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EP4311534A1 - 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
EP4311534A1
EP4311534A1 EP22186906.8A EP22186906A EP4311534A1 EP 4311534 A1 EP4311534 A1 EP 4311534A1 EP 22186906 A EP22186906 A EP 22186906A EP 4311534 A1 EP4311534 A1 EP 4311534A1
Authority
EP
European Patent Office
Prior art keywords
closure
container
closure cap
locking
closure system
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.)
Withdrawn
Application number
EP22186906.8A
Other languages
German (de)
English (en)
Inventor
Horst Koller
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.)
Inductio AG
Original Assignee
Inductio AG
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 Inductio AG filed Critical Inductio AG
Priority to EP22186906.8A priority Critical patent/EP4311534A1/fr
Priority to PCT/EP2023/070562 priority patent/WO2024023082A1/fr
Publication of EP4311534A1 publication Critical patent/EP4311534A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A61J1/1418—Threaded type
    • 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
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/161—Sealing filled ampoules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2842—Securing closures on containers

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 closure cap which can be screwed onto the mouth area of the container opening and is provided with a closure plug provided as a sealing element, a locking ring which can be pushed onto it , which can be fixed in a lockable manner on the closure cap in a position that is completely pushed onto the closure cap by means of a number of snap ribs. It further relates to a medication container with such a closure system and to a use of the closure system.
  • Medications are usually provided in active ingredient or medication containers, also referred to as containers or vials.
  • a medication container is usually designed in the manner of a bottle and includes an interior in which the medication or active ingredient is stored and which is accessible via a container opening designed in the manner of a bottle mouth.
  • the active ingredient is then transferred via suitable transfer systems for the actual administration to suitable systems such as a syringe or an intravenous line that provides fluid access to the patient's circulation.
  • medications or substances can be used that are actually toxic or otherwise harmful or dangerous.
  • Personnel involved in the handling of such substances such as pharmacists and nurses, may therefore pose acute and long-term health risks, particularly if they are repeatedly exposed to medications or solvents released into the air during preparation, administration of medications and other similar treatments could escape.
  • This problem can be particularly serious when cytotoxins, antiviral drugs, antibiotics or radiopharmaceuticals are involved.
  • cytotoxins, antiviral drugs, antibiotics or radiopharmaceuticals are involved.
  • Those caused by exposure to Health risks potentially associated with these medications include an increased risk of cancer, genetic changes, and the like.
  • the active ingredient or medication containers are usually provided with suitable closure systems in which a sealing plug closes the container opening.
  • This sealing plug can then be pierced to remove the medication, for example using a hollow needle, via which the medication can then be sucked out of the container.
  • a closure cap with a ring lid having a central opening can be provided, which can be attached to the "bottle mouth" with the container opening. The sealing plug is then attached centrally in this ring lid.
  • the attachment of such a closure cap is usually carried out by pushing it onto the mouth area of the medication container and then locking it onto it, for example by means of snap or locking hooks arranged on the impact cap, which form a locking connection with locking beads arranged on the container opening form.
  • This locking connection is then usually secured against unintentional loosening by means of a locking ring that can be pushed onto the impact cap and which laterally encloses it in its end position.
  • a locking ring ensures that the snap or locking hooks arranged on the impact cap do not retreat outwards and thus loosen the locking connection with the medication container.
  • the locking ring pushed onto the impact cap is usually also secured in its position on the impact cap by means of locking means, for example a number of snap ribs.
  • locking means for example a number of snap ribs.
  • a closure cap that can be screwed onto the mouth area of the container opening can also be provided.
  • 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 using simple means.
  • the invention is based on the idea that the closure system can be upgraded for automated processing and also for high cycle or throughput rates with the correspondingly high processing speeds, among other things, by, on the one hand, particularly favoring pre-assembly of the closure cap and locking ring components and, on the other hand, a particularly reliable guidance of the pre-assembled components relative to one another is ensured. In particular, this can ensure that potential sources of interference in automated processing, for example due to tilting or tilting of the components, incorrect positioning or the like, are eliminated.
  • the desired reliable guidance of the pre-assembled components relative to one another can be achieved in a particularly simple manner by forming a guide pairing for the components using components that are usually already present, in this case the respective snap ribs. To form such a leadership pairing, the respective A corresponding guide link, for example in the form of a groove, can be assigned to the snap rib in the other component.
