EP3106408A2 - Rigid container for a flexible bag intended for holding a biopharmaceutical fluid and implementation method - Google Patents

Abstract

The container (1) comprises a bottom wall and an erected side wall limiting an opening (6) above a housing (7) adapted to receive a flexible bag (2) containing a biopharmaceutical fluid; contention means (14) comprising a wall (15) of contention, the clearance between its peripheral edge and the side wall being limited; the wall (15) of contention being able to be applied against the pocket (2) and to be fixedly held in this position by means (16) for holding in the active state, which means (16) for holding being arranged in the container (1) and carried by the means (14) of contention by a structural and functional combination, being movable or deformable in between an inactive retracted state and an active expanded state, wherein a distal end portion is spaced from the wall side is applied against it without the possibility of inadvertent sliding; and being adapted to be applied at any desired location in an area of the side wall so that the wall (15) of contention can be applied and held against the pocket (2) regardless of the degree of filling thereof. this.

Description

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.

In one embodiment, 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. Such 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.

With the arrangement according to the document EP-A-1012073 , 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.

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. However, 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. By deploying the jack, the lower transverse wall is moved upwards and compresses the flexible bag between this wall and the lid, which allows to expel the viscous product from the flexible bag to route it to the packaging machine.

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 .

It is also known from the document FR-A-0 932 321 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.

It is also known from the state of the art the document EP-A-0 456 403 which discloses a container for a flexible pouch filled with a pharmaceutical product. According to this embodiment, 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. In particular, 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. Indeed, 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.

There is therefore a need for a rigid container for a large flexible bag 3D which, on the one hand, is able to preserve the integrity of the bag and its contents, even when the bag is only partially filled with biopharmaceutical product, when the bag thus filled is moved and transported a significant distance and / or under conditions that are capable of generating sudden movements or significant accelerations, and which, on the other hand, is compact.

• une paroi transversale inférieure et une paroi axiale périphérique latérale érigée limitant une ouverture transversale supérieure d'accès à un logement défini les faces internes des parois inférieure et latérale, apte à recevoir la poche souple contenant le fluide biopharmaceutique qui vient s'appliquer contre ces faces internes,
• des moyens de contention comprenant une paroi de contention,
• la paroi de contention étant apte à être placée transversalement dans le logement et ayant des dimensions telles que le jeu transversal entre son bord libre périphérique extérieur et la face interne de la paroi latérale en regard soit limité,
• la paroi de contention étant apte à être appliquée avec une certaine force axiale contre la face supérieure libre de la paroi transversale supérieure de la poche et à être maintenue fixement dans cette position par des moyens de maintien à l'état actif,
• des moyens de maintien qui, à l'état actif, s'appliquent sur la face interne de la paroi latérale de sorte à maintenir fixement en position la paroi de contention appliquée avec la dite certaine force contre la face supérieure libre de la poche,

caractérisé en ce que les moyens de maintien, disposés transversalement dans le conteneur et portés par les moyens de contention dont ils font partie, par une association structurelle et fonctionnelle sont mobiles ou déformables en direction transversale entre un état rétracté inactif et un état expansé actif, dans lesquels, respectivement, une partie extrême distale de ces moyens de maintien est soit écartée de la face interne de la paroi latérale en regard soit appliquée contre elle sans possibilité de glissement intempestif, de manière que, à l'état actif des moyens de maintien et de leur partie extrême distale, la paroi de contention soit maintenue fixement en position par rapport aux parois du conteneur,
et en ce que ces moyens de maintien sont aptes à être appliqués à tout emplacement souhaité d'une zone continue de la face interne de la paroi latérale, étendue en direction axiale, de manière que la paroi de contention puisse être placée dans le logement à la distance souhaitée de la paroi transversale inférieure ou de l'ouverture transversale supérieure, pour pouvoir être appliquée et maintenue avec une certaine force axiale contre la face supérieure transversale libre de la poche quel que soit le degré d'emplissage de celle-ci.For this purpose, and according to a first aspect, the invention proposes a rigid container for a flexible bag specifically intended to contain a biopharmaceutical fluid, comprising:

