EP0085360B1 - Elément d'étanchéité - Google Patents

Elément d'étanchéité Download PDF

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Publication number
EP0085360B1
EP0085360B1 EP83100475A EP83100475A EP0085360B1 EP 0085360 B1 EP0085360 B1 EP 0085360B1 EP 83100475 A EP83100475 A EP 83100475A EP 83100475 A EP83100475 A EP 83100475A EP 0085360 B1 EP0085360 B1 EP 0085360B1
Authority
EP
European Patent Office
Prior art keywords
supporting part
filling
sealing element
closure
membrane
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.)
Expired
Application number
EP83100475A
Other languages
German (de)
English (en)
Other versions
EP0085360A3 (en
EP0085360A2 (fr
Inventor
Anstalt Fur Patentverwertung Gesepa
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.)
Individual
Original Assignee
Individual
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
Priority claimed from DE19823203176 external-priority patent/DE3203176A1/de
Priority claimed from DE19823212685 external-priority patent/DE3212685A1/de
Priority claimed from DE19823239302 external-priority patent/DE3239302A1/de
Application filed by Individual filed Critical Individual
Publication of EP0085360A2 publication Critical patent/EP0085360A2/fr
Publication of EP0085360A3 publication Critical patent/EP0085360A3/de
Application granted granted Critical
Publication of EP0085360B1 publication Critical patent/EP0085360B1/fr
Expired legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Definitions

