WO1997008503A1 - Sealed packaging assembly useful for drying, particularly freeze-drying, and drying, particularly freeze-drying method using same - Google Patents
Sealed packaging assembly useful for drying, particularly freeze-drying, and drying, particularly freeze-drying method using same Download PDFInfo
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- WO1997008503A1 WO1997008503A1 PCT/FR1996/001301 FR9601301W WO9708503A1 WO 1997008503 A1 WO1997008503 A1 WO 1997008503A1 FR 9601301 W FR9601301 W FR 9601301W WO 9708503 A1 WO9708503 A1 WO 9708503A1
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- packaging
- bottles
- drying
- sealed package
- cover
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Definitions
- the present invention relates to a sealed package, allowing drying operations to be carried out on a product of interest, in particular chemical or biological, while avoiding contamination of this product by the ambient atmosphere or contamination of the ambient atmosphere. by said product.
- the invention relates in particular to a packaging containing sterile products and which makes it possible to maintain sterility during the operations of evaporation, of pervaporation or in particular of lyophilization. This is why the invention also relates to a method of drying, in particular lyophilization, of a product of interest, using said packaging.
- Freeze-drying operations especially at the final stage of packaging biological or pharmaceutical products, must be carried out under non-contaminating conditions. It is therefore necessary, on the one hand, to avoid contamination of the equipment in which the products treated are viruses or other contaminating substances (DNA, chemicals or molecules with high activity, for example) in order to minimize the risks of cross contamination. .
- the invention also applies to the drying and freeze-drying of products which are dangerous or contaminating for the environment, which must be treated without being able to disseminate in ambient atmospheres.
- the invention is applicable to a large number of products such as pharmaceutical products, in particular biological products, preserved by lyophilization, including products intended for biological or chemical analysis, vaccines, pharmaceutical products such as anti-cancer, anti -inflammatory, antibiotics, but also food products to be dried sterile (sterile nutrition) and to be steamed in the same sachet.
- the invention is also applicable to chemicals dangerous for the environment or health and infectious biological products such as strains of viruses, bacteria (or microorganisms in general). It is generally difficult to carry out such drying industrially, that is to say continuously without increasing the number of manipulations which on the one hand multiply the risks of contamination and on the other hand increase the cost of the final product packaged.
- a European container 343 596 has indeed been proposed for the lyophilization of a biological or pharmaceutical product under sterile conditions, comprising a hydrophobic, porous membrane, impermeable to germs and permeable to water vapor such as a membrane cellulose acetate or polytetrafluoroethylene or polypropylene.
- this container does not have all the guarantees required in the event that the container bursts as this would not prevent contamination of the freeze dryer, then of the sterile unit and of the technicians when the device is unloaded. In addition, such a container does not eliminate additional handling for the final packaging of the product.
- GB 995 930 has proposed a lyophilization process according to which the products to be lyophilized are subjected to this operation in an envelope permeable to water vapor.
- the envelope can then be pressed for subsequent shaping: in order to obtain a reduction in volume of radioactive products for example.
- the object of the present invention is to provide packaging making it possible to considerably simplify the drying operations of products, while maintaining the sterility of said products or while protecting the apparatus from any contamination, then carrying out the packaging of said products.
- drying will generally designate any elimination of a solvent, in particular water, in the form of vapor from a solution, a powder or a paste previously treated in an appropriate manner for the process considered.
- a solvent in particular water
- the solvent in particular the water in the solution, powder or paste will be previously frozen in a known manner.
- pervaporation is meant that the passage of water takes place essentially in vapor form, by simple gaseous diffusion at through the micropores of the membrane separating the product from the ambient atmosphere.
- the invention firstly relates to a sealed package for drying operations under non-contaminating conditions of a product of interest, said package comprising a hydrophobic microporous membrane, impermeable to liquids but permeable to water vapor, characterized in that one or more open containers, in particular vials, containing a product to be lyophilized must be housed in said packaging, in that said packaging comprises a housing for said containers, covered with a cover, said cover being formed at least in part of a hydrophobic microporous membrane impermeable to liquids but permeable to water vapor, a closure means for each of said containers, so that a pressure exerted on said cover closes the opening of each container via closing means.
- the closure means are advantageously lyophilization plugs. These plugs, in a well known manner, are provided at their base with lugs ensuring support on the neck of the containers while leaving a suitable space for the evacuation of the water vapor (position not locked). By pressure exerted on said plugs along the axis of the containers, they are driven in a translation movement from top to bottom and allow the containers to be plugged.
- the packaging is formed of a flexible sheet such as a plastic film forming a tray, in which the containers are located, the edges of said sheet being secured for example by welding of an upper sheet formed of a hydrophobic membrane.
- the containers are provided with lyophilization plugs in the non-closed position during the drying operation. We therefore obtain a flexible closed packaging. This is advantageously placed on a rigid support such as a tray. After the drying operation, pressure exerted on the stoppers, manual or automatic, via the top sheet ensures the closure of the containers.
- the sealed packaging is preferably formed of a skirt ensuring a certain rigidity, a foldable zone, a cover and a bottom, preferably welded, a part at least the cover being formed of a microporous hydrophobic membrane impermeable to liquids but permeable to water vapor, a foldable zone, so that the pressure exerted on the cover folds the foldable zone and locks the closing means thus closing bottle openings.
- the sealed packaging contains receptacles, in particular bottles, which may or may not be integral, removably or not, with the bottom or with a support housed in the packaging and in particular which can be integral with this support or with the bottom through appropriate imprints.
- the bottom can constitute the support on which the bottles or other containers are fixed.
- the support can also be independent of the bottom and made integral with the sealed packaging by appropriate means (cleats for example) fixed to the walls of the packaging.
- the bottom can be formed at least in part from a hydrophobic microporous membrane.
- the foldable zone is located in the extension of the wall of the packaging and is in the form of a bellows.
- the packaging can be in the form of a cylinder of revolution, but also in the form of a solid with several vertical faces, of tetragonal, pentagonal, or more generally polygonal section.
- the waterproof packaging is characterized in that the skirt ensuring a certain rigidity of the packaging, the cover at least part of which is formed of a hydrophobic microporous membrane, impermeable to liquids, but vapor permeable. of water, form a cover, provided with a folding zone, covering said bottles and bearing on said bottom.
- the skirt is connected to the cover by a setback, the setback area being deformable - so that it folds back when a push towards the bottles is exerted.
- the detachment zone is preferably at least partially elastic, so as to move the cover away from the bottles at the end of the push.
- the skirt and the recess are advantageously made of thermoformable or thermomouldable polymeric material or of deformable metal, such as aluminum.
- the polymeric material is of any kind, for example polypropylene or polyethylene.
- thermoformable material is meant a sheet which can be given a shape.
- heat-moldable material is meant a polymeric material which is poured into a mold to give it its shape.
- microporous membrane in addition to its impermeability to liquids has a porosity such that it can oppose any penetration of contaminating microorganisms.
- It is a material made of a hydrophobic polymer which does not absorb water and does not offer a nucleation point to initiate the condensation of water. However, it must be porous enough to allow water vapor to pass without significantly slowing down the evaporation or sublimation process, while not allowing passage for microorganisms or lyophilisate particles.
