Closure plug designed for low temperature applications and system consisting of a container and a closure plug

Abstract

The invention relates to a closure plug (1) designed for cryogenic applications for sealing a container (2), wherein the closure plug (1) has a plug body (3) made of a rubber-like material, which has a plug section (6) which cooperates with an inner container wall (4) of a container opening (5) of the container (2) in a reference mounted state, and a cover section (8) which is arranged at least partially outside the container opening (5) on an opening rim (7), wherein a bottom face of the cover section (8) facing the container (2) has an annularly surrounding groove (9) for accommodating the opening rim (7), wherein the groove (9) is delimited by a radially inner groove inner wall (10) provided by the plug section (6) and by a radially outer groove inner wall (11) with respect to a radial direction (r). In order to maintain the sealing effect between the closure plug (1) and the container (2) even at low temperatures, it is proposed that the radially outer groove inner wall (11) has at least one abutment region (12) whose surface abutting on the opening rim (7) of the container (2) in the mounted state of the closure plug (1) is oriented transversely to a shrinkage direction (s) directed radially inwards towards the radially inner groove inner wall (10), the abutment region (12) moving in the shrinkage direction when a low temperature is applied.

Description

Technical Field

[0001] This invention relates to a sealing plug designed for cryogenic applications, used to seal cryogenically subjected containers containing medical or pharmaceutical substances, particularly for infusion bottles or vaccine vials. The sealing plug has a body made of a rubber-like material, the body having a plug section that engages with the inner wall of the container opening when mounted on the container, and a cap section disposed at least partially outside the container opening on the edge of the opening. The cap section, in the mounted state of the sealing plug, has an annular groove on the bottom surface of the container for receiving the edge of the opening, the groove being defined radially by an inner wall of the groove provided by the plug section and an outer wall of the groove.

[0002] Furthermore, the present invention relates to a system consisting of a container and a sealing plug for medical or pharmaceutical substances subjected to low temperatures, the container being, in particular, an infusion bottle or a vaccine vial. Background Technology

[0003] Containers and sealing plugs designed for cryogenic applications are known in the prior art.

[0004] The container may be, for example, an infusion bottle or vaccine vial, containing medical or pharmaceutical substances. For storage, the container, sealed by a suffix, is subjected to low temperatures, typically corresponding to the boiling point of a liquefied gas such as nitrogen. This temperature may also correspond to the sublimation point of a frozen (solid) gas such as CO2. Special designs for the container and suffix have been developed in the prior art to maintain optimal sealing between the container and the suffix during cooling, storage, and heating.

[0005] For example, WO 2020 / 225687 A1 discloses a container for storing pharmaceuticals at low temperatures, the container having a flange in the container opening region, the flange providing at least one recess and / or at least one protrusion, the recess or protrusion engaging with a corresponding protrusion or recess of a closure plug. It is described that when the closure plug, typically made of a rubber-like material, shrinks from a first configuration to a second configuration due to temperature effects, the surface features of the container and the closure plug remain engaged with each other.

[0006] Disadvantageously, the closure plug typically undergoes shape changes, particularly shrinkage, upon cooling, which can alter the contact surface and potentially impair the sealing performance. Even with the use of additional caps typically used to secure the container and closure plug relative to each other, deformation of the closure plug can occur, which may, for example, eliminate the sealing connection between the closure plug and the container due to relative movement of the contact surfaces. Summary of the Invention

[0007] Therefore, based on the aforementioned prior art, the technical problem to be solved by the present invention is to provide a sealing plug and a system consisting of a container and a sealing plug, wherein the sealing connection between the container and the sealing plug can be maintained even during temperature changes, especially when the container and the sealing plug are cooled to extremely low temperatures in the low-temperature application range.

[0008] To address this technical problem, the present invention first proposes a sealing plug having at least one abutting region on the inner wall of its radially outer groove. This abutting region, in the installed state, abuts against the surface of the container's opening edge, and is oriented laterally relative to a contraction direction pointing radially inward toward the inner wall of the radially inner groove. This abutting region moves along this contraction direction when a low temperature is applied. The orientation of the sealing plug surface is transverse to the radially inward contraction direction, and is particularly understood as an orthogonal orientation. The radially inward contraction direction refers to the longitudinal axis of symmetry of the substantially cylindrical sealing plug. Preferably, the surface of the sealing plug abutting against the container forms an angle of 85° to 95° with respect to the contraction direction of the sealing plug. Particularly preferably, this angle is in the range of 88° to 92°. The foregoing range description also includes, in particular, all sub-ranges encompassed by the aforementioned boundary values. Furthermore, deviations from 90° can also be asymmetrical ranges, such as 89° to 92° or similar cases.

[0009] The proposed design of the sealing plug ensures that even if the sealing plug shrinks due to cooling, the surface of the sealing plug that rests against the outer edge of the container opening will not lose its sealing contact with the container. Crucially, the prescribed contact surface between the sealing plug and the container is oriented laterally relative to the radially inward-pointing direction of contraction of the sealing plug, wherein an orthogonal orientation of the contact surface relative to the radially inward-pointing direction of contraction is optimal. However, even with a small angular deviation between the contact surface and the direction of contraction, for example, when the angle is not optimally 90°, but rather, for example, only 99° or 98°, the seal can still be maintained. The permissible angular deviation relative to the optimal orthogonal orientation also depends particularly on the materials of the container and the sealing plug, especially their surface roughness and temperature characteristics.

[0010] Although the sealing plug changes substantially three-dimensionally in all spatial directions during cooling, it is crucial for the sealing connection between the sealing plug and the container that the primary sealing surface of the sealing plug is orthogonal to the radially inward contraction direction of that sealing surface. Thus, as the plug material is pulled inward due to volume reduction, the contracting sealing plug is contained by the adjacent container wall. Since the sealing plug—referring to the longitudinal axis of the container or the sealing plug—also contracts, for example, in the axial direction, it is advantageous, consequently, that the plug is correspondingly deeply embedded in the container opening or overlaps with the outer wall of the container by a specific axial length dimension, so that the sealing plug does not slip out of the container even during volume reduction.

[0011] In other words, the inner wall of the radially outer groove of the sealing plug is designed to be substantially parallel to the longitudinal axis of the sealing plug. The sealing plug is typically constructed rotationally symmetrically about its longitudinal axis, wherein, as proposed, the plug section of the plug body extends into the interior of the container, i.e., into the container opening constructed at the end. The radially outward-pointing surface of the plug section and the cylindrical sub-region of the cap section together form a groove, which is thus defined on the one hand by the inner wall of the radially inner groove of the plug section and on the other hand by the inner wall of the radially outer groove of the cap section.

