EP4296187A1 - Dispositif de fermeture, en particulier pour bouteilles de produits lyophilisés, et procédé de fermeture d'une bouteille de produits lyophilisés - Google Patents

Dispositif de fermeture, en particulier pour bouteilles de produits lyophilisés, et procédé de fermeture d'une bouteille de produits lyophilisés Download PDF

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Publication number
EP4296187A1
EP4296187A1 EP23181167.0A EP23181167A EP4296187A1 EP 4296187 A1 EP4296187 A1 EP 4296187A1 EP 23181167 A EP23181167 A EP 23181167A EP 4296187 A1 EP4296187 A1 EP 4296187A1
Authority
EP
European Patent Office
Prior art keywords
bottle
inner capsule
closure
capsule
closure device
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
EP23181167.0A
Other languages
German (de)
English (en)
Inventor
Marco Maria Carlo RIZZARDI
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.)
Capsulit SpA
Original Assignee
Capsulit SpA
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 Capsulit SpA filed Critical Capsulit SpA
Publication of EP4296187A1 publication Critical patent/EP4296187A1/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
    • B65D51/24—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
    • 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

Definitions

  • the present finding relates to a closure device, particularly for bottles of lyophilized products, and a related process for closing a bottle of lyophilized products.
  • bottles or flasks containing lyophilized products are generally closed by a perforable rubber cap, for example by a needle, being retained on the neck of the bottle by means of an aluminium capsule entirely covering the rubber cap.
  • Aluminium capsules generally have a tear-off removable portion which allows the access to the perforable portion of the rubber cap.
  • aluminium capsules Another typical drawback of aluminium capsules consists in that the steps of mounting the capsule on the rubber cap and on the neck of the bottle cannot be performed in conditions of sterilization and absence of undesired particles, since the operations of folding and cutting aluminium sheets for making capsules and mounting them on the mouth of the bottle involve producing aluminium powders which remain on the capsule and are incompatible with the conditions of sterilization and absence of undesired particles required for the type of products contained in the bottle itself.
  • such aluminium capsules make keeping the minimum level of particle contamination allowed in controlled-atmosphere environments, such as a cleanroom, difficult.
  • the closure capsules of bottles of lyophilized products made of plastic are capsules having different and several components reciprocally assembled to each other in various operations.
  • multi-component capsules comprising, at least, an outer tab fittable on an inner capsule, also referred to as "cage", fittable in turn on the rubber cap, are generally known.
  • the outer tab once fitted on the cage, allows tabs in the cage itself to engage at the bottom to the lip of the bottle and thus closing the mouth thereof.
  • the closure device particularly for bottles of lyophilized products, globally denoted by reference number 1, comprises:
  • the closure device 1 also has a preassembly configuration, exemplarily shown in figures 4 , 4a and 9 , 9a , wherein:
  • At least one air passage channel 90 is obtained in the inner capsule 9, said channel 90 extending, in the axial direction A, towards the opening 13, beyond the tabs 29.
  • the outer tab 15 is fixedly fitted to the inner capsule 9 to form a preassembled closure assembly 2 wherein the upper portion 17 of the outer tab 15 is in abutment against the upper portion 93 of the inner capsule 9.
  • the at least one air passage channel 90 puts the internal volume 70 of the bottle 7 in fluid communication with the external environment, through the slit 30.
  • the outer tab 15 is fixedly fitted to the inner capsule 9, with the respective upper portions 17 and 93 in abutment against each other, also in the preassembly configuration, as well as in the closing configuration.
  • the preassembled closure assembly 2 formed by the inner capsule 9 and the outer tab 15 fixedly fitted thereto has the same configuration both in preassembly and closure step.
  • the inner capsule 9 and the outer tab 15, as reciprocally fixedly fitted so as to constitute a preassembled closure assembly 2 are handled as a single component, namely are transported in the packaging line and tightened on the mouth 5 of the bottle 7 in the lyophilization and tightening station, as a single component.
  • the inner capsule 9 is made of a plastic-type material, by injection moulding, for example a polycarbonate-type material.
  • the outer tab 15 is also made of a plastic-type material, by injection moulding, for example a polypropylene-type material.
  • the closure cap 3 is made of an elastomer, such as for example natural rubber or synthetic polymers.
  • the inner capsule 9 comprises an upper portion 93 which is preferably disk-shaped, where the opening 13 is obtained, and a side wall 94 preferably cylinder-shaped, linked to the upper portion 93.
