EP4077154A1

EP4077154A1 - Closure arrangement for a vessel containing a pharmaceutical substance

Info

Publication number: EP4077154A1
Application number: EP20838932.0A
Authority: EP
Inventors: Daniel Joel GLOOR; Ralf DITTMER
Original assignee: Datwyler Pharma Packaging Belgium NV
Current assignee: Datwyler Pharma Packaging Belgium NV
Priority date: 2019-12-18
Filing date: 2020-12-16
Publication date: 2022-10-26
Anticipated expiration: 2040-12-16
Also published as: CN114787046A; US20230008277A1; EP4077154B1; WO2021122688A1; SI4077154T1; DE102020133659A1

Abstract

The invention relates to a closure arrangement (1) for a vessel (2) containing a pharmaceutical substance, having a stopper (3), having a metal cap (4), for securing the stopper (3) on the vessel (2), and having an overcap (5) made of plastic, wherein, for the purpose of identifying contents of the vessel (2), a wirelessly readable, electrical memory unit (6) is connected to the closure arrangement (1). In order for a closure arrangement of the type in question to be improved further, in particular in respect of tamper-evident sealing, it is proposed that the memory unit (6) should be operatively connected both to the overcap (5) and to the stopper (3), said operative connection having a lasting effect on the memory unit (6) when the overcap (5) is torn off.

Description

description

Closure arrangement for a vessel with a pharmaceutical substance

Field of technology

[0001] The invention relates to a closure arrangement for a vessel with a pharmaceutical substance, with a closure stopper, a metal cap for fixing the closure stopper on the vessel, and an overcap made of plastic, with a wireless one for identifying the contents of the vessel readable, electrical storage unit is connected to the closure arrangement.

State of the art

Closure caps of the type in question are known, for example, from WO 2013/149844 A1 (US 2015/0298414 A1). In addition, reference is also made to WO 2016/090073 A1 (US 10450116 B2) and WO

2019/076430 Al (US 2020/193262 Al). Such closure caps are used in particular to be assigned to vessels for receiving a pharmaceutical substance, for example for arrangement on an ampoule. The closure cap can be designed as a crimp cap using the metal cap, in particular designed in the manner of an aluminum cap, the metal cap serving to hold a preferably rubber-like closure plug in the area of the container opening. The overcap is used as a further part of the closure arrangement assigned to the metal cap, for example as a cover part. This overcap is removed from the metal cap to expose the metal cap and for possible subsequent use of the vessel closed by the closure arrangement, for example as a result of tearing off. In the overcap, in particular in the existing overcap made of a plastic, it can also be a tamper-evident closure for the metal cap as a whole, further in this context the production of such an overcap is known, for example in the plastic injection molding process. Such an overcap can also be made of polypropylene (PP) or polyethylene (PE), for example.

It is also known to provide such a closure arrangement with a storage unit that can be read out wirelessly. In such a memory unit, for example, information about the content (composition of the vessel contents, active ingredients, manufacturer, etc.) and / or further, for example, information about the filling date and / or expiry date of the substance stored in the vessel can be stored.

Summary of the invention

With regard to the prior art described above, the object of the invention is to further improve a closure arrangement of the type in question, in particular with regard to securing tamper-evident.

One possible solution to the problem is given according to a first inventive idea in a closure arrangement in which it is ensured that an operative connection of the memory unit is given both to the overcap and to the closure plug, which occurs when the overcap is torn off causes a lasting effect on the storage unit.

The removal or tearing off of the overcap from the metal cap and the closure plug covered by the metal cap can represent the status of an initial use of the vessel closed by the closure arrangement. Such an initial use can be replaced by a permanent The effect on the storage unit when the overcap is removed can be detected and, if necessary, registered. In this way, when the memory unit is read out after the overcap has been removed, the first-use status can be determined in an advantageous manner. Such a first-use status can also preferably not be revised by putting the plastic cap back on. Rather, due to the permanent effect on the storage unit, such an initial use status is more or less permanently imprinted, so that removal of the overcap that has been carried out (also earlier) can be detected at any later point in time. When the overcap is torn off, a corresponding status can optionally be set or released actively via an electronic pulse in the memory unit, in particular in a possible memory chip, which status can preferably be read out wirelessly to determine the tamper-evident status. When the overcap is torn off, this removal can also be recorded in or on the storage unit by permanent marking, for example by a mechanically induced marking.

In particular, such a (mechanical) marking can, if necessary, be recognized directly by the user or indirectly using a conventional reading device to read out the information stored in the storage unit.

