EP3268291B1 - Vorrichtung zum fördern eines beutels mit einem biopharmazeutischen fluid und systeme und verfahren mit verwendung davon - Google Patents

Vorrichtung zum fördern eines beutels mit einem biopharmazeutischen fluid und systeme und verfahren mit verwendung davon Download PDF

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Publication number
EP3268291B1
EP3268291B1 EP16715005.1A EP16715005A EP3268291B1 EP 3268291 B1 EP3268291 B1 EP 3268291B1 EP 16715005 A EP16715005 A EP 16715005A EP 3268291 B1 EP3268291 B1 EP 3268291B1
Authority
EP
European Patent Office
Prior art keywords
inner bag
protective element
outer receptacle
wall
biopharmaceutical fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP16715005.1A
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English (en)
French (fr)
Other versions
EP3268291A1 (de
Inventor
Stéphane BAUD
Isabelle Gay
Danilo PONASSI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sartorius Stedim FMT SAS
Original Assignee
Sartorius Stedim FMT SAS
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Filing date
Publication date
Application filed by Sartorius Stedim FMT SAS filed Critical Sartorius Stedim FMT SAS
Publication of EP3268291A1 publication Critical patent/EP3268291A1/de
Application granted granted Critical
Publication of EP3268291B1 publication Critical patent/EP3268291B1/de
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Classifications

    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/06—Liquids or semi-liquids or other materials or articles enclosed in flexible containers disposed within rigid containers
    • 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
    • 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
    • B65D3/00—Rigid or semi-rigid containers having bodies or peripheral walls of curved or partially-curved cross-section made by winding or bending paper without folding along defined lines
    • B65D3/02—Rigid or semi-rigid containers having bodies or peripheral walls of curved or partially-curved cross-section made by winding or bending paper without folding along defined lines characterised by shape
    • 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
    • B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
    • B65D35/02—Body construction
    • B65D35/04—Body construction made in one piece
    • B65D35/08—Body construction made in one piece from plastics material
    • 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
    • B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
    • B65D35/24—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices
    • B65D35/26—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices for filling
    • 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
    • B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
    • B65D35/24—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices
    • B65D35/28—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices for expelling contents
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/02—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage
    • B65D81/05—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents
    • B65D81/051—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents using pillow-like elements filled with cushioning material, e.g. elastic foam, fabric
    • B65D81/052—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents using pillow-like elements filled with cushioning material, e.g. elastic foam, fabric filled with fluid, e.g. inflatable elements
    • 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
    • B65D2581/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D2581/02—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage
    • B65D2581/05—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents
    • B65D2581/051—Details of packaging elements for maintaining contents at spaced relation from package walls, or from other contents

Definitions

  • the invention relates to the field of receiving, storing and transporting biopharmaceutical fluid.
  • the invention relates, more specifically, to a device for storage and transport, in particular a device specifically intended for transport.
  • the invention also relates to a system for receiving and transferring a biopharmaceutical fluid comprising such a device, and to a method for receiving and transferring under controlled pressure a biopharmaceutical fluid, in which such a system is implemented. .
  • Biopharmaceutical fluid means a product derived from biotechnology (culture media, cell cultures, buffer solutions, artificial nutrition liquids, blood products and derivatives of blood products) or a pharmaceutical product or, more generally, a product intended to be used in the medical field. Such a product is in liquid form, pasty, or possibly powdery. The invention also applies to other products but subject to similar requirements as regards their packaging.
  • a device comprises a rigid container in which one or more pockets filled with biopharmaceutical fluid are placed.
  • the device thus allows to maintain and protect the pocket or pockets during transport.
  • significant stresses can be generated in the pocket, for example due to movements of the biopharmaceutical fluid within it.
  • the bag comprises rigid elements, such as ports or connectors of filling or emptying tubes, they may strike the inner wall of the container in case of shock, vibration or turbulence when transport operations.
  • Such stresses may exert a significant mechanical stress on the wall of the pocket, in particular at the locations of fixing the rigid pipes to the wall of the pocket, sufficient to cause rupture of the pocket or damage that could compromise its integrity.
  • the device may further comprise bubble wrap and / or foam disposed on the inner wall of the rigid container to prevent shocks between the bag and the container during transport operations.
  • containers of standard sizes that may be suitable for carrying flexible pockets of various sizes.
  • a free space remains between the inner wall of the container and the pocket so that the pocket is not properly maintained. This can also take place when the container is adapted for a flexible pocket size having a certain predefined fill level but the pocket is under filled or filled with respect to this predefined fill level. The bag is then likely to move in the container under the effect of external constraints and may break by striking the wall of the container.
  • the device may consist of a protective shell in which the bag is suspended and is therefore spaced from the inner wall of the shell.
  • a protective shell in which the bag is suspended and is therefore spaced from the inner wall of the shell.
  • US4857055 discloses a device in which a pouch containing a liquid to be dispensed is placed in a container.
  • the pocket has a drain tube that extends out of the container.
  • Inflatable elements surround the pouch and serve to compress it during emptying.
  • the invention relates to a device for transporting a biopharmaceutical fluid according to claim 1.
  • the bag can be maintained in the outer container and it is possible to better distribute the mechanical stresses experienced by the bag during storage or transport in the container.
  • the invention also relates to a system for the reception and transfer under controlled pressure of a biopharmaceutical fluid according to claim 12.
  • the invention also relates to methods for receiving and transporting a biopharmaceutical fluid according to claims 13 and 14.
  • the invention also relates to a method for receiving and transferring a biopharmaceutical fluid according to claim 15.
  • the invention relates to a device 1 for the storage and transport of a biopharmaceutical fluid 2 (said device 1 is hereinafter referred to as "device").
  • the device 1 comprises an inner bag 3 and an outer container 4.
