EP3106408A2 - Starrer behälter für einen flexiblen beutel für die aufnahme einer biopharmazeutischen flüssigkeit und entsprechendes zusammenbauverfahren - Google Patents

Starrer behälter für einen flexiblen beutel für die aufnahme einer biopharmazeutischen flüssigkeit und entsprechendes zusammenbauverfahren Download PDF

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Publication number
EP3106408A2
EP3106408A2 EP16170052.1A EP16170052A EP3106408A2 EP 3106408 A2 EP3106408 A2 EP 3106408A2 EP 16170052 A EP16170052 A EP 16170052A EP 3106408 A2 EP3106408 A2 EP 3106408A2
Authority
EP
European Patent Office
Prior art keywords
wall
contention
container
pocket
support member
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.)
Granted
Application number
EP16170052.1A
Other languages
English (en)
French (fr)
Other versions
EP3106408A3 (de
EP3106408B1 (de
Inventor
Stéphane BAUD
Bastien Guillot
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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Publication date
Application filed by Sartorius Stedim FMT SAS filed Critical Sartorius Stedim FMT SAS
Publication of EP3106408A2 publication Critical patent/EP3106408A2/de
Publication of EP3106408A3 publication Critical patent/EP3106408A3/de
Application granted granted Critical
Publication of EP3106408B1 publication Critical patent/EP3106408B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/02—Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
    • 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
    • B65D77/061—Liquids or semi-liquids or other materials or articles enclosed in flexible containers disposed within rigid containers the containers being mounted on a pallet
    • 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
    • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/68—Containers, packaging elements or packages, specially adapted for particular articles or materials for machines, engines or vehicles in assembled or dismantled form
    • 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
    • B65D88/00—Large containers
    • B65D88/54—Large containers characterised by means facilitating filling or emptying
    • B65D88/58—Large containers characterised by means facilitating filling or emptying by displacement of walls
    • B65D88/60—Large containers characterised by means facilitating filling or emptying by displacement of walls of internal walls
    • 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
    • B65D90/00—Component parts, details or accessories for large containers
    • B65D90/004—Contents retaining means
    • B65D90/0053—Contents retaining means fixed on the side wall of the container
    • 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
    • B65D90/00—Component parts, details or accessories for large containers
    • B65D90/02—Wall construction
    • B65D90/04—Linings
    • B65D90/046—Flexible liners, e.g. loosely positioned in the container
    • 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
    • B65D2585/00—Containers, packaging elements or packages specially adapted for particular articles or materials
    • B65D2585/68—Containers, packaging elements or packages specially adapted for particular articles or materials for machines, engines, or vehicles in assembled or dismantled form
    • B65D2585/6802—Containers, packaging elements or packages specially adapted for particular articles or materials for machines, engines, or vehicles in assembled or dismantled form specific machines, engines or vehicles
    • B65D2585/6897—Containers, packaging elements or packages specially adapted for particular articles or materials for machines, engines, or vehicles in assembled or dismantled form specific machines, engines or vehicles others
    • 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
    • B65D2590/00—Component parts, details or accessories for large containers
    • B65D2590/02—Wall construction
    • B65D2590/04—Linings
    • B65D2590/043—Flexible liners
    • B65D2590/046—Bladders

