EP0453555B1 - Storage bottle containing a constituent of a medicinal solution - Google Patents

Storage bottle containing a constituent of a medicinal solution Download PDF

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Publication number
EP0453555B1
EP0453555B1 EP19910900240 EP91900240A EP0453555B1 EP 0453555 B1 EP0453555 B1 EP 0453555B1 EP 19910900240 EP19910900240 EP 19910900240 EP 91900240 A EP91900240 A EP 91900240A EP 0453555 B1 EP0453555 B1 EP 0453555B1
Authority
EP
European Patent Office
Prior art keywords
bottle
element
capsule
neck
characterized
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 - Lifetime
Application number
EP19910900240
Other languages
German (de)
French (fr)
Other versions
EP0453555A1 (en
Inventor
Gabriel Meyer
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.)
Becton Dickinson France SA
Original Assignee
Medicorp Holding SA
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Filing date
Publication date
Priority to CH4081/89 priority Critical
Priority to CH408189 priority
Application filed by Medicorp Holding SA filed Critical Medicorp Holding SA
Publication of EP0453555A1 publication Critical patent/EP0453555A1/en
Application granted granted Critical
Publication of EP0453555B1 publication Critical patent/EP0453555B1/en
Anticipated expiration legal-status Critical
Application status is Expired - Lifetime legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2031Separating means having openings brought into alignment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2041Separating means having removable plugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2072Venting means for internal venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents

Abstract

The storage bottle (10) contains a constituent of a medicinal solution (13) and a transfer device for transfering the solution, one it has been mixed with a solvent, into a final-use container. The bottle comprises a constricted neck (12) in which is located, during the storage phase, a sealing device (15) consisting of two elements: a first element (16a) consisting of an elastomeric stopper, and a second element (16b) consisting of an elastomeric O-ring seal. At least one inlet opens into the space between the first and second elements of the sealing device.

Description

  • La présente invention concerne un flacon de stockage contenant une substance médicamenteuse et pourvu d'un dispositif de transfert pour transférer cette substance directement, ou après l'avoir mélangée à une autre substance, dans un autre conteneur, ce flacon comportant un col rétréci ouvert et le dispositif de transfert comportant un organe d'obturation au moins partiellement engagé dans ce col, au moins pendant le stockage, dans lequel l'organe d'obturation se compose de deux éléments : un premier élément constitué par un bouchon plein en élastomère dont le diamètre est sensiblement égal à celui du col du flacon et qui est engagé dans ce col pour l'obturer de manière étanche pendant le stockage, et un second élément constitué par un joint torique en élastomère dont le diamètre extérieur est sensiblement égal à celui du col du flacon et qui est engagé dans ce col. The present invention relates to a storage bottle containing a medicinal substance and having a transfer device for transferring this substance, directly or after mixing it with another substance, into another container, said bottle comprising a narrow open neck and the transfer device comprising a sealing member at least partially engaged in said neck, at least during storage, wherein the closing member consists of two elements: a first element constituted by a solid elastomeric plug which diameter is substantially equal to that of the neck of the bottle and which engages in said neck to close it in leaktight manner during storage, and a second element consisting of an elastomeric O-ring whose outer diameter is substantially equal to that of the neck the bottle and which is engaged in the neck.
  • Les substances médicamenteuses, qu'elles soient utilisables directement ou qu'elles constituent les composants d'un mélange, sont habituellement stockées dans des récipients qui peuvent être soit des ampoules en verre scellées à la flamme, soit des flacons obturés par un bouchon d'obturation. Drug substances, whether used directly or they are the components of a mixture, are usually stored in containers which may be either glass ampoules flame sealed or vials sealed by a plug of shutter. Dans le cas où la substance est obtenue par dissolution d'une poudre ou d'un lyophilisat au moyen d'un solvant liquide, ce liquide doit être introduit dans le flacon de stockage pour entrer en contact avec le composant solide ou pulvérulent et pour le dissoudre. In the case where the substance is obtained by dissolving a powder or a lyophilizate using a liquid solvent, the liquid to be introduced into the storage bottle to come into contact with the solid or powder component and the dissolve. A cet effet, l'organe d'obturation doit être percé pour permettre l'écoulement du liquide ou repoussé entièrement à l'intérieur du flacon de manière à dégager le col, ou encore repoussé partiellement de manière à dégager une ouverture latérale autorisant le passage du liquide. To this end, the closure member must be drilled to allow the flow of liquid or pushed completely inside the bottle so as to disengage the collar, or partially pushed so as to release a lateral opening permitting the passage of the liquid.
  • Un premier problème que posent les flacons connus est celui occasionné par le percement de l'organe d'obturation pour permettre de transvaser le solvant à l'intérieur du flacon. A first problem with known containers is that caused by the piercing of the closure member to allow transferring the solvent into the vial. Ce percement peut arracher de la matière élastomère du bouchon habituellement utilisé comme organe d'obturation, et les particules arrachées peuvent, dans certains cas, être injectées dans l'organisme et engendrer des troubles graves. This breakthrough can tear the elastomeric material usually used as a sealing member stopper, and torn particles may in some cases be injected into the body and cause serious disorders.
  • La présente invention pallie les inconvénients des systèmes antérieurs connus et supprime tous les risques liés au percement d'un organe d' obturation. The present invention overcomes the disadvantages of previously known systems and removes all risks of drilling a closure member.
