EP1296878A1 - Closure system for a reservoir of a freeze-dried product dispensing device - Google Patents

Closure system for a reservoir of a freeze-dried product dispensing device

Info

Publication number
EP1296878A1
EP1296878A1 EP01938326A EP01938326A EP1296878A1 EP 1296878 A1 EP1296878 A1 EP 1296878A1 EP 01938326 A EP01938326 A EP 01938326A EP 01938326 A EP01938326 A EP 01938326A EP 1296878 A1 EP1296878 A1 EP 1296878A1
Authority
EP
European Patent Office
Prior art keywords
reservoir
closure
tank
slot
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.)
Withdrawn
Application number
EP01938326A
Other languages
German (de)
French (fr)
Inventor
Giuseppe Stradella
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.)
Aptar France SAS
Original Assignee
Valois SAS
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 Valois SAS filed Critical Valois SAS
Publication of EP1296878A1 publication Critical patent/EP1296878A1/en
Withdrawn legal-status Critical Current

Links

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
    • B65D51/24Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means
    • 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
    • B65D47/00Closures with filling and discharging, or with discharging, devices
    • B65D47/04Closures with discharging devices other than pumps
    • B65D47/20Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge
    • B65D47/2018Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge comprising a valve or like element which is opened or closed by deformation of the container or closure
    • B65D47/2031Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge comprising a valve or like element which is opened or closed by deformation of the container or closure the element being formed by a slit, narrow opening or constrictable spout, the size of the outlet passage being able to be varied by increasing or decreasing the pressure

