Rigid container for a flexible pouch for holding a biopharmaceutical fluid, assembly comprising such a flexible pouch and such a container, and method for using such a container

Abstract

The container includes a lower wall and an erect side wall limiting an upper opening of a housing for accommodating a flexible pouch containing a fluid; containment elements including a containment wall, the gap between its peripheral edge and the side wall being limited; the containment wall adapted to be applied against the pouch and held fixed in this position by holding elements arranged in the container and borne by the containment elements by a structural and functional combination, and being movable between an inactive retracted state and an active expanded state, in which a distal end part is either moved away from the side wall or applied there against without any chance of sliding; and adapted to be applied at any desired location of a zone of the side wall such that the containment wall can be applied and held against the pouch regardless of how full the latter is.

Claims

1. A process for using a container for containing a biopharmaceutical, comprising: providing an empty flexible pouch; providing a rigid container, comprised of: a lower transverse wall and an erected side peripheral axial wall that limits an upper transverse opening with access to a housing of parallelepiped shape that is defined by an inner surface of the lower transverse wall and by an inner surface of the erected side peripheral axial wall, and is adapted to accommodate the flexible pouch that contains the biopharmaceutical fluid such that said flexible pouch applies against said inner surfaces, the erected side peripheral axial wall having four panels to delimit the housing of parallelepiped shape, a containment wall, including a containment plate and placed transversely in the housing of parallelepiped shape, and having dimensions such that a transverse gap between an outside peripheral free edge of the containment wall and the inner surface of the erected side peripheral axial wall facing opposite the outside peripheral free edge is limited, the containment wall configured to be applied with an axial force against a free upper surface of an upper transverse wall of the pouch and to be held fixed in this position in an active state, the containment plate being an unattached plate with respect to the flexible pouch so that the containment plate and the flexible pouch are adapted to be introduced into the housing separately and have an unattached relationship, the containment plate being in contact with the upper transverse wall of the pouch in the active state and being still applied with the axial force that is exerted vertically downwards to absorb an opposite reaction force in the active state, and a holder that, in the active state, is applied on the inner surface of the erected side peripheral axial wall so as to hold fixed in position the containment wall that is applied with said axial force against the free upper surface of the pouch, wherein the holder, arranged transversely in the container and directly borne by the containment wall, is movable or deformable in the transverse direction between: an inactive retracted state in which a rectangular distal end part of the holder is separated from the inner surface of the erected side peripheral axial wall facing opposite said distal end part, and an active expanded state in which said rectangular distal end part is applied against said inner surface of the erected side peripheral axial wall, in such a way that in the active state of the holder and of said distal end part, the containment wall is held fixed in position with respect to the walls of the container, and the holder is configured to be applied to any desired location of a continuous zone of the inner surface of the erected side peripheral axial wall, extended in axial direction, in such a way that the containment wall can be placed in the housing at a distance from the lower transverse wall or from the upper transverse opening, to be able to be applied and held with the axial force against the free transverse upper surface of the pouch regardless of how full the pouch is, and wherein the holder extends along an entire perimeter of the containment wall; placing the empty flexible pouch in the housing of parallelepiped shape of the container in such a way that the empty flexible pouch can be deployed in the container; filling the pouch through an opening to introduce therein a quantity of biopharmaceutical fluid, with the pouch thus being at least partially deployed, the pouch's side wall being contained by a side wall of the container that is the erected side peripheral axial wall of the container; and then closing the opening of the thus filled pouch; and transversely bringing the containment wall, with the holder in the inactive retracted state, and regardless of how full the pouch is, into the housing of the container until the containment plate of the containment wall comes against the free transverse upper surface of the pouch and is applied on the free transverse upper surface of the pouch with the axial force to push the free transverse upper surface of the pouch downwardly, while the holder remains in the inactive retracted state, wherein, with the free transverse upper surface of the pouch pushed downwardly, the holder that is attached to the containment plate is switched from the inactive retracted state to the active expanded state, and thus the distal end part is locked on the inner surface of the side wall opposite at any corresponding location of the continuous zone, and wherein when the containment wall is brought into the housing of the container and when the holder is switched from an inactive retracted state to an active expanded state, the holder is adjacent the free transverse upper surface of the pouch.