  • Un deuxième problème posé par les flacons connus est celui de la barrière étanche et de la barrière aseptique. A second problem with known containers is that the sealing barrier and the aseptic barrier. L'organe d'obturation doit remplir plusieurs fonctions et doit répondre à plusieurs exigences à la fois pendant le stockage et pendant l'utilisation. The closure member must fulfill several functions and must meet several requirements both during storage and during use.
  • Au stockage, il doit constituer à la fois une barrière étanche et une barrière aseptique empêchant notamment toute pénétration bactérienne à l'intérieur du flacon. Storage, it must be both a tight barrier and an aseptic barrier including preventing bacterial penetration inside the vial. Pendant la phase d'utilisation, l'organe d'obturation doit maintenir, en particulier dans la phase initiale d'activation, une barrière aseptique pour protéger le contenu du flacon et libérer l'accès à l'intérieur de ce flacon pour permettre la pénétration du solvant. During the use phase, the closure member needs to maintain, particularly in the initial activation phase, an aseptic barrier to protect the contents of the vial and release the access to the interior of the bottle to allow the solvent penetration.
  • La présente invention est conçue pour résoudre ce problème en structurant l'organe d'obturation de telle manière qu'il puisse remplir toutes les fonctions définies ci-dessus. The present invention is designed to solve this problem by structuring the closure member so that it can fulfill all functions defined above.
  • Un troisième problème posé par les flacons connus est dû au fait que lors de la dissolution du composant par le solvant, il peut se dégager de fortes quantités de gaz et notamment d'anhydride carbonique qui engendre une surpression importante dans le flacon ou dans le conteneur d'utilisation. A third problem with known containers is due to the fact that when the component dissolved by the solvent, it can release high amounts of gas and in particular of carbon dioxide which generates a significant pressure in the vial or into the container use. Dans le cas où le conteneur d'utilisation a un volume important ou lorsqu'il est rigide et que ses parois résistent à une surpression, ce gaz peut être transféré dans ce conteneur. In the case where the container of use has a large volume or is rigid and that its walls are resistant to pressure, this gas can be transferred into the container. En revanche, lorsque le conteneur est une poche souple et qu'une surpression trop importante risque de la faire éclater, ce gaz doit impérativement être évacué, du moins en partie. In contrast, when the container is a flexible bag and that too much pressure risk of the burst, the gas must always be evacuated, at least in part.
  • L'art antérieur connu est illustré par un dispositif de transfert décrit par US-A-4 865 189 et corréspondant aux définitions du préambule de la revendication 1. Un autre exemple de l'art antérieur est donné par le brevet américain US-A-4 610 374. Ce dispositif de transfert comporte une aiguille solidaire d'une embase creuse coulissant à l'intérieur d'une capsule adaptée sur le col d'un flacon contenant une substance médicamenteuse. The known prior art is illustrated by a transfer device described by US-A-4865189 and corresponding to the definitions of the preamble of claim 1. Another example of the prior art is given by the US-A- 4 610 374. the transfer device includes a needle secured to a base slidable hollow inside of a capsule adapted to the neck of a vial containing a drug substance. Pendant le stockage, le flacon est obturé par une membrane qui est percée ou arrachée par les parois latérales de l'embase creuse lorsque l'utilisateur veut activer le dispositif de transfert et mettre en communication l'aiguille avec l'intérieur du flacon. During storage, the bottle is closed by a membrane which is pierced or torn by the side walls of the hollow base when the user wants to activate the transfer device and port with the needle inside the vial.
  • Indépendamment d'autres inconvénients liés à une construction complexe et peu fiable, ce dispositif ne résout pas le premier problème mentionné ci-dessus puisque l'activation se fait par percement ou arrachage d'une membrane en élastomère. Independently of other drawbacks associated with a complicated construction and unreliable, this device does not solve the first problem mentioned above, since the activation is done by piercing or tearing of an elastomeric membrane.
  • La présente invention permet également de résoudre ce problème en prévoyant des moyens d' évacuation du gaz en surpression à l'intérieur du flacon de stockage au moment de la dissolution de la substance solide pulvérulente par le solvant. The present invention also solves this problem by providing means for discharging the gas pressure inside the storage bottle at the time of dissolution of the pulverulent solid by the solvent.
  • Ces différents objectifs sont atteints soit séparément, soit en combinaison grâce au flacon selon l'invention. These different goals are achieved either separately or in combination with the bottle according to the invention.
  • Dans ce but, le flacon est caractérisé en ce que le dispositif de transfert est constitué par un trocart à double conduit dont les ouvertures sont axialement décalées l'une par rapport à l'autre, et en ce que l'une de ces ouvertures débouche librement dans ledit espace ménagé entre ledit premier et ledit second élément de l'organe d'obturation. For this purpose, the bottle is characterized in that the transfer device consists of a double trocar pipe whose openings are axially offset with respect to one another, and in that one of these openings opens freely in said space between said first and second element of the closure member.
  • D'une façon avantageuse, ledit premier élément est un bouchon de lyophilisation comportant une partie supérieure pleine et un prolongement inférieur pourvu d'évents latéraux, ce prolongement étant conçu pour assurer un prépositionnement du bouchon sur le col du flacon pendant la lyophilisation de la substance contenue dans ce flacon. Advantageously, said first element is a lyophilisation stopper comprising an upper full part and a lower extension provided with lateral vents said extension being adapted to ensure a prepositioning cap on the bottle neck during the lyophilisation of the substance contained in this bottle.