Definitions

  • the present invention relates to a closure system, and more particularly to a closure system for a reservoir of a device for dispensing lyophilized product, in which the lyophilization of the product is carried out directly inside said reservoir.
  • the invention also relates to such a reservoir and such a dispensing device.
  • two reservoirs are generally provided, one containing a lyophilized powder and the other a solvent, the contents of these two reservoirs being mixed just before dispensing to recombine the lyophilized powder into a product. sprayable fluid.
  • the closure of the reservoir is currently the most significant problem to overcome since it must be carried out inside the lyophilization equipment and therefore in a limited and closed space.
  • the final step of tightly closing the tank must not create an overpressure inside said tank.
  • the system should be able to be adaptable to any type of standard tank currently known, and therefore not requiring a modification of said tank, which would imply an increase in the cost of manufacturing and mounting the device.
  • the present invention therefore aims to provide a sealing system which does not reproduce the aforementioned drawbacks, and which fulfills all the above requirements.
  • the present invention therefore aims to provide a closure system which is simple and inexpensive to assemble and which adapts to any type of tank, in particular standard tanks.
  • the present invention also aims to provide a sealing system which allows lyophilization of a fluid product inside said tank.
  • the present invention therefore relates to a closure system adapted to seal a reservoir of a device for dispensing freeze-dried product, characterized in that it comprises a closure element comprising a fixing part cooperating so watertight with the reservoir and a closure portion comprising a radial membrane provided with a slot, the interference between said closure portion and said reservoir being zero or almost zero, so that the slot opens with a side or the other as soon as a pressure is exerted on any side of said shutter portion, said slot being sealed in the absence of such pressure.
  • said pressure sufficient to open said slot on one side is substantially identical to said pressure sufficient to open said slot on the other side.
  • said fixing part comprises a hollow cylindrical body fitted in a leaktight manner axially inside said tank, a radial gap being provided between at least part of the external radial periphery of said membrane and the internal side wall of the tank.
  • said radial gap is provided over the entire outer radial periphery of the membrane, so that the interference between said closure part and said reservoir is zero.
  • said closure part has an outside diameter smaller than the inside diameter of said tank.
  • said external radial periphery of said membrane comprises one or more grooves forming the radial gap with the internal wall of the tank, so that the interference between said closure part and said tank is very weak.
  • said closure element further comprises a prepositioning portion extending radially beyond said closure portion, said grooves of the external radial periphery of the membrane extending in said prepositioning portion, so that the closure element can be prepositioned on the opening of the reservoir, the prepositioning part being inserted inside said reservoir, and said grooves forming a passage between the interior of the reservoir and the exterior of the system allowing lyophilization of the product contained in the tank.
  • the present invention also relates to a reservoir of a device for dispensing lyophilized product comprising a closure system as described above, and a device for dispensing lyophilized product incorporating such a reservoir.
  • a device for dispensing lyophilized product comprising a closure system as described above
  • a device for dispensing lyophilized product incorporating such a reservoir.
  • FIG. 1 showing the 'shutter element of Figure 1 positioned inside the tank
  • - Figure 3 is a view similar to Figures 1 and 2 of a second embodiment of the shutter system according to the invention, with the closure element disposed in a prepositioning position
  • - Figure 4 is a view similar to Figure 3, showing the closure element of Figure 3 disposed inside the tank.
  • this closure system comprises a closure element 1 which is adapted to seal a reservoir 50.
  • This closure element comprises a fixing part 10 which cooperates sealingly with the reservoir 50 in particular with its inner side wall, and in particular by means of peripheral sealing flanges which are crushed against the inner wall of the tank to form several sealing beads.
  • the shutter element 1 also includes a shutter part 11, which is advantageously provided with a slot 12, which is only schematically shown and which is preferably located in the center of said shutter part 11.
  • This closure part 11 is preferably produced in the form of a radial membrane incorporating said slot 12.
  • the closure element 1 is preferably produced with a fixing part formed by a hollow cylindrical body 10 which defines a hollow 2, said hollow cylinder 10 being closed by said radial membrane 11 incorporating said slot 12.