  • the respective snap rib could be arranged on the inside of the locking ring or on the outside of the closure cap, and the associated guide link could be arranged accordingly on the other component.
  • the or each snap rib is preferably arranged on the inside of the locking ring and, correspondingly, the respective guide link is arranged on the outside of the closure cap.
  • 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 closure cap or 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 locking the components as intended by the design.
  • the closure system is designed for a particularly stable pre-assembly of the closure cap and locking ring. It is advantageously provided that the locking ring can first be plugged onto the closure cap during pre-assembly. Subsequently, in the manner of a bayonet lock, twisting the locking ring on the closure cap should provide a mechanically reliable connection of the attached locking ring to the closure cap, from which point the system can be pushed on completely later, starting from this position, when it is finally attached to the medication container.
  • the leadership setting is particularly advantageous Embodiment has a tangential segment designed in the manner of a tangential groove and extending in a tangential direction around the axis of rotation of the closure cap or the locking ring.
  • the tangential segment of the guide link expediently merges into its first axial segment, with a stop for the respective snap rib being formed in the transition area between the tangential segment and axial segment to limit rotation of the locking ring relative to the closure cap.
  • the respective snap rib can first be inserted into the tangential segment of the guide link assigned to it and then the locking ring can be rotated relative to the closure cap. This guides the snap rib in the tangential segment until it hits the stop. This ends the rotation and the locking ring is fixed in a defined and reproducible position on the closure cap.
  • the snap rib is then also located 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 push the locking ring further onto the closure cap in the axial direction.
  • the components are in secure engagement with one another, so that the locking system pre-assembled in this way is particularly well suited for automated further processing, even under high stress and large quantities.
  • a locking tooth with an inclined 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, due to the shape of the locking tooth, a backward movement of the snap rib over the locking tooth is then no longer possible. As a result, the snap rib is fixed in its final position in the tangential direction, so that a particularly stable and reliable pre-assembly of the components is achieved.
  • the closure cap and/or the locking ring is made of a plastic, preferably 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 body of the closure plug is designed as a duckbill valve.
  • Duckbill valves also known as duckbill check valves
  • Duckbill valves are used, among other things, in liquid transfer systems in which the valve opens or closes depending on the flow direction of the medium or liquid. This means that undesirable backflow of the medium can be prevented in common applications.
  • a duckbill valve comprises a number of, usually two, converging valve flanks which, in the "unloaded” resting state, lie against one another along a contact line. If the valve flanks in a liquid channel are subjected to excess pressure "in the flow direction", the valve flanks are forced apart due to the elastic properties of the material forming the valve body and release a flow opening for the medium. This allows the medium to flow in the opening direction.
  • This aspect of the invention is based on the consideration that in order to particularly promote compliance with sterility conditions, possible sources with which an undesirable entry of impurities or contamination into the interior of the container could occur should be eliminated as far as possible.
  • the phase in which the container is filled with the medication or active ingredient is viewed as such a possible source, since open access to the interior of the container must be provided in this phase.
  • a closure membrane provided as part of the closure system is usually pierced using a suitable needle in order to create the desired access to the interior of the container.
  • the design of the closure body as a duckbill valve ensures that the needle system simply displaces or shifts the valve flanks when it is inserted into the interior of the container, without the need to pierce a membrane or the like.
  • the needle system When the needle system is inserted into the beak area of the valve, the needles forming the valve converge towards each other Flank surfaces pushed apart, whereby the valve opens.
  • the flank surfaces When the needle system is pulled out after the medication or active ingredient has been filled in, the flank surfaces then largely close again automatically due to the elastic restoring forces in the valve body.
  • a particularly high sealing effect in general can also be achieved by advantageously selecting a radial sealing element with a radial sealing element which is adapted to the clear width of the container opening and is slightly larger than the clear width of the container opening in view of the deformability of the material of the sealing plug Cross section is formed.
  • This means that the sealing effect that can be achieved by the sealing plug can be further increased by making use of radial force components, i.e. contact forces that press the sealing plug in the radial direction onto the inside of the container mouth, in addition to the usually used axial force components.
  • the closure plug is advantageously designed in its area protruding into the container opening with regard to the shape and dimensioning of its cross section in such a way that a flat pressing or pressing effect on the inner wall of the container mouth is created, taking into account the deformability of its material.
  • the closure system should be particularly secured after it has been attached to the medication container.
