Biopharmaceutical liquid reservoir with mechanical element with rotating and stationary sets of parts

Description

DOMAINE DE L'INVENTION

[0001] The invention relates to a biopharmaceutical liquid reservoir, in particular intended for the mixing of biopharmaceutical products or more particularly for cell culture, comprising a bag, a set of parts fixed relative to the bag, and a set of parts rotating around an axis of rotation. ARRIERE PLAN TECHNOLOGIQUE DE L'INVENTION

[0002] Biopharmaceutical liquid mixing or agitation tanks use an agitator, for example a rotary one, to mix chemical compounds. Often, the components to be mixed require a sterile environment, as is the case when preparing a pharmaceutical product. To guarantee the sterility of the environment, mixing tanks are designed to prevent external contaminants from entering the tank throughout the entire process, whether during filling, mixing, or emptying of the biopharmaceutical liquid.

[0003] According to a prior art, there is a biopharmaceutical liquid reservoir whose main mechanical components, and in particular the bearing of the rotating shaft, are located outside the bag. A drawback of this prior art is that it requires the rotating shaft, equipped with either a rotary seal or a fixed friction seal, to pass through the bag wall. This rotary seal is complex, expensive, and delicate. The fixed friction seal, on the one hand, wears quickly and therefore must be replaced frequently, and on the other hand, generates a large number of particles that contaminate the biopharmaceutical liquid. Either type of seal imposes a limited rotational speed on the rotating shaft.

[0004] According to a second prior art, there is a biopharmaceutical liquid reservoir whose main mechanical component, and in particular the rotating shaft bearing, is located inside the pouch. A drawback of this second prior art is that it is separated from the internal storage space of the biopharmaceutical liquid only by a straight channel, which quickly fills completely with biopharmaceutical liquid. This promotes, on the one hand, the migration of wear particles from the bearing, which contaminate the internal storage space of the biopharmaceutical liquid, and on the other hand, the migration of cells and their supports or microsupports, which become ground up in the bearing. This risks damaging the bearing and contaminating the internal storage space of the biopharmaceutical liquid with the ground-up debris of the microsupports migrating in the opposite direction. Finally, the destruction of some of the cultured cells further reduces the cell culture yield.

[0005] US5385546 discloses a biopharmaceutical liquid reservoir, comprising: a pouch forming an internal storage space for the biopharmaceutical liquid, a mechanical component located at a wall of the pouch, comprising an assembly of parts, fixed relative to the wall of the pouch, an assembly of parts, rotating about an axis of rotation relative to the fixed assembly, a bearing inside the pouch, and a communication passage separating the bearing from the internal storage space, comprising one or more changes of direction. OBJETS DE L'INVENTION

[0006] The aim of the present invention is to provide a biopharmaceutical liquid reservoir that at least partially overcomes the aforementioned drawbacks.

[0007] More particularly, the invention aims to provide a biopharmaceutical liquid reservoir which, on the one hand, locates the essential part of the mechanical component, and in particular the bearing and the rotating component or element supported by this bearing, inside the pouch, thus avoiding a delicate seal and an excessively limited rotation speed of the rotating component or element, and on the other hand, avoids or at least significantly reduces communication between, on the one hand, the surroundings of the bearing, a source of wear particles, and on the other hand, the internal space for storing biopharmaceutical liquid.

[0008] This elimination, or at least this reduction of communication, between the surroundings of the bearing and the internal space for storing the biopharmaceutical liquid, avoids or at least reduces on the one hand the contamination of the stored biopharmaceutical liquid by wear particles from the bearing, and on the other hand the crushing of the contents of the biopharmaceutical liquid, cells and support elements, deteriorating the bearing and risking contaminating the stored biopharmaceutical liquid when they return to the internal storage space of this biopharmaceutical liquid in the reservoir pocket.

[0009] To this end, the present invention proposes a biopharmaceutical liquid reservoir, comprising: a pouch forming an internal storage space for the biopharmaceutical liquid, a mechanical element located at the level of a wall of the pouch, comprising: a set of parts, fixed relative to the wall of the pouch, a set of parts, rotating about an axis of rotation relative to the fixed set, a bearing located between the two sets and inside the pouch, a communication passage: separating the bearing from the internal storage space, comprising one or more changes of direction, being formed by a part of the parts of the rotating set located opposite a part of the parts of the fixed set.In fact, this means that the communication passage is formed, on the one hand, by a part of the parts of the rotating assembly, and on the other hand, by a part of the parts of the fixed assembly, said part of the parts of the rotating assembly being located opposite said part of the parts of the fixed assembly.

[0010] To this end, the invention also proposes a mechanical element for a biopharmaceutical liquid reservoir which includes a biopharmaceutical liquid storage pouch, characterized in that it comprises: a set of fixed parts, a set of parts rotating about an axis of rotation relative to the fixed set, a bearing located between the two sets, a communication passage: separating the bearing from the outside of the mechanical element, comprising one or more changes of direction, being formed by a part of the parts of the rotating set located opposite a part of the parts of the fixed set.

[0011] Preferably, the passage forms an inverted siphon, with air trapped in the bottom of the inverted siphon by liquid located in at least one branch of the inverted siphon extending from the bottom of the inverted siphon into the internal storage space.

[0012] Thus, the presence of the siphon in the communication passage further reduces communication between the surrounding area of ​​the landing and the internal storage space for the biopharmaceutical liquid. The siphon is inverted because it traps air at the bottom of the siphon with liquid in one or both of the siphon branches extending on either side of the bottom, instead of liquid trapped by air as in a conventional sanitary drain siphon.

[0013] Preferably, said air being trapped in the bottom of the inverted siphon by liquid located at least in the two branches of the inverted siphon, the branch starting from the bottom of the inverted siphon and opening into the internal storage space and the branch starting from the bottom of the inverted siphon and going up to the bearing.

[0014] Thus, with air trapped on each side by a liquid plug, communication between the bearing area and the internal biopharmaceutical liquid storage space is further reduced, or may even be practically eliminated.

