EP4190714B1 - Closure system for a drug container and drug container with a closure system - Google Patents

Description

The invention relates to a closure system for a medication container, the interior of which is accessible via a mouth area designed in the manner of a bottle mouth, wherein the closure system comprises, in addition to a snap-on cap provided with a sealing element that can be pushed onto the mouth area, a locking ring that can be pushed onto the snap-on cap and can be locked in place by means of a number of snap ribs on the snap-on cap in a position that is completely pushed onto the snap-on cap. It further relates to a medication container with such a closure system and to a use of the closure system.

Medicines, particularly for treatment in highly specialized or complex therapies, are usually provided in active ingredient or medication containers, also known as containers or vials. Such a medication container is usually designed in the form of a vial and comprises an interior in which the medication or active ingredient is kept and which is accessible via a container opening designed in the form of a bottle mouth. From such a container or container, the active ingredient is then transferred via suitable transfer systems for the actual administration to suitable systems such as a syringe or an intravenous line that provides fluid access to the patient's circulation.

Modern medical procedures or therapies in particular may involve the use of drugs or substances that are intrinsically toxic or otherwise harmful or dangerous. Personnel handling such substances, such as pharmacists and nurses, may therefore face acute and long-term health risks, particularly if they are repeatedly exposed to drugs or solvents that could be released into the air during preparation, drug administration and other similar treatments. This problem can be particularly serious when cytotoxins, antiviral drugs, antibiotics or radiopharmaceuticals are involved. The effects of exposure to Potential health risks associated with these medications include increased risk of cancer, genetic changes, and the like.

Furthermore, in view of the fact that drugs with an extremely high dosage price have recently been approved, it is urgently desirable or even necessary to reliably prevent the unintentional release of even the smallest quantities of such drugs or active substances into the environment.

In order to avoid unintentional loss of active ingredients, the appropriate design of the medication containers is therefore generally necessary. The active ingredient or medication containers are usually provided with suitable closure systems in which a closure plug closes the container opening. This closure plug can then be pierced to remove the medication, for example using a hollow needle, through which the medication can then be sucked out of the container. To fix the closure plug, a snap-on cap with a ring lid with a central opening can be provided, which can be attached to the "bottle mouth" with the container opening. The closure plug is then attached centrally in this ring lid. Such a snap-on cap provided with the sealing element or closure plug is usually attached by pushing it onto the mouth area of the medication container and then locking it into place, for example by means of snap or locking hooks arranged on the snap-on cap, which form a locking connection with locking beads arranged on the container opening. This locking connection is then usually secured against unintentional release by means of a locking ring which can be pushed onto the impact cap and which laterally encloses it in its final position. Such a locking ring ensures that the snap or locking hooks arranged on the impact cap do not move outwards and thus release the locking connection with the medication container. The locking ring pushed onto the impact cap is usually also secured in its position on the impact cap by means of locking means, for example a number of snap ribs. Such a closure system is described in the patent specification US 2018/134457 A1 described.

In addition to the above-mentioned requirements for reliability and tightness of such closure systems, the upgrading for industrial processing in the sense of high quantities is also a common design goal. In particular, Automated filling and, accordingly, automated attachment of the closure system to the respective medication container should be possible for the potentially large number of medication doses that are to be provided. In addition, in view of high quantities, it is desirable to enable simultaneous processing of several medication containers in the form of larger batches, for example in the so-called "nesting" method.

The invention is therefore based on the object of specifying a closure system of the above-mentioned type which largely meets these requirements, in particular the suitability for automated filling processes, using simple means.

This object is achieved according to the invention in that the or each snap rib provided for fixing the locking ring in the position completely pushed onto the impact cap is guided in a corresponding guide slot during a movement of the inner circumferential surface of the locking ring relative to an outer circumferential surface of the impact cap corresponding thereto.

The invention is based on the idea that the closure system can be made more suitable for automated processing and also for high cycle or throughput rates with the correspondingly high processing speeds, among other things, by particularly promoting pre-assembly of the impact cap and locking ring components and by ensuring particularly reliable guidance of the pre-assembled components relative to one another. This can in particular eliminate potential sources of interference during automated processing, for example due to tilting or jamming of the components, incorrect positioning or the like. The desired reliable guidance of the pre-assembled components relative to one another can be achieved in a particularly simple manner by forming a guide pair for the components using components that are usually already present, in this case the respective snap ribs. To form such a guide pair, a corresponding guide slot, for example in the form of a groove, should be assigned to the respective snap rib in the other component.