  • the interference between the closure part and the reservoir is zero or almost zero. In this first embodiment, this interference is effectively zero as can be seen in FIG. 2.
  • a radial gap 30 is provided between the external radial periphery of the membrane 11 and the internal wall of the reservoir 50. This is advantageously achieved at by means of a closure part 11 which has a diameter outside less than the inside diameter of the reservoir 50, and therefore also less than the outside diameter of the fixing part 10 of the shutter element 1.
  • this system shown in FIGS. 1 and 2 can be used to freeze-dry in the reservoir 50.
  • the closure element is introduced inside the reservoir 50, as shown in FIG. 2 , in its closed position, in which the closed part formed by the membrane 11 seals said reservoir 50 in a sealed manner, the slot 12 being closed.
  • Creating a vacuum inside the tank 50 is very easy by creating a pressure sound at the level of the hollow 2 arranged on the outside of the membrane 11 which has the effect of opening the slot 12 in the direction of this hollow 2 and thus make it possible to create a vacuum inside the reservoir 50.
  • pressure rebalancing can be easily achieved through the slot 12 of the membrane 11, said slot 12 closing automatically in the sealed position when the pressure is identical on both sides of the membrane 11.
  • a second embodiment of the present invention will be described with reference to FIGS. 3 and 4.
  • This second embodiment differs from the first embodiment in that the interference between the closure part 11 formed by the membrane incorporating the slot 12 and the inner wall of the reservoir 50 is not completely zero in the closed position of the closed element but is very small due to the presence of grooves 19 in said external radial periphery of said membrane 11, as shown in Figures 3 and 4.
  • the outer diameter of the closure portion 11 is substantially identical to the diameter of the fixing portion 10, the deformation of the membrane 11 and therefore the opening of the slot 12 being facilitated by the presence of said grooves 19.
  • the closure element 1 also comprises prepositioning means 15 which extend axially beyond said membrane 11, said grooves 19 extending in the periphery of said prepositioning part 15, as shown in the figures.
  • prepositioning means 15 which extend axially beyond said membrane 11, said grooves 19 extending in the periphery of said prepositioning part 15, as shown in the figures.
  • the closure element 1 is first placed in its prepositioning position shown in FIG. 3, with the prepositioning part 15 inserted inside the tank 50 and the closure element being retained in this position by the shoulder 7 formed by the external periphery of the membrane 11 incorporating the slot 12.
  • the prepositioning part is inserted into the reservoir 50 with friction, which further promotes the stability of the closure element 1 in this prepositioning position.
  • This prepositioning position allows the creation of a vacuum and the subsequent pressure rebalancing after lyophilization through the grooves 19 which connect the inside of the tank 50 to the outside of the sealing system.
  • the lyophilization of the product contained in the reservoir 50 does not pose any problem since the grooves 19 eliminate any obstacle to evaporation during the lyophilization process.
  • the sealing element 1 is pushed towards its final position shown in FIG. 4, the fixing part 10 coming to fit in the tank 50 and the overpressure formed inside of the reservoir by this action is automatically evacuated through the slot 12 made in the membrane 11.
  • a shoulder or upper radial flange 8 is provided to form a stop for the closure element 1 on the upper edge of the reservoir 50 and defines the closed position.
  • the present invention therefore provides a sealing element which is not only adapted to allow the lyophilization of the product inside the reservoir, but which obviously ensures a tight sealing of said reservoir and allows an easy transformation of the lyophilized powder into a fluid product by mixing with a solvent.
  • the weak interaction between the closure part 11 and the reservoir 50 also allows easy introduction of the solvent inside the reservoir 50 through said slot 12 as well as easy distribution of the remixed product contained in the reservoir also through said slot 12, if desired.
  • other means for re-liquefying the lyophilized product and / or for distributing it can be envisaged.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
  • Drying Of Solid Materials (AREA)

Abstract

The invention concerns a closure system for sealed closure of a reservoir (50) of a freeze-dried product dispenser, characterised in that it comprises a closure element (1) including a fixing part (10) sealingly co-operating with the reservoir (50) and a closure part (11) including a radial diaphragm (11) provided with a slot (12), the interference between said closure part (11) and said reservoir (50) being nil or quasi-nil, such that the slot (12) opens on one side or the other when pressure is exerted on any one side of said closure part (11), said slot (12) being sealingly closed in the absence of such pressure.