• a lower transverse wall and an erected lateral peripheral axial wall limiting an upper transverse opening for access to a housing defined the internal faces of the lower and lateral walls, adapted to receive the flexible pouch containing the biopharmaceutical fluid which is applied against these faces internal,
• restraining means comprising a wall of contention,
• the compression wall being adapted to be placed transversely in the housing and having dimensions such that the transverse clearance between its outer peripheral free edge and the inner face of the side wall facing is limited,
• the compression wall being adapted to be applied with a certain axial force against the upper free face of the upper transverse wall of the bag and to be fixedly held in this position by holding means in the active state,
• holding means which, in the active state, are applied on the internal face of the side wall so as to hold the compression wall applied in position with said certain force against the free upper face of the pocket,

characterized in that the holding means, arranged transversely in the container and carried by the restraining means to which they belong, by a structural and functional combination are movable or deformable in the transverse direction between an inactive retracted state and an active expanded state, in which, respectively, a distal end portion of these holding means is either spaced from the inner face of the side wall opposite or applied against it without the possibility of inadvertent sliding, so that, in the active state of the holding means and their distal end portion, the contention wall is fixedly held in position relative to the walls of the container,
and in that these holding means are adapted to be applied to any desired location of a continuous zone of the inner face of the side wall, extended in the axial direction, so that the compression wall can be placed in the housing to the desired distance from the lower transverse wall or the upper transverse opening, to be able to be applied and maintained with a certain axial force against the free transverse upper face of the pocket whatever the degree of filling thereof.

According to a first embodiment, the wall of contention is intrinsically sufficiently rigid and able, in itself, to cash without substantial deformation, the said certain force.

According to a second embodiment, 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.

In this second embodiment, and according to one possibility, 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. In particular, 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.

In this second embodiment and according to a first variant, the contention wall is distinct but applied against the lower or upper face of the at least one stiffening enclosure. According to a second variant, the compression wall is part of the bottom wall of the at least one stiffening chamber.

In this second embodiment, and according to one variant, the holding means are carried by the stiffening means.

According to another first embodiment, 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.

According to another second embodiment, 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.

In this second alternative embodiment, and in a variant, said means for applying a force are manual or human means, a jack, heavy masses.

According to another possible embodiment, the holding means are carried by the wall of contention.

According to another possible embodiment, 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.

In this latter embodiment and according to a first variant, the rigid linkage and force transmission means are substantially indeformable.

According to a second variant, 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.

In this second variant, and in one embodiment, in the retracted state of the rigid connection and force transmission means, the contention wall is located near the support member.

In this second variant, and in one embodiment, in the expanded state of the rigid connection and force transmission means, the compression wall is located near the lower transverse wall.

According to one embodiment, 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.

According to a variant according to this embodiment, 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. .

According to one embodiment, 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.

In one embodiment, the contention wall is structurally distinct from the flexible pouch for containing a biopharmaceutical fluid.

In one embodiment, the contention wall is structurally part of the flexible pouch for containing a biopharmaceutical fluid.

In one embodiment, the container also has a removable cover.

According to one embodiment, 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.

In one embodiment, the underside of the compression wall is free of asperities likely to damage the pocket.

According to one embodiment, the compression wall is associated with an elastically deformable element intended to match the shape of the free top face of the pocket.

In one embodiment, 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.

According to a second aspect, 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.

According to one embodiment, is associated with the flexible pouch structurally, in the upper part, a wall of contention part of the contention means.

In another embodiment, is associated with the actual pocket, an inherently rigid wall contention.

According to another embodiment, is associated with the actual pocket, 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.

In one embodiment, the bag also comprises holding means carried by the compression wall.

• on dispose d'une poche souple vide ;
• on place la poche souple vide dans le logement du conteneur, de manière qu'elle puisse se déployer dans celui-ci ;
• on emplit la poche par une ouverture pour y introduire une certaine quantité de fluide biopharmaceutique, la poche étant ainsi au moins partiellement déployée, sa paroi latérale étant contenue par la paroi latérale du conteneur, puis on ferme l'ouverture de la poche ainsi emplie ;
• à tout moment et quelque soit le degré d'emplissage de la poche, on amène les moyens de contention, dont les moyens de maintien sont à l'état rétracté inactif, dans le logement du conteneur, transversalement, jusqu'à ce que la paroi de contention vienne contre la face supérieure transversale libre de la poche et appliquée sur elle avec une certaine force axiale ;
• dans cette situation, on fait passer les moyens de maintien de l'état rétracté inactif à l'état expansé actif et, ainsi, on bloque la partie extrême distale sur la face interne de la paroi latérale en regard, sans possibilité de glissement intempestif, à tout emplacement correspondant de la zone continue.

According to a third aspect, and a first embodiment, the invention proposes a method for implementing a container as described above, in which:

• an empty flexible bag is available;
• the empty flexible bag is placed in the container housing so that it can be deployed therein;
• the bag is filled by an opening to introduce a certain amount of biopharmaceutical fluid, the bag thus being at least partially deployed, its side wall being contained by the side wall of the container, and then closing the opening of the bag thus filled;
• at any time and regardless of the degree of filling of the bag, the restraining means, whose holding means are in the retracted inactive state, is brought into the container housing, transversely, until the wall of contention comes against the free transverse upper surface of the pocket and applied to it with a certain axial force;
• in this situation, the means for maintaining the inactive retracted state in the active expanded state are passed and, thus, the distal end portion is blocked on the internal face of the opposite lateral wall, without the possibility of inadvertent sliding, at any corresponding location in the continuous zone.