  • Dans la forme de réalisation préférée du dispositif, le flacon comporte une capsule adaptée par-dessus le col dudit flacon et mobile axialement entre une position de stockage et une position activée, cette capsule ayant une partie intérieure sensiblement cylindrique comprenant au moins un épaulement servant d'appui audit second élément de l'organe d'obturation, et le dispositif de transfert est solidaire de la partie intérieure de la capsule. In the preferred embodiment of the device, the bottle comprises a capsule adapted over the neck of said bottle and axially movable between a storage position and an activated position, this capsule having a substantially cylindrical inner part comprising at least one shoulder serving as support said second element of the closure member, and the transfer device is integral with the inner part of the capsule.
  • Ladite ouverture intérieure débouchant dans l'espace ménagé entre lesdits premier et second éléments peut être ménagée dans la paroi de la partie intérieure de la capsule et fait communiquer ledit espace avec une cavité centrale de cette capsule. Said inner opening into the space between said first and second members may be provided in the wall of the inner part of the capsule and communicating said space with a central cavity in this capsule.
  • Selon une forme de réalisation particulièrement avantageuse, le dispositif de transfert est pourvu d'au moins un évent débouchant également dans l'espace ménagé entre ledit premier élément et ledit second élément de l'organe d'obturation. According to a particularly advantageous embodiment, the transfer device is provided with at least one vent also opening into the space between said first member and said second member of the closure member. Ledit évent peut comporter un orifice calibré et être associé à un filtre. Said vent may comprise a calibrated orifice and associated with a filter.
  • De préférence ledit filtre est du type hydrophobe. Preferably said filter is of the hydrophobic type.
  • Ledit évent peut également être pratiqué dans le fond de la partie intérieure de la capsule et débouche dans la cavité centrale de cette capsule. Said vent may also be formed in the bottom of the inner part of the capsule and opens into the central cavity in this capsule.
  • L'invention sera mieux comprise en référence à la description d'exemples de réalisation et du dessin annexé dans lequel : The invention will be better understood by reference to the description of embodiments and the accompanying drawings wherein:
    • les fig. FIGS. 1, 2, et 3 illustrent une première forme de réalisation du flacon selon l'invention contenant une substance poudreuse, successivement pendant la phase de stockage, la phase de transfert d'un solvant et la phase de transfert de la solution médicamenteuse finale, 1, 2, and 3 illustrate a first embodiment of the bottle according to the invention containing a powdery substance, successively during the storage phase, the phase transfer of a solvent and the transfer phase of the final drug solution,
    • la fig. FIG. 4 représente un flacon de stockage selon l'invention contenant un lyophilisat, et pourvu d'un bouchon d'obturation approprié, 4 shows a storage bottle according to the invention containing a lyophilisate, and provided with a suitable blanking plug,
    • la fig. FIG. 5 représente le flacon de stockage de la fig. 5 shows the storage of FIG vial. 4, contenant une poudre et pourvu d'un bouchon d'obturation approprié, 4, containing a powder and provided with a suitable blanking plug,
    • la fig. FIG. 6 représente une vue en perspective du bouchon d'obturation du flacon de stockage de la fig. 6 shows a perspective view of the closure cap of Fig storage bottle. 4, 4
    • la fig. FIG. 7 représente une vue en perspective du bouchon d'obturation du flacon de stockage de la fig. 7 shows a perspective view of the closure cap of Fig storage bottle. 5, 5
    • la fig. FIG. 8 représente une vue en coupe d'une forme de réalisation de l'organe d'obturation d'un flacon de stockage selon l'invention, 8 shows a sectional view of one embodiment of the closure member of a storage bottle according to the invention,
    • la fig. FIG. 9 représente une vue en coupe d'une autre forme de réalisation de l'organe d'obturation d'un flacon de stockage selon l'invention, 9 shows a sectional view of another embodiment of the closure member of a storage bottle according to the invention,
    • la fig. FIG. 10 représente une vue en coupe d'un flacon de stockage selon l'invention dans le cadre d'une utilisation particulière, 10 shows a sectional view of a storage bottle according to the invention in the context of a particular use,
    • la fig. FIG. 11 représente une vue en coupe d'un flacon de stockage selon l'invention dans le cadre d'une autre utilisation, 11 shows a sectional view of a storage bottle according to the invention as part of another use,
    • la fig. FIG. 12 représente une vue en coupe d'un flacon de stockage selon l'invention dans le cadre d'une troisième utilisation, 12 shows a sectional view of a storage bottle according to the invention in the context of a third use,
    • la fig. FIG. 13 représente une vue en coupe d'un flacon de stockage selon l'invention, équipé d'un dispositif de transfert différent, 13 shows a sectional view of a storage bottle according to the invention, equipped with a different transfer device,
    • les fig. FIGS. 14 et 15 représentent deux vues de flacons de stockage associés à deux seringues distinctes, et 14 and 15 show two views of storage vials associated with two separate syringes, and
    • la fig. FIG. 16 représente une vue en coupe illustrant schématiquement un autre dispositif de transfert adapté sur un flacon de stockage selon l'invention. 16 is a sectional view schematically illustrating another transfer device adapted to a storage bottle according to the invention.
