Closure system for a medicament container, medicament container having closure system and filling system for such medicament containers

Abstract

The invention relates to a closure system (10, 10´) for a medicament container (1, 1´), the interior (4) of which is accessible via a container opening (6, 6´) designed in the manner of a bottle mouth, having a closure lid (12) which has a retaining ring (14) on which a seal membrane (16), which in the mounted state sealingly closes the container opening (6, 6´) and can be pierced, is arranged, said closure system being intended to permit filling in a particularly easy and reliable manner, in compliance with highest quality standards, including at high throughput rates. To this end, according to the invention, the closure lid (12) can be attached at the container opening (6, 6´) by means of a bayonet closure (22) having a number of cams (26) guided in a slotted guide (24), wherein the bayonet closure (22) has, in relation to a rotation of the retaining ring (14) relative to the container opening (6, 6´), a temporarily stabilising position and a finally stabilising position, in addition to an introduction position.

Description

[0001] Description

[0002] Closure system for a medicine container, medicine container with closure system and filling system for such medicine containers

[0003] The invention 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, with a closure lid which has a retaining ring on which a pierceable sealing membrane is arranged which, in the assembled state, tightly closes the container opening. It further relates to a medication container with such a closure system and to a filling system for such medication containers.

[0004] Medications or pharmaceuticals, such as vaccines, are typically provided in active ingredient or drug containers, also known as containers or vials. Such a drug container is typically designed like a vial and includes an interior space in which the medication or active ingredient is held and which is accessible via a container opening designed like a bottle mouth. From such a 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.

[0005] The filling of such medication containers with active ingredients is usually carried out automatically in suitably designed filling systems in which a large number of medication containers can be processed and filled simultaneously. The medication containers are grouped in batches of, for example, 100 units per batch and filled together (so-called "nesting"). Accordingly, the medication containers should be designed to accommodate this type of automated handling, even in high volumes; this aspect is particularly important for active ingredients that are to be made available in large quantities within a short period of time, such as vaccines. For various reasons, for example due to particularly high-quality or possiblyWhen handling active ingredients, including toxic or otherwise harmful ones, it may be desirable or even necessary to minimize or completely avoid unintentional losses of active ingredients, both during filling and during subsequent handling, storage, and removal. Proper functioning of such systems with the desired prevention of unintentional losses of active ingredients may require, among other things, the appropriate design of the medication containers. For this purpose, the active ingredient or medication containers are usually equipped with suitable closure systems in which a closure lid, particularly designed as a tamper-evident seal, closes the container opening.This closure cap may comprise a sealing membrane or the like as the actual sealing element, which can be pierced, for example by means of a hollow needle, after removal of a protective cap serving as a tamper-evident closure in order to remove the medication.

[0006] Such a system of the above-mentioned type, which satisfies the above-mentioned requirements of automated handling on the one hand and a particularly high degree of tightness on the other hand to a particularly large extent, is known, for example, from the unpublished European patent application number 22160078.

[0007] However, it has been shown that, in addition to the aforementioned requirements, sterility in the overall process can also play a key role, especially with regard to the production or filling of large quantities of active ingredients. Typically, medication containers or the components they are composed of are appropriately sterilized during or immediately after their production and then packaged in sterile packaging. They are then used for further processing, such as filling, in the sterile packaging. The filling itself should then also typically be carried out under sterile or aseptic conditions to reliably rule out any contamination or impurity of the active ingredient.Such consistent adherence to the sterility chain can, however, be associated with increased effort, especially if sterility cannot be maintained in an intermediate step during handling of the medication container, necessitating re-sterilization of the material. The invention is therefore based on the object of providing a closure system of the above-mentioned type for a medication container, which, even while adhering to strict sealing criteria and even with high quantities, also particularly facilitates the maintenance of sterile boundary conditions during handling of the system, particularly during filling. Furthermore, a particularly advantageous filling system for a medication container equipped with such a closure system is to be provided.

[0008] With regard to the closure system, this object is achieved according to the invention in that the closure lid can be attached to the container opening by means of a bayonet closure having a number of cams guided in a guide slot, wherein the bayonet closure has, with respect to a rotation of the retaining ring relative to the container opening, in addition to an insertion position, a temporarily stabilized position and a finally stabilized position.

[0009] A “bayonet lock” is generally understood to mean a detachable mechanical connection, in particular between two essentially cylindrical components, which can be established by means of a plug-and-turn movement.

[0010] Advantageous embodiments of the invention are the subject of the subclaims.

[0011] The invention is based on the consideration that, in order to particularly facilitate compliance with sterility conditions, possible sources through which an undesirable introduction of impurities or contamination into the interior of the container could occur should be eliminated as far as possible, even at extremely high cycle rates or batch sizes when filling active ingredients required in large quantities, such as vaccines. In the present case, the phase after the manufacture of the medication container and before filling with the active ingredient is considered to be one such possible source of potential contamination. During this phase, which, depending on the process and active ingredient, can extend over a long period of time, for example, months, reliable storage of the medication containers is essential.The invention therefore aims, on the one hand, to enable the closest possible spatial and temporal connection between the production and filling (with subsequent sterile sealing) of the medication containers. On the other hand, the introduction of contaminants into the interior should be minimized as much as possible during any necessary storage of an already manufactured medication container and prior to its filling.

[0012] To make this possible, the container is intended to remain largely closed after its manufacture and until it is filled. In order to achieve this with the least possible effort and thus in a way that is suitable and reliable for high volumes, the closure system should be designed to temporarily close the container (up to filling) and provide a final seal after filling. To this end, it is now planned to design the connection between the closure lid of the medication container and the medication container as a bayonet lock. Such a bayonet lock offers the advantage that it is generally relatively easy to remove. This means that the closure lid provided anyway can be used to temporarily close the medication container after it has been manufactured; an additional component is not required.The lid can be used to temporarily seal the container. It can then be removed for filling, and after filling, it can be reattached and finally sealed.