In a preferred embodiment, at least that part of the storage unit containing or storing the required information remains permanently on or in the closure arrangement, at least over the usual period of use of the vessel. Further features of the invention are explained below, also in the description of the figures, often in their preferred assignment to the subject matter of claim 1 or to features of further claims. However, they can also be assigned to only individual features of claim 1 or the respective further claim, or in each case regardless of meaning.

Thus, according to a possible embodiment, a separating means can be provided which has a permanent effect on the storage unit when the overcap is torn off. Alternatively, for example, the storage unit can also be attached partly to the overcap and partly to the sealing plug, with a permanent effect on the storage unit if the overcap is torn off. In both cases, an operative connection of the storage unit to both the sealing plug and the overcap is given either directly or indirectly (via the separating means). The memory unit, which has been affected by tearing off the overcap, can, when reading out the stored information, transmit information that is permanently generated by the tearing off of the overcap. Such information can be stored accordingly actively in the memory unit when the overcap is torn off, or such information can be generated in the course of reading out. In a further embodiment, such generation of the information can only take place, for example, using a suitable reading device.

The permanent effect on the memory unit can be given according to a possible embodiment by a complete severing (tearing) of the memory unit, the section of the memory unit containing the relevant and readable information preferably at the Closure plug and thus remains on the vessel. Alternatively, the memory unit and an associated antenna, or only the memory unit or only the antenna, can be removed. As a result of the section of the memory unit that is possibly completely torn off in such an embodiment, an optical signal can be given to the user alone. In addition, such a missing section of the storage unit, for example, can also be registered when the information stored in the storage unit is read out wirelessly. Thus, for example, such a missing or damaged section can influence the data transmission. The result is that data transfer is no longer possible.

Such a lasting effect on the storage unit can also be given by cutting or tearing the storage unit. A section of the storage unit is not completely removed in the process. Such an incision, however, like a complete severing, is also ir reversible and thus initially also recorded optically. In addition, by cutting or tearing in this way, the removal of the overcap can be stored electronically, which can also be shown here, for example, by influencing the data transmission.

In a further embodiment, the memory unit can be an RFID tag or an NFC tag or have such a tag. RFID and NFC are wireless or contactless communication technologies. This enables communication between a memory unit and an electrically operated reading device. Such systems preferably consist of a reader and a transponder (tag), with the tags distinguishing between active and passive transponders. Active tags have their own power source (battery), while passive tags do not have their own power source, but are supplied with energy via the electromagnetic field generated by the reader. In the present invention, passive tags are preferably used.

In a further preferred embodiment, high-frequency RFID (radio frequency identification) or NFC (near field communication) tags are used, further for example at a frequency of about 10 to 15 MHz, further for example about 13 , 56 MHz. Such transponders have a relatively small range, so that a reading device must be in close proximity to the transponder and thus to the closure arrangement and the vessel in order to read out the stored data. This can be a distance of a few centimeters, for example 2 to 5 up to 10 cm.

The lasting effect on such a transponder when the overcap is torn off can be achieved, for example, by correspondingly influencing the antenna of the tag, for example by tearing off or tearing part of the antenna or, moreover, as a result of stretching or stretching the antenna as a whole or part of it.

The storage unit can be adhesively connected to the overcap and / or the sealing plug completely or over its entire surface, preferably partially. In this regard, a permanently fixed adhesive connection is preferred, so that when the overcap is removed or torn off, permanent stress and action on the storage unit is brought about.

As a result of such an adhesive connection, the storage unit, in the same way as when it is embedded in the respective material, on the one hand with the sealing plug and, on the other hand, with the overcap, a tearing or tearing through of the storage unit along a predetermined nominal tear line can be achieved. If the storage unit is torn through in this way, the section storing the relevant information preferably remains on the sealing plug and thus on the vessel and possibly a further section of the storage unit on the removed plastic cap.

The storage unit can also be partially or completely encapsulated with plastic in its area assigned to the overcap, for example with the plastic forming the overcap. Accordingly, the relevant part of the storage unit can be fixed on or in the overcap in the course of the production of the overcap. Another subsection of the storage unit can protrude like a flag and can be glued to the metal cap, for example, or directly to the sealing plug after the plastic cap has been put on to produce the tamper-evident feature. In a further preferred embodiment, the storage unit can be acted upon in a destructive manner by removing the overcap. The memory unit is then preferably irreversibly marked, in particular completely or partially destroyed, but impairing its function, so that the memory unit is permanently influenced in its function and / or with regard to the possibly stored information content after removing the overcap. The destruction can, for example, directly or indirectly affect an RFID tag or NFC tag of the storage unit.