  • En référence aux figures 1 à 3, le flacon de stockage 10 est associé à un dispositif de transfert 11 qui est adapté sur le col 12 du flacon 10 contenant une substance médicamenteuse 13 à l'état de poudre. Referring to Figures 1 to 3, the storage bottle 10 is associated with a transfer device 11 which is fitted onto the neck 12 of bottle 10 containing a drug 13 in the powder state. Le col 12 du flacon 10 est sensiblement cylindrique et de section réduite par rapport à celle du corps. The neck 12 of the bottle 10 is substantially cylindrical and of reduced section relative to that of the body.
  • Le dispositif de transfert 11 se compose dans ce cas d'un élément allongé 14 en forme de trocart constitué d'une aiguille double et d'un organe d'obturation 15. Cet organe d'obturation comprend un premier élément constitué par un bouchon plein en élastomère 16a qui est engagé dans le col et à un diamètre légèrement supérieur à ce dernier, et un second élément 16b également engagé dans le col et qui est constitué par un joint torique en élastomère. The transfer device 11 consists in this case of an elongate element 14 shaped trocar consists of a double needle and a closure member 15. The closure member comprises a first member constituted by a solid plug elastomeric 16a which is engaged in the neck and a diameter slightly greater than the latter, and a second member 16b also engaged in the neck and which is constituted by an elastomeric O-ring. Ce dispositif est protégé par un capuchon 17 qui recouvre l'ensemble du dispositif et dont le bord inférieur libre 18 prend appui contre un épaulement 19 qui assure la liaison entre le col et le corps du flacon 10. L'élément allongé 14 comporte deux conduits axiaux, respectivement 20 et 21, pourvus chacun d'un premier orifice 20a, respectivement 21a, conçu pour déboucher à l'intérieur du flacon, et d'un second orifice 20b, respectivement 21b, débouchant à l'extérieur du flacon. This device is protected by a cap 17 which covers the entire device and whose free lower edge 18 bears against a shoulder 19 which ensures the connection between the neck and the body of the bottle 10. The elongate member 14 comprises two pipes axial, respectively 20 and 21, each provided with a first port 20a, 21a respectively, designed to open into the vial, and a second port 20b, 21b, respectively, opening to the outside of the vial. L'élément allongé 14 se termine par une pointe 22 à son extrémité extérieure au flacon. The elongate member 14 terminates in a tip 22 at its outer end to the flask. On notera que les orifices débouchant à l'intérieur du flacon, c'est-à-dire les orifices 20a et 21a, sont décalés axialement l'un par rapport à l'autre et que les orifices 20b et 21b débouchant à l'extérieur du flacon sont également décalés axialement l'un par rapport à l'autre. Note that the orifices opening inside the bottle, that is to say the openings 20a and 21a, are offset axially with respect to each other and that the orifices 20b and 21b leading to the outside the bottle are offset axially with respect to one another.
  • Une capsule 23 solidaire de l'organe d'obturation 15 est engagée par dessus le col 12 du flacon et sert d'assise au capuchon 17. Dans l'exemple illustré, cette capsule est solidaire de l'élément allongé 14. Par ailleurs elle sert de support au second élément 16b de l'organe d'obturation 15. A capsule 23 secured to the shutter member 15 is engaged over the neck 12 of the vial and serves as the foundation to the cap 17. In the example illustrated, the capsule is secured to the elongate member 14. Furthermore it used to support the second element 16b of the shutter member 15.
  • Dans la position représentée par la fig. In the position shown in FIG. 1, qui est en fait la position de stockage, le flacon 10 est obturé de façon étanche. 1, which is in fact the storage position, the vial 10 is sealingly closed. Ledit bouchon plein 16a constitue une barrière étanche de fermeture du flacon pendant la phase de stockage. Said plug 16a is a full sealing barrier closure of the vial during the storage phase. La capsule 23 comporte une partie intérieure 24, de forme sensiblement cylindrique et concave, agencée pour pouvoir coulisser à l'intérieur du col 12 du flacon, et une partie extérieure 25 qui passe par-dessus le rebord 26 de ce col 12, notamment au moment où l'on amène le dispositif de la position de stockage à la position active. The capsule 23 includes an inner portion 24, of substantially cylindrical and concave shape, arranged to be able to slide inside the neck 12 of the bottle, and an outer portion 25 that passes over the rim 26 of the neck 12, including when it causes the device from the storage position to the active position. La partie annulaire 27, qui assure la liaison entre la partie intérieure 24 et la partie extérieure 25, définit un épaulement 28 sous lequel est disposé le joint torique 29 qui constitue le second élément 16b de l'organe d'obturation et qui prend appui contre la paroi intérieure du col 12 pour former une barrière aseptique pendant le stockage et un joint d'étanchéité et une barrière aseptique pendant la phase d'activation. The annular portion 27, which ensures the connection between the inner portion 24 and outer portion 25, defines a shoulder 28 in which is disposed the O-ring 29 which constitutes the second element 16b of the closure member and which bears against the inner wall of the neck 12 to form an aseptic barrier during storage and a seal and an aseptic barrier during the activation phase.
