EP2614011B1 - Bouchon obturant pour applications pharmaceutiques - Google Patents

Bouchon obturant pour applications pharmaceutiques Download PDF

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Publication number
EP2614011B1
EP2614011B1 EP11763616.7A EP11763616A EP2614011B1 EP 2614011 B1 EP2614011 B1 EP 2614011B1 EP 11763616 A EP11763616 A EP 11763616A EP 2614011 B1 EP2614011 B1 EP 2614011B1
Authority
EP
European Patent Office
Prior art keywords
sealing
closure
projection
sealing flange
closure stopper
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP11763616.7A
Other languages
German (de)
English (en)
Other versions
EP2614011A1 (fr
Inventor
Ronny Prosper Elisabeth Vrijens
Reinhard Louis Jozef Waeben
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Datwyler Pharma Packaging Belgium NV
Original Assignee
Datwyler Pharma Packaging International NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Datwyler Pharma Packaging International NV filed Critical Datwyler Pharma Packaging International NV
Publication of EP2614011A1 publication Critical patent/EP2614011A1/fr
Application granted granted Critical
Publication of EP2614011B1 publication Critical patent/EP2614011B1/fr
Active 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
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
    • 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
    • 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 sealing plugs can consist of various materials. First, they may, as a rule, as a base material with suitable additives, for example of natural rubber or rubber material, continue from a relatively soft plastic material, such as, for example, a thermoplastic elastomer.
  • thermoplastic elastomer consist of a material, such as, for example, from of the US 2002/0113033 A1 is known.
  • a material such as, for example, from of the US 2002/0113033 A1 is known.
  • the production of such a closure plug described in the aforementioned document is a possible production in the context of the present application.
  • the materials mentioned can all be used in the context of the present application.
  • the details of the above-mentioned documents with regard to the materials and methods of preparation described therein are therefore hereby also incorporated in full in the disclosure of the present application, also for the purpose of incorporating features of these applications into claims of the present application.
  • US 3,695,478 discloses a sealing plug according to the preamble of claims 1 and 2, and a closure according to the preamble of claim 15.
  • the invention has the object to provide a sealing plug for pharmaceutical applications, which is advantageously designed with respect to the application to a corresponding container and the achievement of the closed position.
  • a further possible solution of the problem is given according to claim 2 in an object having the features that one of the outer limit of the radial dimension, by which the sealing projection protrudes from a located above the sealing projection axial portion of the engagement portion corresponding radial extent, of the based on a minimum section radius corresponding to 1.05 times or more, and that an axial dimension of the sealing projection measured along a parallels to the center line of the sealing plug, wherein the parallel upper and / or lower side of the sealing projection is a tangent forms to the adjacent region of the axial section or to a region of a possibly underside of the sealing projection extending lower portion of the engagement portion, on the Area, or possibly both, to which, coming from radially outward, initially the tangential system results, which corresponds to 0.5 times or more of the difference of the radial dimension to the lowest section radius.
  • This design is characterized by a comparatively radially far projecting sealing projection and corresponding to this largest radial dimension of the sealing projection receding axial portion.
  • a cross-sectional line representing a lower surface of the sealing flange, based on a cross-sectional representation of the sealing plug has an indentation.
  • the lower surface of the sealing flange may coincide with the boundary plane over a larger radial area. However, it can also coincide with the boundary plane only in one, preferably outer, radial region or point of the sealing flange-furthermore with reference to the mentioned cross-sectional representation.
  • the lower surface of the sealing flange can be seen in particular different from the boundary plane when the boundary plane coincides with the lower surface of the sealing flange only in a radially narrow area, or just in a punctiform manner, based on a cross-sectional view.
  • the boundary plane need not run at right angles to the central axis. But it can run at right angles to this.
  • the insertion section below the possibly first sealing projection has a widening outer contour. In this way, it is possible for example to counteract a tilting tendency, for example.
  • it may be a two-part closure. More preferably, the closure on a sliding part, which can be displaced relative to a fixed cap from an open position in which, for example, a freeze-drying can be performed in a closed position.
  • sealing plugs 1 serve to seal containers in which pharmaceutical agents, ie in particular medicines, are contained. They serve for the sealing closure of such a container, for example an ampoule.
  • the illustrated and described sealing plugs 1 may also be for use in a closure suitable for carrying out a freeze-drying process.
  • the sealing plug 1 has a central axis A. In the exemplary embodiment and also preferably, the sealing plug 1 is rotationally symmetrical with respect to the central axis A.