Description

Système d'obturation d'un réservoir d'un dispositif de distribution de produit lyophilisé. System for closing a reservoir of a device for dispensing lyophilized product.
La présente invention concerne un système d'obturation, et plus particulièrement un système d'obturation d'un réservoir d'un dispositif de distribution de produit lyophilisé, dans lequel la lyophilisation du produit est réalisée directement à l'intérieur dudit réservoir. L'invention concerne aussi un tel réservoir et un tel dispositif de distribution.The present invention relates to a closure system, and more particularly to a closure system for a reservoir of a device for dispensing lyophilized product, in which the lyophilization of the product is carried out directly inside said reservoir. The invention also relates to such a reservoir and such a dispensing device.
Dans les dispositifs de distribution de produit lyophilisé, on prévoit en général deux réservoirs, l'un contenant une poudre lyophilisée et l'autre un solvant, les contenus de ces deux réservoirs étant mélangés juste avant la distribution pour recombiner la poudre lyophilisée en un produit fluide pouvant être pulvérisé. Dans ce type de dispositifs, il est préférable de réaliser la lyophilisation directement à l'intérieur du réservoir du dispositif plutôt que de remplir ce réservoir avec une poudre déjà lyophilisée.In devices for dispensing lyophilized product, two reservoirs are generally provided, one containing a lyophilized powder and the other a solvent, the contents of these two reservoirs being mixed just before dispensing to recombine the lyophilized powder into a product. sprayable fluid. In this type of device, it is preferable to perform the lyophilization directly inside the reservoir of the device rather than filling this reservoir with an already lyophilized powder.
Ce procédé implique toutefois un certain nombre de contraintes qui doivent toutes être réalisées à l'intérieur de l'équipement de lyophilisation. Ainsi, il est d'abord nécessaire de créer un vide à l'intérieur du réservoir contenant le produit à lyophiliser. Ensuite, la lyophilisation est mise en œuvre. Puis il s'agit d'effectuer un rééquilibrage de la pression à l'intérieur du réservoir. Et finalement, il est nécessaire d'obturer de manière étanche ledit réservoir.This process however involves a certain number of constraints which must all be carried out inside the lyophilization equipment. Thus, it is first necessary to create a vacuum inside the tank containing the product to be lyophilized. Then, lyophilization is implemented. Then it is a question of rebalancing the pressure inside the tank. And finally, it is necessary to seal said tank.
L'obturation du réservoir, généralement réalisé en verre, est actuellement le problème le plus significatif à surmonter puisqu'elle doit être réalisée à l'intérieur de l'équipement de lyophilisation et par conséquent dans un espace limité et fermé. De plus, l'étape finale de fermeture étanche du réservoir ne doit pas créer une surpression à l'intérieur dudit réservoir.The closure of the reservoir, generally made of glass, is currently the most significant problem to overcome since it must be carried out inside the lyophilization equipment and therefore in a limited and closed space. In addition, the final step of tightly closing the tank must not create an overpressure inside said tank.
Enfin, le système devrait pouvoir être adaptable à tout type de réservoir standard connu actuellement, et ne nécessitant par conséquent pas une modification du dit réservoir, ce qui impliquerait une élévation du coût de fabrication et de montage du dispositif.Finally, the system should be able to be adaptable to any type of standard tank currently known, and therefore not requiring a modification of said tank, which would imply an increase in the cost of manufacturing and mounting the device.
La présente invention a donc pour but de fournir un système d'obturation qui ne reproduit pas les inconvénients susmentionnés, et qui remplit toutes les exigences ci-dessus.The present invention therefore aims to provide a sealing system which does not reproduce the aforementioned drawbacks, and which fulfills all the above requirements.
La présente invention a donc pour but de fournir un système d'obturation qui soit simple et peut coûteux à assembler et qui s'adapte sur tout type de réservoir, notamment les réservoirs standard.The present invention therefore aims to provide a closure system which is simple and inexpensive to assemble and which adapts to any type of tank, in particular standard tanks.
La présente invention a également pour but de fournir un système d'obturation qui permette une lyophilisation d'un produit fluide à l'intérieur dudit réservoir. La présente invention a donc pour objet un système d'obturation adapté à obturer de manière étanche un réservoir d'un dispositif de distribution de produit lyophilisé, caractérisé en ce qu'il comprend un élément d'obturation comportant une partie de fixation coopérant de manière étanche avec le réservoir et une partie d'obturation comportant une membrane radiale pourvue d'une fente, l'interférence entre ladite partie d'obturation et ledit réservoir étant nulle ou quasi nulle, de telle sorte que la fente s'ouvre d'un côté ou de l'autre dès qu'une pression est exercée d'un côté quelconque de ladite partie d'obturation, ladite fente étant fermée de manière étanche en l'absence d'une telle pression.The present invention also aims to provide a sealing system which allows lyophilization of a fluid product inside said tank. The present invention therefore relates to a closure system adapted to seal a reservoir of a device for dispensing freeze-dried product, characterized in that it comprises a closure element comprising a fixing part cooperating so watertight with the reservoir and a closure portion comprising a radial membrane provided with a slot, the interference between said closure portion and said reservoir being zero or almost zero, so that the slot opens with a side or the other as soon as a pressure is exerted on any side of said shutter portion, said slot being sealed in the absence of such pressure.
Avantageusement, ladite pression suffisante pour ouvrir ladite fente d'un côté est sensiblement identique à ladite pression suffisante pour ouvrir ladite fente de l'autre côté.Advantageously, said pressure sufficient to open said slot on one side is substantially identical to said pressure sufficient to open said slot on the other side.