2. The process according to claim 1, wherein one or more doors arranged in the erected side peripheral axial wall are used to allow access to at least one opening of the flexible pouch.

3. The process according to claim 1, wherein the holder is attached to a rectangular outer circumference of the containment plate so that: the holder is directly borne by the containment plate, and the holder belongs to the containment wall and defines the outside peripheral free edge of the containment wall, and wherein the transverse gap as measured between the outside peripheral free edge of the containment wall and the inner surface of the erected side peripheral axial wall is of a centimeter.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

(1) Several embodiments of the invention are now described using drawings, in which:

(2) FIG. 1 is a cutaway perspective view that is partially disassembled from a unit that comprises a rigid container in the housing of which a flexible 3D pouch filled with biopharmaceutical product is placed.

(3) FIG. 2 is a view that is analogous to FIG. 1, under another angle of view and according to a variant in which the containment wall comprises a hole or passage for one or more pipes, connections, tubes or the like, not shown.

(4) FIG. 3 is a general perspective view of an embodiment of the containment means of the rigid container.

(5) FIG. 4 is a simplified cutaway diagram through a vertical plane of the rigid container, in the case of a containment plate that is inherently rigid enough.

(6) FIGS. 4A and 4B are two partial views, on a larger scale, illustrating respectively the holding means in the inactive retracted state and in the active expanded state.

(7) FIG. 5 is a partial diagram that is analogous to FIG. 4 and that on a larger scale illustrates three possible different positions of the containment means and the continuous zone for application of the holding means.

(8) FIGS. 6A and 6B are two diagrams that are analogous to the diagram of FIG. 4 of a possible variant embodiment in the case of a containment plate with which are combined stiffening means, in this case a stiffening chamber placed above the containment plate, whereby the latter is not inherently rigid enough and able to absorb the force exerted on the 3D pouch without substantial deformation. In FIG. 6A, these stiffening means are inactive, while in FIG. 6B, they are active.

(9) FIGS. 7A and 7B are two diagrams that are analogous to the diagrams of FIGS. 6A and 6B, in another possible variant embodiment, with the stiffening chamber being placed here below the containment plate.

(10) FIGS. 8A and 8B are two diagrams that are analogous to the diagrams of FIGS. 6A, 7A and 6B, 7B in another possible variant embodiment where the containment wall is in the shape of a frame, while the stiffening chamber is placed within the frame.

(11) FIGS. 9A and 9B are two diagrams that are analogous to the diagrams of FIGS. 6A, 7A, and 8A, and 6B, 7B, and 8B, illustrating an inlet/outlet fluid port of the stiffening chamber.

(12) FIGS. 10A and 10B are two diagrams that are analogous to the preceding diagrams, in a variant in which the containment wall is part of the lower wall of the stiffening chamber.

(13) FIGS. 11A and 11B and 12A and 12B are four diagrams that are analogous to the preceding diagrams, in two variants in which the holding means are borne by the stiffening means.

(14) FIGS. 13A, 13B, 14A, 14B, 15A, 15B, 16A, and 16B are diagrams, analogous to the preceding diagrams, of several variant embodiments that relate to rigid connecting means and means for transmission of forces interposed between the containment wall and a support element.

(15) FIGS. 17A, 17B, 18A, and 18B are diagrams, analogous to the preceding diagrams, of several variant embodiments relative to the means for relative movement formed by the deformable, rigid connecting means.

(16) FIG. 19 is a diagram that is analogous to the preceding diagrams illustrating an embodiment where the containment plate incorporates a deformable elastic element.

(17) FIG. 20 is a diagram that is analogous to the preceding diagrams, but separated, illustrating an implementation of the flexible 3D pouch in which the latter incorporates an inherently rigid containment wall.

(18) FIGS. 21A, 21B, 22A and 22B are diagrams that are analogous to the preceding diagrams in which the flexible 3D pouch incorporates parts of containment means.

(19) FIGS. 23A, 23B and 23C are three diagrams that illustrate the draining of the flexible 3D pouch.

