EP4190714A1 - Closure system for a drug container and drug container with a closure system - Google Patents

Abstract

A closure system (10) for a medication container (1), the interior (4) of which is accessible via a mouth area (6) designed in the manner of a bottle mouth, the closure system (10) in addition to a slidable onto the mouth area (6) with a press-on cap (28) provided with a sealing element (24) and comprising a locking ring (60) that can be pushed onto the press-on cap (28) and can be fixed in a snap-lockable manner in a position that is completely pushed onto the press-on cap (28) by means of a number of snap-in ribs (62) on the press-on cap (28), should be particularly suitable for automated filling processes with simple means. For this purpose, according to the invention, the or each snap rib (62) is guided in a corresponding guide slot (82) when the inner lateral surface (84) of the securing ring (60) moves relative to a corresponding outer lateral surface (80) of the press-on cap (28).

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, the closure system comprising, in addition to a snap-on cap that can be pushed onto the mouth area and provided with a sealing element, a safety ring that can be pushed onto this, which is in a completely position pushed onto the press-on cap by means of a number of snap-in ribs on the press-on cap can be locked in place. It further relates to a medicament container with such a closure system and to a use of the closure system.

Medicines, in particular for treatment in highly specialized or complex therapies, are usually made available in active ingredient or medicine containers, also referred to as containers or vials. Such a medicament container is usually designed in the manner of a small bottle and comprises an interior space in which the medicament or the active ingredient is kept and which is accessible via a container opening designed in the manner of a bottle mouth. The active substance is then transferred from such a receptacle or container via suitable transfer systems for the actual administration to suitable systems such as a syringe or an intravenous line which provides fluid access to the patient's circulatory system.

Especially in modern medical procedures or therapies, drugs or substances can be used that are actually toxic or otherwise harmful or dangerous. Personnel handling such substances, such as pharmacists and nurses, can thus face acute and long-term health risks, particularly when they are repeatedly exposed to drugs or solvents released into the air during preparation, drug administration and other similar treatments could escape. This problem can be particularly serious when dealing with cytotoxins, antiviral drugs, antibiotics or radiopharmaceuticals. Died by exposure to Potential health risks associated with these drugs include increased risk of cancer, genetic changes, and the like.

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

In view of the aim of avoiding unintentional losses of active ingredient, it is therefore generally necessary to design the medication container in a suitable manner. For this purpose, the active substance or medication containers are usually provided with suitable closure systems in which a closure stopper closes the container opening. This sealing stopper can then be pierced to remove the medicament, for example by means of a hollow needle, via which the medicament can then be sucked out of the container. To fix the closure stopper, a snap-on cap can be provided with a ring lid having a central opening, which can be attached to the "bottle mouth" with the container opening. The sealing plug is then placed centrally in this ring cover.

Such a press-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 onto it, for example by means of snap or snap-in hooks arranged on the press-on cap, which form a snap-in connection with locking beads arranged on the container opening form. This latching connection is then usually secured against unintentional loosening by means of a securing ring which can be pushed onto the press-on cap and encloses it laterally in its end position. Such a securing ring ensures that the snap-in or snap-in hooks arranged on the press-on cap do not move back outwards and thus loosen the snap-in connection with the medicament container. The locking ring pushed onto the press-on cap is usually likewise secured in its position on the press-on cap by means of latching means, for example a number of snap-in ribs.

In addition to the above-mentioned requirements for reliability and tightness of such closure systems, upgrading for industrial processing in terms of large quantities is also a common design goal. In particular, doing this should be straight Automated filling and correspondingly also automated attachment of the closure system to the respective medicament container can be made possible for the possibly desired large number of medicament doses to be provided. In addition, it is desirable, with regard to large quantities, to enable simultaneous processing of a plurality of medication containers in the manner of larger batches, for example in the manner of so-called "nesting".