- the material moreover, must be sealable by an appropriate means which ensures total tightness of the weld and does not alter the porosity of the envelope in the vicinity of the seal.
- Hydrophobic membranes are generally made from polyolefin, optionally fluorinated, in particular polytetrafluoroethylenes such as those known under the trademark GORE-TEX® (registered trademark of the company WL GORE & Associates, Inc.) or from textured polypropylenes a nonwoven such as that known under the brand name Tyvek®.
- polyolefin optionally fluorinated, in particular polytetrafluoroethylenes such as those known under the trademark GORE-TEX® (registered trademark of the company WL GORE & Associates, Inc.) or from textured polypropylenes a nonwoven such as that known under the brand name Tyvek®.
- Hydrophobic membranes can also be made of hydrophilic polymers specially treated in order to develop a crosslinking of fluocarbon radicals on the surface of the polymer. The passage of water through these membranes takes place at the state of vapor according to an osmotic evaporation process.
- These membranes have a volume porosity greater than 40% and the average pore size is sufficiently reduced to prevent any introduction of microorganisms and is generally between 0.02 and 5 micrometers.
- Figure 1 is a schematic sectional view of a sealed package intended to be introduced into a drying apparatus.
- Figure 2 is a schematic sectional view of the same sealed package after folding the foldable area for subsequent use or storage.
- Figure 3 is a schematic sectional view of another sealed package, provided with a cover intended to be introduced into a drying apparatus, that is to say a package as it appears during lyophilization .
- Figure 4 is a schematic sectional view of the same sealed package during capping.
- Figure 5 is a schematic sectional view of the same sealed package after sealing.
- a series of bottles 2 containing a product to be freeze-dried 3 said bottles being terminated by an open neck 4 and being placed on a support 5.
- the package comprises a bottom 6, a cylindrical envelope 7 terminated by an upper folding zone 8, covered by a waterproof membrane 10 in
- the bottles are prefilled in the usual way for lyophilization.
- the packaging 13 is formed by a support plate 14, a heat conductor on which a base 15 is positioned by means of an external return 16 to ensure the maintenance of the base 15 on the support 14 without slip possible.
- the bottom 15 is a plate of thermoformed material comprising at its periphery hollow guides 17, ensuring the positioning of the bottles 18, provided with necks 19, on which lyophilization plugs 20 are positioned in the open position.
- On the external surface 27 of said bottom released by the guides 17 bears a cover 21 formed by a skirt 22 connected by a recess 23 to the cover 24, the central part 25 of which is made of a hydrophobic microporous membrane.
- the lower end of the cover is terminated by a flap 26 resting on the area 27.
- the cover is made of plastic material, obtained in particular by molding, such as polypropylene or polyethylene but can also be made of aluminum.
- the step is partially elastic so that according to FIG. 4, when a push is exerted by the upper shelf 28, the cover is lowered to lock the plugs 20 on the neck 19.
- the invention also relates to a process for drying a product of interest, in particular a freeze-drying process, characterized in that one places the packaging according to the invention in an appropriate drying apparatus, in particular a freeze-dryer, in that it is dried, in particular a vacuum is produced, for a determined period depending on the product to be dehydrated, in that it is closed the bottles by pressing on the closing means, then in that the packaging is recovered for possible subsequent treatment of destruction or recycling.
- the packaging comprises a foldable zone which is folded so as to bear on the means for closing the bottles.
- This process is advantageously suitable for continuous implementation minimizing the number of manipulations.
- the process can also be carried out automatically.
- the closure by welding of the container filling orifice achieves the conservation of the product in sterile conditions whatever the subsequent manipulations and operations necessary for the lyophilization process to take place.
- the packaging can be used for the prior freezing operation because it can be refrigerated at a temperature low enough to freeze the solution introduced.
- the sealed packaging can also be loaded with frozen product obtained in the form of flakes or beads; the charge thus formed can then be lyophilized without opening the sachet since the vapors pass through the porous hydrophobic wall.
- the container can also receive dry powder, directly recovered from an atomized stream of hot air from a solution of the product to be preserved.
- the powder enclosed in the sachet can then undergo sterilization by irradiation.
- the invention is not limited to the embodiments which have just been described.
- the container can be fitted with inlet and outlet pipes, as found on flexible infusion systems, allowing the reconstitution of the product with its solvent and the aseptic connection of various pipes. infusion.
- the packaging can be reusable or disposable.
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- Life Sciences & Earth Sciences (AREA)
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Abstract
A sealed, gas-permeable packaging assembly in which one or more open flasks (2) containing a product (3) to be freeze-dried are received is characterised in that the packaging has a portion (7) for stiffening said assembly, a lid with at least one portion comprising a liquid-impervious, but water vapour-permeable microporous hydrophobic membrane (10), a base (6), and a foldable region (8), such that the pressure applied to the lid folds said foldable region and locks closure means, thus sealing the openings of the flasks. A freeze-drying method using said packaging assembly is also described.
Description
Emballage étanche pour séchage, notamment lyophilisation, et procédé de séchage, notamment de lyophilisation, à l'aide d'un tel emballage Sealed packaging for drying, in particular lyophilization, and method of drying, in particular for lyophilization, using such packaging
La présente invention concerne un emballage étanche, permettant d'effectuer des opérations de séchage d'un produit d'intérêt, notamment chimique ou biologique, tout en évitant la contamination de ce produit par l'atmosphère ambiante ou la contamination de l'atmosphère ambiante par leditproduit.The present invention relates to a sealed package, allowing drying operations to be carried out on a product of interest, in particular chemical or biological, while avoiding contamination of this product by the ambient atmosphere or contamination of the ambient atmosphere. by said product.
Elle concerne notamment un emballage contenant des produits stériles et qui permet d'assurer le maintien de la stérilité durant les opérations d'évaporation, de pervaporation ou notamment de lyophilisation. C'est pourquoi l'invention concerne également un procédé de séchage, notamment de lyophilisation, d'un produit d'intérêt, mettant en oeuvre ledit emballage.It relates in particular to a packaging containing sterile products and which makes it possible to maintain sterility during the operations of evaporation, of pervaporation or in particular of lyophilization. This is why the invention also relates to a method of drying, in particular lyophilization, of a product of interest, using said packaging.
Les opérations de lyophilisation, notamment au stade final de conditionnement des produits biologiques ou pharmaceutiques, doivent être menées dans des conditions non contaminantes. II faut donc d'une part éviter la contamination de l'appareillage dans lequel les produits traités sont des virus ou d'autres substances contaminantes (ADN, produits chimiques ou molécules à haute activité, par exemple) afin de minimiser les risques de contamination croisée.Freeze-drying operations, especially at the final stage of packaging biological or pharmaceutical products, must be carried out under non-contaminating conditions. It is therefore necessary, on the one hand, to avoid contamination of the equipment in which the products treated are viruses or other contaminating substances (DNA, chemicals or molecules with high activity, for example) in order to minimize the risks of cross contamination. .
D'autre part, pour d'autres substances telles que les produits pharmaceutiques injectables, il est nécessaire de maintenir la stérilité issue du procédé de conditionnement précédent.On the other hand, for other substances such as injectable pharmaceuticals, it is necessary to maintain the sterility resulting from the preceding conditioning process.