De préférence, ladite partie de fixation comporte un corps cylindrique creux emmanché de manière étanche axialement à l'intérieur dudit réservoir, un écart radial étant prévu entre au moins une partie de la périphérie radiale externe de ladite membrane et la paroi latérale interne du réservoir. Selon un premier mode de réalisation de l'invention, ledit écart radial est prévu sur la totalité de la périphérie radiale externe de la membrane, de sorte que l'interférence entre ladite partie d'obturation et ledit réservoir est nulle.Preferably, said fixing part comprises a hollow cylindrical body fitted in a leaktight manner axially inside said tank, a radial gap being provided between at least part of the external radial periphery of said membrane and the internal side wall of the tank. According to a first embodiment of the invention, said radial gap is provided over the entire outer radial periphery of the membrane, so that the interference between said closure part and said reservoir is zero.
Avantageusement, ladite partie d'obturation a un diamètre extérieur inférieur au diamètre intérieur dudit réservoir. Selon un second mode de réalisation de la présente invention, ladite périphérie radiale externe de ladite membrane comporte une ou plusieurs rainures formant l'écart radial avec la paroi interne du réservoir, de sorte que l'interférence entre ladite partie d'obturation et ledit réservoir est très faible.Advantageously, said closure part has an outside diameter smaller than the inside diameter of said tank. According to a second embodiment of the present invention, said external radial periphery of said membrane comprises one or more grooves forming the radial gap with the internal wall of the tank, so that the interference between said closure part and said tank is very weak.
Avantageusement, ledit élément d'obturation comprend en outre une partie de prépositionnement s'étendant radialement au-delà de ladite partie d'obturation, lesdites rainures de la périphérie radiale externe de la membrane se prolongeant dans ladite partie de prépositionnement, de telle sorte que l'élément d'obturation peut être prépositionné sur l'ouverture du réservoir, la partie de prépositionnement étant insérée à l'intérieur dudit réservoir, et lesdits rainures formant un passage entre l'intérieur du réservoir et l'extérieur du système permettant la lyophilisation du produit contenu dans le réservoir.Advantageously, said closure element further comprises a prepositioning portion extending radially beyond said closure portion, said grooves of the external radial periphery of the membrane extending in said prepositioning portion, so that the closure element can be prepositioned on the opening of the reservoir, the prepositioning part being inserted inside said reservoir, and said grooves forming a passage between the interior of the reservoir and the exterior of the system allowing lyophilization of the product contained in the tank.
De préférence, dans lequel ledit élément d'obturation est en matériau élastomère. La présente invention a aussi pour objet un réservoir d'un dispositif de distribution de produit lyophilisé comportant un système d'obturation tel que décrit ci-dessus, et un dispositif de distribution de produit lyophilisé incorporant un tel réservoir. D'autres caractéristiques et avantages de la présente invention apparaîtront plus clairement au cours de la description détaillée suivante de deux modes de réalisation de la présente invention donnés à titre d'exemples non limitatifs en regard des dessins joints, sur lesquels : - la figure 1 est une vue partiellement en section et partiellement de côté d'un élément d'obturation d'un système d'obturation selon un premier mode de réalisation de la présente invention, la figure 2 est une vue similaire à celle de la figure 1 montrant l'élément d'obturation de la figure 1 positionné à l'intérieur du réservoir, - la figure 3 est une vue similaire aux figures 1 et 2 d'un second mode de réalisation du système d'obturation selon l'invention, avec l'élément d'obturation disposé dans une position de prépositionnement, et - la figure 4 est une vue similaire à la figure 3, montrant l'élément d'obturation de la figure 3 disposé à l'intérieur du réservoir.Preferably, in which said closure element is made of elastomeric material. The present invention also relates to a reservoir of a device for dispensing lyophilized product comprising a closure system as described above, and a device for dispensing lyophilized product incorporating such a reservoir. Other characteristics and advantages of the present invention will appear more clearly during the following detailed description of two embodiments of the present invention given by way of nonlimiting examples with reference to the accompanying drawings, in which: - Figure 1 is a partially sectioned and partially side view of a closure element of a closure system according to a first embodiment of the present invention, FIG. 2 is a view similar to that of FIG. 1 showing the 'shutter element of Figure 1 positioned inside the tank, - Figure 3 is a view similar to Figures 1 and 2 of a second embodiment of the shutter system according to the invention, with the closure element disposed in a prepositioning position, and - Figure 4 is a view similar to Figure 3, showing the closure element of Figure 3 disposed inside the tank.
En référence aux figures 1 et 2, il est décrit un premier mode de réalisation de l'invention. Dans ce premier mode de réalisation, ce système d'obturation comporte un élément d'obturation 1 qui est adapté à obturer de manière étanche un réservoir 50. Cet élément d'obturation comporte une partie de fixation 10 qui coopère de manière étanche avec le réservoir 50 en particulier avec sa paroi latérale intérieure, et notamment au moyen de boudins d'étanchéité périphériques qui s'écrasent contre la paroi intérieure du réservoir pour former plusieurs cordons d'étanchéité. L'élément d'obturation 1 comporte également une partie d'obturation 11, qui est avantageusement pourvue d'une fente 12, qui n'est que schématiquement représentée et qui est de préférence située au centre de ladite partie d'obturation 11. Cette partie d'obturation 11 est de préférence réalisée sous la forme d'une membrane radiale incorporant ladite fente 12. Comme représenté sur les dessins, l'élément d'obturation 1 est de préférence réalisé avec une partie de fixation formée par un corps cylindrique creux 10 qui définit un creux 2, ledit cylindre creux 10 étant fermé par ladite membrane radiale 11 incorporant ladite fente 12. Selon l'invention, l'interférence entre la partie d'obturation et le réservoir est nulle ou quasi nulle. Dans ce premier mode de réalisation, cette