[0012] By aligning the abutment region substantially orthogonally to the radially inward contraction direction of the sealing plug, a drawback in the prior art—that the sealing plug may slip off the container via the ramp during its contraction—is overcome. The radially outer groove wall maintains a sealed connection with the container's outer wall during the contraction process and subsequently during the thawing process.

[0013] Even partial separation of the container's inner wall from the plug section is possible in cryogenic applications, but the persistent sealing connection between the container's outer wall and the inner wall of the outer groove of the cap section ensures a tight seal. A cap, typically a metal cap, positioned on the container and pressed against the container or the attached plug, provides additional support if necessary. The grooves on the radially outer inner wall of the cap reliably hold the plug within or on the container, thus ensuring a tight seal even when cooled to extremely low temperatures.

[0014] Furthermore, it is proposed that the surface of the abutment area is oriented laterally relative to the bottom of the groove defined by the inner wall of the inner groove and the inner wall of the outer groove. According to this embodiment, the normal to the surface of the abutment area of ​​the radially outer groove extends parallel to the bottom of the groove. The opening edge of the container's end side, when connected to the sealing plug, abuts against the bottom of the groove of the sealing plug, thereby extending parallel to the normal to the surface of the abutment area of ​​the sealing plug. The sealing plug utilizes this abutment area to contact the outer side of the radially outer groove with the container's outer side. Therefore, if the sealing plug is pushed into the container opening or onto the opening edge until it reaches a predetermined end position based on the contact between the groove bottom and the opening edge, until the sealing plug can no longer move further towards the container, the optimal position of the sealing plug on the container is achieved. This end position realizes the aforementioned advantage of ensuring a sealed connection even in low-temperature applications of the container or sealing plug. Regarding the description of the orientation of the abutment area surface relative to the bottom of the groove, "lateral" is specifically understood to mean an orientation in which the surface of the abutment area of ​​the radially outer groove inner wall of the sealing plug is substantially orthogonal to the groove bottom orientation. Particularly preferably, the substantially orthogonal orientation not only precisely includes an angle of 90°, but may also include a certain tolerance relative to smaller or larger angles. For example, the angle may have a range of 85° to 95°, preferably 88° to 92°, and particularly preferably 89° to 91°. The aforementioned angle description also includes, of course, intermediate values ​​within the aforementioned angle range. Fractions of 1° angles may also be included, for example, angle deviations within the range of 87.5° to 92.5°. Furthermore, symmetry of the angle deviation relative to a 90° angle is not required. For example, a deviation towards an obtuse angle may be greater than a deviation towards an acute angle, thus resulting in, for example, an angle range of 89° to 92°.

[0015] Furthermore, it is proposed that the abutment area is part of a sealing protrusion formed on the inner wall of the radially outer groove, which is annular and radially inwardly pointing, for abutting against the outer side of the container at the opening edge. According to this embodiment, the abutment area is not the entire surface of the inner wall of the outer groove of the sealing plug, but only a sub-region that protrudes radially from other sub-regions of the inner wall of the outer groove and points inward, with its surface abutting against the outer wall of the container. Therefore, free spaces are formed above and below the sealing protrusion (referring to the axial direction), which are neither filled with the material of the sealing plug nor the material of the container. In the longitudinal section of the sealing plug, the sealing protrusion appears as a nose protruding radially inwardly from the inner wall of the outer groove, which can have different cross-sectional shapes, such as semicircular, polygonal, rectangular, or other shapes. The sealing protrusion extends along the entire circumferential portion of the inner wall of the outer groove, thereby forming an annular and radially inwardly pointing sealing protrusion for abutting against the outer side of the container. According to another variant, it can also be specified that the sealing plug has not only a single annular sealing protrusion on the inner wall of its outer groove, but has multiple sealing protrusions arranged overlapping each other with reference to the axial direction of the sealing plug.

[0016] When the closure plug deforms due to cooling to a low temperature, it contracts, and thus the sealing protrusion contracts as well. Because the sealing protrusion, especially in the case of a curved structure, always has a contact area due to its protruding nature, and its surface is oriented laterally relative to the radially inward direction of contraction, the closure plug reliably presses against the outside of the container opening even during its contraction, thereby maintaining a sealed connection between the container and the closure plug.

[0017] Alternatively or additionally, the inner radial wall of the plug groove may have an annular, radially outward-pointing protrusion for abutting against the inner wall of the container opening. According to this embodiment, the inner radial wall of the plug is therefore not planar against the inner wall of the container, but spaced apart by the radially outward-pointing protrusion. Contact may also be ensured as the plug deforms due to cooling, by the protrusion changing shape and maintaining contact with the inner wall of the container due to its protruding structure. This supports a consistently present sealing connection between the outer wall of the plug groove and the outer wall of the container. The protrusions formed on the inner radial wall of the plug groove may also have different cross-sectional profiles, with curved or polygonal profiles being particularly advantageous.

[0018] Furthermore, it is proposed that the bottom of the groove, defined by the inner wall of the inner groove and the inner wall of the outer groove, has an annular surrounding recess. Therefore, the bottom of the groove is not completely flat, but rather has a material recess that is annularly formed in the cap section. This recess, thus constructed, can support the deformation of the sealing plug as it undergoes shape changes due to temperature-related shrinkage. This annular material recess is constructed only in the radial sub-region of the groove bottom, particularly in the transition region between the groove bottom and the radially outer inner wall of the groove.

[0019] The plug body is preferably made of a cross-linked elastomer or thermoplastic elastomer. In particular, the plug body can be made of halogenated butyl rubber, such as brominated butyl rubber or chlorinated butyl rubber. In principle, both thermosetting plastics and thermoplastic plastics are suitable for manufacturing occlusive plugs.

[0020] The sealing plug is recommended to be designed for cryogenic conditions down to -196 degrees Celsius. -196 degrees Celsius corresponds to the boiling point of liquid nitrogen. Nitrogen is a commonly used cooling medium, for example, in industrial or laboratory environments.

[0021] If necessary and perhaps sufficient, the sealing plug is designed for cryogenic temperatures as low as -80 degrees Celsius at atmospheric pressure. This roughly corresponds to the freezing point of carbon dioxide. In most cryogenic applications, it is crucial that the sealing plug or container be cooled to a temperature below the glass transition temperature of the plug material. When the sealing plug is cooled below the glass transition temperature of its material, it loses its rubbery elastic properties and transforms into a rigid glassy state. No further substantial shape changes occur thereafter. A significant change in the coefficient of thermal expansion also occurs in this cooled state.

