Patent Application
20250033836
This disclosure relates to a closure system for a medication container, the interior of which is accessible via a mouth region designed in the manner of a bottle mouth, in particular, a closure system that includes, in addition to a bounce cap which can be pushed onto the mouth region and is provided with a sealing element, a locking ring which can be pushed onto the bounce cap and which, in a position pushed completely onto the bounce cap, can be fixed to the bounce cap in a latchable manner by means of a number of snap-on ribs. This disclosure further relates to a medicament container with such a closure system and to a use of the closure system.
Medications, especially 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 drug container is usually designed in the form of a vial and comprises an interior in which the drug or active ingredient is held and which is accessible via a container opening designed in the form of a bottle mouth. From such a container or receptacle, 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.
Modem medical procedures or therapies in particular can involve the use of drugs or substances that are actually toxic or otherwise harmful or dangerous. This can pose acute and long-term health risks to staff handling such substances, such as pharmacists and nurses, especially if they are repeatedly exposed to drugs or solvents that could become airborne during preparation, administration of medicines and other similar treatments. This problem can be particularly serious when cytotoxins, antiviral medicines, antibiotics or radiopharmaceuticals are involved. The potential health risks arising from exposure to these drugs include an 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 prevent the unintentional release of even the smallest quantities of such drugs or active substances into the environment.
With regard to the prevention of unintentional loss of active ingredients, it is therefore generally necessary to design the medication containers appropriately. Usually, the active ingredient or medication containers are provided with suitable closure systems for this purpose, in which a stopper closes the container opening. This closure plug can then be pierced for removal of the medication by means of a hollow needle, for example, via which the medication can then be sucked out of the container. To secure the stopper, a bounce 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 stopper is then fitted centrally in the ring cap.
Such a bounce cap provided with the sealing element or stopper is usually attached by sliding it onto the mouth area of the medication container and then latching it onto the container, for example by means of snap-in or latching hooks arranged on the bounce cap, which form a latching connection with latching beads arranged on the container opening. This latching connection is then usually secured against unintentional release by means of a locking ring that can be slid onto the bounce cap, which encloses it laterally in its end position. Such a retaining ring ensures that the snap-in or latching hooks arranged on the pop-up cap do not move back outwards and thus release the latching connection with the medication container. The retaining ring pushed onto the bounce cap is usually also secured in its position on the bounce cap by means of latching means, for example a number of snap-in ribs.
In addition to the aforementioned requirements for reliability and leak-tightness of such closure systems, a common design objective is also to make them suitable for industrial processing in terms of high quantities. In particular, automated filling and correspondingly automated application of the closure system to the respective medication container should be possible, especially for the possibly desired large number of medication doses to be provided. To this end, it is desirable to enable simultaneous processing of several medication containers in the form of larger batches, for example in the form of so-called “nesting”, with regard to large quantities.
The present disclosure is therefore based on the objective of providing a closure system of the above-mentioned type which meets these requirements, in particular the suitability for automated filling processes, to a particularly large extent by simple means.
This objective in accordance with this disclosure is achieved in that the snap-on rib or each snap-on rib provided for fixing the retaining ring in the position in which it is fully slid onto the expanding cap is guided in a corresponding guiding slot during a movement of the inner lateral surface of the locking ring relative to a corresponding outer lateral surface of the bounce cap.
This disclosure is based on the consideration that the closure system can be made suitable for automated processing and also for high cycle or throughput rates with the correspondingly high processing speeds by, among other things, on the one hand, particularly favoring pre-assembly of the components bounce cap and securing ring and, on the other hand, ensuring particularly reliable guidance of the pre-assembled components relative to one another. In particular, this makes it possible to eliminate potential sources of interference during automated processing, for example due to tilting or canting of the components, incorrect positioning or the like. The desired reliable guidance of the components mounted upstream relative to each other can be achieved in a particularly simple way by forming a guide pairing for the components using components that are usually already present, in this case the respective snap ribs. To form such a guide pairing, a corresponding guiding slot, for example in the form of a groove, should be assigned to the respective snap rib in the other component.
The term “guide” or “guide pairing” means in particular that the respective elements or components engage with each other in a suitable manner in order to ensure the desired type of relative movement of the components to each other when the retaining ring is displaced relative to the bounce cap. For example, in the case of an “axial” guide, the geometry can be selected in such a way that the relative movement is only possible in the axial direction or at least as far as possible, whereby a twisting or rotation of the components relative to each other should be minimized or preferably even completely excluded. Alternatively, with a “tangential” guide, the geometry can be selected in such a way that only rotation of the components is possible, but no axial displacement relative to each other.
For the formation of the aforementioned guide pairing, it is fundamentally irrelevant which elements of it are arranged on which of the components of the bounce cap or retaining ring; i.e., for the intended use, the respective snap rib could be arranged on the inside of the retaining ring or also on the outside of the bounce cap, and the associated guiding groove correspondingly on the respective other component thereof. Preferably, however, the or each snap rib is arranged on the inside of the retaining ring and, correspondingly, the respective guiding groove is arranged on the outside of the bounce cap.
