Cap for closing a drug delivery container and method of manufacturing the same

Abstract

A cap for closing a dosing container, comprising a pot-shaped body having a cavity with at least one or more openings and a bottom plane for at least partially defining the cavity and at least one septum, wherein the body has a vault with an opening on the end side, which is closed by the septum, wherein the vault protrudes from the bottom plane on the side of the bottom plane opposite the cavity, wherein the septum is inserted under prestress into a receiving cavity of the vault. Also a method for manufacturing such a cap is concerned.

Description

Technical Field

[0001] This application relates to a lid for sealing a drug delivery container and a method for manufacturing the same. Background Technology

[0002] The caps used to seal pharmaceutical containers (such as infusion bottles or bags) are subject to many safety considerations, including both the seal to prevent drug leakage and the seal to prevent the ingress of media from the outside. Therefore, different design aspects often need to be considered in the context of further improvements.

[0003] A closure for a drug container is known from EP 2 376 341 A1. To mechanically decouple the deformation forces acting on the outer wall, this closure has a receiving portion spaced apart from the cap wall and pointing inward from the bottom region of the cap. The outer wall of the cap protects the receiving portion and its contents from external mechanical influences. Simultaneously, a diaphragm is held under prestress within the cap.

[0004] The disadvantage of having the product in the internal undercut, annular gap, etc., in the product-contact area of ​​a closed system is that the product will not remain there, and if the lid is positioned with the diaphragm facing down, the product will not be delivered to the patient.

[0005] In other variations of the prior art, dead volume is created due to the shape of the diaphragm. The diaphragm shape can vary considerably depending on how it is inserted and secured in the cap. In DE 10 2017 000 048 A1, Figures 7 and 8 show a general variation of a cap with a diaphragm, having an annular groove 39 surrounding the puncture area. This annular groove represents dead volume in which fluid not delivered to the patient accumulates. In another variation, Figures 9a and 9b, the diaphragm is constructed to be thick and protruding. Here, dead volume is also present in the bottom region between the puncture site and the edge of the cap. However, the diaphragm shape in this document is designed to ensure a tight seal of the cap and minimize dead volume.

[0006] DE 10 2008 060 457 A1 describes a variation of the cap in which the diaphragm is welded to the cap body without prestress. However, due to the lack of prestressed support for the diaphragm, the retaining and sealing forces applied to fluid transfer devices such as puncture components are relatively small. In this case, the puncture component is preferably needle-shaped, such as a needle or spike. The sealing and retaining forces need to be increased.

[0007] As is known from DE 10 2017 000 048 A1, the sealing force increases with increasing radial prestress, which also adversely increases the puncture force of the puncture element. The radial prestress of the diaphragm must be selected in such a way, when assembled into the cap, to determine the puncture length and therefore the puncture resistance, so as to improve sealing and retention function on the one hand, while still reducing the puncture force on the other. Savings in materials and costs for diaphragm production can also be achieved through the features defined in the independent claim.

[0008] In a diaphragm, the seal between the lid and the diaphragm can be achieved in different ways and by different methods. In DE 19818314A1, the seal between the diaphragm and the lid is mainly achieved by clamping the diaphragm in the lid using the clamping member 26.

[0009] DE 10 2016 003 253 A1, belonging to this category, shows a variation of the diaphragm having a sealing lip 16 surrounding the edge side, which transitions centrally into the sealing surface. In the variation of Figure 3b, this sealing surface may have a planar orientation. However, the sealing lip 16 is solid to ensure sufficient prestress for adequate sealing and protrudes significantly relative to the receiving cavity. Therefore, dead volumes are formed in the intermediate or dead spaces between the diaphragms and also between each diaphragm and the cap wall, as in... Figure 2 This can be seen in DE 10. Compared to other diaphragms, it performs better in DE 10.