• on dispose d'une poche souple vide ;
• on place la poche souple vide dans le logement du conteneur, de manière qu'elle puisse se déployer dans celui-ci ;
• on amène les moyens de contention, dont les moyens de maintien sont à l'état rétracté inactif, dans le logement du conteneur, transversalement, jusqu'à ce que la paroi de contention vienne contre la face supérieure transversale libre de la poche ;
• on emplit la poche par une ouverture pour y introduire une certaine quantité de fluide biopharmaceutique, la poche étant ainsi au moins partiellement déployée, sa paroi latérale étant contenue par la paroi latérale du conteneur, puis on ferme l'ouverture de la poche ainsi emplie ;
• dans cette situation, on fait passer les moyens de maintien de l'état rétracté inactif à l'état expansé actif et, ainsi, on bloque la partie extrême distale sur la face interne de la paroi latérale en regard, sans possibilité de glissement intempestif, à tout emplacement correspondant de la zone continue.

According to a second embodiment, the invention proposes a method for implementing a container as described above, in which:

• an empty flexible bag is available;
• the empty flexible bag is placed in the container housing so that it can be deployed therein;
• bringing the restraining means, whose holding means are in the retracted inactive state, in the housing of the container, transversely, until the wall of contention comes against the free transverse upper face of the pocket;
• the bag is filled by an opening to introduce a certain amount of biopharmaceutical fluid, the bag thus being at least partially deployed, its side wall being contained by the side wall of the container, and then closing the opening of the bag thus filled;
• in this situation, the means for maintaining the inactive retracted state in the active expanded state are passed and, thus, the distal end portion is blocked on the internal face of the opposite lateral wall, without the possibility of inadvertent sliding, at any corresponding location in the continuous zone.

According to one embodiment in the case where there is provided means for relative displacement of the wall of contention relative to the support member, when bringing the means of contention in the housing of the container and when it is passed the means of maintaining the inactive retracted state at the expanded state active, the relative displacement means of the compression wall relative to the flat member are in the retracted state.

According to one embodiment, in the case where means for relative displacement of the retaining wall with respect to the support member are provided, when it is desired to empty the bag, 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.

According to one embodiment, a flexible pouch is chosen which is structurally associated, in the upper part, at least a portion of the contention means.

According to one embodiment, 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.

• La figure 1 est une vue en perspective écorchée et pour partie désassemblée d'un ensemble comportant un conteneur rigide dans le logement duquel est placée une poche souple 3D emplie de produit biopharmaceutique.
• La figure 2 est une vue analogue à la figure 1, sous un autre angle de vue et selon une variante dans laquelle la paroi de contention comporte un trou ou passage pour un ou des tuyaux, raccords, conduits ou analogues non représentés.
• La figure 3 est une vue en perspective générale d'une réalisation des moyens de contention du conteneur rigide.
• La figure 4 est un schéma simplifié, en coupe par un plan vertical du conteneur rigide, dans le cas d'une plaque de contention intrinsèquement suffisamment rigide.
• Les figures 4A et 4B sont deux vues partielles, à plus grande échelle illustrant, respectivement les moyens de maintien à l'état rétracté inactif et à l'état expansé actif.
• La figure 5 est un schéma analogue à la figure 4, partiel et à plus grande échelle illustrant trois positions différentes possibles des moyens de contention et la zone continue d'application des moyens de maintien.
• Les figures 6A et 6B sont deux schémas analogues au schéma de la figure 4, d'une variante de réalisation possible dans le cas d'une plaque de contention à laquelle sont associés des moyens de rigidification, en l'espèce une enceinte de rigidification placée au dessus de la plaque de contention, celle-ci n'étant pas intrinsèquement suffisamment rigide et apte à encaisser sans déformation substantielle la force exercée sur la poche 3D. Sur la figure 6A, ces moyens de rigidification sont inactifs, tandis que sur la figure 6B, ils sont actifs.
• Les figures 7A et 7B sont deux schémas analogues aux schémas des figures 6A et 6B, dans une autre variante de réalisation possible, l'enceinte de rigidification étant ici placée au dessous de la plaque de contention.
• Les figures 8A et 8B sont deux schémas analogues aux schémas des figures 6A, 7A et 6B, 7B, dans une autre variante de réalisation possible où la paroi de contention est en forme de cadre, tandis que l'enceinte de rigidification vient se placer dans le cadre.
• Les figures 9A et 9B sont deux schémas analogues aux schémas des figures 6A, 7A et 8A et 6B, 7B et 8B, illustrant un port entrée/sortie de fluide de l'enceinte de rigidification.
• Les figures 10A et 10B sont deux schémas analogues aux schémas précédents, dans une variante dans laquelle la paroi de contention fait partie de la paroi inférieure de l'enceinte de rigidification.
• Les figures 11A et 11B et 12A et 12B sont quatre schémas analogues aux schémas précédents, dans deux variantes dans lesquelles les moyens de maintien sont portés par les moyens de rigidification.
• Les figures 13A, 13B, 14A, 14B, 15A, 15B, 16A, 16B sont des schémas analogues aux schémas précédents, de plusieurs variantes de réalisation concernant des moyens de liaison rigide et de transmission de forces interposés entre la paroi de contention et un organe support.
• Les figures 17A, 17B, 18A, 18B sont des schémas analogues aux schémas précédents, de plusieurs variantes de réalisation concernant des moyens de déplacement relatif formés par les moyens de liaison rigide déformables.
• La figure 19 est un schéma analogue aux schémas précédents illustrant une réalisation où la plaque de contention incorpore un élément élastique déformable.
• La figure 20 est un schéma analogue aux schémas précédents, mais dissocié, illustrant une réalisation de poche souple 3D dans laquelle celle-ci incorpore une paroi de contention intrinsèquement rigide.
• Les figures 21A, 21B, 22A et 22B sont des schémas analogues aux schémas précédents dans lesquels la poche souple 3D incorpore des parties des moyens de contention.
• Les figures 23A, 23B et 23C sont trois schémas illustrant le vidage de la poche souple 3D.