  • the inner pocket 3 is flexible and waterproof.
  • the inner pocket 3 is formed from a wall 5 made of plastic.
  • the wall 5 forms and delimits an inner enclosure 6, which can be flat ( figure 10A ) or deployed in volume ( Figures 10B and 10C for example) and which is suitable and intended to receive biopharmaceutical fluid 2.
  • the inner pocket 3 is of the 2D type, that is to say in two dimensions, and has a wall 5 comprising two large wall portions 28, opposite to each other, sealed together by welding or similar, on a common peripheral side edge 30 which is also the peripheral lateral edge of the inner pocket 3.
  • the inner pocket 3 can also be of 3D type, that is to say in three dimensions generally of parallelepipedal shape.
  • the inner pocket 3 then typically comprises a main wall 41 in two parts fixedly connected and sealed to two side gussets 46a, 46b by sealed seals.
  • the inner pocket 3 deployed has a capacity of between 1 liter and 70 liters, in particular between 1 and 55 liters, and this according to the needs and applications.
  • the inner bag 3 is provided with an orifice, that is to say a filling passage 7 with the biopharmaceutical fluid 2 and an orifice, that is to say a drain passage
  • the filling orifice 7 and the emptying orifice 8 are situated in the vicinity of each other on the wall 5 of the inside pocket 3 or at the level of the peripheral lateral edge. common 30.
  • a filling tube 9 having, on the opposite side, an inlet of filling 10 of the inner chamber 6 with the biopharmaceutical fluid 2 and a discharge tube 11 having opposite a discharge outlet 12 of the chamber 6 of the biopharmaceutical fluid 2.
  • the inner bag 3 may comprise a single fill and drain port.
  • a single tube acting as filling tube and emptying tube of the biopharmaceutical fluid chamber 6 is then associated by a sealed connection to the orifice of the inner bag 3.
  • the inner bag 3 may comprise more than two filling and emptying holes, and therefore more than two filling and / or emptying tubes.
  • sealed connection is meant an already known structure such as the wall 5 of the inner bag 3 and the tube 9, 11, in fluid communication with the orifice 7, 8, are associated with each other so that, at the same time , not to allow a passage at the level of the link between them, in particular for the biopharmaceutical fluid 2 or a gas or possible contaminants.
  • the wall 5 of the inner bag 3 and the tubes 9, 11 may in particular form a solid integral inseparable or be interconnected by connection systems.
  • Tube means a hollow structure of shorter or longer length, the term also including a single port.
  • the outer container 4 comprises at the very least an outer receptacle 13.
  • the outer receptacle 13, made of plastic or other synthetic or metallic material, can be formed from a wall 14, or even of several pieces in the general form of solid panels. or substantially flat or substantially planar, as well as connecting, reinforcing, accessories, etc.
  • the receptacle 13 may in particular consist of a box or a rigid or semi-rigid shell.
  • rigid or semi-rigid is meant that the outer receptacle 13 has a rigidity greater than that of the wall 5 of the inner pocket 3.
  • the outer receptacle 13 has a parallelepipedal shape and the wall 14 comprises a bottom wall 14a, an upper wall 14b and a lateral peripheral wall 14c erected in four panels two by two perpendicular or parallel to each other.
  • the bottom wall 14a and the top wall 14b are arranged horizontally or substantially horizontally while the lateral peripheral wall 14c is disposed vertically or substantially vertically, possibly slightly flared from the bottom transverse wall 14a.
  • the description is made in connection with this situation. It is also with reference to this situation that the words “horizontal”, “vertical”, “inferior”, “superior” must be understood.
  • the outer receptacle 13 comprises a single wall 14 foldable, for example cardboard, adapted to form once folded an outer receptacle 13 of parallelepiped shape, the wall 14 then comprising at least one bottom wall 14a and a side peripheral wall 14c.
  • the wall 14 of the outer receptacle 13 thus forms an outer enclosure 15.
  • the lateral peripheral wall 14c may also comprise an opening 29a ( figures 12 , 13A and 13B ) can be selectively opened or closed, for example by a cover 35.
  • the opening 29a consists of one of the panels of the lateral peripheral wall 14c which can be either in a closed state or in an open state in which the panel is inclined outwardly of the receptacle 13. In this open state, it it is thus possible to access the interior of the outer receptacle 13.
  • the upper wall 14b of the outer receptacle 13 is open, and may in particular comprise an opening 29b.
  • a cover (not shown on the Figures 13A and 13B ) makes it possible to close the upper wall 14b of the outer receptacle 13.
  • the lid may be provided with gripping and handling members covering the opening 29b. If necessary, there are provided quick locking elements of the lid in the closed position, obscuring the opening 29b. The opening thus provides access to the interior of the outer receptacle 13.
  • the outer receptacle 13 may comprise a single foldable wall 14, which once folded comprises, in addition to a bottom wall 14a and a side wall 14c, also an upper wall 14b.
  • the upper wall 14b can be removable so as to be alternately closed or open.
  • the outer receptacle 13 of the outer container 4 is adapted and intended to receive the inner pocket 3 (and thus the inner enclosure 6) in its entirety.
  • the inner pocket 3 (and thus the inner chamber 6) is placed entirely in the, that is to say inside the, outer receptacle 13 and the outer enclosure 15, or symmetrically, the receptacle 13 is placed so as to surround on the outside the inner bag 3 (and therefore the inner chamber 6).
  • the outer receptacle 13 is larger than the inner pocket 3 or symmetrically the inner pocket 3 is smaller than the receptacle 13.
  • the inner bag 3 is empty of biopharmaceutical fluid 2 or is filled with biopharmaceutical fluid 2
  • the outer container 4, and in particular the outer receptacle 13, can in particular be of large capacity to be able to receive a large quantity of inner pockets 3 filled with biopharmaceutical fluid 2.