[0010] 2016 003 253A1 reduces the formation of dead volume or dead space, but does not completely prevent it. This is necessary because the diaphragm is force-locked in place within the lid without additional material locking, such as adhesives or welds. Summary of the Invention

[0011] Based on existing technology, the present invention now aims to maintain the diaphragm under prestress, but to avoid retaining the bottom cut of the product and annular gaps in the body of the lid as much as possible.

[0012] The present invention solves this problem by using a lid having the features of claim 1 and a method having the features of claim 18.

[0013] A cap for sealing a drug delivery container according to the invention comprises a can-shaped body having a cavity having at least one or more openings and a bottom plane for at least partially defining the cavity. The cavity may have openings, particularly on opposing sides of its outer peripheral surface, such as a conical outer peripheral surface, to allow drug to enter the cavity on the one hand, and to allow a needle to enter the cavity after piercing a septum on the other. The opening may be located in the bottom region of the cap.

[0014] The body further has an arch with an opening at one end, the opening being closed by the diaphragm, wherein the arch protrudes from the bottom plane on the side opposite the cavity on the bottom plane. The opening in the bottom region of the cap transitions into another cavity within the arch. This cavity is closed outwards by the diaphragm. In this invention, no protection against externally acting deformational forces is provided; instead, the arch is exposed to these forces. However, the area of ​​action of the arch is small, thus the probability of deformation in this area is relatively low. However, the dosing of the infusion bag is simultaneously more accurate, especially in cases of overhead infusion with the infusion bag suspended, because there is no undercut in the cap to retain the medication. Furthermore, the cap can be used for various other purposes if necessary.

[0015] The diaphragm is inserted into the receiving cavity of the dome under prestress. This supports a seal-sealing of the diaphragm after a single puncture, and especially multiple punctures, by means of a needle, injection needle, or other element.

[0016] The prestress can be further increased through various structural design modifications, resulting in such a high prestress that even if the outer wall of the arch deforms, the sealing performance of the diaphragm will not be affected.

[0017] The corresponding advantageous construction schemes of the present invention, especially the structural modifications described herein, are the subject of the dependent claims.

[0018] Advantageously, the diaphragm has an interference fit of at least 2.5%, preferably 3-10%, compared to the first inner surface of the radially surrounding cavity. Diaphragms with greater material thickness typically cannot handle this level of interference fit. Therefore, it is advantageous that the axial extension dimension of the region (in which the diaphragm has a closed surface across the width of the vault) extends at less than 70% of the vault height.

[0019] Furthermore, it is advantageous for the establishment of prestressing force that the first inner surface has a tapered orientation, and preferably an orientation that deviates by 3-10° from the parallel orientation of the inner surface about the central axis B of the dome. Compared to diaphragms with a cylindrical basic shape, this allows for an additional retaining effect of the diaphragm and enables a higher sealing force to be achieved at the height of the diaphragm. Under prestress, the diaphragm allows for the establishment of approximately the same sealing force and the same stress level at the height of the receiving portion.

[0020] Additionally, the thickness of the diaphragm or the puncture length within the diaphragm can be reduced. This requires a lower puncture force and reduces material tearing during puncture.

[0021] For optimal sealing, a material-locking connection, such as a welded or adhesive connection, is particularly preferred between the diaphragm and the body. This material-locking connection can be particularly preferably constructed as a welded connection, and is especially preferred in this case as a welded connection that radially surrounds the central axis B of the dome. In addition to the force-locking connection and material-locking connection between the diaphragm and the dome achieved by prestressing, this welded connection thus forms a second safety measure, the so-called "second line of defense," to prevent drug leakage or media ingress.

[0022] Particularly preferably, the welded connection is positioned such that a radial tensile force is applied to the diaphragm upon puncture. This is advantageous because material displacement that occurs in the case of a thick diaphragm can thus be compensated for by the tensile motion. This radial tensile force occurs particularly when the diaphragm is welded to the body in the axial direction about its own diaphragm central axis or diaphragm longitudinal axis.