[0022] In principle, containers and closures can also be stored at temperatures below -196 degrees Celsius, for which various liquefied gases with lower boiling points than nitrogen can be used. Hydrogen, with a boiling point of -253 degrees Celsius, or helium, with a boiling point of -269 degrees Celsius, are considered. However, nitrogen is particularly recommended because these gases are either very expensive or unsuitable due to stricter safety regulations. Alternatively, storage at comparatively higher temperatures is also possible, such as around -80 degrees Celsius, corresponding to the freezing point of carbon dioxide.

[0023] However, for applications such as storing medical or pharmaceutical substances in cryogenic environments, in most cases, sealing plugs designed for temperatures as low as -80 degrees Celsius may be sufficient. As mentioned earlier, this roughly corresponds to the freezing point of carbon dioxide.

[0024] In addition to the aforementioned sealing plug, the present invention also proposes a system comprising a container for medical or pharmaceutical substances subjected to low temperatures, particularly infusion bottles or vaccine vials, and a sealing plug of the aforementioned type, wherein the container has a container neck with a container opening having an opening edge, the container opening being closable by means of the sealing plug, and wherein the container neck has a radially outwardly pointing flange that can be capped when closed by means of the sealing plug.

[0025] The proposed system therefore also uses a sealing plug designed according to one of the aforementioned embodiments. The container is preferably a glass container, which is inert to the medical or pharmaceutical substances stored therein and is also suitable for cryogenic applications. If plastic also meets the aforementioned conditions for storing medical and pharmaceutical substances at low temperatures, the container can also be made of these materials. The advantages and features described above regarding the sealing plug and the container also apply accordingly to the proposed system consisting of a container and a sealing plug.

[0026] The flange is formed on the end side of the container neck and forms a radially outwardly pointing protrusion that completely surrounds the circumference. Particularly preferred is that the cap section of the closure plug rests on the axial end face of the flange, wherein the inner wall of the outer groove abuts against the end face of the flange with its axial end face. Here, preferably, the distance from the flange to the end face of the opening edge of the container opening is coordinated with the length of the inner wall of the outer groove of the closure plug, such that the length from the free end region of the container wall to the end face of the flange is equal to the depth of the groove to the bottom of the groove, i.e., the depth from the end section of the inner wall of the outer groove to the bottom of the groove.

[0027] Furthermore, it is proposed that the outer wall of the container neck has a radially outwardly pointing, annular sealing protrusion between the flange and the opening edge of the container opening, for abutting against the abutment area of ​​the sealing plug. According to this embodiment, referring to the orientation of containers typically placed at the bottom, the container has a sealing protrusion on its outer wall above the flange, which protrudes radially outward. This sealing protrusion thus protrudes beyond an adjacent sub-region of the container outer wall, but is preferably shorter than the flange, which is also annularly constructed on the container outer wall. A free space is provided between the flange and the sealing protrusion, which is not filled by the container wall material. This also applies to the free space above the sealing protrusion in the direction of the end face towards the edge of the container opening. Referring to the longitudinal section of the container, the sealing protrusion preferably has an outwardly projecting profile. As an alternative to a curved design, the profile of the sealing protrusion can also be angular or polygonal. In the proposed case where the sealing protrusion is provided on the outer wall of the container itself, it is not necessary to form a corresponding sealing protrusion on the inner wall of the radially outer groove of the sealing plug.

[0028] Furthermore, the flange, together with the sealing plug abutting thereon, is preferably overlapped by a cap, which is preferably secured by crimping. Here, the cap preferably overlaps the side of the flange away from the sealing plug, thereby securing the cap and the sealing plug to the container.

[0029] In addition, an outer cap (Überkappe) can be provided, which is attached to the cap, for example, as a cover component. This outer cap can be removed from the cap, for example, by tearing, to expose the cap and for possible subsequent use of the still-closed container. The outer cap can, for example, serve as an initial seal for the entire cap underneath. The outer cap can be made of metal or plastic, and furthermore, its manufacture can be, for example, by plastic injection molding. The outer cap can be made of, for example, polypropylene (PP) or polyethylene (PE).

[0030] Caps used to secure the closure plug to a container are, in particular, metal caps, which are then preferably secured to the container by crimping. Thus, the system can include both a container and a closure plug, and also a cap for securing the closure plug to the container. Additionally, the system may include the aforementioned outer cap in addition to the cap. Furthermore, the closure plug can be secured by other means. In particular, the cap and / or outer cap can also be made of plastic or polymer materials. In this case, crimping is not required; instead, the cap is designed to create a clip-on fixation below the container flange. Examples include EP 2569225 B1 and JP 5479029 B2. The cap and outer cap can also be constructed integrally, wherein the outer cap may have certain original anti-counterfeiting features. The closure plug can also be secured to the container by clamping components. Attached Figure Description

[0031] The invention will now be explained in more detail with reference to embodiments. Components described with reference only to one embodiment, and which are not replaced by another component in another embodiment due to their distinctiveness therein, are also described accordingly as at least possible components in that other embodiment. In the drawings:

[0032] Figure 1 A perspective view shows a container for containing medical or pharmaceutical substances, having a container opening with a flange.

[0033] Figure 2 A perspective top view of a container with a closure plug and a cap is shown;

[0034] Figure 3 Showing according to Figure 2 A partial exploded view of the system, showing containers, plugs, and caps;

[0035] Figure 4A side view of the closure plug is shown;

[0036] Figure 5 Showing according to Figure 4 The longitudinal section of the closed plug;

[0037] Figure 6 The side view shows the opening edge of the container on the flanged end side;

[0038] Figure 7 Showing according to Figure 6 The longitudinal section of the container portion;

[0039] Figure 8a A schematic diagram showing the container and sealing plug of the first embodiment before the connection process;

[0040] Figure 8b The diagram shows the sealing plug installed in the container opening after the first step of the connection process. Figure 8a A schematic diagram;

[0041] Figure 8c The diagram shows that after the second step of the connection process, the metal cap overlaps and is pressed tightly against the container according to... Figure 8b A schematic diagram;

[0042] Figure 8d Showing according to Figure 8c A schematic diagram after the cooling process from 22 degrees Celsius to -62 degrees Celsius;

[0043] Figure 8e Showing according to Figure 8d A schematic diagram after the cooling process from -62 degrees Celsius to -80 degrees Celsius;

[0044] Figure 8f Showing with Figure 8a Different views, in which, firstly, a closed plug without cap 20 is set for insertion into the container opening;

[0045] Figure 9a The first embodiment of the container and the first embodiment of the sealing plug are shown;

[0046] Figure 9b The first embodiment of the container and the second embodiment of the sealing plug are shown;

[0047] Figure 9c A first embodiment of the container and a third embodiment of the sealing plug are shown;

[0048] Figure 9d A second embodiment of the container and a fourth embodiment of the sealing plug are shown;

[0049] Figure 10A cross-sectional view of the groove sealing the plug is shown at a temperature of 22 degrees Celsius;

[0050] Figure 11 Showing according to Figure 10 The state of the sealing plug after cooling to -80 degrees Celsius;

[0051] Figure 12 Showing according to Figure 9a A diagram illustrating multiple contact points between the sealing plug and the container wall at a temperature of 22 degrees Celsius;

[0052] Figure 13 Show along Figure 12 Pressure distribution on the contact wire;

[0053] Figure 14 Showing according to Figure 9a or Figure 12 The illustration shows multiple contact points between the sealing plug and the container wall after cooling to -80 degrees Celsius.