  • the outer tab 15 can be made according to variants described below.
  • the outer tab 15 comprises a disk-shaped upper portion 17 and a cylinder-shaped side wall 151 linked to the disk-shaped upper portion 17.
  • the upper portion 17 is linked to the side wall 151 through a weakened circumferential zone adapted for allowing such upper portion 17 to be removed so as to allow the access to the opening 13 in the upper portion 93 of the inner capsule 9.
  • the weakened circumferential zone is defined by a plurality of breakable bridges 175 circumferentially connecting the upper disk-shaped portion 17 to the cylinder-shaped side wall 151.
  • the upper portion 17 also has a ring 171 protruding at the bottom towards the opening 13 and configured to be positioned inside such opening 13, substantially coaxially to the opening 13 itself.
  • the removal of the upper portion 17 of the outer tab 15 is carried out by tearing such upper portion 17 along the weakened circumferential zone, namely breaking the breakable bridges 175, so as to expose the closure cap 3 through the opening 13 in the inner capsule 9.
  • the outer tab 15 always comprises a disk-shaped upper portion 17, which is however associated with a lower portion 152 being capsule shaped itself.
  • capsule shaped portion 152 comprises in turn a disk-shaped upper part 153, and a cylinder-shaped side wall 151, linked to the upper part 153.
  • the upper disk-shaped portion 17 is then associated to the lower portion configured as a capsule 152 through a plurality of retaining tabs 173.
  • the edges of the opening 154 have a reinforcing relief 155 adapted to promote the retaining thereof by the retaining tabs 173, while according to the second variant of outer tab 15, illustrated in figures 11a, 11b, 11c , the edge of the opening 154 has no reinforcing reliefs.
  • the removal of the upper disk-shaped portion 17 of the outer tab 15 is carried out by pulling out the retaining tabs 173 from the edge of the opening 154, thus leaving the opening 13 in the inner capsule 9 exposed.
  • the outer tab 15 comprises a disk-shaped upper portion 17 linked, through a weakened circumferential zone, to a cylinder-shaped side wall 151, as described above with reference to the embodiment of figures 1 to 9a .
  • the weakened circumferential zone is defined by a plurality of breakable bridges 175 connecting the upper disk-shaped portion 17 to the side wall 151.
  • the at least one air passage channel 90 has a length L, in the axial direction, greater than the thickness S, in the axial direction, of the lip 31 of the bottle 7. Furthermore, in the preassembly configuration, the at least one air passage channel 90 faces the lip 31 so that the axial ends 91, 92 thereof are span across the thickness S of the lip 31, respectively.
  • the upper axial end 91 of the channel 90 is at higher height than the height of the tabs 29 of the inner capsule 9, which rest, in the preassembly configuration, on the upper edge of the mouth 5 of the bottle, and the lower axial end 92 of the channel 90 is at lower height than the height of the lower portion of the lip 31. Accordingly, even in the case in which, in the preassembly configuration, the side wall 94 of the inner capsule 9 protrudes at the bottom with respect to the lip 31 of the bottle 7 itself, the at least one channel 90 has a length L sufficient to allow the passage of air between the internal volume 70 of the bottle 7 and the external environment, through the slit 30.
  • the at least one air passage channel 90 is defined by a recess obtained in the side wall 94 of the inner capsule 9.
  • the at least one air passage channel 90 is defined by the through opening 95 obtained in the side wall 94 of the inner capsule 9 and by the surface of the side wall 151 of the outer tab 15 facing such through opening 95. This is particularly shown in figures 6 and 7 .
  • a plurality of air passage channels 90 are obtained in the inner capsule 9. Still more preferably, such air passage channels 90 are inter-spaced with the tabs 29.
  • the air passage channels 90 are angularly distributed around the central axis A, preferably equally spaced from each other.
  • the tabs 29 are also angularly distributed around the central axis A, preferably equally spaced from each other.
  • the channels 90 are in number of four.
  • Each channel 90 has (i) a length, intended as the distance, in the axial direction A, between the ends 91 and 92, (i) a width, intended as the average length of arc of circumference, and (ii) a transverse thickness.
  • the overall width of all the channels 90, or of the single channel 90 if there is only one is comprised between 10% and 50% of the average circumference value of the side wall 94 of the inner capsule 9, preferably comprised between 20% and 30%.
  • each channel has a length comprised between 2.5% and 12.5% of the average circumference value of the side wall 94 of the inner capsule 9, preferably comprised between 5% and 7.5%.