[0013] According to one aspect of the invention, the use of a bayonet lock for connecting the closure cap to the medication container is considered particularly suitable for this purpose, since such a closure is generally relatively easy to detach. According to one aspect of the invention, however, the bayonet lock should be suitably designed so that both the detachable attachment of the closure cap to the container and the final, "sealed" attachment are possible.

[0014] According to one aspect of the invention, the bayonet closure is formed by a guide pair of a cam (or a number of cams) and an associated guide slot for the cam(s). The guide slot is arranged on one of the components to be connected, and the cam(s) on the other. Advantageously, and according to one aspect of the invention, the cam(s) are positioned on the retaining ring of the closure lid, and the associated guide slot is positioned on the container, in particular its mouth area. The ability to choose between two locking types, provided according to one aspect of the invention, is advantageously realized by different rotational positions of the retaining ring relative to the container mouth.In a first locking position, achievable by rotation, the retaining ring is to be releasably locked relative to the container opening, so that the closure lid is temporarily held securely on the container in a parking position. Such a temporarily stabilized position can advantageously be achieved by rotating the retaining ring relative to the container opening, starting from the position after insertion of the bayonet lock, i.e., after the "plug-in" phase and before the "rotation" phase, of approximately 20° to 25°. In contrast, the final stabilized position can advantageously be achieved by rotating the retaining ring relative to the container opening by approximately 50° to 55°.

[0015] Advantageously, the closure system is provided with a tamper-evident closure for the medication container in the form of a disposable closure. This disposable closure, which can, for example, comprise a tear-off or sealed lid, allows easy and reliable identification of whether the container has already been used for liquid transfer or not, and thus facilitates the determination of 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. Advantageously, a sealing plate that can be torn off from the retaining ring is arranged on the retaining ring of the closure cap to form a tamper-evident closure.

[0016] In an advantageous embodiment and according to an aspect considered to be independently inventive, the guide slot forms a suitable guide system for the associated cam(s). For this purpose, the guide slot advantageously comprises, on the one hand, an axial segment designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the retaining ring. In this axial segment, the respective cam can be guided in a direction parallel to the longitudinal or rotational axis of the retaining ring, thus enabling the "plug-in" phase for the bayonet lock to be represented. In a further advantageous embodiment, the guide slot also comprises a tangential segment designed in the manner of a tangential groove and extending in a tangential direction around the axis of rotation of the retaining ring.In this way, the respective cam can be guided in the tangential direction of the retaining ring, which corresponds to a turning or rotational movement of the retaining ring around its longitudinal axis. This allows the "rotational" phase for the bayonet lock to be realized. The tangential segment of the guide slot conveniently merges into its axial segment, so that the desired "plug-in-turn movement" for the bayonet lock can be realized via appropriate guidance of the cam(s).

[0017] To enable a final, irremovable and thus fixed connection of the closure lid to the container, one aspect of the invention provides a locking mechanism that should not be able to be released without causing damage. This is achieved according to one aspect of the invention by a suitable locking hook, which is advantageously arranged in the tangential segment of the guide slot. The locking hook can thus be brought into engagement with the cam guided in the tangential segment and fix it accordingly. For this purpose, the locking hook, in an advantageous embodiment considered to be independently inventive, is provided with a beveled front flank so that the cam can be guided over the locking hook during the forward movement. However, as soon as the cam has passed over the locking hook, it corrodes to the rear flank - which is advantageously designed accordingly steeply - so that backward movement is no longer possible.

[0018] The closure system is particularly advantageous and well-suited for a medication container made of a medical-grade plastic, in particular COP of the 690R® or 790R® variants, or COC of the Topas® 8007S-04, 6013S-04, or 6015S-04 variants. In such a plastic container, the guide slot provided as a component of the bayonet closure, or alternatively, of course, the cam(s), can be directly integrated or molded into the mouth area of ​​the container. This means that the guide slot can be manufactured during container production through suitable contouring and structuring, without the need for additional components or further processing. This potentially reduces manufacturing costs considerably.Advantageously, the guide slot or the cam(s) of the bayonet closure are arranged in the area forming the bottle neck of the medication container and are designed in one piece with it.

[0019] Should such direct integration of components of the bayonet closure into the container mouth not be possible (e.g., in the case of containers made of glass) or should it not be desirable for other reasons, the closure system, according to a further aspect considered to be independently inventive, may also comprise an additional component for suitable modification of the mouth region of the container. Advantageously, the closure system comprises a closure cap provided with an inner plug that can be placed onto the mouth region of the container opening, and a locking ring that can be pushed onto the closure cap and locked in place by means of a number of snap ribs on the closure cap when fully pushed onto the closure cap. The guide slot or cams of the bayonet closure are arranged on the outside of the closure cap and are formed integrally with it.

[0020] 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.

[0021] With regard to the filling system for filling medication containers each provided with a closure system of the type described above, the above-mentioned object is achieved with a preparation station in which the closure lid is lifted off the medication containers delivered pre-assembled with the closure lid attached and aligned in the temporarily stabilized position with respect to the bayonet closure by loosening the bayonet closure and is transported separately from the respective medication container, with a filling station for filling the respective medication container with active ingredient, and with a final assembly station in which the respective closure lid is re-assigned to the respective medication container, re-attached to the respective medication container by means of the bayonet closure and aligned in the final stabilized position with respect to the bayonet closure, wherein the preparation station,the filling station and the final assembly station are arranged in a common outer housing.

[0022] Such an integrated design, combined with a particularly compact overall construction in an integrated overall process with short transport routes and closely coordinated treatment steps, allows the total time required to lift the closure cap from the medication container and thus access its interior to be minimized. Furthermore, by arranging the components in a common outer housing, the entire housing can be kept sterile and free of contamination, similar to a cleanroom atmosphere. Contamination of the container interior during filling can thus be largely eliminated. Advantageously, a sterilization unit upstream of the preparation station is also located in the common outer housing.

[0023] Advantageously, the sterilization unit is designed as an electron beam unit.