  • the container 4 can in particular receive more than an inner pocket 3 or even more than five inside pockets 3, or even more than ten inside pockets 3.
  • the outer receptacle 13 is at least partly transparent or translucent so as to enable the inside pocket 3 to be viewed through its wall 14.
  • the receptacle 13 can also be at least partly, or even all, opaque to light or ultraviolet, for example to ensure optimal conservation of the biopharmaceutical product 2, especially if the biopharmaceutical product 2 is a photosensitive product.
  • an expandable protection element 16 is provided between the outer receptacle 13 of the outer container 4 and the inner pocket 3.
  • the expandable protection element 16 is able to be in two states, an expanded state and a non-state. expanded.
  • the expandable protection member 16 In the expanded state, the expandable protection member 16 is deployed in volume.
  • the inner bag 3 is then held in the outer receptacle 13, and the outer receptacle 13 is entirely occupied by the protective element 16 and the inner bag 3.
  • the expandable protective element 16 substantially surrounds the inner bag 3, that is to say that the majority of the wall 5 of the inner bag 3 is in contact with the expandable protection element 16.
  • the protective element 16 In the unexpanded state, the protective element 16 is not deployed in volume, and the space included in the outer receptacle 13 is at least partially unoccupied.
  • the protective element 16 when expanded can substantially fill the space between the inner pocket 3 and the wall 14 of the receptacle 13.
  • the expandable protection element 16 ensures the maintenance of the internal pocket 3 by compressing it, in particular in several directions, in the outer receptacle 13. It is furthermore possible to dispense with the variable dimensions of the inner bag 3 as a function of its level of filling with biopharmaceutical fluid 2, by adapting the expansion of the expandable protection element 16.
  • the device 1 is also in an intermediate state in which the inner bag 3 is placed in volume, being filled with biopharmaceutical fluid 2, while the expandable protection element 16 is in a non-expanded state. Conversely, it is also possible that the device 1 is in an intermediate state in which the expandable protection element 16 is in the expanded state while the inner bag 3 is empty of biopharmaceutical fluid 2.
  • the outer receptacle 13 must always fulfill a function of confinement and external restraint of the inner pocket 3 and the protective element 16, which requires that the expansion capacity of the outer receptacle 13 when the protective element 16 is in the expanded state, is limited, especially very low. This can be obtained by the choice of rigid or semi-rigid wall 14 of the receptacle 13.
  • the expandable protection element 16 may comprise a material in fluid form, for example a foam, adapted to deploy in volume, especially when it is subjected to certain particular conditions.
  • the expandable protection element 16 may be an expandable fluid whose expansion is effected by drying, by heat, chemical or irradiation treatment (insofar as this process is compatible with the biopharmaceutical materials treated).
  • the expandable protection element 16 may in particular be introduced or injected in the unexpanded state by any means into the outer receptacle 13.
  • the expandable protection element 16 may be introduced into the receptacle before the inner bag 3 has itself been placed in the outer receptacle 13.
  • the expandable protection element 16 can be introduced into the outer receptacle 13 after the inner bag 3 has been placed in the receptacle 13, the inner bag 3 can then be empty or already filled with biopharmaceutical fluid 2.
  • an orifice injection 17 can be directly located on the wall 14 of the receptacle 13 to introduce the expandable protection element into the outer receptacle 13.
  • FIGS. Figures 1 to 13 A second exemplary embodiment of the expandable protection element 16 according to the invention, as shown in FIGS. Figures 1 to 13 .
  • the expandable protection element 16 is an inflatable protection element.
  • the expandable protection member 16 can then be formed from a plastic wall 20. Like its wall 20, the expandable protection element 16 is flexible and waterproof. The wall 20 of the protection element 16 thus forms and delimits a protection chamber 22.
  • the inflatable protection element 16 may be a separate element and separate from the outer receptacle 13.
  • the protective element 16 may for example consist of inflatable elements 21 connected together in fluid communication so as to form together the chamber of 22. These elements 21 may for example be flanges or inflatable beads extending along an axis of elongation X of the inner pocket 3 (FIG. figure 12 ). However, these elements 21 may also have any other shape, for example in the form of cubes or spheres of various sizes.
  • the protective element 16 is thus intended to receive at least one inner pocket 3, for example a single inner pocket 3.
  • the inner pocket 3 can be inserted into the protective element 16, and in particular in the protection 22, by a left-open side of the inflatable protection element 16.
  • the protection element 16 can thus have an open through shape at two opposite ends, or have a single-ended open end shape. by which is inserted the inner pocket 3.
  • the figure 12 represents an inner pocket disposed partially inside the protection chamber 22 of an inflatable protection element 16.
  • the protection element 16 may comprise inflatable elements 21 to form a protective band as will be described in more detail below.
  • the inner bag 3 may be previously disposed inside the inflatable protection element 16 in the protection chamber 22, said inflatable protection element 16 then substantially surrounding the entire wall 5 of the internal pocket 3 and the tubing associated with the inner pocket 3 such as the filling tube 9 and the drain tube 11.
  • the inflatable protection element 16 surrounds the majority of the two large wall portions 28 of the pocket 3.
  • the inflatable protection element 16 also surrounds the wall portion 5 of the inner bag 3 comprising the filling port 7 and the drain port 8.
  • the inflatable protection element 16 may comprise at least a first part 23a and a second part 23b.
  • the first part 23a substantially surrounds the inner bag 3, and in particular the two large wall portions 28 of the inner bag 3.
  • the second part 23b substantially surrounds the filling orifice 7 and the emptying orifice 8 of the inner bag 3 and the filling tube 9 and the drain tube 11.
  • the second portion 23b of the inner bag 3 is thus adapted to receive the tubing while the first portion 23a of the inner bag 3 is adapted to receive the two large wall portions 28, including flexible and sealed.