[0023] The diaphragm can be made of thermoplastic elastomer, especially because it is weldable and particularly well-suited for establishing prestress due to its elastic properties. Individual segments of the diaphragm, such as individual layers, can also be made of different materials, but at least the contact surfaces where welding occurs on the dome should preferably be made of TPE material. However, it is particularly preferred that the entire diaphragm can also be made of TPE.

[0024] The lid may have a second inner surface that defines the receiving cavity in a radially surrounding manner, the average diameter of which is smaller than that of a first inner surface in a radially surrounding manner. Prestress may also be present between the body and the diaphragm. Advantageously, the diaphragm has a smaller interference fit with respect to the second inner surface in a radially surrounding manner than with respect to the first inner surface in a radially surrounding manner.

[0025] Alternatively or additionally, the radially encircling second inner surface may deviate at a greater angle relative to the parallel orientation about the central axis of the vault than the radially encircling first inner surface.

[0026] The diaphragm can have a prestress gradient along the central axis of the vault, which can preferably increase in the puncture direction. This prevents a pit from being left in the diaphragm after the needle is removed.

[0027] The material locking connection can preferably be arranged between the first and second inner surfaces that circumferentially surround the material. Thus, the anchor point of the diaphragm of the cover is located between two substantially equivalent prestressed regions.

[0028] The cylindrical profile of the diaphragm's receiving portion, or the cylindrical profile of its surface (in which the diaphragm is pressed against the cap with an interference fit), and as is known from the prior art, has reduced prestress along the wall direction due to the lever length, thus necessitating the use of a very thick diaphragm. This is particularly disadvantageous due to increased material consumption and the increased force required to puncture.

[0029] By optimizing the positioning of the tapered profile and / or anchor points in the form of welded or bonded points between two relatively short lever arms, a better force distribution of prestress can be achieved in the sealing area, resulting in a better seal. This, in turn, minimizes the thickness of the diaphragm.

[0030] Particularly preferred is that the lid has two domes with the same profile. This can significantly save material, especially by reducing the diaphragm thickness while improving the sealing effect.

[0031] Advantageously, the diaphragm can have a closed sealing surface extending across the width of the diaphragm, from which a radially circumferential tab protrudes. Unlike EP2 376 341A1, this tab is not mechanically decoupled from the outer wall of the cap, but rather forms part of the radially circumferential outer surface of the diaphragm that contacts the inner surface of the dome. Thus, the tab rests on the sidewall of the dome and acts as a spring arm to establish an axial restoring force in the event of axial deformation of the diaphragm. However, deformation of the dome wall also directly causes deformation of the tab.

[0032] The body can be made of thermoplastic materials, preferably PP or PE, especially HDPE.

[0033] Furthermore, the present invention also provides a method for manufacturing a lid according to the present invention, comprising the following steps:

[0034] A provides an ontology, particularly an ontology according to any one of the preceding claims;

[0035] B inserts the diaphragm into the body, particularly by contact pressure;

[0036] C forms a material-locking connection between the diaphragm and the body, particularly while simultaneously maintaining at least partially the contact pressure.

[0037] This achieves a sealed cap through prestressing and material locking connections. The material locking connections reliably seal against lateral drug leakage, and in addition to sealing the edge sides, the prestress also helps the diaphragm re-close after perforation. Attached Figure Description

[0038] A variation of the lid according to the invention is described in more detail below. The accompanying drawings show:

[0039] Figure 1 A cross-sectional view of one embodiment of the lid according to the invention is shown;

[0040] Figure 2 A top view of the lid according to the invention is shown. Detailed Implementation

[0041] Figure 1 and Figure 2 A lid 1 is shown for closing a container, such as an infusion bottle or infusion bag, which is not shown in detail.

[0042] The cover 1 has a body 25, preferably made of a first thermoplastic material, especially polypropylene PP and / or polyethylene PE, especially FIDPE.