L'invention s'applique également au séchage et à la lyophilisation de produits dangereux ou contaminants pour l'entourage, qui doivent être traités sans pouvoir se disséminer dans Patmosphères ambiante. L'invention est applicable à de très nombreux produits comme les produits pharmaceutiques, notamment biologiques, conservés par lyophilisation, y compris les produits destinés à l'analyse biologique ou chimique, les vaccins, les produits pharmaceutiques tels que les anti¬ cancéreux, les anti-inflammatoires, les antibiotiques, mais également les produits alimentaires devant être séchés stérilement (nutrition stérile) et devant être cuits à la vapeur dans le même sachet.The invention also applies to the drying and freeze-drying of products which are dangerous or contaminating for the environment, which must be treated without being able to disseminate in ambient atmospheres. The invention is applicable to a large number of products such as pharmaceutical products, in particular biological products, preserved by lyophilization, including products intended for biological or chemical analysis, vaccines, pharmaceutical products such as anti-cancer, anti -inflammatory, antibiotics, but also food products to be dried sterile (sterile nutrition) and to be steamed in the same sachet.
L'invention est également applicable pour les produits chimiques dangereux pour l'environnement ou la santé et les produits biologiques infectants tels que les souches de virus, de bactéries (ou les microorganismes en général).
Il est en général difficile de réaliser industriellement un tel- séchage, c'est-à-dire en continu sans multiplier les manipulations qui d'une part multiplient les risques de contamination et d'autre part, augmentent le coût du produitfïnal conditionné. On a bien proposé dans le brevet européen 343 596 un récipient pour la lyophilisation d'un produit biologique ou pharmaceutique dans des conditions stériles, comportant une membrane hydrophobe, poreuse, imperméable aux germes et perméable à la vapeur d'eau telle qu'une membrane en acétate de cellulose ou en polytétrafluoroéthylène ou en polypropylène.The invention is also applicable to chemicals dangerous for the environment or health and infectious biological products such as strains of viruses, bacteria (or microorganisms in general). It is generally difficult to carry out such drying industrially, that is to say continuously without increasing the number of manipulations which on the one hand multiply the risks of contamination and on the other hand increase the cost of the final product packaged. A European container 343 596 has indeed been proposed for the lyophilization of a biological or pharmaceutical product under sterile conditions, comprising a hydrophobic, porous membrane, impermeable to germs and permeable to water vapor such as a membrane cellulose acetate or polytetrafluoroethylene or polypropylene.
Ce récipient ne présente toutefois pas toutes les garanties requises dans le cas où le récipient éclaterait car cela n'éviterait pas la contamination du lyophilisateur, puis du bloc stérile et des techniciens lors du déchargement de l'appareil. En outre, un tel récipient ne supprime pas une manipulation supplémentaire pour le conditionnement définitif du produit.However, this container does not have all the guarantees required in the event that the container bursts as this would not prevent contamination of the freeze dryer, then of the sterile unit and of the technicians when the device is unloaded. In addition, such a container does not eliminate additional handling for the final packaging of the product.
Dans le même ordre d'idée, on a proposé dans le brevet GB 995 930 un procédé de lyophilisation selon lequel les produits à lyophiliser sont soumis à cette opération dans une enveloppe perméable à la vapeur d'eau. L'enveloppe peut être ensuite pressée pour mise en forme subséquente : afin d'obtenir une réduction de volume des produits radio-actifs par exemple.In the same vein, GB 995 930 has proposed a lyophilization process according to which the products to be lyophilized are subjected to this operation in an envelope permeable to water vapor. The envelope can then be pressed for subsequent shaping: in order to obtain a reduction in volume of radioactive products for example.
L'objet de la présente invention est de proposer un emballage permettant de simplifier considérablement les opérations de séchage de produits, tout en maintenant la stérilité desdits produits ou tout en protégeant l'appareillage de toute contamination, puis réaliser le conditionnement desdits produits.The object of the present invention is to provide packaging making it possible to considerably simplify the drying operations of products, while maintaining the sterility of said products or while protecting the apparatus from any contamination, then carrying out the packaging of said products.
Le terme de séchage désignera de façon générale toute élimination d'un solvant, eau notamment, sous forme de vapeur à partir d'une solution, d'une poudre ou d'une pâte préalablement traitée de façon appropriée pour le procédé considéré. Dans le cas de la lyophilisation, le solvant, notamment l'eau de la solution, poudre ou pâte sera préalablement congelé de manière connue.The term drying will generally designate any elimination of a solvent, in particular water, in the form of vapor from a solution, a powder or a paste previously treated in an appropriate manner for the process considered. In the case of lyophilization, the solvent, in particular the water in the solution, powder or paste will be previously frozen in a known manner.
Par l'expression "pervaporation", on entend que le passage de l'eau s'effectue essentiellement sous forme vapeur, par simple diffusion gazeuse à
travers les micropores de la membrane séparant le produit de l'atmosphère ambiante.By the expression "pervaporation" is meant that the passage of water takes place essentially in vapor form, by simple gaseous diffusion at through the micropores of the membrane separating the product from the ambient atmosphere.
Par le terme "étanche", on entend que le matériau est cependant perméable à la vapeur d'eau. L'invention a en premier lieu pour objet un emballage étanche pour opérations de séchage en conditions non contaminantes d'un produit d'intérêt, ledit emballage comportant une membrane hydrophobe microporeuse, imperméable aux liquides mais perméable à la vapeur d'eau, caractérisé en ce qu'un ou plusieurs récipients ouverts, notamment des flacons, contenant un produit à lyophiliser doivent être logés dans ledit emballage, en ce que ledit emballage comprend un logement pour lesdits récipients, recouvert d'un couvercle, ledit couvercle étant formé au moins en partie d'une membrane hydrophobe microporeuse imperméable aux liquides mais perméable à la vapeur d'eau, un moyen de fermeture pour chacun desdits récipients, de façon qu'une pression exercée sur ledit couvercle obture l'ouverture de chaque récipient par l'intermédiaire des moyens de fermeture .By the term "waterproof" is meant that the material is however permeable to water vapor. The invention firstly relates to a sealed package for drying operations under non-contaminating conditions of a product of interest, said package comprising a hydrophobic microporous membrane, impermeable to liquids but permeable to water vapor, characterized in that one or more open containers, in particular vials, containing a product to be lyophilized must be housed in said packaging, in that said packaging comprises a housing for said containers, covered with a cover, said cover being formed at least in part of a hydrophobic microporous membrane impermeable to liquids but permeable to water vapor, a closure means for each of said containers, so that a pressure exerted on said cover closes the opening of each container via closing means.
Les moyens de fermeture sont avantageusement des bouchons de lyophilisation. Ces bouchons, de façon bien connue, sont munis à leur base d'ergots assurant un appui sur le col des récipients tout en laissant un espace approprié pour l'évacuation de la vapeur d'eau (position non verrouillée). Par pression exercée sur lesdits bouchons selon l'axe des récipients, ceux-ci sont animés d'un mouvement de translation de haut en bas et permettent le bouchage des récipients.The closure means are advantageously lyophilization plugs. These plugs, in a well known manner, are provided at their base with lugs ensuring support on the neck of the containers while leaving a suitable space for the evacuation of the water vapor (position not locked). By pressure exerted on said plugs along the axis of the containers, they are driven in a translation movement from top to bottom and allow the containers to be plugged.