The destruction can result from an irreversible separation of two areas of the storage unit from one another. Furthermore, as is also preferred, in the course of the destruction, a partial area of the storage unit can be separated out, for example in the manner of a tear-off section. The metal cap can have an opening which, in a preferred embodiment, can be larger than half up to eight tenths or nine tenths or more of the outer diameter of the metal cap. The cap cover that is set up and surrounds the opening can, for example, only grip the sealing plug around the edge in a collar-like manner.

The storage unit can also be gripped loosely between the metal cap and the sealing plug. The storage unit, which is essentially resting on the sealing plug, can optionally be held by the metal cap at least partially reaching over the storage unit. This can result in particular manufacturing advantages, but also advantages in the course of a possible single-type disposal.

Alternatively, the storage unit can also be completely or partially non-destructively removable connected to the sealing plug, further for example by gluing or complete or partial overmolding with the material forming the sealing plug.

In one possible embodiment, the storage unit overmolded with plastic can have a target tear line for separating part of the storage unit. Such a nominal tear line can be given, for example, by a limited thinning of the plastic material along, for example, a straight or circular line. Alternatively, such a nominal tear line can also be given by a perforation along a line, in which perforation along the line the plastic material is preferably evenly spaced apart, optionally in the form of a slot fully penetrating breakthroughs can be provided. The web-like sections of the plastic material connecting these openings are preferably destroyed in the course of removing the overcap, thereby tearing off along the intended tear line. In this context, it can further be provided that, for example, two desired tear lines are formed which are spaced apart from one another in the tear-off direction along the desired tear line and which are simultaneously destroyed in the course of removing the overcap. This can result in a section that can be detached from the storage unit between these nominal tear lines, which afterwards can possibly be present as a lost loose part.

Thus, the storage unit can be reached from below by a reach-through section of the overcap in the area separated by the nominal tear line. By means of such a reach-through section, in the course of removing the overcap, the area of the storage unit separated by the nominal tear line or delimited by two nominal tear lines is acted upon mechanically, so that destruction by separation along the nominal tear line is achieved.

According to a preferred embodiment, the nominal tear line can run through a section of an antenna of the storage unit. The antenna as part of the storage unit is connected to the RFID or NFC tag, for example. The antenna can be completely separated from the tag, for example, by deliberately destroying it by separating it along the target tear line. Alternatively, the destruction of the antenna results in a targeted shortening of the length. The storage unit is then no longer functional. With such a separation of the antenna, a shortening of the antenna length or a power reduction to, for example, 60% or less, further for example to 50 or 40% or less, up to 5% or less of the original, not influenced by destruction Length or power can be achieved.

As a result of the targeted power reduction, for example, the data stored in the tag can no longer be read at the usual distance with a reading unit brought up to the locking arrangement. The reduction in performance of the antenna can be so great through the targeted arrangement of the target tear line that it is not possible to read out the tag in a contactless manner.

In addition, a wire can also be provided as a separating means for separating (tearing through) the storage unit, which wire establishes a connection between the overcap and the storage unit. With regard to the storage unit, the connection can be made in that the wire is firmly connected to a base of the storage unit and thus ensures that the storage unit is torn off or severed when the overcap is torn off. When the overcap is torn off, a targeted separation of the storage unit is carried out or achieved via the wire.

When such a wire is arranged, it can be firmly connected to the overcap, for example as a result of a corresponding bonding or overmolding of the ends of the wire facing the cap from plastic forming the overcap.

Such a separating means can also be provided in the form of a cutting edge. Brief description of the drawings

The invention is explained below with reference to the accompanying drawing, which, however, merely represents exemplary embodiments. A part that is only explained with reference to one of the exemplary embodiments and is not replaced by another part in a further exemplary embodiment due to the special features highlighted there, is thus also described as a possible existing part for this further exemplary embodiment. The drawing shows:

Fig. 1 in perspective representation an applied to a vessel

Closure arrangement with an overcap, relating to a first embodiment;

2 shows the overcap in an individual perspective view;

3 shows the stopper of the closure arrangement with one of the

Metal cap covering sealing plugs, further aufwei send an intact storage unit;

4 shows the section along the line IV-IV in FIG. 1;

5 shows the enlargement of the area V in FIG. 4;