DETAILED DESCRIPTION OF THE INVENTION

(20) A rigid container 1 according to the invention is specially designed to accommodate and to hold a flexible 3D pouch 2, itself specially designed to contain a biopharmaceutical fluid as defined above.

(21) The rigid container 1, made of plastic or another synthetic or metal material, preferably made of stainless steel, comprises a unitif necessary that can be removed and re-installedof several parts in generally solid or substantially solid panels that are flat or substantially flat, as well as connecting pieces for reinforcement, accessories . . . .

(22) Thus, the rigid container 1 comprises a lower transverse wall 3 and an erect side peripheral axial wall 4 in four panels that are two by two in a manner perpendicular or parallel to one another.

(23) In a normal situation, the lower transverse wall 3 is arranged horizontally or essentially horizontally while the erect side peripheral axial wall 4 is arranged vertically or essentially vertically, optionally slightly tapered from the lower transverse wall 3.

(24) The description is given with respect to this situation. It is also in reference to this situation that the words horizontal, vertical, lower, and upper, . . . should be understood.

(25) Of course, the rigid container 1 can, in some cases, be placed differently, for example for cleaning.

(26) Opposite the lower transverse wall 3, the erect side peripheral axial wall 4 forms and limits an upper transverse opening 6 toward its upper free edge 5.

(27) The opening 6 makes it possible to access a housing 7 of general parallelepipedic or essentially parallelepipedic shape, defined and limited by inner surfaces 3a and 4a of the lower and side walls 3 and 4, while being open at the location of the opening 6.

(28) In the embodiment shown in FIGS. 1 and 2, the housing 7 has three lengths, horizontally and vertically, of the same order of magnitude but nevertheless different with a large side and a small side, such that the housing 7 has a general shape that is similar to a parallelepiped or essentially a parallelepiped.

(29) As a variant, these lengths can be similar, such that the housing 7 has a general shape that is similar to a cube or essentially a cube.

(30) As appropriate, these lengths can be encompassed between on the order of 400 cm and 1,200 cm, such that the internal volume of the housing 7 can be on the order of 50 liters, but also can reach 1,000 liters, whereby these data are given by way of example but are nonlimiting.

(31) For example, according to typical embodiments, a container can have the following as dimensions: 410410520 cm (50 liters) or 1,1359351,000 cm or 1,000 liters.

(32) Based on dimensions, the walls 3 and 4 can comprise external reinforcement ribs such as 4b.

(33) In the embodiment shown in FIGS. 1 and 2, the rigid container 1 also comprises a removable cover 8 that is equipped with gripping and manipulation elements 8a, coming to rest by its edge 8b on the free edge 5 of the wall 4. If necessary, quick locking means 8c of the cover 8 are provided in closed position, concealing the opening 6. In the embodiment shown in FIGS. 1 and 2, the rigid container 1 also comprises, on its wall 4 or on one or more of its constituent panels, one or more doors 9, or one or more openings that make it possible to access the interior of the housing 7, and, if necessary, located in such a way as to be able to correspond with ports, openings, and pipes provided on the pouch 3 or combined with it.

(34) If necessary, one or more analogous doors or one or more analogous openings are provided in the lower transverse wall 3 and optionally in the cover 8.

(35) In the embodiment shown in FIGS. 1 and 2, the rigid container 1 also comprises an underframe 10 in the lower part, below the lower transverse wall 3. Such an underframe 10 makes it possible, i.a., to raise the lower transverse wall 3 above the ground and to have access thereto or to make it possible to combine thereto ports, connections, pipes, or the like. Such an underframe 10 also makes it possible to provide spaces for the passage of forks of a palette-type transport vehicle.

(36) The flexible 3D pouch 2 is specially designed for accommodating a biopharmaceutical fluid. Such a pouch 2 comprises a lower end wall 11, an upper end wall 12, and a flexible side wall 13 that can be found in two end statesfolded flat and deployed unfoldedand can be deformed for switching from one to the other of these states or for being in any intermediate state.

(37) Such a disposable, biocompatible, flexible 3D pouch 2 can have a large volume of at least 50 liters, up to 1,000 liters, and even more, which justifies the fact that it is described as 3D. Such a pouch is described in, for example, the International Application WO00/04131, whereby this embodiment is not exclusive of others.