For the formation of the guide pair mentioned above, it is fundamentally irrelevant which elements are arranged on which of the components, impact cap or retaining ring; ie for the intended use, the respective snap rib could be arranged on the inside of the retaining ring or on the outside of the impact cap, and the associated guide slot correspondingly on the other component. Preferably, however, the or each snap rib is arranged on the inside of the retaining ring and, correspondingly, the respective guide slot is arranged on the outside of the impact cap.

Usually, a closure system of the type mentioned is pressed onto the mouth of the medication container in a linear movement after the pre-assembly of the impact cap and locking ring. The impact cap is first pushed onto the mouth until it locks into place or otherwise reaches its intended end position. Then, further pressing of the system results in the locking ring being pushed onto the impact cap and increasingly enclosing it. To stabilize this primarily linear movement of the locking ring on the impact cap, the guide slot advantageously comprises a first axial segment designed in the form of an axial groove and extending in an axial direction parallel to the axis of rotation of the impact cap or locking ring.

In a further advantageous embodiment, a locking bead for locking the respective snap rib is arranged in this first axial segment, so that the snap rib can be used for the locking of the components as provided for in the design.

In a particularly advantageous embodiment, the locking system is designed for particularly stable pre-assembly of the impact cap and locking ring. It is advantageously provided that the locking ring is first placed on the impact cap during pre-assembly. Then, in the manner of a bayonet lock, turning the locking ring on the impact cap should create a mechanically reliable connection between the attached locking ring and the impact cap, whereby the system can later be pushed on completely from this position when it is finally attached to the medication container. To make this possible, in a particularly advantageous embodiment, the guide slot has a tangential segment designed in the manner of a tangential groove and extending in a tangential direction around the axis of rotation of the impact cap or locking ring.

The tangential segment of the guide slot conveniently merges into its first axial segment, whereby in the transition area between the tangential segment and the axial segment, to limit rotation of the locking ring relative to the impact cap a stop is designed for the respective snap rib. This means that during pre-assembly, the respective snap rib can first be pushed into the tangential segment of the guide slot assigned to it and then the locking ring can be rotated relative to the impact cap. This guides the snap rib in the tangential segment until it hits the stop. This stops the rotation and the locking ring is fixed in a defined and reproducible position on the impact cap. In this position, the snap rib is then also in the transition area from the tangential segment of the guide slot to its axial segment, so that from this position it is later possible to push the locking ring further onto the impact cap in the axial direction. The components are securely engaged with one another, so that the locking system pre-assembled in this way is particularly well suited to automated further processing, even under high loads and in high quantities.

In a further advantageous embodiment, a locking tooth with a beveled stop surface for the snap rib is arranged in the tangential segment of the guide slot. The bevel allows the snap rib to be pushed over the locking tooth during the rotation described above when it moves in the tangential segment, but on the other hand, due to the shape of the locking tooth, a backward movement of the snap rib over the locking tooth is then no longer possible. As a result, the snap rib is fixed in its final position in the tangential direction, so that a particularly stable and reliable pre-assembly of the components is achieved.

In an advantageous embodiment, the impact cap and/or the retaining ring is made of a plastic, preferably of polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefin polymer (COP) or polycarbonate.

In an embodiment considered to be independently inventive, a closure system of the above-mentioned type, preferably in conjunction with the embodiment explained above, is provided with a tamper-evident closure for the medication container. The closure system can be provided with an additional external closure element in the form of a disposable closure. This disposable closure, which can comprise, for example, a tear-off or sealed sealing lid, allows easy and reliable identification of whether the container has already been used for liquid transfer or not, and thus makes it easier to determine whether the container has already been "opened" and should therefore preferably be used for further liquid withdrawal until it is completely emptied and thus disposed of. For this purpose, in this preferred embodiment, a sealing plate is formed on the outside of the securing ring and can be torn off from it to form a tamper-evident closure.