  • it advantageously comprises, as a further component, a locking ring which can be pushed onto the closure cap and which can be fixed in a locking manner on the closure cap by means of a snap edge which is formed on the inside and is arranged all around the end.
  • the closure body of the container interior designed as a valve could possibly not meet the highest tightness requirements due to its valve function.
  • the closure body is designed in a design that is considered to be independently inventive
  • the sealing plug is assigned a further sealing element in the form of a pierceable sealing membrane in the manner of a functional addition.
  • a retaining collar for an associated closure cap is formed on the closure cap, surrounding its central opening, so that the closure cap can be attached to the closure cap in a simple manner by means of this retaining collar.
  • the closure cover has a retaining ring on which the pierceable sealing membrane resting on the closure body in the assembled state is arranged.
  • the closure system is advantageously provided with a tamper-evident closure for the medication container in the manner of a disposable closure.
  • This disposable closure which can include, for example, a tear-off or sealed sealing lid, allows problem-free and reliable identification of whether the container has already been used for liquid transfer or not, and thus makes it easier to determine whether the container has already been "opened” and is therefore preferred for Further fluid removal should be used until it is completely drained and should therefore be discarded.
  • a sealing plate that can be torn off from the retaining ring is advantageously arranged on the retaining ring of the closure lid to form a tamper-evident closure.
  • the closure cap is attached to the closure cap in the manner of a bayonet lock for particularly easy assembly and in particular for temporary removal from the closure cap.
  • bayonet lock means in particular that the closure cap can be attached to the closure cap by means of a more or less extensive twist.
  • the retaining collar of the closure cap is advantageously provided on the outside with a number of guide slots, in each of which a corresponding locking pin arranged on the inside of the retaining ring of the closure cap is guided.
  • a medication container the interior of which is accessible via a container opening designed in the manner of a bottle mouth, closed with a closure system of the type described above, is also 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 by providing a guide pairing between the locking ring and the locking cap by means of the respective snap rib on the one hand and the associated guide link on the other hand, a particularly high mechanical stability of the pre-assembled intermediate product made of the locking cap and locking ring can be achieved.
  • This pre-assembled intermediate product is therefore particularly suitable for subsequent processing steps with comparatively high demands, for example in the context of automated processing or in processes with high cycle times or quantities.
  • the design of the closure body of the closure plug as a duckbill valve makes it possible for the medication container to be filled through the closure plug by means of a suitable filling needle system, in that the needle system merely displaces or shifts the components of the valve without This would require piercing a membrane or the like.
  • the needle system When the needle system is inserted into the beak area of the valve, the flank surfaces that form the valve and run towards one another are pushed apart, whereby the valve opens.
  • the flank surfaces When the needle system is pulled out after the medication or active ingredient has been filled in, the flank surfaces then largely close again automatically due to the elastic restoring forces in the valve body.
  • the risk of entry of contaminants, external particles or the like is kept particularly low, so that with such a closure system filling is possible particularly reliably even under high purity requirements, in particular under sterility conditions.
  • the medication container 1 also known as a container or vial, is designed like a bottle. It comprises an interior 4 enclosed by a container wall 2, in which the medication or active ingredient is stored.
  • the container wall 2, and with it the container 1 itself, is made in the exemplary embodiment from a suitably selected plastic with or without a barrier layer.
  • a “medical grade” plastic is particularly preferably provided here, such as COP variants 690R® , 790R® , COC variants Topas® 8007S-04, 6013S-04, 6015S-04, or PP.
  • the plastic is particularly preferably selected in a suitable manner with regard to the criteria transparent, break-resistant, little to no interaction with the intended medication, medical grade, in particular usable as a glass replacement, individually or in combination with each other.
  • the container wall 2 could also be made of glass.
  • the interior 4 is accessible via a container opening 6 designed in the manner of a bottle mouth.
  • the medication container 1 is designed to be particularly suitable for automated filling with active ingredient under aseptic or sterile conditions.
  • the components of the medication container 1 should be sterilized completely or as required after their production and then further treated, stored or used in some other way under sterile conditions without the need for subsequent complete sterilization.
  • the filling of the container with active ingredient is viewed as a weak point in particular, since for this purpose the interior of the container 4 must be made accessible and an entry of impurities or contamination would therefore be conceivable.
  • the medication container 1 is equipped with a closure system 10 that closes the container opening 6, with which, on the one hand, the risk of entry of unwanted contaminants is particularly reduced, especially during filling can be kept low, but on the other hand there should also be particularly effective protection against manipulation.