[0054] Figure 15 Show along Figure 14 Pressure distribution on the contact wire;

[0055] Figure 16 Shown by the container and according to Figure 9b The implementation of a system consisting of a sealed plug at a temperature of 22 degrees Celsius;

[0056] Figure 17 Show along Figure 16 Pressure distribution on the contact wire;

[0057] Figure 18 Show container walls and according to Figure 16 The state of the sealing plug at a temperature of -80 degrees Celsius;

[0058] Figure 19 Show along Figure 18 Pressure distribution on the contact wire;

[0059] Figure 20 Show container walls and according to Figure 9c The state of the sealing plug in the embodiment at a temperature of 22 degrees Celsius;

[0060] Figure 21 Show along Figure 20 Pressure distribution on the contact wire;

[0061] Figure 22 Show the container and according to Figure 20 The state of the sealing plug at -80 degrees Celsius;

[0062] Figure 23 Show along Figure 22Pressure distribution on the contact wire;

[0063] Figure 24 Showing according to Figure 9d The embodiment includes a partially exploded view of the container, the closure plug, and the cap;

[0064] Figure 25 Showing according to Figure 24 Side view of the closed plug;

[0065] Figure 26 A cross-sectional view of the sealing plug is shown;

[0066] Figure 27 The basis for showing the flange is shown. Figure 24 A side view of the edge of the container opening;

[0067] Figure 28 Showing according to Figure 27 A cross-sectional view of the container opening edge;

[0068] Figure 29 Showing according to Figure 9d and Figure 24 A diagram illustrating the contact point between the sealing plug and the container at a temperature of 22 degrees Celsius;

[0069] Figure 30 Show along Figure 29 Pressure distribution on the contact wire;

[0070] Figure 31 Showing according to Figure 29 The state of the system after cooling to -80 degrees Celsius;

[0071] Figure 32 Show along Figure 31 Pressure distribution on the contact wire;

[0072] Figure 33a An enlarged view of a sub-region of a groove with a sealing protrusion is shown;

[0073] Figure 33b Showing the outer wall of the container and Figure 33a Enlarged view of the corresponding sub-region;

[0074] Figure 34a Another embodiment of the groove with a flat mating area is shown;

[0075] Figure 34b Showing the outer wall of the container and Figure 34a Enlarged view of the corresponding sub-region with sealing protrusions. Detailed Implementation

[0076] Figure 1First, a container 2 for medical or pharmaceutical substances is shown. Container 2 is, for example, constructed as an ampoule. Container 2 has a rotationally symmetrical cylindrical shape and has a container bottom 22 and a container wall 24 with a container neck 18 and a container opening 5. The container opening 5 has an opening edge 7. In a typical manner, container 2 also has an inner container wall 4 and an outer container wall 15. A flange 19 is also constructed on the container neck 18, spaced apart from the end face of the opening edge 7. In a typical manner, container 2 is cylindrical, having an axial direction a and a radial direction r.

[0077] Container 2 is preferably made of glass and is suitable for low-temperature applications, such as cooling to very low temperatures. Such container 2 for medical or pharmaceutical substances is stored, for example, at a temperature as low as -196 degrees Celsius.

[0078] like Figure 2 and Figure 3 As shown, container 2, i.e., its container opening 5, can be closed by a sealing plug 1, through which the plug section 6 of the sealing plug is introduced into the container opening 5. The plug body 3 of the sealing plug 1, in addition to the plug section 6, also has a cap section 8, which is placed on the opening edge 7 of the container outside the container 2. The container opening 5, closed by the sealing plug 1, can then be overlapped by a cap 20. The cap 20 can be gecrimped onto the container 2. Other connection methods between the container 2 and the cap 20 are also possible. The cap 20 here, for example, has a cap opening 23, through which the markings of the sealing plug 1 can be seen, and in particular, an entry point for needle, such as a syringe, to be inserted.

[0079] The sealing plug 1—corresponding to the container neck 18 and its container opening 5—is also rotationally symmetrically constructed, having an axial direction a and a radial direction r. The cap section 8 of the sealing plug 1 has a groove 9 radially outside the plug section 6, the groove having a radially inner groove wall 10 and a radially outer groove wall 11. The opening edge 7 of the container neck 18 can be inserted into the groove 9, such that the container wall 24 is positioned between the outer side of the plug section 6 and the outer groove wall 11 of the cap section 8.

[0080] The occlusive plug 1 is preferably made of a rubber-elastic material, such as brominated butyl rubber. Alternatively, the plug body 3 can also be made of a thermoplastic elastomer, such as brominated butyl rubber. Crucially, the material of the occlusive plug 1 is suitable for contact with medical or pharmaceutical substances and can also be stored at very low temperatures.

[0081] The cap 20 covering the container opening 5 and the sealing plug 1 is preferably made of metal, so that the cap 20 can preferably be pressed onto the container 2. Additionally, an outer cap (not shown) can be used above the cap 20; this outer cap is typically made of plastic, but can also be a metal cap. This outer cap is preferably used for quality assurance and can be removed from the container 2 and the cap 20 by tearing.

[0082] Especially Figure 6 and Figure 7 As shown, the flange 19 constructed on the container wall 24 is spaced apart from the opening edge 7 of the container 2 in the axial direction a, thereby forming an end-side region of the container wall 24. This region can be introduced into the groove 9 of the sealing plug 1 without the sealing plug 1 simultaneously covering the flange 19. In fact, the cap section 8 of the sealing plug 1 terminates in the axial direction a of the container 2 before the end face of the flange 19 facing the sealing plug 1.

[0083] Figure 5 For example, the construction of the sealing plug 1 in a longitudinal section is shown. The plug body 3 has a plug section 6 to be introduced into the container 2 and a cap section 8 with a groove 9. Referring to the radial direction r, the groove 9 is defined on the one hand by an inner groove wall 10 provided by the plug section 6, and on the other hand by an outer groove wall 11 spaced apart from the inner groove wall 10 by the radial width of the groove bottom 13, which belongs to the cap section 8.