Definitions

  • the invention relates to the field of conditioning of biopharmaceutical fluids and more particularly to a rigid container for a 3D flexible pouch intended to contain such a biopharmaceutical fluid, a flexible 3D pouch intended for such a container, and a process for implementing such a container.
  • Biopharmaceutical product 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 3D pocket is known for receiving such a biopharmaceutical product, which has a bottom end wall, an upper end wall, and a flexible side wall that can be in two extreme states - folded flat and unfolded deployed - and be deformed to pass from one to the other of these states or be in any intermediate state.
  • the walls of the pouch made of plastics material such as polyethylene or a complex comprising polyethylene, define an internal space which, in the folded state, is of minimum volume and in unfolded and expanded state is maximum. This space is intended to receive the biopharmaceutical product for storage, processing, control.
  • Such a flexible pouch, biocompatible, disposable can be large volume of at least 50 liters, up to 3,000 liters, or even more, which justifies it is called 3D.
  • Such a pocket thus offers a large capacity while being easily stored.
  • An example of such a pocket is described in the international application WO00 / 04131 .
  • Such a 3D flexible pouch when filled with biopharmaceutical product must be placed in a rigid container which holds it from the outside. This requirement is particularly important in the case where the pocket filled with biopharmaceutical product has to be moved and transported by road, train or air. Indeed, there is the risk that the integrity of the pocket is affected by shocks, efforts, deformations ..., which can in turn affect the biopharmaceutical product it contains.
  • such a rigid container comprises a lower transverse wall and an erected lateral peripheral axial wall limiting an upper transverse opening access to a housing defined by the inner faces of these walls, adapted to receive the pocket containing the biopharmaceutical fluid which comes to apply against these internal faces.
  • the document EP-A-1012073 discloses such a container, further provided with a protective wall and contention adapted to be placed transversely in the housing of the rigid container, having dimensions such that the transverse clearance between its outer peripheral free edge and the inner face of the wall side opposite the rigid container is limited.
  • a wall of protection and contention is able to be applied with a certain axial force against the outer face of the upper end wall of the pocket and to be fixedly held in this position by holding means in the active state. , supported by a system of screw jacks on removable spars located in this case in the upper part of the rigid container.
  • axial axial height of the cylinder system conditions the stroke height which can be found on the plate protection and contention. Either this size is chosen restricted, for the advantages that it provides with the disadvantage that the protection plate and contention can be implemented with a completely filled pocket is, if we want the race of the contention plate is the largest possible, for example because the pocket could be only partially filled, the cylinder system necessarily has a large axial size in height, which is a source of inconvenience, the lack of compactness being a problem. serious handicap for travel and transportation.
  • the flexible pouch Since the flexible pouch is of maximum capacity and having regard to the very nature of its contents - a biopharmaceutical product - it must be possible to use the pouch without having to fill it completely, and with variable volumes. continuously.
  • this situation poses another problem when the flexible pouch partially filled with biopharmaceutical product has to be moved and transported, especially over a large distance and under conditions such that it is prone to sudden movements or to significant accelerations, because the high inertia of the content of the flexible pouch then creates a movement of imbalance of the pocket and its contents that can affect the integrity of the pocket and therefore its contents.
  • the document WO 2006/070010 discloses a method of packaging a viscous product contained in a flexible bag of capacity greater than 50 liters, preferably greater than 100 liters, in volume units of less than 50 liters capacity, preferably less than 100 liters.
  • This flexible bag has an evacuation passage of the viscous product located on its upper end wall.
  • This flexible bag, filled with the viscous product is placed in a rigid container having a lower transverse wall forming a pressure piston, mounted to slide vertically and driven by a jack system placed below this lower transverse wall and above a fixed lower floor.
  • This container also comprises a fixed top cover, reversible, provided with a viscous product conveying orifice to a conditioner in a smaller volume, in communication with the discharge passage of the flexible bag.
  • the arrangement according to the document WO 2006/070010 targets viscous products, but not biopharmaceuticals. It is not intended to preserve the integrity of the pouch and its contents, and does not include the case of a pouch partially filled with its contents that can be moved and transported a significant distance and / or under conditions to generate sudden movements or accelerations. This arrangement is not more concerned with the compactness of the rigid container. Finally, this arrangement imposes evacuation from above, whereas in the case of 3D bags for biopharmaceutical products, evacuation is most often from below. In the arrangement according to the document WO 2004/074164 it overcomes this disadvantage, but not others, including the lack of compactness. Similar devices are described in the documents GB-A-2159583 and BE-A-539 623 .
  • a container comprising, on the one hand, a tray inside which is placed an envelope and, on the other hand, a holding plate which comes to rest on the envelope when the latter is not completely filled or when its dimension in height is lower than that of the tray.