Fig. 6 shows an embodiment of a memory unit in plan view, be relevant to the intact execution;

7 shows a perspective illustration essentially corresponding to FIG. 1, but after the overcap has been torn off from the sealing plug with permanent action on the storage unit;

8 shows a detail view according to FIG. 5, but relating to a second embodiment; 9 shows a representation corresponding to FIG. 6, but relating to a further embodiment of the memory unit;

10 shows a further sectional view corresponding to FIG. 5, relating to a further embodiment;

11 shows a schematic perspective illustration of the embodiment in FIG. 10;

FIG. 12 shows a further sectional illustration corresponding to FIG. 5, relating to a further embodiment; FIG.

13 shows a representation corresponding to FIG. 1, relating to a further embodiment;

14 shows the schematic sectional illustration along the line XIV-XIV in FIG. 13;

15 shows a further embodiment in a sectional view according to FIG. 4;

16 shows the enlargement of the region XVI in FIG. 15; FIG. 17 shows the memory unit of the area XVI in FIG. 15;

18 shows an illustration essentially corresponding to FIG. 15, but after the overcap has been removed;

19 shows the storage unit in a plan view according to FIG. 17, but after it has been destroyed by removing the overcap;

20 shows a schematic representation of the section separated out from the storage unit by removing the overcap.

Description of the embodiments

A closure arrangement 1 for a vessel 2, for example an ampoule, with a pharmaceutical substance (not shown) is shown and described.

For this purpose, the closure arrangement 1 initially and essentially has a closure plug 3, a metal cap 4 and an overcap 5. Furthermore, a storage unit 6 that can be read out wirelessly is preferably provided in the closure arrangement 1, in particular for identifying the contents of the vessel 2.

The metal cap 4 can for example be formed and produced from a flat aluminum strip in a preferably combined punching and forming process (deep-drawing process). The aluminum strip preferably used for this purpose can also consist of a laminate, for example consisting of a metallic foil layer which can be coated on the top and bottom with a plastic layer. The metal cap 4 can have a cap cover 7 and, in the usual state of use, for example according to the sectional view in FIG. 4, a cap wall 8 preferably extending downward. At the same time, an opening 9 is preferably punched out in the cap cover 7, which opening can be covered by the plate-like overcap 5 when it is finally applied to the vessel 2, as shown for example in FIG.

The closure arrangement 1 is applied to the upper region of the vessel 2, for example, as shown in FIGS. 1 and 4. In the mouth of the vessel 2, the elastomeric sealing plug 3 is inserted, which is encompassed by the metal cap 4 on the upper side and on the flange side. The metal cap 4 is further preferably bent (crimped) down to the underhand grip to form a vessel mouth edge 10. The relevant lower metal cap edge can be pressed in the course of the application of the metal cap 4 to the vessel 2 by, for example, a pusher tool to rest against the vessel 2, in the underhand grip shown in FIG. 4 to the vessel mouth rim 10.

On the metal cap 4, the plate-shaped overcap 5 is applied further from above, in particular to cover the opening 9, and furthermore preferably to form a tamper-evident feature. This overcap 5 is preferably made of a hard plastic material, and is furthermore preferably produced using a plastic injection molding process.

The overcap 5 can in detail aufwei sen an overcap cover 11, which preferably extends over the entire surface of the metal cap 4, covering the cap cover 7. On the underside of the overcap cover 11, as is also preferred, an extension 12 can be formed, which preferably has a diameter adapted to the opening 9 in the metal cap 4. At the end, the extension 12 also has a collar-like radial extension 13 which, in the covering position representing the tamper-evident security according to FIGS. 1, 4 and 5 and 8, 10, 12 to 14, engages under the edge region of the opening 9.

The plastic overcap 5 can be removed from the metal cap 4 by tearing it off. The radial extension 13 gives way elastically due to the acting tensile force, so that the position behind the grip is canceled. The metal cap 4 also has the above-mentioned opening 9 on the top in the usual manner. This opening 9 is covered by the overcap 5 in accordance with the state in, for example, FIG. 4 to ensure tamper-evident. After removing the overcap 5, the opening 9 is exposed for piercing through the sealing plug 3. The one preferably provided in or on the closure arrangement 1

Storage unit 6 is preferably an RFID or NFC tag, correspondingly an electronic, wirelessly readable storage unit. As shown schematically for example with reference to FIGS. 6 and 9, such a memory unit 6, also referred to as a transponder, essentially has a memory chip 14 and an antenna 15. As further shown schematically, a plurality of antennas 15, here two antenna sections 24 and 25, can be provided.