[0084] Especially Figure 33a As can be seen from the enlarged view of the groove 9 of the sealing plug 1, the groove 9 may have a sealing protrusion 14 on the radially outer groove inner wall 11. The sealing protrusion 14 is constructed, for example, in a curved manner, and has an abutment region 12 for contacting the outer wall 15 of the container 2. The surface normal of the abutment region 12 is substantially parallel to the contraction direction s of the sealing plug, which is oriented in the radial direction r and points towards the direction of contraction caused by deep cooling. In other words, at least one sub-region of the surface of the sealing protrusion 14 is transverse to the contraction direction s of the sealing plug 1, which points towards the opposite radially inner groove inner wall 10.

[0085] According to all the embodiments shown, the plug section 6 also has a protrusion 16 on its outer side outside the groove 9, which points radially outward, i.e., towards the inner wall 11 of the outer groove. The protrusion 16 is arranged at a height offset from the sealing protrusion 14 of the inner wall 11 of the outer groove, with reference to the axial direction a of the sealing plug 1, and is located outside the groove 9. The protrusion 16 particularly ensures the sealing performance of the system above the glass transition temperature.

[0086] The end region of the container wall 24 that can be introduced into the groove 9, for example, has a flat outer container wall 15 without any protrusions, see also [reference needed]. Figure 33bThe end face of the opening edge 7 is chamfered in the radial direction r, wherein the resulting profile does not correspond to the inner profile of the groove 9 in the longitudinal section shown. Thus, a free space 25 is intentionally formed between the profile of the container wall 24 and the profile of the groove 9 (see example...). Figures 8b to 8e During the assembly or connection process and during the shrinkage process, the material of the sealing plug 1 can move into the free space.

[0087] Figures 8a to 8e The assembly process of container 2 and sealing plug 1, as well as the fixing of cap 20 and the subsequent cooling process, are schematically illustrated until a low temperature of, for example, -80 degrees Celsius is reached. Here, as... Figure 8f As shown, typically, the plug 3 is first placed alone into the container opening 5, and then the cap 20 is applied to it, thereby according to... Figure 8f After the state is obtained, it is based on Figure 8b The state is then maintained, and the process continues as described.

[0088] First, place the sealing plug 1 as follows Figure 8f As shown (but also as necessary) Figure 8a As shown, the plug section 6 of the sealing plug 1 is connected to the container 2, wherein the plug section 8 and the groove 9 are pushed together onto the opening edge 7 of the container 2 until the end region of the end section 8 of the sealing plug 1 abuts against the end contact surface of the flange 19. Here, it is preferable that the bottom 13 of the groove 9 of the sealing plug 1 simultaneously contacts the end face of the container wall 24. The established end positions, including the cap 20, are as follows: Figure 8b As shown. Cap 20 in Figure 8b In the state shown, it is not yet connected to container 2 or sealing plug 1, but is simply placed loosely.

[0089] Then, according to this embodiment, a crimping process is performed, wherein the cap 20 is fixed to the container 2 by means of a crimping tool, and the sealing plug 1 and the flange 19 of the container 2 are overlapped thereon. Figure 8c As shown, the cap 20 is therefore positioned so that its edge region surrounds the lower side of the flange 19. The lower side here refers to the side of the flange 19 facing away from the closure plug 1 in the reference axial direction a.

[0090] Then, the system consisting of container 2, sealing plug 1, and cap 20 is cooled from ambient temperature, for example, 22 degrees Celsius, to a low temperature, wherein, as... Figure 8eThe final temperature reached, for example, is -80 degrees Celsius. During cooling, the temperature is below the specified glass transition temperature of the occluder 1 material. The glass transition temperature of the occluder 1 made of brominated butyl rubber, exemplarily suggested here, is -62 degrees Celsius. At the glass transition temperature, the material of the occluder 1 changes from a rubbery elastic consistency to a glassy consistency. The occluder 1 contracts. Contraction occurs in all spatial directions, and therefore especially in... Figure 8d The contraction proceeds in the radially inward direction s shown.

[0091] Because especially Figure 33a The sealing protrusion 14, shown in more detail in the exemplary embodiment, has an abutment region 12 that has at least a portion of its surface transverse to the radial contraction direction s of the sealing plug 1, thus maintaining the sealing effect between the sealing plug 1 and the container 2 during cooling. The sealing plug 1 will not slip off the container wall 24 in the axial direction a because the force acting on the sealing protrusion 14 due to the contraction process is substantially orthogonal to the contact surface of the abutment region 12 on the container 2.

[0092] Figures 9a to 9d Different combinations of the sealing plug 1 and container 2 are shown.

[0093] Figure 9a This relates to embodiments of the sealing plug 1 and container 2 already described in the foregoing figures. For a more detailed description, refer to the preceding descriptive text.

[0094] Figure 9b An alternative embodiment is shown, wherein the design of the container neck 18 is consistent with that of... Figure 9a The designs are the same. However, the sealing plug 1 is designed differently. Specific differences can be seen by comparing magnified images. Figure 12 and Figure 16 It can be seen that, Figure 12 Showing according to Figure 9a The assembly state of the sealing plug 1 and container 2. Figure 16 As another embodiment, it is shown according to Figure 9b The assembly state of the combination of the sealing plug 1 and the container 2.

[0095] like Figure 12 and Figure 16 As can be seen from the comparison, according to Figure 12 or Figure 9a The sealing plug 1 has a greater proportion of the sealing protrusion 14 relative to the outer wall 15 of the container than according to Figure 16 or Figure 9b The implementation method allows for a larger spacing. The resulting effects will be explained later.

[0096] Figure 9c Another possible implementation is disclosed. The container wall 24 and the flange 19 constructed thereon are as described above. Figure 9a and 9b The design is as described in the earlier embodiment. However, the sealing plug 1 has a differently designed groove 9 compared to the earlier embodiment. The design details of the groove 9 will also be explained later. Figure 20 and 22 As seen in [the text]. Figure 20 In particular, it can be seen that the groove 9 has a recess 17 in addition to the sealing protrusion 14. The recess 17 is constructed on the bottom 13 of the groove 9 in the transition area with the radially outer inner wall 11 of the groove, and extends circumferentially along the groove 9 of the sealing plug 1.