  • the first part 23a and the second part 23b constitute two separate parts of the inflatable protection element 16 and can be connected and delimited between them by any means.
  • the first part 23a and the second part 23b may comprise only an opening adapted between them to let the filling tube 9 and the emptying tube 11 pass from the first part 23a into the second part 23b of the element. protection 16.
  • the inflatable protection element 16 may be integral with the outer receptacle 13.
  • the protective element 16 may be temporarily or permanently fixed, for example glued or welded, to the wall 14 of the outer receptacle 13.
  • the inflatable protection element 16 may comprise a wall 20 joined sealingly, by welding or the like, on a common edge 31 with the wall 14 of the outer receptacle 13.
  • the protective element inflatable 16, and in particular the wall 20 covers partially or completely the inside of the wall 14 of the outer receptacle 13.
  • the inflatable protection element 16 is adapted and intended to be inflated under pressure by an inflation gas G, in particular by air or by an inert gas.
  • the protective element 16 may alternatively be in an expanded state in which it is inflated, or in an unexpanded state in which it is not inflated.
  • the protective element 16 is flat, that is to say empty of inflation gas G or substantially empty to the constructive requirements.
  • the deformation capacity of the inflatable protection element 16 then firstly falls under the conformation of the protection element 16, typically so as to pass from an empty and flat conformation ( figure 10A ) to a volume conformation ( Figure 10C ) due to the inflation gas G.
  • This deformation capacity may, secondly, relate to an intrinsic deformation capacity of the walls 20 of the protection element 16, because they may have a certain capacity of extension, especially elastic.
  • the protection element 16 In order to fill the protection element 16 with inflation gas G, the protection element 16 is provided with an injection orifice 17, that is to say a gas injection passage, inflating G in fluid communication with the protection element 16.
  • an injection tube 18 (this term to be understood as previously described) having an injection inlet 19 of the inflation gas G in the protection element 16.
  • the injection orifice 17 consists of an automatic shut-off valve. Such a valve thus makes it possible to automatically close the protective element 16 hermetically once it has been inflated.
  • the injection orifice 17, with the injection tube 18, may be formed in, respectively through, the wall 14 of the outer receptacle 13 with a tight connection also formed on the wall 14.
  • the injection orifice 17 can be directly located on the wall. 14 of the receptacle 13.
  • the expandable protection element 16 is preferably at least partly, or even entirely, transparent or translucent so as to allow visualization through, and in particular to through the wall 20, the inner bag 3.
  • the expandable protection element 16 may also be at least partly, or even entirely, opaque to light or ultraviolet rays for example to ensure optimal conservation of the biopharmaceutical product 2, especially if the biopharmaceutical product 2 is a photosensitive product.
  • the same outer receptacle 13 can be large in capacity to receive a plurality of inner pockets 3, each being disposed and protected in a protective element 16 individual.
  • the device 1 thus allows the transport, for example "loose” or disordered manner, of a large number of inner pockets 3.
  • the outer container 4 comprises the outer receptacle 13.
  • the outer receptacle 13 is more particularly a rigid box providing the external restraint function of the inner bag 3 and the protective element 16.
  • the expandable protection element 16 which is here represented as being an inflatable element.
  • the expandable protection element 16 is then in the unexpanded state, in particular non-inflated, as shown in FIG. figure 4 .
  • the expandable protection element 16 is then disposed together with the inner bag 3 inside the receptacle 13.
  • the outer receptacle 13 may comprise a removable wall such as for example an opening 29a, 29b, which can be opened to allow to introduce the inner bag 3 into the outer enclosure 15 formed by the outer receptacle 13 and the wall 14.
  • the protection element 16 when the protective element 16 forms a protective band, the protection element 16 can be placed in the outer receptacle 13 before the inner bag 3.
  • the protective element 16 then comprises at least one end, in particular two ends, protruding from the outer receptacle 13.
  • the inner pocket 3 is then itself disposed in the outer receptacle 13, in particular on the protective element 16.
  • the end of the protective element 16, in particular the two ends can then be folded over the upper part of the inner bag 3 so that the protective element 16 surrounds the inner bag 3.
  • the inner bag of biopharmaceutical fluid 2 is filled.
  • the expandable shielding member 16 is an inflatable member
  • the expandable shielding member 16 is then filled with inflation gas G.
  • the inflation gas G can in particular be injected from the outside via the injection orifice 17.
  • the inner bag 3 When the expandable protection element 16 is in the expanded state, and is especially filled with inflation gas G as shown in FIGS. Figures 1 to 3 , the inner bag 3 is not in contact with or near the outer receptacle 13, the inflation gas G then completely surrounding the inner bag 3. More specifically, the wall 5 of the inner bag 3 and the wall 14 of the outer receptacle 13 are separated from each other on all or substantially all their periphery.
  • the opening 29a, 29b of the outer receptacle 13 is then closed so that the outer receptacle 13 defines an outer enclosure 15 at least closed, which may be sealed if necessary.
  • the outer receptacle 13 slightly compresses the protective element 16 and the inner pocket 3 to ensure a satisfactory maintenance of the inner pocket 3 in the outer receptacle 13.
  • the outer receptacle 13 may further comprise a partition 33 formed by a delimiting partition.
  • the boundary wall 33 may in particular have a variable height.
  • the boundary wall 33 may also extend completely between two opposite side walls 14c of the outer receptacle 13 and have one or more openings.
  • the partition 33 may comprise two partitions 33a, 33b defining a central opening between them.
  • the partition 33 defines a first compartment 25a of the outer receptacle 13 in which the wall 5 of the inner pocket 3, and in particular the two large wall portions 28 of the inner pocket 3, is located when the latter is introduced into the outer receptacle 13.