  • the sealing projection 5 is, as in particular about FIG. 3 results, compared to a first below the sealing flange 3 adjoining the sealing plug 1 axial section 6 formed radially projecting. Namely, by a radial dimension R1, which is connected to a smallest section radius D1- with respect to an outer surface of the engagement section 4 - radially outward (R1 corresponds to the difference of r and D1).
  • the swept as well as the unswept sealing flange 3 and / or the swept or unswept sealing projection 5 preferably, as well as from the cross-sectional views, for example, the Figures 3 . 5 . 7 . 9 and 11 can be seen, a peripheral edge, which runs vertically relative to the representation. Sometimes, in particular If it is a punched out area, the marginal edge may indeed be generally vertical, but in detail also irregular, for example, with slightly curved sections run.
  • the sealing flange 3 has a contact plane E5 on the underside.
  • the contact plane E5 extends at right angles to the central axis A and is defined by the plane which is in first contact with the latter at an imaginary approach from below to the sealing flange 3.
  • the system is given in a radially outer region 7 of the sealing flange 3.
  • a return region R b is formed on the sealing flange 3. In the recess region R b , the underside contour line L of the sealing flange 3 deviates upward with respect to the contact plane E5.
  • the sealing projection 5 has an axial dimension Ax.
  • the axial dimension Ax becomes along a parallels P to the center axis A of the sealing plug 1 measured.
  • the parallel P extends at such a radial distance from the central axis A, in which it, coming from the outside, for the first time forms a tangent to the axial region of the engagement section adjoining the sealing projection 5.
  • the plant of the tangent can be given here on the underside or top side or bottom and top of the sealing projection 5. In the embodiment of the FIGS. 1 to 3 this system is evident given the upper side of the sealing projection 5.
  • the parallel P coincides with the boundary line of the section radius D1.
  • the radial dimensions R1 and R2 are different.
  • the axial dimensions Ax1 and Ax2 are also differently.
  • the radial dimension R2 of the lower protrusion 21 is smaller than the radial dimension R1 of the upper sealing protrusion 5.
  • the dimension r is determined by the upper sealing protrusion 5. More preferably, the axial dimension Ax2 is smaller than the axial dimension Ax1.
  • the return area R b formed in the contour line L by a circular section shape.
  • the sealing flange 3 which in total, relative to a central axis MX extends at right angles to the central axis A, a portion B, which is formed without return area R b .
  • the portion B is formed radially outward with respect to the recess portion R b .
  • the section B has a length which preferably corresponds to half to 4 times the dimension R1.
  • the return area R b is basically a comparable design to the embodiment of FIGS. 6 and 7 given.
  • the groove bottom N of the return area R b is formed with respect to the contour line L as a straight line.
  • the sealing projection 5 is formed here only in the form of a sliding projection 21.
  • the sliding projection 21, as described in the context of this application, does not have in addition to a Sealing projection 5 may be provided, it may also be provided alone or instead of a sealing projection 5.
  • a return area R b which results from a deviation of the contour line L from a straight line, cf. the embodiments of FIGS. 6 to 9 , in the context of this application also referred to as (lower) indentation.
  • the maximum radial extension of the recess R b in this embodiment exceeds the dimension D1 plus the dimension R1.
  • FIGS. 10 and 11 are in turn two projections 5, 21 formed axially with each other, corresponding approximately to the embodiment of FIGS. 4 and 5 , However, the axial distance Z is much lower. Also, the difference of the largest radial extent R is larger in proportion to the dimension D1 plus R1.
  • the comparatively large axial dimension Ax of the embodiments of FIGS. 1 to 3 also be provided in the sealing projections 5 of the embodiments 4, 5 or 8, 9.
  • the design of the area R b according to the embodiment of the FIG. 6 can also in the embodiment of FIGS. 1 to 3 . 4 . 5 . 8, 9 or 10.11 be provided.
  • the design of the area R b according to the embodiment of the FIGS. 6, 7 also in the embodiment of FIGS. 1 to 3 . 4 . 5 . 8th . 9 or 10.11 be provided.
  • the straight running design of the sealing flange 3, as basically from the embodiments of FIGS. 6, 7 or 8, 9 is known, even in the embodiments of FIGS. 1 to 3 . 4 . 5 or 10, 11 be realized.
  • All illustrated plugs are rotationally symmetrical with respect to the central axis A.
  • the areas of relative or percentage dimensions mentioned above also include all intermediate values with regard to the disclosure content, in particular in one-tenth increments, especially, for example, in one-tenths of a percent increments, ie on the one hand to delimit the stated range boundaries from below and / or above, alternatively or additionally but also with regard to the disclosure of one or more singular values from the respective area.
  • the closure stopper has a central first cavity 8 extending from its lower end and / or a further central cavity 9 extending from its upper end.
  • the cavity 8 and / or the cavity 9 may initially, in their initial region, have a cylindrical configuration and subsequently a curved in the contour line termination design. For example. in the form of a circle.
  • FIGS. 8 and 9 and, although less pronounced, the embodiment of FIGS. 10 and 11 shows, at the beginning of the cavity 8 and / or 9, a tapered portion may be formed. Overall, then results in a cross-sectional line that corresponds to a bell shape.
  • a closure 11 which is placed on a medical ampoule 12.
  • a drug In the ampoule 12 is, preferably initially in liquid form, a drug. By lyophilization, this drug is then more preferably transferred in powder form.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (15)