  • Cette phase est représentée notamment par la fig. This phase is shown in particular by FIG. 2. Le capuchon de protection 17 a été retiré et l'élément allongé a été enfoncé à l'intérieur d'un récipient 30 contenant un liquide 31 destiné à dissoudre la poudre 13 contenue dans le flacon 10. A cet effet, l'élément allongé a été utilisé pour percer le bouchon d'obturation 32 du récipient 30. Ensuite, la capsule 23 a été enfoncée sur le col 12 du flacon 10, ce qui a eu pour effet de repousser le premier élément 16a de l'organe d'obturation 15 à l'intérieur de ce flacon et de dégager les orifices 20a et 21a. 2. The protective cap 17 has been removed and the elongate member has been pressed within a container 30 containing a liquid 31 for dissolving the powder 13 contained in the vial 10. To this end, the element elongate was used to pierce the closure plug 32 of container 30. Thereafter, the capsule 23 has been pressed onto the neck 12 of bottle 10, which had the effect of pushing the first element 16a of the body of shutter 15 inside of the bottle and hold the orifices 20a and 21a.
  • En raison du décalage de ces orifices, le liquide 31, contenu dans le récipient 30, s'écoule à travers le conduit axial 20 à l'intérieur du flacon 10, et l'air, initialement contenu dans le flacon 10, ou les gaz générés par la réaction du solvant 31 sur la poudre 13, sont évacués à travers le canal axial 21 dans le récipient 30. Dans le cas où la poudre est une substance qui réagit avec le solvant en dégageant une forte quantité de gaz, il est indispensable que le récipient soit en verre ou en une matière qui résiste à une surpression élevée. Because of the shift of these orifices, the liquid 31 contained in container 30, flows through the axial channel 20 inside the bottle 10, and the air initially contained in the bottle 10, or the gas generated by the reaction of the solvent 31 of the powder 13, are discharged through the axial channel 21 into the container 30. in the case where the powder is a substance which reacts with the solvent by releasing a large amount of gas, it is essential the container is of glass or a material which is resistant to high pressure. Le liquide 31 dissout la substance poudreuse 13 et constitue une solution médicamenteuse liquide qui peut ensuite être transférée quasi intégralement dans le récipient 30, après retournement de l'ensemble comme le montre la fig. The liquid 31 dissolves the powder material 13 and constitutes a liquid drug solution which can then be transferred almost entirely into the container 30, after turning together as shown in Fig. 3. 3.
  • On notera que le dispositif de transfert permet de raccorder deux flacons rigides et que l'opération de transfert proprement dite peut être effectuée en milieu stérile avec un minimum de risques de contamination. Note that the transfer device is used to connect two rigid bottles and the actual transfer operation can be performed in a sterile environment with a minimum of contamination. Le dispositif permet d'effectuer un transvasement dans les deux sens, c'est-à-dire d'un flacon vers un autre ou réciproquement, de toute substance liquide. The device allows a transfer in both directions, that is to say a vial to another or vice versa, any liquid substance. L'activation du dispositif se fait de manière simple par un coulissement du dispositif de transfert associé à l'un des flacons. Activation of the device is effected in a simple manner by sliding the transfer device associated with one of the vials. Le processus peut être interrompu à tout moment. The process can be interrupted at any time.
  • Les fig. FIGS. 4 et 5 illustrent deux flacons de stockage qui diffèrent essentiellement par le fait que le premier est destiné à contenir un lyophilisat 40 et le second une poudre 41. Cette différence de destination entraîne une différence de construction : le premier flacon comporte un organe d'obturation 15 dont le premier élément 16a est un bouchon de lyophilisation tel que représenté en perspective par la fig. 4 and 5 illustrate two storage bottles which essentially differ in that the former is intended to contain a lyophilisate 40 and the second powder 41. This destination difference causes a difference of construction: the first bottle comprises a sealing member 15, the first member 16a is a lyophilization stopper as shown in perspective in fIG. 6, et le second flacon comporte un organe d'obturation 15 dont le premier élément 16a est un bouchon simple tel que représenté en perspective par la fig. 6, and the second vial comprises a sealing member 15, the first member 16a is a simple plug as shown in perspective in FIG. 7. 7.
  • Dans ces deux réalisations, le dispositif de transfert 11 se compose d'une aiguille 42 et de l'organe d'obturation 15. Il est, comme pour la réalisation précédente, protégé par un capuchon 17. Pendant le stockage, ce capuchon 17 est lié au flacon 10 par une étiquette d'inviolabilité 43. In these two embodiments, the transfer device 11 comprises a needle 42 and the shutter member 15. It is, as for the previous embodiment, protected by a cap 17. During storage, the cap 17 is linked to the flask 10 by a tamper-evident label 43.
  • L'organe d'obturation 15 se compose dudit premier élément 16a défini ci-dessus et du second élément 16b qui est à nouveau un joint torique en élastomère localisé entre la surface interne du col 12 du flacon et la partie intérieure 24 de la capsule 23. Cette partie intérieure comporte une cavité centrale 44 et est équipée, dans la zone située entre le premier élément 16a et le second élément 16b de l'organe d'obturation 15, de larges ouvertures 45. Dans cette réalisation, la partie intérieure 24 de la capsule 23 est couplée audit premier élément 16a de l'organe d'obturation. The closure member 15 consists of said first member 16a defined above and the second element 16b which is again an elastomeric O-ring located between the inner surface of the neck 12 of the bottle and the inner part 24 of the capsule 23 . this inner part comprises a central cavity 44 and is equipped, in the area between the first member 16a and the second element 16b of the shutter member 15 with large openings 45. in this embodiment, the inner part 24 of the capsule 23 is coupled to said first member 16a of the shutter member. Ceci a pour but d'éviter que cet élément ne tombe à l'intérieur du flacon lorsque ce dernier est activé. This is to prevent that element from falling inside the bottle when it is activated.
