EP4190714A1 - Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture - Google Patents

Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture Download PDF

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Publication number
EP4190714A1
EP4190714A1 EP21211721.2A EP21211721A EP4190714A1 EP 4190714 A1 EP4190714 A1 EP 4190714A1 EP 21211721 A EP21211721 A EP 21211721A EP 4190714 A1 EP4190714 A1 EP 4190714A1
Authority
EP
European Patent Office
Prior art keywords
cap
press
closure system
snap
container
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.)
Pending
Application number
EP21211721.2A
Other languages
German (de)
English (en)
Inventor
Thorsten Kellner
Jennifer Karina SEIB
Andreas DUNZ
Björn WINTERFELD
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.)
Wirthwein Medical GmbH and Co KG
Original Assignee
Wirthwein Medical GmbH and Co KG
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 Wirthwein Medical GmbH and Co KG filed Critical Wirthwein Medical GmbH and Co KG
Priority to EP21211721.2A priority Critical patent/EP4190714A1/fr
Priority to PCT/EP2022/083817 priority patent/WO2023099547A1/fr
Publication of EP4190714A1 publication Critical patent/EP4190714A1/fr
Pending legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1425—Snap-fit type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means

Definitions

  • the invention relates to a closure system for a medication container, the interior of which is accessible via a mouth area designed in the manner of a bottle mouth, the closure system comprising, in addition to a snap-on cap that can be pushed onto the mouth area and provided with a sealing element, a safety ring that can be pushed onto this, which is in a completely position pushed onto the press-on cap by means of a number of snap-in ribs on the press-on cap can be locked in place. It further relates to a medicament container with such a closure system and to a use of the closure system.
  • Medicines in particular for treatment in highly specialized or complex therapies, are usually made available in active ingredient or medicine containers, also referred to as containers or vials.
  • active ingredient or medicine containers also referred to as containers or vials.
  • Such a medicament container is usually designed in the manner of a small bottle and comprises an interior space in which the medicament or the active ingredient is kept and which is accessible via a container opening designed in the manner of a bottle mouth.
  • the active substance is then transferred from such a receptacle or container via suitable transfer systems for the actual administration to suitable systems such as a syringe or an intravenous line which provides fluid access to the patient's circulatory system.
  • drugs or substances can be used that are actually toxic or otherwise harmful or dangerous.
  • Personnel handling such substances such as pharmacists and nurses, can thus face acute and long-term health risks, particularly when they are repeatedly exposed to drugs or solvents released into the air during preparation, drug administration and other similar treatments could escape.
  • This problem can be particularly serious when dealing with cytotoxins, antiviral drugs, antibiotics or radiopharmaceuticals. Died by exposure to Potential health risks associated with these drugs include increased risk of cancer, genetic changes, and the like.
  • the active substance or medication containers are usually provided with suitable closure systems in which a closure stopper closes the container opening.
  • This sealing stopper can then be pierced to remove the medicament, for example by means of a hollow needle, via which the medicament can then be sucked out of the container.
  • a snap-on cap can be provided with a ring lid having a central opening, which can be attached to the "bottle mouth" with the container opening. The sealing plug is then placed centrally in this ring cover.
  • Such a press-on cap provided with the sealing element or closure plug is usually attached by pushing it onto the mouth area of the medication container and then locking it onto it, for example by means of snap or snap-in hooks arranged on the press-on cap, which form a snap-in connection with locking beads arranged on the container opening form.
  • This latching connection is then usually secured against unintentional loosening by means of a securing ring which can be pushed onto the press-on cap and encloses it laterally in its end position.
  • a securing ring ensures that the snap-in or snap-in hooks arranged on the press-on cap do not move back outwards and thus loosen the snap-in connection with the medicament container.
  • the locking ring pushed onto the press-on cap is usually likewise secured in its position on the press-on cap by means of latching means, for example a number of snap-in ribs.
  • the invention is therefore based on the object of specifying a closure system of the type mentioned above, which meets these requirements, in particular the suitability for automated filling processes, to a particularly large extent with simple means.