The invention is therefore based on the object of specifying a closure system of the type mentioned above, which meets these requirements, in particular the suitability for automated filling processes, to a particularly large extent with simple means.

This object is achieved according to the invention in that the or each snap-in rib provided for fixing the securing ring in a position completely pushed onto the press-on cap is guided in a corresponding guide slot during a movement of the inner lateral surface of the securing ring relative to a corresponding outer lateral surface of the press-on cap.

The invention is based on the consideration that the closure system for automated processing and also for high cycle or throughput rates with the correspondingly high processing speeds can be upgraded, among other things, by the fact that on the one hand a pre-assembly of the components impact cap and safety ring is particularly favored and on the other hand a particularly reliable guidance of the preassembled components relative to one another is ensured. In this way, it can be achieved in particular that potential sources of interference in the automated processing, for example due to tilting or canting of the components, incorrect positioning or the like, are eliminated. The desired reliable guidance of the preassembled 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 present anyway, in this case the respective snap ribs. In order to form such a guide pairing, a corresponding guide link, for example in the form of a groove, should be assigned to the respective snap rib in the respective other component.

For the formation of the said pair of guides, it is fundamentally irrelevant which of these elements is arranged on which of the components: impact cap or locking ring; ie for the intended use, the respective snap rib be arranged on the inside of the locking ring or on the outside of the press-on cap, and the associated guide slot corresponding to the other component. Preferably, however, the or each snap-in rib is arranged on the inside of the securing ring and, corresponding thereto, the respective guide link is arranged on the outside of the press-on cap.

A closure system of the type mentioned is usually pressed onto the mouth opening of the medicament container in the manner of a linear movement after the pre-assembly of the press-on cap and the securing ring. In this case, the press-on cap is first pushed onto the muzzle until it latches there or reaches its intended end position in some other way. Further pressing on the system then results in the retaining ring being pushed onto the press-on cap and increasingly enclosing it. In order to stabilize this primarily linear movement of the locking ring on the press-on cap, the guide link advantageously comprises a first axial segment 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 or of the 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 design-related locking of the components.

In a particularly advantageous embodiment, the closure system is designed for a particularly stable pre-assembly of the press-on cap and the securing ring. In this case, it is advantageously provided that the retaining ring is first attached to the press-on cap during pre-assembly. Then, in the manner of a bayonet lock, twisting the locking ring on the press-on cap should produce a mechanically reliable connection of the attached locking ring with the press-on cap, and starting from this position later, when the system is finally attached to the medication container, the system can be pushed open completely. In order 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 about the axis of rotation of the press-on cap or the securing ring.

The tangential segment of the guide slot expediently transitions into its first axial segment, with the transition area between the tangential segment and the axial segment being used to limit rotation of the securing ring relative to the press-on cap a stop is formed for the respective snap rib. Thus, during pre-assembly, the respective snap rib can first be pushed into the tangential segment of the guide slot associated with it and then the securing ring can be rotated relative to the press-on cap. As a result, the snap rib is guided in the tangential segment until it hits the stop. This stops the twisting and the retaining ring is fixed in a defined and reproducible position on the press-on cap. In this position, the snap rib is then also in the transition area from the tangential segment of the guide link to its axial segment, so that from this position it is later possible to slide the locking ring further onto the press-on cap in the axial direction. The components are securely engaged with each other, so that the closure system pre-assembled in this way is particularly well suited for automated further processing even with high loads and large 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 link. Due to the bevel, the snap rib can be pushed over the locking tooth during the rotation described above during its movement in the tangential segment, but on the other hand a backward movement of the snap rib over the locking tooth is then no longer possible due to the shape of the locking tooth. As a result, the snap rib is thus fixed in its end 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 securing ring is made from a plastic, preferably from 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 type mentioned above, preferably in connection 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 outer closure element in the form of a one-way closure. This one-way closure, which can include a sealing lid that can be torn off or is sealed, for example, allows for easy and reliable identification as to 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 is therefore preferred for another fluid withdrawal should be used until it is completely drained and thus discarded should be. For this purpose, in this preferred embodiment, a sealing plate is formed on the outside of the securing ring and can be torn off to form a tamper-evident seal.