Several embodiments of the invention will now be described with the aid of the drawings, in which:

• The figure 1 is a perspective view cut away and partially disassembled of an assembly comprising a rigid container in the housing of which is placed a 3D flexible pouch filled with biopharmaceutical product.
• The figure 2 is a view similar to the figure 1 , from another angle of view and according to a variant in which the compression wall comprises a hole or passage for one or pipes, fittings, conduits or the like not shown.
• The figure 3 is a general perspective view of an embodiment of the contention means of the rigid container.
• The figure 4 is a simplified diagram, in section by a vertical plane of the rigid container, in the case of an inherently sufficiently rigid support plate.
• The Figures 4A and 4B are two partial views, on a larger scale illustrating, respectively, the holding means in the inactive retracted state and the active expanded state.
• The figure 5 is a diagram similar to the figure 4 , partial and on a larger scale illustrating three different possible positions of the contention means and the continuous zone of application of the holding means.
• The Figures 6A and 6B are two schemas analogous to the schema of the figure 4 , of an alternative embodiment possible in the case of a contention plate which is associated stiffening means, in this case a stiffening chamber placed above the support plate, the latter being not inherently rigid enough and able to cash without deformation substantial force exerted on the 3D pocket. On the Figure 6A these stiffening means are inactive, while on the Figure 6B they are active.
• The Figures 7A and 7B are two diagrams similar to the diagrams of Figures 6A and 6B , in another possible embodiment, the stiffening chamber being placed here below the support plate.
• The Figures 8A and 8B are two diagrams similar to the diagrams of Figures 6A , 7A and 6B , 7B , in another possible embodiment where the retaining wall is in the form of a frame, while the stiffening chamber is placed in the frame.
• The Figures 9A and 9B are two diagrams similar to the diagrams of Figures 6A , 7A and 8A and 6B , 7B and 8B , illustrating a fluid inlet / outlet port of the stiffening chamber.
• The Figures 10A and 10B are two diagrams similar to the previous diagrams, in a variant in which the compression wall is part of the lower wall of the stiffening chamber.
• The Figures 11A and 11B and 12A and 12B are four diagrams similar to the previous diagrams, in two variants in which the holding means are carried by the stiffening means.
• The Figures 13A, 13B , 14A, 14B , 15A, 15B , 16A, 16B are diagrams similar to the previous diagrams, several embodiments relating to rigid connection means and force transmission interposed between the wall of contention and a support member.
• The Figures 17A, 17B , 18A, 18B are diagrams similar to the previous diagrams, several embodiments relating to relative displacement means formed by the rigid deformable connecting means.
• The figure 19 is a diagram similar to the previous diagrams illustrating an embodiment where the contention plate incorporates a deformable elastic element.
• The figure 20 is a diagram similar to the previous diagrams, but dissociated, illustrating a 3D flexible pouch embodiment in which it incorporates an inherently rigid compression wall.
• The Figures 21A, 21B , 22A and 22B are diagrams similar to the previous diagrams in which the 3D flexible bag incorporates parts of the contention means.
• The Figures 23A, 23B and 23C are three diagrams illustrating the emptying of the flexible pouch 3D.