  1. Bouchon obturant (1) pour applications pharmaceutiques, en particulier pour la fermeture étanche d'un récipient contenant une substance pharmaceutique, par exemple pour fermer une ampoule (12) contenant un médicament, ayant une collerette étanche (3) destinée à prendre appui en réalisant l'étanchéité sur une surface frontale d'une embouchure de fermeture du récipient, la collerette étanche (3) présentant une surface étanche inférieure et un plan de délimitation (E5) s'étendant perpendiculairement à un axe médian du bouchon obturant (1) et reposant sur une zone proéminente le plus loin vers le bas, une section d'engagement qui s'étend en dessous de la collerette étanche (3) et qui est formée avec une plus petite extension radiale que la collerette étanche (3) et, de préférence, une section de manipulation (2) qui s'étend au-dessus de la collerette étanche (3), caractérisé en ce qu'il est formé, plus loin sur la section d'engagement (4), d'une saillie étanche périphérique (5) qui forme une avancée d'une dimension radiale (R1) par rapport à une section axiale de la section de prise (4) se rattachant directement en dessous de la collerette étanche (3), et présentant un rayon de section (D1), et en ce que la saillie étanche (5), au moins concernant sa section de pied, s'étend verticalement en recouvrant une zone de retrait (Rb) formée sur la collerette étanche par rapport au plan de délimitation (E5).
  2. Bouchon obturant (1) pour applications pharmaceutiques, en particulier pour la fermeture étanche d'un récipient contenant une substance pharmaceutique, par exemple pour fermer une ampoule (12) contenant un médicament, ayant une collerette étanche (3) destinée à prendre appui en réalisant l'étanchéité sur une surface frontale d'une embouchure de fermeture du récipient, la collerette étanche (3) présentant une surface étanche inférieure et un plan de délimitation (E5) s'étendant perpendiculairement à un axe médian du bouchon obturant (1) et reposant sur une zone proéminente le plus loin vers le bas, une section d'engagement qui s'étend en dessous de la collerette étanche (3) et qui est formée avec une plus petite extension radiale que la collerette étanche (3) et, de préférence, une section de manipulation (2) qui s'étend au-dessus de la collerette étanche (3), caractérisé en ce qu'il est formé, plus loin sur la section d'engagement (4), d'une saillie étanche périphérique (5) qui forme une avancée d'une dimension radiale (R1) par rapport à une section, axiale de la section de prise (4) se rattachant directement en dessous de la collerette étanche (3), et présentant un rayon de section (D1), en ce qu'une extension radiale r du bouchon obturant correspondant à la dimension radiale (R1) correspond à 1,05 fois ou davantage par rapport à un plus petit rayon de section (D1), et en ce qu'une dimension axiale (Ax) de la saillie étanche, mesurée le long d'une parallèle (P) à une ligne médiane (A) du bouchon obturant (1), la parallèle (P) formant, sur le côté supérieur et/ou inférieur de la saillie étanche (5), une tangente par rapport à la zone adjacente de la section axiale ou à une zone d'une section inférieure de la section d'engagement (4) s'étendant, le cas échéant, sur le côté inférieur de la saillie étanche, et ce dans la zone, ou le cas échéant, dans les deux zones où la position tangentielle est obtenue en premier lieu depuis une perspective extérieure radiale, correspond à 0,5 fois ou davantage la différence entre la dimension radiale (R1) et le plus petit rayon de section (D1), et le cas échéant, en ce que la saillie étanche (5), au moins en ce qui concerne sa section de pied, s'étend verticalement en recouvrant une zone de retrait (Rb) formée sur la collerette étanche par rapport au plan de délimitation (5).
  3. Bouchon obturant selon la revendication 1 ou 2, caractérisé en ce qu'une surface inférieure de la collerette étanche (3) coïncide avec le plan de délimitation (5) sur une plus grande zone radiale ou ne coïncide avec le plan de délimitation (E) que dans une zone radiale extérieure de la collerette étanche (3).