(38) Of course, the dimensions of the rigid container 1 and those of the flexible 3D pouch 2 are suitable, such that the housing 7 of the rigid container 1 is able to accommodate the flexible 3D pouch 2.

(39) When the flexible 3D pouch 2 is filled with biopharmaceutical fluid, it is inflated, more or less greatly. Whereas its lower wall 11 can rest on the inner surface 3a of the wall 3 of the rigid container 1, its side wall 13 comes to be applied against the inner surface 4a of the side wall 4 of the rigid container 1.

(40) The 3D pouch 2 comprises one or more inlet or intake 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 outlet or evacuation or drain openings 25 (FIGS. 23A, 23B and 23C) in particular on the lower 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.

(41) The rigid container 1 also comprises containment means 14 that comprise a containment wall 15 that is movable, and, if necessary, removable.

(42) The containment wall 15 is arranged in such a way as to be able to be arranged transversely in a general horizontal or essentially horizontal direction, in the housing 7, at any level or height desired between the lower transverse wall 3 and the upper free edge 5 or the opening 6 or the cover 8 when it is provided.

(43) Furthermore, horizontally, the containment wall 15 has two lengths that are defined based on corresponding lengths of the housing 7 in such a way that between the outside peripheral free edge 15a of the containment wall 15 and the inner surface 4a of the side wall 4 opposite the rigid container 1, the transverse gap is limited, for example on the order of a centimeter. For example, the containment plate has a general rectangular or square shape.

(44) The containment wall 15 is arranged in such a way as, on the one hand, to be able to be applied with a certain downward vertical axial force against the upper outside surface 12a of the transverse upper wall 12 of the 3D pouch 2and to absorb the opposite reaction forceand, on the other hand, to be held fixed in this application position by holding means 16 that are then in the active state.

(45) The rigid container 1 therefore also comprises holding means 16.

(46) As indicated, these holding means 16, when they are in the active state, hold fixed in position the containment wall 15 that is applied with a certain force against the upper outside surface 12a of the transverse upper wall 12 of the 3D pouch 2.

(47) Contrary to known arrangements of the prior art in which such holding means are arranged with respect to the rigid container in an axial vertical way, in this invention, the holding means 16 are arranged transversely in the rigid container 1, i.e., in general horizontally or essentially horizontally.

(48) Furthermore, the holding means 16 are borne not by the walls that comprise the container, but are borne by the containment means 14 of which they are part, in a structural and functional combination.

(49) The holding means 16 are arranged in such a way as to be movable or deformable in the transverse direction, i.e., in general horizontally or essentially horizontally, between an inactive retracted state and an active expanded state.

(50) In the inactive retracted state, as illustrated by FIG. 4A, a distal end part 16a of the holding means 16 is separated from the inner surface 4a of the side wall 4 opposite the rigid container 1, such that the holding means 16 then are not held fixed in position with respect to the walls 3, 4 of the rigid container 1.

(51) In contrast, in the active expanded state, as illustrated by FIG. 4B, the distal end part 16a is applied against the inner surface 4a of the side wall 4 opposite the rigid container 1 without any chance of inadvertent sliding. Thus, in the active expanded state, the holding means 16 are held fixed in position with respect to the walls 3, 4 of the rigid container 1.

(52) On the other hand, the holding means 16 are arranged in such a way as to be able to be applied at any desired location of a continuous zone 17 of the inner surface 4a of the side wall 4, according to a continuous variation. This zone 17 is extended in the vertical axial direction, in particular over the entire height or essentially the entire height of the rigid container 1, in such a way that the containment wall 15 can be placed in the housing 7 at any desired distancevarying continuouslyfrom the lower transverse wall 3 or at any desired distance from the upper transverse opening 6.

(53) FIG. 5 illustrates three possible particular different positions in height of the containment plate 15, corresponding to three different volumes of the biopharmaceutical product contained in the flexible 3D pouch 2, namely a volume V1, a volume V2 that is greater than V1, and a volume V3 that is greater than V2.