[0015] Preferably, the communication passage runs mainly between two parts which are on the one hand a cap of the rotating assembly and a bowl of the fixed assembly, the cap rotating around the axis of rotation relative to the bowl, the cap and the bowl being at least partially nested within each other to form the communication passage.

[0016] Thus, the space between the rotating and fixed assemblies, the weak point of the tank, is arranged in such a way as to eliminate or at least reduce the possibility of communication between the bearing area and the interior space for storing biopharmaceutical liquid, the other spaces being able to be more easily made sealed, preferably by simply clipping one part onto another or one part into another.

[0017] Preferably, one of the sets forms a protrusion fitting into a hollow of the other set, the communication passage bypassing the protrusion by running along the walls of the hollow.

[0018] Thus, communication between the bearing's surroundings and the internal biopharmaceutical liquid storage space is further reduced, and this is achieved in a simple way. Indeed, a simple penetration of a male part into a female part creates a baffle that effectively reduces communication between the bearing's surroundings and the internal biopharmaceutical liquid storage space.

[0019] Preferably, the rotating assembly forms the hollow and the fixed assembly forms the protrusion.

[0020] Thus, the air is trapped more effectively, in the bottom of the siphon located higher than the branches of the siphon, the mechanical part then being placed in the lower part of the reservoir, advantageously at the level of the lower wall of the bag.

[0021] Preferably, the communication passage is a passage exhibiting rotational symmetry around the axis of rotation.

[0022] Thus, the space around the axis of rotation is minimized.

[0023] Preferably, the width of the communication passage in a plane containing the axis of rotation is between 0.5mm and 5mm, preferably between 1mm and 3mm.

[0024] Thus, the rotation of the assembly rotating around the fixed assembly is better secured, the space being wide enough to guarantee the absence of friction or snagging during rotation, while significantly reducing communication between the bearing's surroundings and the internal storage space for biopharmaceutical liquid, the space also being narrow enough to effectively trap air in the bottom of the siphon and effectively hinder or even prevent the migration of undesirable elements from one side to the other, bearing wear particles to the internal storage space, or cells and supports to the vicinity of the bearing.

[0025] Preferably, the communication passage includes at least two corridors parallel to the axis of rotation, separated by a bend.

[0026] Thus, the presence of this baffle effectively reduces communication between the surroundings of the bearing and the internal storage space for biopharmaceutical liquid.

[0027] Preferably, one of the corridors parallel to the axis of rotation connects the turn to a cavity including the landing.

[0028] Thus, this very simple and very short baffle, already sufficient, further reduces the risk of friction or snagging during the rotation of the assembly rotating around the fixed assembly, even after a significant time when both assemblies already show signs of wear due to rotation.

[0029] Preferably, the communication passage comprises radial fins, advantageously regularly distributed around the axis of rotation, advantageously located in the branch of the inverted siphon extending from the bottom of the inverted siphon and opening into the internal storage space, advantageously numbering 8 to 15 fins. Advantageously, these radial fins extend only over a portion of the width of the communication passage.

[0030] Thus, the presence of these radial fins makes it possible to better trap any solid particles that may be located in the communication passage forming an inverted siphon, or to prevent or hinder such solid particles that would tend to enter the communication passage forming an inverted siphon or even to cross it.

[0031] Preferably, the radial fins extend, advantageously perpendicularly, from the outer face of the inner wall of a part of the fixed assembly.

[0032] Thus, the presence of these radial fins less disturbs the hydrodynamics of the liquid located in the communication passage forming an inverted siphon. Alternatively, the radial fins can extend, advantageously perpendicularly, from the inner face of the outer wall of a portion of the rotating assembly.

[0033] Preferably, the radial fins extend at an angle to a wall inside the communication passage, the direction of the inclination being such that, given the direction of rotation of the assembly rotating around the fixed assembly, any solid particles located in the communication passage remain retained or blocked between the fins and said wall inside the communication passage.

[0034] Alternatively, the radial fins can extend straight out from a wall of the inside of the communication passage forming an inverted siphon.

[0035] In alternative terms: ➢ these fins can be flat plates parallel to the axis of rotation, ➢ these fins can be curved plates inclined globally with respect to the axis of rotation at an acute angle, preferably less than 30 degrees, advantageously of the order of 15 degrees, ➢ these fins can be straight plates inclined with respect to the axis of rotation at an acute angle, preferably less than 30 degrees, advantageously of the order of 15 degrees.

[0036] Preferably, the bearing is the only area of ​​support for the rotating assembly by the fixed assembly.

[0037] Therefore, reducing communication between the surroundings of the landing and the internal space for storing biopharmaceutical liquid is particularly critical.

[0038] Preferably, the bearing is the only contact area between the rotating assembly and the fixed assembly.

[0039] Therefore, reducing communication between the surroundings of the landing and the internal space for storing biopharmaceutical liquid is particularly critical.

[0040] Preferably, the bearing is a ball bearing.

[0041] Thus, reducing communication between the bearing environment and the internal storage space of biopharmaceutical liquid is particularly interesting because the ball bearing is particularly adept at grinding into small pieces all small elements, such as the cells of the biopharmaceutical liquid or their supports, these small pieces being particularly adept at returning to contaminate the stored biopharmaceutical liquid and being particularly difficult to filter during a subsequent partial or total emptying of the bag, once the cells have multiplied sufficiently in the biopharmaceutical liquid stored in the internal storage space of the bag.

[0042] Preferably, the mechanical component passes through the wall of the bag at the level of an opening in the wall of the bag.

[0043] Thus, keeping the bearing inside the pocket is particularly advantageous, as it avoids any complex and delicate joint, such as a rotating joint, present in the earlier art.

[0044] Preferably, the opening of the pocket wall is fixed in a watertight manner around the mechanical part.

[0045] Thus, any direct leakage of the biopharmaceutical liquid stored in the bag to the outside of the bag, as well as any contamination of this stored biopharmaceutical liquid by particles coming directly from outside the bag, can be avoided.