[0024] An embodiment of the invention is explained in more detail with reference to a drawing. In the drawing:

[0025] Fig. 1 a medicine container closed with a locking system,

[0026] Fig. 2 shows the medication container according to Fig. 1 with associated closure system in longitudinal section in exploded view,

[0027] Fig. 3 shows the end area of ​​the medication container. Fig. 1 in perspective view,

[0028] Fig. 4 shows the retaining ring of a closure cover of the closure system according to Fig. 1 in perspective from below (Fig. 4a) and in longitudinal section (Fig. 4b),

[0029] Fig. 5 shows the end section of the medication container. Fig. 1 shows the closed lid in section.

[0030] Fig. 6 shows an enlarged detail of a locking hook of the locking system according to Fig. 1,

[0031] Fig. 7 shows an alternative embodiment of a medicine container closed with a closure system in perspective view,

[0032] Fig. 8 shows the medication container according to Fig. 6 with associated closure system in longitudinal section in exploded view,

[0033] Fig. 9 shows a snap-on cap of the closure system of the medication container according to Fig. 7 in a perspective view,

[0034] Fig. 10 shows the medication container according to Fig. 7 in longitudinal section at the beginning of the pre-assembly (Fig. 10a) and after pre-assembly (Fig. 10b), Fig. 11 shows a sequence of steps in filling the medication container according to Fig. 1 pre-assembled with the closure system with an active ingredient,

[0035] Fig. 12 shows a sequence of steps in filling the drug container according to Fig. 7 pre-assembled with the closure system with an active ingredient,

[0036] Fig. 13 shows a filling system for filling medication containers as shown in Fig. 1 and Fig. 7 in perspective view.

[0037] Fig. 14 the filling system according to Fig. 13 in plan view,

[0038] Fig. 15 a transport batch of medication containers within the filling system according to Fig. 13 in front view,

[0039] Fig. 16 the transport batch according to Fig. 15 in rear view, and

[0040] Fig. 17 the transport batch according to Fig. 15 in longitudinal section.

[0041] Identical parts are provided with the same reference numerals in all figures.

[0042] The medication container 1 (see Fig. 1), also referred to as a container or vial, is designed in the manner of a small bottle. It comprises an interior space 4 enclosed by a container wall 2, in which interior space the medication or active ingredient is held. 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, such as COP variants 690R®, 790R®, COC variants Topas® 8007S-04, 6013S-04, 6015S-04. The plastic is very particularly preferably suitably selected with regard to the criteria of being transparent, break-resistant, having little to no interaction with the intended medication, being medical grade, and in particular being suitable for use as a glass substitute, either individually or in combination with one another.However, it could also be formed from another suitably moldable material, particularly one suitable for casting, such as molded glass. The interior 4 is accessible via a container opening 6 designed like a bottle mouth. The medication container 1 is particularly well-suited for automated filling with active ingredients under aseptic or sterile conditions. In particular, the components of the medication container are to be sterilized completely or as needed after their production and then further processed, stored, or otherwise used under sterile conditions without the need for subsequent complete re-sterilization.In this regard, the filling of the container with active ingredient is considered to be a particular weak point, since this requires access to the container interior 4, thus potentially leading to the introduction of impurities or contamination. In order to best meet the associated requirements with regard to the desired continuous maintenance of sterility, the medication container 1 is equipped with a closure system 10 that closes the container opening 6. This closure system, on the one hand, allows the risk of unwanted impurities entering the container during filling to be kept particularly low, while, on the other hand, also provides particularly effective protection against tampering.

[0043] The closure system 10 comprises, as can be clearly seen from the longitudinal section in Fig. 2 in exploded view, as an essential component a closure lid 12 designed as a sealing means. This in turn is designed in several parts and comprises, as the actual sealing means, a sealing membrane 16 attached to a retaining ring 14, which seals the container opening 6 when the system is in the assembled state. The sealing membrane 16 is dimensioned and positioned such that, in the assembled state, it completely covers the central opening of the container mouth 6 and thus the exposed access surface of the container interior 4 accessible via this opening. In particular, it is contoured such that a plug-like central thickening 17 projects into the container mouth 6 in the assembled state and conforms radially to its inner wall.Together with the upper, plate-shaped collar, which rests axially on the end face of the container mouth, this results in an overall high sealing effect. The sealing membrane 16 can be pierced by a suitable instrument, such as a hollow needle, so that the active ingredient stored in the container interior 4 can be removed in this way. Accordingly, the sealing membrane 16 is formed from a suitable material, preferably and according to one aspect of the invention from PP or PE, and is in any case softer and more deformable than the retaining ring 14. In an advantageous manner and considered to be independently inventive, the sealing membrane 16, designed as a sealing element, contributes to sealing the container opening 6 in two ways. On the one hand, the sealing membrane 16 has a sealing plate 130 formed on the central thickening 17 and radially encircling it.This achieves a sealing effect, comparable to known systems, in that in the assembled system the sealing plate 130, whose dimensions, in particular its outer diameter, are suitably adapted to the mouth edge 132 of the container opening 6, is pressed onto the mouth edge 132 when the closure lid 12 is attached. Due to this axial force effect with respect to the longitudinal axis of the container opening, the sealing plate 130 can already exert 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 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.

[0044] For this purpose, according to one aspect of the invention, the sealing plate 130, with its lateral surface 134, forms a first radial sealing element. The sealing plate 130 is slightly oversized compared to a circumferential edge 136 arranged at the end of the container mouth, such that, taking into account the deformability of its material, a flat pressing or pressing effect is created against the inner wall of the edge 136. On the other hand, according to one aspect of the invention, the central thickening 17 provided "beneath" the sealing plate 130, i.e., on its side facing the container interior 4 in the assembled state, forms a second radial sealing element 138. For this purpose, the cross-sectional shape of the central thickening 17 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 membrane 16, is designed to be slightly larger than the clear width I of the container opening 6. This creates a flat pressing or pressing effect on the inner wall of the container in the area of ​​the container opening 6 when the radial sealing element 138 is introduced into the container opening 6, taking into account the deformability of its material. The container opening can be suitably selected and dimensioned in accordance with common standards and usual norms for such components; for example, its clear width can be suitably matched to the standard "13 Neck" size (corresponds to an outer diameter of the container opening of 13 mm), to the standard "20 Neck" size (corresponds to an outer diameter of the container opening of 20 mm), or to match special variants for the neck geometry for the inner diameter.