  • the transverse thickness of the channel 90 is at least higher than 70% of the transverse thickness of the side wall 94 of the inner capsule 9. Even more preferably, the transverse thickness of the channel 90 is equal to 100% of the transverse thickness of the side wall 94 of the inner capsule 9, namely, as said above, the channel 90 is constituted by a through opening 95 obtained in the side wall 94 of the inner capsule 9.
  • the rib 35 circumferentially extends around all the side wall 151 of the outer tab 15, as the corresponding seat 37 circumferentially extends around all the outer surface of the side wall 94 of the inner capsule 9.
  • the inner capsule 9 comprises one or more protrusions 45 protruding radially towards the inside of the inner capsule 9 configured to retain, with interference, the closure cap 3 inside the inner capsule 9.
  • such one or more protrusions 45 are obtained in proximity of the top of the inner capsule 9 and are adapted to retain the closure cap 3 inside the inner capsule 9 such that the upper surface of the closure cap 3 is in abutment against the upper portion 93 of the inner capsule 9.
  • At least three, and even more preferably at least six of said protrusions 45, are provided, which are angularly distributed around the central axis A, preferably equally spaced from each other.
  • the one or more protrusions 45 can be defined by a circumferential rib radially protruding towards the inside of the inner capsule 9.
  • the protrusions 45 are defined by a plurality of radial sectors of the outer tab 15 in relief towards the inside of the same.
  • the closure cap 3 can be a closure cap 3' for lyophilized products comprising an upper disk-shaped portion 300, and a lower hollow shank 301.
  • the upper disk-shaped portion 300 of the closure cap 3' is adapted to close the mouth 5 of the bottle 7.
  • the lower shank 301 of the cap 3' has a through opening 302.
  • the lower shank 301 has a length, in the axial direction A, such that, in the preassembly configuration of the closure device 1, the lower part of the shank 301 of the closure cap 3' penetrates inside the mouth 5 of the bottle 7.
  • the through opening 302 in the cap 3' ensures the formation of the slit 30, between the shank 301 and the upper part of the neck 11 of the bottle 7, adapted for allowing the passage of air inside the bottle 7, towards the outside.
  • the upper disk-shaped portion 300 of the closure cap 3" is adapted for closing the mouth 5 of the bottle 7.
  • the lower shank 301 has a length, in the axial direction A, such that, in the preassembly configuration of the closure device 1, the lower part of the shank 301 of the closure cap 3" remains spaced from the mouth 5 of the bottle 7.
  • the slit 30 is defined in the space separating the lower portion of the shank 301 of the cap 3" and the upper portion of the mouth 5 of the bottle 7.
  • the closure device 1 consists of two capsules 9 and 15 which can be reciprocally fixedly fitted to each other, during the steps of producing the same, indeed being such two capsules 9, 15 able to reach the line for packaging lyophilized products being already assembled in a single preassembled closure assembly 2.
  • channels 90 for passing air are provided, which allow to extract air from the internal volume 70 of the bottle, in order to lyophilize the product contained therein, when the preassembled closure assembly 2 is placed, with their tabs 29, on the upper edge of the mouth 5 of the bottle 7.
  • closure cap 3 can also be retained, with interference, inside the preassembled closure assembly 2. In this way, all the three components of the closure device 1 can be handled as a single body.
  • Another advantage of the invention consists in being entirely made of a plastic-type material and being pressure-appliable on the bottles, without generating powders incompatible with hygiene and sterility requirements of the product contained in the bottle itself, as instead occurs in the case of closure systems made at least partially of aluminium.
  • a further advantage of the closure device consists in being made in a minimum number of pieces, i.e., outer tab, inner capsule, and closure cap, being easy to be assembled to each other and easy to be transported and handled as a single body.
  • closure device consists in that it drastically reduces the problems arising from losing one or more components when packaging bottles of lyophilized products, or from incorrectly positioning a component with respect to the other, being the three components of the closure device already pre-assembled to each other.
  • closure device particularly for bottles of lyophilized products, thus conceived is susceptible to a number of modifications and variants, all falling within the scope of the inventive concept.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
EP23181167.0A 2022-06-23 2023-06-23 Dispositif de fermeture, en particulier pour bouteilles de produits lyophilisés, et procédé de fermeture d'une bouteille de produits lyophilisés Pending EP4296187A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT102022000013321A IT202200013321A1 (it) 2022-06-23 2022-06-23 Dispositivo di chiusura, particolarmente per flaconi di prodotti liofilizzati, e procedimento per chiudere un flacone di prodotti liofilizzati.