[0046] Preferably, the opening is welded or glued around the fixed assembly.

[0047] Thus, this seal between the pouch and the outside of the pouch, at the level of the mechanical component, is achieved simply.

[0048] Preferably, the rotating assembly carries a rotating shaft.

[0049] Thus, a rotating shaft requiring a relatively high rotational speed of the assembly rotating around the fixed assembly, it is particularly interesting to reduce communication between the bearing environment and the internal space for storing biopharmaceutical liquid.

[0050] Preferably, the rotating shaft itself carries a propeller.

[0051] Thus, since this propeller leads to increased risks of pollution due to the significant vibrations it generates, it is particularly important to reduce communication between the bearing area and the internal space for storing biopharmaceutical liquid.

[0052] Preferably, the fixed assembly includes a drain port opening to the outside of the pouch.

[0053] Therefore, maintaining the tightness of the mechanical component at the level of the pocket wall is all the more important.

[0054] Preferably, a gas distributor is located around the units, in the interior storage space.

[0055] Thus, since this gas distributor causes an increase in the circulation of the biopharmaceutical liquid in the vicinity of the mechanical part, it is all the more important to reduce the communication between the surroundings of the bearing and the internal space for storing the biopharmaceutical liquid.

[0056] Preferably, the gas distributor is annular.

[0057] Thus, the increase in the circulation of the biopharmaceutical liquid in the vicinity of the mechanical part is even carried out all around the mechanical part, it is then all the more important to reduce the communication between the surroundings of the bearing and the internal space for storing biopharmaceutical liquid.

[0058] Preferably, the gas distributor includes a bypass capable of blowing air into the communication passage in such a way as to tend to make it exit into the interior storage space.

[0059] Thus, this bypass will help to improve the reduction of communication between the surroundings of the bearing and the internal storage space of biopharmaceutical liquid, by pushing the biopharmaceutical liquid back into the internal storage space from which it came.

[0060] Preferably, the rotating assembly includes an intermediate connecting piece carrying the rotating shaft and the bearing.

[0061] Thus, the presence of this intermediate connecting piece makes it easier to arrange the bearing surround in such a way as to then more easily reduce communication between the bearing surround and the internal space for storing biopharmaceutical liquid.

[0062] Preferably, the rotation shaft is clipped into the intermediate connecting piece.

[0063] Thus, sealing in this area is more easily achieved in a simple and effective manner.

[0064] Preferably, the bearing includes a rotating ring, preferably the outer ring of the bearing, which is clipped into the intermediate connecting piece.

[0065] Thus, sealing in this area is more easily achieved in a simple and effective manner.

[0066] Preferably, the intermediate connecting piece carries the rotating cap which is clipped onto this intermediate connecting piece.

[0067] Thus, sealing in this area is more easily achieved in a simple and effective manner.

[0068] Preferably, the fixed assembly includes a base which supports the bearing and which has a drain port opening to the outside of the interior storage space.

[0069] Therefore, it is particularly important to ensure a good seal between the inside and outside of the pouch at the level of the mechanical component.

[0070] Preferably, the gas distributor is clipped around the base.

[0071] Thus, sealing in this area is more easily achieved in a simple and effective manner.

[0072] Preferably, the bearing is clipped around the base.

[0073] Thus, sealing in this area is more easily achieved in a simple and effective manner.

[0074] Preferably, the bearing includes a fixed ring, which is preferably the inner ring of the bearing, which keeps the bowl locked against the base.

[0075] Thus, sealing in this area is more easily achieved in a simple and effective manner.

[0076] Preferably, the biopharmaceutical liquid comprises: inert micro-supports, the largest dimension of which is less than 0.3mm, preferably less than 0.1mm, advantageously greater than 10µm, cells attached to these micro-supports.

[0077] Thus, it is particularly important to reduce communication between the surroundings of the bearing and the internal storage space for biopharmaceutical liquid, since the very small size of the solid elements of the stored biopharmaceutical liquid makes them particularly capable of moving everywhere, and in particular of sliding right into the bearing if they could.

[0078] Preferably, the micro-supports are beads.

[0079] Thus, these spherical elements of the stored biopharmaceutical liquid move even more easily, even in confined spaces; hence the interest in further reducing communication between the surroundings of the bearing and the internal space for storing biopharmaceutical liquid.

[0080] Preferably, the majority of the parts of the assemblies are made of rigid plastic, slightly deformable so as to be able to perform a clipping operation with them, are preferably made of polyethylene (PE).

[0081] Thus, sealing at this location is more easily achieved in a simple and effective manner, while easily allowing the mechanical component to fulfill its mechanical function, here in particular a mechanical function of rotation requiring a certain rigidity of its constituent parts.

[0082] Preferably, the pocket wall is made of a material that is flexible and deformable enough to be able to be folded.

[0083] Therefore, sealing at the level of a wall, and in particular at an opening in the wall, is all the more important to achieve.

[0084] A bearing is a mechanical component that supports and guides a rotating mechanical component, preferably a rotating shaft.

[0085] A clip is a fastening system, integrated or not into the part, which deforms elastically upon insertion, and after insertion, generally no longer undergoes any stress.

[0086] A clip-on joint is an assembly operation in which the elastic deformation of one or both parts involved during the insertion phase allows them to be joined after elastic return. The clip-on joint creates a fitting of parts using the elastic deformation of certain elements, for example, a female part, often made of plastic, and advantageously includes one or more prongs (or tabs) whose shape allows for easy and quick disassembly.

