preferably at most 20 N, and particularly preferably at most 10 N.

[0029] The Shore hardness is a measure of the hardness of a material. For classical thermoplastic elastomers, the Shore hardness is measured based on the penetration depth of a spring-biased steel pin. The measurement of the Shore A hardness can be carried out with a sample thickness of 4 mm, a holding time of 3 s or 15 s, and a load of 12.5 N based on ISO 868:2003-10.

[0030] In a preferred embodiment of the primary packaging, the hollow body has at least one shape coupling element on the outer surface of the hollow body, which is used to accommodate the primary packaging in a shape-coupled manner in the device.

[0031] The shape - coupling element is particularly important when the primary packaging does not have a classical flange. The shape - coupling element may be arranged on the outer surface of the hollow body in the form of a notch or a protrusion. Preferably, the shape - coupling element is arranged on the body of the hollow body. There may be a single or multiple shape - coupling elements. The shape - coupling element preferably consists of the same material as the hollow body and is preferably coupled to the hollow body in a macro - shape - coupling manner and / or a micro - shape - coupling manner and / or a material - coupling manner or is formed in one piece with the hollow body.

[0032] In a preferred embodiment of the primary packaging, the closure covers at least a part of the outer surface of the hollow body.

[0033] Covering the surface with a closure material can, inter alia, enhance the grip of the primary packaging or strengthen the connection with the device. Depending on the use of the primary packaging, the closure can cover various parts of the outer surface of the hollow body. In this case, it is also possible that the parts of the outer surface of the hollow body are covered by a separate closure material that is not originally bonded to the closure.

[0034] In a preferred embodiment of the primary packaging, the closure has at least one first layer containing a normal elastomer or a thermoplastic elastomer and at least one second layer containing a normal elastomer or a thermoplastic elastomer. At this time, the layers may be bonded in a macro - shape - coupling manner and / or a micro - shape - coupling manner and / or a material - coupling manner.

[0035] Multi-layer closures enable combinations of various materials. In this case, for the various layers, material-specific properties can be advantageously utilized. For example, the layer in contact with the contained substance may consist of a thermoplastic elastomer that is chemically inert to the contained substance. Another adjacent layer may consist of a normal elastomer that ensures enhanced sealing of the primary packaging. For closures consisting of multiple layers, various material combinations and numbers of layers that utilize different advantageous material properties are possible. In addition, by using multiple layers, the material cost can be reduced.

[0036] In a preferred embodiment of the primary packaging, the primary packaging contains a substance, preferably a substance for therapeutic and / or diagnostic purposes, particularly preferably a single-dose substance.

[0037] A substance, such as an active substance or a pharmaceutical, can be placed in the primary packaging. Preferably, a predetermined dose of the active substance or pharmaceutical is placed in the primary packaging. This significantly simplifies dosing or direct administration.

[0038] In another preferred embodiment of the primary packaging, the gap dimension existing between the closure and the hollow body is of molecular size, and preferably, there is no gap.

[0039] A gap between the closure and the hollow body may exist in the case of micro-shaped bonding. However, the gap is limited to the order of individual molecules or atoms depending on the materials of the closure and the hollow body.

[0040] In another preferred embodiment of the primary packaging, the hollow body is formed in accordance with ISO 13926-1:2005-10, and preferably, it is formed with an angle of approximately 30° between the shoulder and the neck, an angle of 10° - 20° between the neck and the flange, and an angle of 8° - 14° between the flange and the opening.

[0041] In another preferred embodiment of the primary packaging material, the closure is formed in accordance with ISO 8872:2003, preferably having a tensile strength of 100 N / mm 2 ~180 N / mm 2 and an elongation at break of at least 80 N / mm 2 is formed.

[0042] In another preferred embodiment of the primary packaging material, the hollow body is formed in accordance with ISO 11040-1:2015(E), preferably having an angle of 35° to 45° between the shoulder and the neck, an angle of 10° to 20° between the neck and the flange, and an angle of 9° to 13° between the flange and the mouth.

[0043] In another preferred embodiment of the primary packaging material, the closure is formed in accordance with ISO 11040-3:2012(E), preferably having a height of 1.3 mm to 1.5 mm or 1.45 mm to 1.95 mm, a diameter of 7.5 mm, and a diameter of the piercing area (8) of 3.0 mm.

[0044] Forming the hollow body and the closure in accordance with the above-mentioned standards includes the advantage that the primary packaging material according to the present invention can be used with existing established devices and methods.

[0045] Furthermore, the present invention is a method for manufacturing a primary packaging material, step a of optionally preparing at least one component selected from a hollow body and at least a part of a closure; step b of manufacturing the remaining components selected from a hollow body and at least a part of a closure by an injection molding method; and a non-detachable connection that closes the opening of the closure and cannot be separated without breaking occurs between the closure and the hollow body, including a method for manufacturing a primary packaging material.

