EP3457062B1 - Poche et procédé de lyophilisation sans contamination d'une substance - Google Patents

Poche et procédé de lyophilisation sans contamination d'une substance Download PDF

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Publication number
EP3457062B1
EP3457062B1 EP18194693.0A EP18194693A EP3457062B1 EP 3457062 B1 EP3457062 B1 EP 3457062B1 EP 18194693 A EP18194693 A EP 18194693A EP 3457062 B1 EP3457062 B1 EP 3457062B1
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EP
European Patent Office
Prior art keywords
bag
freeze
storage compartment
substance
drying
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EP18194693.0A
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German (de)
English (en)
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EP3457062A1 (fr
Inventor
Rolf LENHARDT
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Individual
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Individual
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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
    • B65D31/12—Bags or like containers made of paper and having structural provision for thickness of contents with two or more compartments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D33/00—Details of, or accessories for, sacks or bags
    • B65D33/01—Ventilation or drainage of bags

Definitions

  • the invention relates to a bag and a method for the contamination-free freeze-drying of a substance in a bag, the bag having at least one vapor-permeable layer.
  • Freeze drying or lyophilization enables the preservation of numerous products, primarily from the fields of pharmacy, food industry and biology.
  • the process as such is well known in the art. Freeze-drying is being used more and more frequently, especially in the case of medicinal products, since this process can be used to extend its shelf life while maintaining the bioactivity of the medicinal products.
  • freeze drying measures must be taken to prevent contamination both before and during freeze drying in the freeze drying cabinet and after freeze drying.
  • freeze drying took place in open containers in a vacuum device (freeze dryer).
  • a vacuum device freeze dryer
  • the inside of the freeze dryer was first sterilized, for example with the help of steam or suitable chemicals.
  • steam or suitable chemicals for example.
  • a further development of the aseptic freeze-drying led to the use of bags that have securely closed the substance to be freeze-dried and thus protected against contamination.
  • the environment was also protected against contamination with the substance sealed in the bag, so that advantageously the inside of the freeze dryer did not have to be cleaned of the substance after it had been processed.
  • the bag includes an upper and a lower wall that are sealed at their edges to a peripheral side wall, thereby defining the inner volume of the bag.
  • sterile freeze-drying can be found in the US patent US 5,309,649 in which a container sealed with a vapor permeable membrane is disclosed in which the substance is freeze-dried in a non-sterile environment.
  • a further embodiment of a container for freeze-drying is of the US design US D430,939 , which has a rigid, fixed predetermined rectangular shape.
  • containers of the aforementioned type enables freeze-drying without contamination, but is associated with numerous disadvantages.
  • a prefabricated container sealed with a membrane has an already defined dimension (length x width x height) and therefore proves to be unsuitable with regard to the maximum area yield when it is used on storage areas in freeze dryers from different manufacturers, which is usually the case have different dimensions.
  • the use of the space available in a respective freeze dryer is very rarely optimal for a given container size, and if so, then mostly by chance.
  • the container dimensions could ideally always be individually adapted to the storage areas in a freeze dryer or containers of the aforementioned type would have to be provided which are variable in terms of their dimensions.
  • the freeze-dried substance material to be dried
  • the items to be dried are usually removed by opening them on the membrane or bottom side.
  • the membrane or the base film or the base is cut open with a scalpel or another suitable tool. With each cut, however, particles of the cut material are released. Since the container is always cut open above the material to be dried, it is inevitably contaminated by falling particles. To minimize the foreign particle entry, only a small opening can be provided through which the material to be dried can be removed.
  • a closure can already be provided on the container, for example a screw closure, through which the material to be dried can be removed without cutting the container open.
  • the disadvantage here is that in the joints between the membrane-based cover and the container wall to which the membrane-based cover is applied or at the undercut between the threaded connector and the container, residues of the drying material remain and represent a loss from the process perspective.
  • a pouch in which the substance to be freeze-dried is present.
  • a bag which has a laminate that is sterile at least in its partial area Has barrier layer that is permeable to water vapor, for example from the publication WO 96/31748 known.