  • the closure system 10 comprises, as shown in the longitudinal section in Fig. 2 as well as the perspective view in Fig. 3 , each in an exploded view, can be clearly seen, as essential elements a sealing plug 12, with which the container opening 6 of the container interior 4 is closed, a fixing cap 16 designed as a sealing cap 14, with which the sealing plug 12 is fastened on the mouth opening 18 of the medication container 1, and a closure lid 20 with an attached tamper-evident closure 22.
  • a sealing plug 12 with which the container opening 6 of the container interior 4 is closed
  • a fixing cap 16 designed as a sealing cap 14 with which the sealing plug 12 is fastened on the mouth opening 18 of the medication container 1
  • closure lid 20 with an attached tamper-evident closure 22.
  • the container wall 2 of the medication container 1 is provided in the area of the container opening 6 with an external thread 24 as a fastening element for the closure system 10.
  • the external thread 24 is designed as a common thread, in particular as a thread in the sense of and in accordance with the specifications of the standard DIN ISO 11418-3 or DIN ISO 11418-7.
  • the sealing element designed as a closure plug 12 for closing the container opening 6 and the fixing cap 16, with which the closure plug 12 can be firmly attached to the container opening 6.
  • the fixing cap 16 is designed as a closure cap 14 that can be screwed onto the medication container 1 and is provided on its inner jacket side 26 with an internal thread 28 that is adapted to the external thread 24 in its thread parameters. When attaching the closure cap 14, it can thus be screwed onto the container opening 6.
  • the closure cap 14 comprises an annular cover 34 having a central opening 32.
  • Closing plug 12 shown enlarged in various views comprises, in the manner of a basic element, a central closure body 36, which can be brought into locking engagement with the ring lid 34 in the opening 32 at its "upper" end, which is remote from the container interior 4 in the assembled state.
  • the closure body 36 is provided in its connection area with the ring cover 34 with a circumferential groove 38 forming an undercut.
  • the one-piece sealing plug 12 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 TPE, preferably "medical grade". Using these material properties, in particular the deformability, the closure plug 12 can be connected approximately firmly to the closure cap 14 by inserting the closure body 36 into the opening 32 in the ring cover 34 and the peripheral edge of the opening 32 then engaging in the groove 38 and thus the sealing element 12 is fixed on the closure cap 14.
  • the closure plug 12 is specifically designed to reduce the risk of entry of contaminants during media transfer into the medication container 1, i.e. during filling, and also out of the medication container, i.e. when active ingredient is removed from the container interior 4 , external particles or the like to be kept particularly low. This is intended to ensure, in particular, that the filling of the container interior 4 and also the removal of active ingredient can be ensured even under high purity requirements, especially under sterility conditions.
  • the closure body 36 of the closure plug 12 is designed as a so-called duckbill valve.
  • Such a duckbill valve also known as a duckbill check valve
  • a duckbill check valve is widely used in liquid transfer systems, where depending on the flow direction of the medium or liquid, the valve opens or closes. This means that undesirable backflow of the medium can be prevented in common applications.
  • a duckbill valve comprises a number of, usually two or three, converging valve flanks 40, of which two adjacent ones lie against each other along a contact line 42 in the "unloaded" rest state. If the valve flanks in a liquid channel are subjected to excess pressure "in the flow direction", the valve flanks 40 are forced apart due to the elastic properties of the material forming the valve body and release a flow opening for the medium. This allows the medium to flow in the opening direction.
  • valve flanks 40 are pressed together in the area of the contact line 42 and thus close the valve; Backflow is then not possible or at least only possible to a very small extent.
  • a media transfer i.e. the filling of the medication container 1 or the removal of active ingredient from the medication container 1, through the closure plug 12 by means of a respectively suitable needle system
  • a media transfer i.e. the filling of the medication container 1 or the removal of active ingredient from the medication container 1, through the closure plug 12 by means of a respectively suitable needle system
  • a respectively suitable needle system For example, an injection needle or a spike system for removal, can be done in that the filling needle system only has to displace or move the valve flanks 40 of the valve, without the need to puncture a membrane or the like.
  • the valve flanks 40 which form the actual valve and run towards one another are pushed apart, with the valve opening.
  • the valve flanks 40 When the filling needle system is pulled out after the medication or active ingredient has been filled in or removed through an injection needle, the valve flanks 40 then largely close again automatically due to the elastic restoring forces in the valve body.