A medicine container, the interior of which is accessible via a container opening designed in the manner of a bottle mouth, closed with a closure system of the type described above, is also considered to be independently inventive.

The use of a closure system of the type mentioned for a medication container is also considered to be independently inventive.

The advantages achieved with the invention are in particular that by providing a guide pair between the locking ring and the impact cap by means of the respective snap rib on the one hand and the associated guide slot on the other hand, a particularly high mechanical stability of the pre-assembled intermediate product consisting of the impact cap and locking ring can be achieved. This pre-assembled intermediate product is therefore also particularly well suited for subsequent processing steps with comparatively high stress, for example in the context of automated processing or in processes with high cycle rates or quantities.

Fig. 1

einen mit einem Verschlusssystem verschlossenen Medikamentenbehälter,

Fig. 2

die Behälteröffnung des Medikamentenbehälter nach Fig. 1 in perspektivischer Ansicht,

Fig. 3

die Behälteröffnung des Medikamentenbehälter nach Fig. 1 im Längsschnitt,

Fig. 4

den Medikamentenbehälter nach Fig. 1 mit zugeordnetem Verschlusssystem im Längsschnitt in Explosionsdarstellung,

Fig. 5

ein Dichtelement für den Medikamentenbehälters nach Fig. 1,

Fig. 6

die Aufprellkappe des Verschlusssystems des Medikamentenbehälters nach Fig. 1,

Fig. 7

einen Sicherungsring des Verschlusssystems des Medikamentenbehälters nach Fig. 1,

Fig. 8

die Aufprellkappe nach Fig. 6 in vergrößerter perspektivischer Ansicht,

Fig. 9-12

eine Sequenz von Schritten bei der Anbringung des Verschlusssystems an den Medikamentenbehälter nach Fig. 1.

An embodiment of the invention is explained in more detail with reference to a drawing. In it:

Fig.1

a medicine container closed with a locking system,

Fig. 2

the container opening of the medication container Fig.1 in perspective view,

Fig.3

the container opening of the medication container Fig.1 in longitudinal section,

Fig.4

the medicine container after Fig.1 with associated locking system in longitudinal section in exploded view,

Fig.5

a sealing element for the medication container according to Fig.1 ,

Fig.6

the impact cap of the closure system of the medication container after Fig.1 ,

Fig.7

a locking ring of the closure system of the medication container Fig.1 ,

Fig.8

the impact cap after Fig.6 in enlarged perspective view,

Fig. 9-12

a sequence of steps in attaching the closure system to the medication container according to Fig.1 .

Identical parts are provided with the same reference numerals in all figures.

The medication container 1 acc. Fig.1 , also referred to as a container or vial, is designed in the manner of a small bottle. It comprises an interior 4 enclosed by a container wall 2, in which the medication or active ingredient is kept. In the exemplary embodiment, the container wall 2 is made from a suitably selected plastic with or without a barrier layer. A "medical grade" plastic is particularly preferably provided here, such as COP variants 690R ^® , 790R ^® , COC variants Topas ^® 8007S-04, 6013S-04, 6015S-04. The plastic is particularly preferably selected with regard to the criteria of being transparent, break-resistant, having little to no interaction with the intended medication, medical grade, in particular usable as a glass substitute, individually or in combination with one another. The interior 4 is accessible via a container opening 6 designed in the manner of a bottle mouth.

The medication container 1 is designed especially for the storage of active substances or medications, where any loss of material due to unintentional release into the environment or surroundings should be avoided as far as possible. This can be the case, for example, for substances that are toxic, hazardous to health or otherwise dangerous for the people handling them, or for particularly expensive substances or active substances, such as those that are increasingly used in modern therapies. In order to keep such undesirable loss of material particularly low, the medication container 1 is equipped with a closure system 10 that closes the container opening 6, which on the one hand ensures a particularly high tightness and, on the other hand, is designed for particularly effective protection against manipulation.