[0043] The body 25 is constructed to be substantially shape-stable. The body 25 has a basic can-like shape with an open cavity 24 typical of this shape. An opening 27 is used here to insert or fit a lid into a corresponding container, such as a bottle or bag. The cavity 24 is defined by a conical first wall segment 6, which defines the central axis A of the lid. The conical shape of this wall segment deviates from the cylindrical shape by less than 5°, preferably between 1-3°. This allows contact pressure to be applied to the container.

[0044] The conical first wall segment 6 terminates on the bottom plane 4 with a base plate 5. Depending on the shape of the mating piece on the container corresponding to the lid 1, the bottom plane 4 can be defined by the base plate 5 and form a closed plane relative to the container. However, the base plate 5 is not necessarily arranged perpendicular to the wall segment 6; rather, the wall segment 6 transitions into the base plate 5 through a surrounding edge, bend, or rounding, such that at least the surrounding edge, bend, or rounding is on the bottom plane 4, thereby defining the position of the bottom plane 4. In other words, the surrounding, preferably circular, line formed by the apex of the edge, bend, or rounding can lie on the bottom plane 4 at half the wall thickness of the edge.

[0045] Starting from the bottom plane 4, the cavity 24 of the lid has no protrusions or undercuts in the direction of the interior space of the lid, so that scale will not form, for example, when the components of a drug that is usually in solution form crystals.

[0046] Starting from the bottom plane 4, the body 25 has a receiving geometry for the two diaphragms 2 above the cavity 24 defined by the first wall segment 6. The transition from the bottom plate 5 to the receiving geometry is stepped. The diaphragms are made of a second material with a lower hardness than the body 2, allowing them to be punctured using conventional medical techniques. This material is particularly preferably TPE, i.e., thermoplastic elastomer.

[0047] exist Figure 1 In this embodiment, the housing geometry of the body 25 includes two domes 26 connected to each other by tabs 9, which protrude from the bottom plane 5 or from the side of the base plate 5 away from the cavity 24. The tabs 9 have recesses in the form of channels 23. Of course, in a modification of the invention, only one dome may be constructed.

[0048] Each dome 26 defines a dome centerline B and defines a receiving cavity 20 for each diaphragm 2, wherein the receiving cavity is axially open on both sides relative to the dome centerline B.

[0049] The first opening 15 of the receiving cavity 20 represents a transition section into the cavity 24, and the second opening 17 is closed by the diaphragm 2. (As from...) Figure 1 As can be seen, the sum of the average diameters of the two cavities of the dome 26 is less than the average diameter of the cavity 24.

[0050] Each dome 26 also has a radially circumferential first conical inner surface 16 that defines a receiving cavity for accommodating the diaphragm 2. The conical circumferential inner surface 16 defines the average diameter as the average of all diameters above the contact area between the inner surface and the diaphragm.

[0051] Conversely, the corresponding diaphragm 2 has an interference of at least 2.5%, preferably 3-10%, in the contact area with the first inner surface 16. Figure 1 The interference amount is shown by reference numeral 3 in the accompanying drawings. The diaphragm 2 has, in particular, a radially circumferential first conical outer surface 13 defining an average diameter. The interference amount 3 is defined by the difference between the diameter of the outer surface 13 of the diaphragm 2 (in the disassembled state) and the diameter of the inner surface 16 of the dome 26, such that the average diameter of the outer surface 13 of the diaphragm 2 is at least 2.5% larger than the diameter of the inner surface 16 of the dome 26 in the disassembled state.

[0052] The inner surface 16 here includes the largest contact surface between the diaphragm 2 and the dome 26. The second opening 17 defines a sealing plane 50. Drug leakage should be prevented along this sealing plane 50.

[0053] The dome 26 includes a stepped transition portion 7 having a second conical inner surface 11 that radially surrounds the dome and terminates in an opening 17. Conversely, the outer surface 12 of the corresponding diaphragm 2 has an interference fit 18 of at least 2.5%, preferably 3-10%, in the contact area with the second inner surface 11, wherein the interference fit 18 refers to the disassembled state of the diaphragm 2.