(54) As a result of the preceding, the containment wall 15 can be applied and held with a certain axial force against the upper outside surface 12a of the transverse upper wall 12 of the 3D pouch 2, regardless of how full the latter is, with this degree of filling able to vary continuously.

(55) The rigid continuer 1 as it was just described can be the object of different embodiments.

(56) Thus, in the embodiment shown in FIG. 1, the containment wall 15 is solid. In the embodiment of FIG. 2 or other derived embodiments, the containment wall 15 comprises one or more holes, cutouts or pipe passages 18, connections, pipes, or the like, not shown, that are functionally combined with or designed to be functionally combined with the flexible 3D pouch 2.

(57) In the embodiment shown in FIG. 4, the containment wall 15 has a certain thickness or excess thicknesses, such that it is inherently rigid enough and able, in itself, to absorb the force exerted on the flexible 3D pouch 2 without substantial deformation.

(58) In the embodiment shown in FIGS. 6A and 6B, the containment wall 15 is not inherently rigid enough and able, in itself, to absorb the force exerted on the flexible 3D pouch 2 without substantial deformation. In this case, it is provided that the containment means 14 also comprise stiffening means 19.

(59) The stiffening means 19 are arranged in such a way that when they are active, they act on the containment wall 15 to stiffen it enough so that, thus stiffened, it is able to absorb the force exerted on the flexible 3D pouch 2 without substantial deformation.

(60) In the variant embodiment of FIGS. 6A and 6B, the stiffening means 19 are in the form of a stiffening chamber 19a that is placed above and adjacent to the containment wall 15, which is generally a solid plate. This stiffening chamber 19a is deformable and substantially inelastic. It can be made active by being filled with a fluid that is brought to it via an inlet/outlet port 19b (see FIGS. 9A and 9B) in such a way as to provide in general a certain overall stiffness that in turn imparts the necessary overall stiffness to the containment plate 15. In this embodiment, means for filling and draining the stiffening chamber 19a, able to be combined with the inlet/outlet port 19b, are also provided.

(61) In the variant embodiment of FIGS. 7A and 7B, the stiffening means 19 are in the form of a stiffening chamber 19a placed below and adjacent to the containment wall 15.

(62) In the variant embodiment of FIGS. 8A and 8B, the containment wall 15 is generally not a solid plate as above but in the shape of a frame forming an opening 20, whereby the stiffening chamber 19a is placed in this opening 20.

(63) In the variant embodiment of FIGS. 6A and 6B, the containment wall 15 is separate but applied against the lower surface of the stiffening chamber 19a. In the variant embodiment of FIGS. 7A and 7B, the containment wall 15 is separate but applied against the upper surface of the stiffening chamber 19a.

(64) In the variant embodiment of FIGS. 10A and 10B, the containment wall 15 is part of the lower wall of the stiffening chamber 19a.

(65) As appropriate, a single stiffening chamber 19a or several chambers are provided. In contrast, unless it is not possible, combining the different variants described above can be considered.

(66) According to another possible variant that is illustrated by FIGS. 11A, 11B, 12A, and 12B, the holding means 16 are borne by the stiffening means 19, when such means are provided. When such stiffening means 19 are not provided, the holding means 16 are borne by the containment wall 15, as illustrated by, for example, FIG. 3.

(67) According to a possible embodiment, the containment means 14 are inherently heavy enough and able, in themselves, to exert by their own weight the desired force on the flexible 3D pouch 2.

(68) According to another possible embodiment, in contrast, the containment means 14 are not inherently rigid enough and able, in themselves, to exert by their own weight the desired force on the flexible 3D pouch 2.

(69) In this case, it is provided that the containment means 14 also comprise additional suitable means for application of such a force. These means, when they are active, are able to act on the containment wall 15 to exert on it a force such that the containment means 14 in turn exert the desired force on the flexible 3D pouch 2. Such means for application of a force are, according to the embodiments considered, manual or human means, or else a cylinder, or else heavy weights.

(70) According to another possible embodiment, the containment means 14 comprise: Below, the containment wall 15, Above, a support element 21, extended transversely, i.e., horizontally or essentially horizontally, placed perpendicular to the containment wall 15, bearing the holding means 16, And, interposed between the containment wall 15 and the support element 21 and combined with them structurally and functionally, means 22 for rigid connection and transmission of forces.