[0046] In a preferred embodiment of the method, in step a, a closure is prepared, in step b, a hollow body is manufactured by injection molding, using a cycloolefin polymer or cycloolefin copolymer, and injection molding is carried out so as to cover the closure, and preferably, the closure and the hollow body are joined in a macro shape joining manner.

[0047] For manufacturing the primary packaging material, it is possible to pre-place a closure manufactured by injection molding or other methods. It is also possible to pre-place a closure composed of a plurality of parts. Preferably, a cycloolefin polymer or cycloolefin copolymer is injection molded so as to cover the pre-placed closure, and at this time, a hollow body is formed.

[0048] In a preferred embodiment of the method, in step a, a hollow body having an opening is prepared, and optionally at least a part of the closure is placed on the opening, and in step b, the closure is completely formed by injection molding with a thermoplastic elastomer, and preferably, the closure and the hollow body are joined in a material joining manner and / or micro shape joining manner.

[0049] For manufacturing the primary packaging material, it is possible to pre-place a hollow body manufactured by injection molding or other methods. Additionally, a first part of the closure, preferably a normal elastomer, may be pre-placed. Preferably, a thermoplastic elastomer is injection molded so as to cover these pre-placed members, and at this time, a second part of the closure is formed. Further, injection molding may be carried out so as to cover the pre-placed hollow body without pre-placing a part of the closure. In this case, preferably, a thermoplastic elastomer is injection molded so as to cover the pre-placed hollow body, and at this time, the entire closure is formed.

[0050] In a preferred embodiment of the method, in step a, at least a part of the closure is optionally provided, and in step b, by multi-component injection molding, a cycloolefin polymer or cycloolefin copolymer is injection molded to produce a hollow body, and a thermoplastic elastomer is injection molded to completely form the closure. Preferably, the closure and the hollow body are joined in a macro shape joining manner and / or a material joining manner and / or a micro shape joining manner.

[0051] Preferably, the entire primary packaging material, that is, the hollow body and the closure, is produced as a whole by multi-component injection molding. During multi-component injection molding, one injection molding member made of two or more different plastics can be produced. By the multi-component injection molding method, different plastics can be injection molded so as to be in contact with each other, and thus it is possible to form a physical bond between the plastics. An injection molding machine for multi-component injection molding usually has two or more injection units and only one clamping unit. Further, a member pre-injection molded or pre-produced by other methods may be inserted so as to perform injection molding to cover this. Various methods of multi-component injection molding are possible. Thus, in particular, a multi-component method with clearly separated components can also be implemented. First, a pre-injection molded body is formed, and then another component is injection molded so as to cover the pre-injection molded body. Various methods, such as transfer technology, rotation technology / slide technology or core-back technology, are possible to provide a space for the second component. The multi-component injection molding method enables low-cost production in one working process using only one mold. Additionally, smaller positional tolerances can be achieved compared to the conventional assembly of single components. Further, the risk of contamination is minimized.

[0052] In a preferred embodiment of the method, at least a part of the closure is placed under compressive stress during or before the injection molding process, and the compressive stress is retained after the cooling of the injection molded material.

[0053] The closure is compressed during injection molding in which injection molding is performed so as to cover this or adhere to this. The compression may be caused by a component member that exerts pressure on the closure. Preferably, the component member that exerts pressure is removed again before the end of injection molding while maintaining the compression stress on the closure.

[0054] In a preferred embodiment of the method, at least a part of the contact surface between the hollow body and the closure is pretreated, preferably by activation, roughening or structuring of at least one surface, preferably both surfaces.

[0055] Activation of the surface can be carried out, among other things, by flame, plasma or corona. Roughening of the surface can be carried out mechanically or chemically. Structuring of the surface can include patterns such as grooves and grids, chemical functionalization or coating. At that time, only the surface of the contact surface of the hollow body or the closure may be pretreated, or both surfaces may be pretreated.

Brief Description of the Drawings

[0056]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5a

Figure 5b

Modes for Carrying Out the Invention

[0057] Figure 1 shows a cross-sectional view of a preferred first embodiment of a primary packaging material according to the present invention. The hollow body (1) has a shape-coupling element (5) extending annularly on its outer surface. The opening (3) of the hollow body (1) is closed by a closure (2). The hollow body (1) and the closure (2) are coupled in a macro shape-coupling manner. The closure (2) engages a notch provided on the inner surface of the hollow body (1) in the region of the mouth (2). The closure (2) has a through volume element forming a piercing region (4) at its central part. The hollow body (1) is made of a cycloolefin polymer or a cycloolefin copolymer, and the closure (2) is made of a normal elastomer or a thermoplastic elastomer. The wall thickness of the hollow body (1) is 0.5 mm to 3 mm. To manufacture the preferred first embodiment, a closure (2) is prepared, and a cycloolefin polymer or a cycloolefin copolymer is injection-molded to cover the closure (2) to form the hollow body (1).

