PROTECTIVE HOUSING FOR A BAG CONTAINING A BIOPARMACEUTICAL LIQUID, CORRESPONDING PROTECTIVE ARRANGEMENT AND CORRESPONDING ASSEMBLY METHOD

Description

DOMAINE DE L'INVENTION

[0001] The invention relates to the field of protective housings for biopharmaceutical liquid bags, the field of protective assemblies integrating a protective housing and a biopharmaceutical liquid bag, as well as the field of assembly methods for a protective assembly integrating a protective housing and a biopharmaceutical liquid bag. CONTEXTE DE L'INVENTION

[0002] According to a prior art, a protective case for biopharmaceutical liquid bags is known, comprising two upper and lower shells assembled one on top of the other, and two elastic plastic films located inside these shells and enclosing two biopharmaceutical liquid bags. The biopharmaceutical liquid bags are held in place between the films and protected from external damage and impacts to the protective case by the spaces maintained respectively between the upper shell and the upper film, and between the lower shell and the lower film. This protective case ensures that the biopharmaceutical liquid bags are securely held inside.On the other hand, this protective case has shells with a complex and delicate structure, because of the elastic plastic film to be fixed on each of the shells, and has a significant height due to the two empty spaces stacked one on top of the other, the one between the upper film and upper shell and the one between the lower film and lower shell.

[0003] According to a second prior art, for example presented in patent application EP1993921, a protective case for biopharmaceutical liquid bags is known, comprising on the one hand two upper and lower shells assembled one on top of the other, and enclosing a biopharmaceutical liquid bag.This protective casing has the disadvantage of either insufficient lateral support of the biopharmaceutical liquid bag (in cases where the bag is smaller than the available inter-shell space) or excessive pressure exerted by the shells directly on the biopharmaceutical liquid bag (in cases where the bag is just sized for the available inter-shell space), due to the construction of the bag housing by the cooperation of the two shells with each other (each shell defining only a part of the housing), and on the other hand the disadvantage of a delicate assembly requiring the exact and precise superposition of the two shells by the cooperation of a set of pins and bore.

[0004] US 2010 / 140124 discloses a protective case for a biopharmaceutical liquid bag, comprising a lower shell, an upper shell that is insertable into the lower shell and which includes a housing and side walls, such that between the housing and the side walls is an annular storage space. RESUME DE L'INVENTION

[0005] The object of the present invention is to provide a protective case for a biopharmaceutical liquid bag, and / or a protective assembly for a biopharmaceutical liquid bag, and / or a method for assembling a protective assembly for a biopharmaceutical liquid bag, at least partially mitigating the aforementioned disadvantages.

[0006] More specifically, the invention aims to provide a protective case for a biopharmaceutical liquid bag that improves the lateral support of the bag, this bag being held in a housing of an upper shell itself held between the walls of a lower shell into which it is inserted, without exerting excessive stress on the biopharmaceutical liquid bag, and while facilitating the assembly of the protective case, the simple insertion of an upper shell into a lower shell, the upper shell defining almost the entire housing by itself (the lateral movement in the housing being entirely limited by the upper shell alone), thus resulting in a good compromise between on the one hand the effectiveness of holding the bag (without risking damage to this bag) and on the other hand the ease of assembly of the protective case.

[0007] According to the invention, a protective case for a biopharmaceutical liquid bag is provided, according to claim 1, comprising: a lower shell including a base and side walls, an upper shell: which includes a housing for receiving the bag, and which is insertable into the lower shell, so that the opening of the housing is in the vicinity and opposite the base of the lower shell, and so that the upper shell is held in place laterally between the side walls of the lower shell.

[0008] According to this first object of the invention, a bag full of biopharmaceutical liquid being placed in the protective case, there is also provided a protection assembly for a bag of biopharmaceutical liquid comprising: a protective case according to the invention, a bag of biopharmaceutical liquid placed in said protective case.

[0009] According to this first object of the invention, an empty bag of biopharmaceutical liquid being placed in the protective case, there is also provided a protective assembly for a bag intended to receive a biopharmaceutical liquid comprising: a protective case according to the invention, an empty bag intended to receive biopharmaceutical liquid placed in said protective case.

[0010] According to this first object of the invention, a bag filled with biopharmaceutical liquid being placed in the protective case, a protective assembly for a bag of biopharmaceutical liquid is further provided, comprising: a bag of biopharmaceutical liquid, a protective case comprising: a lower shell including a base and side walls, an upper shell: which includes a compartment receiving the bag, and which is inserted into the lower shell, such that the opening of the compartment is in the vicinity and opposite the base of the lower shell, and such that the upper shell is held in place laterally between the side walls of the lower shell. Laterally means in the entire mean plane of the base of the lower shell, that is to say, both longitudinally and laterally "stricto sensu" that is to say "from the side": this is true throughout the text of the patent application, unless otherwise stated.