[0097] Figure 9d Another embodiment is shown, wherein the sealing plug 1 and the container wall 24 of the container 2 are different from those according to the embodiment. Figures 9a to 9c The aforementioned embodiment. In this case, the sealing plug 1 does not have a sealing protrusion 14. Instead, the corresponding outer wall 15 of the container 2 has a sealing protrusion 21 that points radially outward, i.e., towards the radially outer inner wall 11 of the sealing plug 1. The radially outer inner wall 11 of the sealing plug 1 correspondingly has a flat abutment area 12, transitioning into a recess 17 at the bottom 13 of the groove. The recess 17 is arranged on the bottom 13 of the groove in a radially outer transition region that transitions into the radially outer inner wall 11. The relative transition region between the radially inner inner wall 10 and the bottom 13 of the groove does not have such a recess 17.

[0098] Figure 10 and 11 Now, firstly, for example, according to... Figure 9a The embodiment illustrates a comparison of the temperature-dependent shape changes of the sealing plug 1 in the region of the groove 9. This comparison relates, on the one hand, to the state of the sealing plug 1 at an ambient temperature of 22 degrees Celsius. Figure 10 On the other hand, it involves the state at minus 80 degrees Celsius. Figure 11 The consideration is the assembly state, such as... Figure 8c (22 degrees Celsius) or Figure 8e (After cooling to -80 degrees Celsius) as shown. For simplicity only, only the sealing plug 1 is shown here. This comparison is used for comparing the contact pressure along the contact line within the groove 9 in subsequent figures. The contact line extends along the radially inner groove wall 10, the groove bottom 13, and the radially outer groove wall 11. As shown Figure 10 and 11As can be seen, when the sealing plug 1 is cooled from a normal ambient temperature, for example 22 degrees Celsius, to a low temperature, for example -80 degrees Celsius, it undergoes stretching in the radial direction r. This is because the sealing plug 1 generally contracts, i.e., contracts in all spatial directions. In particular, deformation of the sealing plug 1 towards the radially inward side also occurs. However, since the inner wall 11 of the radially outer groove abuts against the outer wall 15 of the container, while the inner wall 10 of the inner groove is part of the plug section 6 that extends into the container opening 5, the inner wall 10 of the radially inner groove deforms radially inward, while the inner wall 11 of the radially outer groove is blocked by the outer wall 15 of the container and thus essentially maintains its previous radial position. This results in an increase in the width of the groove 9 when viewed in the radial direction. Consequently, the pressure conditions along the indicated contact line change. This refers to... Figures 12 to 15 Regarding the first implementation method (according to) Figure 9a (To be explained in more detail) Figure 10 and 11 The arrows in the diagram are used to explain how the contact length between the sealing plug and the container wall is determined at different temperatures. The contact length is measured from the origin of the arrow along its direction.

[0099] Figure 12 First, five defined contact points A, B, C, D, and E along the contact line are shown. Contact points A, B, C, D, and E are formed in a clockwise direction along the inner contour of groove 9.

[0100] Figure 13 The contact pressures at contact points A, B, C, D, and E at an ambient temperature of 22 degrees Celsius are shown graphically. The x-axis plots the circumferential lengths of contact points A, B, C, D, and E along the groove 9. The y-axis represents the contact pressure. It can be seen that the contact pressure is greatest at contact point C, specifically in the contact area between the bottom of the groove 13 and the end face of the opening edge 7 of the container 2. This is particularly attributable to the force of the cap 20 pressing against the sealing plug 1, which acts from above on the sealing plug 1 towards the container 2. Conversely, contact point D at the contact area 12 of the sealing protrusion 14 is unloaded, especially due to the adjacent free space 25 of no material between the sealing protrusion 14 and the bottom of the groove 13.

[0101] In comparison, Figure 14 and 15The diagram shows the case of the sealing plug 1 cooled to -80 degrees Celsius. It can be seen that essentially only at contact points C and D remain relevant pressure values. Other contact points A and B, which define the contact between the radially inner groove wall 11 and the container inner wall 4 of the container 2, no longer contact the container 2 due to the contraction of the sealing plug 1. Contact pressure along the inner contour of the groove 9 at these locations is almost no longer measurable. In contrast, the contact pressure at contact point C increases significantly, as can be seen from the y-axis scale. This increase in contact pressure at contact point C is attributed to the contraction of the sealing plug 1 material, which causes the sealing plug 1 to contract overall, and contact points C and D of the sealing plug 1 are pulled towards the container wall 24 to a greater extent. As contact points A and B detach from the container wall 24, the sealing plug 1 abuts against the outer wall 15 of the container, particularly through the contact area 12 (contact point D) of the sealing protrusion 14. At an ambient temperature of 22 degrees Celsius, there is negligible contact pressure at contact point D. At a temperature of -80 degrees Celsius, the main contact pressure of the sealing plug 1 on the container 2 is applied instead at that location.

[0102] The curved structure of the sealing protrusion 14 is particularly helpful in maintaining a sealed connection between the sealing plug 1 and the container 2. This is because the contact area 12 of the sealing protrusion 14 is transverse to the contraction direction s, which points radially inward toward the inner wall 10 of the radially inner groove. Thus, even if the sealing plug 1 is generally distorted in shape due to the contraction process, it is always possible to maintain contact between the sealing plug 1 and the outer wall 15 of the container at the contact point D. Furthermore, since the contact area 12 extends laterally relative to the contraction direction s, there is no risk of the sealing plug 1 slipping upward on the outer wall 15 of the container, i.e., slipping relative to the peeling direction of the container 2, which would result in a lack of seal in the container 2. In addition, there is no ramp (refer to axial direction a) in the contact area between the container 2 and the sealing plug 1 at the contact point D. Such a ramp would also be inclined relative to the contraction direction s, causing the sealing plug 1 to also acquire a component of motion in a direction orthogonal to the contraction direction s, which would result in slippage of the sealing plug 1.

[0103] To ensure high contact pressure at contact point D even at very low temperatures, such as -80°C or -196°C, the contact area 12 does not need to be precisely orthogonal to the contraction direction s. A small deviation from the 90° position is acceptable, for example, within + / -5°, preferably + / -2° or + / -1°. This angular deviation is generally tolerable by the system. Similarly, the orientation of the outer wall 15 of the container has a certain standard deviation and is slightly inclined in the radial direction r, and therefore also slightly inclined in the contraction direction s, which is the direction in which the sealing plug 1 points radially inward toward the inner wall 10 of the radially inner groove.

[0104] Figures 16 to 19 Showing according to Figure 9bAn embodiment of the system consisting of a sealing plug 1 and a container 2. This embodiment is similar to the aforementioned embodiment ( Figure 9a The difference is that the free space 25 above the sealing protrusion 14 is smaller.