  • the invention relates to a sealing element for containers with pharmaceutical content, in particular for bottle-shaped containers with substances intended for infusion, transfusion or injection, which consists of a support part with at least one cavity and a filling part made of elastic material, which fills the cavity and one which rests against the container neck Sealing surface forms.
  • a method for producing such a sealing element is also specified.
  • Stopper-shaped or disk-shaped elastic sealing elements for containers with pharmaceutical contents are known, for example, from DE-A-27 27 737 and from DE-C-23 27 553.
  • the bottle neck is sealed with the aid of a pierceable elastic sealing element which is overlaid by a closure cap which can be removed in the central region and / or as a whole.
  • the closure cap can, as shown in DE-B-23 61 350, be formed by a metal crimp cap, which is fixed with its crimp edge to the bottle neck and thereby holds the sealing element.
  • the stopper-shaped or disc-shaped sealing elements used for pre-closing the bottle-shaped containers are made of solid rubber or a plastic with corresponding rubber-elastic properties.
  • Such massive training means a considerable waste of material of the relatively expensive elastic rubber material.
  • rubber components penetrate into the container contents, mix with it and thereby contaminate it.
  • particles of the stopper detached from the needle tip are also introduced into the container contents and passed on with the container contents.
  • a pot-shaped support part forms one or more cavities which are filled with an elastic filling material. The filler does not penetrate the support part.
  • FR-A-1 325 077 describes a plug-shaped sealing element in two-component design. This consists of a plastic support part, which forms receiving spaces for introducing separate rubber-elastic filler parts and for an edge seal against the container neck.
  • the rubber-elastic filler parts which are inserted as form-fitting insert parts in corresponding cylindrical-shaped receiving spaces, cover molded membrane sections in the support part, which can be pierced together with the rubber-elastic filler parts when used with an injection needle.
  • the invention is based on the task of designing a sealing element of the type mentioned at the outset, which can be found in CH-A-397 953, in such a way that a filling part consisting of several parts can advantageously be connected to the supporting part in one operation.
  • This object is achieved in that the support part is designed as an open skeleton, in which the filler part is inserted in such a way that the filler part and the skeleton part penetrate, so that the filling of the cavity and the support layer with sealing surface form a coherent part.
  • the filling part produced by injection into the support part is firmly - preferably permanently - connected to it.
  • This firm connection of a relatively dimensionally stable skeleton with a penetrating, injected elastic filler sufficient dimensional stability and elasticity can be achieved with inexpensive use of materials.
  • the sealing element can be designed in various ways, expediently as a plug.
  • the support part has an upper cover part with a flange edge, which is connected to a cylindrical plug-in part via webs.
  • the support part has an upper cover part with a flange edge, which is connected to a solid cylindrical or hollow cylindrical plug-in part, with passage-side recesses being provided as penetration points between the support part and the filler part.
  • a membrane part superimposed with a support layer made of the coherent filling part can advantageously be integrally molded in the support part.
  • the elastic support layer which forms the filling part on the membrane part, holds infusion and injection needles in place thanks to their clamping action.
  • a stripping effect occurs on it, which results in the filling part ejected particles and the like are kept away from the container contents.
  • the filler part forms a support layer on a membrane part
  • Puncture orientation recesses for the circular and annular surface formed by the reinforcing strips on the membrane part are preformed on the surface of the support layer of the filling part on the membrane part. These orientation recesses enable the targeted insertion of the transfusion needle or an additional injection needle.
  • a further use advantage when pulling out the plug-shaped sealing element can optionally be achieved in that a pull-off element is integrally formed on the support part.
  • the pull-off element can expediently be designed in a ring shape, its height essentially corresponding to the thickness of the cover part enclosed by the ring-shaped pull-off element.
  • the pull-off ring forms the outer edge of the cover part and can be overlaid with it by a crimp cap when producing a cap closure.
  • Various pharmaceutically compatible plastics are suitable as the material for the essentially dimensionally stable but not always rigid support part. Since the supporting part as a skeleton does not have to have any significant elastic properties, its selection can be made primarily from the point of view of a material that is well compatible with the container contents. The required elastic properties are generated by the elastic filler. A sprayable rubber compound appears to be particularly suitable for this. The weight proportion of the support part is expediently more than 25% of the proportion of the filler part. As a result, the use of the expensive elastic filling material remains restricted to the areas in which elastic properties for edge sealing or for additional holding of puncture needles must be present.
  • a cap closure can advantageously be produced by covering the sealing element with a closure cap.
  • An expedient method for producing a sealing element of the type described at the outset can be carried out in such a way that in a first operation the support part is molded in one mold recess of a displaceable or rotatable injection mold, and that in the mold recess after the mold has been moved remaining support part is injected in a second operation of the filling part, while a support part is injected in the other mold recess. This enables cyclical work at high working speeds.
  • FIGS. 1 and 2 show a support part 1, which as a skeleton consists of an upper cover part 2 with a flange edge 3 which is open on the underside and a cup-shaped inner wall part 5 which forms part of a hollow insert part 4.
  • a membrane part 6 is molded in one piece into the bottom of the pot-shaped inner wall part 5.
  • connection between the cup-shaped inner wall part 5 and the cover part 2 is made via webs 7 which are integrally connected to the two parts 2.5.
  • the lower edge of the cup-shaped inner wall part 5 is raised with a conical outer wall part 8 up to the sealing surface formed when the plug is completely closed.
  • Injection recesses 9 are located on the cover part 2, through which the material of the filling part can be injected and connected to the support part 1.
  • the embodiment of the complete sealing plug essentially corresponds to FIG. 3.
  • annular reinforcement strips 10, 11 are arranged, which delimit an outer annular puncture surface 12 and an inner circular puncture surface 13.
  • Orientation recesses 15, 16 are formed in the filling part 14 (cf. FIG. 5).
  • a pull-off ring 17 is integrally connected to the cover part 2 via a connecting web 18 for pulling out the sealing plug from the container neck.
  • the dashed position of the pull ring 17 shows the position of use.
  • the height of the pull ring 17 is adapted to the thickness of the cover part 2.
  • the filling part is formed on the cylindrical, solid insertion part 4 as a support layer 19.
  • the connection between the support layer 20 resting on the membrane part 6 and the support layer 19 takes place via passage recesses 21.
  • FIG. 4 shows a support part 1 corresponding to FIG. 3, in which the membrane part 6 is not, however, covered by a support layer of the filling part 14. Rather, in the edge region of the membrane part 6 there is a tube holder 22 with lip seals 23 which clamp a piercing part 24 after the membrane part 6 has been severed and the edge seal.
  • the bearing layer 19 of the filling part 14 is delimited in the edge region of the cylindrical insert part 4 by an integrally molded edge strip 25.
  • the sealing element consisting of a support part designed as an open skeleton and a filler part produced by injection and thereby firmly connected to it, can be used both as part of a cap closure and on its own, i.e. H. can be used without an overlapping cap for closing containers.
  • the overlapping closure cap can also be replaced by an open closure strip, a cover film or the like.

Landscapes

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

Claims (13)