[0011] According to the invention, to easily assemble the protective case, even with the empty bag inside this protective case, a method for assembling a protective unit for a biopharmaceutical liquid bag according to the invention is further provided, characterized in that: an operator hooks, with one of his hands, the bag by its handle to the upper shell, this upper shell being in a vertical position, this upper shell remaining in a vertical position, this operator positions and holds, with a second of his hands, the end of the bag opposite its handle against the upper shell so that the bag is in its housing in the upper shell, this operator places the upper shell containing the bag into the lower shell placed in a horizontal position.

[0012] According to a second object of the invention, in order to improve the retention of the bag by reducing its longitudinal movement in the housing of the upper shell and in order to be able to reduce or even eliminate the "accordion" effect by immobilizing the bag at the two longitudinal ends of the housing by immobilizing, attaching or blocking it at the two longitudinal ends of the upper shell, a protective assembly for a biopharmaceutical liquid bag is provided, comprising: a biopharmaceutical liquid bag, a protective case comprising: a lower shell including a base and side walls, an upper shell: which includes a housing receiving the bag and which has two longitudinal ends, and which is inserted into the lower shell, so that the opening of the housing is opposite the base of the lower shell,and so that the pouch is held in place by being immobilized at both longitudinal ends of the upper shell without touching either the bottom or the side walls of the lower shell.

[0013] Preferably, the distance between the opening of the housing and the bottom of the lower shell is at least three times less than the depth of the housing, preferably at least six times less than the depth of the housing, and even more preferably at least ten times less than the depth of the housing. Thus, with the upper shell closer to the bottom of the lower shell, the lateral movement of the pouch—that is, the movement of the pouch in a plane parallel to the average plane of the bottom of the lower shell—is more limited, and in this way, the retention of the pouch is improved.

[0014] Preferably, the upper shell is also insertable into the lower shell so that the opening of the compartment is in contact with the bottom of the lower shell. Thus, with the upper shell in contact with the bottom of the lower shell, the lateral movement of the pouch—that is, the movement of the pouch in a plane parallel to the average plane of the bottom of the lower shell—is further limited, and in this way, the retention of the pouch is further improved.

[0015] The housing comprises a base and side walls extending approximately perpendicularly to said base. This extension of the side walls of the upper shell perpendicular to the base of the upper shell allows the housing to better reduce the lateral movement of the pouch, that is, the movement of the pouch between the walls of the upper shell. In this way, the pouch is even more securely held laterally.

[0016] Preferably, the upper shell should also fit into the lower shell so that an outer edge of the upper shell is guided by the side walls of the lower shell. This makes assembling the protective case even easier.

[0017] The upper shell also features external side walls surrounding the housing's side walls and extending substantially parallel to them. This makes assembling the protective case even easier.

[0018] Ideally, the thickness of the top case should be less than the thickness of the bottom case. This will make stacking the protective cases easier.

[0019] Ideally, the upper case should fit snugly inside the lower case so that it does not protrude vertically from the lower case. This makes stacking the protective cases even easier, as it avoids exerting vertical force or transmitting vertical stress directly to the pocket, even when the cases are stacked multiple times.

[0020] Ideally, the upper shell should fit completely inside the lower shell. This way, the upper shell, which almost entirely surrounds the pocket, will not be directly subjected to impacts from outside the protective case, but will itself be protected by the lower shell. This improves the pocket's protection against mechanical damage and impacts from outside the protective case. This shock protection is then effective not only against vertical impacts but also against horizontal ones.

[0021] Preferably, at least when the upper shell is inserted into the lower shell, baffles are arranged around the housing to hold at least one tube from the pouch in place. This way, the tube(s) can also be stored securely in the protective case. This secure positioning of the tubes also provides sufficient tension on the tube connectors at one end of the pouch, further improving the pouch's stability relative to the upper shell that protects it.

[0022] Preferably, even when the upper shell is not inserted into the lower shell, baffles are arranged around the housing so that at least one tube from the pouch can be held in place around the housing. In this way, the tube(s) can be stored and held in place immediately upon insertion of the pouch into the upper shell, without having to wait for the upper shell to be inserted into the lower shell.

[0023] Preferably, the upper shell also includes, at least at one end of the housing intended to receive the bottom of the pocket, a rim surrounding the opening of the housing, preferably extending substantially in the plane of the opening of the housing.

[0024] The upper shell includes a fastener which is located outside the housing and is positioned so that the handle at the bottom of the pocket can hook onto the fastener.

[0025] In this way, the longitudinal movement of the pouch in the upper shell housing is further reduced, which in turn improves the lateral support of the pouch, i.e. the support of the pouch between the walls of the housing of this upper shell.