  • Le fond 46 de la capsule est pourvu d'évents 47 dont le rôle sera expliqué ci-dessous. The bottom 46 of the capsule is provided with vents 47 whose function will be explained below. Un filtre 48 est fixé à l'intérieur du fond 46 et constitue le passage obligé entre l'intérieur du flacon et le canal central de l'aiguille 42. Cette aiguille est solidaire d'un embout porte-aiguille 49 et est fixée sur un cône 50 solidaire du fond 46 de la capsule. A filter 48 is secured within the bottom 46 and constitutes the forced passage between the interior of the bottle and the central channel of the needle 42. This needle is secured to a holder 49 and needle hub is attached to a cone 50 integral with the bottom 46 of the capsule.
  • La protection de l'aiguille 42 est assurée par un élément tubulaire 51 qui est engagé par sa base annulaire 52 à section coudée, sur l'extrémité de la capsule 23. The needle cap 42 is provided by a tubular element 51 which is engaged by the annular base 52 to bent section on the end of the capsule 23.
  • Lors de l'activation, l'opérateur, après avoir préalablement piqué l'aiguille 42 dans un flacon ou une poche contenant un solvant liquide (non représenté), repousse la capsule pour l'engager à fond dans le col du flacon. Upon activation, the operator, after having previously pricked needle 42 in a bottle or a bag containing a liquid solvent (not shown) pushes the capsule to engage fully in the bottle neck. Le premier élément 16a de l'organe d'obturation 15 pénètre entièrement à l'intérieur du flacon sans toutefois tomber dans ce flacon puisqu'il est retenu par l'extrémité de la partie intérieure 24 de la capsule 23. Le liquide traverse le canal central de l'aiguille, la cavité centrale de la capsule, les ouvertures 45 et pénètre dans le flacon. The first member 16a of the shutter member 15 fully penetrates inside the bottle without falling into the bottle since it is retained by the end of the inner portion 24 of the capsule 23. The liquid passes through the channel center of the needle, the central cavity of the capsule, the apertures 45 and enters the vial. La dissolution du lyophilisat 40 ou de la poudre 41 peut, dans certains cas, entraîner un fort dégagement de gaz, notamment d'anhydride carbonique, qui peut s'échapper à travers les larges ouvertures 45 et les évents 47 sans perturber l'écoulement du liquide ou engendrer des surpressions excessives dans le flacon. Dissolving the lyophilisate 40 or powder 41 may, in some cases, result in a vigorous evolution of gas, in particular carbon dioxide, that may escape through the wide openings 45 and the vents 47 without disturbing the flow of liquid or cause excessive overpressure in the vial.
  • L'élément 16a représenté par la fig. The element 16a shown in FIG. 6 comporte une partie supérieure pleine 60 et un embout 61 qui présente une section droite en forme de croix ménageant des évents latéraux 62 qui permettent l'évacuation des gaz lorsque l'élément 16a est prépositionné sur le col du flacon au cours de l'opération de lyophilisation. 6 has a solid upper portion 60 and a tip 61 which has a cross-shaped cross section leaving the lateral vents 62 that allow the removal of gas when the element 16a is prepositioned on the bottle neck during the operation lyophilization.
  • L'élément 16a illustré par la fig. The element 16a illustrated in FIG. 7 correspond à la partie supérieure pleine de l'élément représenté par la fig. 7 corresponds to the solid upper portion of the element shown in FIG. 6. Lorsque le flacon est rempli de poudre, l'embout de prépositionnement nécessaire pour la lyophilisation peut être supprimé. 6. When the bottle is filled with powder, the pre-positioning tip required for lyophilization may be deleted.
  • Les fig. FIGS. 8 et 9 illustrent deux formes de réalisation, vues en coupe de l'organe d'obturation du flacon selon l'invention. 8 and 9 illustrate two embodiments, sectional views of the bottle of the closing member according to the invention. La fig. Fig. 8 représente un organe d'obturation en tout point identique à celui décrit ci-dessus en référence à la fig. 8 shows a closure member in all respects identical to that described above with reference to fig. 5. Toutefois, l'organe d'obturation de la fig. 5. However, the closure member of FIG. 5 est représenté en position de stockage alors que celui de la fig. 5 is shown in the storage position as that in Fig. 8 est représenté en position activée. 8 is shown in the activated position. On notera en particulier que le premier élément 16a de l'organe d'obturation est relié à l'extrémité inférieure de la partie intérieure 24 de la capsule 23, ce qui empêche cet élément de tomber à l'intérieur du flacon. Of particular note is that the first element 16a of the sealing member is connected to the lower end of the inner portion 24 of the capsule 23, thereby preventing this member from falling inside the bottle. Dans cette forme de réalisation, le fond de la cavité centrale 44 de la capsule est obturé par un filtre 48. Un évidement 70 ménagé au fond de cette cavité centrale communique par un conduit 71 avec une gorge annulaire 72 pour constituer lesdits évents dont le rôle a été décrit ci-dessus. In this embodiment, the bottom of the central cavity 44 of the capsule is closed by a filter 48. A recess 70 formed at the bottom of this central cavity communicates via a conduit 71 with an annular groove 72 to form said vents whose role described above.