[0045] The sealing membrane 16 is advantageously designed, according to an aspect considered to be independently inventive, for an even further improved sealing effect in the radial direction. For this purpose, the shape is selected such that the central thickening 17 is surrounded by a circumferential groove- or trench-like recess 140 extending deep into the sealing plate 130. Adapted to this, the retaining ring 14 has a circumferential reinforcement ring 142 formed on its underside. During assembly of the two components, this reinforcement ring 142 is inserted into the recess 140 of the sealing membrane 16. The dimensions are coordinated such that the reinforcement ring 142 imparts increased strength and rigidity to the radial sealing element 138 of the sealing membrane 16 towards the outside, i.e. in the radial direction, and thus further improves the radial seal.In particular, by means of the appropriately selected dimensions of the reinforcing ring 142, the radial sealing element 138 can be slightly deformed more or less outwards and in doing so generate an additional contact force in the radial direction against the inner wall of the medication container 1 in the region of the container opening 6.

[0046] According to further aspects of the invention, any combination of the elements first and second radial sealing element, axial sealing element, reinforcement ring, circumferential recess, in particular in combination with the retaining ring of the closure cover 12, are considered to be independently inventive.

[0047] To form a tamper-evident seal 18, a sealing plate 20 is also attached to the retaining ring 14 and can be torn off. To access the interior of the medication container 1, i.e., to remove the active ingredient, the sealing plate 20 must first be removed before a corresponding needle system can be pierced through the sealing membrane 16 for the actual removal of the active ingredient.

[0048] The closure system 10, and with it the medication container 1 as a whole, are designed for particularly easy handling when filling the container 1 with active ingredient, even under the highest quality and sterility requirements, and for particularly high handling efficiency. For this purpose, the medication container 1 is pre-assembled with all components of its closure system 10 after its manufacture and is thus made available in this pre-assembled state for filling. This eliminates the need for separate component management in the sense of packaging or the like in connection with the actual filling process.On the other hand, a particularly simple handling of the actual closure system 10 should also be possible in order to keep the filling process, including the previously planned disassembly of the pre-assembled closure system 10 and the final assembly with final attachment of the closure system 10 after filling, particularly simple and efficient.

[0049] To meet these requirements, according to one aspect of the invention and in a configuration considered to be independently inventive, the connection of the closure lid 12 to the medication container 1 is designed as a so-called bayonet lock 22. A "bayonet lock" is generally understood to mean a detachable mechanical connection, in particular between two essentially cylindrical components, which can be established by means of a plug-and-twist movement. In the present case, the bayonet lock 22 is designed as a guide pair of a guide slot 24 with a number of associated cams 26. The guide slot 24 on the one hand and the cams 26 guided therein on the other hand are arranged on different components to be connected to establish the mechanical connection.In the present case, the bayonet lock 22 is intended to establish the connection between the retaining ring 14 of the closure cap 12 and the end region of the medication container 1, which is designed in the manner of a bottle mouth. For this purpose, the guide slot 24 could be attached to the inside of the retaining ring 14 and the cams 26 could be attached to the outside of the medication container 1 in the area of ​​the container opening 6.

[0050] In the present case and according to one aspect of the invention, however, as can be seen from the enlarged perspective view of the mouth area of ​​the medication container 1 in Fig. 3, the guide slot 24 is molded onto the outside of the bottle neck of the medication container 1. For this purpose, the outer area of ​​the "bottle neck" is designed with a corresponding contour, with the choice of material for the medication container in this exemplary embodiment, namely plastic, enabling a correspondingly simple and reliable production of such a one-piece, contoured design.

[0051] As can be clearly seen from the illustration in Fig. 3, the guide slot 24 comprises a number of axial segments 30 designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the container mouth 6 and thus also parallel to the axis of rotation of the retaining ring 14. Each axial segment 30 is delimited on both sides by a respective linear guide edge 32, 34. Furthermore, the guide slot 24 has, for each axial segment 30, a tangential segment 36 designed in the manner of a tangential groove and extending in a tangential direction around the axis of rotation of the retaining ring 14 or the container mouth 6, wherein the respective axial segment 30 merges into the associated tangential segment 36 in a transition region 38. Each tangential segment 36 is delimited on both sides by a respective linear guide edge 40, 42.

[0052] Corresponding to this guide slot 24, the retaining ring 14 of the closure cover 12 is provided on the inside with a number of molded-on cams 26 to form the bayonet lock 22, as can be seen from the perspective view of the retaining ring 14 of the closure cover 12 “from below” in Fig. 4a and its longitudinal section in Fig. 4b. In the exemplary embodiment and according to one aspect of the invention, the number of cams 26 is equal to the number of axial segments 30 of the guide slot 24, so that the combination of one of the cams 26 with one of the axial segments 30 (and of course with the tangential segment 36 connected thereto) results in a guide pairing. According to one aspect of the invention, the dimensions of the cam 26 are suitably adapted to the guide channel formed by the axial and tangential segments 30, 36.In particular, the respective cam 26 is designed with a width B of less than the clear width b of the respective axial segment 30, so that the retaining ring 14 placed on the mouth region 6 of the medication container 1 can be pushed on, wherein the cams 26 are pushed into the respective axial segment 30. This process corresponds to the "plug-in movement" of the bayonet closure 22. The lower boundary surface 40 of the transition region 38 between the axial segment 30 and the tangential segment 36 forms a stop surface which limits this plug-in process and thus positions the respective cam 26 suitably adjacent to the respective tangential segment 36.