[0026] Preferably, the portion of the upper shell rim located between the attachment and the end of the housing is positioned so that, when the pocket bottom handle hooks onto the attachment, the connection between the handle and the pocket bottom wraps around this portion of the rim. The pocket bottom is close to the bottom of the housing, the handle is hooked onto the attachment, and the connection linking the pocket bottom on one side and the handle on the other wraps around the rim, following its shape. In this way, the pocket's stability is further improved by reducing its longitudinal movement within the upper shell housing. Thus, the "accordion" effect, caused by the intermediate section between the handle hole and the pocket bottom, which could otherwise fold back on itself, is reduced or even eliminated.

[0027] The attachment is formed by one or more notches cut into a side wall of the upper shell. This is a particularly simple and effective way to create this attachment. These notches in the wall, in addition to their ease of manufacture, also allow, thanks to their number, for adaptation to different handle widths for different types of pockets.

[0028] Preferably, the housing is shorter than the upper shell to allow sufficient space for the tube(s) to exit the bag. This provides better protection for the connector area between the tube(s) and the bag.

[0029] Preferably, the side wall of the lower shell on the side of the bag's tube(s) outlet includes an opening for the tube(s) to exit laterally from the lower shell. This allows access to the tube(s) even when the bag is inserted into the protective case, thus enabling full operational use of the bag even inside its protective case.

[0030] Preferably, the side wall of the lower shell includes a recess facing inwards and located above or below the exit opening. This allows access to the tube(s), even when the bag is inserted into the protective case and the protective cases are stacked on top of each other. This recess then creates an exit space allowing the tubes to escape from the top or bottom, rather than solely horizontally, which would make them more susceptible to shocks and their direct transmission to the bag.

[0031] Ideally, the protective case should also include an external cover that protects the top shell and seals the bottom shell. This prevents excessive direct vertical or lateral force from being exerted on the top shell, thus better protecting the pocket.

[0032] Preferably, the lower and upper shells are interlocking so that they can be subsequently detached from each other, and preferably the lower shell also includes holes in one or more of its side walls arranged so that the upper shell can be riveted to the lower shell. The protective case is then more securely closed while remaining flexible in use.

[0033] Preferably, the lower and upper shells are joined together so that they cannot be subsequently detached from each other without damage, and preferably the lower shell also includes holes in one or more of its side walls arranged so that the upper shell can be fixed to the lower shell by rivets. The protective case is then more securely closed and even becomes tamper-proof, meaning that the pouch cannot be removed from the protective case without causing visible damage to the case itself.

[0034] Preferably, the upper and lower shells are made of plastic. Plastic offers better biocompatibility and facilitates sterilization of the bag and its contents. Furthermore, since plastic is less resistant than metal, the structure of the protective case according to the invention becomes all the more advantageous as it better redistributes stress forces, particularly when several protective cases are stacked on top of each other.

[0035] Preferably, the plastic is polyethylene terephthalate glycol (PETG). This PETG material, in addition to being highly resistant to gamma irradiation and freezing, has the advantage of being transparent, which allows the user filling the biopharmaceutical liquid bag, when it is empty but already in the closed protective case, to clearly observe the filling process and ensure that it proceeds correctly.

[0036] Other examples of plastics that can be used for the lower shell and / or the upper shell and / or the outer cover, with identical or different plastics even being able to be used for the various components of the protective case, include: ➢ Polyethylene Terephthalate Glycol (PETG) and its derivatives PET and APET, ➢ Polymethacrylate: PMMA, ➢ Polyethylene PE or High Density Polyethylene HDPE, ➢ Acryloitrile Butadiene Styrene: ABS, ➢ Acrylic resin co-extruded onto ABS: ABS / PMMA, ➢ Polycarbonate: PC, ➢ Acryloitrile Butadiene Styrene / Polycarbonate: ABS / PC - (bi-material), ➢ Polyvinyl Chloride: PVC or KYDEX, ➢ Polypropylene: PP, ➢ Polystyrene: PS, ➢ Polystyrene / Polyethylene: PS / PE - (bi-material), ➢ Polyamide: PA.

[0037] Preferably, the upper and lower shells are made of the same common material, and preferably the outer cover that encloses the upper shell and closes the lower shell, if present, is also made of this same common material. The fact that at least both shells, upper and lower, and advantageously also the outer cover, are all made of the same common material not only simplifies the manufacture of the protective casing, but above all simplifies all validation and biopharmaceutical compatibility procedures. This common material can be a single material or a composite material, such as a bi-material.

[0038] Preferably, the protective case is stackable. This makes stacking the protective cases on top of each other easier, while further preventing direct transmission of vertical stress to the pocket.