  • the partition 33 also defines a second compartment 25b in which the tubes or tubings associated with the inner bag 3, such as the filling tube and the emptying tube 9, 11 are located when the inner bag 3 is introduced into the outer receptacle 13.
  • the tubes 9, 11 are thus located in a space separated from the flexible wall 5 of the inner bag 3 during the transport phases. It is thus possible to avoid in particular that the tubes 9, 11 come into contact, for example hit or rub against the wall 5 of the inner bag 3 during the transport of the inner bag 3.
  • the tubes 9, 11 are further maintained in the second compartment 25b to avoid being subjected to bending or twisting forces which may compromise their integrity.
  • the invention may also relate to a device for emptying the inner bag 3 when it is positioned in the outer receptacle 13.
  • the filling inlet 10 and the discharge outlet 12 associated with the inner bag 3 are located outside the outer receptacle 13, so as to be easily accessible.
  • the inner bag 3 is separated from the outer receptacle 13 so as not to hinder the passage of the biopharmaceutical fluid 2 to the orifices 7 and 8. All these constructive arrangements contribute to the efficiency and effectiveness of the implementation of the device 1 during emptying operations of the inner bag 3.
  • the device 1 is arranged so that, when the expandable protection element 16 is introduced, and in particular when the pressurized inflation gas G is injected into the compression chamber 16 in the case where the protective element expandable 16 is inflatable, the inner bag 3 can be compressed so that the biopharmaceutical fluid 2 therein is emptied under pressure by the discharge outlet 12.
  • the device 1 is such that it comprises or is capable of being associated with a drain element.
  • the emptying element is itself adapted so that, at least during the emptying of the biopharmaceutical fluid 2, the emptying orifice 8 is located towards the lower part of the inner bag 3 and the inner chamber 6 and in particular towards the lowest part. This is to facilitate the emptying of the inner bag 3 and to ensure that, for safety reasons, the air in the upper part of the inner bag 3 and the inner chamber 6 can not get out through the drain hole 8.
  • this drain element may be a tilting element 32a of the device 1, in particular the outer receptacle 13.
  • This tilting element 32a may comprise one or more legs, for example articulated, associated with the bottom wall 14a of the outer receptacle 13 and resting on the opposite side on a horizontal bearing surface 34.
  • the device 1 can be arranged inclined on the horizontal bearing surface 34 with the emptying orifice 8 downwards.
  • this drain element 32 may also be a suspension element of the device 1 situated opposite the drain orifice 8, such as a suspension eyelet (not shown) provided in the upper part of the outer receptacle. 13, or possibly in the upper part of the inner bag 3 when they are inclined.
  • the device 1 can be arranged vertically with the emptying orifice 8 downwards.
  • this drain element 32 may also consist of an inclined part 32b of the wall 20 of the expandable protection element 16, the space between the inner bag 3 and the wall 14 of the receptacle 13 being locally increased in order to create this part inclined 32b when the protective element 16 is in the expanded state.
  • the receptacle 13 may also comprise a rigid inner wall 26 for inclining the inner bag 3 when it is disposed in the outer receptacle 13.
  • the device 1, in particular the outer container 4 can be arranged horizontally with the inner pocket 3 which is inclined with the drain hole 8 downwards.
  • an inner bag 3 such as that described of the amount of biopharmaceutical fluid 2 which was in its chamber 6 by compressing it without the need to provide a pump, such as a peristaltic pump, associated with the drain tube 11 or at the discharge outlet 12.
  • a pump such as a peristaltic pump
  • the inflation gas G can be injected so that the pressure of the biopharmaceutical fluid 2 in the discharge outlet 12 is substantially constant. during all the emptying.
  • a pressure loss element 36 such as a filter with the discharge tube 11 or the discharge outlet 12.
  • the invention also relates to a system 40 for the receipt and transfer under controlled pressure of a biopharmaceutical fluid 2 comprising the device 1 and a method for the reception and transfer under controlled pressure of a biopharmaceutical fluid 2, in which there is available and the system 40 is implemented.
  • the system 40 for the receipt and transfer under controlled pressure of a biopharmaceutical fluid 2 may firstly comprise a system 45 for the introduction, and in particular the inflation, of an expandable protection element 16 in the outer receptacle 13.
  • the system 40 comprises the device 1 for receiving and then transporting a biopharmaceutical fluid 2 as described above, in particular a device 1 according to the embodiments described by the Figures 7 to 9 .
  • the system 45 then comprises an element 38 adapted and intended to deliver the expandable protection element 16 or the pressurized inflation gas G when the latter is an inflatable element.
  • the system 45 includes a source 37 of pressurized inflation gas G and an injection line 39 of pressurized inflating gas G, capable of being associated in fluidic or associated communication in fluidic communication at the outlet with the injection port 17 for inflating pressurized gas G of the device 1.
  • the system 45 also comprises a control and control element 42.
  • the control and control element 42 may for example be a pressurized pressure gas pressure controller G in the injection line 39, so as to control the injection of inflation gas G when desired and to order the injection with the desired pressure.
  • Such an element 42 may be a manometer, an adjustable valve and / or a control line between them.
  • the pressurized inflation gas G is delivered under a pressure at least equal to 100mbar and at most equal to 1500 mbar. More particularly and as required, this pressure is at least 1000 mbar, more particularly at least 700 mbar,
  • the system 40 for receiving and transfer under controlled pressure of a biopharmaceutical fluid 2 also comprises, or it is associated with the system 40, a filling line 43 and a drain line 44 adapted to be associated in fluid communication or associated in fluid communication output respectively with the filling orifice 7 and the drain orifice 8 of the device 1
  • the method for the reception, transport and transfer under controlled pressure of a biopharmaceutical fluid 2 according to the invention is such that a system 40 is initially available as described, then in the empty state of fluid 2.