The storage unit 6 can be formed in a strip-like manner according to the illustrated embodiments, optionally with reference to a plan view according to the representations in FIGS. 6 and 9 along a circular line. elongated section. In this regard, however, total ring-shaped storage units 6 are also possible, for example.

The storage unit 6 is arranged in such a way that it lies in a hidden position in the position covered by the overcap 5 and, when the overcap 5 is removed, in particular torn off, a permanent effect, in particular as a result of tearing, tearing or stretching of a section of the Storage unit 6, learns. This permanent effect on the memory unit 6 can be detected in particular when the memory unit 6 is read out via a read-out unit, so that in the course of such a readout it can be seen whether the overcap 5 (even if it is subsequently replaced on the metal cap 4) has been removed or respectively is. This provides evidence of the proper assurance of tamper-evident or of the cancellation of the assurance of tamper-evident.

The lasting effect on the storage unit 6 is preferably irreversible.

FIGS. 1 to 7 show a first embodiment in which the storage unit 6 is fastened on the sealing plug 3 via subsections 16 and 17 on the top, facing the cap cover 7 of the metal cap 4. The attachment can, as is also preferred, be achieved by an adhesive layer 19. The subsections 16 and 17 can further, as preferred, each be end sections of the storage unit 16. A central section 18 viewed in the longitudinal extension of the storage unit 6, on the other hand, is preferably not connected to the sealing plug 3, but rather to the overcap 5.

In particular, for reading out the memory arranged essentially in a position between the sealing plug 3 and the metal cap 4 unit 6, a window-like opening 20 is preferably provided in the metal cap 4. This can be completely in the width direction of the storage unit 6 - correspondingly in the usual position of use in the radial direction, based on a closure axis x, to which preferably both the closure plug 3 and the metal cap 4 and the overcap 5, as well as the mouth edge 10 run concentrically - extend. Viewed in the longitudinal direction, the opening 20 can optionally extend beyond the end-side subsections 16 and 17 of the storage unit 6. In a preferred embodiment, the resulting opening area of the opening 20 in the surface plane of the cap cover 7 is selected to be less than 40 percent up to, for example, 20 or 15 percent of the total annular metal cap surface.

In this embodiment, the opening 20 is preferably also used to pass through the middle section 18 of the storage unit 6 and to fix it on the underside of the cap top 7 of the overcap 5. An adhesive layer 21 can also be provided for this purpose.

In the course of the assembly of the closure arrangement 1, this middle section 18, after fixing the closure plug 3 using the metal cap 4 on the mouth edge 10 of the vessel 2 with its upwardly facing adhesive layer 21, can protrude freely beyond the surface of the metal cap 4, in such a way that with a final latching placement, or bending or crimping of the overcap 5 or the metal cap 4 already connected to it, the cap cover 7 steps against this adhesive layer 21 to define the central section 18 and is attached to it. Both on the top side of the sealing plug 3 and on the underside of the cap cover 7, recesses 22, 23 can be provided for receiving the respective section of the storage unit 6. In the representations (for example FIG. 5), the respective depth of such a depression 22, 23, which usually moves in the tenths of a meter, further for example up to 1 mm, is shown exaggerated.

As further illustrated, for example, in FIG. 6, the memory chip 14 of the memory unit 6 is preferably provided in the area of one of the subsections 16 or 17, more preferably together in the same subsection 17 with an antenna section 24. The further subsection 17 has the second At antenna section 25, which is connected via the middle section 18 of the memory unit 6 to the memory chip 14 in the subsection 17. The antenna copy 25 can also extend further over the central section 18. Alternatively, in the area of the central section 18, there is possibly only one connection line from the second antenna section 25 to the memory chip 14.

When the overcap 5 is torn off, as is shown schematically in FIG. 7, a permanent effect on the storage unit 6 is effected such that, according to the first exemplary embodiment, the middle section 18 is torn off due to its adhesive bond on the underside of the overcap 5 and thus the storage unit 6 is severed essentially transversely to its longitudinal extension. For this purpose, the storage unit 6, as further shown schematically in FIG. 6, can have predetermined, for example pre-embossed, nominal tear lines 26 on both sides of the central section 18. The punctiform or partial area gluing of the storage unit 6, in particular the subsections 16 and 17 with the plug 3 and the Mitenabschnites 18 with the overcap 5 is selected in terms of strength so that this is ensured even if the overcap 5 is torn off. After the overcap 5 has been torn off, the center section 18 preferably remains attached to the underside of the ceiling. The storage unit 6 is permanently severed.