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 ...

Thus, 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.

In a normal situation, 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 description is made in connection with this situation. It is also in reference to this situation that must be understood the words "horizontal", "vertical", "lower", "higher" ...

Of course, the rigid container 1 may, in some cases, be placed differently, for example for cleaning.

Opposite the lower transverse wall 3, 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.

In the embodiment shown on the figures 1 and 2 , 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.

Alternatively, these lengths may be close, so that the housing 7 has a general shape close to a cube or substantially a cube.

These lengths can be included, depending on the case, of the order of 400 cm and 1200 cm, so that the internal volume of the housing 7 can be of the order of 50 liters, but also reach 1000 liters, these data being exemplary but not limiting.

For example, according to typical embodiments, a container may have dimensions of 410x410x520 cm (50 liters) or 1,135x935x1,000 cm or 1,000 liters.

Depending on the dimensions, the walls 3 and 4 may include external reinforcing ribs such as 4b.

In the embodiment shown on the figures 1 and 2 , 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.

In the embodiment shown on the figures 1 and 2 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.

Where appropriate, 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.

In the embodiment shown on the figures 1 and 2 , the rigid container 1 also comprises a base 10 in the lower part, below the lower transverse wall 3. Such 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. Such 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. Such a pocket is described for example in the international application WO00 / 04131 , this realization not being exclusive of others.

Of course, 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.

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.

Furthermore, 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. For example, 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.

As indicated, 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.

Unlike arrangements known in the state of the art in which such holding means are arranged relative to the rigid container vertically in the axial direction, in the present invention, the holding means 16 are arranged transversely in the rigid container 1 , that is to say globally horizontally or substantially horizontally.

Furthermore, 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.

In the retracted inactive state, as illustrated by the Figure 4A , 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.

On the contrary, in the expanded state, as illustrated by Figure 4B , the distal end portion 16a is applied against the inner face 4a of the side wall 4 facing the rigid container 1 without the possibility of inadvertent sliding. Thus, in the active expanded state, the holding means 16 are fixedly held in position relative to the walls 3, 4 of the rigid container 1.

On the other hand, 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.

As a result of the above, 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.

Thus, in the embodiment shown on the figure 1 the contention wall 15 is full. In the realization of the figure 2 or other derivative embodiments, 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.

In the embodiment shown on the figure 4 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.

In the embodiment shown on the Figures 6A and 6B 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. In this case, it is expected that 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. flexible 3D, 2.

In the variant embodiment of Figures 6A and 6B , 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. In this embodiment, it is also provided means for filling and emptying the rigidification chamber 19a, adapted to be associated with the input / output port 19b.

In the variant embodiment of Figures 7A and 7B , the stiffening means 19 are in the form of a stiffening chamber 19a placed below and adjacent to the compression wall 15.

In the variant embodiment of Figures 8A and 8B 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.

In the variant embodiment of Figures 6A and 6B , the contention wall 15 is distinct but applied against the underside of the stiffening chamber 19a. In the variant embodiment of Figures 7A and 7B , the contention wall 15 is distinct but applied against the upper face of the stiffening chamber 19a.

In the variant embodiment of Figures 10A and 10B the retaining wall 15 is part of the lower wall of the stiffening chamber 19a.

Depending on the case, there is provided a single rigidification chamber 19a or more speakers. On the other hand, unless impossible, we can consider combining the different variants described above.

According to another possible variant illustrated by the Figures 11A, 11B , 12A, 12B , the holding means 16 are carried by the stiffening means 19, when such means are provided. When such stiffening means 19 are not provided, the holding means 16 are carried by the compression wall 15, as illustrated for example by the figure 3 .

According to one possible embodiment, 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.

According to another possible embodiment, on the contrary, 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.

In this case, it is provided that 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.

• en dessous, la paroi de contention 15,
• au dessus, un organe support 21, étendu transversalement c'est-à-dire horizontalement ou sensiblement horizontalement, placé à l'aplomb de la paroi de contention 15, portant les moyens 16 de maintien
• et, interposés entre la paroi de contention 15 et l'organe support 21 et associés à eux structurellement et fonctionnellement, des moyens 22 de liaison rigide et de transmission de forces.