interférence est effectivement nulle comme visible sur la figure 2. En effet, un écart radial 30 est prévu entre la périphérie radiale externe de la membrane 11 et la paroi interne du réservoir 50. Ceci est avantageusement réalisé au moyen d'une partie d'obturation 11 qui comporte un diamètre extérieur inférieur au diamètre intérieur du réservoir 50, et donc également inférieur au diamètre extérieur de la partie de fixation 10 de l'élément d'obturation 1. Cette absence d'interférence entre la périphérie externe de la partie d'obturation 11 et la paroi latérale interne du réservoir 50 a pour effet qu'aucune pression n'est exercée sur cette partie d'obturation 11, de sorte que la fente 12 s'ouvre très facilement dès l'apparition d'une pression d'un côté ou de l'autre de la membrane 11.Referring to Figures 1 and 2, there is described a first embodiment of the invention. In this first embodiment, this closure system comprises a closure element 1 which is adapted to seal a reservoir 50. This closure element comprises a fixing part 10 which cooperates sealingly with the reservoir 50 in particular with its inner side wall, and in particular by means of peripheral sealing flanges which are crushed against the inner wall of the tank to form several sealing beads. The shutter element 1 also includes a shutter part 11, which is advantageously provided with a slot 12, which is only schematically shown and which is preferably located in the center of said shutter part 11. This closure part 11 is preferably produced in the form of a radial membrane incorporating said slot 12. As shown in the drawings, the closure element 1 is preferably produced with a fixing part formed by a hollow cylindrical body 10 which defines a hollow 2, said hollow cylinder 10 being closed by said radial membrane 11 incorporating said slot 12. According to the invention, the interference between the closure part and the reservoir is zero or almost zero. In this first embodiment, this interference is effectively zero as can be seen in FIG. 2. In fact, a radial gap 30 is provided between the external radial periphery of the membrane 11 and the internal wall of the reservoir 50. This is advantageously achieved at by means of a closure part 11 which has a diameter outside less than the inside diameter of the reservoir 50, and therefore also less than the outside diameter of the fixing part 10 of the shutter element 1. This absence of interference between the external periphery of the shutter part 11 and the wall internal lateral side of the reservoir 50 has the effect that no pressure is exerted on this closure part 11, so that the slot 12 opens very easily as soon as a pressure appears on one side or the other of the membrane 11.
Par conséquent, ce système représenté sur les figures 1 et 2 peut être utilisé pour réaliser une lyophilisation dans le réservoir 50. A cet effet, l'élément d'obturation est introduit à l'intérieur du réservoir 50, comme représenté sur la figure 2, dans sa position d'obturation, dans laquelle la partie d'obturation formée par la membrane 11 obture de manière étanche ledit réservoir 50, la fente 12 étant fermée. La création d'un vide à l'intérieur du réservoir 50 est très facile en créant une sons-pression au niveau du creux 2 disposé du côté extérieur de la membrane 11 qui a pour effet de faire s'ouvrir la fente 12 en direction de ce creux 2 et permettre ainsi de créer un vide à l'intérieur du réservoir 50. De même, le rééquilibrage de la pression peut être facilement réalisé à travers la fente 12 de la membrane 11, ladite fente 12 se refermant automatiquement en position étanche lorsque la pression est identique des deux côtés de la membrane 11. Toute interférence entre la périphérie externe radiale de la membrane 11 et l'intérieur du réservoir 50 aurait pour conséquence la création d'un certain seuil de pression en dessous duquel la fente ne s'ouvrirait pas, alors que la présence dudit écart radial 30 permet une déformation sans contrainte de ladite membrane et donc une ouverture très facile de ladite fente 12.Consequently, this system shown in FIGS. 1 and 2 can be used to freeze-dry in the reservoir 50. For this purpose, the closure element is introduced inside the reservoir 50, as shown in FIG. 2 , in its closed position, in which the closed part formed by the membrane 11 seals said reservoir 50 in a sealed manner, the slot 12 being closed. Creating a vacuum inside the tank 50 is very easy by creating a pressure sound at the level of the hollow 2 arranged on the outside of the membrane 11 which has the effect of opening the slot 12 in the direction of this hollow 2 and thus make it possible to create a vacuum inside the reservoir 50. Likewise, pressure rebalancing can be easily achieved through the slot 12 of the membrane 11, said slot 12 closing automatically in the sealed position when the pressure is identical on both sides of the membrane 11. Any interference between the radial external periphery of the membrane 11 and the interior of the reservoir 50 would result in the creation of a certain pressure threshold below which the slot does not would not open, whereas the presence of said radial gap 30 allows unconstrained deformation of said membrane and therefore very easy opening of said slot 12.
Un second mode de réalisation de la présente invention va être décrit en référence aux figures 3 et 4. Ce second mode de réalisation diffère du premier mode de réalisation en ce que l'interférence entre la partie d'obturation 11 formée par la membrane incorporant la fente 12 et la paroi intérieure du réservoir 50 n'est pas totalement nulle en position d'obturation d'élément d'obturation mais est très faible grâce à la présence de rainures 19 dans ladite périphérie radiale externe de ladite membrane 11, comme représenté sur les figures 3 et 4. Dans ce cas, le diamètre extérieur de la partie d'obturation 11 est sensiblement identique au diamètre de la partie de fixation 10, la déformation de la membrane 11 et donc l'ouverture de la fente 12 étant facilitée par la présence desdites rainures 19.A second embodiment of the present invention will be described with reference to FIGS. 3 and 4. This second embodiment differs from the first embodiment in that the interference between the closure part 11 formed by the membrane incorporating the slot 12 and the inner wall of the reservoir 50 is not completely zero in the closed position of the closed element but is very small due to the presence of grooves 19 in said external radial periphery of said membrane 11, as shown in Figures 3 and 4. In this case, the outer diameter of the closure portion 11 is substantially identical to the diameter of the fixing portion 10, the deformation of the membrane 11 and therefore the opening of the slot 12 being facilitated by the presence of said grooves 19.