  • the formulation is placed directly in the bag and freeze-dried in it.
  • the flexible nature of the bag means that the layer thickness of the substance to be dried is subject to variations. In particular, the layer thickness decreases towards the edge, since the bag has a natural bend towards the seam towards its edges, ie away from the footprint on which it is placed (see FIGS. 4 and 6 in WO 96/31748 ).
  • a pouch for contamination-free freeze-drying of a substance which has a top and a bottom, the top having a vapor-permeable film. Furthermore, the bag has at least three side surfaces, which are arranged between the top side and the bottom side, wherein a joint is arranged between two laterally adjacent side surfaces, which extends from the bottom side to the top side.
  • the bag according to the invention also has a storage compartment which has an upper side and a lower side, both of which have a vapor-impermeable film, the storage compartment being able to be attached to a side surface of the bag from the outside and its interior communicating with the interior of the bag.
  • the storage compartment can correspond to a flat bag that prefers to a side surface of the bag is arranged.
  • the width of the storage bag can correspond to the width of a side surface, but it can also be smaller.
  • the top of the storage compartment can be joined with an upper film part of the corresponding side surface, while the underside of the storage compartment can be joined with a lower film part of the same side surface, wherein the joining can be done by welding.
  • the storage compartment can be used to store the freeze-dried substance after freeze-drying.
  • the storage compartment can also be attached to the underside of the bag instead of to a side surface.
  • the top of the bag according to the invention has a water vapor or gas permeable film or membrane which is also germ-tight (i.e. bacteria-retaining).
  • the top of the bag can consist entirely of the vapor-permeable film, so that the vapor-permeable film is joined to the side surfaces at the edge of the bag, for example by means of a weld seam.
  • only a partial area of the upper side can have the vapor-permeable film, for example a central area of the upper side, and the edge area of the upper side of the bag can have a different, not necessarily water vapor or gas permeable (but germ-tight) material, for example a water vapor or gas impermeable film.
  • the underside and at least part of the side surfaces of the bag according to the invention can have or consist of a water vapor or gas impermeable film or membrane, for example a polypropylene film.
  • the vapor-permeable film can be, for example, a membrane made of expanded polytetrafluoroethylene (PTFE) with a laminated nonwoven made of polypropylene (PP).
  • PTFE polytetrafluoroethylene
  • PP polypropylene
  • the substance can be any formulation, for example a pharmaceutical solution or another liquid mixture, which is to be processed by freeze-drying.
  • the substance can be introduced into the bag under sterile conditions and sealed.
  • the bag can be designed to form a three-dimensional body and the joints can represent edges of the three-dimensional body.
  • these joints can be referred to as vertical (vertically running) joints.
  • the bag can, for example, be set up to take the shape of a triangular prism.
  • the bottom and top can expediently have the same basic shape.
  • the bag can have four side surfaces and can be configured to take the shape of a cuboid or cube.
  • the bag can correspond to a three-dimensional body of any shape.
  • the bag can assume its "native" three-dimensional shape, for example by inflation, and depending on the size of the bag and the rigidity of the joints, the bag can essentially maintain this shape, even if a pressure equalization between its interior and the surroundings can take place.
  • the bag By forming joints that are essentially perpendicular to the underside and possibly also to the top of the bag, the bag can be given a three-dimensional, angular shape. When empty, the stiffness of the joints can be sufficient to give the bag its inherent three-dimensional shape.
  • the three-dimensional basic shape of the bag according to the invention makes it possible for the substance to be freeze-dried which is filled therein to have an essentially identical fill level over its entire volume.
  • the joints act as shaping structures, which give the bag its three-dimensional shape.
  • a joint can be arranged between two side surfaces.
  • a joint can therefore correspond to an edge of the three-dimensional bag.
  • the joints can all be of the same length and thus define the height of the bag. However, it is by no means necessary for all the joining points or edges of the bag to be of the same length, even if it is an embodiment which is expedient from a possible way of producing the bag.
  • the joints can have weld seams.
  • the bag according to the invention can be produced, for example, from a flat bag by appropriately folding the flat bag and welding its corner regions. The protruding triangular corner sections of the folded flat bag can then be separated from it. The locations along which the protruding corner sections of the folded flat bag are separated from this then correspond to the joints of the side surfaces of the bag, which also represent (side) edges of the bag.