According to another possible embodiment, the compression means 14 comprise:

• underneath, the wall of contention 15,
• above, a support member 21, extended transversely, that is to say horizontally or substantially horizontally, placed vertically above the compression wall 15, carrying the holding means 16
• and, interposed between the contention wall 15 and the support member 21 and associated structurally and functionally with them, means 22 for rigid connection and transmission of forces.

These means 22 of rigid connection are able to ensure between the wall of contention 15 and the support member 21 a rigid connection of transmission of the desired force on the flexible bag 3D, 2.

According to a variant of this embodiment, the means 22 of rigid connection and force transmission are substantially indeformable.

According to another variant, illustrated for example by Figures 13A and 13B , 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 ).

In the retracted state, 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.

Furthermore, appropriate operating means are provided, able to pass the means 22 of rigid connection and transmission of forces, deformable, between their two extreme states. 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.

According to one embodiment, in the retracted state of the rigid connection and force transmission means 22, the contention wall 15 is situated close to the support member, which gives the assembly a great compactness in the vertical axial direction. .

According to another embodiment, which can be combined with the preceding one, in the expanded state of the rigid linkage and force transmission means 22, 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.

In the case of Figures 13A and 13B , 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.

In the case of Figures 14A and 14B , the support member 21 is a rigid frame.

In the case of Figures 15A and 15B and 16A and 16B , 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.

In the case of Figures 17A and 17B the relative displacement means 22 comprise two jacks.

In the case of Figures 18A and 18B , 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.

According to other possible embodiments, the contention wall 15 is either structurally distinct from the flexible bag 3D, 2 or, conversely, is structurally part of it.

According to one embodiment, the underside of the contention wall 15 is free of asperities likely to damage the flexible pouch 3D, 2.

According to an embodiment illustrated by the figure 19 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.

With a rigid container 1 as just described, it is possible to implement the flexible bags 3D, 2 usual, without them need to be adapted for this purpose.

It is also possible to provide for the use of flexible pouches 3D, 2 specially adapted to the rigid container 1 provided with the previously described compression means 14, such a pocket 3D, 2 having, structurally associated, towards the upper wall 12 at least part of the means 14 of contention.

For example, the 3D flexible pouch 2 may structurally include the retaining wall 15.

In a possible realization illustrated by the figure 20 the 3D flexible pouch 2 incorporates an intrinsically rigid containment wall.

In another possible realization illustrated by the Figures 21A and 21B , 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. In such an embodiment, the flexible pouch 3D, 2 is part of the bottom wall of such a stiffening chamber placed above the compression wall 15 itself. As already described, such a stiffening chamber, deformable and substantially inextensible, is made rigid and active by filling with a fluid.

In the embodiment illustrated by Figures 221 and 22B , 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.

• on dispose d'une poche souple 3D, 2 vide ;
• on place la poche souple 3D, 2 vide dans le logement 7 du conteneur rigide 1, de manière qu'elle puisse se déployer dans celui-ci ;
• on emplit la poche souple 3D, 2 par une ouverture prévue à cet effet, pour y introduire une certaine quantité de fluide biopharmaceutique, la poche 2 étant ainsi au moins partiellement déployée, sa paroi latérale 13 étant contenue par la paroi latérale 4 du conteneur rigide 1, puis on ferme l'ouverture de la poche 2 ainsi emplie de façon étanche ;
• à tout moment et quelque soit le degré d'emplissage de la poche souple 3D, 2, on amène les moyens 14 de contention, dont les moyens 16 de maintien sont à l'état rétracté inactif, dans le logement 7 du conteneur rigide 1, transversalement, jusqu'à ce que la paroi de contention 15 vienne contre la face 12a de la paroi supérieure de la poche souple 3D, 2, et appliquée sur elle avec une certaine force axiale ;
• dans cette situation, on fait passer les moyens 16 de maintien de l'état rétracté inactif à l'état expansé actif et, ainsi, on bloque la partie extrême distale 16a sur la face interne 4a de la paroi latérale 4 en regard, sans possibilité de glissement intempestif, à tout emplacement correspondant de la zone continue 17.

In a first variant embodiment, the method comprises the following successive steps:

• we have a flexible 3D pocket, 2 empty;
• placing the empty 3D flexible pouch 2 in the housing 7 of the rigid container 1, so that it can be deployed therein;
• the flexible pouch 3D is filled, 2 by an opening provided for this purpose, to introduce a certain amount of biopharmaceutical fluid, the bag 2 is thus at least partially deployed, its side wall 13 being contained by the side wall 4 of the rigid container 1, then closing the opening of the pocket 2 and filled tightly;
• at any time and irrespective of the degree of filling of the flexible bag 3D, 2, the means 14 of contention, the means 16 of which are in the retracted inactive state, are brought into the housing 7 of the rigid container 1, transversely, until the contention wall 15 comes against the face 12a of the upper wall of the flexible bag 3D, 2, and applied to it with a certain axial force;
• in this situation, the means 16 for maintaining the inactive retracted state in the active expanded state are passed through and, thus, the distal end portion 16a is blocked on the internal face 4a of the lateral wall 4 opposite, without possibility inadvertent slip at any location in the continuous zone 17.