Selon une forme de réalisation, l'emballage est formé d'une feuille souple telle qu'un film plastique formant un bac, dans lequel les récipients sont situés, les bords de ladite feuille étant solidaire par exemple par soudage d'une feuille supérieure formée d'une membrane hydrophobe. Les récipients sont munis de bouchons de lyophilisation en position non fermée pendant l'opération de séchage. On obtient donc un emballage fermé souple. Celui-ci est avantageusement posé sur un support rigide tel qu'un plateau. Après l'opération de séchage, une pression exercée sur les bouchons, manuelle ou automatique, par l'intermédiaire de la feuille supérieure assure l'obturation des récipients.According to one embodiment, the packaging is formed of a flexible sheet such as a plastic film forming a tray, in which the containers are located, the edges of said sheet being secured for example by welding of an upper sheet formed of a hydrophobic membrane. The containers are provided with lyophilization plugs in the non-closed position during the drying operation. We therefore obtain a flexible closed packaging. This is advantageously placed on a rigid support such as a tray. After the drying operation, pressure exerted on the stoppers, manual or automatic, via the top sheet ensures the closure of the containers.
Par opérations de séchage en conditions non contaminantes, on entendra donc, comme ceci a été dit précédemment, qu'il s'agit de conditions
qui évitent la contamination des produits d'intérêt par des substances présentes dans l'atmosphère ambiante (conditions stériles) ou qui évitent la contamination par le produit d'intérêt de l'atmosphère ambiante. On pourra également parler de confinement Selon une variante préférée, l'emballage étanche est de préférence formé d'une jupe assurant une certaine rigidité, d'une zone repliable, d'un couvercle et d'un fond, de préférence soudés, une partie au moins du couvercle étant formée d'une membrane hydrophobe microporeuse imperméable aux liquides mais perméable à la vapeur d'eau, une zone repliable, de telle façon que la pression exercée sur le couvercle replie la zone repliable et verrouille les moyens de fermeture obturant ainsi les ouvertures des flacons.By drying operations under non-contaminating conditions, it will therefore be understood, as has been said previously, that these are conditions which avoid contamination of the products of interest by substances present in the ambient atmosphere (sterile conditions) or which avoid contamination by the product of interest of the ambient atmosphere. We can also speak of confinement. According to a preferred variant, the sealed packaging is preferably formed of a skirt ensuring a certain rigidity, a foldable zone, a cover and a bottom, preferably welded, a part at least the cover being formed of a microporous hydrophobic membrane impermeable to liquids but permeable to water vapor, a foldable zone, so that the pressure exerted on the cover folds the foldable zone and locks the closing means thus closing bottle openings.
L'emballage étanche contient des récipients, notamment des flacons, qui peuvent ou non être solidaires, de façon amovible ou non, du fond ou d'un support logé dans l'emballage et en particulier qui peuvent être solidaires de ce support ou du fond grâce à des empreintes appropriées.The sealed packaging contains receptacles, in particular bottles, which may or may not be integral, removably or not, with the bottom or with a support housed in the packaging and in particular which can be integral with this support or with the bottom through appropriate imprints.
Le fond peut constituer le support sur lequel les flacons ou autres récipients sont fixés. Le support peut également être indépendant du fond et rendu solidaire de l'emballage étanche par des moyens appropriés (taquets par exemple) fixés aux parois de l'emballage. Dans cette forme de réalisation, le fond peut être formé au moins en partie d'une membrane hydrophobe microporeuse.The bottom can constitute the support on which the bottles or other containers are fixed. The support can also be independent of the bottom and made integral with the sealed packaging by appropriate means (cleats for example) fixed to the walls of the packaging. In this embodiment, the bottom can be formed at least in part from a hydrophobic microporous membrane.
Avantageusement, la zone repliable est située dans le prolongement de la paroi de l'emballage et se présente sous la forme d'un soufflet.Advantageously, the foldable zone is located in the extension of the wall of the packaging and is in the form of a bellows.
Elle est, de préférence, située à la partie supérieure de l'emballage. L'emballage peut se présenter sous la forme d'un cylindre de révolution, mais également sous la forme d'un solide à plusieurs faces verticales, de section tétragonale, pentagonale, ou plus généralement polygonale.It is preferably located at the top of the package. The packaging can be in the form of a cylinder of revolution, but also in the form of a solid with several vertical faces, of tetragonal, pentagonal, or more generally polygonal section.
Selon une variante préférée, l'emballage étanche est caractérisé en ce que la jupe assurant une certaine rigidité de l'emballage, le couvercle dont au moins une partie est formée d'une membrane hydrophobe microporeuse, imperméable aux liquides, mais perméable à la vapeur d'eau, forment un capot, muni d'une zone repliable, venant recouvrir lesdits flacons et prenant appui sur ledit fond. Avantageusement, la jupe est reliée au couvercle par un
décrochement, la zone formant décrochement étant déformable- de sorte qu'elle se replie lorsqu'une poussée en direction des flacons est exercée.According to a preferred variant, the waterproof packaging is characterized in that the skirt ensuring a certain rigidity of the packaging, the cover at least part of which is formed of a hydrophobic microporous membrane, impermeable to liquids, but vapor permeable. of water, form a cover, provided with a folding zone, covering said bottles and bearing on said bottom. Advantageously, the skirt is connected to the cover by a setback, the setback area being deformable - so that it folds back when a push towards the bottles is exerted.
La zone formant décrochement est de préférence au moins partiellement élastique, de façon à éloigner le couvercle des flacons en fin de poussée.The detachment zone is preferably at least partially elastic, so as to move the cover away from the bottles at the end of the push.
La jupe et le décrochement sont avantageusement en matière polymère thermoformable ou thermomoulable ou en métal déformable, tel que l'aluminium. La matière polymère est de nature quelconque, par exemple en polypropylène ou polyethylene. Par matière thermoformable on entend une feuille à laquelle on peut donner une forme.The skirt and the recess are advantageously made of thermoformable or thermomouldable polymeric material or of deformable metal, such as aluminum. The polymeric material is of any kind, for example polypropylene or polyethylene. By thermoformable material is meant a sheet which can be given a shape.
Par matière thermomoulable on entend une matière polymère que l'on coule dans un moule pour lui donner sa forme.By heat-moldable material is meant a polymeric material which is poured into a mold to give it its shape.
La membrane microporeuse outre son imperméabilité aux liquides présente une porosité telle qu'elle puisse s'opposer à toute pénétration de microorganismes contaminants.The microporous membrane in addition to its impermeability to liquids has a porosity such that it can oppose any penetration of contaminating microorganisms.
Il s'agit d'un matériau constitué d'un polymère hydrophobe qui n'absorbe pas d'eau et n'offre pas de point de nucléation pour amorcer la condensation de l'eau. II doit être néanmoins suffisamment poreux pour laisser passer la vapeur d'eau sans ralentissement significatif du procédé d'évaporation ou de sublimation, tout en ne laissant pas le passage aux microorganismes ni aux particules de lyophilisât.It is a material made of a hydrophobic polymer which does not absorb water and does not offer a nucleation point to initiate the condensation of water. However, it must be porous enough to allow water vapor to pass without significantly slowing down the evaporation or sublimation process, while not allowing passage for microorganisms or lyophilisate particles.