  • the vapor-permeable film can extend over the entire top of the bag, so that the joints extend from the bottom of the bag to the vapor-permeable film.
  • the joints e.g. weld seams
  • Such an embodiment of the bag can be produced from a flat bag with an upper and lower side, in which the vapor-permeable membrane is arranged as a window in the upper side of the flat bag.
  • the vapor-permeable membrane can be joined, for example welded, to the material of the upper side which surrounds it and which, for example, can be vapor-impermeable.
  • the vapor-permeable membrane with its nonwoven carrier can preferably face the surrounding film (for example made of polypropylene) with which it is welded, the functional membrane being able to be arranged, for example, on the inside of the bag .
  • the nonwoven backing can be, for example, a grid or fabric made of polypropylene or another plastic such as polyethylene or polyester.
  • the vapor-impermeable film which surrounds the membrane can, for example, have polyethylene, polyester or co-extruded films with two or more layers or consist of one of these materials. Both surfaces, which are joined together by welding, can preferably consist of the same material, for example polypropylene.
  • At least one of the side surfaces can have two film parts which are joined together by means of a further joint, which preferably runs from one vertical edge to the other vertical edge of the corresponding side surface.
  • This further joint which runs between two film parts of a side surface (and not between directly adjacent side surfaces), can be referred to as horizontal (horizontally running) joints.
  • This embodiment can result quite naturally from the production of the bag according to the invention from a flat bag, the further joint (e.g. weld seam) corresponding to the joint between the top and bottom of the flat bag and running parallel to the bottom and / or top of the bag.
  • the upper side and a part of at least one of the side surfaces adjoining the surface can have the vapor-permeable film.
  • the vapor-permeable film can extend seamlessly over an upper edge between the upper side and the side surface.
  • the vapor-permeable film can extend to the further joint of the corresponding side surface.
  • the upper part of the bag which is separated from the lower part of the bag by the further joining points, can have or consist of the vapor-permeable film.
  • the top of the bag may correspond to the top half of the bag. This means that the other joints can run centrally through the side surfaces of the bag.
  • the bag can furthermore have an access opening through which the substance can be filled into the bag, wherein the access opening can preferably be arranged on a side surface of the bag.
  • the access opening can be formed, for example, by an incomplete sealing / assembly along a further joint. In other words, the access opening can be formed between two film parts of one side surface.
  • a filler neck (filling / removal funnel) can be attached to the access opening of the bag, for example by welding.
  • the filler neck can be used, for example, to introduce and remove the substance into or out of the bag by means of a suction lance.
  • the filler supports can be made, for example, from a flat bag with a flat dimension of 5 cm, so that it has a diameter of approximately 1.6 cm.
  • the filler neck and the side surface of the bag to which it is attached can have or consist of the same material, for example polypropylene.
  • the opening of the filler neck can be welded or the filler neck can be closed / sealed by means of a folding / labyrinth / roll / zipper / Velcro sealing method or another suitable method.
  • the bag can have a holding structure which is set up to support a lower part of the bag.
  • the holding structure can be used in particular when the bag is large. In the case of large bags (for example from a side surface length of 0.5 m), the side surfaces may bulge outward from the substance filled into the bag.
  • the holding structure can be made of a plastic suitable for vacuum applications and comprise a lower part of the bag according to the invention, for example a part of the bag up to the level to which it is filled with the substance, and thus prevent the bulging of the side surfaces. This prevents a rounding off of the shape which the bag assumes in a top view, which under certain circumstances can lead to poorer exploitation of the space in the freeze dryer.
  • the holding structure can, for example, have a base area which essentially corresponds to the underside of the bag. Furthermore, the holding structure can have lateral holding elements which, for example, protrude perpendicularly from its base plate. Overall, the holding structure can have a shell shape or frame shape (without bottom), both the bottom of the shell shape and the lateral holding elements for the shell and frame shape can be structured and can have, for example, a grid or mesh structure.