[0039] Preferably, when the two cases are stacked one inside the other, the bottom of the upper case's lower shell should rest either on the lid of the case below or on the upper shell of the case below. This allows for better distribution of stress across the entire surface of the convex upper shell rather than solely on the walls of the concave lower shell, thus preventing the creation of a weak point in the concave lower shell. The robustness of the protective case is therefore less stressed when these protective cases are stacked on top of each other.

[0040] Preferably, the side walls of the lower shell include one or more shoulders, preferably parallel to the average plane of the bottom of the lower shell, against which the cover rests. This helps to better distribute the stresses across the entire cover and the entire lower shell, and consequently across the entire protective housing.

[0041] Preferably, the side walls of the lower shell include one or more shoulders, preferably parallel to the average plane of the bottom of the lower shell, against which the upper shell rests. This helps to better distribute the stresses across the entire upper and lower shells, and consequently across the entire protective housing.

[0042] Preferably, the side walls of the lower shell include one or more shoulders, preferably perpendicular to the mean plane of the bottom of the lower shell, against which the upper shell butts longitudinally when inserted into the lower shell. This helps to hold the upper shell between the walls of the lower shell, thus contributing to improved retention of the pouch within the protective case, since the pouch itself is housed within the upper shell.

[0043] Preferably, the upper shell includes one or more longitudinal pocket attachments, and no other lateral pocket attachments. The longitudinal pocket attachment alone is sufficient to properly secure the pocket between the walls of the lower shell, simplifying the structure and arrangement of the pocket's support elements. This improves pocket retention while simplifying the structure of both the upper shell and the pocket. Furthermore, the process of assembling the pocket into its protective case is quicker, easier, and therefore more ergonomic.

[0044] Preferably, the upper shell includes one or more baffles formed in a side wall of the upper shell opposite the side wall of the attachment, designed to guide one or more tubes. This secures the tube(s) when the pouch is inserted into the protective case. Preferably, the upper shell includes one or more baffles formed in each of the two side walls of the upper shell, connecting the side wall of the attachment to the side wall opposite the side wall of the attachment, these baffles being designed to guide one or more tubes.

[0045] Preferably, as an alternative, where the upper shell is sufficiently spaced from the bottom of the lower shell, in order to reduce the depth of the baffles and to facilitate the installation of the tubes around the housing, the distance between the opening of the housing and the bottom of the lower shell is greater than or equal to half, preferably three-quarters, of the depth of the housing, and in that, at least when the upper shell is inserted into the lower shell, baffles are arranged around the housing so as to be able to hold in place around the housing at least one tube from the pocket.

[0046] Preferably, the pouch is attached longitudinally within the protective case, and only longitudinally within the case. This maintains a secure fit while simplifying the attachment system. This improves pouch retention and simplifies the structure of both the upper shell and the pouch. Furthermore, the assembly process is also simplified.

[0047] Preferably, the biopharmaceutical liquid bag is flat and elongated and has at its base a handle connected to said base by a planar connection, and at the opposite side one or more connections for tubing.

[0048] Preferably, the pouch is not attached anywhere other than longitudinally within the upper shell. This maintains good pouch retention while simplifying the attachment system. Thus, pouch retention is improved while simplifying the structure of both the upper shell and the pouch. In this way, the reduction of the pouch's longitudinal movement within the upper shell housing is achieved with only two longitudinal attachments, improving the balance between retention efficiency and structural and assembly simplicity.

[0049] Preferably, the bag has a handle at the bottom of the bag and one or more tube connections on the opposite side of the bottom of the bag.

[0050] Preferably, the bag is attached to one longitudinal end of the upper shell by its handle, and the bag is held in place at the other longitudinal end of the upper shell by the simple longitudinal tension exerted by the tube(s) on the bag. This simple longitudinal tension is achieved by securing the tube(s) at this longitudinal end of the bag, for example, by wedging the tube(s) into a baffle in the front side wall of the upper shell. This further improves the bag's stability while reducing its longitudinal movement within the housing by a simple attachment on one longitudinal side working in conjunction with simple tension on the other.

[0051] Preferably, the pouch is a flexible pouch. The pouch is advantageously flexible so that it can deform under the effect of the liquid it contains. The pouch is advantageously flexible so that it can deform under the effect of a solution having a density close to that of water. The flexible pouch is advantageously a single-use pouch, that is to say, a pouch that is disposable after a single use. 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