  • La forme de réalisation représentée par la fig. The embodiment shown in FIG. 9 diffère quelque peu par le fait que les évents 47 sont conçus différemment. 9 differs somewhat by the fact that the vents 47 are designed differently. La cavité centrale 44 communique par des canaux 80 avec une gorge annulaire 81 qui est séparée d'une gorge annulaire 82 par un filtre annulaire 83 qui a la propriété d'être hydrophobe. The central cavity 44 communicates through channels 80 with an annular groove 81 which is separated from an annular groove 82 by an annular filter 83 which has the property of being hydrophobic. La gorge 82 communique avec l'extérieur par l'intermédiaire d'un canal 84 qui a un diamètre calibré. The groove 82 communicates with the outside via a channel 84 which has a calibrated diameter. Le diamètre de ce canal est déterminé de telle manière que la surpression engendrée par exemple par la génération de gaz au moment de la dissolution de la poudre par le solvant, puisse s'évacuer lentement. The diameter of this channel is determined such that the pressure generated for example by the generation of gas at the time of the powder is dissolved by the solvent can escape slowly. Le canal 84 définit une fuite calibrée. The channel 84 defines a calibrated leak.
  • La fig. Fig. 10 illustre une autre utilisation du flacon selon l'invention. 10 illustrates another use of the bottle according to the invention. Le flacon 10, l'organe d'obturation 15 et la capsule 23 sont en tout point identiques à ceux décrits précédemment. The bottle 10, the shutter member 15 and the capsule 23 are in all respects identical to those described above. La capsule est adaptée pour recevoir une aiguille 90 destinée à percer un bouchon 91 d'une bouteille souple 92 contenant un solvant liquide. The capsule is adapted to receive a needle 90 for piercing a stopper 91 of a flexible bottle 92 containing a liquid solvent. L'aiguille 90 est avantageusement en matière synthétique et comporte un canal central 93 et une ouverture latérale 94 à travers laquelle peut s'écouler le liquide destiné à dissoudre la substance médicamenteuse poudreuse ou à l'état de lyophilisat initialement contenue dans le flacon. The needle 90 is preferably made of synthetic material and has a central channel 93 and a side opening 94 through which can flow the liquid for dissolving the drug substance powder or in the form of lyophilisate initially contained in the vial. Comme précédemment, la capsule 23 est pourvue d' évents 47 permettant l'évacuation des gaz en surpression contenus dans le flacon. As above, the capsule 23 is provided with vents 47 for the escape of gas pressure contained in the bottle.
  • La fig. Fig. 11 illustre une autre utilisation du flacon selon l'invention. 11 illustrates another use of the bottle according to the invention. Ce flacon est en tout point identique à celui représenté par la fig. This bottle is completely identical to that shown in FIG. 5. L'aiguille 42 a été piquée dans le bouchon de fermeture 100 d'une poche souple de perfusion 101 équipée d'un perfuseur 102. Cette poche de perfusion contient le solvant qui est destiné à être introduit dans le flacon 10 pour dissoudre la poudre ou le lyophilisat qu'il contient avant que la solution soit à nouveau déversée dans la poche de perfusion. 5. The needle 42 has been stuck into the closure cap 100 of a flexible pouch 101 equipped infusion of infuser 102. This infusion bag contains the solvent which is to be introduced into the vial 10 to dissolve the powder or lyophilisate contained before the solution is again discharged into the infusion bag.
  • La fig. Fig. 12 illustre une forme d'utilisation du flacon dans lequel la capsule 23 est agencée pour permettre le couplage par vissage d'un embout d'extrémité 103 d'un flacon 104 contenant un solvant liquide. 12 illustrates a vial using form wherein the capsule 23 is arranged to allow coupling by screwing an end fitting 103 of a vial 104 containing a liquid solvent. Cet embout d'extrémité contient un obturateur 105 qui ménage un conduit axial 106 de passage du liquide dans la zone élargie 107 du col 108 du flacon 104. Le premier élément 16a de l'organe d'obturation 15 est fixé à l'extrémité de la capsule 23 qui comporte au moins une ouverture 45 permettant le passage du liquide. The end cap contains a shutter 105 that provides a axial conduit 106 for passage of liquid into the enlarged area 107 of the bottle neck 108 104. The first member 16a of the shutter member 15 is fixed to the end of the capsule 23 which comprises at least one opening 45 allowing the passage of liquid.
  • La fig. Fig. 13 illustre un autre mode de réalisation dans lequel la capsule 23 est équipée d'un embout 110 du type Luer-Lock. 13 illustrates another embodiment wherein the capsule 23 is equipped with an endpiece 110 of the Luer-Lock.
  • Les fig. FIGS. 14 et 15 illustrent deux utilisations du flacon selon l'invention lorsque ce dernier est raccordé à des seringues. 14 and 15 illustrate two uses of the bottle according to the invention when the latter is connected to syringes. Dans l'exemple de la fig. In the example of FIG. 14, une seringue préremplie 120, d'un type connu en soi, est couplée à un flacon dont la capsule est pourvu d'un embout du type Luer-Lock tel que représenté par la fig. 14, a prefilled syringe 120, of a type known per se, is coupled to a bottle the capsule is provided with a tip of the Luer-Lock as shown in FIG. 13. 13.
  • Dans l'exemple de la fig. In the example of FIG. 15, une seringue traditionnelle 130 est couplée à un embout de raccordement 131 pourvu d'un cône Luer, solidaire de la capsule 23. 15, a conventional syringe 130 is coupled to a connecting piece 131 provided with a Luer cone, integral with the capsule 23.