  • the closure plug 12 is designed in an embodiment with three valve flanks 40, which abut each other on three contact lines 42.
  • a duckbill valve could also be designed in a "usual" design, namely with two valve flanks 40, or with more than three valve flanks 40, which then abut each other in the idle state to form several contact lines 42.
  • the closure plug 12 designed as a sealing element, contributes to sealing the container opening 6 in two ways.
  • the closure plug 12 has a sealing plate 44 which is molded onto the closure body 36 and runs radially around it.
  • This achieves a sealing effect which is quite comparable to known systems, in that in the assembled system the sealing plate 44, which is suitably adapted to the mouth edge 46 of the container opening 6 in terms of its dimensions, in particular its outer diameter, is screwed onto the sealing cap 14 which can be screwed onto the container mouth Mouth edge 46 is pressed on. Due to this axial force effect, seen in relation to the longitudinal axis of the container opening, the sealing plate 44 can already develop a sealing effect due to the deformability of the material.
  • the provision of radial force components i.e. contact forces, which press the sealing element in the radial direction against the inside of the container wall 2 in the area of its mouth, is also provided here for a particularly increased overall sealing effect.
  • a radial sealing element 50 is formed on the closure body 36 “below” the sealing plate 44, i.e. on its side facing the container interior 4 in the assembled state.
  • the cross-sectional shape of this is adapted to the cross-sectional shape of the container opening 6 in the mouth area (in the exemplary embodiment both are round). In terms of its dimensions, it is also adapted to the clear width I of the container opening 6 and is designed to be slightly larger than the clear width I of the container opening 6 with regard to the deformability of the material of the sealing element 12. This creates a flat pressing or pressing effect on the inner wall of the container in the area of the container opening when the radial sealing element 50 is inserted into the container opening 6, taking into account the deformability of its material.
  • the container opening can be suitably selected and dimensioned; For example, their clear width can be suitably matched to the standard dimension "13mm Neck” (corresponds to an outside diameter of the container opening of 13mm), to the standard dimension “20mm Neck” (corresponds to an outside diameter the container opening of 20mm) or coordinated with special variants for the neck geometry for the inner diameter.
  • the sealing element 12 is advantageously designed for an even further improved sealing effect in the radial direction.
  • the shape is chosen such that the central region of the closure plug 12 that forms the closure body 36 is surrounded by a circumferential groove or trench-like recess 52 that extends deep into the sealing plate 44.
  • the recess 52 can also completely penetrate the material thickness of the sealing plate 44, so that the sealing element 12 is designed to be multi-component in this embodiment.
  • the closure cap 14 has, as in the Figs. 4 and 5 can be seen, a reinforcing ring 54 formed on the underside of the ring cover 34 and surrounding the opening 32. When assembling the two components, this reinforcing ring 54 is inserted into the recess 52 of the sealing element 12.
  • the dimensions are coordinated with one another in such a way that the reinforcing ring 54 gives the radial sealing element 50 of the sealing element 12 increased strength and rigidity towards the outside, i.e. in the radial direction, and thus further improves the radial sealing.
  • the reinforcing ring 54 can deform the radial sealing element 50 more or less slightly outwards and thereby generate an additional contact force in the radial direction on the inner wall of the medication container 1 in the area of the container opening 6.
  • the closure cap 14 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 includes a locking ring 60 that can be pushed onto the closure cap 14.
  • This is designed as a ring structure with a cylindrical lateral surface 64, leaving a sufficiently large central opening 62; This can be pushed onto the closure cap 14 from the outside after the closure cap 14 has been screwed on.
  • the locking ring 60 thus additionally fixes the internal thread 28 of the closure cap 14 radially via its cylindrical lateral surface 64.
  • the locking ring 60 in turn has a number of snap ribs 66 formed on the inside of its cylindrical lateral surface and positioned at the ends, by means of which it can be fixed in a locking manner on the closure cap 14.
  • the medication container 1 closed with the closure system 10 has the in Fig. 7 in side view and in Fig. 8 tamper-evident closure 22 shown in the longitudinal section.
  • This is intended to ensure, in the manner of a disposable closure, that the user can easily and reliably determine whether the medication container 1 has already been used for liquid transfer or not, ie whether active ingredient has already been removed or not. It therefore makes it easier to determine whether the container has already been “opened” and should therefore preferably be used for further liquid removal until it is completely emptied and should therefore be disposed of.