[0054] The radially encircling second conical inner surface 11 has a greater taper than the radially encircling first conical inner surface 16, i.e., a greater deviation from the orientation of the parallel-extending cylindrical shape. Preferably, the interference fit can be smaller than the interference fit in the region of the first inner surface 16, so that a gradual prestress is established along the orientation of the central axis of the dome. This allows the material of the diaphragm 2 to initially shift outward in the puncture region, while simultaneously achieving a sealing effect in that region.

[0055] The stepped transition 7 of the vault 26 includes a surface section 10 that extends substantially parallel to the sealing plane 50. The surface section 10 may also have an inclined orientation, particularly a tapered orientation. The surface section 10 has a material-locking connection between the vault 26 and the diaphragm 2.

[0056] The material locking connection in surface section 10 is preferably a welded connection. The welded connection can be produced by laser welding, wherein the laser beam is guided to the outer surface of the cover 1 forming the sealing plane 50, especially the end face 8 of the cover 1, which has advantages in manufacturing technology and sealing effect.

[0057] In the area of ​​surface section 10, the diaphragm is attached to the inner surface of the dome 26 with virtually no prestress. This reduces material stress during welding, thereby enhancing the sealing effect and preventing material separation.

[0058] The diaphragm 2 has a closed sealing surface 19 extending toward the cavity 24 and across the width of the diaphragm. A radially circumferential tab 14 protrudes from the sealing surface, forming part of the radially circumferential outer surface of the diaphragm 2 that contacts the inner surface 16 of the dome. (See from...) Figure 1 It is immediately apparent that the sealing surface 19 has a planar orientation, especially a completely planar orientation, in the region between the radially surrounding tabs 15.

[0059] Figure 1 It is also shown that the width of this planar orientation of the sealing surface 19 occupies significantly more than 50% of the total width of the diaphragm 2.

[0060] from Figure 1 It can also be seen that the splice 14 is attached to the inner surface 16 of the vault 26 and terminates flush with the receiving cavity 20 of the vault 26.

[0061] The vault 26 protrudes relative to the base plate 5, wherein the receiving cavity 20 of the vault 26 is based on... Figure 1 Extends to the inner surface of the base plate 5 facing the cavity 24.

[0062] The tab 14 improves the sealing effect of the diaphragm 2 in the edge region and allows for the establishment of high prestress, wherein the free space between the opposing sections of the tab 14 can also be used for material displacement, for example, when a needle is inserted into the diaphragm. When the diaphragm deforms in the axial direction, for example, when a larger injection needle is inserted into the diaphragm, the section of the tab 14 simultaneously acts as a spring arm. This generates a restoring force in the axial direction, so that when the injection needle is removed, in addition to the radial prestress, the axial component also acts to close the puncture site.

[0063] The radial average width of the connector is preferably less than 50% of the axial height of the outer surface of the diaphragm 2 that contacts the inner surface 16 of the dome 26, and preferably less than 35%.

[0064] The taper of the second inner surface 16 of the dome 26 is also smaller than that of the first inner surface 11, which results in a different, particularly smaller, prestress being established in the diaphragm 2 during puncture in the upper region than in the lower region, where “upper” and “lower” are based on the puncture direction E and the position of the sealing surface 50 where the puncture is performed.

[0065] Figure 1 Not shown, the tab 9 between the two diaphragms 2 is connected to the base plate 5 in the illustrated plane. Overall, the lid forms an elliptical basic shape along the puncture direction in the top view, encompassing the entire containment geometry, including the dome 26.

[0066] Figure 1 The cap 1 shown is illustrated in an ideal manner. Here, the sealing plane 50 is defined by the opening edge of the opening 17. In practice, the diaphragm end face, which is substantially perpendicular to the puncture direction, may be slightly bent relative to the sealing plane due to prestress.

[0067] Furthermore, a part of the invention also relates to a method for manufacturing the aforementioned cap 1. The method includes a first step in which a body 25 is provided. The body 25 can be manufactured, for example, by injection molding or by other suitable plastic processing techniques.