A medicament 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 a particularly high mechanical stability of the preassembled intermediate product consisting of the safety cap and safety ring can be achieved by providing a guide pairing between the safety ring and the safety cap by means of the respective snap rib on the one hand and the associated guide link on the other hand. This pre-assembled intermediate product is therefore also particularly well suited for subsequent processing steps with comparatively high demands, for example as part of automated processing or in processes with a high number of cycles or pieces.

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. Show in it:

1

a medication container closed with a locking system,

2

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

3

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

4

the medication container 1 with associated closure system in longitudinal section in exploded view,

figure 5

a sealing element for the medication container 1 ,

6

the snap-on cap of the medication container closure system 1 ,

7

a locking ring of the locking system of the medication container 1 ,

8

the press-on cap 6 in enlarged perspective view,

Figures 9-12

depicts a sequence of steps in attaching the closure system to the medicament container 1 .

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

The drug container 1 acc. 1 , also referred to as a container or vial, is designed in the manner of a small bottle. It comprises an interior space 4 which is enclosed by a container wall 2 and in which the medicament or the active ingredient is kept. In the exemplary embodiment, the container wall 2 is made of a suitably selected plastic with or without a barrier layer. A “medical grade” plastic is particularly preferred here, such as COP variants ^690R® , ^790R® , COC variants ^Topas® 8007S-04, 6013S-04, 6015S-04. The plastic is very particularly preferably selected with regard to the criteria transparent, insensitive to breakage, little or no interaction with the envisaged drug, 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 medicament container 1 is designed to a particular extent for the provision of active ingredients or medicaments in which any loss of material through unintentional release into the environment or environment is to 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 also for particularly expensive substances or active ingredients, such as are increasingly being used in modern therapies in particular. In order to keep such undesirable material losses particularly low, the medication container 1 is equipped with a closure system 10 that closes the container opening 6 particularly high tightness and, on the other hand, is designed for particularly effective protection against tampering.

The container wall 2 of the medication container 1 is, as shown in the perspective view in 2 as well as the representation in longitudinal section in 3 can clearly be seen, in the area of the container opening 6 with a number of, in the exemplary embodiment two, peripherally attached outer beads 12 as a fastening element for the closure system 10 . A first of these outer beads 12 is arranged immediately adjacent to the mouth opening 14 of the container 1; a second outer bead 12, on the other hand, is located somewhat further away from the mouth opening 14. In the following, based on 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", on the other hand, positioning more towards the mouth opening 14 and thus towards the free, open end of the container opening 6 is referred to as "up" or "distal".

As in particular the representation in longitudinal section acc. Figure 3b It can be clearly seen that the two upper outer beads 12 applied circumferentially to the container opening 6 have an approximately or completely equal bead width w. This design is chosen with regard to the intended use of these outer beads for latching or fixing with associated latching or snap-in elements of the closure system 10 . In contrast, the lowermost or proximal outer bead 16, seen in the direction of the muzzle opening, has a bead width W that is significantly larger than that of the outer beads 12 by about three times, i.e. significantly more than at least 150%, of the bead width w of the adjacent outer bead 12 to improve protection against tampering. executed.

In the exemplary embodiment, as can be seen from the illustration in 2 is clearly visible, the outer beads 12, 16 run completely circumferential. In other embodiments, the outer beads 12, 16 could be completely or partially segmented, that is, they could comprise a plurality of segments that follow one another, seen in the direction of rotation, and are positioned at a distance from one another, with the formation of gaps in between.

