EP4077154B1 - Dispositif de fermeture pour récipient comprenant une substance pharmaceutique - Google Patents

Dispositif de fermeture pour récipient comprenant une substance pharmaceutique Download PDF

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Publication number
EP4077154B1
EP4077154B1 EP20838932.0A EP20838932A EP4077154B1 EP 4077154 B1 EP4077154 B1 EP 4077154B1 EP 20838932 A EP20838932 A EP 20838932A EP 4077154 B1 EP4077154 B1 EP 4077154B1
Authority
EP
European Patent Office
Prior art keywords
overcap
storage unit
closure
memory unit
closure arrangement
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20838932.0A
Other languages
German (de)
English (en)
Other versions
EP4077154A1 (fr
Inventor
Daniel Joel GLOOR
Ralf DITTMER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Datwyler Pharma Packaging Belgium NV
Original Assignee
Datwyler Pharma Packaging Belgium NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Datwyler Pharma Packaging Belgium NV filed Critical Datwyler Pharma Packaging Belgium NV
Publication of EP4077154A1 publication Critical patent/EP4077154A1/fr
Application granted granted Critical
Publication of EP4077154B1 publication Critical patent/EP4077154B1/fr
Active legal-status Critical Current
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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/24Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/245Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with decoration, information or contents indicating devices, labels
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/18Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2203/00Decoration means, markings, information elements, contents indicators
    • B65D2203/10Transponders
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2251/00Details relating to container closures
    • B65D2251/0003Two or more closures
    • B65D2251/0006Upper closure
    • B65D2251/0015Upper closure of the 41-type
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2251/00Details relating to container closures
    • B65D2251/0003Two or more closures
    • B65D2251/0068Lower closure
    • B65D2251/0075Lower closure of the 39-type