Publications (1)

Publication Number Publication Date
EP4296187A1 true EP4296187A1 (fr) 2023-12-27

Family

ID=83188437

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23181167.0A Pending EP4296187A1 (fr) 2022-06-23 2023-06-23 Dispositif de fermeture, en particulier pour bouteilles de produits lyophilisés, et procédé de fermeture d'une bouteille de produits lyophilisés

Country Status (2)

Country Link
EP (1) EP4296187A1 (fr)
IT (1) IT202200013321A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5314084A (en) * 1992-08-21 1994-05-24 The West Company, Incorporated Two piece all plastic seal
FR2893922A1 (fr) * 2005-11-30 2007-06-01 Biocorp Rech Et Dev Sa Dispositif de bouchage pour un recipient et recipient equipe d'un tel dispositif
WO2011032798A1 (fr) 2009-09-15 2011-03-24 A. Raymond Et Cie Coiffe de verrouillage pour recipient a col
ITMI20110789A1 (it) * 2011-05-09 2012-11-10 Ibsa Inst Biochimique Sa Gruppo per la sigillatura di flaconi contenenti farmaci sterili iniettabili o sostanze simili, idoneo per l'impiego in linee di produzione dei flaconi ad alta velocita', rispettivo tappo di sigillatura, e corrispondente flacone sigillato
US20130240476A1 (en) * 2010-11-24 2013-09-19 West Pharmaceutical Services Deautschland GmbH & Co. KG Device for stopping a container, container provided with such a device, and method for closing a batch of such containers
US8777031B2 (en) * 2008-02-11 2014-07-15 West Pharmaceutical Services Deutschland Gmbh & Co. Kg Stopper device comprising a supporting cap, and container device provided with such a device
US8839971B2 (en) * 2007-02-09 2014-09-23 West Pharmaceutical Services Deutschland Gmbh & Co. Kg Device for stopping a container, container equipped with such a device and method for closing a batch of such containers

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5314084A (en) * 1992-08-21 1994-05-24 The West Company, Incorporated Two piece all plastic seal
FR2893922A1 (fr) * 2005-11-30 2007-06-01 Biocorp Rech Et Dev Sa Dispositif de bouchage pour un recipient et recipient equipe d'un tel dispositif
US8839971B2 (en) * 2007-02-09 2014-09-23 West Pharmaceutical Services Deutschland Gmbh & Co. Kg Device for stopping a container, container equipped with such a device and method for closing a batch of such containers
US8777031B2 (en) * 2008-02-11 2014-07-15 West Pharmaceutical Services Deutschland Gmbh & Co. Kg Stopper device comprising a supporting cap, and container device provided with such a device
WO2011032798A1 (fr) 2009-09-15 2011-03-24 A. Raymond Et Cie Coiffe de verrouillage pour recipient a col
EP2464577B1 (fr) * 2009-09-15 2018-02-21 A. RAYMOND et Cie Coiffe de verrouillage pour recipient a col
US20130240476A1 (en) * 2010-11-24 2013-09-19 West Pharmaceutical Services Deautschland GmbH & Co. KG Device for stopping a container, container provided with such a device, and method for closing a batch of such containers
ITMI20110789A1 (it) * 2011-05-09 2012-11-10 Ibsa Inst Biochimique Sa Gruppo per la sigillatura di flaconi contenenti farmaci sterili iniettabili o sostanze simili, idoneo per l'impiego in linee di produzione dei flaconi ad alta velocita', rispettivo tappo di sigillatura, e corrispondente flacone sigillato

Also Published As

Publication number Publication date
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