  • the holding plate is then held inside the tank by means of pressure screws cooperating with threaded recesses arranged in the inner wall of the tray, as shown in FIG. figure 4 of this document.
  • a disadvantage of this device is that it does not preserve the integrity of the envelope regardless of its filling volume. Indeed, the position of the holding plate necessarily depends on the position of the threaded recesses. Therefore, the position of this holding plate with respect to the bottom of the tray can not be modulated continuously according to the filling of the envelope.
  • EP-A-0 456 403 discloses a container for a flexible pouch filled with a pharmaceutical product.
  • a support element is attached to the upper face of the flexible bag to move the upper face to the same level as the product when a portion of this product flows from the flexible bag.
  • Such an embodiment has, like the previous embodiments, several disadvantages.
  • the use of a support element is insufficient to prevent the pharmaceutical product contained in the flexible pouch from wobbling inside thereof when the container is set in motion.
  • the sole weight of the support element does not provide a holding force sufficient to counter the forces exerted on the flexible bag when the product it contains moves and agitates.
  • the wall of contention is intrinsically sufficiently rigid and able, in itself, to cash without substantial deformation, the said certain force.
  • the wall of contention is not inherently rigid enough and able, in itself, to cash without substantial deformation, the said certain force, the retaining means comprising suitable stiffening means, being active, to act on the wall of contention to stiffen it sufficiently so that, stiffened, it is able to cash without substantial deformation, the said certain force.
  • the contention wall is stiffened by stiffening means in the form of at least one stiffening chamber placed above or below (according to two different variants) of the compression wall or in an opening of the frame-shaped stiffening wall (according to a third possible variant), which rigidifying, deformable and substantially inextensible enclosure is rigid and active by filling with a fluid.
  • the stiffening means comprise at least one stiffening chamber provided with an inlet / outlet port of the filling fluid and means for filling and emptying the at least one enclosure adapted to be associated with the input / output port.
  • the contention wall is distinct but applied against the lower or upper face of the at least one stiffening enclosure.
  • the compression wall is part of the bottom wall of the at least one stiffening chamber.
  • the holding means are carried by the stiffening means.
  • the contention means are intrinsically sufficiently heavy and able, in themselves, to exert by their own weight the said certain force against the free upper face of the pocket.
  • the restraining means are not inherently rigid enough and able, in themselves, to exert by their own weight the said certain force against the free upper face of the pocket, the restraining means comprising means application of a force able, being active, to act on the wall of contention to exert on it a force such that the means of contention in turn exert said certain force against the free upper face of the pocket.
  • said means for applying a force are manual or human means, a jack, heavy masses.
  • the holding means are carried by the wall of contention.
  • the restraining means comprise below the support wall and above a transversely extended support member placed directly above the retaining wall, the holding means being carried by said support member, rigid connection means and force transmission being interposed between and associated with the wall of contention and the support member, and being able to ensure between the wall of contention and the support member a rigid connection of transmission of said certain strength.
  • the rigid linkage and force transmission means are substantially indeformable.
  • the rigid connection and force transmission means are deformable between two extreme states, a retracted state and an expanded state, in which, respectively, the compression wall is closer and further away from the holding means carried. by said support member, operating means being provided and able to pass the rigid connection means and force transmission are deformable between their two extreme states, these operating means constituting means for relative movement of the wall of contention by relative to the support member.
  • the contention wall is located near the support member.
  • the compression wall is located near the lower transverse wall.
  • the support member is chosen from the group comprising either a rigid plate, a rigid frame, a deformable and substantially inextensible enclosure made rigid by filling with a fluid, provided with an inlet / outlet port of the filling fluid, filling and emptying means being able to be associated with the input / output port, an association thereof.
  • a support member is in the form of a plate capable of being placed transversely in the housing, having dimensions such that the transverse clearance between its outer peripheral free edge and the inner face of the lateral wall opposite is limited. .
  • the relative displacement means comprising the rigid connection and force transmission means and the actuating means are chosen from the group comprising either a jack, a deformable enclosure made more or less flat or more or less expanded by a filling more or less important with a fluid, provided with a port inlet / outlet of the fluid of filling, filling and emptying means being adapted to be associated with the input / output port, an association thereof, placed between the support wall and the support member.
  • the contention wall is structurally distinct from the flexible pouch for containing a biopharmaceutical fluid.
  • the contention wall is structurally part of the flexible pouch for containing a biopharmaceutical fluid.
  • the container also has a removable cover.