Definitions

  • the invention relates to a closure arrangement for a vessel with a pharmaceutical substance, with a closure plug, a metal cap for fixing the closure plug on the vessel, and an overcap made of plastic, wherein a wirelessly readable, electrical storage unit with the closure arrangement is used to identify the contents of the vessel connected is.
  • Closing caps of the type in question are, for example, from the WO 2013/149844 A1 ( US 2015/0298414 A1 ) known. In addition, it is also about the WO 2016/090073 A1 ( US 10 450 116 B2 ) and WO 2019/076430 A1 ( US 2020/193262 A1 ) to refer.
  • Such closure caps are used in particular for assignment to vessels for holding a pharmaceutical substance, for example for arrangement on an ampoule.
  • the closure cap can in particular 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 associated with the metal cap, for example as a lid part. This overcap is removed from the metal cap, for example by tearing it off, to expose the metal cap and for possible subsequent use of the vessel closed by the closure arrangement.
  • the overcap in particular the overcap made of plastic, can also be a tamper-evident closure for the metal cap as a whole, and in this context the production of such an overcap is known, for example using the plastic injection molding process.
  • Such an overcap can also consist of polypropylene (PP) or polyethylene (PE), for example.
  • Such a closure arrangement with a wirelessly readable memory unit.
  • information about the contents for example, information about the contents (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.
  • a closure arrangement for, for example, a wine bottle in which a readable electrical storage unit is arranged in a cap, which is destroyed when the cap is removed due to a tear strip located in the cap, which is connected to an element located above the stopper.
  • the invention is concerned with the task of further improving a closure arrangement of the type in question, particularly with regard to ensuring originality.
  • Removing or tearing off the overcap from the metal cap and the closure plug covered by the metal cap can represent the status of a first use of the vessel closed by the closure arrangement.
  • Such initial use can be detected and, if necessary, registered by a permanent impact on the storage unit when the overcap is removed.
  • the first use status can be determined in an advantageous manner when the storage unit is read out after the overcap has been removed.
  • a first-use status cannot be revised by putting the plastic cap on again. Rather, due to the permanent impact on the storage unit, such a first-use status is virtually permanently imprinted, so that removal of the overcap (even earlier) can be proven at any later point in time.
  • 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 for determining the tamper-evident status can preferably be read out wirelessly.
  • this removal can also be recorded in or on the storage unit by a permanent marking, for example by a mechanically caused marking.
  • such a (mechanical) marking can optionally be recognized directly by the user or indirectly using a conventional reading device for reading the information stored in the storage unit.
  • At least the 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.
  • a release agent which has a permanent effect on the storage unit if the overcap is torn off.
  • the storage unit can be partially attached to the overcap and partially to the closure plug, with this resulting in a permanent effect on the storage unit if the overcap is torn off.
  • the storage unit which has been affected by tearing off the overcap, can transmit information when the stored information is read out that is permanently generated by tearing off the overcap is. Such information can be actively stored in the storage unit when the overcap is torn off or such information can be generated during the reading process. In a further embodiment, such information can only be generated using a suitable reading device, for example.
  • the permanent effect on the storage unit can be achieved by completely severing (tearing through) the storage unit, with the section of the storage unit containing the relevant and readable information preferably remaining on the closure plug and thus on the vessel.
  • the storage unit and an associated antenna, or just the storage unit or just the antenna can also be removed.
  • the section of the storage unit which may be completely torn off in such an embodiment, can alone provide an optical signal for the user.
  • such a missing section of the storage unit can also be registered when the information stored in the storage unit is read out wirelessly. For example, such a missing or damaged section can influence data transmission. The result is that data transfer is no longer possible.
  • Such a permanent effect on the storage unit can also be caused by cutting or tearing the storage unit. Not a section of the storage unit is completely removed. However, such an incision, like a complete transection, is irreversible and is therefore initially recorded visually.
  • the removal of the overcap can also be permanently recorded electronically through such a cutting or tearing, which is further, for example can also show here, for example, by influencing data transmission.
  • the storage unit can be an RFID tag or an NFC tag or can have such a tag.
  • RFID and NFC are wireless or contactless communication technologies. This enables communication between a storage unit and an electrically operated reading device.
  • Such systems preferably consist of a reading device 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 powered by the electromagnetic field generated by the reader. In the present invention, passive tags are preferably used.
  • high-frequency RFID Radio Frequency Identification
  • NFC Near Field Communication
  • Such transponders have a relatively short range, so that in order to read out the stored data, a reading device must be in close proximity to the transponder and thus to the closure arrangement and the vessel. This can be a distance of a few centimeters, for example 2 to 5 up to 10 cm.
  • the permanent 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 a part of the antenna or beyond Stretching or stretching of the antenna as a whole or part of it.
  • the storage unit can be adhesively bonded completely or over the entire surface, preferably partially, to the overcap and/or the sealing plug.
  • a permanently strong adhesive connection is preferred, so that removing or tearing off the overcap causes permanent stress and impact on the storage unit.