  • the invention is based on the consideration that the closure system for automated processing and also for high cycle or throughput rates with the correspondingly high processing speeds can be upgraded, among other things, by the fact that on the one hand a pre-assembly of the components impact cap and safety ring is particularly favored and on the other hand a particularly reliable guidance of the preassembled components relative to one another is ensured. In this way, it can be achieved in particular that potential sources of interference in the automated processing, for example due to tilting or canting of the components, incorrect positioning or the like, are eliminated.
  • the desired reliable guidance of the preassembled components relative to one another can be achieved in a particularly simple manner by forming a guide pair for the components using components that are usually present anyway, in this case the respective snap ribs. In order to form such a guide pairing, a corresponding guide link, for example in the form of a groove, should be assigned to the respective snap rib in the respective other component.
  • the respective snap rib be arranged on the inside of the locking ring or on the outside of the press-on cap, and the associated guide slot corresponding to the other component.
  • the or each snap-in rib is arranged on the inside of the securing ring and, corresponding thereto, the respective guide link is arranged on the outside of the press-on cap.
  • a closure system of the type mentioned is usually pressed onto the mouth opening of the medicament container in the manner of a linear movement after the pre-assembly of the press-on cap and the securing ring.
  • the press-on cap is first pushed onto the muzzle until it latches there or reaches its intended end position in some other way. Further pressing on the system then results in the retaining ring being pushed onto the press-on cap and increasingly enclosing it.
  • the guide link advantageously comprises a first axial segment designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the press-on cap or of the locking ring.
  • a locking bead for locking the respective snap rib is arranged in this first axial segment, so that the snap rib can be used for the design-related locking of the components.
  • the closure system is designed for a particularly stable pre-assembly of the press-on cap and the securing ring.
  • the retaining ring is first attached to the press-on cap during pre-assembly. Then, in the manner of a bayonet lock, twisting the locking ring on the press-on cap should produce a mechanically reliable connection of the attached locking ring with the press-on cap, and starting from this position later, when the system is finally attached to the medication container, the system can be pushed open completely.
  • the guide slot has a tangential segment designed in the manner of a tangential groove and extending in a tangential direction about the axis of rotation of the press-on cap or the securing ring.
  • the tangential segment of the guide slot expediently transitions into its first axial segment, with the transition area between the tangential segment and the axial segment being used to limit rotation of the securing ring relative to the press-on cap a stop is formed for the respective snap rib.
  • the respective snap rib can first be pushed into the tangential segment of the guide slot associated with it and then the securing ring can be rotated relative to the press-on cap.
  • the snap rib is guided in the tangential segment until it hits the stop. This stops the twisting and the retaining ring is fixed in a defined and reproducible position on the press-on cap.
  • the snap rib is then also in the transition area from the tangential segment of the guide link to its axial segment, so that from this position it is later possible to slide the locking ring further onto the press-on cap in the axial direction.
  • the components are securely engaged with each other, so that the closure system pre-assembled in this way is particularly well suited for automated further processing even with high loads and large quantities.
  • a locking tooth with a beveled stop surface for the snap rib is arranged in the tangential segment of the guide link. Due to the bevel, the snap rib can be pushed over the locking tooth during the rotation described above during its movement in the tangential segment, but on the other hand a backward movement of the snap rib over the locking tooth is then no longer possible due to the shape of the locking tooth. As a result, the snap rib is thus fixed in its end position in the tangential direction, so that a particularly stable and reliable pre-assembly of the components is achieved.
  • the impact cap and/or the securing ring is made from a plastic, preferably from polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefin polymer (COP) or polycarbonate.
  • PP polypropylene
  • COC cyclo-olefin copolymer
  • COP cyclo-olefin polymer
  • a closure system of the type mentioned above preferably in connection with the embodiment explained above, is provided with a tamper-evident closure for the medication container.
  • the closure system can be provided with an additional outer closure element in the form of a one-way closure.
  • This one-way closure which can include a sealing lid that can be torn off or is sealed, for example, allows for easy and reliable identification as to whether the container has already been used for liquid transfer or not, and thus makes it easier to determine whether the container has already been "opened” and is therefore preferred for another fluid withdrawal should be used until it is completely drained and thus discarded should be.