[0052] There figure 1 schematically represents an exploded view of an example of a protective case without a pocket according to one embodiment of the invention. figure 1A schematically represents a section AA of the upper shell shown on the figure 1 . There figure 2 schematically represents an assembled perspective view of an example of a protective case incorporating a pocket according to an embodiment of the invention. figure 3 schematically represents a top-mounted assembled view of an example of a protective case incorporating a pocket according to an embodiment of the invention. figure 4 schematically represents a detailed perspective view of an example of the attachment of the upper shell of a protective case cooperating with the handle of a pocket according to an embodiment of the invention. figure 5A schematically represents a partial perspective view of an example of the longitudinal end of the upper shell of a protective housing according to an embodiment of the invention. figure 5B schematically represents a partial perspective view of an alternative longitudinal end of the upper shell of a protective housing according to an embodiment of the invention. figure 6 schematically represents a detailed top view of an example of baffles in the upper shell of a protective housing according to an embodiment of the invention. figures 7A, 7B , 7C et 7D The diagrams schematically represent, from a top view, four successive steps of an example of a method for assembling a protective cover for a pocket according to an embodiment of the invention. figures 8A et 8B schematically represent, in perspective, examples of stacking several protective cases incorporating pockets on top of each other, according to an embodiment of the invention. figure 8C schematically represents in perspective an example of a group of several protective cases incorporating pockets according to an embodiment of the invention. DESCRIPTION DETAILLEE DE L'INVENTION

[0053] There figure 1 schematically represents an exploded view of an example of a protective case without a pocket according to an embodiment of the invention.

[0054] The protective case comprises a lower shell 2, an upper shell 3 with a housing 4, and an outer cover 1. The biopharmaceutical liquid bag, not shown in the figure 1 The upper shell 3 is placed in the bottom 20 of the lower shell 2, which is covered by the upper shell 3 so that it fits into the housing 4. The upper shell 3 is inserted into the lower shell 2 and covered by an external cover 1 that closes the protective casing. The thickness e3 of the upper shell 3 is less than the thickness e2 of the lower shell 2. Thus, the upper shell 3 can be inserted into the lower shell 2 without protruding above it.

[0055] The lower shell 2 comprises a base 20 and four side walls 21, including the side walls 21 and the front and rear side walls 21. On its front side wall 21, there is a recess 22 extending inwards towards the lower shell 2. In its front side wall 21, above the recess 22, the lower shell 2 has an opening 23 through which the pouch tubes can exit. The side walls 21 have horizontal shoulders 24 on which the upper shell 3, and more specifically the rim 45 of the upper shell 3, can rest. The height h between the horizontal shoulders 24 and the base 20 of the lower shell 2 corresponds to the distance between the opening of the housing 4 and the base of the lower shell 2.The side walls 21 also have horizontal shoulders 25 against which the outer cover 1 can be placed, and more specifically the rim 11 of the outer cover 1. The side walls 21 also have vertical shoulders 26 against which the upper shell 3 can abut, and more specifically the front side wall 32 of the upper shell 3. The side walls 21 also have holes 27 through which fixing rivets will pass to fix the lower shell 2 and the upper shell 3 together.

[0056] The upper shell 3 includes a housing 4 in its center. The upper shell 3 has side walls 32, two lateral side walls 32, a front side wall 32, and a rear side wall 32. Between the housing 4 and the front side wall 32 is a space 30 including a passage 31 through which the pouch tubes exit the housing 4 and then emerge from the protective casing by passing through the exit opening 23 of the lower shell 2. The rear side wall 32 of the upper shell includes a fastener 33 in the form of several notches 33 formed in this rear side wall 32. The handle of the pouch base is designed to attach to this fastener 33. The front side wall 32 of the upper shell 3 also includes baffles 34 in the form of notches 34 between which the pouch tubes can pass and be held in place.The front side wall 32 of the upper shell 3 abuts against the vertical shoulders 26 of the lower shell 2. The side walls 32 include protrusions 35 that cooperate with the protrusions 36 of the side walls 41 of the housing to form baffles through which the pouch tubes can pass and be held in place. The side walls 32 of the upper shell 3 also have holes 37 through which fastening rivets pass, allowing the lower shell 2 and the upper shell 3 to be secured together. Between the housing 4 and the side walls 32 of the upper shell is an annular space 38 in which one or more pouch tubes can be placed. This annular space 38 is therefore a storage space for all or part of the pouch tubes.

[0057] The housing 4, designed to hold the pocket, has a base 40, here in the ceiling position, side walls 41, a front side wall 43 from which the passage 31 extends, and a rear side wall 42 forming the back of the housing 4 against which the pocket base, including the pocket handle, rests. Between the side walls 41 to 43 of the housing 4 and the side walls 32 of the upper shell 3 is an annular rim 45 forming the base of the annular space 38. This annular rim 45 of the upper shell 3 rests on the horizontal shoulders 24 of the lower shell 2. The connection between the handle and the pocket base is wound around the rear part 46 of this annular rim 45 when the pocket handle is attached to the fastener 33.The bottom 40 of the housing 4 includes small circular protrusions 47 intended to receive the circular cavities 13 of the bottom 10 of the external cover 1, when this external cover 1 rests on the bottom 40 of the housing 4 of the upper shell 3. The bottom 40 of the housing 4 of the upper shell 3 is at the same level as the upper edge of the side walls 32 of the upper shell 3.