The partial section 17 of the memory unit 6 remaining on the sealing plug 3 preferably also has the memory chip 14 with the information stored therein, in particular about the contents of the vessel 2 and a directly assigned and electrically connected antenna section 24.

FIGS. 8 and 9 show an embodiment in which the storage unit 6 has, for example, only two subsections 16 and 17, which are connected via only one nominal tear line 26. Here, too, the nominal tear line 26 extends transversely over a connection area between the memory chip 14 and the second antenna section 25.

Such a storage unit 6 can, as is also preferred, be connected to the top of the sealing plug 3 in the end areas of the subsections 16 and 17 facing away from each other, for example, glued, while a central area, also having the nominal tear line 26, is unaffected the plug 3 extends.

This central, preferably unattached area of the storage unit 6 can be accompanied by a separating means 27, which is preferably permanently connected to the overcap 5. Such a separating means 27 can, as shown in the embodiments according to Figures 8 to 11, be a wire 28, which according to the embodiment in Figures 8 and 9, for example L- may be shaped or curved LL-shaped. First free, preferably appropriately bent L-legs 30 of the wire 28 can be connected to the overcap 5, for example as a result of the injection-molding of the free legs, the L-web 29 connecting the L-legs 30 connects the storage unit 6, or a material area suitable for a possible effect on the storage unit 6, preferably in the area of the target tear line 26, with the overcap 5. Here, the connection to an adhesive layer 19, which underpins the storage unit 6, can be be given. The second L-leg 30 can, however, also be integrated into rubber material in the course of vulcanization, as a result of injection molding or embedding. The second free L-leg 30 is further preferably arranged along the storage unit 6 ver.

When the overcap 5 is torn off, the wire 28, in particular its L-bar 29, ensures that the memory unit 6 is preferably severed along the intended tear line 26, so that the memory chip 24 also occurs there Embodiment is separated from the second antenna section 25.

According to a further embodiment, which is not shown in detail in the ligures, the second and / or first L-leg 30 can also span a surface, for example as a result of a zigzag course of the respective L-leg 30.

In addition, as shown schematically in Ligur 12, the separating means 27 can also be, for example, a cutting element 31 which can be fastened to the overcap 5 on the underside via a web 32 and an adhesive layer 21. Such a cutting element 31 can also be formed in one piece and made of the same material with the overcap 5. Here the overcap 5 can be torn off a (merely) tearing of the storage unit 6, possibly along a predetermined target tear line 26. However, this tearing can, for example, result in a separation of the memory chip 14 from the second Antennenab section 25 according to the embodiments described above. In any case, this also makes it possible to achieve a lasting effect on the storage unit 6.

FIGS. 13 and 14 show a further possible embodiment in which the storage unit 6 is connected to the overcap 5 in the region of one end viewed in the longitudinal direction, in particular in the region of a free end of the partial section 16, as a result of overmolding. Thus, the storage unit 6 is preferably permanently attached at the end in or on the overcap 5 in the course of the production of the overcap 5 in the plastic injection molding process. The further part of the memory unit 6 (in particular the subsection 17, which is preferably also connected to the subsection 16 via a predetermined tear line 26 and has the memory chip 14 and preferably a first antenna section 24) extends in a flag-like manner starting from a position in the arrangement the surface of the cap cover 11 facing the surface of the metal cap 4. The free end of the storage unit 6 or the further subsection 17 facing away from this can, as also shown, be provided facing the metal cap 4 with an adhesive layer 19.

When the overcap 5 is put on in the course of (initial) assembly, for example, a lower side of the overcap 5 can be used to act on the section of the storage unit 6 having the adhesive layer 19 on the underside, in such a way that a desired adhesive connection the storage unit 6 can be reached with the surface of the metal cap 4. In this embodiment, too, the storage unit 6, in particular between two subsections 16 and 17, can have a target tear line 26 along which a permanent effect can be achieved due to the severing of the storage unit 6 when the overcap 5 is torn off.

Another possible embodiment is shown in FIGS. 15 to 20. As can be seen, the cover of the plug 3 in this embodiment does not extend in a coupling-like manner, as in the embodiments described above, but rather essentially oriented along a plane running transversely to the closure axis x . As in the exemplary embodiments described above, a bead-like indentation 34 can be provided, as is also preferred, centrally penetrated by the closure axis x, into which the radial extension 13 of the overcap 5 can protrude in the embodiment according to FIGS.