  • a method for freeze-drying a substance in the bag according to the invention comprises: providing the substance in the pouch, sealing the pouch; Freeze-drying the substance present in the bag in a freeze dryer and decanting the freeze-dried substance from the bag into the storage compartment, which has an upper side and a lower side, both of which have a vapor-impermeable film, and is attached from the outside to a side surface of the bag, with the The interior of the storage compartment communicates with the interior of the bag.
  • the freeze-dried substance which is then in powder form, can be transferred from the bag into the storage compartment without contamination, in particular without having to open the outer casing of the bag and / or the storage compartment.
  • the method can furthermore have the storage compartment disconnected from the bag by means of a clamp closure.
  • the method can furthermore fold the clamped storage compartment so that the total contact area of the bag together with the storage compartment attached to it is reduced.
  • the folding of the clamped-off storage compartment can, for example, include rolling up, the rolled-up storage compartment additionally being fixed to the clamp closure.
  • the clamp closure can have, for example, two straight arms which are coupled to one another on a hinge and between which the top and bottom of the storage compartment can be clamped.
  • the clamp closure can have holding parts which are set up to accommodate the rolled-up storage compartment. As a result, the storage compartment can be compressed in a space-saving manner, so that the bag occupies a minimal space in the freeze dryer.
  • this can further comprise removing the clamp closure after freeze-drying in order to transfer the freeze-dried substance from the bag into the storage compartment.
  • the transfer of the dried substance takes place without tearing / opening the bag, ie in the sealed / closed state of the bag and thus free of contamination.
  • the transfer process can be carried out by changing the position of the bag so that the freeze-dried substance (which is then in powder form) is transferred from the bag to the storage compartment by gravity and by shaking the bag.
  • the method can further comprise airtight sealing of the storage compartment containing the freeze-dried substance with respect to the bag and subsequent separation of the storage compartment from the bag.
  • the clamp closure used in advance to separate the storage compartment from the bag can be used. After the freeze-dried substance has been transferred from the bag into the storage compartment and the transition between the bag and the storage compartment has been disconnected, the freeze-dried substance is sealed in a sterile and airtight manner in the storage compartment, so that the bag can be safely separated from it.
  • the clamp closure constitutes a barrier and seals the contents of the storage compartment securely and airtight and therefore protects in particular from contamination with foreign particles.
  • the bag that is no longer required can therefore be separated without any special safety or sterility precautions, in particular under non-clean room conditions.
  • a second clamp closure can be attached to the storage compartment, the second clamp closure being attached at a location between the first clamp closure and the transition from the storage compartment to the bag, for example as close as possible to the first clamp closure.
  • the top of the side of the bag (without storage compartment) is referred to, which at least partially consists of the vapor-permeable membrane, which is a gas and in particular Permits water vapor exchange with the environment.
  • the underside of the bag means the side which is arranged opposite the top and is in contact with the volume of the substance filled into the bag.
  • FIG. 1 One embodiment of the bag 1 according to the invention for contamination-free freeze-drying is illustrated.
  • the exemplary bag 1 has the shape of a cuboid and is shown in an empty state.
  • the bag 1 has an upper side 2 and a lower side 3, between which four side surfaces (a first side surface 4, a second side surface 5, a third side surface 6 and a fourth side surface 7) are arranged.
  • the side surfaces 4, 5, 6, 7 are each joined together in pairs by means of a joint.
  • first side surface 4 is joined to the second side surface 5 by means of a first joint 8
  • second side surface 5 is joined to the third side surface 6 by means of a second joint 9
  • third side surface 6 is joined to the fourth side surface 7 by means of a third joint 10 joined together
  • fourth side surface 7 is finally joined to the first side surface 4 by means of a fourth joint 11.
  • each of the joints 8, 9, 10, 11 extends vertically at a substantially right angle from the bottom 3 of the bag to its top 2, the angle between the top 2 and the joints 8, 9, 10, 11 is essentially 90 °.
  • the joints 8, 9, 10, 11 thus correspond to side edges of the three-dimensional bag 1 and are designed as weld seams.
  • Each joint 8, 9, 10, 11 and each side part 4, 5, 6, 7 has the same height, which also corresponds to the height H of the bag.
  • the bag 1 has additional joints.
  • the top 2 which in the exemplary embodiment shown is made entirely of the water-vapor-permeable membrane material, is fastened along its edges to the side surfaces 4, 5, 6, 7 by means of upper joints 17.