[0053] Furthermore, the respective cam 26 is designed with a height H of less than the clear height h of the respective tangential segment 36, so that the inserted retaining ring 14 can be inserted into the tangential segment 36 from this position by rotating the retaining ring 14 relative to the container mouth 6. This process corresponds to the "rotating movement" of the bayonet closure 22. In such a position, the cam 26 is limited in an axial movement by the guide edges 40, 42, so that the retaining ring 14 is axially fixed as a whole. With regard to the rotational orientation of the retaining ring 14 relative to the container opening 6, the positioning of the respective cam 26 in the respective axial segment 30 thus forms a defined insertion position, since the sliding of the retaining ring 14 onto the mouth area 6 of the container 1 is only possible in this relative orientation.Starting from this insertion position, the bayonet closure 22 has, in a design considered to be independently inventive, two further defined positions, namely, on the one hand, a temporarily stabilized position and, on the other hand, a finally stabilized position.

[0054] According to one aspect of the invention, the temporarily stabilized position serves to temporarily, releasably, rotationally fix the retaining ring 14 relative to the mouth region 6 of the container 1. A variety of configurations are conceivable for this purpose. In the present exemplary embodiment, and in a configuration considered to be independently inventive, this is achieved by a number of parking cams 46 formed on the end face 44 of the container mouth 6, which interact with a corresponding number of counter cams 50 formed on the inside of the end face 48 of the retaining ring 14.According to one aspect of the invention, the design of these components with regard to the choice of material, dimensioning, and, above all, the shape of the parking cam 46 on the one hand and the counter cam 50 on the other hand is such that rotation of the retaining ring 14 is possible when pushed on completely, i.e. until the respective cam 26 reaches the respective stop surface 40, whereby the respective cam 26 is pushed into the respective tangential segment 36. As soon as the respective parking cam 46 reaches the associated counter cam 50 and passes over it, it "slightly" engages behind it, so that the reaching of this first, temporarily stabilized position, intended as the parking position, can be recognized.In this rotational position, the retaining ring 14 is thus temporarily fixed relative to the container mouth 6, whereby this fixation can be overcome by applying a corresponding torque and the retaining ring 14 can rotate further relative to the container opening 6 or can also be rotated “backwards”, i.e. in the opposite direction.

[0055] For further explanation, Fig. 5 shows a partial section of the mouth area of ​​the medication container 1 provided with the closure lid 12, in which a section of the retaining ring 14 is kept transparent and see-through, thus allowing a view of the interior. The rear side of the cam 26, which is actually molded onto the inner wall of the retaining ring 14, can be seen; in the state shown in Fig. 5a, the cam 26 is still in the axial segment 30, but is fully advanced in the longitudinal direction and strikes the boundary surface 40. It is clearly visible here how the parking cam 46 molded onto the end surface 44 of the container mouth is positioned adjacent to the counter cam 50 molded onto the inside of the end surface 48 of the retaining ring 14. In the state shown in Fig. 5b, the retaining ring 14 has been rotated into the temporarily stabilized position: the counter cam 50 has thereby passed over the parking cam 46 and is now “behind” it.The cam 26 has penetrated the tangential segment 36 of the guide slot 24. It can be seen that the cam 26—and with it the entire retaining ring 14—is axially fixed in this position by the guide edges 40, 42 of the tangential segment 36; removal of the retaining ring 14 and, with it, the closure cover 12 as a whole is therefore not possible in this rotational position.

[0056] In contrast, according to one aspect of the invention, the finally stabilized position serves for a final, no longer non-destructively releasable rotational fixation of the retaining ring 14 relative to the mouth region 6 of the container 1. A variety of designs are also conceivable for this purpose. In the present exemplary embodiment and in a design considered to be independently inventive, this is achieved by a molded-on latching hook 52 arranged within the respective tangential segment 36, which interacts with the respective cam 26. The design of these components with regard to the choice of material, dimensioning and, above all, the shape of the latching hook 52 is, according to one aspect of the invention, such that rotation of the retaining ring 14 relative to the container mouth 6 is possible, wherein the respective cam 26 is displaced in the respective tangential segment 36 until it reaches the latching hook 52 and beyond it.This can be achieved in particular by a comparably flat front flank 54 of the respective locking hook 52. However, as soon as the respective cam 26 has passed over the associated locking hook 52, it “finally” engages there.

[0057] In the position shown in Fig. 5b, namely the temporarily stabilized position, the cam 26 is still "in front of" the locking hook 52 and has therefore not yet passed over it. This means that "reverse rotation" and thus release of the connection is still possible. However, if the retaining ring 14 is rotated further beyond this position, the cam 26 passes over the locking hook 52 and is thus finally fixed. This is shown in Fig. 5c, where the mouth area of ​​the container 1 and also the cam 26, which is actually molded onto the inner wall of the retaining ring 14, are shown in a rear view. As mentioned, a backward movement, i.e. in the opposite direction, should no longer be possible. This can be achieved in particular by a comparably steep rear flank 56 of the respective locking hook 52, as can be seen in particular from the enlarged illustration in Fig. 6.In this rotational position, the retaining ring 14 is thus finally fixed relative to the container mouth 6.

[0058] An alternative embodiment of a medication container 1' closed with a closure system 10', which is considered to be independently inventive, is shown in Fig. 7 in a perspective view and in Fig. 8 in a longitudinal section in an exploded view. This embodiment is suitable both for medication containers 1' made of plastic and preferably for medication containers 1' made of glass, in particular if the contoured design of the mouth region 6 for providing the guide slot 24 in an integrally formed form is not possible or, for example, should not be expedient for cost or efficiency reasons. In this embodiment, the closure system 10' has, in addition to the closure lid 12, a fixing cap 62 designed as a snap-on cap 60.According to an aspect considered to be independently inventive, this is intended, among other functionalities, to provide the guide slot 24 for forming the bayonet closure 22 in combination with the cams 26 attached to the retaining ring 14. With the impact cap 60, an inner plug 64, preferably made of a comparably soft material, preferably TPE or rubber, is also attached to the mouth opening 66 of the medication container 1'.