1. Elément d'étanchéité pour un récipient ayant un contenu pharmaceutique, notamment pour des récipients en forme de bouteilles contenant des substances destinées à la perfusion, à la transfusion ou à l'injection, lequel élément d'étanchéité est constitué par un élément de soutien (1) comportant au moins un volume creux et un remplissage en matériau élastique qui remplit le volume creux et constitue une surface d'étanchéité reposant sur le goulot du récipient, caractérisé en ce que l'élément de soutien (1) est réalisé sous forme de structure ouverte dans laquelle le matériau de remplissage (14) est injecté de telle sorte que matériau de remplissage (14) et structure (1) se pénètrent, en sorte que le remplissage du volume creux et la couche d'appui forment avec la surface d'étanchéité un élément cohérent.
2. Elément d'étanchéité selon la revendication 1, caractérisé en ce que l'élément d'étanchéité est réalisé sous forme de bouchon d'obturation.
3. Bouchon d'obturation selon la revendication 2, caractérisé en ce que l'élément de soutien (1) comporte une partie couvercle supérieure (2) avec un rebord (3), qui est reliée par des nervures (7) à une partie d'introduction (4) en forme de cylindre.
4. Bouchon d'obturation selon la revendication 2, caractérisé en ce que l'élément de soutien (1) comporte une partie couvercle supérieure (2) avec un rebord (3), qui est reliée à une partie d'introduction (4) en forme de cylindre plein ou de cylindre creux, des évidements de passage étant prévus côté paroi dans l'élément de soutien (1) en tant que points de pénétration entre l'élément de soutien (1) et le remplissage (14).
5. Bouchon d'obturation selon la revendication 3 ou 4, caractérisé en ce que la couche d'appui (19) du remplissage (14) est délimitée sur la surface extérieure de la partie d'introduction cylindrique (4), à son bord inférieur, par un bourrelet (25) formé sur l'élément de soutien (1).
6. Bouchon d'obturation selon la revendication 2, caractérisé en ce que dans l'élément de soutien (1) est formée monobloc une membrane (6) recouverte d'une couche d'appui (20) constituée par le matériau de remplissage cohérent (14).
7. Bouchon d'obturation selon la revendication 6, caractérisé en ce que sur la membrane (6) est formée une nervure extérieure annulaire de renforcement (10) qui entoure une nervure de renforcement intérieure annulaire (11) formée sur la membrane (6), et que sur la surface de la couche d'appui du remplissage (14) au-dessus de la membrane (6) sont préformés des évidements d'orientation (15, 16) pour les piqûres dans la surface circulaire (13) et la surface annulaire (12) délimitées sur la membrane (6) par les nervures de renforcement (10, 11).
8. Bouchon d'obturation selon la revendication 2, caractérisé en ce qu'un élément d'arrachage (17) est formé monobloc sur l'élément de soutien (1).
9. Bouchon d'obturation selon la revendication 3, 4 ou 8, caractérisé en ce que l'élément d'arrachage (17) est de forme annulaire, et a une hauteur qui correspond à l'épaisseur de la partie couvercle (2) entourée par l'élément d'arrachage annulaire (17).
10. Elément d'étanchéité selon la revendication 1, caractérisé en ce que l'élément de soutien '(1) est constitué par une matière plastique injectable, dimensionnellement stable et le matériau de remplissage élastique (14) est un composé caoutchouteux.
11. Elément d'étanchéité selon la revendication 10, caractérisé en ce que le pourcentage en poids de l'élément de soutien (1) correspond à plus de 25% du matériau de remplissage (14).
12. Fermeture à capuchon utilisant un élément d'étanchéité selon l'une des revendications 1-11, caractérisé en ce que l'élément d'étanchéité est doublé par un capuchon d'obturation.
13. Procédé pour fabriquer un élément d'étanchéité selon l'une des revendications 1-11, caractérisé en ce que, dans une première opération l'élément de soutien (1) est moulé dans l'une des cavités d'un moule d'injection pouvant coulisser ou tourner, et que, dans une seconde opération, le matériau de remplissage (14) est injecté dans l'élément de soutien (1) restant dans la cavité du moule après déplacement du moule, tandis qu'un élément de soutien (1) est injecté dans l'autre cavité du moule.
EP83100475A 1982-01-30 1983-01-20 Elément d'étanchéité Expired EP0085360B1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE3203176 1982-01-30
DE19823203176 DE3203176A1 (de) 1982-01-30 1982-01-30 Durchstechbarer verschlussstopfen und herstellungsverfahren hierzu
DE19823212685 DE3212685A1 (de) 1982-04-05 1982-04-05 Kappenverschluss
DE3212685 1982-04-05
DE3239302 1982-10-23
DE19823239302 DE3239302A1 (de) 1982-10-23 1982-10-23 Verschlussstopfen mit abziehgriff

Publications (3)

Publication Number Publication Date
EP0085360A2 EP0085360A2 (fr) 1983-08-10
EP0085360A3 EP0085360A3 (en) 1984-08-22
EP0085360B1 true EP0085360B1 (fr) 1986-05-28

Family

ID=27189873

Family Applications (1)

Application Number Title Priority Date Filing Date
EP83100475A Expired EP0085360B1 (fr) 1982-01-30 1983-01-20 Elément d'étanchéité

Country Status (10)

Country Link
US (1) US4482069A (fr)
EP (1) EP0085360B1 (fr)
AR (1) AR231626A1 (fr)
AU (1) AU561490B2 (fr)
BR (1) BR8300439A (fr)
CA (1) CA1178929A (fr)
DE (1) DE3363620D1 (fr)
ES (1) ES277999Y (fr)
MX (1) MX158986A (fr)
PH (1) PH20180A (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018137760A1 (fr) * 2017-01-24 2018-08-02 Nolato Treff Ag Degersheim Récipient de réception, technique de remplissage d'un récipient de réception, procédé de transport de récipients de réception et utilisation d'un récipient de réception