Le matériau, de plus, doit être scellable par un moyen approprié qui assure l'étancheite totale de la soudure et n'altère pas la porosité de l'enveloppe au voisinage du scellage.The material, moreover, must be sealable by an appropriate means which ensures total tightness of the weld and does not alter the porosity of the envelope in the vicinity of the seal.
Les membranes hydrophobes sont généralement faites à partir de polyoléfine, éventuellement fluorée, notamment les polytétrafluoroéthylènes tels que ceux connus sous la marque GORE-TEX® (marque enregistrée de la société W.L. GORE & Associates, Inc.) ou à partir de polypropylènes textures sous forme d'un non- tissé comme celui connu sous le nom de marque Tyvek®.Hydrophobic membranes are generally made from polyolefin, optionally fluorinated, in particular polytetrafluoroethylenes such as those known under the trademark GORE-TEX® (registered trademark of the company WL GORE & Associates, Inc.) or from textured polypropylenes a nonwoven such as that known under the brand name Tyvek®.
Les membranes hydrophobes peuvent également être faites de polymères hydrophiles spécialement traités afin de développer une réticulation de radicaux de fluocarbone à la surface du polymère. Le passage de l'eau au travers de ces membranes s'effectue à
l'état de vapeur selon un procédé d'évaporation osmotique.Hydrophobic membranes can also be made of hydrophilic polymers specially treated in order to develop a crosslinking of fluocarbon radicals on the surface of the polymer. The passage of water through these membranes takes place at the state of vapor according to an osmotic evaporation process.
Ces membranes présentent une porosité volumique supérieure à 40 % et la taille moyenne des pores est suffisamment réduite pour empêcher toute introduction de microorganismes et est généralement comprise entre 0,02 et 5 micromètres.These membranes have a volume porosity greater than 40% and the average pore size is sufficiently reduced to prevent any introduction of microorganisms and is generally between 0.02 and 5 micrometers.
On a constaté par contre que les membranes à base de polymères cellulosiques ne convenaient pas dans le cadre de la présente invention.On the other hand, it has been found that membranes based on cellulose polymers are not suitable in the context of the present invention.
D'autres caractéristiques, buts et avantages de l'invention ressortiront de la description suivante, donnée à titre d'exemple, et sans caractère limitatif, en regard des figures 1 et 5 annexées.Other characteristics, objects and advantages of the invention will emerge from the following description, given by way of example, and without limitation, with reference to Figures 1 and 5 appended.
La figure 1 est une vue schématique en coupe d'un emballage étanche destiné à être introduit dans un appareillage de séchage.Figure 1 is a schematic sectional view of a sealed package intended to be introduced into a drying apparatus.
La figure 2 est une vue en coupe schématique du même emballage étanche après repliement de la zone repliable pour utilisation ou stockage subséquent.Figure 2 is a schematic sectional view of the same sealed package after folding the foldable area for subsequent use or storage.
La figure 3 est une vue schématique en coupe d'un autre emballage étanche, muni d'un capot destiné à être introduit dans un appareil de séchage, c'est-à-dire un emballage tel qu'il se présente en cours de lyophilisation.Figure 3 is a schematic sectional view of another sealed package, provided with a cover intended to be introduced into a drying apparatus, that is to say a package as it appears during lyophilization .
La figure 4 est une vue en coupe schématique du même emballage étanche en cours de bouchage.Figure 4 is a schematic sectional view of the same sealed package during capping.
La figure 5 est une vue en coupe schématique du même emballage étanche après bouchage.Figure 5 is a schematic sectional view of the same sealed package after sealing.
Selon la figure 1, à l'intérieur de l'emballage 1, sont logés une série de flacons 2 contenant un produit à lyophiliser 3, lesdits flacons étant terminés par un col 4 ouvert et étant placés sur un support 5. L'emballage comprend un fond 6, une enveloppe cylindrique 7 terminée par une zone repliable supérieure 8, recouverte par une membrane étanche 10 enAccording to Figure 1, inside the package 1, are housed a series of bottles 2 containing a product to be freeze-dried 3, said bottles being terminated by an open neck 4 and being placed on a support 5. The package comprises a bottom 6, a cylindrical envelope 7 terminated by an upper folding zone 8, covered by a waterproof membrane 10 in
GORE-TEX® de porosité appropriée pour empêcher le passage des microorganismes tout en ne restreignant pas le passage de la vapeur d'eau, soudée au bord 9 de ladite zone repliable. Les flacons sont prébouchés de façon habituelle pour une lyophilisation.GORE-TEX® of suitable porosity to prevent the passage of microorganisms while not restricting the passage of water vapor, welded to the edge 9 of said foldable zone. The bottles are prefilled in the usual way for lyophilization.
Après lyophilisation, sous l'action d'une pression, on replie la zone repliable 8 de façon à introduire les bouchons 11 dans l'ouverture délimitée par les cols 4 et assurer ainsi l'étancheite des flacons sans perte de stérilité (figure 2).
L'emballage 13 selon la figure 3, est formé d'un plateau support 14, conducteur de chaleur sur lequel est positionné un fond 15 à l'aide d'un retour externe 16 pour assurer le maintien du fond 15 sur le support 14 sans glissement possible. Le fond 15 est une plaque en matériau thermoformé comprenant à sa périphérie des guides 17 creux, assurant le positionnement des flacons 18, pourvus de cols 19, sur lesquels sont positionnés en position ouverte des bouchons de lyophilisation 20. Sur la plage externe 27 dudit fond dégagé par les guides 17 prend appui un capot 21 formé d'une jupe 22 reliée par un décrochement 23 au couvercle 24 dont la partie centrale 25 est en membrane microporeuse hydrophobe.After lyophilization, under the action of a pressure, the foldable zone 8 is folded so as to introduce the caps 11 into the opening delimited by the necks 4 and thus ensure the sealing of the bottles without loss of sterility (FIG. 2) . The packaging 13 according to FIG. 3 is formed by a support plate 14, a heat conductor on which a base 15 is positioned by means of an external return 16 to ensure the maintenance of the base 15 on the support 14 without slip possible. The bottom 15 is a plate of thermoformed material comprising at its periphery hollow guides 17, ensuring the positioning of the bottles 18, provided with necks 19, on which lyophilization plugs 20 are positioned in the open position. On the external surface 27 of said bottom released by the guides 17 bears a cover 21 formed by a skirt 22 connected by a recess 23 to the cover 24, the central part 25 of which is made of a hydrophobic microporous membrane.
L'extrémité inférieure du capot est terminée par un replat 26 s'appuyant sur la plage 27. Le capot est en matériau plastique, obtenu notamment par moulage, tel que du polypropylène ou du polyethylene mais peut également être en aluminium. Le décrochement est partiellement élastique de sorte que selon la figure 4, lorsqu'une poussée est exercée par l'étagère supérieure 28, le couvercle s'abaisse pour verrouiller les bouchons 20 sur le col 19.The lower end of the cover is terminated by a flap 26 resting on the area 27. The cover is made of plastic material, obtained in particular by molding, such as polypropylene or polyethylene but can also be made of aluminum. The step is partially elastic so that according to FIG. 4, when a push is exerted by the upper shelf 28, the cover is lowered to lock the plugs 20 on the neck 19.