Typically, a closure system of this type is pressed onto the mouth opening of the medication container in a linear movement after the preassembly of the pop-up cap and retaining ring. In the process, the bounce cap is first pushed onto the mouth until it locks into place or otherwise reaches its final position as seen before. Further pressing of the system then causes the retaining ring to be pushed onto the bounce cap, increasingly enclosing it. To stabilize this primarily linear movement of the circlip on the bounce cap, the guiding groove 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 bounce cap or the circlip.
In a further advantageous embodiment, a latching bead for latching the respective snap rib is arranged in this first axial segment, so that the snap rib can be used for latching the components as intended by the design.
In a particularly advantageous embodiment, the locking system is designed for a particularly stable pre-assembly of the bounce cap and retaining ring. It is envisaged in some cases before that the retaining ring is first fitted onto the bounce cap during pre-assembly. Then, in the manner of a bayonet lock, a twisting of the retaining ring on the bounce cap should provide a mechanically reliable connection between the attached retaining ring and the bounce cap, whereby the system can be fully pushed on from this position later, when it is finally attached to the medication container. To make this possible, the guiding groove in a particularly advantageous embodiment has a tangential segment in the form of a tangential groove extending in a tangential direction around the axis of rotation of the cap or the retaining ring.
The tangential segment of the guiding groove expediently merges into its first axial segment, whereby a stop for the respective snap-on rib is formed in the transition area between the tangential segment and axial segment to limit the rotation of the retaining ring relative to the cap. This means that during pre-assembly, the respective snap-in rib can first be pushed into the tangential segment of the guiding slot assigned to it and then the retaining ring can be rotated relative to the bounce cap. This guides the snap-in rib in the tangential segment until it hits the stop. This ends the twisting process and the retaining ring is fixed in a defined and reproducible position on the bounce cap. In this position, the snap rib is then also located in the transition area from the tangential segment of the guiding groove to its axial segment, so that the retaining ring can be pushed onto the bounce cap in the axial direction from this position. The components are in secure engagement with each other, so that the pre-assembled closure system is particularly well suited for automated further processing, even with high loads and high quantities.
In a further advantageous embodiment, a detent tooth with a beveled stop surface for the snap-in rib is arranged in the tangential segment of the guiding groove. Due to the bevel, the snap-in rib can be pushed over the detent tooth when it is moved in the tangential segment during the torsion described above, although on the other hand, due to the shape of the detent tooth, a backward movement of the snap-in rib over the detent tooth is no longer possible. As a result, the snap-in 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 bounce cap and/or the retaining ring is made of a plastic, preferably polypropylene (PP), a polyolefin, cyclo-olefin-co polymer (COC), cyclo-olefin-polymer (COP) or polycarbonate.
In an embodiment which is regarded as 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 for example comprise 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 empty and should therefore be disposed of For this purpose, in this preferred embodiment, a sealing plate is firmly attached to the outside of the retaining ring and can be torn off from it to form a tamper-evident seal.
A medication 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 regarded as independently inventive.
The use of a closure system of the aforementioned type for a medication container is also regarded as independently inventive.
The advantages achieved with the invention include, in particular, the fact that a particularly high mechanical stability of the pre-assembled intermediate product consisting of the retaining ring and the bounce cap can be achieved by providing a guide pairing between the retaining ring and the bounce cap by means of the respective snap rib on the one hand and the associated guiding groove on the other side. This pre-assembled intermediate product is therefore also particularly suitable for subsequent processing steps with comparatively high stresses, for example as part of automated processing or in processes with a high number of cycles or units.
An embodiment of the invention is explained in more detail with reference to a drawing. It shows:
Identical parts are marked with the same reference numerals in all figures.
The medication container 1 as shown in
The medication container 1 is designed in particular for holding active substances or medicines for which any loss of material due to unintentional release into the environment or surroundings should be avoided as far as possible. This may be the case, for example, for toxic substances, substances that are hazardous to health or otherwise dangerous for the persons handling them, or for particularly expensive substances or active ingredients, such as those increasingly used in modern therapies. 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 and is designed for particularly high tightness on the one hand and for particularly effective protection against manipulation on the other.
As can be clearly seen from the perspective view in
As can be clearly seen in particular from the representation in longitudinal section as shown in
In the embodiment example, as can be clearly seen from the illustration in
A further particularly preferred aspect of the present invention relates to the transverse sectional profile of the limiting outer bead 16. As can be seen from the illustration in
Furthermore, on its upper side facing the mouth opening 14, the limiting outer bead 16 has an orifice-side flank 20 which, as explained below, is specifically designed for favourable interaction with the closure system 10. In particular, the upper flank 20 of the limiting outer bead 16 forms a contact surface 22.
In
The bounce cap 28 comprises a ring cover 44 having a central opening 42. The sealing element 24, which in itself is designed as a single piece and is shown enlarged in
In an advantageous manner, the sealing element 24 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 locking plate 46, which is suitably adapted in its dimensions, in particular its outer diameter, to the mouth edge 52 of the container opening 6, is pressed onto the mouth edge 52 by the rim of the sealing element 24 by means of the bounce cap 28, which can be latched onto the mouth edge 52. As a result of this axial force seen in relation to the longitudinal axis of the container opening, the locking plate 46 can already develop a sealing effect due to the deformability of the material. In addition, however, the provision of radial force components, i.e., contact pressure forces that press the sealing element 24 in the radial direction against the inside of the container wall 2 in the area of its mouth, is also provided in the present case for a particularly increased sealing effect overall.