Another particularly preferred aspect of the present invention relates to the cross-sectional profile of the outer bead 16. As shown in FIG 3 can be removed, the delimiting outer bead 16 has on its lower side, from the mouth opening 14 side facing away from a largely straight running, with its normal to the longitudinal axis of the container opening 6 tilted by at most 10 ° flank 18. On the one hand, this configuration achieves a particularly reliable, flat covering of the closure system 10 arranged above, and on the other hand, a contact surface that is particularly favorable and suitable for automated handling purposes is formed.

Furthermore, the delimiting 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 delimiting outer bead 16 forms a contact surface 22 .

In 4 is the mouth area of the medication container 1 together with the associated closure system 10 in an exploded view, in Figure 4a in lateral plan view and in Figure 4b shown 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 press-on cap 28, on the outer circumference of which a number of snap hooks or latching elements 30 that can be brought into engagement with the respective outer bead 12 are arranged. When attaching the press-on cap 28, it can thus be placed or pressed onto the container opening 6, with the latching elements 30 first being bent outwards by the respective outer bead 12 and then, after being pushed on further, gripping behind the outer bead 12 and in the manner of a snap connection with it snap. Furthermore, in terms of its dimensioning in the longitudinal direction of the container opening 6, the press-on cap 28 is adapted to its outer contour formed by the outer beads 12, 16 in such a way that the end face 34 of the or each latching element 30 formed by the end edge 32 of the press-on cap 28 fits completely onto the Container opening 6 in the pushed-on state of the press-on cap 28 against the contact surface 22 arranged on the mouth-side flank 20 of the limiting outer bead 16 .

The press-on cap 28 includes an annular cover 44 having a central opening 42. The integrally designed per se, in figure 5 Sealing element 24 shown enlarged, however, comprises a closure plate 46 in the manner of a basic element, at the first Plate side a central opening 42 of the ring cover 44 completely fills, with this lockingly engageable thickening 48 is formed. The thickening 48 is provided in its connection area with the closure plate 46 with a circumferential groove 50 forming an undercut. The one-piece sealing element 24 is, also with regard to the desired sealing purposes, made of a suitable and also comparatively soft and easily deformable material, in the exemplary embodiment made of rubber or of TPE, preferably "medical grade". This choice of material also ensures that the sealing element 24 can be pierced by means of a suitable instrument, for example a hollow needle, if necessary, ie if the active substance is to be removed from the medication container 1 . Using these material properties, in particular the deformability, the sealing element 24 can be connected almost firmly to the press-on cap 28 by the thickening 48 being introduced 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 the sealing element 24 is fixed to the press-on cap 28 .

The sealing element 24 advantageously contributes to the sealing of the container opening 6 in two ways. On the one hand, a sealing effect is achieved, which is certainly comparable to 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 pushed out by the snap-on cap 28, which can be snapped onto the mouth edge 52, with its edge of the Sealing element 24 is pressed onto the mouth edge 52. As a result of this axial force effect, viewed in relation to the longitudinal axis of the container opening, the closure plate 46 can already develop a sealing effect as a result of the deformability of the material. In addition, the provision of radial force components, ie contact forces that press the sealing element 24 in the radial direction against the inside of the container wall 2 in the region 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 plate 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 region (both are round in the exemplary embodiment). With regard to its dimensioning, it is also adapted to the clear width I of the container opening 6 and is designed slightly larger than the clear width I of the container opening 6 with regard to the deformability of the material of the sealing element 24 . With the radial sealing element 54 introduced into the container opening 6, taking into account the deformability of its material, a flat pressing or pressing effect on the inner wall of the container in the area of the container opening. With regard to current standards and customary norms for such components, the container opening can be suitably selected and dimensioned; For example, their clear width can be suitably matched to the standard "13 neck" dimension (corresponds to an outer diameter of the container opening of 13 mm) or to the standard "20 neck" dimension (corresponds to an outer diameter of the container opening of 20 mm).