  • the container also comprises one or more doors or one or more orifices formed in the lower transverse wall and / or the erected lateral peripheral axial wall, adapted to come into correspondence with ports, orifices, or ducts of or associated with the pocket. flexible.
  • the underside of the compression wall is free of asperities likely to damage the pocket.
  • the compression wall is associated with an elastically deformable element intended to match the shape of the free top face of the pocket.
  • the containment wall comprises one or more holes, notches or passages of pipes, fittings or conduits or analogs associated functionally or intended to be functionally associated with the pocket.
  • the invention proposes an assembly of a container and a flexible bag specifically intended to contain a biopharmaceutical fluid, with which at least a part of the compression means is structurally associated, in the upper part, with the pocket thus being specially adapted to form part of a container according to one of the previously described embodiments.
  • the flexible pouch structurally, in the upper part, a wall of contention part of the contention means.
  • a compression wall which is not intrinsically rigid, which is part of the bottom wall of at least one enclosure of rigidification placed above the wall of contention, which stiffening enclosure, deformable and substantially inextensible, is made rigid and active by filling with a fluid.
  • the bag also comprises holding means carried by the compression wall.
  • the means of relative displacement of the wall of the bag are passed through. contention relative to the support member of the retracted state in the expanded state.
  • a flexible pouch is chosen which is structurally associated, in the upper part, at least a portion of the contention means.
  • the holding means once the holding means has been passed from the inactive retracted state to the active expanded state, and thus the distal end portion is blocked on the internal face of the lateral wall. without any possibility of inadvertent sliding, at any corresponding location in the continuous zone, the container is moved and transported keeping the pocket filled with its contents. As indicated above, this movement and transport are done without the integrity of the pocket is impaired.
  • a rigid container 1 according to the invention is specially intended to receive and maintain a flexible 3D bag 2, itself specifically intended to contain a biopharmaceutical fluid as previously defined.
  • the rigid container 1 made of plastic or other synthetic or metallic material, preferably made of stainless steel, comprises an assembly - possibly dismountable and remountable - of several pieces in the general form of solid or substantially solid flat or substantially flat panels, as well as connecting parts, reinforcement, accessories ...
  • the rigid container 1 comprises a lower transverse wall 3 and a lateral peripheral axial wall erected 4 into four panels two by two perpendicular or parallel to each other.
  • the lower transverse wall 3 is arranged horizontally or substantially horizontally while the erected lateral peripheral axial wall 4 is arranged vertically or substantially vertically, possibly slightly flared from the lower transverse wall 3.
  • the rigid container 1 may, in some cases, be placed differently, for example for cleaning.
  • the erected lateral peripheral axial wall 4 forms and limits towards its upper free edge 5 an upper transverse opening 6.
  • the opening 6 provides access to a housing 7 of generally parallelepipedal or substantially parallelepipedal shape, defined and limited by the inner faces 3a and 4a of the lower and lateral walls 3 and 4, while being open at the location of the opening 6.
  • the housing 7 has horizontal and vertical three lengths of the same order of magnitude but nevertheless different with a large and a short side, so that the housing 7 has a general shape close to a parallelepiped or substantially a parallelepiped.
  • these lengths may be close, so that the housing 7 has a general shape close to a cube or substantially a cube.
  • a container may have dimensions of 410x410x520 cm (50 liters) or 1,135x935x1,000 cm or 1,000 liters.
  • the walls 3 and 4 may include external reinforcing ribs such as 4b.
  • the rigid container 1 also comprises a removable cover 8 provided with gripping and handling members 8a, resting by its edge 8b on the free edge 5 of the wall 4. Where appropriate, there is provided rapid locking means 8c of the cover 8 in the closed position, obscuring the opening 6.
  • the rigid container 1 also has, on its wall 4 or on one or more of its component panels, one or more doors 9 or one or more orifices allowing access to the interior of the housing 7 and, where appropriate, located from so as to be able to correspond with ports, orifices, conduits provided on the pocket 3 or associated therewith.
  • one or more similar doors or one or more similar orifices are formed in the lower transverse wall 3 and possibly in the cover 8.
  • the rigid container 1 also comprises a base 10 in the lower part, below the lower transverse wall 3.
  • a base 10 makes it possible, among other things, to raise the lower transverse wall 3 above the ground and to have access thereto or to allow to associate ports, fittings, conduits or the like.
  • Such a base 10 also allows to provide spaces for the passage of forks of a pallet type carrier.
  • the flexible pouch 3D, 2 is specially designed to receive a biopharmaceutical fluid.
  • a pocket 2 comprises a lower end wall 11, an upper end wall 12 and a flexible side wall 13 which can be in two extreme states - folded flat and deployed unfolded - and be deformed to move from one to the other. to the other of these states or be in any intermediate state.
  • Such a flexible pouch 3D, 2, biocompatible, disposable can be of large volume of at least 50 liters, up to 1,000 liters, or even more, which justifies that it is called 3D.
  • a pocket is described for example in the international application WO00 / 04131 , this realization not being exclusive of others.
  • the dimensions of the rigid container 1 and those of the flexible bag 3D, 2 are in adequation, so that the housing 7 of the rigid container 1 is adapted to receive the flexible bag 3D, 2.