  • a sealing plate is formed on the outside of the securing ring and can be torn off to form a tamper-evident seal.
  • a medicament container the interior of which is accessible via a container opening designed in the manner of a bottle mouth, closed with a closure system of the type described above, is also considered to be independently inventive.
  • closure system of the type mentioned for a medication container is also considered to be independently inventive.
  • the advantages achieved with the invention are, in particular, that a particularly high mechanical stability of the preassembled intermediate product consisting of the safety cap and safety ring can be achieved by providing a guide pairing between the safety ring and the safety cap by means of the respective snap rib on the one hand and the associated guide link on the other hand.
  • This pre-assembled intermediate product is therefore also particularly well suited for subsequent processing steps with comparatively high demands, for example as part of automated processing or in processes with a high number of cycles or pieces.
  • the drug container 1 acc. 1 also referred to as a container or vial, is designed in the manner of a small bottle. It comprises an interior space 4 which is enclosed by a container wall 2 and in which the medicament or the active ingredient is kept.
  • the container wall 2 is made of a suitably selected plastic with or without a barrier layer.
  • a “medical grade” plastic is particularly preferred here, such as COP variants 690R® , 790R® , COC variants Topas® 8007S-04, 6013S-04, 6015S-04.
  • the plastic is very particularly preferably selected with regard to the criteria transparent, insensitive to breakage, little or no interaction with the envisaged drug, medical grade, in particular usable as a glass substitute, individually or in combination with one another.
  • the interior 4 is accessible via a container opening 6 designed in the manner of a bottle mouth.
  • the medicament container 1 is designed to a particular extent for the provision of active ingredients or medicaments in which any loss of material through unintentional release into the environment or environment is to be avoided as far as possible. This can be the case, for example, for substances that are toxic, hazardous to health or otherwise dangerous for the people handling them, or also for particularly expensive substances or active ingredients, such as are increasingly being used in modern therapies in particular.
  • the medication container 1 is equipped with a closure system 10 that closes the container opening 6 particularly high tightness and, on the other hand, is designed for particularly effective protection against tampering.
  • the container wall 2 of the medication container 1 is, as shown in the perspective view in 2 as well as the representation in longitudinal section in 3 can clearly be seen, in the area of the container opening 6 with a number of, in the exemplary embodiment two, peripherally attached outer beads 12 as a fastening element for the closure system 10 .
  • a first of these outer beads 12 is arranged immediately adjacent to the mouth opening 14 of the container 1; a second outer bead 12, on the other hand, is located somewhat further away from the mouth opening 14.
  • the two upper outer beads 12 applied circumferentially to the container opening 6 have an approximately or completely equal bead width w.
  • This design is chosen with regard to the intended use of these outer beads for latching or fixing with associated latching or snap-in elements of the closure system 10 .
  • the lowermost or proximal outer bead 16 seen in the direction of the muzzle opening has a bead width W that is significantly larger than that of the outer beads 12 by about three times, i.e. significantly more than at least 150%, of the bead width w of the adjacent outer bead 12 to improve protection against tampering. executed.
  • the outer beads 12, 16 run completely circumferential.
  • the outer beads 12, 16 could be completely or partially segmented, that is, they could comprise a plurality of segments that follow one another, seen in the direction of rotation, and are positioned at a distance from one another, with the formation of gaps in between.
  • Another particularly preferred aspect of the present invention relates to the cross-sectional profile of the outer bead 16.
  • the delimiting outer bead 16 has on its lower side, from the mouth opening 14 side facing away from a largely straight running, with its normal to the longitudinal axis of the container opening 6 tilted by at most 10 ° flank 18.
  • this configuration achieves a particularly reliable, flat covering of the closure system 10 arranged above, and on the other hand, a contact surface that is particularly favorable and suitable for automated handling purposes is formed.
  • the delimiting outer bead 16 has a mouth-side flank 20 on its upper side facing the mouth opening 14 which, as explained below, is specifically designed for a favorable interaction with the closure system 10 .
  • the upper flank 20 of the delimiting outer bead 16 forms a contact surface 22 .
  • the closure system 10 comprises as essential components a sealing element 24 designed as a closure plug for closing the container opening 6 and a fixing cap 26 with which the sealing element 24 can be firmly attached to the container opening 6 .