The container wall 2 of the medication container 1 is, as shown in the perspective view in Fig. 2 and the longitudinal section in Fig.3 can be clearly seen, in the area of the container opening 6, it is provided with a number of peripherally mounted outer beads 12, in the exemplary embodiment two, as a fastening element for the closure system 10. A first of these outer beads 12 is arranged directly adjacent to the mouth opening 14 of the container 1; a second outer bead 12, however, is located at a distance somewhat further away from the mouth opening 14. In the following, with reference to the longitudinal direction of the container opening designed in the manner of a bottle mouth, such a positioning further away from the mouth opening is referred to as "below" or "proximal", whereas a positioning more towards the mouth opening 14 and thus towards the free, open end of the container opening 6 is referred to as "above" or "distal".

As can be seen particularly from the longitudinal section shown in Fig. Fig. 3b can be clearly seen, the two upper outer beads 12 attached all the way around the container opening 6 have an almost or completely identical bead width w. This design is chosen with regard to the intended use of these outer beads for locking or fixing with associated locking or snap elements of the closure system 10. In contrast, the lowest or proximal outer bead 16, viewed in the direction of the mouth opening, is designed with a bead width W that is significantly larger than that of the outer beads 12, approximately three times the bead width w of the adjacent outer bead 12, in order to improve protection against manipulation.

In the example, as can be seen from the illustration in Fig. 2 As can be clearly seen, the outer beads 12, 16 are designed to be completely circumferential. In other embodiments, the outer beads 12, 16 could be designed to be completely or partially segmented, ie comprise a plurality of segments which follow one another in the rotational direction and are positioned at a distance from one another, with gaps being formed between them.

Another particularly preferred aspect of the present invention relates to the cross-sectional profile of the limiting outer bead 16. As shown in Fig.3 can be removed, the limiting outer bead 16 has on its lower side, from the mouth opening 14 facing away from the container opening 6 has a largely straight flank 18, the normal of which is tilted by a maximum of 10° relative to the longitudinal axis of the container opening 6. This design achieves, on the one hand, a particularly reliable flat covering of the closure system 10 arranged above, while, on the other hand, an attack surface is formed which is particularly favorable and suitable for automated handling purposes.

Furthermore, the limiting outer bead 16 has a mouth-side flank 20 on its upper side facing the mouth opening 14, which, as explained below, is specifically designed for a favorable interaction with the closure system 10. In particular, the upper flank 20 of the limiting outer bead 16 forms a contact surface 22.

In Fig.4 is the mouth area of the medication container 1 together with the associated closure system 10 in an exploded view, in Fig. 4a in side view and in Fig. 4b in longitudinal section. The closure system 10 comprises as essential components a sealing element 24 designed as a closure plug for closing the container opening 6 and a fixing cap 26 with which the sealing element 24 can be firmly attached to the container opening 6. Adapted to the outer beads 12, the fixing cap 26 is designed as a snap-on cap 28, on the outer circumference of which a number of snap hooks or locking elements 30 that can be brought into engagement with the respective outer bead 12 are arranged. When attaching the snap-on cap 28, it can thus be pushed or snapped onto the container opening 6, wherein the locking elements 30 are first bent outwards by the respective outer bead 12 and then, after further pushing on, engage behind the outer bead 12 and lock with it in the manner of a snap connection. Furthermore, the impact cap 28 is adapted in terms of its dimensioning in the longitudinal direction of the container opening 6 to the outer contour formed by the outer beads 12, 16 in such a way that the end face 34 of the or each locking element 30 formed by the end edge 32 of the impact cap 28 rests against the contact surface 22 arranged on the mouth-side flank 20 of the limiting outer bead 16 when the impact cap 28 is completely pushed onto the container opening 6.

The impact cap 28 comprises a ring cover 44 having a central opening 42. The ring cover 44, which is made in one piece and Fig.5 The sealing element 24 shown enlarged comprises, in the manner of a basic element, a closure plate 46, at the first A thickening 48 is formed on the plate side, completely filling the central opening 42 of the ring cover 44 and engaging therewith in a locking manner. The thickening 48 is provided with a circumferential groove 50 in its connection area with the closure plate 46, forming an undercut. The sealing element 24, which is essentially a single piece, is made of a suitable and also comparatively soft and easily deformable material, in the exemplary embodiment made of rubber or TPE, preferably "medical grade", also with regard to the desired sealing purposes. This choice of material also ensures that the sealing element 24 can be pierced using a suitable instrument, for example a hollow needle, if necessary, i.e. when active ingredient is to be removed from the medication container 1. By using these material properties, in particular the deformability, the sealing element 24 can be almost firmly connected to the impact cap 28 by introducing the thickening 48 into the opening 42 in the ring cover 44 and the peripheral edge of the opening 42 then engaging in the groove 50 and thus fixing the sealing element 24 to the impact cap 28.