[0105] Figure 16 and 17 First, the state at an ambient temperature of 22 degrees Celsius is shown. For example... Figure 17 and Figure 13 (according to Figure 9a A comparison of the implementation methods shows that the difference in contact pressure along the contact line of groove 9 at 22 degrees Celsius is essentially only due to the fact that... Figure 17 The implementation method exhibits higher contact pressure at contact point D.

[0106] At temperatures as low as -80 degrees Celsius, also see Figure 18 and 19 The contact pressure at contact point D is significantly increased compared to the first embodiment (see [reference]). Figure 15 and 19 (comparison), because relative to the basis Figure 14 , 15 The modified version has more material in the contraction direction s to exert pressure on the outer wall 15 of the container.

[0107] Figures 20 to 23 Showing according to Figure 9c The temperature characteristics of the system consisting of the sealing plug 1 and the container 2. The container 2, especially its container neck 18, is constructed in the same manner as in the aforementioned embodiment. However, the sealing plug 1 and the system according to... Figure 9a and 9b The difference in the implementation is that the bottom 13 of the groove 9 has a recess 17, which is located in the transition region between the bottom 13 of the groove and the radially outer inner wall 11 of the groove. For example... Figure 21 As shown, this embodiment differs essentially only at contact point D in terms of contact pressure along the contact line between the sealing plug 1 and the container 2. At an ambient temperature of 22 degrees Celsius, the relevant contact pressure at this point is, for example, similar to that in the first two embodiments (according to...). Figure 9a and 9b The values ​​are between 0 and 1. The contact pressures at the remaining contact points A, B, C, and E are essentially the same.

[0108] The contact pressure at a temperature of -80 degrees Celsius is determined by... Figure 23 It can be seen that the contact pressure at contact point C is essentially equivalent to the value in the earlier described embodiment. However, according to... Figure 22 and 23 In this implementation, the contact point D is significantly shifted to a later length position because, according to Figure 22 , 23The profile length of the inner wall 11 of the radial outer groove is greater than that of the recess 17 according to Figure 14 , 15 The implementation is longer. Therefore, the maximum pressure at contact point D only appears to shift outward due to the recess 17. According to Figure 15 The maximum values ​​of the two contact pressures at contact point D can be determined according to... Figure 23 The concave portion merges into a single maximum value, thus helping to better define the contact point. Furthermore, as... Figure 15 The comparison shows that the contact pressure in the contact point D region also increases significantly.

[0109] at last, Figures 24 to 32 Involving according to Figure 9d A variant in which the outer wall 15 of the container has a sealing protrusion 21, while the inner wall 11 of the radially outer groove of the sealing plug 1 is constructed flat, i.e., without a sealing protrusion.

[0110] Figures 24 to 28 First, individual views of the sealing plug 1 and container 2, as well as a sectional view, are shown. From Figure 27 and 28 In particular, the sealing protrusion 21 can be seen, which is located above the flange 19 on the outer wall 15 of the container, that is, between the end face of the flange 19 and the opening edge 7 of the container 2. The sealing protrusion 21 is constructed with a curved shape relative to the longitudinal section, as shown... Figure 29 And afterwards Figure 34b This is particularly evident in the design. In this variant, the sealing plug 1 also has a recess 17 on the bottom 13 of the groove.

[0111] At an ambient temperature of 22 degrees Celsius Figure 29 and 30 The contact pressure at contact points A to E is based on Figure 20 , 21 The situation in the previous embodiment was not significantly different. Only the contact pressure at contact point D was slightly increased.

[0112] If the system is thus cooled to a low temperature, for example -80 degrees Celsius, then the contact pressure at contact point D (see...) Figure 31 and 32 (Lower than according to) Figure 22 , 23 The implementation of the variant plan, based on Figure 22 , 23 In the modified implementation scheme, the sealing plug 1 has a sealing protrusion 14. According to... Figure 31 , 32 In the embodiment of (the sealing protrusion 21 on the outer wall 15 of the container), the contact pressure ratio is based on Figure 22 , 23 The implementation method is about 10% lower.

[0113] Finally, Figure 33a and 33b Or in 34a and 34b, it will also be based on Figure 9a and 9d A comparison was made with variant embodiments. As can be seen in the enlarged view of the contact surface of the relevant sealing plug 1 or container 2, in the embodiment described herein, the sealing protrusion 14 or 21 is convexly curved. Alternatively, other profiles are also feasible. However, the curved shape is advantageous in order to form the largest possible contact area 12 on the outer wall 15 of the container or the sealing protrusion 21, independent of the current cooling state of the system, with its surface substantially orthogonal to the radially inwardly oriented contraction direction s. This ensures that the sealing plug 1 does not slip off from the container 2 during the shape change due to contraction, or at least does not lose its sealing contact.

[0114] The above description is used to explain the inventions covered by this application as a whole, which independently improve upon the prior art through the following combinations of features, wherein two, more, or all of these combinations of features can also be combined, namely:

[0115] A sealing plug 1 designed for cryogenic applications is characterized in that the inner wall 11 of the radially outer groove has at least one abutment area 12, the surface of the abutment area abutting against the opening edge 7 of the container 2 in the installed state of the sealing plug 1 is oriented laterally, especially substantially orthogonally, preferably at an angle of 80° to 100° relative to the contraction direction s pointing radially inward toward the inner wall 10 of the radially inner groove, the abutment area 12 moving along the contraction direction when a cryogenic temperature is applied.

[0116] A sealing plug 1 designed for low-temperature applications is characterized in that the surface of the contact area 12 is oriented laterally, and in particular substantially orthogonally, relative to the bottom 13 of the groove 9 defined by the inner groove wall 10 and the outer groove wall 11.

[0117] A sealing plug 1 designed for cryogenic applications is characterized in that the abutment area 12 is part of a sealing protrusion 14 formed on the inner wall 11 of the radially outer groove, for abutting against the outer container 15 of the opening edge 7 of the container 2.

[0118] A sealing plug 1 designed for low-temperature applications is characterized in that the inner wall 10 of the radially inner groove has an annular and radially outwardly pointing protrusion 16, which is used to abut against the inner wall 4 of the container opening 5.

[0119] A sealing plug 1 designed for low-temperature applications is characterized in that the bottom 13 of the groove 9, defined by the inner groove wall 10 and the outer groove wall 11, has an annular surrounding recess 17.

[0120] A sealing plug 1 designed for low-temperature applications is characterized in that the plug body 3 has a cross-linked elastomer, especially a halogenated butyl rubber, such as brominated butyl rubber or chlorinated butyl rubber, or has a thermoplastic elastomer.

[0121] A sealing plug 1 designed for low-temperature applications, characterized in that the sealing plug 1 is designed for low temperatures down to -196 degrees Celsius.