  • the flexible pouch 3D, 2 When the flexible pouch 3D, 2 is filled with biopharmaceutical fluid, it is inflated, more or less strongly. While its bottom wall 11 can rest on the inner face 3a of the wall 3 of the rigid container 1, its side wall 13 is pressed against the inner face 4a of the side wall 4 of the rigid storyteller 1.
  • the 3D pocket, 2 comprises one or more inlet or delivery or filling openings, in particular in the form of ports, not shown, in particular on the upper wall 12, able to be closed when necessary and one or more openings of exit, or discharge or dump 25 ( Figures 23A, 23B and 23C ), in particular on the bottom wall 11, in particular in the form of ports, able to be opened when necessary.
  • the rigid container 1 is arranged to allow access to these openings.
  • the rigid container 1 also comprises means 14 of contention comprising a contention wall 15, movable, possibly removable.
  • the retaining wall 15 is arranged so that it can be placed transversely, in a generally horizontal or substantially horizontal direction, in the housing 7, at any desired level or height between the lower transverse wall 3 and the upper free edge 5 or the opening 6 or the cover 8 when provided.
  • the wall 15 has, in horizontal, two lengths defined as a function of the corresponding lengths of the housing 7, so that between the outer peripheral free edge 15a of the compression wall 15 and the inner face 4a of the wall lateral 4 facing the rigid container 1, the transverse clearance is limited, for example of the order of one centimeter.
  • the contention plate has a generally rectangular or square shape.
  • the retaining wall 15 is arranged so as, on the one hand, to be able to be applied with a certain vertical downward axial force against the upper outer face 12a of the transverse upper wall 12 of the 3D pocket, 2 - and to take up the force of opposite reaction, and, secondly, to be fixedly held in this application position by maintaining means 16 then in the active state.
  • the rigid container 1 thus also comprises the holding means 16.
  • these holding means 16 when in the active state, hold fixedly in position the compression wall 15 applied with a certain force against the upper outer face 12a of the transverse upper wall 12 of the 3D pocket, 2.
  • the holding means 16 are arranged transversely in the rigid container 1 , that is to say globally horizontally or substantially horizontally.
  • the holding means 16 are carried not by the constituent walls of the container, but are carried by the means 14 of contention of which they are part, and this by a structural and functional association.
  • the holding means 16 are arranged to be movable or deformable in the transverse direction, that is to say generally horizontally or substantially horizontally, between an inactive retracted state and an active expanded state.
  • a distal end portion 16a of the holding means 16 is spaced from the inner face 4a of the side wall 4 facing the rigid container 1, so that the holding means 16 are not then fixedly held in position relative to the walls 3, 4 of the rigid container 1.
  • the holding means 16 are arranged so as to be applied at any desired location of a continuous zone 17 of the inner face 4a of the side wall 4, and this in a continuous variation.
  • This zone 17 is extended in the vertical axial direction, in particular over all or substantially the entire height of the rigid container 1, so that the compression wall 15 can be placed in the housing 7 at any desired distance - continuously varying - from the lower transverse wall 3 or at any desired distance from the upper transverse opening 6.
  • the figure 5 illustrates three different particular possible positions in height of the compression plate 15, corresponding to three different volumes of the biopharmaceutical product contained in the flexible bag 3D, 2, namely a volume V1, a volume V2 greater than V1, and a higher volume V3 at V2.
  • the compression wall 15 can be applied and maintained with a certain axial force against the upper outer face 12a of the transverse upper wall 12 of the pocket 3D, 2, whatever the degree of filling of this, this degree of filling can vary continuously.
  • the rigid container 1 as just described can be the subject of different embodiments.
  • the contention wall 15 is full.
  • the containment wall 15 has one or more holes, indentations or passages 18 of pipes, fittings, conduits or the like, not represented, functionally associated or intended to be functionally associated with the 3D flexible pouch, 2.
  • the retaining wall 15 has a certain thickness or thickness, so that it is intrinsically sufficiently rigid and able, in itself, to cash without substantial deformation, the force exerted on the flexible bag 3D, 2.
  • the contention wall 15 is intrinsically not sufficiently rigid and able, in itself, to withstand without substantial deformation the force exerted on the flexible bag 3D, 2.
  • the means 14 of contention also include means 19 for stiffening.
  • the stiffening means 19 are arranged in such a way that, when they are active, they act on the compression wall 15 to stiffen it sufficiently so that, thus stiffened, it is able to withstand without substantial deformation the force exerted on the pocket.
  • the stiffening means 19 are in the form of a stiffening chamber 19a placed above and adjacent the contention wall 15, which is generally in the form of a solid plate.
  • This rigidification chamber 19a is deformable and substantially inextensible. It can be made active by filling with a fluid that is brought to it via an input / output port 19b (see Figures 9A and 9B ), so as to have overall overall rigidity which, in turn gives the contention plate 15 the necessary overall rigidity.
  • the stiffening means 19 are in the form of a stiffening chamber 19a placed below and adjacent to the compression wall 15.
  • the contention wall 15 is not in the general form of a solid plate as above, but in the form of a frame forming an opening 20, the stiffening chamber 19a being placed in this opening 20.
  • the contention wall 15 is distinct but applied against the underside of the stiffening chamber 19a.
  • the contention wall 15 is distinct but applied against the upper face of the stiffening chamber 19a.