[0068] In the second step of the method, the diaphragm 2 can be inserted into the receiving cavity 20 of the dome 26 of the body 25. This insertion can be achieved by applying contact pressure to press the diaphragm.

[0069] This contact pressure can be at least partially maintained in subsequent steps, in which a material-locking connection is formed between the respective diaphragm 2 and body 25. This material-locking connection is preferably formed on the surface section 10 by welding. This can be achieved by laser welding.

[0070] A diaphragm, or sealing surface, can then be covered by a covering element 22, such as a plastic film, aluminum foil, or a molded plastic body, which can be part of a lid. This can be, for example, in... Figure 2 As can be seen in the top view.

[0071] The caps can then be packaged under aseptic conditions.

[0072] List of reference numerals

[0073] 1. Lid

[0074] 2. Diaphragm

[0075] 3. Interference

[0076] 4. Bottom plane

[0077] 5. Base plate

[0078] 6 wall segments

[0079] 7. Stepped transition section

[0080] 8. End face of the lid

[0081] 9. Splicing

[0082] 10 Surface Sections

[0083] 11 Second conical inner surface

[0084] 12. The second conical outer surface of the diaphragm

[0085] 13 The first conical outer surface of the diaphragm

[0086] 14. Surrounding splice

[0087] 15 First Opening

[0088] 16 First conical inner surface

[0089] 17 Second opening

[0090] 18. Interference

[0091] 19 Sealing surface

[0092] 20 Receiving cavity

[0093] 21. Circular splice

[0094] 22 Covering elements

[0095] 23 Ditch

[0096] 24. Cavity

[0097] 25 body

[0098] 26. Vaulted ceiling

[0099] 27 Opening

[0100] 50 Sealing plane

[0101] A. The longitudinal axis of the lid

[0102] B. Central axis of the vault

[0103] E Puncture direction

Claims

1. A lid (1) for sealing a drug delivery container, comprising a can-shaped body (25) having a cavity (24), the cavity (24) having one or more openings (15, 27) and a bottom plane (4) for at least partially defining the cavity (24) and at least one diaphragm (2), wherein the body (25) has an arch (26) having an end-side opening (17) closed by the diaphragm (2). The dome (26) protrudes from the bottom plane (4) on the side opposite to the cavity (24) of the bottom plane (4), wherein the diaphragm (2) is inserted into the receiving cavity (20) of the dome (26) under prestress. Its features are, The diaphragm (2) and the body (25) are provided with a material locking connection. The material locking connection is arranged between a first inner surface (16) and a second inner surface (11) of the dome (26) for defining the receiving cavity (20) in a radially surrounding manner. The diaphragm (2) has a closed sealing surface (19) extending across the width of the diaphragm (2), and radially surrounding tabs (14) protrude from the sealing surface (19). The tabs (14) form part of the outer surface (13) of the diaphragm (2) in contact with the first inner surface (16) of the dome (26), and the sealing surface (19) has a planar orientation in the region between the radially surrounding tabs (14). The material locking connection is arranged in a stepped transition portion (7) between the radially surrounding first inner surface (16) and the radially surrounding second inner surface (11). And wherein the opening (17) on the end side defines a sealing plane, wherein the stepped transition (7) of the dome (26) has a surface section (10) that extends substantially parallel to the sealing plane (50) of the diaphragm, wherein the surface section (10) has the material locking connection between the dome (26) and the diaphragm (2).

2. The lid according to claim 1, characterized in that, The radial average width of the tab (14) is less than 50% of the axial height of the outer surface of the diaphragm (2) that contacts the first inner surface (16) of the dome (26).

3. The lid according to claim 2, characterized in that, The radial average width of the tab (14) is less than 35% of the axial height of the outer surface of the diaphragm (2) that contacts the first inner surface (16) of the dome (26).

4. The lid according to claim 1, characterized in that, The dome (26) protrudes relative to the base plate (5), wherein the receiving cavity (20) of the dome (26) extends to the inner surface of the base plate (5) facing the cavity (24).