  • the tamper-evident closure 22 is designed as a sealing plate 68 molded onto the closure lid 20.
  • the closure lid 20 is provided in a design that is considered to be independently inventive as a functional supplement to the closure body 36 of the closure plug 12, which is designed as a duckbill valve. Since the closure plug 12 could possibly not have a completely hermetically sealing effect precisely because of its design as a valve function, especially if the filled medication container 1 is stored for a long time, the closure lid 20 is designed as a supplementary sealant. For this purpose, it includes a sealing membrane 72 attached to a retaining ring 70, which rests directly on the closure body 36 when the system is assembled and thus seals it from the outside.
  • the sealing membrane 72 is dimensioned and positioned in such a way that, in the assembled state, it completely covers the central opening 32 of the ring cover 34 and thus the exposed surface of the sealing element 12 that is accessible therefrom.
  • the sealing plate 68 is also attached to the retaining ring 70 so that it can be torn off.
  • the sealing plate 68 In order to access the interior of the medication container 1, i.e. to remove active ingredient, the sealing plate 68 must first be removed and then the sealing membrane 72 must be pierced before a corresponding needle system can be passed through the duckbill valve underneath.
  • Fig. 7 some of the fixing points 74 can be seen, at which the sealing plate 68 is attached to the retaining ring 70 so that it can be torn off.
  • the closure system 10 of the medication container 1 is designed in a design that is considered to be independently inventive for a particularly stable pre-assembly of the locking ring 60 on the closure cap 14, so that the pre-assembled system is also suitable for subsequent process steps with high demands, for example in the context of automated Filling or packaging processes are particularly suitable.
  • the snap ribs 66 arranged on the inside of the locking ring 60 are also used in the manner of an additional function to form a guide pairing, which in addition, as in the perspective view of the closure cap 14 in Fig. 9 shown, for each of the snap ribs 66 also includes a guide link 82 arranged in the outer lateral surface 80.
  • the guide pairing formed by the snap rib 66 on the one hand and the corresponding guide link 82 on the other hand causes the respective snap rib 66 to be guided in the corresponding guide link 82 when the inner lateral surface 84 of the locking ring 60 moves relative to the corresponding outer lateral surface 80 of the closure cap 14 is so that the positions of these components relative to one another can be adjusted in a reproducible and controllable manner.
  • the respective snap rib 66 is arranged on the inside of the locking ring 60 and, correspondingly, the respective guide link 82 is arranged on the outside of the closure cap 14;
  • the snap rib 66 could also be positioned on the closure cap 14 and, correspondingly, the guide link 82 on the inner lateral surface 84 of the locking ring 60.
  • the guide link 82 comprises a first axial segment 86 which is designed in the manner of an axial groove and extends in an axial direction parallel to the axis of rotation of the closure cap 14.
  • This axial segment 86 is delimited on both sides by a linear guide edge 88, 90, which is in the Slide the locking ring 60 onto the closure cap 14 to guide the respective snap rib 66.
  • a locking bead 92 is arranged in the first axial segment 86. As soon as the snap rib 66 has been pushed over the locking bead 92 when the locking ring 60 is pushed onto the closure cap 14, the respective snap rib 66 is locked with the locking bead 92.
  • the guide link 82 has a tangential segment 94 designed in the manner of a tangential groove and extending in a tangential direction about the axis of rotation of the closure cap 14.
  • the tangential segment 94 has a lower or proximal guide edge 96 in a first region, above which an extension of a second axial segment 98 is formed with an opening region that is kept open, into which the respective snap rib 66 can be inserted.
  • the leading edge 96 forms when the locking ring is attached 60 on the closure cap 14 a stop for the respective snap rib 66 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 66 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 closure cap 14.
  • a locking tooth 104 with an inclined stop surface 106 for the snap rib 66 is also arranged in the tangential segment 94 of the guide link 82.
  • a holding collar 110 surrounding the central opening 32 in the ring cover 34 is formed on the closure cap 14. This is intended and designed so that the closure cap 20 can be attached to it via its retaining ring 70.
  • a type of bayonet lock is also provided - somewhat analogous to the intended connection of the locking ring 60 to the closure cap 14 - in which cams arranged on the inside of the retaining ring 70 engage in an assigned guide link 112 formed on the outside of the retaining collar 110.
  • the medication container 1 together with its closure system 10 is designed to be pre-assembled after the individual parts have been produced and sterilized in such a way that the complete system can be fed into an automated filling process.