(71) These rigid connecting means 22 are able to ensure a rigid connection for transmission of the desired force to the flexible 3D pouch 2 between the containment wall 15 and the support element 21.

(72) According to a variant of this embodiment, the means 22 for rigid connection and transmission of forces are substantially non-deformable.

(73) According to another variant, illustrated by, for example, FIGS. 13A and 13B, the means 22 for rigid connection and transmission of forces are deformable between two end states, namely a retracted state (FIG. 13A) and an expanded state (FIG. 13B).

(74) In the retracted state, the containment wall 15 is brought closer to the means 16 for holding that are borne by said support element, whereas in the expanded state, it is moved farther away.

(75) Furthermore, suitable maneuvering means are provided that can switch the deformable means 22 for rigid connection and transmission of forces between their two end states. Such maneuvering means consequently constitute means for relative movement of the containment wall 15 with respect to the support element 21 for bringing it closer thereto or moving it away therefrom.

(76) According to one embodiment, in the retracted state of the means 22 for rigid connection and transmission of forces, the containment wall 15 is located close to the support element, which provides to the unit a great compactness in the vertical axial direction.

(77) According to another embodiment, which can be combined with the preceding embodiment, in the expanded state of the means 22 for rigid connection and transmission of forces, the containment wall 15 is located close to the lower transverse wall 3 of the rigid container 1. This constructive arrangement makes it possible to evacuate the biopharmaceutical product via an evacuation port 25 that is provided on the lower wall 11 of the flexible 3D pouch 2, until the pouch 2 is completely drained.

(78) The support element 21 can be the object of different variant embodiments.

(79) In the case of FIGS. 13A and 13B, the support element 21 is a rigid plate, having dimensions such that the transverse gap between its outside peripheral free edge and the inner surface 4a of the side wall 4 opposite the rigid container 1 is limited.

(80) In the case of FIGS. 14A and 14B, the support element 21 is a rigid frame.

(81) In the case of FIGS. 15A and 15B and 16A and 16B, the support element 21 is a deformable chamber and substantially inelastic, made rigid by being filled with a fluid, provided with an inlet/outlet port for the filling fluid (not shown), with filling and draining means being able to be combined with the inlet/outlet port.

(82) The relative movement means formed by the deformable connecting means 22 can be the object of different variant embodiments.

(83) In the case of FIGS. 17A and 17B, the relative movement means 22 comprise two cylinders.

(84) In the case of FIGS. 18A and 18B, the relative movement means 22 comprise a deformable chamber that is made more or less flat or more or less expanded by a more or less significant filling with a fluid, whereby this chamber 22 is provided for this purpose with an inlet/outlet port for filling fluid, with means for filling and draining being provided that can be combined with the inlet/outlet port.

(85) According to other possible variant embodiments, the containment wall 15 is either structurally separate from the flexible 3D pouch 2 or, in contrast, is a structural part of it.

(86) According to one embodiment, the lower surface of the containment wall 15 lacks rough spots that are likely to damage the flexible 3D pouch 2.

(87) According to one embodiment that is illustrated by FIG. 19, an elastically deformable element 23, such as a plate made of alveolar material, designed to assume the shape of the surface 12a of the upper wall 12 of the flexible 3D pouch 2, is combined with the containment wall 15.

(88) With a rigid container 1 as it was just described, it is possible to implement conventional flexible 3D pouches 2 without the latter needing to be adapted for this purpose.

(89) It is also possible to provide for implementing flexible 3D pouches 2 that are specially adapted to the rigid container 1 that is provided with the containment means 14 described above, such a 3D pouch 2 comprising, combined structurally, toward the upper wall 12, at least a portion of the containment means 14.

(90) For example, the flexible 3D pouch 2 can include the containment wall 15 in a structural way.

(91) In a possible embodiment illustrated by FIG. 20, the flexible 3D pouch 2 incorporates an inherently rigid containment wall 15.