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 in such a way that the central area of the sealing element 24 that forms the thickening 48 is surrounded by a circumferential groove-like or trench-like depression 56 that extends deep into the closure plate 46 . The indentation 56 can also completely penetrate the material thickness of the closure plate 46, so that the sealing element 24 has a multi-component design in this embodiment. Adapted to this, the press-on cap 28, as shown in Figure 6a in perspective view from below and in Figure 6b shown enlarged in a longitudinal section, has a reinforcement ring 58 which is integrally formed on the underside of the ring cover 44 and runs around the opening 42 . During assembly of the two components, this reinforcement ring 58 is introduced into the depression 56 of the sealing element 24 . The dimensions are matched to one another in such a way that the reinforcement ring 58 gives the radial sealing element 54 of the sealing element 24 increased strength and rigidity towards the outside, ie in the radial direction, and thus improves the radial seal even further. In particular, the appropriately selected dimensions of the reinforcement ring 58 can deform the radial sealing element 54 more or less slightly outwards and generate an additional pressing 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 press-on 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 shown in turn in the illustration in 4 As becomes clear, the closure system 10 comprises a locking ring 60, shown enlarged in a perspective view from below in Fig. 7, which can be slid onto the press-on cap 28. After the press-on cap 28 has been pressed open and it has latched with the outer beads 12, this can engage around the press-on cap 28 from the outside be pushed. With that he fixes the locking elements 30 radially, so that they can no longer escape to the outside. This means that the locking of the press-on cap 28 with the outer bead 12 can no longer be easily released and is therefore fixed. The securing ring 60 in turn has a number of snap ribs 62 formed on the inside and positioned at the ends, by means of which it can be fixed to the press-on cap 28 in a latching manner.

Furthermore, the medicament container 1 closed with the closure system 10 has a tamper-evident closure 70 as a component. In the manner of a one-way closure, this is intended to ensure that the user can determine in a simple and reliable manner whether the medication container 1 has already been used for liquid transfer or not, i. H. whether active substance has already been removed or not. It thus makes it easier to determine whether the container has already "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, in the installed state, it completely covers the central opening 42 of the ring cover 44 and thus the exposed surface of the sealing element 24 that is accessible via it. In order to gain access to the interior of the medicament container 1, ie to remove active substance, 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 securing ring 60 on the press-on cap 28, so that the pre-assembled system is also particularly well suited for subsequent process steps with high stress, for example as part of automated filling or packaging processes. For this purpose, the snap-in ribs 62 are also used in the manner of an additional function to form a pair of guides which, as shown in the perspective view of the press-on cap 28 in 8 shown, for each of the snap ribs also includes a guide link 82 arranged in the outer lateral surface 80 . The guide pairing formed by the snap rib 62 on the one hand and the corresponding guide link 82 on the other hand causes the respective snap rib 62 to be guided in the corresponding guide link 82 when the inner lateral surface 84 of the retaining ring 60 moves relative to the outer lateral surface 80 of the press-on cap 28 that corresponds to it is, so that the positions of these components can be adjusted relative to each other in a reproducible and controllable manner.

In the exemplary embodiment, the respective snap rib 62 is arranged on the inside of the securing ring 60 and, corresponding thereto, the respective guide link 82 is arranged on the outside of the press-on cap 28; alternatively, however, the snap-in rib 62 could also be positioned on the press-on cap 28 and, corresponding thereto, the guide link 82 on the inner lateral surface 84 of the securing ring 60 .

As shown in 8 can clearly be seen, the guide link 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 inflation cap 28. This axial segment 86 is delimited on both sides by a linear guide edge 88, 90, which Sliding the locking ring 60 onto the press-on cap 28 guide the respective snap rib 62. 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 securing ring 60 is pushed onto the press-on cap 28, the respective snap rib 62 is latched to the locking bead 92.