  4. Bouchon obturant selon l'une des revendications précédentes, caractérisé par une section de manipulation (2), la collerette étanche (3) commençant à l'extrémité inférieure de la section de manipulation (2).
  5. Bouchon obturant selon l'une des revendications précédentes, caractérisé en ce que la zone de retrait est formée en ce qu'une ligne de coupe transversale (L) qui, dans une représentation en coupe transversale du bouchon obturant, représente la surface inférieure de la collerette étanche (3), présente un enfoncement (Rb), et de préférence, l'enfoncement (Rb) s'étend au moins en partie en forme de section de cercle et/ou la ligne de coupe transversale (L) s'étend, dans la zone de l'enfoncement (Rb), au moins en partie perpendiculairement à la ligne médiane (A) et/ou la ligne de coupe transversale (L) s'étend au moins en partie de façon droite ou en incluant un angle aigu avec la ligne médiane (A).
  6. Bouchon obturant selon la revendication 5, caractérisé en ce que l'enfoncement (Rb) se transforme directement dans la zone ayant le plus petit rayon de section (D1).
  7. Bouchon obturant selon l'une des revendications précédentes, caractérisé en ce qu'une saillie supplémentaire (21) est formée en dessous de la saillie étanche (5), à une certaine distance axiale, sur la section d'engagement (4).
  8. Bouchon obturant selon la revendication 7, caractérisé en ce que les deux saillies (5, 21) présentent chacune des dimensions radiales (R1, R2) différentes.
  9. Bouchon obturant selon l'une des revendications 7 ou 8, caractérisé en ce qu'une saillie supérieure (5), vue depuis la collerette étanche (3), présente une plus grande dimension radiale (R1) qu'une saillie inférieure (21, dimension radiale R2).
  10. Bouchon obturant selon l'une des revendications précédentes, caractérisé en ce que le bouchon obturant (1) présente un évidement central (8) dans la zone de la section d'insertion (4).
  11. Bouchon obturant selon la revendication 10, caractérisé en ce que l'évidement (8) présente une section de paroi cylindrique dans la zone de la saillie étanche (5).
  12. Bouchon obturant selon l'une des revendications 10 ou 11, caractérisé en ce que l'évidement (8) présente une zone de paroi s'élargissant vers l'extérieur en direction radiale dans la zone de la saillie étanche (5), au moins dans la zone d'une deuxième saillie (21) prévue le cas échéant.
  13. Bouchon obturant selon l'une des revendications précédentes, caractérisé en ce que la section d'insertion (4) présente un contour extérieur allant en s'élargissant en dessous de la saillie, ou le cas échéant de la première saillie (5, 21).
  14. Bouchon obturant selon l'une des revendications précédentes, caractérisé en ce qu'un effet d'étanchéité peut être atteint aussi bien au niveau d'une étanchéification du côté frontal d'un récipient qui peut être fermé avec le bouchon obturant qu'au moins en partie, par rapport à un effet d'étanchéité global, dans la direction radiale.
  15. Obturateur (11) pour un récipient, par exemple une ampoule (12), dans lequel se trouve de préférence un médicament, comprenant un couvercle obturant (13) et un bouchon obturant (1) logé dans l'obturateur (11) et présentant une collerette étanche (3), caractérisé en ce que des façonnages d'arrêt (16) sont formées sur le couvercle obturant (13) pour maintenir l'obturateur (11) en arrêt sur l'ampoule (12), en ce que le bouchon obturant (1) présente une section d'engagement (4) avec une saillie étanche périphérique (5) et en ce que la collerette étanche (3) réalisée dans une forme retombant radialement vers l'extérieur est soulevée dans la position d'obturation par la coopération avec un bord de l'embouchure du récipient, la déviation étant la plus grande radialement à l'extérieur et diminuant en direction du centre.
EP11763616.7A 2010-09-09 2011-09-01 Bouchon obturant pour applications pharmaceutiques Active EP2614011B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102010037438 2010-09-09
DE102011050983A DE102011050983A1 (de) 2010-09-09 2011-06-09 Verschlussstopfen für pharmazeutische Anwendungen
PCT/EP2011/065085 WO2012031969A1 (fr) 2010-09-09 2011-09-01 Bouchon obturant pour applications pharmaceutiques