(92) In another possible embodiment that is illustrated by FIGS. 21A and 21B, the flexible 3D pouch 2 incorporates a containment wall 15 that is not inherently rigid, as it was described above, and it comes in the form of a stiffening chamber. In such an embodiment, the flexible 3D pouch 2 is part of the lower wall of such a stiffening chamber that is placed above the containment wall 15 itself. As already described, such a deformable and substantially inelastic stiffening chamber is made rigid and active by being filled with a fluid.

(93) In the embodiment that is illustrated by FIGS. 22A and 22B, the flexible 3D pouch 2 incorporates a containment wall 15 that supports the holding means 16, with a chamber also being provided for stiffening the containment wall 15.

(94) In addition to the rigid container 1 and the flexible 3D pouch 2, the invention also relatesin that it incorporates at least a portion of the containment means 14to the process for implementing such a rigid container, as it was described above.

(95) In a first variant embodiment, the process comprises the following successive stages: An empty flexible 3D pouch 2 is provided; The empty flexible 3D pouch 2 is placed in the housing 7 of the rigid container 1 in such a way that it can be deployed in the latter; The flexible 3D pouch 2 is filled through an opening that is provided for this purpose, to introduce therein a certain quantity of biopharmaceutical fluid, with the pouch 2 thus being at least partially deployed, its side wall 13 being contained by the side wall 4 of the rigid container 1, and then the opening of the thus filled pouch 2 is sealed; At any moment and regardless of how full the flexible 3D pouch 2 is, the containment means 14, whose holding means 16 are in the inactive retracted state, are brought transversely into the housing 7 of the rigid container 1 until the containment wall 15 comes against the surface 12a of the upper wall of the flexible 3D pouch 2, and is applied on it with a certain axial force; In this situation, the holding means 16 are switched from the inactive retracted state to the active expanded state, and thus the distal end part 16a is locked on the inner surface 4a of the side wall 4 opposite it, without any chance of inadvertent sliding, at any corresponding location of the continuous zone 17.

(96) In another possible embodiment, the following stages are initiated: An empty flexible 3D pouch 2 is provided; The empty flexible 3D pouch 2 is placed in the housing 7 of the rigid container 1 in such a way that it can be deployed in the latter; The containment means 14, whose holding means 16 are in the inactive retracted state, are brought transversely into the housing 7 of the rigid container 1 until the containment wall 15 comes against the surface 12a of the upper wall of the flexible 3D pouch 2; The flexible 3D pouch 2 is filled through an opening to introduce therein a certain quantity of biopharmaceutical fluid, with the pouch 2 thus being at least partially deployed, its side wall 13 being contained by the side wall 4 of the rigid container 1, and then the opening of the thus filled pouch 2 is closed; In this situation, the holding means 16 are switched from the inactive retracted state to the active expanded state, and thus the distal end part 16a is locked on the inner surface 4a of the side wall 4 opposite it, without any chance of inadvertent sliding, at any corresponding location of the continuous zone 17.

(97) In the case where means 22 for relative movement of the containment wall 15 with respect to a support element 21 are provided, the process is such that when the containment means 14 are brought into the housing 7 of the rigid container 1 and when the holding means 16 are switched from the inactive retracted state to the active expanded state, the means 22 for relative movement of the containment wall 15 with respect to the support element 21 are controlled so that they are in the retracted state.

(98) FIGS. 23A, 23B and 23C illustrate the process in the case where means 22 for relative movement of the containment wall 15 with respect to the support element 21 are provided and in the case where it is desired to drain the pouch. Then, the means 22 for relative movement of the containment wall 15 relative to the support element 21 are switched from the retracted state to the expanded state in such a way as to flatten the flexible 3D pouch 2 and to ensure its complete draining, with the containment wall 15 coming against the lower wall 3 of the rigid container.

(99) The purpose of the invention is also the process in the case where a flexible 3D pouch 2 is selected, with which pouch is structurally combined at least one portion of the containment means 14, in the upper part.

(100) As indicated above, the implementation is quite particularly noteworthy because after the stage in which the holding means 16 are switched from the inactive retracted state to the active expanded state, the rigid container 1 that holds the flexible 3D pouch 2, filled with its contents, is shipped and transported without its integrity being affected, regardless of how full the flexible 3D pouch 2 is.