The storage unit 6 can overall, as shown, be designed in the form of a disk or disk, with a diameter which can essentially correspond to the outer diameter of the sealing plug 3.

In the middle, centrally penetrated by the geometric closure axis x, a bore-like opening 35 is provided in the storage unit 6, which is penetrated by the extension 12 of the overcap 5 when the closure arrangement 1 is properly closed according to FIG. The radial extension 13 adjoining the extension 12 engages under the edge section 36 of the storage unit 6 surrounding the opening 35 (see also FIG. 16).

Concentric to the geometrical central axis of the opening 35 and at a radial distance from the opening edge in the preferably from one Plastic, the carrier material of the storage unit 6 consists of a nominal tear line 26 formed, for example, by perforation. Between this nominal tear line 26 and the opening 35 there is a circular ring-like edge section 36.

The radial extension 13 of the overcap 5 engages under the area of the edge section 36 and ends accordingly in the radial direction, preferably at a radial distance from the nominal tear line 26.

A memory chip 14 is held in the carrier material of the memory unit 6, for example by being partially or completely encapsulated with plastic. An antenna 15 is electrically connected to the memory chip 14 and can extend in a spiral shape in approximately concentric circles to the locking axis x (see FIG. 17).

A substantially radially extending antenna boom 37 extends out of the spiral circles of the antenna 15, crossing the predetermined tear line 26 inwardly into the area of the radial section 36 (see FIG. 17).

The storage unit 6 of this embodiment is held by the metal cap 4 resting on the sealing plug 3 reaching over it. The storage unit 6 can accordingly lie essentially unsecured between the metal cap 4 and the sealing plug 3. The opening 9 of the metal cap 4 has a diameter e which can be approximately 0.8 to 0.95 times the outer diameter d of the metal cap 4. A cap cover 7 that overlaps the storage unit 6 in a collar-like manner can thus result around the edge. The outside diameter of the Spirally formed antenna 15 can, as preferred, be selected to be smaller than the diameter e of the opening 9 in the metal cap 4.

The overcap 5 can lie essentially flat on the collar-like edge of the cap top 7. When the overcap 5 is torn off, the radial extension 13 acts as a separating means 27. The edge section 36 under which the separating means 27 engages tears off this edge section 36 like a circular ring along the nominal tear line 26, cutting through the radially inwardly protruding into the edge section 36 Antenna boom 37. The antenna 15 is thereby divided into two electrically separate antenna sections 24 and 25, of which a maximum of one antenna section can be electrically connected to the memory chip 14.

The torn off edge section 36 with the separated antenna arm 37 preferably remains on the extension 12 of the overcap 5. The separated antenna arm 37 and the associated cancellation of the functionality of the antenna 15 as a whole is a permanent effect on the Storage unit 6 reached.

The above explanations serve to explain the inventions covered by the application as a whole, which develop the state of the art independently at least by means of the following combinations of features, whereby two, more or all of these combinations of features can also be combined, namely : A closure arrangement which is characterized in that there is an operative connection of the storage unit 6 to both the overcap 5 and to the sealing plug 3, which causes a permanent effect on the storage unit 6 when the overcap 5 is torn off. A closure arrangement, which is characterized in that the

Memory unit 6, which has an effect by tearing off the overcap 5, he has transmitted information when read out, which is caused by the tearing off.

A closure arrangement which is characterized in that the memory unit 6 has an RFID or NFC tag.

A closure arrangement which is characterized in that the storage unit 6 is adhesively connected to the overcap 5 and / or the closure plug 3.

A closure arrangement which is characterized in that the storage unit 6 is partially or completely encapsulated with plastic in its area assigned to the overcap 5.

A closure arrangement which is characterized in that the storage unit 6 is partially or completely embedded in the material of the closure plug 3 in its area assigned to the closure plug 3. A closure arrangement which is characterized in that the storage unit 6 can be destroyed by removing the overcap 5. A closure arrangement, which is characterized in that the metal cap 4 has an opening 9 which is larger than half up to eight tenths or nine tenths or more of the outer diameter d of the metal cap 4. [0091] A closure arrangement, which is characterized in that the molded storage unit 6 is gripped loosely between the metal cap 4 and the sealing plug 3.

A closure arrangement, which is characterized in that the storage unit 6 overmolded with plastic has a predetermined tear line 26 for separating a part of the storage unit 6.