  • a tearing or tearing through of the storage unit along a predetermined target 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 closure plug and thus on the vessel and, if necessary, 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. In this way, the relevant part of the storage unit can be fixed on or in the overcap during the production process.
  • a further section of the storage unit can protrude like a flag and can be glued, for example, to the metal cap or directly to the sealing plug after the plastic cap has been put on to ensure tamper-evident protection.
  • the storage unit can be destroyed by removing the overcap.
  • the storage unit is then preferably irreversibly marked, in particular completely or partially, but in the process impairs the function, is destroyed, so that the function of the storage unit and/or the information content that may be stored after removal of the overcap is permanently affected.
  • 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, a portion of the storage unit can be separated from it during the destruction, for example in the manner of a tear-off section.
  • the metal cap may have an opening which, in a preferred embodiment, may be larger than half to eight tenths or nine tenths or more of the outer diameter of the metal cap.
  • the cap cover that is created and surrounds the opening can, for example, only extend over the edge of the sealing plug in a collar-like manner.
  • the storage unit can also be held loosely between the metal cap and the sealing plug.
  • the storage unit which rests essentially on the closure plug, can possibly be held simply by the metal cap reaching over the storage unit at least partially. This can result in particular advantages in terms of manufacturing technology, but also advantages in terms of possible sorted disposal.
  • the storage unit can also be connected, for example, completely or partially to the closure plug in a non-destructively removable manner, for example by gluing or more completely partial encapsulation with the material forming the sealing plug.
  • the storage unit which is coated with plastic in a possible embodiment, can have a desired tear line for separating part of the storage unit.
  • a target tear line can be provided, for example, by a limited thinning of the plastic material along, for example, a straight or circular line.
  • a desired tear line can also be provided by a perforation along a line, in which perforations along the line, preferably evenly spaced openings, possibly slot-like openings which completely penetrate the plastic material, can be provided.
  • the web-like sections of the plastic material connecting these openings are preferably destroyed when the overcap is removed, which results in tearing along the desired tear line.
  • two desired tear lines spaced apart from one another in the tearing direction along the desired tear line are formed, which are simultaneously destroyed in the course of removing the overcap. This can result in a section that can be separated from the storage unit between these desired tear lines, which can then possibly be present as a lost loose part.
  • the storage unit can be gripped under by a reach-through section of the overcap in the area separated by the desired tear line.
  • a reach-through section By means of such a reach-through section, in the course of removing the overcap, the area of the storage unit that is separated by the desired tear line or delimited by two desired tear lines is mechanically acted upon, so that destruction is achieved by separation along the target tear line.
  • the target 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, for example, be completely separated from the tag. Alternatively, the destruction results in a targeted shortening of the length of the antenna. The storage unit will then no longer be functional.
  • the data stored in the tag can no longer be read at the usual distance with a reading unit brought close to the closure arrangement.
  • the power reduction of the antenna can be so great that the tag cannot be read without contact.
  • a wire can also be provided as a separating means, which establishes a connection between the overcap and the storage unit.
  • the connection can be given with regard to the storage unit in that the wire is firmly connected to a base of the storage unit and thus when the wire is torn off Overcap ensures that the storage unit can be torn off or severed. By tearing off the overcap, a targeted separation of the storage unit is carried out or achieved via the wire.
  • wire If such a wire is arranged, it can be firmly connected to the overcap, for example as a result of appropriate gluing or also encapsulating the ends of the wire facing the cap with plastic forming the overcap.
  • Such a separating agent can also be provided in the form of a cutting edge.
  • a closure arrangement 1 for a vessel 2, for example an ampoule, with a pharmaceutical substance (not shown) is shown and described.
  • the closure arrangement 1 initially and essentially has a closure plug 3, a metal cap 4 and an overcap 5. Furthermore, a wirelessly readable memory unit 6 is provided in the closure arrangement 1, in particular for identifying the contents of the vessel 2.
  • the metal cap 4 can be formed and manufactured, for example, 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 Figure 4 , have a cap wall 8 that preferably runs downwards.
  • An opening 9 is preferably punched out in the middle of the cap cover 7, which in the final state applied to the vessel 2, as shown, for example, in Figure 4 is shown, which can preferably be covered by the plate-like overcap 5 here.
  • the closure arrangement 1 is, for example, as shown in the Figures 1 and 4 applied to the upper area of the vessel 2.
  • the elastomeric sealing plug 3 is inserted into the mouth of the vessel 2 and is surrounded by the metal cap 4 on the top and flange sides.
  • the metal cap 4 is further preferably bent (flared) up to the underhand grip to form a vessel mouth edge 10.
  • the relevant lower edge of the metal cap can, in the course of applying the metal cap 4 to the vessel 2, be placed in contact with the vessel 2, for example using a pusher tool below handle shown Figure 4 to the vessel mouth edge 10.
  • the plate-shaped overcap 5 in the illustrated embodiments is applied further from above, in particular to cover the opening 9, and more preferably to form a tamper-evident device.
  • This overcap 5 is preferably made of a hard plastic material and is also preferably manufactured using the plastic injection molding process.