Avantageusement, dans ce second mode de réalisation, l'élément d'obturation 1 comporte en outre des moyens de prépositionnement 15 qui s'étendent axialement au-delà de ladite membrane 11, lesdites rainures 19 se prolongeant dans la périphérie de ladite partie de prépositionnement 15, comme représenté sur les figures. Cette mise en œuvre permet un procédé de lyophilisation légèrement différent que celui expliqué en référence au premier mode de réalisation. En effet, dans ce second mode de réalisation, l'élément d'obturation 1 est d'abord placé dans sa position de prépositionnement représenté sur la figure 3, avec la partie de prépositionnement 15 inséré à l'intérieur du réservoir 50 et l'élément d'obturation étant retenu dans cette position par l'épaulement 7 formé par la périphérie externe de la membrane 11 incorporant la fente 12. Avantageusement, la partie de prépositionnement s'insère dans le réservoir 50 avec frottement, ce qui favorise en outre la stabilité de l'élément d'obturation 1 dans cette position de prépositionnement. Cette position de prépositionnement permet la création d'un vide et le rééquilibrage de pression subséquent après la lyophilisation à travers les rainures 19 qui relient l'intérieur du réservoir 50 à l'extérieur du système d'obturation. Ainsi, dans ce second mode de réalisation, la lyophilisation du produit contenu dans le réservoir 50 ne pose aucun problème puisque les rainures 19 éliminent tout obstacle à l'évaporation lors du procédé de lyophilisation. Puis, à la fin du procédé de lyophilisation, l'élément d'obturation 1 est poussé vers sa position finale représentée sur la figure 4, la partie de fixation 10 venant s'emmancher dans le réservoir 50 et la surpression formée à l'intérieur du réservoir par cette action est automatiquement évacuée à travers la fente 12 réalisée dans la membrane 11. Comme dans le premier mode de réalisation décrit précédemment, un épaulement ou bride radiale supérieure 8 est prévu former une butée pour l'élément d'obturation 1 sur le bord supérieur du réservoir 50 et définit la position d'obturation.Advantageously, in this second embodiment, the closure element 1 also comprises prepositioning means 15 which extend axially beyond said membrane 11, said grooves 19 extending in the periphery of said prepositioning part 15, as shown in the figures. This implementation allows a slightly different lyophilization process than that explained with reference to the first embodiment. Indeed, in this second embodiment, the closure element 1 is first placed in its prepositioning position shown in FIG. 3, with the prepositioning part 15 inserted inside the tank 50 and the closure element being retained in this position by the shoulder 7 formed by the external periphery of the membrane 11 incorporating the slot 12. Advantageously, the prepositioning part is inserted into the reservoir 50 with friction, which further promotes the stability of the closure element 1 in this prepositioning position. This prepositioning position allows the creation of a vacuum and the subsequent pressure rebalancing after lyophilization through the grooves 19 which connect the inside of the tank 50 to the outside of the sealing system. Thus, in this second embodiment, the lyophilization of the product contained in the reservoir 50 does not pose any problem since the grooves 19 eliminate any obstacle to evaporation during the lyophilization process. Then, at the end of the lyophilization process, the sealing element 1 is pushed towards its final position shown in FIG. 4, the fixing part 10 coming to fit in the tank 50 and the overpressure formed inside of the reservoir by this action is automatically evacuated through the slot 12 made in the membrane 11. As in the first embodiment described above, a shoulder or upper radial flange 8 is provided to form a stop for the closure element 1 on the upper edge of the reservoir 50 and defines the closed position.
La présente invention fournit donc un élément d'obturation qui est non seulement adapté à permettre la lyophilisation du produit à l'intérieur du réservoir, mais qui évidemment assure une obturation étanche dudit réservoir et permet une transformation aisée de la poudre lyophilisée en produit fluide par mélangeage avec un solvant. En effet, la faible interaction entre la partie d'obturation 11 et le réservoir 50 permet aussi une introduction aisée du solvant à l'intérieur du réservoir 50 à travers ladite fente 12 ainsi qu'une distribution aisée du produit remélangé contenu dans le réservoir également à travers ladite fente 12, si souhaité. Bien entendu, d'autres moyens pour reliquéfier le produit lyophilisé et/ou pour le distribuer peuvent être envisagés. Par contre, quel que soit le système utilisé pour mélanger le produit lyophilisé avec le solvant, il est important que l'air contenu dans le réservoir de poudre 50 soit facilement expulsé lors de l'introduction du solvant, ce qui est garanti par la présente invention. L'invention a été décrite en référence à deux modes de réalisation particuliers de celle-ci, mais il est clair que diverses modifications peuvent être apportées sans sortir du cadre de la présente invention définie par les revendications annexées. The present invention therefore provides a sealing element which is not only adapted to allow the lyophilization of the product inside the reservoir, but which obviously ensures a tight sealing of said reservoir and allows an easy transformation of the lyophilized powder into a fluid product by mixing with a solvent. Indeed, the weak interaction between the closure part 11 and the reservoir 50 also allows easy introduction of the solvent inside the reservoir 50 through said slot 12 as well as easy distribution of the remixed product contained in the reservoir also through said slot 12, if desired. Of course, other means for re-liquefying the lyophilized product and / or for distributing it can be envisaged. On the other hand, whatever the system used for mixing the lyophilized product with the solvent, it is important that the air contained in the powder tank 50 is easily expelled during the introduction of the solvent, which is guaranteed by the present invention. The invention has been described with reference to two particular embodiments thereof, but it is clear that various modifications can be made without departing from the scope of the present invention defined by the appended claims.