Selon la figure 5, lorsque la poussée est terminée, le couvercle s'écarte des bouchons du fait du caractère élastique du décrochement. Outre le caractère avantageux du dispositif décrit aux figures 3 à 5, du fait de sa simplicité et de son efficacité, on remarquera que ledit dispositif présente des avantages supplémentaires en ce qui concerne la manipulation des différents éléments le composant. En effet, les fonds 15 peuvent être empilés les uns sur les autres ainsi que les capots 21. L'invention concerne également un procédé de séchage d'un produit d'intérêt, notamment un procédé de lyophilisation, caractérisé en ce que l'on place l'emballage selon l'invention dans un appareil de séchage approprié, notamment un lyophilisateur, en ce que l'on sèche, notamment on fait le vide, pendant une période déterminée fonction du produit à déshydrater, en ce que l'on obture les flacons par pression sur les moyens de fermeture, puis en ce qu'on récupère l'emballage pour traitement ultérieur éventuel de destruction ou de recyclage.According to Figure 5, when the push is complete, the cover moves away from the plugs due to the elastic nature of the recess. In addition to the advantageous nature of the device described in Figures 3 to 5, due to its simplicity and efficiency, it will be noted that said device has additional advantages with regard to the handling of the various elements composing it. Indeed, the bottoms 15 can be stacked on top of each other as well as the covers 21. The invention also relates to a process for drying a product of interest, in particular a freeze-drying process, characterized in that one places the packaging according to the invention in an appropriate drying apparatus, in particular a freeze-dryer, in that it is dried, in particular a vacuum is produced, for a determined period depending on the product to be dehydrated, in that it is closed the bottles by pressing on the closing means, then in that the packaging is recovered for possible subsequent treatment of destruction or recycling.
Selon un procédé préféré, l'emballage comporte une zone repliable qui est repliée de façon à prendre appui sur les moyens de fermeture des flacons.
SAccording to a preferred method, the packaging comprises a foldable zone which is folded so as to bear on the means for closing the bottles. S
Ce procédé se prête avantageusement à une mise en oeuvre en continu minimisant le nombre de manipulations.This process is advantageously suitable for continuous implementation minimizing the number of manipulations.
Avantageusement, le procédé peut également être effectué en automatique. La fermeture par soudage de l'orifice de remplissage du récipient réalise la conservation du produit en conditions stériles quelles que soient les manipulations et opérations ultérieures nécessaires au déroulement du processus de lyophilisation.Advantageously, the process can also be carried out automatically. The closure by welding of the container filling orifice achieves the conservation of the product in sterile conditions whatever the subsequent manipulations and operations necessary for the lyophilization process to take place.
Par ailleurs, l'emballage peut être utilisé pour l'opération de congélation préalable car il peut subir une mise au froid à température suffisamment basse pour congeler la solution introduite.Furthermore, the packaging can be used for the prior freezing operation because it can be refrigerated at a temperature low enough to freeze the solution introduced.
L'emballage étanche peut également être chargé en produit congelé obtenu sous forme de paillettes ou de billes ; la charge ainsi constituée peut ensuite être lyophilisée sans ouverture du sachet puisque les vapeurs traversent la paroi hydrophobe poreuse.The sealed packaging can also be loaded with frozen product obtained in the form of flakes or beads; the charge thus formed can then be lyophilized without opening the sachet since the vapors pass through the porous hydrophobic wall.
Le récipient peut également recevoir de la poudre sèche, directement récupérée à partir d'un atomisât en courant d'air chaud d'une solution du produit à conserver. La poudre enfermée dans le sachet peut ensuite subir une stérilisation par irradiation. L'invention n'est pas limitée aux réalisations qui viennent d'être décrites.The container can also receive dry powder, directly recovered from an atomized stream of hot air from a solution of the product to be preserved. The powder enclosed in the sachet can then undergo sterilization by irradiation. The invention is not limited to the embodiments which have just been described.
Selon une autre variante, par exemple, le récipient peut être muni de tubulures d'entrée et de sortie, telles qu'on les trouve sur les systèmes de perfusion souples, permettant la reconstitution du produit avec son solvant et le branchement aseptique de diverses tubulures de perfusion.According to another variant, for example, the container can be fitted with inlet and outlet pipes, as found on flexible infusion systems, allowing the reconstitution of the product with its solvent and the aseptic connection of various pipes. infusion.
Selon d'autres variantes, l'emballage peut être réutilisable ou à usage unique.
According to other variants, the packaging can be reusable or disposable.
Claims
1. Emballage étanche (1) pour opérations de séchage en conditions non contaminantes d'un produit d'intérêt (3), comportant une membrane hydrophobe (10) microporeuse, imperméable aux liquides mais perméable à la vapeur d'eau, caractérisé en ce qu'un ou plusieurs récipients ouverts (2), notamment des flacons, contenant un produit (3) à lyophiliser doivent être logés dans ledit emballage, en ce que ledit emballage comprend un logement (7) pour lesdits récipients recouvert d'un couvercle (10), ledit couvercle étant formé au moins en partie d'une membrane hydrophobe microporeuse (10) imperméable aux liquides mais perméable à la vapeur d'eau, un moyen de fermeture (11) pour chaque récipient, de façon qu'une pression exercée sur le couvercle obture l'ouverture de chaque récipient par l'intermédiaire des moyens de fermeture.1. Sealed packaging (1) for drying operations under non-contaminating conditions of a product of interest (3), comprising a hydrophobic membrane (10) microporous, impermeable to liquids but permeable to water vapor, characterized in that that one or more open containers (2), in particular bottles, containing a product (3) to be lyophilized must be housed in said packaging, in that said packaging comprises a housing (7) for said containers covered with a lid ( 10), said cover being formed at least in part of a hydrophobic microporous membrane (10) impermeable to liquids but permeable to water vapor, a closure means (11) for each container, so that a pressure exerted on the lid closes the opening of each container by means of the closing means.
2. Emballage étanche selon la revendication 1, caractérisé en ce que les moyens de fermeture (11) sont des bouchons de lyophilisation positionnés sur l'ouverture des récipients en position non verrouillée.2. A sealed package according to claim 1, characterized in that the closing means (11) are lyophilization plugs positioned on the opening of the containers in the unlocked position.
3. Emballage étanche selon la revendication 1 ou 2, caractérisé en ce que le logement est formé d'une feuille souple dont les bords sont solidaires des bords d'une feuille supérieure formant couvercle en membrane hydrophobe microporeuse.3. A sealed package according to claim 1 or 2, characterized in that the housing is formed of a flexible sheet whose edges are integral with the edges of an upper sheet forming a cover in microporous hydrophobic membrane.
4. Emballage étanche selon la revendication 3, caractérisé en ce que le logement est posé sur un support rigide.4. A sealed package according to claim 3, characterized in that the housing is placed on a rigid support.