[0059] In such a variant, in a completely conventional design, the container wall 2 of the medication container 1' can be provided in the region of the container opening 6 with a number of, in the exemplary embodiment, one, circumferentially mounted outer beads 68 as a fastening element for the closure system 10'. In the exemplary embodiment, the outer bead 68 is completely circumferential and positioned near the mouth opening 66 of the container opening 6. In other embodiments, the outer bead 68 could be completely or partially segmented, ie, comprise several segments that follow one another in the rotational direction and are positioned at a distance from one another, forming gaps between them.

[0060] With the fixing cap 62, the inner plug 64 can be firmly attached to the container opening 6. Adapted to the outer bead 68, the fixing cap 62 is designed as a snap-on cap 60, on whose outer circumference a number of snap hooks or locking elements 70 are arranged, which can be engaged with the respective outer bead 68. When attaching the snap-on cap 60, it can thus be pushed or snapped onto the container opening 6, whereby the locking elements 70 are first bent outward by the respective outer bead 68 and then, after further sliding on, engage behind the outer bead 68 and lock with it in the manner of a snap connection.

[0061] The impact cap 60 comprises an annular lid 74 having a central opening 72. The inner plug 64, which is essentially a single-piece construction, comprises, in the manner of a base element, a central plug body which, at its "upper" end facing away from the container interior 4 in the assembled state, can be brought into locking engagement with the annular lid 74 in the opening 72. For this purpose, the plug body 76 is provided with a circumferential groove 78 forming an undercut in its connection area with the annular lid 74. The inner plug 64, which is essentially a single-piece construction, 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.By utilizing these material properties, in particular the deformability, the inner plug 64 can be connected almost firmly to the impact cap 60 by inserting the plug body 76 into the opening 72 in the ring cover 74 and the circumferential edge of the opening 72 then engaging in the groove 78 and thus fixing the inner plug 64 to the impact cap 60.

[0062] The impact cap 60 shown in perspective view in Fig. 9 is made of a suitably selected plastic in the exemplary embodiment, namely polypropylene (PP), a polyolefin, cycloolefin copolymer (COC), cycloolefin polymer (COP), or polycarbonate. As a further component and to complement the impact cap 60, as is again clear from the illustrations in Figs. 7 and 8, the closure system 10' comprises a retaining ring 80 that can be pushed onto the impact cap 60. This retaining ring 80 is designed as a ring structure with a cylindrical outer surface 84, leaving a sufficiently large central opening 82 free; this can be pushed onto the impact cap 60 from the outside, encompassing it, after the impact cap 60 has been pushed open and locked with the outer beads 68. The retaining ring 80 thus fixes the locking elements 70 radially via its cylindrical outer surface 84 so that they can no longer escape outwards.As a result, the locking of the impact cap 60 to the outer bead 68 can no longer be easily released and is thus fixed. The retaining ring 80, in turn, has a number of snap ribs 86 formed on the inside of its cylindrical outer surface and positioned at the ends, by means of which it can be locked onto the impact cap 60. As can be seen from the illustration in Fig. 9, the impact cap 60 is provided on its outside with the guide slots 24, which, analogous to the above explanations regarding the closure system 10, together with the cams 26 on the retaining ring 14, form the bayonet lock 22. Furthermore, on its upper end surface 44, analogous to the container 1 described above, it has the parking cams 46 for adjusting the temporarily stabilized position. In addition, however, a further axial segment 90 is provided at each end of the tangential segments 36.For pre-assembly of the system, i.e., for securing the impact cap 60 to the medication container 1' and prior to attaching the closure lid 12 by means of the bayonet lock 22, one aspect of the invention also provides for the use of the guide slot 24. After the impact cap 60 has been pushed onto the container mouth 6', the snap ribs 86 of the retaining ring 80 are initially inserted into the axial segments 30, analogous to the cams 26, so that the retaining ring 80 can be pushed onto the impact cap 60 until the snap ribs 86 abut the guide edge 40. The retaining ring 80 is then rotated relative to the impact cap 60, with the snap ribs 86 being guided in the tangential segments 36. In the end area of ​​the tangential segments 36, these merge into the second axial segments 90, so that the retaining ring 80 can then be pushed on even further.At the end of the second axial segments 90, locking recesses 92 are arranged, into which the snap-in ribs 86 can snap. This fixes the retaining ring 80 on the impact cap 60, and thus on the container mouth 6'.

[0063] This pre-assembly of the closure system 10' is shown as an example for the medication container 1' in longitudinal section in Fig. 10. Fig. 10a shows the system with the impact cap 60 pushed on, wherein the retaining ring 80 has not yet been pushed on. The locking hooks 70 of the impact cap 60 are already in engagement with the outer bead 68 on the mouth area of ​​the container 1'. The retaining ring 80 can then be pushed on according to the procedure described above; the result is shown in Fig. 10b. The snap ribs 86 are in locking engagement with the locking recesses 92 on the outer casing of the impact cap 60, so that it is securely fixed. The medication container 1' is now prepared for the attachment of the closure lid 12, which can be carried out in the same way as for the medication container 1 using the bayonet lock 22.After attaching the closure lid 12, which is done in an identical manner for both medication containers 1, 1' using the bayonet lock 22, namely in the case of medication container 1 directly at the correspondingly contoured mouth end and in the case of medication container 1' after its attachment to the impact cap 60, the medication container 1, 1' can be subjected to an automated filling process. In particular, the medication container 1, 1' provided with the closure lid 12 can be provided in a filling device for filling with the active ingredient in a manner considered to be independently inventive. According to one aspect of the present invention, this can be done while maintaining sterile conditions due to the design of the closure system 10, 10', without the need for re-sterilization of the medication container 1 at the filling site or after filling. The filling of the medication container 1 is shown in Fig.11, and that of the medication container 1' in Fig. 12, each shown using a sequence of steps. The sequences are largely identical for both variants.