[0087] Other features and advantages of the invention will become apparent from the following description of a preferred embodiment of the invention, given by way of example and with reference to the accompanying drawings. BREVE DESCRIPTION DES DESSINS

[0088] [ Fig 1 ] There figure 1 schematically represents a global perspective view cut off from an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 2 ] There figure 2 schematically represents an overall view in cut perspective, of an optional detail showing fins in the communication passage, of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 3 ] There figure 3 schematically represents an overall view in cut perspective, of an optional detail showing fins in the communication passage, of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.[ Fig 4 ] There figure 4 schematically represents an overall view in cut perspective, of an optional detail showing fins in the communication passage, of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 5 ] There figure 5 schematically represents an overall view in cut perspective, of an optional detail showing fins in the communication passage, of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 6 ] There figure 6 schematically represents an overall view in cut perspective, of an optional detail showing fins in the communication passage, of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 7 ] There figure 7 schematically represents an exploded perspective view of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 8 ] There figure 8 schematically represents an overall perspective view of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 9 ] There figure 9 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 10 ] There figure 10 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 11 ] There figure 11 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 12 ] There figure 12 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 13 ] There figure 13 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 14 ] There figure 14 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 15 ] There figure 15 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 16 ] There figure 16 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 17 ] There figure 17 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 18 ] There figure 18 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 19 ] There figure 19 schematically represents a local perspective view cut off from an example of a fixed assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 20 ] There figure 20 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 21 ] There figure 21 schematically represents a local perspective view cut off from an example of a fixed assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 22 ] There figure 22 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. [ Fig 23 ] There figure 23 schematically represents a global view in perspective cut off an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention, showing the bypass connecting the gas distributor and the communication passage. [ Fig 24 ] There figure 24 schematically represents a global perspective view cut off from an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 25 ] There figure 25 schematically represents an exploded perspective view of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 26 ] There figure 26 schematically represents an overall perspective view of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 27 ] There figure 27 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 28 ] There figure 28 schematically represents a local perspective view cut off from an example of a fixed assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 29 ] There figure 29 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 30 ] There figure 30 schematically represents a local perspective cutaway view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 31 ] There figure 31 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 32 ] There figure 32 schematically represents a local perspective cutaway view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. [ Fig 33 ] There figure 33 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. DESCRIPTION DE MODES DE REALISATION PREFERES DE L'INVENTION

[0089] THE figures 1 à 22 represent a first embodiment of the invention, advantageously corresponding to a pocket volume of between 50 and 200 liters.

[0090] THE figures 23 à 33 represent a second embodiment of the invention, advantageously corresponding to a pocket volume of between 500 and 1000 liters.

[0091] There figure 1 schematically represents a global perspective view cut off from an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0092] The biopharmaceutical liquid reservoir comprises a bag 1 and a mechanical component 4. The mechanical component 4 is fixed at an opening in the wall of the bag 1, which is not shown in the figure 1 but extends around the mechanical part 4 in the directions of arrows 1. The pouch 1 forms an internal space 2 for storing a biopharmaceutical liquid 3. The mechanical part 4 passes through the wall of the pouch 1.

[0093] The mechanical organ 4 comprises a set 10 of parts, fixed relative to the wall of the pocket 1, and a set 30 of parts, rotating about an axis of rotation 31 relative to the fixed set 10. A bearing 50 is located on one side between the two sets 10 and 30 and on the other side inside 2 of the pocket 1.

[0094] A communication passage 60 separates the platform 50 from the interior storage space 2. This communication passage 60 includes one or more changes of direction, for example here from the outside to the inside. This communication passage 60 begins at the level of the small protrusion 17 with a small horizontal corridor inwards, then a fairly large ascending corridor, then a small horizontal corridor inwards (in fact, it's a turn), then a fairly large descending corridor, and finally a small horizontal corridor inwards, before arriving in the cavity 51 where the platform 50 is located. This communication passage 60 is formed by a portion of the parts of the rotating assembly 30 located opposite a portion of the parts of the fixed assembly 10.

[0095] This passage 60 forms an inverted siphon 61, with air being trapped in the bottom 62 of the inverted siphon 61 by liquid located at least in one branch 63 of the inverted siphon 61 starting from the bottom 62 of the inverted siphon 61 and opening into the internal storage space 2. Air is trapped in the bottom 62 of the inverted siphon 61 by liquid preferably located at least in the two branches 63 and 64 of the inverted siphon 61, branch 63 starting from the bottom 62 of the inverted siphon 61 and opening into the internal storage space 2 and branch 64 starting from the bottom 62 of the inverted siphon 61 and going up to the bearing 50. This inverted siphon 61, whose bottom 62 contains air and whose branches 63 and 64 contain liquid, possibly biopharmaceutical liquid 3, makes it possible to block the passage of this biopharmaceutical liquid, on the one hand from branch 63 to branch 64, and on the other hand from branch 64 to branch 63.

[0096] This communication passage 60 runs mainly between two parts, which are on the one hand a cap 32 of the rotating assembly 30 and on the other hand a recess 12 of the fixed assembly 10, the cap 32 rotating around the axis of rotation 31 relative to the recess 12, the cap 32 and the recess 12 being at least partially nested within each other to form the communication passage 60. One of the assemblies 10 forms a protrusion 18 fitting into a recess 37 of the other assembly 30, the communication passage 60 bypassing the protrusion 18 by running along the walls of the recess 37. Preferably, the rotating assembly 30 forms the recess 37 and the fixed assembly 10 forms the protrusion 18.

[0097] The communication passage 60 is a passage exhibiting rotational symmetry about the axis of rotation 31. The width l of the communication passage 60 in a plane (for example, the plane of the figure 1 The diameter of the shaft containing the rotation axis 31 is between 0.5 mm and 5 mm, preferably between 1 mm and 3 mm. The communication passage 60 comprises at least two parallel channels 63 and 64 to the rotation axis 31, separated by a bend 62. One of the 64 parallel channels to the rotation axis 31 connects the bend 62 to a cavity 51 comprising the bearing 50. The bearing 50 is the only support area for the rotating assembly 30 by the fixed assembly 10. The bearing 50 is also the only contact area between the rotating assembly 30 and the fixed assembly 10. Advantageously, the bearing is a ball bearing.