  • the fixing cap 26 is designed as a press-on cap 28, on the outer circumference of which a number of snap hooks or latching elements 30 that can be brought into engagement with the respective outer bead 12 are arranged.
  • the press-on cap 28 When attaching the press-on cap 28, it can thus be placed or pressed onto the container opening 6, with the latching elements 30 first being bent outwards by the respective outer bead 12 and then, after being pushed on further, gripping behind the outer bead 12 and in the manner of a snap connection with it snap. Furthermore, in terms of its dimensioning in the longitudinal direction of the container opening 6, the press-on cap 28 is adapted to its outer contour formed by the outer beads 12, 16 in such a way that the end face 34 of the or each latching element 30 formed by the end edge 32 of the press-on cap 28 fits completely onto the Container opening 6 in the pushed-on state of the press-on cap 28 against the contact surface 22 arranged on the mouth-side flank 20 of the limiting outer bead 16 .
  • the press-on cap 28 includes an annular cover 44 having a central opening 42.
  • the integrally designed per se, in figure 5 Sealing element 24 shown enlarged, however, comprises a closure plate 46 in the manner of a basic element, at the first Plate side a central opening 42 of the ring cover 44 completely fills, with this lockingly engageable thickening 48 is formed.
  • the thickening 48 is provided in its connection area with the closure plate 46 with a circumferential groove 50 forming an undercut.
  • the one-piece sealing element 24 is, also with regard to the desired sealing purposes, made of a suitable and also comparatively soft and easily deformable material, in the exemplary embodiment made of rubber or of TPE, preferably "medical grade".
  • This choice of material also ensures that the sealing element 24 can be pierced by means of a suitable instrument, for example a hollow needle, if necessary, ie if the active substance is to be removed from the medication container 1 .
  • a suitable instrument for example a hollow needle
  • the sealing element 24 can be connected almost firmly to the press-on cap 28 by the thickening 48 being introduced into the opening 42 in the ring cover 44 and the peripheral edge of the opening 42 then engaging in the groove 50 and thus the sealing element 24 is fixed to the press-on cap 28 .
  • the sealing element 24 advantageously contributes to the sealing of the container opening 6 in two ways.
  • a sealing effect is achieved, which is certainly comparable to known systems, in that, in the assembled system, the closure plate 46, which is suitably adapted in terms of its dimensions, in particular its outer diameter, to the mouth edge 52 of the container opening 6, is pushed out by the snap-on cap 28, which can be snapped onto the mouth edge 52, with its edge of the Sealing element 24 is pressed onto the mouth edge 52.
  • the closure plate 46 can already develop a sealing effect as a result of the deformability of the material.
  • the provision of radial force components, ie contact forces that press the sealing element 24 in the radial direction against the inside of the container wall 2 in the region of its mouth is also provided for an overall particularly increased sealing effect.
  • a radial sealing element 54 is formed on the second plate side of the closure plate 46 .
  • the cross-sectional shape of the radial sealing element 54 is adapted to the cross-sectional shape of the container opening 6 in the mouth region (both are round in the exemplary embodiment). With regard to its dimensioning, it is also adapted to the clear width I of the container opening 6 and is designed slightly larger than the clear width I of the container opening 6 with regard to the deformability of the material of the sealing element 24 .
  • the container opening can be suitably selected and dimensioned; For example, their clear width can be suitably matched to the standard "13 neck” dimension (corresponds to an outer diameter of the container opening of 13 mm) or to the standard "20 neck” dimension (corresponds to an outer diameter of the container opening of 20 mm).
  • the sealing element 24 is advantageously designed for an even further improved sealing effect in the radial direction.
  • the shape is selected in such a way that the central area of the sealing element 24 that forms the thickening 48 is surrounded by a circumferential groove-like or trench-like depression 56 that extends deep into the closure plate 46 .
  • the indentation 56 can also completely penetrate the material thickness of the closure plate 46, so that the sealing element 24 has a multi-component design in this embodiment.
  • the press-on cap 28 as shown in Figure 6a in perspective view from below and in Figure 6b shown enlarged in a longitudinal section, has a reinforcement ring 58 which is integrally formed on the underside of the ring cover 44 and runs around the opening 42 .
  • this reinforcement ring 58 is introduced into the depression 56 of the sealing element 24 .
  • the dimensions are matched to one another in such a way that the reinforcement ring 58 gives the radial sealing element 54 of the sealing element 24 increased strength and rigidity towards the outside, ie in the radial direction, and thus improves the radial seal even further.