5. Emballage étanche selon la revendication 3, caractérisé en ce que les feuilles souple et supérieure sont soudées. 5. A sealed package according to claim 3, characterized in that the flexible and upper sheets are welded.
6. Emballage étanche selon la revendication 1, caractérisé en ce que ledit emballage comporte une partie (7) assurant une certaine rigidité de l'emballage, un couvercle dont au moins une partie est formée d'une membrane hydrophobe microporeuse (10) imperméable aux liquides mais perméable à la vapeur d'eau, un fond (6), une zone repliable (8) de telle façon que la pression exercée sur le couvercle replie la zone repliable et verrouille les moyens de fermeture obturant ainsi les ouvertures des flacons.6. Waterproof packaging according to claim 1, characterized in that said packaging comprises a part (7) ensuring a certain rigidity of the packaging, a cover at least part of which is formed of a microporous hydrophobic membrane (10) impermeable to liquids but permeable to water vapor, a bottom (6), a foldable area (8) so that the pressure exerted on the cover folds the foldable area and locks the closure means thus closing the openings of the bottles.
7. Emballage étanche selon la revendication 6, caractérisé en ce qu'il contient des récipients (2), notamment des flacons, qui peuvent être solidaires de façon amovible ou non du fond (6) de l'emballage ou d'un support (5) logé dans l'emballage. 7. A sealed package according to claim 6, characterized in that it contains containers (2), in particular bottles, which may be removably or not integral with the bottom (6) of the package or of a support ( 5) housed in the packaging.
8. Emballage étanche selon la revendication 6, caractérisé en ce que la zone repliable est constituée d'un soufflet (8).8. A sealed package according to claim 6, characterized in that the foldable zone consists of a bellows (8).
9. Emballage selon l'une des revendications 6 à 8, caractérisé en ce que l'emballage est un cylindre de révolution ou un solide polygonal dont une partie de l'enveloppe forme la zone repliable.9. Packaging according to one of claims 6 to 8, characterized in that the packaging is a cylinder of revolution or a polygonal solid of which a part of the envelope forms the foldable area.
10. Emballage selon l'une des revendications 6 à 9, caractérisé en ce que le fond (6) de l'emballage est formé d'une membrane hydrophobe microporeuse et les flacons sont maintenus par un support approprié (5) solidaire de l'emballage. 10. Packaging according to one of claims 6 to 9, characterized in that the bottom (6) of the packaging is formed of a microporous hydrophobic membrane and the bottles are held by a suitable support (5) integral with the packaging.
11. Emballage selon la revendication 1, caractérisé en ce que la membrane hydrophobe microporeuse présente une porosité volumique supérieure à 40 % et en ce que la taille moyenne des pores est comprise entre 0,02 et 5 μm.11. Packaging according to claim 1, characterized in that the hydrophobic microporous membrane has a volume porosity greater than 40% and in that the average pore size is between 0.02 and 5 microns.
12. Emballage selon la revendication 11, caractérisé en ce que la membrane hydrophobe microporeuse est formée au moins en partie d'un polymère de polyoléfine éventuellement fluorée.12. Packaging according to claim 11, characterized in that the hydrophobic microporous membrane is formed at least in part of an optionally fluorinated polyolefin polymer.
13. Emballage selon la revendication 12, caractérisé en ce que la membrane microporeuse est en polypropylène tramé ou en polytétrafluoroéthylène. 13. Packaging according to claim 12, characterized in that the microporous membrane is in woven polypropylene or in polytetrafluoroethylene.
14. Emballage selon la revendication 1, caractérisé en ce que les produits à lyophiliser sont choisis dans le groupe constitué par les produits biologiques, les produits chimiques, les produits pharmaceutiques ou les produits alimentaires.14. Packaging according to claim 1, characterized in that the products to be lyophilized are chosen from the group consisting of biological products, chemicals, pharmaceutical products or food products.
15. Emballage selon la revendication 14, caractérisé en ce que les produits à lyophiliser sont sous forme congelée et aseptique, ou sont dangereux pour l'environnement.15. Packaging according to claim 14, characterized in that the products to be lyophilized are in frozen and aseptic form, or are dangerous for the environment.
16. Emballage étanche selon l'une des revendications 6 à 15, caractérisé en ce que la jupe (22) assurant une certaine rigidité de l'emballage, le couvercle (24) dont au moins une partie est formée d'une membrane hydrophobe microporeuse (25) imperméable aux liquides mais perméable à la vapeur d'eau forment un capot (21) muni d'une zone repliable (23), venant recouvrir lesdits flacons (18) et prenant appui sur le fond (15).16. Waterproof packaging according to one of claims 6 to 15, characterized in that the skirt (22) ensuring a certain rigidity of the packaging, the cover (24) at least part of which is formed of a microporous hydrophobic membrane. (25) impermeable to liquids but permeable to water vapor form a cover (21) provided with a folding zone (23), covering said bottles (18) and bearing on the bottom (15).
17. Emballage étanche selon la revendication 16, caractérisé en ce que la jupe (22) est reliée au couvercle (24) par un décrochement (23), la zone formant décrochement étant déformable de sorte qu'elle se replie lorsqu'une poussée en direction des flacons est exercée sur le couvercle.17. A sealed package according to claim 16, characterized in that the skirt (22) is connected to the cover (24) by a recess (23), the zone forming a recess being deformable so that it folds back when a thrust towards the bottles is exerted on the lid.
18. Emballage étanche selon la revendication 17, caractérisé en ce que la zone formant décrochement est au moins partiellement élastique.18. A sealed package according to claim 17, characterized in that the recess forming area is at least partially elastic.
19. Emballage étanche selon l'une des revendications 16 à 18, caractérisé en ce que la jupe et le décrochement sont en matière polymère thermoformable ou en métal déformable.19. A sealed package according to one of claims 16 to 18, characterized in that the skirt and the recess are made of thermoformable polymeric material or of deformable metal.
20. Emballage étanche selon la revendication 19, caractérisé en ce que le matériau est choisi dans le groupe constitué par le polypropylène, le polyethylene, l'aluminium. 20. A sealed package according to claim 19, characterized in that the material is chosen from the group consisting of polypropylene, polyethylene, aluminum.
21. Emballage étanche selon l'une des revendications 16 à 20, caractérisé en ce que le fond est pourvu à proximité de la périphérie d'un bord (17) formant guide assurant le positionnement des flacons.21. Sealed packaging according to one of claims 16 to 20, characterized in that the bottom is provided near the periphery of an edge (17) forming a guide ensuring the positioning of the bottles.
22. Emballage étanche selon la revendication 21, caractérisé en ce que la partie intérieure du guide est creuse de façon à ce que les fonds soient empilables les uns sur les autres.22. A sealed package according to claim 21, characterized in that the inner part of the guide is hollow so that the bottoms are stackable on top of each other.
23. Emballage étanche selon l'une des revendications 16 à 22, caractérisé en ce que le fond (15) est pourvu sur le pourtour d'un retour (16) assurant le positionnement du fond sur le support (14) sur lequel ledit fond est placé. 23. Sealed packaging according to one of claims 16 to 22, characterized in that the bottom (15) is provided on the periphery of a return (16) ensuring the positioning of the bottom on the support (14) on which said bottom is placed.