The sealing element 24 advantageously contributes to sealing the container opening 6 in two ways. On the one hand, a sealing effect is achieved, quite comparable with known systems, in that in the assembled system the closure plate 46, which is suitably adapted in terms of its dimensions, in particular its outer diameter, to the mouth edge 52 of the container opening 6, is pressed onto the mouth edge 52 with its edge of the sealing element 24 by the impact cap 28 which can be snapped onto the mouth edge 52. As a result of this axial force effect in relation to the longitudinal axis of the container opening, the closure plate 46 can already develop a sealing effect due to the deformability of the material. In addition, in the present case, the provision of radial force components, i.e. contact forces which press the sealing element 24 in a radial direction against the inside of the container wall 2 in the area of its mouth, is also provided for an overall particularly increased sealing effect.

For this purpose, a radial sealing element 54 is formed on the second side of the closure plate 46. The cross-sectional shape of the radial sealing element 54 is adapted to the cross-sectional shape of the container opening 6 in the mouth area (in the exemplary embodiment, both are round). In terms of its dimensions, it is also adapted to the clear width I of the container opening 6 and, with regard to the deformability of the material of the sealing element 24, is designed to be slightly larger than the clear width I of the container opening 6. This creates a flat pressure area when the radial sealing element 54 is inserted into the container opening 6, taking into account the deformability of its material. or pressure effect on the inner wall of the container in the area of the container opening. With regard to common standards and usual norms for such components, the container opening can be suitably selected and dimensioned; for example, its clear width can be suitably matched to the standard size "13 neck" (corresponds to an outer diameter of the container opening of 13mm) or to the standard size "20 neck" (corresponds to an outer diameter of the container opening of 20mm).

The sealing element 24 is advantageously designed for an even further improved sealing effect in the radial direction. For this purpose, the shape is selected such that the central area of the sealing element 24 forming the thickening 48 is surrounded by a circumferential groove or trench-like depression 56 that extends deep into the closure plate 46. The depression 56 can also completely penetrate the material thickness of the closure plate 46, so that the sealing element 24 in this embodiment is designed to be multi-component. Adapted to this, the impact cap 28, as shown in Fig. 6a in perspective view from below and in Fig. 6b shown enlarged in longitudinal section, has a reinforcing ring 58 which is formed on the underside of the ring lid 44 and runs around the opening 42. When the two components are assembled, this reinforcing ring 58 is inserted into the recess 56 of the sealing element 24. The dimensions are coordinated with one another in such a way that the reinforcing ring 58 gives the radial sealing element 54 of the sealing element 24 increased strength and rigidity towards the outside, i.e. in the radial direction, and thus improves the radial seal even further. In particular, the appropriately selected dimensions of the reinforcing ring 58 can deform the radial sealing element 54 more or less slightly towards the outside and in doing so generate an additional contact force in the radial direction on the inner wall of the medication container 1 in the area of the container opening 6.

In the exemplary embodiment, the impact cap 28 consists of a suitably selected plastic, namely polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefin polymer (COP) or polycarbonate.

As a further component, as can be seen from the illustration in Fig.4 As is clear, the closure system 10 comprises a Fig.7 enlarged perspective view from below of the locking ring 60 which can be pushed onto the impact cap 28. This can be pushed onto the impact cap 28 from the outside after the impact cap 28 has been pushed onto the outside and locked into place with the outer beads 12. This fixes the locking elements 30 radially so that they can no longer move outwards. This means that the locking of the impact cap 28 with the outer bead 12 can no longer be easily released and is therefore fixed. The locking ring 60 in turn has a number of snap ribs 62 formed on the inside and positioned at the end, by means of which it can be fixed to the impact cap 28 in a locking manner.