  • the inner bag 3 is then disposed in the outer receptacle 13, the expandable protective member 16 in the unexpanded state being then formed between the inner bag 3 and the outer receptacle 13.
  • the inner bag 3 can be arranged in the outer receptacle 13, without the outer receptacle 13 initially comprises the expandable protection element 16.
  • biopharmaceutical fluid 2 to receive and transfer under controlled pressure.
  • the element 38 suitable and intended to deliver the expandable protection element 16 or the pressurized gas G.
  • the inner chamber 6 is filled with the inner pocket 3 of biopharmaceutical fluid 2 , especially via the opening 29 of the outer receptacle 13, via the filling inlet 10, then brings the filling inlet 10 in the closed state, the discharge outlet 12 being on its side in the closed state.
  • the protective element 16 is then introduced or the protective element 16 is inflated, the filling inlet 10 and the emptying outlet 12 being in the closed state.
  • the injection line 39 of the pressurized inflation gas G and the injection inlet 19 of the pressurized inflating gas G of the outer receptacle 13 are associated in fluid communication.
  • the expandable protective element 16 is introduced in the unexpanded state into the outer receptacle 13 via the injection line 39.
  • the expandable protection element 16 can then pass from the unexpanded state to the expanded state, for example when it is subjected to a heat treatment.
  • the device 1 can then be dissociated from the system 40 so that the device 1 then makes it possible to transport the inner bag 3 after the protection element 16 is in the expanded state as described previously.
  • the device 1 can be loaded on a boat, a truck, an aircraft for the purpose of transporting the inner pocket 3.
  • the inner bag 3 can be compressed by further increasing the expansion of the protective element.
  • the injection line in particular via the opening 29a, 29b of the outer receptacle 13, is associated in fluid communication with the injection line.
  • 39 of pressurized inflation gas G of the system 40 and the injection inlet 19 of pressurized inflating gas G of the outer receptacle 13 and the emptying outlet 12 is brought to the open state.
  • the pressurized inflation gas G is injected into the inflatable protection element 16 between the outer receptacle 13 and the inner bag 3, so as to compress the inner bag 3 and to empty it under pressure.
  • biopharmaceutical fluid 2 that is there.
  • the drain orifice 8 can be placed towards the lower part, in particular the lower part, of the inner bag 3 with the aid of the emptying element 32 adapted for this purpose.
  • the inner bag 3 and the protective element 16 can be removed from the outer receptacle 13.
  • the bag Inner 3, the protective element 16 and the container 4 can be discarded, these being disposable.
  • the protective element 16 and the container 4 can be reused for the future transport of other pockets.
  • the process described above can be carried out partially, the steps described above being able to be carried out independently of one another.
  • the inner bag 3 can be arranged in the outer receptacle 13 while it is already filled with biopharmaceutical fluid 2.
  • the protective element 16 can also be arranged in the outer receptacle 13 while it is already in the expanded state, and especially in the inflated state. According to this alternative, it is then possible to carry out only the process emptying step with the system 40. According to another alternative, it is only possible to receive the biopharmaceutical fluid 2 according to the method with the system 40 and not to perform the emptying step. as indicated above.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Claims (15)

  1. Vorrichtung (1) zum Speichern und Transportieren eines biopharmazeutischen Fluids (2), aufweisend:
    - einen weichen und dichten Innenbeutel (3) aus Kunststoff, der einen Innenraum (6) bildet, der geeignet und vorgesehen ist, um ein biopharmazeutisches Fluid (2) aufzunehmen, wobei der Innenbeutel (3) mit einer Wand (5) und mit mindestens einer Öffnung zum Einfüllen und/oder zum Ablassen (7, 8) des biopharmazeutischen Fluids (2) und einem auf dichte Weise mit der Einfüll- und/oder Ablassöffnung (7, 8) verbundenen Einfüll- und/oder Ablassrohr (9,11) versehen ist,
    - einen Außencontainer (4), der einen Außenbehälter (13) aufweist, wobei der Außenbehälter (13) eine Wand (14) aufweist, die einen Außenraum (15) bildet, in dem die Gesamtheit des Innenbeutels (3) angeordnet ist,
    - ein expandierbares Schutzelement (16), das mindestens teilweise zwischen dem Außenbehälter (13) und dem Innenbeutel (3) angeordnet ist und geeignet ist, den Innenbeutel (3) aufzunehmen, wobei das expandierbare Schutzelement (16) angepasst ist, sich im Volumen in einen expandierten Zustand zu entfalten, um sich zwischen dem Außenbehälter (13) und dem Innenbeutel (3) auszubreiten,
    dadurch gekennzeichnet, dass das expandierbare Schutzelement (16) im expandierten Zustand den Innenbeutel (3) und das Einfüll- und/oder Ablassrohr (9, 11) umgibt und den Zwischenraum zwischen der Wand (14) des Außenbehälters (13) und dem Innenbeutel (3) ausfüllt.
  2. Vorrichtung (1) nach Anspruch 1, in welcher der Außencontainer (4) den Außenbehälter (13) im Wesentlichen aufweist, insbesondere durch diesen gebildet ist.
  3. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher der Außenbehälter (13) eine einzige faltbare Wand (14) aufweist, die angepasst ist, wenn sie gefaltet ist, den parallelepipedförmigen Außenbehälter (13) zu bilden, wobei der Außenbehälter (13) mindestens eine untere Wand (14a) und eine Seitenumfangswand (14c) aufweist.
  4. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher der Außencontainer (4) und insbesondere der Außenbehälter (13) ein großes Fassungsvermögen hat, um mehrere mit biopharmazeutischem Fluid (2) gefüllte Innenbeutel (3) aufzunehmen, wobei der Außencontainer (4) mehr als einen Innenbeutel (3), sogar mehr als fünf Innenbeutel (3), ferner sogar mehr als zehn Innenbeutel (3) aufnehmen kann.