  • the membrane material ie the top 2 of the bag 1 can be arranged as a window in a corresponding side of the tubular bag.
  • the upper joints 17 then correspond to joints by means of which the membrane material is joined to the side surfaces 4, 5, 6, 7 of the bag 1.
  • each side surface 4, 5, 6, 7 has a further joint 16, which runs centrally and horizontally between two adjacent joints relative to the associated side surface.
  • Two opposing further joining points 16 and, in addition, a further (then left or right) joining point can correspond to joining points by means of which an upper side of a flat bag is joined to the underside thereof, assuming a flat bag that is only opened to one side. This means that these three further joining points 16 can already be present in the starting product from which the three-dimensional bag 1 can be produced. The remaining fourth of a total of four further joining points 16 can be formed during the production of the three-dimensional bag 1. Each side surface 4, 5, 6, 7 is divided into two parts or partial foils by the further joining points 16. In Fig.
  • the vertical extent of the first, upper part of the fourth side surface 6 being identified by a first double arrow 13 (hereinafter, the first, upper part of the fourth side surface 6 is identified by the reference symbol 13 associated) and the vertical extent of the second, lower part of the fourth side surface 6 is identified by a first double arrow 12 (hereinafter, the second, lower part of the fourth side surface 6 is associated with the reference symbol 12).
  • first, upper part 13 can correspond to a part or top of the flat bag or tubular bag
  • the second, lower part 12 can correspond to a part of the underside of the flat bag or tubular bag.
  • the embodiment shown can additionally have parts of the side surfaces 4, 5, 6, 7 a vapor-permeable membrane, for example the first, upper parts 13 of the side surfaces 4, 5, 6, 7.
  • the three-dimensional bag 1 is manufactured from a flat bag, the top side of which, for example consists entirely of the vapor-permeable membrane.
  • the first upper part 13 corresponds to a side surface (for example the second side surface 5), the top side 2 and the first upper part 13 of an opposite side surface (for example the fourth side surface 7) just this top of the flat bag.
  • the further joining points 16 of the second and fourth side surfaces 5, 7 represent boundary lines between the vapor-impermeable film and the vapor-permeable film.
  • the latter has an access opening 14.
  • the access opening is arranged at the end of a filler neck 15 which is attached to the bag 1.
  • the filler neck 15 can be attached to the bag 1, for example in the form of a correspondingly shaped flat bag in the region of the further joint 16 of one of the side surfaces 4, 5, 6, 7.
  • the top of the filler neck 15 can be joined to the first, upper part 13 of the first side face 4 and the bottom of the filler neck 15 can be joined to the second, lower part 12 of the first side face 4.
  • the filler neck 15 is in Fig. 1 in a shape tapering from the side surface of the bag 1 to its inlet opening 15, which is an optional feature. At the transition from the side surface of the bag 1 to the filler neck 15, this can also be wider or narrower than shown.
  • FIG Figure 2 Another embodiment of the bag 1 is shown in FIG Figure 2 shown. Since the bag 1 except for the storage compartment 20 additionally attached to it in the Figure 1 bags shown, are already based on Figure 1 explained characteristics of the bag in Figure 2 do not describe again. Compared to the representation in Figure 1 the top 2 is only shown in part in order to better illustrate the interface between the bag 1 and the storage compartment 20.
  • the storage compartment 20 can, for example, correspond to a flat bag which has an upper side 21 and a lower side 22. Both sides of the bag can have a vapor impermeable film.
  • the storage compartment 20 is fastened to the third side surface 6. Alternatively, it can be attached to any further side surface 4, 5, 7 or else to an opening provided in the underside 3 of the bag 1.
  • the storage compartment 20 is attached to the bulge 1 in a manner similar to that of the filler neck 15, that is to say in the region of the further joint 16 of the third side surface 6.
  • the storage compartment 20 can also be attached to other locations on the side surfaces 4, 5, 6, 7 be, in which case corresponding openings in the side surfaces 4, 5, 6, 7 can be provided.
  • the receiving compartment 20 can be used to store the substance in an airtight and germ-free manner after freeze-drying has taken place.
  • the latter can be clamped from the bag 1 by means of the clamp closure and at the same time sealed airtight, for example at the location of the receiving compartment 20 indicated by the arrows 23 and has aseptically sealed freeze-dried substance, can then be separated from the bag 1.
  • a second clamp closure can be attached to the storage compartment 20 between the location of the first clamp closure (indicated by arrows 23) and the transition from the storage compartment 20 to the bag 1. The bag 1 can then be separated from the storage compartment 20 at a location between the first and the second clamp closure.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)
  • Bag Frames (AREA)