[0058] FIG. 2 shows a cross-sectional view of a preferred second embodiment of the primary packaging material according to the present invention. The hollow body (1) has at least two bent shape coupling elements (5) on its outer surface. The opening (3) of the hollow body (1) is closed by a closure (2). The closure (2) has a lower closure layer (2a) and an upper closure layer (2b). The lower closure layer (2a) is held on the opening (3) in a micro shape coupling manner and a macro shape coupling manner by the upper closure layer (2b). The lower closure layer (2a) may be under an axial compressive stress at the contact surface with the hollow body (1) and the upper closure layer (2b). The upper closure layer (2b) and the hollow body (1) are coupled in a material coupling manner and / or a micro shape coupling manner. The hollow body (1) has a notch on the outer surface in the region of the opening (3) to expand the contact surface with the upper closure layer (2b). The closure (2) has a volume element penetrating the lower closure layer (2a) and the upper closure layer (2b) to form a piercing region (4) at the central part. The hollow body (1) is made of a cycloolefin polymer or a cycloolefin copolymer. The lower closure layer (2a) is made of a normal elastomer, and the upper closure layer (2b) is made of a thermoplastic elastomer. The wall thickness of the hollow body (1) is 0.5 mm to 3 mm. To manufacture the preferred second embodiment, prepare the lower closure layer (2a), and by multi-component injection molding, inject a cycloolefin polymer or a cycloolefin copolymer to form the hollow body (1), and inject a thermoplastic elastomer to form the upper closure layer (2b). Alternatively, to manufacture the preferred second embodiment, prepare a hollow body (1) having an opening (3), prepare the lower closure layer (2a) and place it on the opening (3), and form the upper closure layer (2b) by injection molding with a thermoplastic elastomer.

[0059] Figure 3 shows a cross-sectional view of a preferred third embodiment of the primary packaging material according to the present invention. The hollow body (1) has a body portion (6), a shoulder portion (7), a neck portion (8), and a curled edge portion (9). The opening (3) of the hollow body (1) is closed by a closure (2). The hollow body (1) and the closure (2) are joined by a material bonding method and / or a micro-shape bonding method. The closure (2) has a penetrating volume element that forms a piercing region (4) in the central portion. The hollow body (1) is made of a cycloolefin polymer or a cycloolefin copolymer, and the closure (2) is made of a thermoplastic elastomer. The wall thickness of the hollow body (1) is 0.5 mm to 3 mm. To manufacture the preferred third embodiment, in multi-component injection molding, a cycloolefin polymer or a cycloolefin copolymer is injection molded to manufacture the hollow body (1), and a thermoplastic elastomer is injection molded to form the closure (2).

[0060] Figure 4 shows a cross-sectional view of a preferred fourth embodiment of the primary packaging material according to the present invention. The hollow body (1) has a body portion (6), a shoulder portion (7), a neck portion (8), and a curled edge portion (9). The opening (3) of the hollow body (1) is closed by a closure (2). The hollow body (1) and the closure (2) are joined by a material bonding method and / or a micro-shape bonding method. The closure has a lateral closure layer (2c), and the lateral closure layer (2c) covers at least a part of the curled edge portion (9). The lateral closure layer (2c) enhances the gripability of the primary packaging material. The closure (2) has a penetrating volume element that forms a piercing region (4) in the central portion. The hollow body (1) is made of a cycloolefin polymer or a cycloolefin copolymer, and the closure (2) and the lateral closure layer (2c) are made of a thermoplastic elastomer. The wall thickness of the hollow body (1) is 0.5 mm to 3 mm. To manufacture the preferred fourth embodiment, a hollow body (1) having an opening (3) is prepared, and the closure (2) and the lateral closure layer (2c) are formed by injection molding with a thermoplastic elastomer.

[0061] Figures 5a and 5b each show a schematic view of a closure (2). The piercing region (4) is formed as a partial volume of the closure (2). The piercing region (4) reaches from the upper surface to the lower surface of the closure (2). This enables the introduction of a cannula into the hollow body of the primary packaging material. The closure may be formed in various different ways. The shapes exemplarily shown by Figures 5a and 5b should not be construed as limiting. Rather, the shape depends on the properties and formation of the hollow body in the region of the opening. The same applies to the piercing region (4). The piercing region (4) may be formed in various different geometric shapes. Preferably, the piercing region shows a homogeneous transition to the remaining part of the closure (2) and has no distinct boundary surface.

[0062] The primary packaging material according to the present invention is fundamentally different from the conventionally used primary packaging material comprising a closure consisting of a septum and an aluminum crimp. Based on the connection according to the present invention between the hollow body and the closure, the shape of the hollow body can be freely adapted to the corresponding application. Thus, for example, the dead volume in the region of the opening of the cannula and the losses resulting from the dead volume during the extraction of the contained substance can be eliminated or at least minimized.