For this purpose, a radial sealing element 54 is formed on the second plate side of the locking plate 46. The cross-sectional shape of the radial sealing element 54 is adapted to the transverse cross-sectional shape of the container opening 6 in the mouth area (in the embodiment example, both are round). In terms of its dimensions, it is also adapted to the clear width 1 of the container opening 6 and, with regard to the deformability of the material of the sealing element 24, is slightly larger than the clear width 1 of the container opening 6. As a result, when the radial sealing element 54 is inserted into the container opening 6, taking into account the deformability of its material, a surface pressure or pressing effect is created 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 adapted to the standard dimension “13 neck” (corresponds to an outer diameter of the container opening of 13 mm) or to the standard dimension “20 neck” (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 such that the central area of the sealing element 24 forming the thickening 48 is surrounded by a circumferential nut or trench-like deepening 56 extending deep into the locking plate 46. The deepening 56 can also completely penetrate the material thickness of the locking plate 46, so that the sealing element 24 is more component in this design. Adapted to this, the bounce cap 28, as shown in
In the embodiment example, the bounce cap 28 is made 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 is again clear from the illustration in
Furthermore, the medication container 1 closed with the closure system 10 has an originality seal closure 70 as a component. This is intended to ensure, in the manner 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 withdrawal until it is completely empty and should therefore be disposed of. The originality seal 70 is designed as a sealing plate 72 moulded onto the locking ring 60. The sealing plate 72 is dimensioned and positioned in such a way that, in the assembled state, it completely covers the central opening 2 of the ring cover 44 and thus the exposed surface of the sealing element 24 accessible by it. To access the inside of the medication container 1, i.e., to remove the 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 bounce cap 28, so that the system assembled before is also particularly suitable 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 in the manner of an additional function to form a guide pairing which, in addition, as shown in the perspective view of the bounce cap 28 in
In the embodiment shown, the respective snap rib 62 is arranged on the inside of the locking ring 60 and correspondingly the respective guiding groove 82 is arranged on the outside of the bounce cap 28; alternatively, however, the snap rib 62 could also be positioned on the bounce cap 28 and correspondingly the guiding groove 82 on the inner lateral surface 84 of the locking ring 60.
As can be clearly seen from the illustration in
Furthermore, the guiding groove 82 has a tangential segment 94 which is designed in the manner of a tangential groove and extends in a tangential direction around the axis of rotation of the bounce cap 28. In a first area, the tangential segment 94 has a lower or proximal guiding edge 96, above which an extension of a second axial segment 98 is formed with an open opening area, into which the respective snap rib 62 can be inserted. When the locking ring 60 is pushed onto the bounce cap 28, the guiding edge 96 forms a stop for the respective snap rib 62 and thus prevents a further linear push-on movement. The tangential segment 94 also merges into the axial segment 86, whereby a stroke 102 for the respective snap rib 62 is formed in the transition area 100 between tangential segment 94 and axial segment 86. This is used to limit the rotation of the locking ring 60 relative to the bounce cap 28.
In the tangential segment 94 of the guiding groove 82 there is also a latching tooth 104 with an inclined stop surface 106 for the snap rib 62.
The attachment of the closure system 10 to the medication container 1 is shown in
Subsequently, it is intended to rotate the locking ring 60 relative to the bounce cap 28; this is shown in
In this position, the snap rib 62 is then also located in the transition area 100 from the tangential segment 94 of the guiding groove 82 to its first axial segment 86. From this position, the locking ring 60 can later be pushed onto the bounce cap 28 in the axial direction. The components are in secure engagement with each other, so that the pre-assembled closure system 10 is particularly suitable for automated further processing, even under high loads and in large 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. Under certain circumstances and depending on requirements, the intermediate position shown in
This position can be used, for example, for freeze-drying, also known as lyophilization or sublimation drying, of the active ingredient in the medication container 1. This is now a widely used process for the gentle drying of products, which is used for a variety of medications or active ingredients in order to preserve them. In such a freeze-drying process, it may be necessary to be able to release the resulting gases or vapors, in particular water vapor, into the environment, and the positioning of the components shown in
After this intermediate step, or possibly also directly after the pre-assembly shown in
From this illustration, i.e., in the fully assembled state, it can also be seen that the lower limiting outer bead 16 secures the slid-on closure system 10 at the bottom 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 open end area of the components pushed on top of each other (bounce cap 28, locking ring 60) is covered from below and thus protected against tampering. In addition, the edge 32 of the impact cap lies against the contact surface 22, so that further support can be provided here.
As can also be clearly seen from the representation of the bounce cap 28 in
| Number | Date | Country | Kind |
|---|---|---|---|
| 21211721.2 | Dec 2021 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/083817 | 11/30/2022 | WO |