Claims (14)

  1. Poche (1) pour une lyophilisation sans contamination d'une substance, comportant:
    une face supérieure (2) et une face inférieure (3), dans laquelle la face supérieure (2) comporte un film perméable à la vapeur qui est également étanche aux germes;
    au moins trois faces latérales (4-7) agencées entre la face supérieure (2) et la face inférieure (3);
    dans laquelle entre deux faces latérales (4-7) latéralement adjacentes un point de jointure (8-11) chacun est agencée s'étendant de la face inférieure (3) jusqu'à la face supérieure (2); et
    un compartiment de conservation (20) comportant une face supérieure (21) et une face inférieure (22), les deux comportant un film imperméable à la vapeur, dans lequel le compartiment de conservation (20) est ajouté de l'extérieur à une face latérale (4-7) de la poche (1) et son intérieur est en communication avec l'intérieur de la poche (1).
  2. Poche selon la revendication 1, dans laquelle la poche (1) est adaptée pour former un corps tridimensionnel et les points de jointure (8-11) représentent des arêtes du corps tridimensionnel.
  3. Poche selon la revendication 1 ou 2, dans laquelle les points de jointure (8-11) définissent la hauteur (H) de la poche (1).
  4. Poche selon l'une quelconque des revendications 1 à 3, dans laquelle la poche (1) comporte quatre faces latérales (4-7).
  5. Poche selon l'une quelconque des revendications 1 à 4, dans laquelle le point de jointure (8-11) comporte une soudure.
  6. Poche selon l'une quelconque des revendications 1 à 5, dans laquelle le film perméable à la vapeur s'étend sur toute la face supérieure (2) de la poche (1) de sorte que les points de jointure (8-11) s'étendent de la face inférieure (3) jusqu'au film perméable à la vapeur.
  7. Poche selon l'une quelconque des revendications 1 à 6, dans laquelle au moins l'une des faces latérales (4-7) comporte deux films (12, 13) qui sont joints au moyen d'un autre point de jointure (8-11) qui s'étend de préférence d'un bord vertical à l'autre bord vertical de la face latérale (4-7) correspondante.
  8. Poche selon l'une quelconque des revendications 1 à 7, dans laquelle la face supérieure (2) et une partie (13) adjacente à la surface de l'au moins une des faces latérales (4-7) comporte le film perméable à la vapeur.
  9. Poche selon l'une quelconque des revendications 1 à 8, comportant en outre:
    un orifice d'accès (14) par lequel la substance peut être versée dans la poche (1), dans lequel l'orifice d'accès (14) est agencé de préférence sur une face latérale (4-7) de la poche (1).
  10. Procédé pour une lyophilisation sans contamination d'une substance dans la poche selon l'une quelconque des revendications 1 à 9, dans lequel le procédé comporte les étapes suivantes:
    fournir la substance dans la poche (1);
    sceller la poche (1);
    lyophiliser la substance existant dans la poche (1) dans un lyophilisateur;
    transvaser la substance lyophilisée de la poche (1) dans le compartiment de conservation (20).
  11. Procédé selon la revendication 10, comportant en outre:
    déconnecter le compartiment de conservation (20) de la poche (1) au moyen d'une fermeture à serrage.
  12. Procédé selon la revendication 10 ou 11, comportant en outre:
    plier le compartiment de conservation (20) déconnecté de sorte qu'une surface d'appui totale de la poche (1) ensemble avec le compartiment de conservation (20) y ajouté est réduite.
  13. Procédé selon l'une quelconque des revendications 10 à 12, comportant en outre:
    enlever la fermeture à serrage après la lyophilisation pour transvaser la substance lyophilisée de la poche (1) dans le compartiment de conservation (20).
  14. Procédé selon l'une quelconque des revendications 10 à 13, comportant en outre:
    fermer hermétiquement le compartiment de conservation (20) contenant la substance lyophilisée vis-à-vis la poche (1); et
    séparer le compartiment de conservation (20) de la poche (1).
EP18194693.0A 2017-09-18 2018-09-17 Poche et procédé de lyophilisation sans contamination d'une substance Active EP3457062B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102017121537.9A DE102017121537A1 (de) 2017-09-18 2017-09-18 Beutel und Verfahren zur kontaminationsfreien Gefriertrocknung einer Substanz