  • Le flacon illustré par la fig. The bottle illustrated in fig. 16 comporte une capsule dont la partie orientée vers l'intérieur du flacon 10 se prolonge par un téton 140 qui sert de poussoir pour repousser ledit premier élément 16a de l'organe d'obturation 15, lorsque le flacon est amené de la position de stockage dans la position d'activation. 16 comprises a capsule whose portion facing the interior of the vial 10 is extended by a stud 140 that serves as pusher for urging said first member 16a of the shutter member 15, when the bottle is moved from the storage position in the activation position. Dans ce cas, ledit premier élément 16a de l'organe d'obturation 15 n'est pas lié à la capsule comme cela était le cas dans la plupart des réalisations précédentes. In this case, said first member 16a of the shutter member 15 is not bound to the capsule as was the case in most of the preceding embodiments.
  • On constate que dans l'ensemble de ces réalisations le deuxième élément 16b de l'organe d'obturation assure une double fonction. It is noted that in all these embodiments, the second element 16b of the shutter member has a dual function. Pendant le stockage, cet élément assure une fonction de barrière de protection contre les bactéries et empêche la contamination de la substance stockée à l'intérieur du flacon. During storage, this element provides a protective barrier function against bacteria and prevents contamination of the substance stored within the vial. Pendant l'utilisation ce second élément constitue un joint d'étanchéité qui évite un écoulement indésirable de la solution médicamenteuse entre la capsule et la paroi intérieure du col du flacon. During use this second element forms a seal which prevents undesired flow of the drug solution between the capsule and the inner wall of the bottle neck.
  • La présente invention n'est pas limitée aux formes de réalisation décrites mais à l'étendu des revendications suivantes. The present invention is not limited to the embodiments described but the extent of the following claims.

Claims (10)

  1. Storage bottle containing a medicinal substance and having a transfer device for transferring this substance, directly or after mixing it with another substance, into another container, said bottle comprising a narrow open neck and the transfer device comprising a sealing means at least partially engaged in said neck, at least during storage, in which the sealing means (15) is composed of two elements : a first element (16a) consisting of a solid elastomeric plug with a diameter substantially equal to that of the neck (12) of the bottle (10) and which engages in said neck to seal it tightly during storage, and a second element (16b) consisting of an elastomeric toric ring with an exterior diameter substantially equal to that of the neck (12) of the bottle (10) and which engages in said neck, characterized in that the transfer device (11) consists of a trocar having two conduits (20, 21), the openings of which being axially spaced apart from each other, and in that one of these openings is located in the space formed between said first element (16a) and said second element (16b) of the sealing means (15).
  2. Bottle according to claim 1, characterized in that said first element (16a) is a lyophilisation stopper comprising an upper full part (60) and an inferior extension having lateral vents (62) said extension being adapted to provide a prepositionning of the stopper on the neck (12) of the bottle during the lyophilisation of the substance contained in this bottle.
  3. Bottle according to claim 1, characterized in that it comprises a capsule (23) mounted on the neck (12) of the bottle and axially movable between a storage position and an activated position, this capsule (23) having a substantially cylindrical central portion (24) comprising at least one shoulder used to support said second element (16b) of the sealing means (15).
  4. Bottle according to claim 3, characterized in that the transfer device (11) is integral with the central portion (24) of the capsule (23).
  5. Bottle according to claim 1, characterized in that the opening located in the space formed between said first element (16a) and said second element (16b) is disposed in the wall of the central portion (24) of the capsule (23) and provides communication between said space and a central cavity (44) in this capsule.
  6. Bottle according to claim 1, characterized in that the transfer device (11) is provided with at least one vent (47) also opening into the space formed between said first element (16a) and said second element (16b) of the sealing means (15).
  7. Bottle according to claim 6, characterized in that said vent comprises a calibrated orifice (84).
  8. Bottle according to claim 6, characterized in that said vent incorporates a filter (48).
  9. Bottle according to claim 8, characterized in that said filter (48) is of the hydroponic type.
  10. Bottle according to claim 6, characterized in that said vent is formed in the base of the central portion (24) of the capsule (23) and opens into the central cavity (44) in this capsule.
EP19910900240 1989-11-13 1990-11-10 Storage bottle containing a constituent of a medicinal solution Expired - Lifetime EP0453555B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CH4081/89 1989-11-13
CH408189 1989-11-13

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EP0453555A1 EP0453555A1 (en) 1991-10-30
EP0453555B1 true EP0453555B1 (en) 1993-10-06

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EP (1) EP0453555B1 (en)
JP (1) JPH0659302B2 (en)
AT (1) AT95415T (en)
CA (1) CA2045408A1 (en)
DE (2) DE69003805T2 (en)
DK (1) DK0453555T3 (en)
ES (1) ES2046039T3 (en)
WO (1) WO1991007160A1 (en)

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WO1991007160A1 (en) 1991-05-30
DE69003805T2 (en) 1994-05-19
CA2045408A1 (en) 1991-05-14
DE69003805D1 (en) 1993-11-11
JPH0659302B2 (en) 1994-08-10
ES2046039T3 (en) 1994-01-16
US5358501A (en) 1994-10-25
JPH04500331A (en) 1992-01-23
DK0453555T3 (en) 1994-01-31
EP0453555A1 (en) 1991-10-30
AT95415T (en) 1993-10-15

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