  • the appropriately selected dimensions of the reinforcement ring 58 can deform the radial sealing element 54 more or less slightly outwards and generate an additional pressing force in the radial direction on the inner wall of the medication container 1 in the area of the container opening 6 .
  • the press-on cap 28 consists of a suitably selected plastic, namely polypropylene (PP), a polyolefin, cyclo-olefin copolymer (COC), cyclo-olefin polymer (COP) or polycarbonate.
  • PP polypropylene
  • COC cyclo-olefin copolymer
  • COP cyclo-olefin polymer
  • the closure system 10 comprises a locking ring 60, shown enlarged in a perspective view from below in Fig. 7, which can be slid onto the press-on cap 28.
  • a locking ring 60 shown enlarged in a perspective view from below in Fig. 7, which can be slid onto the press-on cap 28.
  • the securing ring 60 has a number of snap ribs 62 formed on the inside and positioned at the ends, by means of which it can be fixed to the press-on cap 28 in a latching manner.
  • the medicament container 1 closed with the closure system 10 has a tamper-evident closure 70 as a component.
  • a tamper-evident closure 70 is designed as a sealing plate 72 molded onto the securing ring 60 .
  • the sealing plate 72 is dimensioned and positioned in such a way that, in the installed state, it completely covers the central opening 42 of the ring cover 44 and thus the exposed surface of the sealing element 24 that is accessible via it. In order to gain access to the interior of the medicament container 1, ie to remove active substance, the sealing plate 72 must first be removed so that the sealing element 24 can be pierced.
  • the closure system 10 of the medication container 1 is designed for a particularly stable pre-assembly of the securing ring 60 on the press-on cap 28, so that the pre-assembled system is also particularly well suited for subsequent process steps with high stress, for example as part of automated filling or packaging processes.
  • the snap-in ribs 62 are also used in the manner of an additional function to form a pair of guides which, as shown in the perspective view of the press-on cap 28 in 8 shown, for each of the snap ribs also includes a guide link 82 arranged in the outer lateral surface 80 .
  • the guide pairing formed by the snap rib 62 on the one hand and the corresponding guide link 82 on the other hand causes the respective snap rib 62 to be guided in the corresponding guide link 82 when the inner lateral surface 84 of the retaining ring 60 moves relative to the outer lateral surface 80 of the press-on cap 28 that corresponds to it is, so that the positions of these components can be adjusted relative to each other in a reproducible and controllable manner.
  • the respective snap rib 62 is arranged on the inside of the securing ring 60 and, corresponding thereto, the respective guide link 82 is arranged on the outside of the press-on cap 28; alternatively, however, the snap-in rib 62 could also be positioned on the press-on cap 28 and, corresponding thereto, the guide link 82 on the inner lateral surface 84 of the securing ring 60 .
  • the guide link 82 comprises a first axial segment 86 designed in the manner of an axial groove and extending in an axial direction parallel to the axis of rotation of the inflation cap 28.
  • This axial segment 86 is delimited on both sides by a linear guide edge 88, 90, which Sliding the locking ring 60 onto the press-on cap 28 guide the respective snap rib 62.
  • a locking bead 92 is arranged in the first axial segment 86 . As soon as the snap rib 62 has been pushed over the locking bead 92 when the securing ring 60 is pushed onto the press-on cap 28, the respective snap rib 62 is latched to the locking bead 92.
  • the guide link 82 has a tangential segment 94 embodied in the manner of a tangential groove and extending in a tangential direction about the axis of rotation of the press-on cap 28 .
  • the tangential segment 94 has a lower or proximal guide edge 96, above which an attachment of a second axial segment 98 is formed with a junction area that is kept open, into which the respective snap-in rib 62 can be inserted.
  • the guide edge 96 forms a stop for the respective snap rib 62 when the locking ring 60 is pushed onto the press-on cap 28 and thus prevents a further linear push-on movement.
  • the tangential segment 94 also merges into the axial segment 86, with a stop 102 for the respective snap rib 62 being formed in the transition region 100 between the tangential segment 94 and the axial segment 86. This serves to limit rotation of the locking ring 60 relative to the press-on cap 28.
  • a latching tooth 104 with a beveled stop surface 106 for the snap-in rib 62 is also arranged in the tangential segment 94 of the guide link 82 .
  • the attachment of the closure system 10 to the drug container 1 is in the Figures 9 to 12 shown as a sequence of steps.
  • a first step in 9 shown, the locking ring 60 designed as a tamper-evident closure 70 and provided with the sealing plate 72 with its snap-in ribs 62 above the junction areas of the respective second axial segments 98 on the preassembled, already provided with the sealing element 24 AufprellCAP 28 positioned.
  • the locking ring 60 is pressed linearly downwards onto the press-on cap 28 and thus plugged onto it.
  • the snap-in ribs 62 dip into the second axial segment 98 of the respective associated guide link 82 until they strike the guide edge 96 .