[0098] The mechanical element 4 passes through the wall of pocket 1 at an opening in the wall of pocket 1, which pocket 1 therefore extends around the mechanical element 4 in the directions of the arrows 1. The opening in the wall of pocket 1 (not shown in the figure 1 , but whose location is marked by the extension of arrows 1) is fixed in a sealed manner around the mechanical member 4. This opening is welded or glued around the fixed assembly 10. The rotating assembly 30 carries a rotating shaft 31. The rotating shaft 31 itself carries a propeller 33. The propeller 33 can, for example, rotate between 10 and 500 revolutions per minute, for example at 50 revolutions per minute for a bag 1 of 2000 liters of biopharmaceutical liquid 3 and for example at 250 revolutions per minute for a bag 1 of 50 liters of biopharmaceutical liquid 3.The biopharmaceutical liquid 3 is advantageously a cultured cell medium, also called "cell culture", which will require fairly strong agitation to develop, resulting in a relatively high rotation speed of the rotation shaft 31, which makes the reverse siphon isolation system 61 between the cavity 51 of the bearing 50 on the one hand and the internal space 2 for storing the biopharmaceutical liquid 3 on the other hand, proposed by the invention all the more interesting.

[0099] A gas distributor 20 is located around assemblies 10 and 30, in the internal storage space 2. This gas distributor 20 is annular. This gas distributor 20 includes a bypass 21 adapted to blow air into the communication passage 60 so as to tend to force it out into the internal storage space 2, which helps to further push back the biopharmaceutical liquid 3 attempting to pass from the internal storage space 2 towards the branch 63 of the inverted siphon 61.

[0100] The rotating assembly 30 includes an intermediate connecting piece 34 carrying the rotating shaft 31 and the bearing 50. The rotating shaft 31 is clipped into the intermediate connecting piece 34. The bearing 50 includes a rotating ring 52, preferably the outer ring 52 of the bearing 50, which is clipped into the intermediate connecting piece 34. The intermediate connecting piece 34 carries the rotating cap 32, which is clipped onto this intermediate connecting piece 34.

[0101] The fixed assembly 10 comprises a base 15 which supports the bearing 50 and which has a drain port 11 opening to the outside of the internal storage space 2. This drain port 11 is used for the partial emptying of the pouch 1. This drain port 11 opens to the outside of the pouch 1. It is through this drain port 11 that the fixing piece 14 of the rotating assembly 30 relative to the fixed assembly 10 is inserted. This fixing piece 14 fits into the fixed assembly 10 by separating the walls of a central chimney 19 which itself pushes on the bearing 50, thus fixing the rotating assembly 30 and the fixed assembly 10 relative to each other. It is this fixing part 14 which holds the assembly of the rotating assembly 30 onto the fixed assembly 10. The gas distributor 20 is clipped around the base 15. The bearing 50 is clipped around the base 15.The bearing 50 includes a fixed ring 53, which is preferably the inner ring 53 of the bearing 50, which keeps the cup 12 locked against the base 15 via the inner lip 16 of the cup 12.

[0102] Biopharmaceutical liquid 3 comprises inert micro-supports (not shown in the figure 1 but they are uniformly distributed within the biopharmaceutical liquid 3), the largest dimension of which is less than 0.3 mm, preferably less than 0.1 mm, advantageously greater than 10 µm, for example, between 30 µm and 80 µm. Living cells are attached to these micro-supports. These micro-supports are advantageously beads. The capacity of bag 1 can range from a few tens of liters to a few thousand liters of biopharmaceutical liquid 3, preferably from 50 liters to 2000 liters of biopharmaceutical liquid 3. For example, every 3 weeks or every month, bag 1 undergoes partial emptying and a sample of the cell culture medium in bag 1 is taken. The wall of bag 1 is made of a material sufficiently flexible and deformable to be able to be folded, for example, the wall of bag 1 is made of flexible plastic.

[0103] The majority of the assembly components are made of rigid plastic, slightly deformable to allow for clipping, and are preferably made of polyethylene (PE), advantageously high-density polyethylene (HDPE), or polyethylene terephthalate (PET). Except for the bearing 50, which can be made of metal, all other components of the mechanical element 4 can advantageously be made by injection molding. Preferably, all components of the rotating 30 and fixed 10 assemblies can be made without threads or adhesives and can be assembled simply by clipping. A sealing lip 40, directly overmolded onto the cap 32, ensures a seal with the rotating shaft 31, particularly when it is rotating, as the cap 32 is integral with the rotating shaft 31 and rotates with it.

[0104] There figure 2 schematically represents an overall perspective view cut off from an optional detail of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0105] There figure 2 shows fins 113 regularly distributed around the axis of rotation 31 in the branch 63 of the communication passage 60 forming the inverted siphon 61, these fins 113 extending perpendicularly to the inner face 111 of the outer wall 110 of the cap 32 of the rotating assembly 30, these fins 113 being flat plates parallel to the axis of rotation 31.

[0106] There are approximately between 8 and 15 fins regularly distributed around the axis of rotation 31. These fins 113 extend over half the width l of the branch 63 of the communication passage 60. These fins 113 are advantageously made of material with the inner face 111 of the outer wall 110 of the cap 32, but alternatively they can be separate plates welded to the inner face 111 of the outer wall 110 of the cap 32. The fins 113 do not protrude downwards from the outer wall 110 of the cap 32, they advantageously stop before the end of this wall.

[0107] There figure 3 schematically represents an overall perspective view cut off from an optional detail of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0108] There figure 3 shows fins 114 regularly distributed around the axis of rotation 31 in the branch 63 of the communication passage 60 forming the inverted siphon 61, these fins 114 extending perpendicularly to the inner face 111 of the outer wall 110 of the cap 32 of the rotating assembly 30, these fins 114 being curved plates inclined overall with respect to the axis of rotation 31 at an acute angle, preferably less than 30 degrees, advantageously on the order of 15 degrees. These fins 114 could also be straight plates inclined with respect to the axis of rotation 31 at an acute angle, preferably less than 30 degrees, advantageously on the order of 15 degrees.