  5. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher der Außenbehälter (13) eine erste Kammer (25a) und eine zweite Kammer (25b) aufweist, wobei die erste Kammer (25a) geeignet und vorgesehen ist, die Wand (5) des Innenbeutels (3) aufzunehmen, und die zweite Kammer (25b) geeignet und vorgesehen ist, das Einfüll- und/oder Ablassrohr (9,11) des Innenbeutels (3) aufzunehmen.
  6. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher das expandierbare Schutzelement (16) aufblasbar ist, wobei das expandierbare Schutzelement (16) mit einer Injektionsöffnung (17), das heißt einem Durchgang, zum Injizieren von Aufblasgas (G) in Fluidverbindung mit dem Schutzelement (16) versehen ist, wobei an der Injektionsöffnung (17) des Schutzelements (16) über eine dichte Verbindung ein Injektionsrohr (18) angeschlossen ist, das an der gegenüberliegenden Seite einen Injektionseingang (19) zum Injizieren von Aufblasgas (G) in das expandierbare Schutzelement (16) hat.
  7. Vorrichtung (1) nach Anspruch 6, in welcher das expandierbare Schutzelement (16) eine Wand (20) aufweist, wobei die Wand (20) aufblasbare Elemente (21) aufweist, die untereinander in Fluidverbindung sind, so dass sie gemeinsam eine Schutzkammer (22) bilden, wobei der Innenbeutel (3) geeignet ist, in der Schutzkammer (22) angeordnet zu werden.
  8. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher das expandierbare Schutzelement (16) mindestens einen ersten Teil (23a) und einen zweiten Teil (23b) aufweist, wobei der erste Teil (23a) im Wesentlichen die Wand (5) des Innenbeutels (3) umgibt, der zweite Teil (23b) im Wesentlichen die Einfüll- und/oder Ablassöffnung (7, 8) des Innenbeutels (3) sowie das Einfüll- und/oder Ablassrohr (9, 11) umgibt.
  9. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher das Einfüll- und/oder Ablassrohr (9, 11) den Außenbehälter (13) durchquert.
  10. Vorrichtung (1) nach einem der vorstehenden Ansprüche, die ein Ablasselement aufweist oder geeignet ist, an ein Ablasselement angeschlossen zu werden, geeignet dazu, dass zumindest beim Ablassen die Ablassöffnung (8) gegen den unteren Teil des Innenbeutels (3), insbesondere den untersten Teil des Innenbeutels (3), angeordnet ist.
  11. Vorrichtung (1) nach einem der vorstehenden Ansprüche, in welcher der Außenbehälter (13) eine starre Innenwand (26) aufweist, die erlaubt, den Innenbeutel (3) zu neigen, wenn sich dieser in dem Außenbehälter (13) befindet.
  12. System (40) zur Aufnahme und zum Transferieren eines biopharmazeutischen Fluids (2) unter kontrolliertem Druck, aufweisend:
    - eine Vorrichtung (1) nach Anspruch 6 oder 7, wobei der Innenbeutel (3) mit einer Einfüllöffnung (7) zum Einfüllen des biopharmazeutischen Fluids (2) und einer Ablassöffnung (8) zum Ablassen des biopharmazeutischen Fluids (2) versehen ist, und wobei an der Einfüllöffnung (7) und an der Ablassöffnung (8) auf dichte Weise angeschlossen sind: ein Einfüllrohr (9) mit einem an einer Einfüllleitung für biopharmazeutisches Fluid (2) anschließbaren Einfülleingang (10) zum Füllen des Raums mit dem biopharmazeutischen Fluid (2) und ein Ablassrohr (11) mit einem an einer Ablassleitung für biopharmazeutisches Fluid anschließbaren Ablassausgang (12) zum Ablassen des biopharmazeutischen Fluids (2) aus dem Raum,
    - ein System (45) zum Aufblasen des expandierbaren Schutzelements (16), aufweisend ein Element (38) geeignet und vorgesehen zum Zuführen eines Aufblasgases (G) unter Druck mit einer Druckgasinjektionsleitung (39) zum Injizieren von Aufblasgas (G) unter Druck, die mit der Druckgasinjektionsöffnung oder dem Druckgasinjektionseingang (19) des expandierbaren Schutzelements (16) der Vorrichtung (1) in Fluidverbindung gebracht werden kann oder in Fluidverbindung ist, wobei das System (45) zudem ein Element zur Steuerung und Überwachung des Drucks des unter Druck stehenden Aufblasgases (42) in der Druckgasinjektionsleitung (39) aufweist,
    - eine Einfüllleitung (43) und eine Ablassleitung (44), die mit der Einfüllöffnung (7) bzw. der Ablassöffnung (8) der Vorrichtung (1) in Fluidverbindung gebracht werden können oder in Fluidverbindung am Ausgang sind.
  13. Verfahren zur Aufnahme und zum Transportieren eines biopharmazeutischen Fluids (2), aufweisend:
    - Bereitstellen einer Vorrichtung (1) nach Anspruch 6 oder 7, wobei die Vorrichtung (1) sich in dem leeren Zustand, also frei von biopharmazeutischem Fluid (2) und Druckaufblasgas (G), befindet, und der Außenbehälter (13) geöffnet ist,
    - Anordnen des Innenbeutels (3) innerhalb des Schutzelements (16),
    - Anordnen des expandierbaren Schutzelements (16) zusammen mit dem Innenbeutel (3) innerhalb des Behälters (13), Füllen des Innenraums (6) des Innenbeutels (3) mit biopharmazeutischem Fluid (2) über die Einfüllöffnung (7),
    - Füllen des expandierbaren Schutzelements (16) mit Aufblasgas (G), und
    - Schließen des Außenbehälters (13).