[0064] As a starting point, step a) shows the pre-assembled container 1, 1', provided with the closure lid 12 in its "parking position", i.e. in the temporarily stabilized position of the bayonet lock 22, after it has been brought to the filling location. In a first step, in preparation for filling, the closure lid 12 is detached from the container mouth 6 or the impact cap 60 by "reverse rotation", i.e., by twisting its retaining ring 14 relative to the container mouth 6, 6' in the opposite direction to the pre-assembly described above. This creates the state shown in b), in which the closure lid 12 and with it the sealing membrane 16 have been lifted from the container mouth 6, 6', thus opening access to the container interior 4. This preferably takes place under sterile or aseptic conditions within the filling system.The removed closure lid 12 is separated during the subsequent filling and stored independently of the medication container 1, 1 '.

[0065] The medication container 1, 1' is now ready to be filled with active ingredient. For this purpose, a filling needle 96 of an injector unit connected to a storage container for the substance to be filled is positioned in the container mouth 6, 6' within the filling device, as shown in c). After the intended fill quantity has been introduced, the filling needle 96 can be removed again, and the closure cap 12 is made ready again. This is shown in d). Subsequently, the closure lid 12 is replaced and connected via the bayonet lock 22 (not explicitly shown). This is done definitively this time, so that the container 1, 1' cannot be opened again without causing damage, as is the case after the described pre-assembly. For this purpose, the bayonet lock 22 is set to the finally stabilized position so that the retaining ring 14 is then also secured against rotation relative to the container mouth 6, 6'.The closure cap 12 is thus secured to the container mouth 6, 6' in a tamper-proof manner, and access to the container interior 4 is only possible by opening the tamper-evident closure 18, i.e., by tearing the sealing plate 20 off the retaining ring 14 and then piercing the sealing membrane 16. Later, possibly after the medication has been transported to the actual location of use, the sealing plate 20 is removed, as shown in e), and the tamper-evident closure 18 is thus opened. This allows the underlying sealing membrane 16 to be pierced and the medication to be removed.

[0066] To carry out the method described above, which is considered to be independently inventive, a filling system 100 is provided, as shown in Fig. 13 in a perspective front view (Fig. 13a) and rear view (Fig. 13b) and in Fig. 14 in a top view. The filling system is designed as a sequential system and comprises a number of functional modules that are connected in series in a suitable functional manner with regard to the intended processing steps. On the input side, an input station 102 is provided, to which the medication containers 1, 1' to be filled are delivered, each with a temporarily stable closure lid 12 still attached. Delivery is generally in the form of larger batches of, for example, 100 containers 1, 1', which are first separated in the input station 102 (so-called "de-nesting").

[0067] The receiving station 102 is followed by a sterilization unit 104 configured as an ionizing radiation source, preferably an electron beam unit ("e-beam"). In this unit, the incoming containers 1, 1' can be re-sterilized to reliably eliminate any contamination that may have occurred during storage or safekeeping.

[0068] On the process side, the sterilization unit 104 is followed by a preparation station 106, in which the closure lid 12 of the medication containers 1, 1', which are delivered pre-assembled with the closure lid 12 attached and aligned in the temporarily stabilized position with respect to the bayonet closure 22, is lifted off by loosening the bayonet closure 22 and transported further separately from the respective medication container 1, 1'. For particularly simple handling and correspondingly high efficiency, the design of the closure system 10, 10' using the bayonet closure 22 is used according to an aspect considered to be independently inventive. In the preparation station 104, the medication containers 1, 1' are guided on circular arcs by means of suitably placed transport wheels 108. The respective medication container 1, 1' can be held in a constant orientation relative to the respective transport wheel 108.In contrast, the respective closure lid 12 can be held in a constant orientation relative to the overall system by a moving gripper system with which it engages. In combination, this leads to a rotation of the closure lid 12 relative to the respective medication container 1, 1'. By selecting suitable parameters, for example, the transport path along the respective transport wheel 108, dimensions, etc., a targeted relative rotation of the closure lid 12 relative to the container 1, 1' can be set as a result of the further transport of the containers, so that the bayonet lock 22 is released. This allows the detachment and subsequent lifting of the closure lid 12 from the container 1, 1' to be automated and possible without further intervention.

[0069] Downstream of the preparation station 106 is the actual filling station 110 for filling the respective medication container 1, 1' with active ingredient, in which the filling needle 96 is arranged. This is followed by a final assembly station 112, in which the respective closure lid 12 is re-assigned to the respective medication container 1, 1', reattached to the respective medication container 1, 1' by means of the bayonet catch 22, and aligned with respect to the bayonet catch 22 in the final stabilized position. This is also carried out by means of transport wheels 114, with the targeted rotation between the closure lid 12 and medication container 1, 1' being adjusted analogously to the manner described above until the final stabilized rotational position of the bayonet catch 22 is reached.

[0070] The filling system 100 is specifically designed for a compact, efficient construction to meet even the highest quality standards. For this purpose, the sterilization unit 104, the preparation station 106, the filling station 110, and the final assembly station 112 are arranged in a common outer housing 116.

[0071] During processing in the filling system 100, in particular after the aforementioned "de-nesting" and before being fed into the sterilization unit 104, the medication containers 1, 1' are suitably regrouped and combined into particularly suitable transport batches 118 according to an aspect of the invention considered to be independently inventive. Such a transport batch 118 is shown in Fig. 15 in a front view, in Fig. 16 in a rear view, and in Fig. 17 in longitudinal section. Such a transport batch 118, which in the example shown is composed of six medication containers 1, 1', is - in contrast to the usual "nesting" - arranged linearly and thus comprises only a single lane of medication containers 1, 1'. This ensures that each container 1, 1' is guided individually past the sterilization unit 104 and is thus reliably detected by the sterilization process.For the production of the transport batches 118, corresponding holding combs 120 are provided, which have suitable recesses 124 in a frame 122 for receiving the individual containers 1, 1'.