Furthermore, the guide link 82 has a tangential segment 94 embodied in the manner of a tangential groove and extending in a tangential direction about the axis of rotation of the press-on cap 28 . In a first area, the tangential segment 94 has a lower or proximal guide edge 96, above which an attachment of a second axial segment 98 is formed with a junction area that is kept open, into which the respective snap-in rib 62 can be inserted. The guide edge 96 forms a stop for the respective snap rib 62 when the locking ring 60 is pushed onto the press-on cap 28 and thus prevents a further linear push-on 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 rotation of the locking ring 60 relative to the press-on cap 28.

A latching tooth 104 with a beveled stop surface 106 for the snap-in rib 62 is also arranged in the tangential segment 94 of the guide link 82 .

The attachment of the closure system 10 to the drug container 1 is in the Figures 9 to 12 shown as a sequence of steps. In a first step, in 9 shown, the locking ring 60 designed as a tamper-evident closure 70 and provided with the sealing plate 72 with its snap-in ribs 62 above the junction areas of the respective second axial segments 98 on the preassembled, already provided with the sealing element 24 AufprellCAP 28 positioned. Subsequently, like this in Figure 10a in perspective view and in Figure 10b is shown in perspective section, the locking ring 60 is pressed linearly downwards onto the press-on cap 28 and thus plugged onto it. The snap-in ribs 62 dip into the second axial segment 98 of the respective associated guide link 82 until they strike the guide edge 96 . Thus, during pre-assembly, the respective snap rib 62 is first pushed into the tangential segment 94 of the guide link 82 assigned to it.

It is then provided that the retaining ring 60 is rotated relative to the press-on cap 28; this is in Figure 11a in perspective view and in Figure 11b shown in perspective section. As a result of this twisting, the respective snap rib 62 is guided in the respective tangential segment 94 until it strikes the stop 102 . This ends the twist. During the twisting, the snap-in rib 62 is also moved over the latching tooth 104 arranged in the tangential segment 94, which is possible in this twisting direction due to the bevel of the stop surface 106. Due to the asymmetrical contour of the locking tooth 104, reverse rotation is no longer possible, however, so that the securing ring 60 is then also secured against rotation with respect to the impact cap 28. The securing ring 60 is thus fixed both axially and rotationally in a defined and reproducible position on the press-on cap 28 .

In this position, the snap rib 62 is then also 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 securing ring 60 can later be pushed onto the press-on cap 28 in the axial direction. The components are securely engaged with one another, so that the closure system 10 preassembled in this way is particularly well suited for automated further processing, even with high loads and large quantities.

Starting from this pre-assembled state, the closure system 10 can be attached to the container opening 6 immediately or at a later point in time, as required. Under certain circumstances and depending on requirements, the in Figure 11b shown intermediate position are taken. In this intermediate step, the embodiment provided in the exemplary embodiment is used, in which two circumferential outer beads 12 are provided on the outside in the mouth area of the container opening 6 in the manner of a double bead. In this version, the Outer beads 12 are separated from one another by a groove 74 extending therebetween. Such a design makes it possible to push the closure system 10 in a first step only far enough onto the container opening 6 that the latching hooks 76 formed on the latching elements 30 only engage in the groove 74 and initially lock the system there. In this intermediate state, which in Figure 11b is 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 annular gap that is still open is formed between the radial sealing element 54 and the mouth 14 of the container 1 . Together with the peripheral spaces between the individual latching elements 30 of the press-on cap 28, there is still a gas-side connection of the interior 4 of the medication container 1 to the outside environment in this state.

This position can be used, for example, for freeze-drying, also referred to as lyophilization, lyophilization or sublimation drying, of the active substance in the medicament container 1 . This is a process that is now widespread for the gentle drying of products, which is used for a large number of medicines or active ingredients in order to make them durable. In the case of such freeze-drying, it may be necessary to be able to release gases or vapors, in particular water vapor, into the environment, and such a possibility is offered by the Figure 11b shown positioning of the components.