Publications (2)

Publication Number Publication Date
EP2614011A1 EP2614011A1 (fr) 2013-07-17
EP2614011B1 true EP2614011B1 (fr) 2015-08-05

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP11763616.7A Active EP2614011B1 (fr) 2010-09-09 2011-09-01 Bouchon obturant pour applications pharmaceutiques

Country Status (5)

Country Link
US (1) US10273059B2 (fr)
EP (1) EP2614011B1 (fr)
JP (1) JP2013540655A (fr)
DE (1) DE102011050983A1 (fr)
WO (1) WO2012031969A1 (fr)

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EP3028947A1 (fr) 2014-12-05 2016-06-08 F. Hoffmann-La Roche AG Fermeture d'une chambre d'un récipient pour un produit pharmaceutique
USD778725S1 (en) * 2015-01-08 2017-02-14 Runway Blue, Llc Spout for a container
USD757543S1 (en) * 2015-01-08 2016-05-31 Runway Blue, Llc Spout for a container
US11104489B2 (en) * 2018-07-13 2021-08-31 Aktiebolaget Skf Annular seal having a garter spring for establishing a minimum interior diameter and seal plug including the seal
CN116157333A (zh) * 2020-09-28 2023-05-23 豪夫迈·罗氏有限公司 闭合系统和套件
CN114955215B (zh) * 2022-05-27 2023-11-28 中国航空工业集团公司沈阳飞机设计研究所 一种带可观察剩余容量刻度的瓶体密封结构

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Also Published As

Publication number Publication date
EP2614011A1 (fr) 2013-07-17
WO2012031969A1 (fr) 2012-03-15
US10273059B2 (en) 2019-04-30
DE102011050983A1 (de) 2012-03-15
JP2013540655A (ja) 2013-11-07
US20130213924A1 (en) 2013-08-22

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