24. Emballage étanche selon l'une des revendications 16 à 23, caractérisé en ce que l'extrémité inférieure de la jupe est prolongée par un replat externe horizontal qui prend appui sur la plage (27) du fond, externe au guide.24. Sealed packaging according to one of claims 16 to 23, characterized in that the lower end of the skirt is extended by a horizontal external flap which bears on the surface (27) of the bottom, external to the guide.
25. Procédé de lyophilisation d'un produit d'intérêt, caractérisé en ce que l'on place un emballage selon l'une des revendications 1 à 24 dans un lyophilisateur approprié, en ce que l'on fait le vide pendant une période déterminée, fonction du produit à déshydrater,en ce que l'on obture les flacons par pression exercée sur les moyens de fermeture et en ce que l'on récupère l'emballage pour traitement ultérieur éventuel. 25. A method of lyophilization of a product of interest, characterized in that a packaging according to one of claims 1 to 24 is placed in an appropriate lyophilizer, in that a vacuum is produced for a determined period , depending on the product to be dehydrated, in that the bottles are closed by pressure exerted on the closure means and in that the packaging is recovered for possible subsequent treatment.
26. Procédé de lyophilisation d'un produit d'intérêt, caractérisé en ce que l'on place un emballage selon l'une des revendications 6 à 24 dans un lyophilisateur approprié, en ce que l'on fait le vide pendant une période déterminée, fonction du produit à déshydrater, en ce que l'on obture les flacons par pression exercée sur les moyens de fermeture, et en ce que l'on replie la zone repliable de façon à prendre appui sur les moyens de fermeture des flacons et en ce que l'on récupère l'emballage pour traitement ultérieur éventuel.26. A method of lyophilization of a product of interest, characterized in that a packaging according to one of claims 6 to 24 is placed in a suitable lyophilizer, in that the vacuum is produced for a determined period , depending on the product to be dehydrated, in that the bottles are closed by pressure exerted on the closure means, and in that the foldable zone is folded so as to bear on the closure means bottles and in that the packaging is recovered for possible further processing.
27. Procédé selon la revendication 25 ou 26, caractérisé en ce que le procédé est effectué en automatique. 27. The method of claim 25 or 26, characterized in that the method is carried out automatically.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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FR9509972A FR2738057B1 (en) | 1995-08-22 | 1995-08-22 | WATERPROOF PACKAGING FOR DRYING, ESPECIALLY LYOPHILIZATION, AND DRYING METHOD, ESPECIALLY LYOPHILIZATION, USING SUCH PACKAGING |
FR95/09972 | 1995-08-22 | ||
FR9608075A FR2740108B1 (en) | 1995-08-22 | 1996-06-28 | WATERPROOF PACKAGING FOR DRYING, ESPECIALLY LYOPHILIZATION, AND DRYING METHOD, ESPECIALLY LYOPHILIZATION, USING SUCH PACKAGING |
FR96/08075 | 1996-06-28 |
Publications (1)
Publication Number | Publication Date |
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WO1997008503A1 true WO1997008503A1 (en) | 1997-03-06 |
Family
ID=26232167
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/FR1996/001301 WO1997008503A1 (en) | 1995-08-22 | 1996-08-21 | Sealed packaging assembly useful for drying, particularly freeze-drying, and drying, particularly freeze-drying method using same |
Country Status (2)
Country | Link |
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FR (1) | FR2740108B1 (en) |
WO (1) | WO1997008503A1 (en) |
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EP0949150A2 (en) | 1998-04-09 | 1999-10-13 | Schott Glas | Container for freeze-drying and storing medical products |
EP1279913A1 (en) * | 2001-07-27 | 2003-01-29 | Steris GmbH | Chamber for freeze drying apparatus |
LU92648B1 (en) * | 2015-02-04 | 2016-08-05 | Project Pharmaceutics Gmbh | Method and device for optimized freeze-drying of a pharmaceutical product |
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GB0417309D0 (en) * | 2004-08-03 | 2004-09-08 | Micropharm Ltd | Freeze-drying apparatus |
US20240200871A1 (en) * | 2022-12-20 | 2024-06-20 | Teleflex Life Sciences Llc | Freeze-drying tray assembly |
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GB995930A (en) * | 1961-11-28 | 1965-06-23 | Leybold Hochvakuum Anlagen | Method of freeze drying |
US3564727A (en) * | 1969-03-03 | 1971-02-23 | Virtis Co Inc | Freeze dryer using an expendable refrigerant |
EP0343596A2 (en) * | 1988-05-26 | 1989-11-29 | Roche Diagnostics GmbH | Container for freeze drying under sterile conditions |
EP0413620A1 (en) * | 1989-08-16 | 1991-02-20 | Societe D'utilisation Scientifique Et Industrielle Du Froid Usifroid | Air-tight box for treating products |
WO1992018058A1 (en) * | 1991-04-12 | 1992-10-29 | Cryopharm Corporation | Blood bag for lyophilization |
-
1996
- 1996-06-28 FR FR9608075A patent/FR2740108B1/en not_active Expired - Fee Related
- 1996-08-21 WO PCT/FR1996/001301 patent/WO1997008503A1/en active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB995930A (en) * | 1961-11-28 | 1965-06-23 | Leybold Hochvakuum Anlagen | Method of freeze drying |
US3564727A (en) * | 1969-03-03 | 1971-02-23 | Virtis Co Inc | Freeze dryer using an expendable refrigerant |
EP0343596A2 (en) * | 1988-05-26 | 1989-11-29 | Roche Diagnostics GmbH | Container for freeze drying under sterile conditions |
EP0413620A1 (en) * | 1989-08-16 | 1991-02-20 | Societe D'utilisation Scientifique Et Industrielle Du Froid Usifroid | Air-tight box for treating products |
WO1992018058A1 (en) * | 1991-04-12 | 1992-10-29 | Cryopharm Corporation | Blood bag for lyophilization |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0949150A2 (en) | 1998-04-09 | 1999-10-13 | Schott Glas | Container for freeze-drying and storing medical products |
EP1279913A1 (en) * | 2001-07-27 | 2003-01-29 | Steris GmbH | Chamber for freeze drying apparatus |
WO2003012355A1 (en) * | 2001-07-27 | 2003-02-13 | Steris Gmbh | Chamber for a freeze-drying device |
US6920701B2 (en) | 2001-07-27 | 2005-07-26 | Steris Gmbh | Chamber for a freeze-drying device |
LU92648B1 (en) * | 2015-02-04 | 2016-08-05 | Project Pharmaceutics Gmbh | Method and device for optimized freeze-drying of a pharmaceutical product |
WO2016125095A1 (en) * | 2015-02-04 | 2016-08-11 | Project Pharmaceutics Gmbh | Method and device for optimized freeze-drying of a pharmaceutical product |
US10809002B2 (en) | 2015-02-04 | 2020-10-20 | Project Pharmaceutics Gmbh | Method and device for optimized freeze-drying of a pharmaceutical product |
Also Published As
Publication number | Publication date |
---|---|
FR2740108B1 (en) | 1998-03-27 |
FR2740108A1 (en) | 1997-04-25 |
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