5. The lid according to claim 1, characterized in that, The tab (14) rests against the first inner surface (16) of the dome (26) and terminates flush with the receiving cavity (20).

6. The lid according to claim 1, characterized in that, The material locking connection is a welded connection.

7. The lid according to claim 6, characterized in that, The welded connection is a radial welded connection that surrounds the central axis (B) of the vault.

8. The lid according to claim 6, characterized in that, The welded connection is positioned such that a radial tensile force is applied to the diaphragm (2) whenever a puncture is performed.

9. The lid according to claim 1, characterized in that, The material locking connection is a laser welding connection, which can be produced by guiding a laser beam to the outer surface of the cover that forms the sealing plane (50).

10. The lid according to claim 1, characterized in that, The diaphragm (2) is attached to the inner surface of the dome (26) without prestress in the area of ​​the surface section (10).

11. The lid according to claim 1, characterized in that, The diaphragm (2) has an interference of at least 2.5% (3) compared to the first inner surface (16) of the radially surrounding dome (26).

12. The lid according to claim 11, characterized in that, The diaphragm (2) has an interference of 3-10% (3) compared to the first inner surface (16) of the radially surrounding dome (26).

13. The lid according to claim 1, characterized in that, The first inner surface (16) of the radially surrounding vault (26) has a tapered orientation.

14. The lid according to claim 13, characterized in that, The first inner surface (16) of the radial circumference has a direction that deviates by 3-10° from the parallel direction of the first inner surface (16) about the central axis (B) of the vault.

15. The lid according to claim 1, characterized in that, The diaphragm (2) is made of thermoplastic elastomer.

16. The lid according to any one of claims 1 to 15, characterized in that, The average diameter of the second inner surface (11) that is radially surrounded is smaller than the average diameter of the first inner surface (16) that is radially surrounded.

17. The lid according to claim 16, characterized in that, The diaphragm (2) has a smaller interference with respect to the second inner surface (11) of the radial surrounding than with respect to the first inner surface (16) of the radial surrounding.

18. The lid according to any one of claims 1 to 15, characterized in that, The cover (1) has two identical domes (26).

19. The lid according to any one of claims 1 to 15, characterized in that, The lid (1) has two diaphragms (2) with the same outline.

20. The lid according to any one of claims 1 to 15, characterized in that, The second inner surface (11) of the radial circumference is offset at a greater angle relative to the parallel orientation about the central axis of the vault than the first inner surface (16) of the radial circumference.

21. The lid according to any one of claims 1 to 15, characterized in that, The diaphragm (2) has a prestress gradient along the central axis (B) of the arch.

22. The lid according to any one of claims 1 to 15, characterized in that, The body (25) is made of thermoplastic material.

23. The lid according to claim 22, characterized in that, The body (25) is made of PP or PE.

24. The lid according to claim 23, characterized in that, The body (25) is made of HDPE.

25. The lid according to any one of claims 1 to 15, characterized in that, The height of the dome (26) is less than 30% of the total height of the cover (1).

26. The lid according to claim 25, characterized in that, The height of the dome (26) is between 10% and 25% of the total height of the cover (1).

27. The lid according to claim 4, characterized in that, In the plane defined by the base plate (5), the cavity (24) of the cover (1) has no protrusions or undercuts to avoid scaling when the components of the drug crystallize.

28. A method for manufacturing a lid (1) according to any one of claims 1 to 27, characterized by the following steps: A provides the main body (25); B. Insert the diaphragm (2) into the body (25); C. A material locking connection is formed between the diaphragm (2) and the body (25), wherein the material locking connection is constructed as a welded connection by laser welding, wherein a laser beam is directed to the outer surface of the cover (1) forming the sealing plane (50).

29. The method according to claim 28, characterized in that, In step B, the diaphragm (2) is inserted into the body (25) under contact pressure.

30. The method according to claim 29, characterized in that, In step C, the material locking connection is formed while at least partially maintaining the contact pressure.

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