  • the overcap 5 can specifically have an overcap cover 11, which preferably extends over the entire surface of the metal cap 4, covering the cap cover 7.
  • an extension 12 can be formed on the underside of the overcap cover 11, which preferably has a diameter adapted to the opening 9 in the metal cap 4.
  • the extension 12 also has a collar-like radial extension 13, which in the covering position which represents the tamper-evident protection according to Figures 1 , 4 and 5 and 8, 10, 12 to 14 reach under the edge area of the opening 9.
  • the plastic overcap 5 can be removed by tearing it off the metal cap 4.
  • the radial extension 13 deflects elastically due to the acting tensile force, so that the rear grip position is canceled.
  • the metal cap 4 also has the above-mentioned top opening 9 in the usual manner.
  • This opening 9 is in accordance with the state, for example Figure 4 covered by the overcap 5 to ensure originality. After removing the over cap 5, the opening 9 is exposed for piercing through the sealing plug 3.
  • the storage unit 6 provided in or on the closure arrangement 1 is preferably an RFID or NFC tag, correspondingly an electronic, wirelessly readable storage unit.
  • a memory unit 6 also known as a transponder, essentially has a memory chip 14 and an antenna 15.
  • a plurality of antennas 15, here two antenna sections 24 and 25, can also be provided.
  • the storage unit 6 can be formed in a strip-like manner according to the illustrated embodiments, if necessary with reference to a top view according to the illustrations in FIGS Figures 6 and 9 running elongated along a circular line section. In this regard, however, overall ring-shaped storage units 6 are also possible.
  • 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 tearing off, it experiences a permanent effect, in particular as a result of a partial section of the storage unit 6 being torn off, torn or stretched.
  • This permanent effect on the storage unit 6 can be detected in particular when the storage unit 6 is read out via a readout unit, so that in the course of such a readout it can be seen whether the overcap 5 has been or is removed (even if it is subsequently replaced on the metal cap 4). This provides proof of proper originality assurance or of the removal of originality assurance.
  • the permanent 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 to the closure plug 3 via sections 16 and 17 on the top side, 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 sections 16 and 17 can also, as preferred, each be end sections of the storage unit 16.
  • a central section 18 viewed in the longitudinal extent of the storage unit 6 is, however, preferably not connected to the closure plug 3, but rather to the overcap 5.
  • a window-like opening 20 is preferably provided in the metal cap 4, in particular for reading out the storage unit 6, which is essentially arranged in a position between the closure plug 3 and the metal cap 4. This can be completely in the width direction of the storage unit 6 - correspondingly in the usual usage position in the radial direction, based on a closure axis x, to which preferably both the closure plug 3 as well as the metal cap 4 and the overcap 5, as well as more preferably also the mouth edge 10 are concentric run - extend. Viewed in the longitudinal direction, the opening 20 can optionally extend beyond the end sections 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 smaller than 40 percent up to, for example, 20 or 15 percent of the entire annular metal cap surface.
  • the breakthrough 20 is preferably also used to pass through the middle section 18 of the storage unit 6 and on the underside on the cap ceiling 7 of the overcap 5.
  • An adhesive layer 21 can also be provided for this purpose.
  • this middle section 18 can protrude freely beyond the surface of the metal cap 4 with its upward-facing adhesive layer 21 after the closure plug 3 has been fixed using the metal cap 4 on the mouth edge 10 of the vessel 2, in such a way that with a After the final locking placement, or bending or flanging of the overcap 5 or the metal cap 4 that may already be connected to it, the cap cover 7 for fixing the middle section 18 comes against this adhesive layer 21 and is arrested with it.
  • Recesses 22, 23 can be provided both on the top side of the sealing plug 3 and on the underside of the cap cover 7 to accommodate the respective section of the storage unit 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 antenna section 25, which extends over the middle section 18 of the memory unit 6 is connected to the memory chip 14 in the section 17.
  • the antenna copy 25 can also extend over the middle section 18. Alternatively, this may only result in the area of the central section 18 a connecting line from the second antenna section 25 to the memory chip 14.
  • the storage unit 6 By tearing off the overcap 5, as shown schematically in Figure 7 is shown, a permanent effect on the storage unit 6 is caused in such a way 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 extent.
  • the storage unit 6 can be used, as further in Figure 6 shown schematically, have predetermined, for example pre-embossed, desired tear lines 26 on both sides of the central section 18.
  • the selective or partial bonding of the storage unit 6, in particular the sections 16 and 17 with the sealing plug 3 and the middle section 18 with the overcap 5, is selected in terms of strength so that this is ensured even if the overcap 5 is torn off.
  • the middle section 18 preferably remains attached to the underside of the ceiling. The storage unit 6 is permanently severed.
  • the section 17 of the storage unit 6 remaining on the closure plug 3 preferably also has the storage 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, for example, only has two sections 16 and 17, which are connected via only one desired tear line 26. This also extends here Target tear line 26 across 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 closure plug 3 on the top side, for example glued, in the mutually repelling end regions of the sections 16 and 17, while a central area, which also has the desired tear line 26, is unattached to the closure plug 3 extends.
  • This central, preferably unattached area of the storage unit 6 can be accompanied by a separating agent 27, which is preferably permanently connected to the overcap 5.
  • a separating agent 27 can, as in the embodiments according to Figures 8 to 11 shown, be a wire 28, which according to the exemplary embodiment in the Figures 8 and 9 For example, it can be curved in an L-shape or LL-shape.