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

From this illustration, that is to say in the fully assembled state, it can also be seen that the lower delimiting outer bead 16 secures the pushed-on closure system 10 downwards and thus increases the protection against tampering. Due to the significantly increased bead width W of the limiting outer bead 16 compared to the outer beads 12, the area open at the end of the components that are pushed onto one another (press-on cap 28, securing ring 60) is covered from below and thus protected from manipulative access. Furthermore, the edge 32 of the press-on cap is in contact with the contact surface 22 so that further support can be provided here.

As shown for the 28 in Figure 6a or 8 is also easily removable, an RFID chip 110 is arranged on its ring cover 44 in an embodiment considered to be independently inventive, preferably also injected into it. The RFID chip 110 can be provided with a code or identifier that individually identifies the drug container and/or other information regarding the content, for example the drug or active ingredient composition, a possible expiry date, a batch number, the raw materials used, production and manufacturing information of the manufacturer or the like. In particular, since such a chip can also be read without contact, automated handling of the medication container 1 and its contents, up to fully or partially automated manufacture of medication in mixing systems or the like, can be achieved.

Reference List

1

medication container

2

container wall

4

inner space

6

container opening

10

locking system

12

outer bead

14

muzzle opening

16

Delimitation outer bead

18

lower flank

20

upper flank

22

contact surface

24

sealing element

26

fixation cap

28

press-on cap

30

locking elements

32

edge

34

face

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

locking ring

62

snap ribs

70

tamper evident closure

72

sealing plate

74

groove

76

latch hook

80

lateral surface

82

leadership backdrop

84

lateral surface

86

axial segment

88, 90

leading edge

92

detent bead

94

tangent segment

96

leading edge

98

second axial segment

100

transition area

102

attack

104

ratchet tooth

106

stop surface

110

RFID chip

w

bead width

W

Bead width of the limiting outer bead

D

diameter

L

clear expanse

Claims (11)

Closure system (10) for a medication container (1), the interior (4) of which is accessible via a mouth area (6) designed in the manner of a bottle mouth, the closure system (10) in addition to being slid onto the mouth area (6) and having a sealing element (24) provided with a press-on cap (28) comprises a locking ring (60) which can be slid onto the latter and which can be fixed in a latching manner on the press-on cap (28) by means of a number of snap-in ribs (62) when it is completely pushed onto the press-on cap (28), and wherein the or each snap rib (62) is guided in a corresponding guide link (82) when the inner lateral surface (84) of the securing ring (60) moves relative to a corresponding outer lateral surface (80) of the press-on cap (28). 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 link (82) is arranged on the outside of the press-on cap (28). Closure system (10) according to Claim 1 or 2, the guide slot (82) of which has 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) or the retaining ring (60). includes. 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. Closure system (10) according to one of Claims 1 to 4, the guide link (82) of which has 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) or of the securing ring (60). ) includes. Closure system (10) according to Claim 5, in which the tangential segment (94) of the guide link (82) merges into its first axial segment (86), with the transition area (100) between the tangential segment (94) and the axial segment (86) being used to limit a rotation of the Securing ring (60) relative to the press-on cap (28), a stop (102) for the respective snap rib (62) is formed. Closure system (10) according to Claim 5 or 6, in whose tangential segment (94) a locking tooth (104) with a beveled stop surface (106) for the snap-in rib (62) is arranged. Closure system (10) according to one of Claims 1 to 7, whose press-on cap (28) and/or safety ring (6) is made from a plastic, preferably from polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefins -Polymer (COP) or polycarbonate. Closure system (10) according to one of Claims 1 to 8, on the outside of which a sealing plate (72) is integrally formed on the securing ring (60) and can be torn off to form a tamper-evident closure (70). Medicament container (1) for a medicinal active substance or a 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 one of Claims 1 to 9. Use of a closure system (10) according to one of Claims 1 to 9 for closing the mouth opening of a medicament container (1) for a medicinal substance or a medicament.

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