A closure arrangement which is characterized in that a separating means 27 of the overcap 5 engages under the storage unit 6 in the area separated by the nominal tear line 26.

A closure arrangement which is characterized in that the nominal tear line 26 runs through a section 24, 25 of an antenna 15 of the storage unit 6.

A closure arrangement which is characterized in that a wire 28 is provided as a separating means 27 for separating the storage unit 6. A closure arrangement, which is characterized in that the

Wire 28 is firmly connected to the overcap 5. All the features disclosed are essential to the invention (individually, but also in combination with one another). In the disclosure of the application, the disclosure content of the associated / attached priority documents (copy of the previous application) is hereby fully included, also for the purpose of including features of these documents in the claims of the present application. The subclaims characterize, even without the features of a referenced claim, with their features independent inventive developments of the prior art, in particular in order to make divisional applications on the basis of these claims. The invention specified in each claim can additionally have one or more of the features provided in the above description, in particular provided with reference numbers and / or specified in the list of reference numbers. The invention also relates to design forms in which some of the features mentioned in the above description are not implemented, in particular if they are recognizable for the respective purpose or can be replaced by other technically equivalent means.

List of reference signs

1 locking arrangement 27 separating agents

2 vessel 28 wire

3 sealing plugs 29 L-bar

4 metal caps 30 L-legs

5 overcap 31 cutting element

6 storage unit 32 bar

7 cap cover 33 hold-down devices

8 Cap wall 34 recess

9 opening 35 opening

10 rim of the vessel mouth 36 rim section

11 Over cap cover 37 antenna bracket

12 appendix

13 radial expansion

14 memory chip

15 antenna

16 sections

17 section d outer diameter

18 center sections diameter

19 Adhesive layer x locking axis

20 breakthrough

21 adhesive layer

22 deepening

23 deepening

24 antenna sections

25 antenna sections

26 Target tear line

Claims

Expectations

1. Closure arrangement (1) for a vessel (2) with a pharmaceutical substance, with a closure stopper (3), a metal cap (4) for securing the closure stopper (3) on the vessel (2), and an overcap ( 5) made of plastic, wherein a wirelessly readable, electrical storage unit (6) is connected to the locking arrangement (1) to identify the contents of the vessel (2), characterized in that an operative connection of the storage unit (6) to both the overcap (5) as well as the sealing plug (3), which causes a permanent effect on the storage unit (6) if the overcap (5) is torn off.

2. Closure arrangement according to claim 1, characterized in that the memory unit (6), which has been affected by the tearing off of the overcap (5), transmits information when it is read which is caused by the tearing off.

3. Closure arrangement according to one of the preceding claims, characterized in that the memory unit (6) has an RFID or NFC tag.

4. Closure arrangement according to one of the preceding claims, characterized in that the storage unit (6) is adhesively bonded to the overcap (5) and / or the closure plug (3).

5. Closure arrangement according to one of the preceding claims, characterized in that the storage unit (6) is partially or completely encapsulated with plastic in its area associated with the over-cap (5).

6. Closure arrangement according to one of the preceding claims, characterized in that the storage unit (6) is partially or completely embedded in the material of the closure plug (3) in its area associated with the closure plug (3).

7. Closure arrangement according to one of the preceding claims, characterized in that the overcap (5) can be destroyed in a destructive manner on the storage unit (6).

8. Closure arrangement according to one of the preceding claims, characterized in that the metal cap (4) has an opening (9) which is larger than half up to eight tenths or nine tenths or more of the outer diameter (d) of the Metal cap (4).

9. Closure arrangement according to one of the preceding claims, characterized in that the overmolded storage unit (6) is loosely held between the metal cap (4) and the closure plug (3).

10. Closure arrangement according to one of the preceding claims, characterized in that the plastic-coated storage unit (6) has a nominal tear line (26) for separating part of the storage unit (6).

11. Closure arrangement according to one of the preceding claims, characterized in that the storage unit (6) is gripped from below by a separating means (27) of the overcap (5) in the area separated by the nominal tear line (26).

12. Closure arrangement according to one of the preceding claims, characterized in that the nominal tear line (26) runs through a section (24, 25) of an antenna (15) of the memory unit (6).

13. Closure arrangement according to one of the preceding claims, characterized in that for separating the storage unit (6)

Wire (28) is provided as a separating means (27).

14. Closure arrangement according to one of the preceding claims, characterized in that the wire (28) is firmly connected to the overcap (5).