Furthermore, the medication container 1 closed with the closure system 10 has a tamper-evident closure 70 as a component. This is intended to ensure, in the form of a disposable closure, that the user can easily and reliably determine whether the medication container 1 has already been used for liquid transfer or not, i.e. whether active ingredient has already been removed or not. It therefore makes it easier to determine whether the container has already been "opened" and should therefore preferably be used for further liquid removal until it is completely empty and should therefore be disposed of. The tamper-evident closure 70 is designed as a sealing plate 72 molded onto the securing ring 60. The sealing plate 72 is dimensioned and positioned in such a way that, when installed, it completely covers the central opening 42 of the ring lid 44 and thus the exposed surface of the sealing element 24 accessible via it. In order to access the interior of the medication container 1, i.e. to remove active ingredient, the sealing plate 72 must first be removed so that the sealing element 24 can be pierced.

The closure system 10 of the medication container 1 is designed for a particularly stable pre-assembly of the locking ring 60 on the impact cap 28, so that the pre-assembled system is also particularly well suited for subsequent process steps with high stress, for example in the context of automated filling or packaging processes. For this purpose, the snap ribs 62 are also used as an additional function to form a guide pair, which in addition to this, as shown in the perspective view of the impact cap 28 in Fig.8 shown, for each of the snap ribs, a guide slot 82 is arranged in the outer surface 80. The guide pairing formed by the snap rib 62 on the one hand and the corresponding guide slot 82 on the other hand has the effect that the respective snap rib 62 is guided in the corresponding guide slot 82 when the inner surface 84 of the locking ring 60 moves relative to the outer surface 80 of the impact cap 28 corresponding to it, so that the positions of these components relative to one another can be set in a reproducible and controllable manner.

In the exemplary embodiment, the respective snap rib 62 is arranged on the inside of the locking ring 60 and, correspondingly, the respective guide slot 82 is arranged on the outside of the impact cap 28; alternatively, however, the snap rib 62 could also be positioned on the impact cap 28 and, correspondingly, the guide slot 82 could be positioned on the inner surface 84 of the locking ring 60.

As shown in Fig.8 can be clearly seen, the guide slot 82 comprises a first axial segment 86 designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the impact cap 28. This axial segment 86 is delimited on both sides by a linear guide edge 88, 90, which guide the respective snap rib 62 when the locking ring 60 is pushed onto the impact cap 28. Furthermore, a locking bead 92 is arranged in the first axial segment 86. As soon as the snap rib 62 has been pushed over the locking bead 92 when the locking ring 60 is pushed onto the impact cap 28, the respective snap rib 62 is locked to the locking bead 92.

Furthermore, the guide slot 82 has a tangential segment 94 designed in the manner of a tangential groove and extending in a tangential direction around the axis of rotation of the impact cap 28. The tangential segment 94 has a lower or proximal guide edge 96 in a first region, above which a projection of a second axial segment 98 is formed with an open opening region into which the respective snap rib 62 can be inserted. When the locking ring 60 is placed on the impact cap 28, the guide edge 96 forms a stop for the respective snap rib 62 and thus prevents any further linear sliding movement. The tangential segment 94 also merges into the axial segment 86, with a stop 102 for the respective snap rib 62 being formed in the transition region 100 between the tangential segment 94 and the axial segment 86. This serves to limit the rotation of the retaining ring 60 relative to the impact cap 28.

In the tangential segment 94 of the guide slot 82 there is also a locking tooth 104 with a bevelled stop surface 106 for the snap rib 62.

The attachment of the closure system 10 to the medication container 1 is shown in the Fig. 9 to 12 shown using a sequence of steps. In a first step, in Fig.9 shown, the locking ring 60, designed as a tamper-evident closure 70 and provided with the sealing plate 72, is first attached with its snap ribs 62 above the junction areas of the respective second axial segments 98 to the pre-assembled, already with the sealing element 24 is positioned on the impact cap 28. Then, as shown in Fig. 10a in perspective view and in Fig. 10b shown in perspective section, the locking ring 60 is pressed linearly downwards onto the impact cap 28 and thus placed onto it. The snap ribs 62 are inserted into the second axial segment 98 of the respective associated guide slot 82 until they strike the guide edge 96. During pre-assembly, the respective snap rib 62 is thus initially inserted into the tangential segment 94 of the associated guide slot 82.