[0058] A cover 1 includes a base 10 and an annular rim 11, as well as a recess 12 in the front part of this rim 11 and circular cavities 13 intended to fit together with the protrusions 47 of the upper shell 3, when the external cover 1 rests on the base 40 of the housing 4 of the upper shell 3.

[0059] There figure 1A schematically represents a section AA of the upper shell shown on the figure 1 .

[0060] Housing 4 has a bottom 40, side walls 41, and a rear side wall 42. The opening 48 of housing 4 is surrounded by the annular rim 45, the rear part of which 46 extends the rear side wall 42 of housing 4. Between the side walls 32 of the upper shell 3 and the side walls 41 of housing 4 are arranged baffles formed by the interaction between, on the one hand, the protrusions 35 of the side walls 32 of the upper shell 3 and, on the other hand, the protrusions 36 of the side walls 41 of housing 4. The depth p of housing 4 is the distance between the opening 48 (formed by the annular rim 45, the rear part of which 46) and the bottom 40 of housing 4.

[0061] There figure 2 schematically represents an assembled perspective view of an example of a protective case incorporating a pocket according to an embodiment of the invention.

[0062] The upper shell 3 was fully inserted into the lower shell 2. The side walls 32 of the upper shell 3 slid along the side walls 21 of the lower shell 2, and are practically against them, once the upper shell 3 is resting on the horizontal shoulders 24 (not visible here) of the lower shell 2. The pocket not visible on the figure 2 is located in housing 4 between the upper shell 3 and the lower shell 2. The tubes 52 of the pocket exit through the passage 31, open into the free space 39 between the front side walls of the two shells, before passing through the notched baffles 34 to go around housing 4 in the free space 38 passing through the baffles 35 and 36. A connector 53 at the end of tube 52 is fixed in the baffle 34 of the front side wall 32 of the upper shell 3. A tube could also exit through the outlet opening 23.

[0063] There figure 3 schematically represents an assembled top view of an example of a protective case incorporating a pocket according to an embodiment of the invention.

[0064] The upper shell 3 is completely inserted into the lower shell 2, the side walls 32 of the upper shell 3 being practically against the side walls 21 of the lower shell 2. The tube 52, attached to the pocket contained in the housing 4, exits through the passage 31, opens into the free space 39 located between the front side walls of the two shells, passes through the notch-shaped baffle 34, goes around the housing 4 in the free space 38 located between the walls 41 to 43 of the housing 4 and the side walls 32 of the upper shell 3, passing through the baffles 35 and 36, to come to be blocked by its connector 53 in the baffle 34.

[0065] There figure 4 schematically represents a detailed perspective view of an example attachment of the upper shell of a protective case cooperating with the handle of a pocket according to an embodiment of the invention.

[0066] The handle 54, extending from the pocket bottom, is attached to the notched fastener 33 on the rear side wall 32 of the upper shell 3. This handle 54 passes through the notches 33, alternating from one side to the other of the rear side wall 32 of the upper shell 3. The connection between the handle 54 and the pocket bottom is wound underneath (and therefore not visible on the figure 3 ) around the rear edge 46 of the upper shell 3, this rear edge 46 joining the rear side wall 32 of the upper shell 3 to the rear side wall 42 of the housing 4. On the figure 3 , there is no pocket tube in free space 38.

[0067] There figure 5A schematically represents a partial perspective view of an example of the longitudinal end of the upper shell of a protective housing according to an embodiment of the invention.

[0068] The upper shell 3 is completely inserted into the lower shell 2, the side walls 32 of the upper shell 3 being practically against the side walls 21 of the lower shell 2. The tube 52, attached to the pocket contained in the housing 4, exits through the passage 31, opens into the free space 39 located between the front side walls of the two shells, passes through the notch-shaped baffle 34, goes around the housing 4 in the free space 38 located between the walls 41 of the housing 4 and the side walls 32 of the upper shell 3, passing through the baffles 35 and 36, to come to be locked by its connector 53 in the baffle 34.

[0069] There figure 5B schematically represents a partial perspective view of an alternative longitudinal end example of the upper shell of the protective housing according to an embodiment of the invention.

[0070] There figure 5B is similar to the figure 5A Only the shape of the baffle 34 changes. Here, instead of being one or more simple notches in a flat front side wall of the upper hull 3, this baffle 34 consists of a succession of tubular sections and bends, which have the advantage of being less aggressive against the walls of the tubes 52 when they are wedged in these baffles 34, thus avoiding damage to the outer layer of these tubes 52.

[0071] There figure 6 schematically represents a detailed top view of an example of baffles in the upper shell of a protective housing according to an embodiment of the invention.