[0109] There are approximately 8 to 15 fins 114 regularly distributed around the axis of rotation 31. These fins 114 extend over half the width l of the branch 63 of the communication passage 60. These fins 114 are advantageously made of material with the inner face 111 of the outer wall 110 of the cap 32, but alternatively they can be separate plates welded to the inner face 111 of the outer wall 110 of the cap 32. The fins 114 do not protrude downwards from the outer wall 110 of the cap 32, they advantageously stop before the end of this wall.

[0110] There figure 4 schematically represents an overall perspective view cut off from an optional detail of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0111] There figure 4 shows fins 115 regularly distributed around the axis of rotation 31 in the branch 63 of the communication passage 60 forming the inverted siphon 61, these fins 115 extending perpendicularly to the external face 112 of the protuberance 18 of the fixed assembly 10, these fins 115 being straight plates parallel to the axis of rotation 31.

[0112] There are approximately 8 to 15 fins 115 regularly distributed around the axis of rotation 31. These fins 115 extend over half the width l of the branch 63 of the communication passage 60. These fins 115 are advantageously made of material with the outer face 112 of the protrusion 18, but alternatively they can be separate plates welded to the outer face 112 of the protrusion 18. The fins 115 rest on the small protrusion 17.

[0113] There figure 5 schematically represents an overall perspective view cut off from an optional detail of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0114] There figure 5 shows fins 116 regularly distributed around the axis of rotation 31 in the branch 63 of the communication passage 60 forming the inverted siphon 61, these fins 116 extending perpendicularly to the outer face 112 of the protrusion 18 of the fixed assembly 10, these fins 116 being straight plates inclined with respect to the axis of rotation 31 at an acute angle, preferably less than 30 degrees, advantageously on the order of 15 degrees. These fins 116 could also be curved plates inclined overall with respect to the axis of rotation 31 at an acute angle, preferably less than 30 degrees, advantageously on the order of 15 degrees.

[0115] There are approximately 8 to 15 fins 116 regularly distributed around the axis of rotation 31. These fins 116 extend over half the width l of the branch 63 of the communication passage 60. These fins 116 are advantageously made of material with the outer face 112 of the protrusion 18, but alternatively they can be separate plates welded to the outer face 112 of the protrusion 18. The fins 116 rest on the small protrusion 17.

[0116] There figure 6 schematically represents an overall perspective view cut off from an optional detail of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0117] There figure 6 shows fins 117 regularly distributed around the axis of rotation 31 in the branch 63 of the communication passage 60 forming the inverted siphon 61, these fins 117 extending in an inclined manner with respect to the external face 112 of the protuberance 18 of the fixed assembly 10, the direction of the inclination being such that, given the direction of rotation of the rotating assembly 30 around the fixed assembly 10, any solid particles located in the branch 63 of the communication passage 60 remain retained or blocked between the fins 117 and the external wall 112 of the protuberance 18, these fins 117 being straight plates parallel to the axis of rotation 31.

[0118] There are approximately 8 to 15 fins 117 regularly distributed around the axis of rotation 31. These fins 117 extend over half the width l of the branch 63 of the communication passage 60. These fins 117 are advantageously made of material with the outer face 112 of the protrusion 18, but alternatively they can be separate plates welded to the outer face 112 of the protrusion 18. The fins 117 rest on the small protrusion 17.

[0119] There figure 7 schematically represents an exploded perspective view of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0120] The cap 32 fits into the intermediate piece 34. The gas distributor 20 is directly clipped onto the base 15. The intermediate piece 34 fits into the bowl 12 which fits into the base 15. The connecting piece 14 fits into the drain port 11, passes through the base 15 until it reaches the top of the chimney 19, thus fixing the rotating assembly 30 relative to the fixed assembly 10, the bearing 50 being blocked on one side at the top by the external radial lugs located at the top of the chimney 19 and on the other side at the bottom by the inner lip 16 of the bowl 12.

[0121] There figure 8 This schematically represents an overall perspective view of an example of the assembly of the fixed and rotating parts of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention. The mechanical component 4 is in the fully assembled position.

[0122] There figure 9 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0123] In a first step of assembling the mechanical component 4, the rotation shaft 31 is first fitted into the cap 32, thanks to a certain flexibility of the sealing lip 40 (which can be made of LLDPE for example).

[0124] In a second assembly step of the mechanical component 4, the bearing 50 is clipped into the bottom of the intermediate part 34, advantageously using a tool or by simple manual pressure. The intermediate part exhibits both good rigidity and a slight degree of flexibility at its clips in the lower part beneath the outer ring 52 of the bearing 50.

[0125] There figure 10 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0126] The lower inner ring of the intermediate connecting piece 34 includes on its inner surface six protrusions arranged to absorb manufacturing tolerances and prevent free rotation between the outer ring 52 of the bearing 50 on the one hand and this inner ring of the intermediate piece 34 in which the bearing 50 is housed.

[0127] There figure 11 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0128] In a third stage of assembly of the mechanical organ 4, the rotating shaft 31 carrying the cap 32 enters the upper part of the intermediate connecting piece 34 so as to clip into it, by means of external radial lugs located in the lower part of the rotating shaft 31, cooperating with hollows located in the middle part of the intermediate connecting piece 34.

[0129] There figure 12 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0130] There figure 13 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0131] The intermediate connecting piece 34 has a flat 38 which will cooperate with the flat 39 of the rotation shaft 31, to block the relative rotation of the rotation shaft 31 with respect to the intermediate connecting piece 34.

[0132] The upper inner ring of the intermediate connecting piece 34 includes on its inner surface four protrusions arranged to absorb manufacturing tolerances and prevent free rotation between the rotation shaft 31 on the one hand and this inner ring of the intermediate piece 34 in which the rotation shaft 31 is housed.

[0133] There figure 14 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0134] In a fourth step of mounting the mechanical component 4, the cap 32, located around the rotation shaft 31, slides around the rotation shaft 31 downwards until it butts against the notch of the intermediate connecting piece 34, this notch being located at the junction between the upper ring and the lower ring of this intermediate connecting piece 34.