Publications (2)

Publication Number Publication Date
EP3457062A1 EP3457062A1 (fr) 2019-03-20
EP3457062B1 true EP3457062B1 (fr) 2020-04-22

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP18194693.0A Active EP3457062B1 (fr) 2017-09-18 2018-09-17 Poche et procédé de lyophilisation sans contamination d'une substance

Country Status (4)

Country Link
EP (1) EP3457062B1 (fr)
DE (1) DE102017121537A1 (fr)
ES (1) ES2807076T3 (fr)
PT (1) PT3457062T (fr)

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Publication number Priority date Publication date Assignee Title
US5309649A (en) 1988-05-26 1994-05-10 Boehringer Mannheim Gmbh Process and container for freeze drying under sterile conditions
US4973327A (en) * 1989-11-01 1990-11-27 Cryopharm Blood bag for lyophilization
US5257983A (en) * 1991-04-12 1993-11-02 Cryopharm Corporation Blood bag for lyophilization
US6620436B1 (en) * 1991-10-09 2003-09-16 Lectec Corporation Mixing and dispensing package for a wound dressing
DE9407863U1 (de) * 1993-05-19 1994-07-14 Helvoet Pharma Belgium N.V., Alken Beutel zur Aufnahme und Sterilisation von medizinischen Geräten
AU4755196A (en) 1995-04-07 1996-10-23 W.L. Gore & Associates, Inc. A freeze-drying bag and method for minimizing contamination of freeze-dried products
DE29802833U1 (de) * 1998-02-19 1998-05-07 Imer, Rodney Haydn, Barcelona, Vallvidrera Verbundfolie, insbesondere zur Herstellung von Verpackungsbeuteln, sowie aus einer derartigen Verbundfolie hergestellter Verpackungsbeuteln
USD430939S (en) 1999-02-11 2000-09-12 Gore Enterprise Holdings, Inc. Lyophilization container
US20050092636A1 (en) * 2003-10-31 2005-05-05 Wu Su-Syin Sterilization packaging
US20050268573A1 (en) * 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
DE202010001261U1 (de) * 2010-01-22 2010-05-06 Mondi Ag Kunststofffolienbeutel mit Relief
DE202010010331U1 (de) * 2010-07-17 2011-11-24 Bischof + Klein Gmbh & Co. Kg Sterilisierbarer Polyolefinbeutel
DE102011001816B4 (de) * 2011-04-05 2016-11-17 Nordenia Technologies Gmbh Flachgelegter Beutel aus einem flexiblen, siegelfähigen Material zur Verwendung als Verpackung
DE102014105787A1 (de) * 2014-04-24 2015-10-29 Schott Ag Verpackungseinheit für ein pharmazeutisches, medizinisches oder kosmetisches Objekt und Verfahren zum Sterilisieren eines in der Verpackungseinheit anordenbaren pharmazeutischen, medizinischen oder kosmetischen Objekts

Non-Patent Citations (1)

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Title
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Also Published As

Publication number Publication date
ES2807076T3 (es) 2021-02-19
DE102017121537A1 (de) 2019-03-21
PT3457062T (pt) 2020-07-23
EP3457062A1 (fr) 2019-03-20

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