  • the respective snap rib 62 is first pushed into the tangential segment 94 of the guide link 82 assigned to it.
  • the retaining ring 60 is rotated relative to the press-on cap 28; this is in Figure 11a in perspective view and in Figure 11b shown in perspective section.
  • the respective snap rib 62 is guided in the respective tangential segment 94 until it strikes the stop 102 .
  • the snap-in rib 62 is also moved over the latching tooth 104 arranged in the tangential segment 94, which is possible in this twisting direction due to the bevel of the stop surface 106. Due to the asymmetrical contour of the locking tooth 104, reverse rotation is no longer possible, however, so that the securing ring 60 is then also secured against rotation with respect to the impact cap 28.
  • the securing ring 60 is thus fixed both axially and rotationally in a defined and reproducible position on the press-on cap 28 .
  • the snap rib 62 is then also in the transition area 100 from the tangential segment 94 of the guide slot 82 to its first axial segment 86. From this position, the securing ring 60 can later be pushed onto the press-on cap 28 in the axial direction.
  • the components are securely engaged with one another, so that the closure system 10 preassembled in this way is particularly well suited for automated further processing, even with high loads and large quantities.
  • the closure system 10 can be attached to the container opening 6 immediately or at a later point in time, as required.
  • the in Figure 11b shown intermediate position are taken.
  • the embodiment provided in the exemplary embodiment is used, in which two circumferential outer beads 12 are provided on the outside in the mouth area of the container opening 6 in the manner of a double bead.
  • the Outer beads 12 are separated from one another by a groove 74 extending therebetween.
  • This position can be used, for example, for freeze-drying, also referred to as lyophilization, lyophilization or sublimation drying, of the active substance in the medicament container 1 .
  • freeze-drying also referred to as lyophilization, lyophilization or sublimation drying
  • This is a process that is now widespread for the gentle drying of products, which is used for a large number of medicines or active ingredients in order to make them durable.
  • it may be necessary to be able to release gases or vapors, in particular water vapor, into the environment, and such a possibility is offered by the Figure 11b shown positioning of the components.
  • the process of closing is then terminated and the system in the in 12 shown, fully closed state transferred.
  • the press-on cap 28 is first pushed axially downwards onto the container opening 6, so that the sealing element 24 now penetrates with its radial sealing element 54 into the container opening 6 until the closure plate 46 rests with its outer edge on the mouth of the container 1 and then , Seen with slight deformation of the closure plate 46 in the longitudinal direction of the container opening 6, the snap-in hooks 76 of the press-on cap 28 engage below the second or lower outer bead 12.
  • the locking ring 60 is then pushed down so that it encompasses the press-on cap 28 on the outside.
  • the latching elements 30 are thus locked in their position and the medication container 1 in the 12 position shown is securely locked.
  • the lower delimiting outer bead 16 secures the pushed-on closure system 10 downwards and thus increases the protection against tampering. Due to the significantly increased bead width W of the limiting outer bead 16 compared to the outer beads 12, the area open at the end of the components that are pushed onto one another (press-on cap 28, securing ring 60) is covered from below and thus protected from manipulative access. Furthermore, the edge 32 of the press-on cap is in contact with the contact surface 22 so that further support can be provided here.
  • an RFID chip 110 is arranged on its ring cover 44 in an embodiment considered to be independently inventive, preferably also injected into it.
  • the RFID chip 110 can be provided with a code or identifier that individually identifies the drug container and/or other information regarding the content, for example the drug or active ingredient composition, a possible expiry date, a batch number, the raw materials used, production and manufacturing information of the manufacturer or the like.
  • a code or identifier that individually identifies the drug container and/or other information regarding the content, for example the drug or active ingredient composition, a possible expiry date, a batch number, the raw materials used, production and manufacturing information of the manufacturer or the like.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
EP21211721.2A 2021-12-01 2021-12-01 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture Pending EP4190714A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP21211721.2A EP4190714A1 (fr) 2021-12-01 2021-12-01 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture
PCT/EP2022/083817 WO2023099547A1 (fr) 2021-12-01 2022-11-30 Système de fermeture d'un récipient de médicament, et récipient de médicament comprenant un système de fermeture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP21211721.2A EP4190714A1 (fr) 2021-12-01 2021-12-01 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture

Publications (1)

Publication Number Publication Date
EP4190714A1 true EP4190714A1 (fr) 2023-06-07

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Family Applications (1)

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EP21211721.2A Pending EP4190714A1 (fr) 2021-12-01 2021-12-01 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture

Country Status (2)

Country Link
EP (1) EP4190714A1 (fr)
WO (1) WO2023099547A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3613928A (en) 1970-12-28 1971-10-19 Eyelet Specialty Co Safety-closure device
WO1984002117A1 (fr) 1982-11-22 1984-06-07 Carl W Cooke Recipient et fermeture de securite
US20050252877A1 (en) 2003-01-22 2005-11-17 Moller Claus S Locking arrangement for a container with a cap
US20100224632A1 (en) * 2005-11-30 2010-09-09 Antoine Aneas Plug Device for a Container and Container Provided With One Such Device
US20180134457A1 (en) * 2015-06-29 2018-05-17 Antonio Mutterle Closing assembly for a bottle, associated bottle and assembly method
US20180141729A1 (en) * 2013-12-02 2018-05-24 Antonio Mutterle Closure assembly for bottle, associated bottle and assembly method

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3613928A (en) 1970-12-28 1971-10-19 Eyelet Specialty Co Safety-closure device
WO1984002117A1 (fr) 1982-11-22 1984-06-07 Carl W Cooke Recipient et fermeture de securite
US20050252877A1 (en) 2003-01-22 2005-11-17 Moller Claus S Locking arrangement for a container with a cap
US20100224632A1 (en) * 2005-11-30 2010-09-09 Antoine Aneas Plug Device for a Container and Container Provided With One Such Device
US20180141729A1 (en) * 2013-12-02 2018-05-24 Antonio Mutterle Closure assembly for bottle, associated bottle and assembly method
US20180134457A1 (en) * 2015-06-29 2018-05-17 Antonio Mutterle Closing assembly for a bottle, associated bottle and assembly method

Also Published As

Publication number Publication date
WO2023099547A1 (fr) 2023-06-08

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