  • First free, preferably correspondingly bent L-legs 30 of the wire 28 can be connected to the overcap 5, for example by overmolding the free leg ends in the course of producing the overcap 5.
  • the L-web 29 connecting the L-legs 30 connects the storage unit 6 , or a material area suitable for a possible impact on the storage unit 6, preferably in the area of the desired tear line 26, with the overcap 5.
  • the connection to an adhesive layer 19, which underpins the storage unit 6, can be given.
  • the second L-leg 30 can also be integrated into rubber material during vulcanization by overmolding or embedding.
  • the second free L-leg 30 is further preferably arranged running along the storage unit 6.
  • the wire 28, in particular its L-web 29, ensures that the storage unit 6 is preferred is severed along the desired tear line 26, so that the memory chip 24 is also separated from the second antenna section 25 in this embodiment.
  • the second and/or first L-leg 30 can also span a surface, for example due to a zigzag course of the respective L-leg 30.
  • the release agent 27 can also, as in Figure 12 shown schematically, for example a cutting element 31, which can be attached to the underside of the overcap 5 via a web 32 and an adhesive layer 21.
  • a cutting element 31 can also be made in one piece and made from the same material as the overcap 5.
  • tearing off the overcap 5 can lead to a (mere) tearing of the storage unit 6, possibly along a predetermined target tear line 26.
  • this tearing can, for example, result in a separation of the memory chip 14 from the second antenna section 25 according to the previously described exemplary embodiments.
  • a lasting effect on the storage unit 6 can also be achieved in this way.
  • the Figures 13 and 14 show a further possible embodiment in which the storage unit 6 is connected to the overcap 5 in the area of one end viewed in the longitudinal extent, in particular in the area of a free end of the section 16, by overmolding.
  • the storage unit 6 is preferably permanently fixed at the end in or on the overcap 5 during the production of the overcap 5 using the plastic injection molding process.
  • the further part of the storage unit 6 (in particular the one preferably connected to the section 16 via a desired tear line 26,
  • the memory chip 14 and preferably a first antenna section 24 having a section 17) extends like a flag starting from a surface of the overcap cover 11 facing the surface of the metal cap 4 in the arrangement position.
  • the free end of the memory unit 6 or the further section 17 facing away from this can, as also shown, facing the metal cap 4 with an adhesive layer 19.
  • the overcap 5 When the overcap 5 is placed in place during the (initial) assembly, the section of the storage unit 6 which has the adhesive layer 19 on the underside can be acted upon, for example via a hold-down device 33 formed on the underside of the overcap 5, in such a way that a desired adhesive connection of the storage unit 6 with the Surface of the metal cap 4 can be achieved.
  • the storage unit 6, in particular between two sections 16 and 17, can have a desired tear line 26, along which a permanent effect can be achieved due to the storage unit 6 being severed if the overcap 5 is torn off.
  • FIG. 15 to 20 Another possible embodiment is shown in: Figures 15 to 20
  • the ceiling of the closure plug 3 in this design does not extend like a dome, as in the previously described embodiments, but rather essentially oriented along a plane running transversely to the closure axis x.
  • a bead-like recess 34 can be provided in the middle of the closure axis x, as is also preferred, into which also in the embodiment according to Figures 15 to 20 the radial extension 13 of the overcap 5 can protrude.
  • the storage unit 6 can be designed overall, as shown, in the shape of a disc or disk, with a diameter that can essentially correspond to the outer diameter of the closure plug 3.
  • a bore-like opening 35 is provided in the storage unit 6, which in the proper closure state of the closure arrangement 1 according to Figure 15 is penetrated by the extension 12 of the overcap 5.
  • 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 Figure 16 ).
  • a desired tear line 26 Concentric to the geometric central axis of the opening 35 and at a radial distance from the opening edge, a desired tear line 26, formed for example by perforation, runs in the carrier material of the storage unit 6, which is preferably made of plastic. This results between this desired tear line 26 and the opening 35 a circular ring-like edge section 36.
  • the radial extension 13 of the overcap 5 extends under the area of the edge section 36 and ends accordingly in the radial direction, preferably at a radial distance from the desired tear line 26.
  • a memory chip 14 is held in the carrier material of the memory unit 6, for example by partially or completely encapsulating it with plastic.
  • An antenna 15 is electrically connected to the memory chip 14, which can extend spirally in approximately concentric circles to the closure axis x (compare Figure 17 ).
  • a substantially radial antenna boom 37 extends out of the spiral circles of the antenna 15, crossing the desired tear line 26 inwards into the area of the radial section 36 (see Figure 17 ).
  • the storage unit 6 of this embodiment is held by gripping over the metal cap 4 resting on the closure plug 3.
  • the storage unit 6 can accordingly lie essentially unfastened between the metal cap 4 and the closure plug 3.
  • the opening 9 of the metal cap 4 has a diameter e, which can correspond to approximately 0.8 to 0.95 times the outer diameter d of the metal cap 4. This can result in a cap cover 7 covering the storage unit 6 in a collar-like manner around the edge.
  • the outer diameter of the spiral-shaped antenna 15 can, as preferred, be chosen to be smaller than the diameter e of the opening 9 in the metal cap 4.
  • the overcap 5 can rest essentially flat on the collar-like edge of the cap cover 7.
  • the radial extension 13 acts as a separating means 27.
  • the edge section 36 under which the separating means 27 is gripped tears off this edge section 36 in a circular ring manner along the desired tear line 26, severing the antenna boom 37 which protrudes radially inwards into the edge section 36.
  • the Antenna 15 is thereby divided into two electrically separate antenna sections 24 and 25, of which a maximum of one antenna section can then still be electrically connected to the memory chip 14.
  • the torn edge section 36 with the separated antenna boom 37 preferably remains on the extension 12 of the overcap 5.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)