It is then intended to rotate the locking ring 60 relative to the impact cap 28; this is shown in Fig. 11a in perspective view and in Fig. 11b shown in perspective section. This twisting guides the respective snap rib 62 in the respective tangential segment 94 until it hits the stop 102. This ends the twisting. During the twisting, the snap rib 62 is also moved over the locking tooth 104 arranged in the tangential segment 94, which is possible in this direction of twist due to the bevel of the stop surface 106. Due to the asymmetrical contour of the locking tooth 104, however, it is then no longer possible to rotate it, so that the locking ring 60 is then also secured against rotation relative to the impact cap 28. The locking ring 60 is thus fixed both axially and rotationally in a defined and reproducible position on the impact cap 28.

In this position, the snap rib 62 is then also located in the transition area 100 from the tangential segment 94 of the guide slot 82 to its first axial segment 86. From this position, the locking ring 60 can then be pushed further onto the impact cap 28 in the axial direction. The components are securely engaged with one another, so that the locking system 10 pre-assembled in this way is particularly well suited for automated further processing, even under high loads and in high quantities.

Starting from this pre-assembled state, the closure system 10 can then be attached to the container opening 6 immediately or at a later time, as required. In this case, under certain circumstances and as required, the Fig. 11b shown intermediate position. In this intermediate step, the embodiment provided in the embodiment is used, in which two circumferential outer beads 12 in the form of a double bead are provided on the outside in the mouth area of the container opening 6. In this embodiment, the Outer beads 12 are separated from one another by a groove 74 running between them. In such a design, it is possible to push the closure system 10 in a first step only so far onto the container opening 6 that the locking hooks 76 formed on the locking elements 30 only engage in the groove 74 and initially lock the system there. In this intermediate state, which in Fig. 11b As shown, the sealing element 24 does not yet close the container opening 6, since the radial sealing element 54 has not yet penetrated into the interior of the container opening 6. Rather, in this state, a circumferential, still open annular gap is formed between the radial sealing element 54 and the mouth 14 of the container 1. Together with the circumferential gaps between the individual locking elements 30 of the impact cap 28, there is thus still a gas-side connection between the interior 4 of the medication container 1 and the external environment in this state.

This position can be used, for example, for freeze-drying, also referred to as lyophilization, lyophilization or sublimation drying, the active ingredient in the medication container 1. This is a now widely used method for gently drying products, which is used for a variety of medications or active ingredients in order to preserve them. During such freeze-drying, it may be necessary to be able to release gases or vapors, in particular water vapor, into the environment, and such an option is offered by the Fig. 11b shown positioning of the components.

After this intermediate step, or possibly directly after the Fig. 11 pre-assembly shown, if no such intermediate step is required, the closing process is then completed and the system is in the Fig. 12 shown, completely closed state. To do this, the impact cap 28 is first pushed axially downwards onto the container opening 6, so that the sealing element 24 now penetrates into the container opening 6 with its radial sealing element 54 until the closure plate 46 rests with its outer edge on the mouth of the container 1 and then, with slight deformation of the closure plate 46, seen in the longitudinal direction of the container opening 6, the locking hooks 76 of the impact cap 28 engage below the second or lower outer bead 12. The locking ring 60 is then pushed downwards so that it surrounds the impact cap 28 on the outside. The locking elements 30 are thus locked in their position and the medication container 1 is in the Fig. 12 shown position is securely closed.

From this illustration, i.e. in the fully assembled state, it can also be seen that the lower limiting outer bead 16 secures the pushed-on closure system 10 from below and thus increases the protection against manipulation. Due to the bead width W of the limiting outer bead 16, which is significantly larger than that of the outer beads 12, the open end area of the pushed-on components (impact cap 28, locking ring 60) is covered from below and thus protected against tampering. Furthermore, the edge 32 of the impact cap rests on the contact surface 22, so that further support can be provided here.