  14. Verfahren zur Aufnahme und zum Transportieren eines biopharmazeutischen Fluids (2), aufweisend:
    - Bereitstellen einer Vorrichtung (1) nach Anspruch 6 oder 7, wobei die Vorrichtung (1) sich in dem leeren Zustand, also frei von biopharmazeutischem Fluid (2) und Druckaufblasgas (G), befindet und der Außenbehälter (13) geöffnet ist,
    - Anordnen des expandierbaren Schutzelements (16) innerhalb des Behälters (13), wobei mindestens ein Ende des expandierbaren Schutzelements (16) aus dem Außenbehälter (13) herausragt,
    - Anordnen des Innenbeutels (3) innerhalb des Behälters (13) über dem Schutzelement (16), wobei das Ende des expandierbaren Schutzelements (16) anschließend auf den Innenbeutel (3) zurückgefaltet wird, derart, dass das expandierbare Schutzelement (16) den Innenbeutel (30) umgibt,
    - Füllen des Innenraums (6) des Innenbeutels (3) mit biopharmazeutischem Fluid (2) über die Einfüllöffnung (7),
    - Füllen des expandierbaren Schutzelements (16) mit Aufblasgas (G), und
    - Schließen des Außenbehälters (13).
  15. Verfahren zur Aufnahme und zum Transferieren eines biopharmazeutischen Fluids (2), in welchem über ein System (40) zur Aufnahme und zum Transferieren eines biopharmazeutischen Fluids (2) unter kontrolliertem Druck nach Anspruch 12 verfügt, und wenn gewünscht ist, das biopharmazeutische Fluid (2) unter kontrolliertem Druck aus dem Innenraum (6) zu transferieren, die Druckgasinjektionsleitung (39) und den Druckgasinjektionseingang (19) des Schutzelements (16) in Fluidverbindung gebracht, dann das Aufblasgas unter Druck in das Schutzelement (16) injiziert wird, um auf diese Weise den Innenbeutel zu komprimieren und aus diesem das darin befindliche biopharmazeutische Fluid (2) unter Druck abzulassen.
EP16715005.1A 2015-03-09 2016-03-08 Vorrichtung zum fördern eines beutels mit einem biopharmazeutischen fluid und systeme und verfahren mit verwendung davon Active EP3268291B1 (de)

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FR1551955A FR3033496A1 (fr) 2015-03-09 2015-03-09 Dispositif de transport d'une poche comprenant un fluide biopharmaceutique et systemes et procede mettant en oeuvre un tel dispositif
PCT/FR2016/050526 WO2016142618A1 (fr) 2015-03-09 2016-03-08 Dispositif de transport d'une poche comprenant un fluide biopharmaceutique et systèmes et procédé mettant en oeuvre un tel dispositif

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Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106999347A (zh) 2014-08-08 2017-08-01 弗雷蒙科学公司 在感测装有生物物质的包袋的生理和/或物理参数中使用的智能包袋
CN110239834A (zh) * 2018-03-09 2019-09-17 上海锦蕊新材料科技有限公司 囊中囊包装袋及其制造方法
WO2019217488A1 (en) 2018-05-07 2019-11-14 Fremon Scientific, Inc. Thawing biological substances
GB2573547B (en) * 2018-05-09 2022-06-15 Pat Mcgrath Cosmetics Llc Product pouch arrangement and method of manufacture thereof
CN109335289A (zh) * 2018-10-08 2019-02-15 王新 一种具有防碰撞功能的化妆品收纳装置
CN109760929A (zh) * 2019-03-07 2019-05-17 昆山紫鼎塑胶有限公司 一种具有膨胀内衬袋的中空桶

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1376830A (fr) * 1963-10-28 1964-10-31 Continental Aviat & Eng Corp Procédé d'emballage
CA1272918A (en) * 1986-04-15 1990-08-21 Paul Y. Wang Compression device enabling flexible solution containers to produce constant delivery rate
JPH07165265A (ja) * 1993-10-28 1995-06-27 K Jasai Z 緩衝保護装置
JPH0858897A (ja) * 1994-08-12 1996-03-05 Japan Storage Battery Co Ltd 流体供給装置
DE19613678C1 (de) * 1996-04-05 1998-01-08 Fresenius Ag Anordnung zum Verabreichen einer medizinischen Flüssigkeit
US5950833A (en) * 1998-08-05 1999-09-14 Nabisco Technology Company Inflated, stackable, bag package for crushable round articles
US6641562B1 (en) * 2000-05-10 2003-11-04 Hps Medical, Inc. Apparatus and method of intravenous fluid infusion
JP2004203488A (ja) * 2002-12-13 2004-07-22 Otsuka Pharmaceut Factory Inc 輸液バッグの梱包方法
EP1539608B1 (de) * 2003-09-04 2007-01-03 Millipore Corporation Stützsystem für beutel
US20060272288A1 (en) * 2005-06-03 2006-12-07 Sealed Air Corporation (Us) Small box shipper with internal inflatable bag
US20070256904A1 (en) * 2006-05-02 2007-11-08 Jean-Marcel Ribaut Method and an apparatus for safe packing
US20130056480A1 (en) * 2011-09-02 2013-03-07 Bayer Healthcare Llc Biopharmaceutical product storage system
SG11201407506SA (en) * 2012-05-18 2014-12-30 Atmi B V B A Fluid handling containers, systems, and related methods
FR3003245B1 (fr) * 2013-03-13 2015-03-20 Sartorius Stedim Biotech Reception, vidage et transfert sous pression d'une grande quantite de fluide biopharmaceutique en vue d'un traitement ulterieur.

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

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US20180050856A1 (en) 2018-02-22
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EP3268291A1 (de) 2018-01-17

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