[0135] There figure 15 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0136] There figure 16 schematically represents a local perspective view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0137] On the lower outer rim of the intermediate connecting piece 34 are distributed eight small hollows cooperating with the eight small protrusions distributed on the lower inner surface of the cap 32, to clip the cap 32 onto the outside of the intermediate connecting piece 34.

[0138] There figure 17 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0139] In a fifth step of assembly of the mechanical component 4, the gas distributor 20 is clipped around the base 15 by means of the external radial lugs of the base 15 located in the upper part of the periphery of the base 15.

[0140] There figure 18 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0141] In a sixth step of assembly of the mechanical component 4, the cup 1 is pushed into the bottom of the receptacle of the base 15. The gutter 17 located in the external middle part of the cup 12 pushes the upper external radial lugs of the base 15, thus helping to maintain the clipping of the gas distributor 20 around the external periphery of the base 15.

[0142] There figure 19 schematically represents a local perspective view cut off from an example of a fixed assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0143] The inner lip 16 ensures on the one hand that the bowl 12 is held in the bottom of the receptacle of the base 15 until the next assembly step, and then once the assembly is complete, will help to ensure the seal between the bowl 12 and the base 15.

[0144] There figure 20 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0145] In a seventh step of assembly of the mechanical component 4, the bearing 50 is clipped around the chimney 19 of the base 15, thanks to the external radial lugs of the upper part of this chimney 19.

[0146] There figure 21 schematically represents a local perspective view cut off from an example of a fixed assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0147] Clipping bearing 50 around chimney 19 will be even more easily achieved by using low-density polyethylene (LLDPE) for chimney 19, at least partially.

[0148] There figure 22 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention.

[0149] In an eighth step of the assembly of the mechanical component 4, the fixing piece 14 is introduced through the drain port 11 until it reaches the chimney 19. This fixing piece 14 will preferably be fitted into the base 15 with a hand tool having a stop position to ensure that this connecting piece 14 has been properly fitted all the way to the top of the chimney 19.

[0150] There figure 23 schematically represents a global view in perspective cut off an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a first embodiment of the invention, showing the bypass connecting the gas distributor and the communication passage.

[0151] A branch 21 connects the interior of the gas distributor 20 to the interior of the communication passage 60. The function of this branch 21 is to blow air into the communication passage 60 in such a way as to force it out into the interior storage space 2. In the preferred embodiment of the figure 23 This bypass channel 21 opens at one end into the ring forming the interior of the gas distributor 20, specifically into its inner wall, and at the other end into the branch 64 extending from the bottom 62 of the inverted siphon 61 to the bearing 50, specifically into its outer wall. The inner and outer walls are defined with respect to the center of symmetry of the tank, the inner wall of a given element being radially closer to this center of symmetry than the outer wall of that element.

[0152] There figure 24 This schematically represents a cross-sectional perspective view of an example of the assembly of the fixed and rotating parts of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. The second embodiment is similar to the first embodiment, except for certain aspects mentioned later in the text.

[0153] There figure 25 schematically represents an exploded perspective view of an example of assembly of the fixed and rotating assemblies of the mechanical organ of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0154] The intermediate connecting piece 34 and the fixing piece 14 have been replaced by a central shaft 36, the upper part of which is surrounded by the inner ring 53 of the bearing 50 and covered by an upper piece 35 resting on the top of the outer ring 52 of the bearing 50. The lower part of the central shaft 36 is surrounded by a lower ring 13. The central shaft 36 and the lower ring 13 belong to the fixed assembly 10, while the upper piece 35 belongs to the rotating assembly 30. The outer ring 52 of the bearing 50 remains attached to the rotating assembly 30, while the inner ring 53 of the bearing 50 remains attached to the fixed assembly 10. The upper piece 35 has holes to limit dead zones. In the fixed assembly 10, from the center to the periphery, the central trunk 36 pushes radially on the lower ring 13 which pushes radially on the chimney 19 of the base 15, which chimney (visible only on the figure 25 but not on the figure 24 ) pushes radially on the bowl 12 which pushes radially on the periphery of the base 15.

[0155] There figure 26 This schematically represents an overall perspective view of an example of the assembly of the fixed and rotating parts of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention. The mechanical component 4 is shown in the fully assembled position.

[0156] There figure 27 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0157] There figure 28 schematically represents a local perspective view cut off from an example of a fixed assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0158] In a first step of assembling the mechanical component 4, the lower ring 13 is clipped inside the central chimney 19 of the base 15. Peripheral protuberances inclined conically in the direction of penetration and arranged on the external surface of the lower ring 13 clip into corresponding holes in the central chimney 19 of the base 15.

[0159] There figure 29 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0160] There figure 30 schematically represents a local perspective cutaway view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0161] In a second assembly stage of the mechanical component 4, the bearing 50 is clipped around the central shaft 36, and more specifically around external tabs having external radial lugs, the inner ring 53 of the bearing 50 being locked between these external radial lugs of these external tabs of the central shaft 36 and the inner lip 16 of the cup 12. The lower part of the central shaft 36 includes four peripheral protuberances so as to prevent free rotation between the central shaft 36 and the lower ring 13.

[0162] There figure 31 schematically represents a global perspective view cut off from a rotating assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0163] There figure 32 schematically represents a local perspective cutaway view of an example of a rotating assembly part of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0164] In a third assembly stage of the mechanical component 4, the upper part 35 is clipped, by its annular protrusion in the lower part, into the inner wall of the cap 32 which includes eight small protrusions to absorb manufacturing tolerances and prevent free rotation in the cap 32, of both the upper part 35 and the outer ring 52 of the bearing 50.

[0165] There figure 33 schematically represents a global perspective view cut off from a fixed assembly example of the mechanical component of the biopharmaceutical liquid reservoir according to a second embodiment of the invention.

[0166] In a fourth step of assembling the mechanical component 4, the rotation shaft (not shown in the figure 33 ) is fitted into the upper part 35.

[0167] In a fifth step of assembling mechanical component 4, the gas distributor (not shown in the figure 33 ) is clipped around the rest of the mechanical component 4.