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5328279A (en) 1984-05-22 1994-07-12 Seiko Epson Corporation Dot matrix printer head
US4697717A (en) * 1986-08-18 1987-10-06 Becton, Dickinson And Company Rubber/plastic stopper composite with mechanical adhesive joints
WO1989002399A1 (fr) * 1987-09-10 1989-03-23 Joseph Parsons Nominees Pty. Ltd. Bouchon d'obturation
JPH0412986Y2 (fr) * 1987-12-16 1992-03-27
NL8801643A (nl) * 1988-06-28 1990-01-16 Microplast Bv Werkwijze voor het vervaardigen van een dopsamenstel alsmede dopsamenstel.
CA2015571A1 (fr) * 1990-04-26 1991-10-26 Samco Scientific, Inc. Obturateur pouvant etre reinsere dans les tubes pour la collecte de specimens
US5016771A (en) * 1990-09-04 1991-05-21 J. G. Finneran Associates Cap closure and liner
FR2672540B1 (fr) * 1991-02-08 1994-12-09 Itw De France Bouchon pour une ouverture circulaire pratiquee dans une tole, et procede de fabrication de panneaux sandwichs utilisant ce bouchon.
DE4109455A1 (de) * 1991-03-12 1992-09-17 Spang & Brands Gmbh Verfahren zur herstellung einer verschlusskappe mit dichtungseinlage fuer flaschen mit sterilem inhalt
DE4231750C1 (de) * 1992-09-23 1994-03-10 Pohl Gmbh & Co Kg Infusionsflasche aus Kunststoff
ATE199006T1 (de) * 1995-10-18 2001-02-15 Daikyo Seiko Ltd Kunststoffkappe und verfahren zu ihrer herstellung
DE10127779A1 (de) 2001-06-01 2002-12-12 Vetter & Co Apotheker Verschlusselement
DE10127823C1 (de) * 2001-06-07 2002-08-22 West Pharm Serv Drug Res Ltd Verschluss für eine Medikamentenflasche sowie Verfahren zu dessen Herstellung
US8668400B2 (en) * 2007-04-05 2014-03-11 The Hartz Mountain Corporation Fluid applicator
US8109236B2 (en) * 2007-04-05 2012-02-07 Sumitomo Corporation Of America Fluid delivery assembly
US8967255B2 (en) * 2011-11-04 2015-03-03 Halliburton Energy Services, Inc. Subsurface release cementing plug

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2926008A1 (de) * 1978-06-28 1980-01-10 Hitachi Ltd Verbundformteil

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB693298A (en) * 1950-09-06 1953-06-24 William Simon Freeman Improvements in or relating to blood transfusion apparatus
CH397953A (de) * 1959-09-21 1965-08-31 Rubberfabriek Helvoet N V Behälterverschluss
FR1325077A (fr) * 1962-03-16 1963-04-26 Bouchon, en particulier pour flacon de perfusion sanguine
FR1333642A (fr) * 1962-09-18 1963-07-26 Bellignite Sa Procédé et dispositif de moulage automatique de boutons bicolores en matière plastique
JPS549119B1 (fr) * 1970-09-16 1979-04-21
US3888377A (en) * 1973-05-30 1975-06-10 Reinhard Stadler Closure cap for an infusion flask
DE2361350B1 (de) * 1973-12-08 1975-05-28 Matthias Faensen, Kleinmetallwarenfabrikation, 5190 Stolberg Verschluß für pharmazeutische Flaschen
DE2727737C2 (de) * 1977-06-21 1982-07-29 Franz Pohl, Metall- und Kunststoffwarenfabrik GmbH, 7500 Karlsruhe Bördelkapsel
JPS56119254A (en) * 1980-02-25 1981-09-18 Takeda Chemical Industries Ltd Rubber stopper for vial

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2926008A1 (de) * 1978-06-28 1980-01-10 Hitachi Ltd Verbundformteil

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018137760A1 (fr) * 2017-01-24 2018-08-02 Nolato Treff Ag Degersheim Récipient de réception, technique de remplissage d'un récipient de réception, procédé de transport de récipients de réception et utilisation d'un récipient de réception

Also Published As

Publication number Publication date
DE3363620D1 (en) 1986-07-03
US4482069A (en) 1984-11-13
MX158986A (es) 1989-04-05
ES277999Y (es) 1985-04-01
CA1178929A (fr) 1984-12-04
AU1090783A (en) 1983-08-04
AU561490B2 (en) 1987-05-07
BR8300439A (pt) 1983-11-01
PH20180A (en) 1986-10-16
EP0085360A3 (en) 1984-08-22
EP0085360A2 (fr) 1983-08-10
ES277999U (es) 1984-10-01
AR231626A1 (es) 1985-01-31

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