As shown in the illustration of the impact cap 28 in Fig. 6a or Fig.8 is also easy to remove, an RFID chip 110 is arranged on its ring lid 44, preferably injected into it, in a design considered to be independently inventive. The RFID chip 110 can be provided with a code or identifier that individually identifies the medication container and/or can contain further information regarding the contents, for example the medication or active ingredient composition, a possible expiration date, a batch number, the raw materials used, production and manufacturing information from the manufacturer or the like. In particular, since such a chip can also be read contactlessly, automated handling of the medication container 1 and its contents can be achieved, up to fully or partially automated medication production in mixing systems or the like.

List of reference symbols

1

Medicine container

2

Container wall

4

Interior

6

Container opening

10

Locking system

12

Outer bead

14

Muzzle opening

16

Limiting outer bead

18

lower flank

20

upper flank

22

Contact surface

24

Sealing element

26

Fixing cap

28

Impact cap

30

Locking elements

32

Edge

34

Frontal area

42

opening

44

Ring lid

46

Locking plate

48

thickening

50

Groove

52

Mouth edge

54

Radial sealing element

56

Deepening

58

Reinforcement ring

60

Retaining ring

62

Snap ribs

70

Tamper-evident closure

72

Sealing plate

74

Groove

76

Latching hook

80

Shell surface

82

Leadership backdrop

84

Shell surface

86

Axial segment

88, 90

Leading edge

92

Locking bead

94

Tangential segment

96

Leading edge

98

second axial segment

100

Transition area

102

stop

104

Ratchet tooth

106

Stop surface

110

RFID chip

w

Bead width

W

Bead width of the outer limiting bead

D

diameter

L

clear width

Claims (11)

1. Closure system (10) for a drug container (1), the interior (4) of which can be accessed via a mouth region (6) designed in the manner of a bottle mouth, wherein the closure system (10) comprises, besides a press-fit cap (28) which can be pushed onto the mouth region (6) and is provided with a sealing element (24), a securing ring (60) which can be pushed onto said press-fit cap and which, when in a position in which it is pushed completely onto the press-fit cap (28), can be fixed in a lockable manner on the press-fit cap (28) by means of a number of snap ribs (62), and wherein the or each snap rib (62) is guided in a corresponding guide slot (82) by a movement of the inner lateral surface (84) of the securing ring (60) relative to a corresponding outer lateral surface (80) of the press-fit cap (28).
2. Closure system (10) according to Claim 1, in which the or each snap-in rib (62) is arranged on the inside of the securing ring (60) and, corresponding thereto, the respective guide slot (82) is arranged on the outside of the press-on cap (28).
3. Closure system (10) according to Claim 1 or 2, the guide slot (82) of which comprises a first axial segment (86) designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the press-on cap (28) and the retaining ring (60).
4. Closure system (10) according to Claim 3, in the first axial segment (86) of which there is a locking bead (92) for locking the respective snap rib (62) in place.
5. Closure system (10) according to any one of Claims 1 to 4, the guide slot (82) of which comprises a tangential segment (94) which is designed in the manner of a tangential groove and extends in a tangential direction about the axis of rotation of the press-on cap (28) and the securing ring (60).
6. Closure system (10) according to Claim 5, in which the tangential segment (94) of the guide slot (82) transitions into its first axial segment (86), wherein a limit stop (102) for the respective snap rib (62) is formed between the tangential segment (94) and the axial segment (86) in the transition area (100) to delimit a rotation of the securing ring (60) relative to the press-on cap (28).
7. Closure system (10) according to Claim 5 or 6, in the tangential segment (94) of which a locking tooth (104) with bevelled stop surface (106) for the snap-in rib (62) is arranged.
8. Closure system (10) according to any one of Claims 1 to 7, of which the press-on cap (28) and/or securing ring (6) is/are made from a plastic, preferably from polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefin-polymer (COP) or polycarbonate.
9. Closure system (10) according to any one of Claims 1 to 8, wherein a sealing plate (72) is overmoulded fixedly on the outside of the securing ring (60) and can be torn off to form a tamper-evident closure (70).
10. Drug container (1) for a medicinal substance or medicament, the interior (4) of which is accessible via a mouth region (6) designed in the manner of a bottle mouth, with a closure system (10) according to any one of Claims 1 to 9.
11. Use of a closure system (10) according to any one of Claims 1 to 9 for closing the mouth opening of a drug container (1) for a medicinal substance or medicament.

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