[0122] A sealing plug 1 designed for low-temperature applications, characterized in that the sealing plug 1 is designed for low temperatures down to -80 degrees Celsius.

[0123] A system comprising a container 2, particularly an infusion bottle or vaccine vial, for use with medical or pharmaceutical substances subjected to low temperatures, and a sealing plug 1, wherein the container 2 has a container neck 18 with a container opening 5 having an opening edge 7, the container opening being closable by means of the sealing plug 1, and wherein the container neck 18 has a radially outwardly pointing flange 19, the flange being lapped by a cap 20 when closed by means of the sealing plug 1.

[0124] A system comprising a container 2 and a sealing plug 1, characterized in that the outer wall 15 of the container neck 18 has an annular, radially outwardly pointing sealing protrusion 21 between the flange 19 and the opening edge 7 of the container opening 5, the sealing protrusion being used to abut against the abutment area 12 of the sealing plug 1.

[0125] A system comprising a container 2 and a sealing plug 1, characterized in that the container 2 is a glass container.

[0126] A system comprising a container 2 and a sealing plug 1, having a cap 20 for securing the sealing plug 1 to the container 2, wherein the cap 20 is typically a metal cap, but may also be a plastic cap.

[0127] All disclosed features (albeit individually and in combination) constitute the essence of this invention. The disclosures of the appended priority documents (copies of earlier applications) are hereby fully incorporated into the disclosures of this application, and also to incorporate the features of those documents into the claims of this application. Dependent claims, by their features, even without the features of the cited claims, represent independent inventive improvements to the prior art, particularly for the purpose of filing divisional applications based on those claims. The invention specified in each claim may additionally have one or more features mentioned in the foregoing description, particularly those marked with reference numerals and / or specified in the list of reference numerals. The invention also relates to designs in which individual features mentioned in the foregoing description are not implemented, particularly when they are clearly dispensable for their respective purposes or can be replaced by other means that have the same technical function.

[0128] List of reference numerals

[0129] 1. Sealing plug

[0130] 2 containers

[0131] 3. Plug

[0132] 4 Inner wall of container

[0133] 5. Container opening

[0134] Section 6

[0135] 7. Opening edge

[0136] 8 Covered Sections

[0137] 9 slots

[0138] 10 Inner wall of the inner groove

[0139] 11. Inner wall of the outer groove

[0140] 12 Adhesive Area

[0141] 13 Bottom of the slot

[0142] 14 Sealing protrusion

[0143] 15 Container outer wall

[0144] 16. Protrusions

[0145] 17 recess

[0146] 18. Container neck

[0147] 19 Flange

[0148] 20 blocks

[0149] 21 Sealing protrusion

[0150] 22 Bottom of container

[0151] 23. Cap opening

[0152] 24 container wall

[0153] 25 Free Space

[0154] a Axial direction

[0155] r radial direction

[0156] s Contraction direction

[0157] A contact point

[0158] B contact point

[0159] C Contact point

[0160] D contact point

[0161] E contact point

Claims

1. A sealing plug (1) designed for cryogenic applications, for sealing cryogenically subjected containers (2) containing medical or pharmaceutical substances, said sealing plug being particularly suitable for infusion bottles or vaccine vials, wherein, The sealing plug (1) has a plug body (3) made of a rubber-like material, the plug body having a plug section (6) that engages with the inner wall (4) of the container opening (5) of the container (2) when mounted on the container (2), and a cap section (8) disposed at least partially outside the container opening (5) on the opening edge (7), wherein the cap section (8) has an annular groove (9) on the bottom surface of the container (2) facing the container (2) in the mounted state of the sealing plug (1), for receiving the opening edge (7), wherein the groove (9) passes through the plug body in the radial direction (r). The section (6) provides a radially inner groove wall (10) and is defined by a radially outer groove wall (11), characterized in that the radially outer groove wall (11) has at least one abutment area (12), the surface of which abuts against the opening edge (7) of the container (2) in the installed state of the closure plug (1) is oriented laterally, especially substantially orthogonally, preferably at an angle of 80° to 100° relative to the contraction direction (s) pointing radially inward toward the radially inner groove wall (10), the abutment area (12) moving along the contraction direction when a low temperature is applied.

2. The sealing plug (1) according to claim 1, characterized in that, The surface of the abutment area (12) is oriented laterally, and in particular substantially orthogonally, relative to the bottom (13) of the groove (9) defined by the inner groove wall (10) and the outer groove wall (11).

3. The sealing plug (1) according to claim 1 or 2, characterized in that, The abutment area (12) is part of a sealing protrusion (14) formed on the inner wall (11) of the radially outer groove, which is annular and radially inwardly pointing, and is used to abut against the outer side (15) of the opening edge (7) of the container (2).

4. The sealing plug (1) according to any one of the preceding claims, characterized in that, The inner wall (10) of the radially inner groove has an annular and radially outward protrusion (16) for abutting against the inner wall (4) of the container opening (5).

5. The sealing plug (1) according to any one of the preceding claims, characterized in that, The groove (9) has an annular surrounding recess (17) at its bottom (13), which is defined by the inner groove wall (10) and the outer groove wall (11).

6. The sealing plug (1) according to any one of the preceding claims, characterized in that, The plug (3) has a cross-linked elastomer, especially a halogenated butyl rubber, such as brominated butyl rubber or chlorinated butyl rubber, or a thermoplastic elastomer.

7. The sealing plug (1) according to claim 1 or 2, characterized in that, The sealing plug (1) is designed for low temperatures down to -196 degrees Celsius.

8. The sealing plug (1) according to claim 1 or 2, characterized in that, The sealing plug (1) is designed for low temperatures down to -80 degrees Celsius.

9. A system comprising a container (2), particularly an infusion bottle or vaccine vial, for use with medical or pharmaceutical substances subjected to low temperatures, and a sealing plug (1) according to any one of the preceding claims, wherein, The container (2) has a container neck (18) with a container opening (5) having an opening edge (7) which can be closed by means of the sealing plug (1), and wherein the container neck (18) has a radially outwardly pointing flange (19) which can be overlapped by a cap (20) when closed by means of the sealing plug (1).

10. The system according to claim 9, characterized in that, The outer wall (15) of the container neck (18) has an annular, radially outwardly pointing sealing protrusion (21) between the flange (19) and the opening edge (7) of the container opening (5), the sealing protrusion being used to abut against the abutment area (12) of the sealing plug (1).

11. The system according to claim 9 or 10, characterized in that, The container (2) is a glass container.

12. The system according to any one of claims 9 to 11, the system having a cap (20) for securing the sealing plug (1) to the container (2), the cap being typically a metal cap, but may also be a plastic cap.

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