Claims

Revendications : Claims:
1.- Système d'obturation adapté à obturer de manière étanche un réservoir (50) d'un dispositif de distribution de produit lyophilisé, caractérisé en ce qu'il comprend un élément d'obturation (1) comportant une partie de fixation (10) coopérant de manière étanche avec le réservoir (50) et une partie d'obturation (11) comportant une membrane radiale (11) pourvue d'une fente (12), l'interférence entre ladite partie d'obturation (11) et ledit réservoir (50) étant nulle ou quasi nulle, de telle sorte que la fente (12) s'ouvre d'un côté ou de l'autre dès qu'une pression est exercée d'un côté quelconque de ladite partie d'obturation (11), ladite fente (12) étant fermée de manière étanche en l'absence d'une telle pression. 1.- Sealing system adapted to seal a tank (50) of a freeze-dried product distribution device, characterized in that it comprises a sealing element (1) comprising a fixing part (10 ) cooperating in a sealed manner with the reservoir (50) and a closure part (11) comprising a radial membrane (11) provided with a slot (12), the interference between said closure part (11) and said reservoir (50) being zero or almost zero, so that the slot (12) opens on one side or the other as soon as pressure is exerted on any side of said closure part ( 11), said slot (12) being closed in a sealed manner in the absence of such pressure.
2.- Système selon la revendication 1, dans lequel ladite pression suffisante pour ouvrir ladite fente (12) d'un côté est sensiblement identique à ladite pression suffisante pour ouvrir ladite fente (12) de l'autre côté.2. A system according to claim 1, wherein said pressure sufficient to open said slot (12) on one side is substantially identical to said pressure sufficient to open said slot (12) on the other side.
3.- Système selon la revendication 1 ou 2, dans lequel ladite partie de fixation (10) comporte un corps cylindrique creux (10) emmanché de manière étanche axialement à l'intérieur dudit réservoir (50), un écart radial (30) étant prévu entre au moins une partie de la périphérie radiale externe de ladite membrane (11) et la paroi latérale interne du réservoir3.- System according to claim 1 or 2, wherein said fixing portion (10) comprises a hollow cylindrical body (10) fitted in an axially sealed manner inside said tank (50), a radial gap (30) being provided between at least part of the outer radial periphery of said membrane (11) and the inner side wall of the tank
(50).(50).
4.- Système selon la revendication 3, dans lequel ledit écart radial (30) est prévu sur la totalité de la périphérie radiale externe de la membrane (11), de sorte que l'interférence entre ladite partie d'obturation (11) et ledit réservoir (50) est nulle.4.- The system of claim 3, wherein said radial gap (30) is provided over the entire outer radial periphery of the membrane (11), so that the interference between said shutter portion (11) and said tank (50) is zero.
5.- Système selon la revendication 4, dans lequel ladite partie d'obturation (11) a un diamètre extérieur inférieur au diamètre intérieur dudit réservoir (50).5.- The system of claim 4, wherein said shutter portion (11) has an outer diameter less than the inner diameter of said tank (50).
6.- Système selon la revendication 3, dans lequel ladite périphérie radiale externe de ladite membrane (11) comporte une ou plusieurs rainures (19) formant l'écart radial (30) avec la paroi interne du réservoir (50), de sorte que l'interférence entre ladite partie d'obturation (11) et ledit réservoir (50) est très faible.6.- The system of claim 3, wherein said outer radial periphery of said membrane (11) has one or more grooves (19) forming the radial gap (30) with the inner wall of the reservoir (50), so that the interference between said shutter portion (11) and said reservoir (50) is very slight.
7.- Système selon la revendication 6, dans lequel ledit élément d'obturation (1) comprend en outre une partie de prépositionnement (15) s'étendant radialement au-delà de ladite partie d'obturation (11), lesdites rainures (19) de la périphérie radiale externe de la membrane (11) se prolongeant dans ladite partie de prépositionnement (15), de telle sorte que l'élément d'obturation (1) peut être prépositionné sur l'ouverture du réservoir (50), la partie de prépositionnement (15) étant insérée à l'intérieur dudit réservoir (50), et lesdites rainures (19) formant un passage entre l'intérieur du réservoir (50) et l'extérieur du système, notamment lors de la lyophilisation du produit contenu dans le réservoir (50).7.- The system of claim 6, wherein said closure element (1) further comprises a prepositioning portion (15) extending radially beyond said closure portion (11), said grooves (19 ) of the outer radial periphery of the membrane (11) extending into said prepositioning part (15), so that the closure element (1) can be prepositioned on the opening of the reservoir (50), the prepositioning part (15) being inserted inside said tank (50), and said grooves (19) forming a passage between the interior of the reservoir (50) and the exterior of the system, in particular during the lyophilization of the product contained in the reservoir (50).
8.- Système selon l'une quelconque des revendications précédentes, dans lequel ledit élément d'obturation (1) est en matériau élastomère.8.- System according to any one of the preceding claims, wherein said closure element (1) is made of elastomeric material.
9.- Réservoir (50) d'un dispositif de distribution de produit lyophilisé, caractérisé en ce qu'il comporte un système d'obturation selon l'une quelconque des revendications 1 à 8.9.- Reservoir (50) of a device for dispensing freeze-dried product, characterized in that it comprises a closure system according to any one of claims 1 to 8.
10.- Dispositif de distribution de produit lyophilisé, caractérisé en ce qu'il comporte un réservoir (50) selon la revendication 9. 10.- Device for dispensing freeze-dried product, characterized in that it comprises a reservoir (50) according to claim 9.
EP01938326A 2000-05-30 2001-05-23 Closure system for a reservoir of a freeze-dried product dispensing device Withdrawn EP1296878A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0006885A FR2809710B1 (en) 2000-05-30 2000-05-30 SYSTEM FOR SEALING A TANK OF A LYOPHILIZED PRODUCT DISPENSING DEVICE
FR0006885 2000-05-30
PCT/FR2001/001607 WO2001092126A1 (en) 2000-05-30 2001-05-23 Closure system for a reservoir of a freeze-dried product dispensing device

Publications (1)

Publication Number Publication Date
EP1296878A1 true EP1296878A1 (en) 2003-04-02

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EP01938326A Withdrawn EP1296878A1 (en) 2000-05-30 2001-05-23 Closure system for a reservoir of a freeze-dried product dispensing device

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US (1) US20040011826A1 (en)
EP (1) EP1296878A1 (en)
JP (1) JP2003534993A (en)
CN (1) CN1440350A (en)
FR (1) FR2809710B1 (en)
WO (1) WO2001092126A1 (en)

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GB2448709A (en) * 2007-04-24 2008-10-29 Pentapharm Ag Cap for sealing a vial
JP2009196666A (en) * 2008-02-21 2009-09-03 Toyo Seikan Kaisha Ltd Sealing stopper, sealed container, and freeze drying method
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PL3177359T3 (en) * 2014-08-04 2020-09-21 F. Hoffmann-La Roche Ag Apparatus and methods for sealing a medicament within a medical delivery device
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Also Published As

Publication number Publication date
FR2809710A1 (en) 2001-12-07
FR2809710B1 (en) 2002-12-13
JP2003534993A (en) 2003-11-25
US20040011826A1 (en) 2004-01-22
CN1440350A (en) 2003-09-03
WO2001092126A1 (en) 2001-12-06

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