  • pre-assembly takes place, in which the closure system 10 is pre-assembled with all of its components ready for use. It can then be delivered to a suitable filling device and automatically filled with the active ingredient.
  • Fig. 10 The attachment of the closure system 10 to the medication container 1 in the sense of said pre-assembly is in Fig. 10 shown using a sequence of steps.
  • a first step in Fig. 10a shown, the intended locking ring 60 is first shown with its snap ribs 66 above the opening areas of the respective second axial segments 98 on the pre-assembled closure cap, which is already provided with the sealing element 12 comprising the closure body 36 and screwed onto the container mouth 14 positioned.
  • the locking ring 60 is then pressed linearly downwards onto the closure cap 14 and thus placed onto it.
  • the snap ribs 66 dip into the second axial segment 98 of the respectively assigned guide link 82 until they abut the guide edge 96.
  • the respective snap rib 66 is first inserted into the tangential segment 94 of the guide link 82 assigned to it.
  • the locking ring 60 is rotated relative to the closure cap 14.
  • This twisting causes the respective snap rib 66 to be guided in the respective tangential segment 94 until it abuts the stop 102.
  • the snap rib 66 is also moved over the locking tooth 104 arranged in the tangential segment 94, which is possible due to the bevel of the stop surface 106 in this direction of rotation.
  • the locking tooth 104 due to the asymmetrical contour of the locking tooth 104, turning backwards is no longer possible, so that the locking ring 60 is then also secured against rotation relative to the closure cap 14.
  • the locking ring 60 is thus fixed both axially and rotationally in a defined and reproducible position on the closure cap 14.
  • the snap rib 66 is then also located in the transition region 100 from the tangential segment 94 of the guide link 82 to its first axial segment 86. From this position, the locking ring 60 can later be pushed further onto the closure cap 14 in the axial direction.
  • the components are in secure engagement with one another, so that the locking system 10 preassembled in this way is particularly well suited for automated further processing, even under high stress and large quantities. This corresponds to that in Fig. 10a condition shown.
  • the locking ring 60 is then moved downwards so that its cylindrical lateral surface surrounds the closure cap 14 on the outside. This additionally secures the connection of the internal thread 28 of the closure cap 14 with the external thread 24 of the container mouth, and the medication container 1 in the in Fig. 10b Position shown is securely connected to the closure cap 14 and the closure plug 12 located in it, the retaining ring 110 formed on the closure cap 14 protruding "upwards" from the locking ring 60 and is therefore freely accessible. In this in Fig. 10b The position shown is the medication container 1 now ready for the temporary attachment of the closure cap 20 together with tamper-evident closure 22 and sealing membrane 72 on the retaining ring 110.
  • Such a temporary attachment can be significant in an embodiment that is considered to be independently inventive in that the closure cap 20 should first be removed again after the pre-assembled medication container 1 has been delivered to a filling system, so that the closure body 36 designed as a valve is exposed and thus accessible and filling the medication container 1 is permitted.
  • the retaining ring 70 of the closure lid 20 is placed onto the retaining collar 110 of the closure cap 14 in such a way that the locking pins mounted on its inside each engage in one of the assigned guide slots 112 on the retaining collar 110. Subsequently, by appropriately rotating the retaining ring 70 relative to the retaining collar 110 and the corresponding guide pairing in the respective guide slot 112, the closure cap 20 can be releasably fixed to the retaining collar 110 in such a way that the sealing membrane 72 rests on the top of the sealing plug 12.
  • the medication container 1 pre-assembled in this way is in Fig. 10c shown.
  • the pre-assembled medication container 1 can then be provided in a filling device for filling with the active ingredient. According to one aspect of the present invention, due to the design of the closure system 10, this can be done while maintaining sterile conditions without the medication container 1 having to be sterilized again at the filling point.
  • the medication container 1 is now being filled Fig. 11 shown using a sequence of steps. The starting point is in Fig. 11a the pre-assembled container 1 after it has been transported to the filling location, but otherwise in the same condition as in Fig. 10c , shown.
  • a first step in preparation for filling, the closure cap 20 is removed from the closure cap by "turning backwards", i.e. by rotating its retaining ring 70 relative to the retaining collar 110 in the opposite direction to the pre-assembly described above 14 replaced.