Claims (14)

  1. Dispositif de fermeture (1) pour un récipient (2) contenant une substance pharmaceutique, avec un bouchon de fermeture (3), un capuchon métallique (4) pour la fixation du bouchon de fermeture (3) sur le récipient (2), et un surcapuchon (5) en matière plastique, dans lequel, pour l'identification d'un contenu du récipient (2), une unité de mémoire électrique (6) de lecture sans fil est prévue, reliée à l'agencement de fermeture (1), caractérisée en ce qu'une liaison active de l'unité de mémoire (6) est donnée aussi bien au surcapuchon (5) qu'au bouchon de fermeture (3), laquelle provoque une action permanente sur l'unité de mémoire (6) en cas de déchirement du surcapuchon (5).
  2. Dispositif de fermeture selon la revendication 1, caractérisé en ce que l'unité de mémoire (6), qui a subi une action par arrachement du surcapuchon (5), transmet, lors d'une lecture, une information provoquée par ledit arrachement.
  3. Dispositif de fermeture selon l'une quelconque des revendications précédentes, caractérisé en ce que l'unité de mémoire (6) comprend une étiquette RFID ou NFC.
  4. Dispositif de fermeture selon l'une quelconque des revendications précédentes, caractérisé en ce que l'unité de mémoire (6) est reliée par collage au surcapuchon (5) et/ ou au bouchon de fermeture (3).
  5. Dispositif de fermeture selon l'une des revendications précédentes, caractérisé en ce que l'unité de mémoire (6) est partiellement ou totalement surmoulée de matière plastique dans sa zone associée au surcapuchon (5).
  6. Dispositif de bouchage selon l'une quelconque des revendications précédentes, caractérisé en ce que l'unité de mémoire (6) est partiellement ou totalement noyée dans le matériau du bouchon de bouchage (3) dans sa zone associée au bouchon de bouchage (3).
  7. Dispositif de fermeture selon l'une des revendications précédentes, caractérisé en ce qu'il est possible d'agir de manière destructive sur l'unité de mémoire (6) en enlevant le surcapuchon (5).
  8. Dispositif de fermeture selon l'une quelconque des revendications précédentes, caractérisé en ce que le capuchon métallique (4) présente une ouverture (9) supérieure à la moitié jusqu'à huit dixièmes ou neuf dixièmes ou plus du diamètre extérieur (d) du capuchon métallique (4).
  9. Dispositif de fermeture selon la revendication 5 ou selon l'une quelconque des revendications 6 à 8, lorsque ces dernières dépendent de la revendication 5, caractérisé en ce que l'unité de mémoire surmoulée (6) est prise en sandwich de manière lâche entre le capuchon métallique (4) et le bouchon de fermeture (3).
  10. Dispositif de fermeture selon l'une des revendications 5 ou 9, ou selon l'une des revendications 6 à 8 si ces dernières dépendent de la revendication 5, caractérisé en ce que l'unité de mémoire (6) surmoulée de matière plastique présente une ligne de déchirure (26) pour séparer une partie de l'unité de mémoire (6).
  11. Dispositif de fermeture selon la revendication 10, caractérisé en ce que l'unité de mémoire (6) est saisie par en dessous par un moyen de séparation (27) du surcapuchon (5) dans la zone séparée par la ligne de déchirure théorique (26).
  12. Dispositif de fermeture selon l'une des revendications 10 ou 11, caractérisé en ce que la ligne de déchirure de consigne (26) passe par une partie (24, 25) d'une antenne (15) de l'unité de mémoire (6).
  13. Dispositif de fermeture selon l'une des revendications précédentes, caractérisé en ce qu'un fil (28) est prévu comme moyen de séparation (27) pour séparer l'unité de mémoire (6).
  14. Dispositif de fermeture selon la revendication 13, caractérisé en ce que le fil (28) est solidaire du surcapuchon (5).
EP20838932.0A 2019-12-18 2020-12-16 Dispositif de fermeture pour récipient comprenant une substance pharmaceutique Active EP4077154B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019135009 2019-12-18
PCT/EP2020/086343 WO2021122688A1 (fr) 2019-12-18 2020-12-16 Dispositif de fermeture pour récipient comprenant une substance pharmaceutique