[0072] The details of the baffles formed by the succession of protrusions 35 and 36 between, on the one hand, the side walls 41 of the housing 4 and, on the other hand, the side walls 32 of the upper shell 3 are shown. A long protrusion 36 of the side wall 41 of the housing 4 is framed by two shorter protrusions 36 of the side wall 41 of the housing 4, while opposite, an absence of a protrusion 35 of the side wall 32 of the upper shell 3 is framed by two protrusions 35 of the side wall 32 of the upper shell 3. Here again, the side wall 32 of the upper shell 3 is practically located against the side wall 21 of the lower shell 2.

[0073] THE figures 7A, 7B , 7C et 7D , schematically represent in top view four successive steps of an example of a method for assembling a protective set for a pocket according to an embodiment of the invention.

[0074] On the figure 7A The pocket 50 is arranged in the bottom 20 of the lower shell 2. From a top opening 51 of pocket 50 extend tubes 52 terminated by connectors 53, these tubes 52 exiting through the outlet opening 23 of the lower shell 2. The bottom 55 of pocket 50 is on the side of the rear side wall 21 of the lower shell 2.

[0075] On the figure 7B The upper shell 3 covers the pocket 50, which is therefore no longer visible. Only the tubes 52 exiting the upper shell 3 through the passage 31 are still visible. The annular free space 38 surrounds the housing 4 inside the side walls 32 of the upper shell 3. This annular free space 38, equipped with baffles 35 and 36, is empty, as it does not yet contain the tubes 52.

[0076] On the figure 7C , the tubes 52, exiting the passage 31, having emerged between the front side walls of the two shells, pass through the baffles 34, go around the housing 4 inside the side walls 32 of the upper shell 3 by passing through the baffles 35 and 36, before the connector 53 of one of these tubes 52 is blocked in the baffle 34, another connector 53 being located between the rear side wall 42 of the housing 4 and the rear side wall 32 of the upper shell 3.

[0077] On the figure 7D , the outer cover 1 having a base 10 and an annular rim 11, can then be used to cover the upper shell 3 and thus close the lower shell 2, the protective case then being completely closed.

[0078] According to another method of assembling the pouch in its protective case, which is shorter and easier, and therefore more ergonomic than the one presented in connection with the figures 7A à 7D To facilitate the assembly of the protective case, even with the empty bag inside, a method for assembling a protective unit for a biopharmaceutical liquid bag according to the invention is provided, comprising the following successive steps. First, an operator attaches the bag by its handle to the upper shell with one hand, the upper shell being in a vertical position. Then, with the upper shell remaining in a vertical position, the operator positions and holds the end of the bag opposite its handle against the upper shell with a second hand so that the bag is in its compartment in the upper shell. Finally, the operator places the upper shell containing the bag into the lower shell, which is positioned horizontally.Finally, this operator can close the lower shell by covering it with an external cover and / or this operator can stack the protective case filled by the pouch on top of another protective case also filled by its pouch.

[0079] THE figures 8A et 8B schematically represent in perspective examples of stacking several protective cases incorporating pockets on top of each other according to an embodiment of the invention.

[0080] Four protective cases are stacked one on top of the other. Each contains a pouch from which the tube(s) 52 exit respectively through the outlet openings 23 of their lower shells 2.

[0081] There figure 8C schematically represents in perspective an example of a group of several protective cases incorporating pockets according to an embodiment of the invention.

[0082] Four protective cases are respectively arranged on shelves 28 of a piece of furniture 29. They each contain a pocket from which the tube(s) 52 exit respectively through the exit openings 23 of their lower shells 2.

Claims

1. Protective casing for a biopharmaceutical liquid pouch (50), comprising: • a lower shell (2) comprising a bottom (20) and lateral walls (21), • an upper shell (3) which comprises a housing (4) intended to receive the pouch (50), and which is insertable into the lower shell (2), so that, when the pouch (50) is placed in the bottom (20) of the lower shell (2), the pouch (50) is covered by the upper shell (3) so as to end up in the housing (4) between the upper shell (3) and the lower shell (2), ∘ the housing (4) comprising a bottom (40), and lateral walls (41 to 43) extending substantially perpendicularly to the bottom (40) of the housing, and the upper shell (3) also presenting external lateral walls (32) surrounding the lateral walls (41 to 43) of the housing (4) and extending substantially parallel to the lateral walls (41 to 43) of the housing (4), so that, between the housing (4) on one hand and the lateral walls (32) of the upper shell (3) on the other hand, there is an annular storage space (38) in which one or more tubes of the pouch (50) can be arranged; the lateral walls of the housing comprising side lateral walls (41), a front lateral wall from which a passage (31) exits and a rear lateral wall (42) forming the rear of the housing; the lateral walls (32) of the upper shell comprising two side lateral walls, a front lateral wall, and a rear lateral wall; each side lateral wall (32) of the upper shell comprising protuberances (35) cooperating with protuberances (36) of a side lateral wall (41) of the housing to form baffles in which the pouch tubes can pass and be maintained in place, • the upper shell being insertable into the lower shell (2), ∘ so that the opening (48) of the housing (4) is in the vicinity of and facing the bottom (20) of the lower shell (2), ∘ and so that the upper shell (3) is maintained in place laterally between the lateral walls (21) of the lower shell (2), • the upper shell comprising a fastener (33) which is located outside the housing (4) and which is arranged so that a handle (54) of the bottom (55) of the pouch (50) can hook onto the fastener (33), the fastener (33) being formed by several notches formed in one of the lateral walls (32) of the upper shell (3).