[0072] List of reference symbols

[0073] 1.1 ' medicine container

[0074] 2 container wall

[0075] 4 Interior

[0076] 6, 6' container opening

[0077] 10, 10' locking system

[0078] 12 closure lids

[0079] 14 Retaining ring

[0080] 16 Sealing membrane

[0081] 17 Thickening

[0082] 18 Tamper-evident seal

[0083] 20 Sealing plate

[0084] 22 bayonet lock

[0085] 24 leadership backdrop

[0086] 26 cams

[0087] 30 axial segment

[0088] 32, 34 leading edge

[0089] 36 Tangential segment

[0090] 38 Transition area

[0091] 40, 42 leading edge

[0092] 44 End face

[0093] 46 parking cams

[0094] 48 frontal area

[0095] 50 counter cams

[0096] 52 locking hooks

[0097] 54 front flank

[0098] 56 flank

[0099] 60 impact cap

[0100] 62 Fixing cap

[0101] 64 inner plugs

[0102] 66 Muzzle opening

[0103] 68 Outer bead

[0104] 70 locking elements

[0105] 72 Opening

[0106] 74 Ring cover 6 Plug body 8 Groove 0 Retaining ring 2 Opening 4 Shell surface 6 Snap ribs 0 Axial segment 6 Filling needle 00 Filling system 02 Inlet station

[0107] 104 Sterilization unit

[0108] 106 Preparation Station

[0109] 108 Transport bike

[0110] 110 filling station

[0111] 112 Final assembly station

[0112] 114 Transport wheel

[0113] 116 outer casing

[0114] 118 Transport batch

[0115] 120 holding comb

[0116] 122 indentation

[0117] 130 sealing plate

[0118] 132 Mouth edge

[0119] 134 lateral surface

[0120] 136 around running edge

[0121] 138 Radial sealing element

[0122] 140 Deepening

[0123] 142 Reinforcement ring

[0124] B Width b Width

[0125] H Height h Height

Claims

Claims 1. A closure system (10, 10') for a medication container (1, 1'), the interior (4) of which is accessible via a container opening (6, 6') designed in the manner of a bottle mouth, with a closure lid (12) which has a retaining ring (14) on which a pierceable sealing membrane (16) is arranged which, in the assembled state, tightly closes the container opening (6, 6'), and which can be attached to the container opening (6, 6') by means of a bayonet closure (22) having a number of cams (26) guided in a guide slot (24), wherein the bayonet closure (22) has, with respect to a rotation of the retaining ring (14) relative to the container opening (6, 6'), in addition to an insertion position, a temporarily stabilized position and a finally stabilized position.

2. Closure system (10, 10') according to claim 1, the temporarily stabilized position of which is arranged in an interval of approximately 20° - 25° upon rotation of the retaining ring (14) relative to the container opening (6, 6').

3. Closure system (10, 10') according to claim 1 or 2, whose final stabilized position is arranged in an interval of approximately 50° - 55° upon rotation of the retaining ring (14) relative to the container opening (6, 6').

4. Closure system (10, 10') according to one of claims 1 to 3, on whose retaining ring (14) a sealing plate (20) which can be torn off from the retaining ring (14) is arranged to form a tamper-evident closure (18).

5. Closure system (10, 10') according to one of claims 1 to 4, whose guide slot (24) comprises an axial segment (30) designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the retaining ring (14).

6. Closure system (10, 10') according to one of claims 1 to 5, whose guide slot (24) comprises a tangential segment (36) designed in the manner of a tangential groove and extending in a tangential direction around the axis of rotation of the retaining ring (14).

7. Closure system (10, 10') according to claim 6, wherein the tangential segment (36) of the guide slot (24) merges into its axial segment (30).

8. Closure system (10, 10') according to claim 7, in whose tangential segment (36) a locking hook (52) with a bevelled front flank (54) is arranged.

9. Closure system (10) according to one of claims 1 to 8, for a medication container (1) formed from a medical grade plastic, in particular from COP of the variants 690R® or 790R®, or from COC of the variants Topas® 8007S-04, 6013S-04 or 6015S-04, in which the guide slot (24) or the cams (26) of the bayonet closure (22) are arranged in the area forming the bottle neck of the medication container (1) and are designed in one piece with the latter.

10. Closure system (10') according to one of claims 1 to 8, further comprising a closure cap (60) which can be placed on the mouth region of the container opening (6, 6') and is provided with an inner plug (64), and a locking ring (80) which can be pushed onto the latter and which, in a position completely pushed onto the closure cap (60), can be locked to the closure cap (60) by means of a number of snap ribs (68), wherein the guide slot (24) or the cams (26) of the bayonet closure (22) are arranged on the outside of the closure cap (60) and are designed in one piece with the latter.

11. Closure system (10, 10') according to one of claims 1 to 10, in which the or each cam (26) of the bayonet closure (22) is arranged on the inside of the retaining ring (14) and, correspondingly thereto, the respective guide slot (24) is arranged on the outside in the area forming the bottle neck of the medicine container (1) on the latter or on the outside of the closure cap (60).

12. A medication container (1, 1') having an interior space (4) accessible via a container opening (6, 6') designed in the manner of a bottle mouth, the container opening (6, 6') being closed by a closure system (10, 10') according to one of claims 1 to 11.

13. Filling system (100) for filling medicament containers (1, 1') each provided with a closure system (10, 10') according to one of claims 1 to 11, with a preparation station (106) in which from the pre-assembled with attached, with respect to the bayonet closure (22) in the temporarily stabilized Position aligned closure lid (12) delivered to the medicament containers (1, 1'), the closure lid (12) is lifted off by loosening the bayonet catch (22) and transported further separately from the respective medicament container (1, 1'), with a filling station (110) for filling the respective medicament container (1, 1') with active ingredient, and with a final assembly station (112), in which the respective closure lid (12) is again assigned to the respective medicament container (1, 1'), is reattached to the respective medicament container (1, 1') by means of the bayonet catch (22) and is aligned with respect to the bayonet catch (22) in the finally stabilized position, wherein the preparation station (106), the filling station (110) and the final assembly station (112) are arranged in a common outer housing (116).

14. Filling system (100) according to claim 13, with a sterilization unit (104) upstream of the preparation station (106) and also arranged in the common outer housing (116).

15. Filling system (100) according to claim 14, whose sterilization unit (104) is designed as an electron beam unit.

Images