• on dispose d'une poche souple 3D, 2 vide ;
• on place la poche souple 3D, 2, vide dans le logement 7 du conteneur rigide 1, de manière qu'elle puisse se déployer dans celui-ci ;
• on amène les moyens 14 de contention, dont les moyens 16 de maintien sont à l'état rétracté inactif, dans le logement 7 du conteneur rigide 1, transversalement, jusqu'à ce que la paroi de contention 15 vienne contre la face 12a de la paroi supérieure de la poche souple 3D, 2;
• on emplit la poche souple 3D, 2 par une ouverture pour y introduire une certaine quantité de fluide biopharmaceutique, la poche 2 étant ainsi au moins partiellement déployée, sa paroi latérale 13 étant contenue par la paroi latérale 4 du conteneur rigide 1, puis on ferme l'ouverture de la poche 2 ainsi emplie ;
• dans cette situation, on fait passer les moyens 16 de maintien de l'état rétracté inactif à l'état expansé actif et, ainsi, on bloque la partie extrême distale 16a sur la face interne 4a de la paroi latérale 4 en regard, sans possibilité de glissement intempestif, à tout emplacement correspondant de la zone continue 17.

In another possible embodiment, the following steps are carried out:

• we have a flexible 3D pocket, 2 empty;
• the empty flexible pouch 3, 2, is placed in the housing 7 of the rigid container 1, so that it can be deployed therein;
• the means 14 of contention, whose holding means 16 are in the retracted inactive state, are brought into the housing 7 of the rigid container 1, transversely, until the compression wall 15 comes against the face 12a of the upper wall of the 3D flexible pouch, 2;
• the flexible pouch 3D, 2 is filled with an opening to introduce a certain amount of biopharmaceutical fluid, the bag 2 is thus at least partially deployed, its side wall 13 being contained by the side wall 4 of the rigid container 1, then closed the opening of the pocket 2 thus filled;
• in this situation, the means 16 for maintaining the inactive retracted state in the active expanded state are passed through and, thus, the distal end portion 16a is blocked on the internal face 4a of the lateral wall 4 opposite, without possibility inadvertent slip at any location in the continuous zone 17.

In the case where means 22 for relative displacement of the compression wall 15 with respect to a support member 21 are provided, 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.

The Figures 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.

As indicated above, 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.

Claims (16)