2. Protective casing according to claim 1, characterized in that the upper shell (3) is insertable into the lower shell (2) also so that an outer periphery of the upper shell (3) is guided by the lateral walls (21) of the lower shell (2).

3. Protective casing according to any one of the preceding claims, characterized in that the thickness (e3) of the upper shell (3) is less than the thickness (e2) of the lower shell (2).

4. Protective casing according to claim 1, characterized in that the upper shell (3) also comprises, at least at the level of one end (42) of the housing (4) intended to receive the bottom (55) of the pouch (50), a rim (45) surrounding the opening (48) of the housing (4), extending preferentially substantially in the plane of the opening (48) of the housing (4), and in that a portion (46) of rim (45) of the upper shell (3), located between the fastener (33) and said end (42) of the housing (4), is arranged so that, when the handle (54) of the bottom (55) of the pouch (50) hooks onto the fastener (33), the connection between the handle (54) and the bottom (55) of the pouch (50) wraps around said portion (46) of rim (45).

5. Protective casing according to any one of the preceding claims, characterized in that the housing (4) is shorter than the upper shell (3) so as to clear a free space (39) allowing the exit of the tube or tubes (52) of the pouch (50).

6. Protective casing according to any one of the preceding claims, characterized in that the lateral wall (21) of the lower shell (2) located on the side of the tube or tubes (52) exit of the pouch (50) comprises an exit opening (23) for the tube or tubes (52) to exit laterally out of the lower shell (2), and in that said lateral wall (21) of the lower shell (2) comprises a recess (22) arranged toward the interior of the lower shell (2) and located above or below said exit opening (23).

7. Protective casing according to any one of the preceding claims, characterized in that it also comprises an external cover (1) covering the upper shell (3) and closing the lower shell (2).

8. Protective casing according to any one of the preceding claims, characterized in that the upper shell (3) and the lower shell (2) are made of plastic, and preferably in that the plastic is polyethylene terephthalate glycol.

9. Protective casing according to any one of claims 7 and 8, characterized in that the lateral walls (21) of the lower shell (2) comprise one or more shoulders (25), preferably parallel to the mean plane of the bottom (20) of the lower shell (2), on which the cover (1) rests.

10. Protective casing according to any one of the preceding claims, characterized in that the lateral walls (21) of the lower shell (2) comprise one or more shoulders (24), preferably parallel to the mean plane of the bottom (20) of the lower shell (2), on which the upper shell (3) rests.

11. Protective casing according to any one of the preceding claims, characterized in that the lateral walls (21) of the lower shell (2) comprise one or more shoulders (26), preferably orthogonal to the mean plane of the bottom (20) of the lower shell (2), against which the upper shell (3) comes into longitudinal abutment when it is inserted into the lower shell (2).

12. Protective casing according to claim 1, characterized in that the distance (h) between the opening (48) of the housing (4) and the bottom (20) of the lower shell (2) is greater than or equal to half, preferably three-quarters, of the depth (p) of the housing (4).

13. Protective assembly for a biopharmaceutical liquid pouch comprising: • a protective casing according to any one of the preceding claims, • a biopharmaceutical liquid pouch (50) placed in said protective casing or an empty pouch (50) intended to receive the biopharmaceutical liquid placed in said protective casing, the biopharmaceutical liquid pouch (50) being flat and elongated and presenting at the level of its pouch bottom (55) a handle (54) connected to said bottom (55) by a flat-shaped connection, and at the level of the opposite side one or more connections for tube (52); the handle (54) of the pouch bottom being hooked to the fastener (33).

14. Assembly process for a protective assembly for a biopharmaceutical liquid pouch according to claim 13, characterized in that: • an operator hooks, by a first of his hands, the pouch (50) by its handle (54) to the upper shell (3), this upper shell (3) being in a vertical position, • this upper shell (3) remaining in vertical position, this operator positions and maintains, by a second of his hands, the end (51) of the pouch (50) opposite to its handle (54) against the upper shell (3) so that the pouch (50) is in its housing (4) of the upper shell (3), • this operator places the upper shell (3) containing the pouch (50) into the lower shell (2) placed in horizontal position.