  • the retaining wall 15 is part of the lower wall of the stiffening chamber 19a.
  • the holding means 16 are carried by the stiffening means 19, when such means are provided.
  • the holding means 16 are carried by the compression wall 15, as illustrated for example by the figure 3 .
  • the means 14 of contention are intrinsically sufficiently heavy and able, in themselves, to exert by their own weight the desired force on the flexible bag 3D, 2.
  • the means 14 of contention are not intrinsically sufficiently rigid and able, in themselves, to exert by their own weight the desired force on the flexible bag 3D, 2.
  • the means 14 of contention further comprise additional means of applying such a force apt.
  • These means when they are active, are able to act on the wall of contention 15 to exert on it a force such that the means 14 of contention in turn exert the desired force on the flexible bag 3D, 2.
  • Such means application of a force are, according to the embodiments envisaged, manual or human means, or a jack, or heavy masses.
  • the means 22 of rigid connection and force transmission are substantially indeformable.
  • the means 22 of rigid connection and force transmission are deformable between two extreme states, namely a retracted state ( figure 13A ) and an expanded state ( Figure 13B ).
  • the compression wall 15 is closer to the holding means 16 carried by said support member, while in the expanded state, it is further away.
  • Such maneuvering means therefore constitute means of relative displacement of the compression wall 15 relative to the support member 21 to bring it closer to or away from it.
  • the contention wall 15 is situated close to the support member, which gives the assembly a great compactness in the vertical axial direction. .
  • the compression wall 15 is located near the bottom transverse wall 3 of the rigid container 1. This constructive arrangement makes it possible to evacuate the biopharmaceutical product through a discharge port 25 formed on the lower wall 11 of the flexible pouch 3D 2 until the bag 2 is completely emptied.
  • the support member 21 may be subject to different embodiments.
  • the support member 21 is a rigid plate, having dimensions such that the transverse clearance between its outer peripheral free edge and the inner face 4a of the side wall 4 facing the rigid container 1 is limited.
  • the support member 21 is a rigid frame.
  • the support member 21 is a deformable and substantially inextensible enclosure made rigid by filling with a fluid, provided with an inlet / outlet port of the filling fluid (not shown), filling and emptying means being able to be associated at the entrance / exit port.
  • the relative displacement means formed by the deformable connecting means 22 may be the subject of different embodiments.
  • the relative displacement means 22 comprise two jacks.
  • the relative displacement means 22 comprise a deformable enclosure made more or less flat or more or less expanded by more or less filling with a fluid, this enclosure 22 being provided for this purpose with an inlet / outlet port of the fluid of filling, filling and emptying means being provided suitable for being associated with the input / output port.
  • the contention wall 15 is either structurally distinct from the flexible bag 3D, 2 or, conversely, is structurally part of it.
  • the underside of the contention wall 15 is free of asperities likely to damage the flexible pouch 3D, 2.
  • the compression wall 15 is associated with an elastically deformable element 23, such as a plate of cellular material intended to conform to the shape of the face 12a of the top wall 12 of the flexible bag 3D, 2.
  • the 3D flexible pouch 2 may structurally include the retaining wall 15.
  • the 3D flexible pouch 2 incorporates an intrinsically rigid containment wall.
  • the flexible pouch 3D, 2 incorporates a contention wall 15 which is not intrinsically rigid, as described above and is in the form of a stiffening enclosure.
  • the flexible pouch 3D, 2 is part of the bottom wall of such a stiffening chamber placed above the compression wall 15 itself.
  • a stiffening chamber deformable and substantially inextensible, is made rigid and active by filling with a fluid.
  • the flexible pouch 3D, 2 incorporates a contention wall 15 which supports the holding means 16, an enclosure being also provided to stiffen the contention wall 15.
  • the invention also relates, in addition to the rigid container 1 and the flexible bag 3D, 2 in that it incorporates at least a portion of the means 14 of contention, the method of implementation of such a rigid container as it has been previously described.
  • the method is such that, when the support means 14 is brought into the housing 7 of the rigid container 1 and when the means 16 for maintaining the inactive retracted state in the active expanded state are passed through, the means 22 for relative displacement of the compression wall 15 with respect to the support member 21 are controlled so that they are in the retracted state.
  • FIGS 23A, 23B and 23C illustrate the method in the case where there is provided relative movement means 22 of the compression wall 15 relative to the support member 21 and in the case where it is desired to empty the bag. Then, the means 22 are moved relative to the compression wall 15 relative to the support member 21 of the retracted state in the expanded state, so as to flatten the flexible bag 3D, 2 and ensure its emptying complete, the wall of contention 15 coming against the bottom wall 3 of the rigid container.
  • the invention also relates to the method in the case where one chooses a flexible bag 3D, 2 which is associated structurally, in the upper part, at least a portion of the means 14 of contention.
  • the implementation is particularly remarkable in that after the step in which the means 16 for maintaining the inactive retracted state in the active expanded state are passed through, the container is moved and transported. rigid 1 now the flexible pouch 3D, 2 filled with its contents, without its integrity is affected, and this whatever the degree of filling of the flexible pouch 3D, 2.