[0168] In a sixth step of mounting the mechanical part 4, the mechanical part 4 is fixed inside the opening in the wall of the pocket 1.

Claims

1. Biopharmaceutical liquid reservoir, comprising: > a bag (1) forming an interior space (2) for storing the biopharmaceutical liquid (3), > a mechanical member (4) situated at the level of a wall of the bag (1), comprising: - a set of parts, fixed (10) relative to the wall of the bag (1), - a set of parts, rotating (30) about an axis of rotation (31) relative to the fixed set (10), - a bearing (50) situated on the one hand between the two sets (10, 30) and on the other hand inside (2) the bag (1), - a communication passage (60) separating the bearing (50) from the interior storage space (2), comprising one or more changes of direction (62), characterized in that the communication passage is formed by a portion (32) of the parts of the rotating set (30) situated facing a portion (12) of the parts of the fixed set (10).

2. Biopharmaceutical liquid reservoir according to claim 1, characterized in that the passage (60) forms an inverted siphon (61), air being trapped in the bottom (62) of the inverted siphon (61) by liquid situated at least in one branch (63) of the inverted siphon (61) starting from the bottom (62) of the inverted siphon (61) and opening into the interior storage space (2), preferably said air being trapped in the bottom (62) of the inverted siphon (61) by liquid situated at least in the two branches (63, 64) of the inverted siphon (61), the branch (63) starting from the bottom (62) of the inverted siphon (61) and opening into the interior storage space (2) and the branch (64) starting from the bottom (62) of the inverted siphon (61) and extending to the bearing (50).

3. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the communication passage (60) runs predominantly between two parts (12, 32) which are a cap (32) of the rotating set (30) and a cup (12) of the fixed set (10), the cap (32) rotating about the axis of rotation (31) relative to the cup (12), the cap (32) and the cup (12) being at least partially nested one within the other to form the communication passage (60).

4. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that one of the sets (10, 30) forms a protuberance (18) entering into a recess (37) of the other set (30), the communication passage (60) running around the protuberance (18) along the walls of the recess (37), and, preferably, the rotating set (30) forms the recess (37) and the fixed set (10) forms the protuberance (18).

5. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the communication passage (60) is a passage presenting a symmetry of revolution about the axis of rotation (31), preferably the width (l) of the communication passage (60) in a plane containing the axis of rotation (31) is comprised between 0.5mm and 5mm, preferably comprised between 1mm and 3mm, more preferably the communication passage (60) comprises at least two parallel channels (63, 64) parallel to the axis of rotation (31), separated by a bend (62), and, more preferably, one (64) of the parallel channels (63, 64) parallel to the axis of rotation (31) connects the bend (62) to a cavity (51) comprising the bearing (50).

6. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the communication passage (60) comprises radial fins (113 to 117), advantageously regularly distributed around the axis of rotation (31), advantageously situated in the branch (63) of the inverted siphon (61) starting from the bottom (62) of the inverted siphon (61) and opening into the interior storage space (2), advantageously numbering 8 to 15 fins, preferably the radial fins (115 to 117) extend from the outer face (112) of an inner part (112) of a portion (18) of the fixed set (10), and, more preferably, the radial fins (117) extend in an inclined manner relative to a wall (111, 112) of the interior of the communication passage (60), the direction of the inclination being such that, taking into account the direction of rotation of the rotating set (30) about the fixed set (10), any solid particles situated in the communication passage (60) remain retained or blocked between the fins (117) and said wall (111, 112) of the interior of the communication passage (60).

7. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the bearing (50) is the only support zone of the rotating set (30) by the fixed set (10), preferably the bearing (50) is the only contact zone between the rotating set (30) and the fixed set (10), and, more preferably, the bearing (50) is a ball bearing.

8. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the mechanical member (4) passes through the wall of the bag (1) at the level of an opening of the wall of the bag (1), preferably the opening of the wall of the bag (1) is fixed in a sealed manner around the mechanical member (4), and, more preferably, the opening is welded or glued around the fixed set (10).

9. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the rotating set (30) carries a rotation shaft (31), preferably the rotation shaft (31) itself carries a propeller (33).

10. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the fixed set (10) comprises a drain port opening to the exterior of the bag (1).

11. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that a gas distributor (20) is situated around the sets (10, 30), in the interior storage space (2), preferably the gas distributor (20) is annular, and, more preferably, the gas distributor (20) comprises at least one bypass (21) adapted to blow air into the communication passage (60) so as to tend to expel it into the interior storage space (2).

12. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the rotating set (30) comprises an intermediate connecting piece (34) carrying the rotation shaft (31) and the bearing (50), preferably the rotation shaft (31) is clipped into the intermediate connecting piece (34), more preferably the bearing (50) comprises a rotating ring (52), preferably the outer ring (52) of the bearing (50), which is clipped into the intermediate connecting piece (34), and, more preferably, the intermediate connecting piece (34) carries the cap (32) which is clipped onto said intermediate connecting piece (34).

13. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the fixed set (10) comprises a base (15) which carries the bearing (50) and which has a drain port (11) opening to the exterior of the interior storage space (2), preferably the gas distributor (20) is clipped around the base (15), more preferably the bearing (50) is clipped around the base (15), and, more preferably, the bearing (50) comprises a fixed ring (53), which is preferably the inner ring (53) of the bearing (50), which holds the cup (12) against the base (15).

14. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the biopharmaceutical liquid (3) comprises inert micro-carriers, whose largest dimension is less than 0.3mm, preferably less than 0.1mm, advantageously greater than 10µm, cells attached to these micro-carriers, preferably the micro-carriers are beads.

15. Biopharmaceutical liquid reservoir according to any one of the preceding claims, characterized in that the majority of the parts of the sets (10, 30) are made of rigid plastic, slightly deformable so as to be able to perform a clipping operation therewith, are preferably made of polyethylene (PE), preferably the wall of the bag (1) is made of a material sufficiently flexible and deformable to be able to be folded.