[0063] Furthermore, the complexity and effort in the manufacture of the primary packaging material according to the present invention are lower compared to the conventionally used primary packaging material. The number of required components is less, and the primary packaging material according to the present invention can be manufactured by injection molding in one process. By manufacturing in one process step, the risk of foreign matter or bacteria getting mixed in can be eliminated or at least reduced. Thereby, the manufacturing costs can generally be reduced.

Explanation of Reference Numerals

[0064] 1 Hollow body 2 Closure 2a Lower closure layer 2b Upper closure layer 2c Lateral closure layer 3 Opening 4 Thrust-through area 5 Shape coupling element 6 Trunk 7 Shoulder 8 Head 9 Edge bending edge

Claims

1. A primary packaging material used for containing a substance, wherein the primary packaging material comprises a hollow body (1), a closure (2), and is provided with the hollow body (1) contains a cycloolefin polymer or a cycloolefin copolymer and has an opening (3), in the primary packaging material where the closure (2) closes the opening (3), contains a thermoplastic elastomer, and has a piercing region (4) used for introducing a cannula into the hollow body (1), the thermoplastic elastomer of the closure (2) is inseparably bonded to the hollow body (1) without being destroyed, the piercing region (4) reaches from the upper surface to the lower surface of the closure (2), the closure (2) has at least one lower first layer (2a) containing a thermoplastic elastomer and at least one upper second layer (2b) containing a thermoplastic elastomer, the upper second layer (2b) and the hollow body (1) are bonded by material bonding and / or micro shape bonding, A primary packaging material characterized by the above.

2. The thermoplastic elastomer of the closure (2) is bonded to the hollow body (1) by material bonding and / or micro shape bonding. The primary packaging material according to Claim 1.

3. The closure (2) tightly closes the hollow body (1), and the tightness remains after the introduction of the cannula through the piercing region (4). The primary packaging material according to Claim 1 or 2.

4. The hollow body (1) and the closure (2) are molded such that they are macro shape bonded to each other. The primary packaging material according to any one of Claims 1 to 3.

5. At least a part of the closure (2) is under compressive stress at least in a part of the contact surface between the hollow body (1) and the closure (2). The primary packaging material according to any one of Claims 1 to 4.

6. The closure has a Shore hardness (Shore A) of 20 to 70 in the piercing region (4). The primary packaging material according to any one of Claims 1 to 5.

7. The hollow body (1) has at least one shape bonding element (5) on the outer surface of the hollow body (1) used for shape bonding and containing the primary packaging material in a device. The primary packaging material according to any one of Claims 1 to 6.

8. The closure (2) covers at least a part of the outer surface of the hollow body (1). The primary packaging material according to any one of claims 1 to 7.

9. The primary packaging material contains substances for therapeutic and / or diagnostic purposes. The primary packaging material according to any one of claims 1 to 8.

10. A method for manufacturing the primary packaging material according to any one of claims 1 to 9, comprising: Step a of preparing at least one component selected from the hollow body (1) and at least a part of the closure (2); Step b of manufacturing the remaining component selected from the hollow body (1) and at least a part of the closure (2) by an injection molding method; including The closure (2) closes the opening (3), and a non-detachable connection that cannot be separated without being destroyed is formed between the closure (2) and the hollow body (1). Method

11. Prepare the closure (2) in step a, Manufacture the hollow body (1) by an injection molding method in step b, Use a cycloolefin polymer or a cycloolefin copolymer, Injection mold to cover the closure (2), Connect the closure (2) and the hollow body (1) in a macro shape connection manner. The method according to claim 10.

12. In step a, prepare the hollow body (1) having the opening (3), Place at least a part of the closure (2) on the opening (3), In step b, completely form the closure (2) by injection molding with a thermoplastic elastomer, Connect the closure (2) and the hollow body (1) in a material connection manner and / or a micro shape connection manner. The method according to claim 10.

13. In step a, prepare at least a part of the closure (2), In step b, by multi-component injection molding, inject and mold a cycloolefin polymer or a cycloolefin copolymer to manufacture the hollow body (1), and inject and mold a thermoplastic elastomer to completely form the closure (2), Connect the closure (2) and the hollow body (1) in a macro shape connection manner and / or a material connection manner and / or a micro shape connection manner. The method according to claim 10.

14. Place at least a part of the closure (2) under a compressive stress during or before the injection molding process, and leave the compressive stress after cooling the injection molded material. The method according to any one of claims 10 to 13.

15. Pretreat at least a part of the contact surface between the hollow body (1) and the closure (2) by activating, roughening or structuring at least one of the surfaces. The method according to any one of claims 10 to 14.

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