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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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bag Frames (AREA)
  • Packages (AREA)
EP16170052.1A 2009-05-27 2010-05-25 Starrer behälter für einen flexiblen beutel für die aufnahme einer biopharmazeutischen flüssigkeit und verfahren zum einsatz eines solchen behälters Active EP3106408B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0953513A FR2946032B1 (fr) 2009-05-27 2009-05-27 Conteneur rigide pour poche souple 3d destinee a contenir un fluide biopharmaceutique ; poche 3d destinee a un tel conteneur ; procede de mise en oeuvre.
EP10728811.0A EP2435335B1 (de) 2009-05-27 2010-05-25 Starrer behälter für einen biegsamen beutel für eine biopharmazeutische flüssigkeit und verfahren zur verwendung eines derartigen behälters
PCT/FR2010/051001 WO2010136714A1 (fr) 2009-05-27 2010-05-25 Conteneur rigide pour poche souple destinee a contenir un fluide biopharmaceutique, assemblage d'une poche souple et d'un tel conteneur, et procede de mise en oeuvre d'un tel conteneur

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP10728811.0A Division EP2435335B1 (de) 2009-05-27 2010-05-25 Starrer behälter für einen biegsamen beutel für eine biopharmazeutische flüssigkeit und verfahren zur verwendung eines derartigen behälters
EP10728811.0A Division-Into EP2435335B1 (de) 2009-05-27 2010-05-25 Starrer behälter für einen biegsamen beutel für eine biopharmazeutische flüssigkeit und verfahren zur verwendung eines derartigen behälters