  • a filling needle system 120 of an injector unit connected to a storage container for the substance to be filled is positioned within the filling device, not shown, on or near the closure body 36 designed as a valve, as shown in Fig. 11c is shown.
  • the closure lid 20 is put back on, this time permanently, so that it would not be possible to reopen the container 1 without causing damage, as is the case after the pre-assembly described.
  • the locking of the retaining ring 70 of the closure lid 20 on the retaining collar 110 of the closure cap 14 is designed analogously to the locking of the locking ring 60 on the closure cap 14.
  • the retaining ring 70 is rotated relative to the retaining collar 110, with the locking pins arranged on the inside of its cylindrical lateral surface being guided in the guide link 112 assigned to them on the outside of the retaining collar 110.
  • the respective locking pin is moved over a locking tooth with a bevelled front surface arranged in the respective guide link 112, which is possible due to the bevelling of the front surface in this direction of rotation.
  • the retaining ring 70 is then secured against rotation relative to the retaining collar 110 of the closure cap 14.
  • the closure lid 20 is thus fixed on the closure cap 14 in a tamper-proof manner, and access to the container interior 4 is only possible by opening the tamper-evident closure, i.e. by tearing the sealing plate 68 off the retaining ring 70 and then piercing the sealing membrane 72.
  • the simultaneous filling of a plurality of such medication containers 1 can be carried out automatically in a filling process, as shown schematically in Fig. 12 is shown. In addition to the respective process steps indicated schematically, one of the medication containers 1 is shown in its current state for clarity.
  • a plurality of medication containers 1 with a pre-assembled closure system 10 are fed in a common arrangement ("nesting", shown in plan view in the diagram) to a transport system 142 of the filling device 144 and separated there in the sense that they are now transported sequentially one after the other in the transport system. Via the transport system 142, they sequentially reach a unit in which, in a step 146, the closure lid 20 is removed by "turning backwards" as described above and supplied for temporary storage in an intermediate storage facility 148. The actual filling then takes place in a filling step 150 according to the concept described above.
  • closure lids 20 are removed again from the intermediate storage 148 and, in a step 152, are reapplied to the respective, now filled medication container 1.
  • the application now takes place in a latching manner, so that the respective closure lid 20 can no longer be removed from the respective medication container 1 without being destroyed.
  • the now filled and tamper-proof sealed medication containers 1 are again combined into several bundles or pallets and conveyed out of the filling system 144 in these units.

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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)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Closures For Containers (AREA)
EP22186906.8A 2022-07-26 2022-07-26 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture Withdrawn EP4311534A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP22186906.8A EP4311534A1 (fr) 2022-07-26 2022-07-26 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture
PCT/EP2023/070562 WO2024023082A1 (fr) 2022-07-26 2023-07-25 Système de fermeture pour récipient de médicament, et récipient de médicament comprenant un système de fermeture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP22186906.8A EP4311534A1 (fr) 2022-07-26 2022-07-26 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture

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EP4311534A1 true EP4311534A1 (fr) 2024-01-31

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EP22186906.8A Withdrawn EP4311534A1 (fr) 2022-07-26 2022-07-26 Système de fermeture pour un récipient à médicaments, ainsi que récipient à médicaments doté d'un système de fermeture

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EP (1) EP4311534A1 (fr)
WO (1) WO2024023082A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025233204A1 (fr) * 2024-05-06 2025-11-13 Inductio Ag Procédé de remplissage d'un récipient de médicament et récipient de médicament destiné à être utilisé dans un tel procédé

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1034116A2 (fr) * 1997-10-28 2000-09-13 Alpla Werke Alwin Lehner GmbH & CO. KG Coiffe de fermeture cooperant avec un recipient du type bouteille
WO2017108186A1 (fr) * 2015-12-23 2017-06-29 Remy & Geiser Gmbh Bouchon pour un récipient rempli de fluide

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1034116A2 (fr) * 1997-10-28 2000-09-13 Alpla Werke Alwin Lehner GmbH & CO. KG Coiffe de fermeture cooperant avec un recipient du type bouteille
WO2017108186A1 (fr) * 2015-12-23 2017-06-29 Remy & Geiser Gmbh Bouchon pour un récipient rempli de fluide

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025233204A1 (fr) * 2024-05-06 2025-11-13 Inductio Ag Procédé de remplissage d'un récipient de médicament et récipient de médicament destiné à être utilisé dans un tel procédé

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WO2024023082A9 (fr) 2024-02-29

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