Publications (2)

Publication Number Publication Date
EP4077154A1 EP4077154A1 (fr) 2022-10-26
EP4077154B1 true EP4077154B1 (fr) 2024-01-31

Family

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Application Number Title Priority Date Filing Date
EP20838932.0A Active EP4077154B1 (fr) 2019-12-18 2020-12-16 Dispositif de fermeture pour récipient comprenant une substance pharmaceutique

Country Status (5)

Country Link
US (1) US20230008277A1 (fr)
EP (1) EP4077154B1 (fr)
CN (1) CN114787046A (fr)
DE (1) DE102020133659A1 (fr)
WO (1) WO2021122688A1 (fr)

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5152413A (en) * 1990-07-26 1992-10-06 The West Company, Incorporated Bridge design for tamper evident closures
TWI268258B (en) * 2004-09-06 2006-12-11 Ind Tech Res Inst Package container cover with counterfeit identification functions with antenna functions for transmitting product identification information and detachment destruction functions for preventing re-use of identification chip
GB0604591D0 (en) * 2006-03-07 2006-04-19 Glaxosmithkline Biolog Sa Novel device
US7839288B2 (en) * 2006-06-26 2010-11-23 Chung Hua University Sealing detection mechanism using RFID tag for container
US7782212B2 (en) * 2007-12-14 2010-08-24 Avery Dennison Corporation Radio frequency sealing apparatus for a container
DE102012102881A1 (de) 2012-04-03 2013-10-10 Datwyler Pharma Packaging International Nv Verfahren zur Herstellung einer Bördelkappe, Bördelkappe und Behältnis mit Bördelkappe
EP2865607B1 (fr) * 2012-06-25 2017-11-22 Toyo Seikan Group Holdings, Ltd. Couvercle composite de récipient
FR3027700B1 (fr) * 2014-10-27 2018-01-19 Les Bouchages Delage Procede d'authentification de l'ensemble de fermeture d'un recipient
US10035631B2 (en) 2014-12-05 2018-07-31 Integrated Liner Technologies, Inc. Tagged products and tracking thereof using customizable data points
GB201701133D0 (en) * 2017-01-23 2017-03-08 Rieke Packaging Systems Ltd Packaging
DE102017107619A1 (de) * 2017-04-10 2018-10-11 Datwyler Pharma Packaging International Nv Verfahren zur Herstellung einer Vielzahl von Aluminium-Verschlusskappen, sowie Verwendung von bedruckten Teilen einer Aluminium-Verschlusskappe
MX2020003886A (es) 2017-10-16 2020-11-06 Gcl Int Sarl Elemento de cierre.

Also Published As

Publication number Publication date
CN114787046A (zh) 2022-07-22
WO2021122688A1 (fr) 2021-06-24
EP4077154A1 (fr) 2022-10-26
US20230008277A1 (en) 2023-01-12
DE102020133659A1 (de) 2021-06-24

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