Rigid container (1) for a flexible pouch (2) specially adapted for containing a biopharmaceutical fluid, comprising: a lower transverse wall (3) and an erected lateral peripheral axial wall (4) limiting an upper transverse opening (6) for access to a housing (7) defined the inner faces (3a, 4a) of the lower and lateral walls ( 3, 4), adapted to receive the flexible pouch (2) containing the biopharmaceutical fluid which is applied against these inner faces (3a, 4a), - means (14) of contention comprising a wall (15) of contention, - the wall (15) of contention being able to be placed transversely in the housing (7) and having dimensions such that the transverse clearance between its outer peripheral free edge (15a) and the inner face (4a) of the side wall ( 4) with regard to being limited, - the wall (15) of contention being adapted to be applied with a certain axial force against the upper free face (12a) of the upper transverse wall (12) of the pocket (2) and to be fixedly held in this position by means (16) for maintaining the active state, - holding means (16) which, in the active state, is applied to the inner face (4a) of the side wall (4) so as to hold the wall (15) of compression applied with the said certain force against the free upper face (12a) of the pocket (2), characterized in that the holding means (16), arranged transversely in the container (1) and carried by the means (14) of contention of which they form part, by a structural and functional combination are movable or deformable in the transverse direction between a inactive retracted state and an active expanded state, wherein, respectively, a distal end portion (16a) of these holding means (16) is either spaced from the inner face of the side wall (4) opposite or applied against it without possibility of inadvertent sliding, so that, in the active state of the holding means (16) and their distal end portion, the wall (15) of contention is fixedly held in position relative to the walls of the container (1),
and in that these holding means are adapted to be applied to any desired location of a continuous zone (17) of the inner face (4a) of the side wall (4), extended in the axial direction, so that the wall (15) can be placed in the housing (7) at the desired distance from the lower transverse wall or the upper transverse opening (6), so that it can be applied and maintained with a certain axial force against the transverse upper face free (12a) of the pocket (2) regardless of the degree of filling thereof. Container (1) according to claim 1, characterized in that the wall (15) of contention is intrinsically sufficiently rigid and able, in itself, to cash without substantial deformation, the said certain force is not , the means (14) of restraint then comprising means (19) of stiffening suitable, being active, to act on the wall (15) of contention to stiffen it sufficiently so that, stiffened, it is able to cash without substantial deformation , the so-called certain strength. Container (1) according to any one of claims 1 and 2, characterized in that the means (14) of contention 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 (2). Container (1) according to any one of claims 1 to 3, characterized in that the means (14) of contention are not intrinsically sufficiently suitable, in themselves, to exert by their own weight the said certain force against the free upper face of the pocket (2), the means (14) of contention comprising means for applying a force capable, being active, to act on the wall (15) of contention to exert on it a force such as that the means (14) of contention in turn exert said certain force against the upper free face of the pocket (2). Container (1) according to claim 4, characterized in that said means for applying a force are manual or human means, a cylinder, heavy masses. Container (1) according to any one of claims 1 to 4, characterized in that the means (16) for holding are carried by the wall (15) of contention. Container (1) according to any one of claims 1 to 4, characterized in that the means (14) of contention comprise below the wall (15) contention and above a transversely extended support member placed at the a plumb of the wall (15) of contention, the means (16) for holding being carried by said support member, rigid connecting means and force transmission being interposed between and associated with the wall (15) of contention and to the support member, and being able to provide between the wall (15) of contention and the support member a rigid transmission link of said certain force. Container (1) according to claim 7, characterized in that the rigid connection means and force transmission are substantially indeformable. Container (1) according to claim 7, characterized in that the rigid connection and force transmission means are deformable between two extreme states, a retracted state and an expanded state, in which, respectively, the wall (15) of contention is closer and further away from the holding means (16) carried by said support member, maneuvering means being provided and capable of passing the rigid connection means and transmission of forces between their two extreme states, these means actuating means constituting means for relative displacement of the wall (15) of contention relative to the support member. Container (1) according to claim 9, characterized in that the support member is selected from the group comprising a plate or a rigid frame, in particular a plate adapted to be placed transversely in the housing (7), having dimensions such that the transverse clearance between its outer peripheral free edge and the inner face of the facing side wall is limited. Container (1) according to any one of claims 9 and 10, characterized in that the relative displacement means comprising the rigid connection means and transmission of forces and the actuating means are selected from the group comprise either a jack , a deformable enclosure made more or less flat or more or less expanded by more or less filling with a fluid, provided with an inlet / outlet port of the filling fluid, filling and emptying means being able to be associated at the input / output port, an association thereof, placed between the wall (15) of contention and the support member. Container (1) according to any one of claims 1 to 11, characterized in that the wall (15) of contention is associated with an elastically deformable element intended to match the shape of the free upper face of the pocket (2 ). Container (1) according to any one of claims 1 to 12, characterized in that the wall (15) of contention 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 (2). Process for the implementation of a container (1) according to any one of Claims 1 to 13, in which: - There is a pocket (2) empty flexible; - Place the empty flexible bag (2) in the housing (7) of the container (1), so that it can be deployed therein; the pocket (2) is filled by an opening to introduce a certain amount of biopharmaceutical fluid, the bag (2) thus being at least partially deployed, its side wall being contained by the side wall of the container (1), then closes the opening of the pocket (2) thus filled; - at any time and regardless of the degree of filling of the pocket (2), the means (14) of contention, whose means (16) for holding are in the retracted inactive state, are brought into the housing ( 7) of the container (1), transversely, until the wall (15) of contention comes against the free transverse upper face of the pocket (2) and applied on it with a certain axial force; in this situation, the means (16) for maintaining the inactive retracted state in the active expanded state are passed and, thus, the distal end portion is blocked on the internal face of the facing lateral wall, with no possibility of inadvertent slip at any corresponding location in the continuous zone. A method according to claim 14, in which there is provided means for relative displacement of the wall (15) of contention relative to the support member, characterized in that when the means (14) of contention in the housing (7) of the container (1) and when passing means (16) for maintaining the inactive retracted state in the active expanded state, the means of relative displacement of the wall (15) of contention with respect to the flat member are in the retracted state. Method according to any one of claims 14 and 15, in the case where there is provided means for relative displacement of the wall (15) of contention relative to the support member, characterized in that when one wishes emptying the bag (2), the means of relative displacement of the wall (15) of contention relative to the support member of the retracted state in the expanded state is passed.

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