Publications (3)

Publication Number Publication Date
EP3106408A2 true EP3106408A2 (de) 2016-12-21
EP3106408A3 EP3106408A3 (de) 2017-01-11
EP3106408B1 EP3106408B1 (de) 2019-08-14

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EP16170052.1A Active EP3106408B1 (de) 2009-05-27 2010-05-25 Starrer behälter für einen flexiblen beutel für die aufnahme einer biopharmazeutischen flüssigkeit und verfahren zum einsatz eines solchen behälters
EP10728811.0A Active EP2435335B1 (de) 2009-05-27 2010-05-25 Starrer behälter für einen biegsamen beutel für eine biopharmazeutische flüssigkeit und verfahren zur verwendung eines derartigen behälters

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US (2) US9266657B2 (de)
EP (2) EP3106408B1 (de)
FR (1) FR2946032B1 (de)
WO (1) WO2010136714A1 (de)

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US9687852B2 (en) 2015-04-14 2017-06-27 Pall Corporation Support for biocontainer bag
FR3055317B1 (fr) * 2016-08-23 2020-12-25 Sartorius Stedim Fmt Sas Conteneur pour poche souple comprenant deux positions de fonctionnement
CN110114283B (zh) 2016-12-22 2021-05-11 荷兰联合利华有限公司 包装件
EP3653519A1 (de) * 2018-11-14 2020-05-20 Sartorius Stedim Fmt Sas Vorrichtung zum entleeren eines flexiblen beutels
DE102019100209A1 (de) 2019-01-07 2020-07-09 Sartorius Stedim Biotech Gmbh Vorrichtung und Verfahren zum Ausgleich von kurzfristigen Druck- oder Volumenschwankungen eines Mediums in einem kontinuierlich geführten biopharmazeutischen Prozess

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WO2006070010A1 (fr) 2004-12-31 2006-07-06 Rhodia Chimie Procede de conditionnement d'un conteneur souple renfermant un produit visqueux

Also Published As

Publication number Publication date
EP3106408A3 (de) 2017-01-11
EP2435335A1 (de) 2012-04-04
FR2946032A1 (fr) 2010-12-03
WO2010136714A1 (fr) 2010-12-02
US20160114950A1 (en) 2016-04-28
US9266657B2 (en) 2016-02-23
FR2946032B1 (fr) 2015-02-20
EP3106408B1 (de) 2019-08-14
US20120110960A1 (en) 2012-05-10
US10618716B2 (en) 2020-04-14
EP2435335B1 (de) 2016-06-29

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