초록 ▼

A receptacle (1) for biopharmaceutical use includes a flexible container (2) having a wall (4), an internal space (5) for receiving a liquid or pasty biopharmaceutical content, mixing elements (20) adjacent to a given portion (21) of the wall (4), elements (22) for rigid and leaktight connection bet

A receptacle (1) for biopharmaceutical use includes a flexible container (2) having a wall (4), an internal space (5) for receiving a liquid or pasty biopharmaceutical content, mixing elements (20) adjacent to a given portion (21) of the wall (4), elements (22) for rigid and leaktight connection between the mixing elements (20) and the given portion (21), the mixing elements (20) including a sleeve (24), a suction-delivery opening (26), a suction-delivery part (28), a suction-delivery cavity (29), drive elements (23) for driving in an alternating forward/backward axial sliding sequence, elements (32) for immobilizing the sleeve and the given portion (21), including during the axial sliding movement of the suction-delivery part (28).

대표청구항 ▼

1. Receptacle (1) for biopharmaceutical use, comprising: a flexible container (2) having a flexible wall (4) delimiting, at a front, an inside space (5) able to receive content that is a biopharmaceutical product which is generally liquid or pasty at least when it is to be mixed,mixing means (20) ab

1. Receptacle (1) for biopharmaceutical use, comprising: a flexible container (2) having a flexible wall (4) delimiting, at a front, an inside space (5) able to receive content that is a biopharmaceutical product which is generally liquid or pasty at least when it is to be mixed,mixing means (20) able to mix the content of the inside space (5), adjacent to a given part (21) of the flexible wall (4), including movable displacement means (28a) adjoining the inside space (5) and able to displace the content,drive means (23) for driving the movable displacement means (28a),and rigid and leaktight connection means (22) ensuring a rigid and leaktight connection between the mixing means (20) and the given part (21) of the flexible wall (4),characterized by the fact that:the mixing means (20) comprise:an axial guiding and peripheral closure sleeve (24) which is rigid, has a lateral inside face, has a constant transverse cross-section along its axis (BB), and has towards its front part (25) a suction-discharge opening (26) adjoining the inside space (5),a suction-discharge part (28) which is unpierced and arranged transversely in the sleeve (24) in a leaktight manner, has a front inside face, and of which at least one movable part (28a) is mounted to slide alternately forwards and backwards axially,a suction-discharge cavity (29), delimited by the lateral inside face (30a) of the sleeve (24) and the front inside face (31a) of the suction-discharge part (28), in communication with the inside space (5) via the suction-discharge opening (26),the drive means (23) are able to drive the movable part (28a) of the suction-discharge part (28) and assure its movement in at least one sequence of sliding alternately forwards and backwards axially such that the volume of the suction-discharge cavity (29) has at least one sequence of alternately compressing and expanding, and thus the content of the flexible container (2) adjacent to the suction-discharge opening (26) is moved about and the content of the flexible container (2) is mixed,immobilization means (32) ensure the relative immobilization of the axial guiding and peripheral closure sleeve (24) and of the given part (21) of the flexible wall (4), including during the sliding axial movement of the movable part (28a) of the suction-discharge part (28). 2. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the given part (21) of the flexible wall (4) comprises a mounting through-hole (34), with which the mixing means (20) are axially associated, and wherein the rigid and leaktight connection means (22) are secured in a leaktight manner on the one hand to the sleeve (24) by a side part (35a) that is peripheral and external to the sleeve (24), and on the other hand to the given part (21) of the flexible wall (4) by a peripheral portion (35b) around the mounting through-hole (34) and lying flat on the flexible wall (4). 3. Receptacle (1) for biopharmaceutical use according to claim 2, wherein the hole (34) in the given part (21) of the flexible wall (4) allows passage of the sleeve (24), and wherein the suction-discharge opening (26) is axially substantially adjacent to the flexible wall (4), the mixing means (20) extending axially substantially rearwards from the given part (21) of the flexible wall (4), or wherein the hole (34) in the given part (21) of the flexible wall (4) provides the communication between the suction-discharge cavity (29) and the inside space (5), and wherein the suction-discharge opening (26) is axially offset rearwards from the given part (21) of the flexible wall (4), the mixing means (20) extending axially substantially rearwards from the given part (21) of the flexible wall (4), or whereinthe hole (34) in the given part (21) of the flexible wall (4) allows passage of the sleeve (24), and wherein the suction-discharge opening (26) is axially offset frontwards from the given part (21) of the flexible wall (4), the mixing means (20) extending axially either partially frontwards and partially rearwards or substantially frontwards from the given part (21) of the flexible wall (4). 4. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the given part (21) of the flexible wall (4) is unpierced, the rigid and leaktight connection means (22) are secured in a leaktight manner to the sleeve (24) by a part (36a) external to the sleeve (24) and to the given part (21) of the flexible wall (4) by a part (36b) lying flat on the flexible wall (4), and wherein the mixing means (20) extend axially substantially frontwards from the given part (21) of the flexible wall (4). 5. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the rigid and leaktight connection means (22) comprise a transverse face (22a) adjoining the sleeve (24), rigidly secured, to lie flat, in a leaktight manner, to the flexible wall (4) at or near the given part (21). 6. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the axial guiding and peripheral closure sleeve (24) comprises a front part (25) laterally delimited by the lateral inside face (30a) of the sleeve (24), delimited at a back by the front inside face (31a) of the suction-discharge part (28) in an extreme rearward sliding position, and delimited at the front by the suction-discharge opening (26). 7. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the axial guiding and peripheral closure sleeve (24) comprises a rear part (27) laterally delimited by the lateral inside face (30a) of the sleeve (24) and delimited at the front by a rear face of the suction-discharge part (28) in the extreme rearward sliding position, and in particular wherein the sleeve (24) comprises a rear part delimited at the back by a transverse terminal rear wall (37). 8. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the suction-discharge part (28) is either a rigid piston mounted in the sleeve (24) or a deformable membrane having a fixed peripheral part (28b) attached to the lateral inside face (30a) of the sleeve (24) and a central movable part (28a). 9. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the suction-discharge part (28) is mounted to slide axially between an extreme rearward position and an extreme forward position, respectively further from and closer to the suction-discharge opening (26), and optionally when in its extreme forward position, the suction-discharge part (28) closes off the suction-discharge opening (26). 10. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the suction-discharge cavity (29) is transversely flattened, its size in the transverse direction being larger than its size in the axial direction. 11. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the suction-discharge opening (26) is formed either by a single opening able to shape a single flow or by a plurality of basic openings (26a) able to shape a plurality of basic flows. 12. Receptacle (1) for biopharmaceutical use according to claim 1, wherein a suction-discharge opening (26) is associated with flow orientation means (38) and/or shaping means and/or concentration means and/or spreading means, able to orient and/or shape and/or concentrate and/or spread out a flow, wherein in particular the suction-discharge opening (26, 26a) comprises a peripheral edge (26b) which extends either in an axial direction along an axis or in a direction that is angled relative to said axis, able to form a flow which extends either in the axial direction or in a direction that is angled relative to said axis. 13. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the drive means (23) comprise means (39a) for driving an axial movement in one direction combined with means (39b) for axial return in the opposite direction, in particular wherein the means (39a) for driving an axial movement in the one direction are electromechanical or electromagnetic means and the means (39b) for axial return in the opposite direction are elastic means such as a spring, in particular wherein the drive means (23) comprise means (39c) for driving an axial movement sequentially in the two opposing directions, such as pneumatic means, and optionally said receptacle comprises a movable plunger core (40), arranged transversely in the sleeve (24) behind the suction-discharge part (28) and mounted to slide alternately forwards and backwards axially, and wherein it comprises an axially sliding connection member (41) connecting the movable plunger core (40) and the suction-discharge part (28), the means (39a) for driving an axial movement in the one direction and the means (39b) for axial return in the opposite direction acting on the movable plunger core (40). 14. Receptacle (1) for biopharmaceutical use according to claim 1, wherein the immobilization means (32) comprise an application face (42) rigidly adjoining the sleeve (24) and an abutting face (43) of a supporting part (44), the given part (21) of the flexible wall (4) and the abutting face (43) of the supporting part (44) having a fixed relative position, and fixed and rigid retention means (45) for retaining said application face (42) applied in a fixed and rigid manner to said abutting face (43), arranged to be detachable or non-detachable. 15. Receptacle (1) for biopharmaceutical use according to claim 14, wherein the fixed and rigid retention means (45) for retaining said application face (42) applied in a fixed and rigid manner to said abutting face (43) comprise a clamping member (46a) rigidly adjoining the sleeve (24) which cooperates, in clamping, with a complementary clamping member (46b) of an immobilization part (47) having a second application face (48) applied to and retained in a fixed and rigid manner on a second abutting face (49) of a second supporting part (50), the given part (21) of the flexible wall (4) and the second abutting face (49) of the second supporting part (50) having a fixed relative position, or wherein the application face (42) is a rear face of a transverse shoulder at an end of the sleeve (24), the abutting face (43) is a front face of a supporting part (44, 60), and the fixed and rigid retention means (45) for retaining said application face (42) applied in a fixed and rigid manner against said abutting face (43) are mutual clamping means, the supporting part (44) being part of a rigid receiving and retention assembly of a freezing/thawing system. 16. Receptacle (1) for biopharmaceutical use according to claim 15, wherein the supporting part (44, 60) and the rigid receiving and retention assembly of the freezing/thawing system comprises two walls pressing against one another about the application face (42) and spaced apart from one another in one or more areas distanced from the application face (42) in order to leave a free space suitable for accommodating a heat transfer means, and optionally the supporting part (44) of the rigid receiving and retention assembly of the freezing/thawing system comprises a passage to allow passage of the drive means (23). 17. Receptacle (1) for biopharmaceutical use according to claim 1, wherein it additionally comprises control means (33) for controlling the drive means (23) of the movable displacement means and/or means (9a) which respond to a control parameter of the control means (33) to which the control means (33) are coupled in a responsive manner, and wherein the suction-discharge part (28) when in its extreme forward position closes off the suction-discharge opening (26), characterized by the control means (33) controlling the drive means (23) of the movable displacement means (28a, 28) so that when finished functioning, the suction-discharge part (28) is in its extreme forward position where it closes off the suction-discharge opening (26). 18. Receptacle (1) for biopharmaceutical use according to claim 1, wherein a mixing means unit (20) is located either on a bottom part (10a) or on a side part (10b) or on a top part (7) of the flexible wall (4) of the flexible container (2), and wherein it comprises a single mixing means unit (20) or a plurality of mixing means units (20). 19. Receptacle (1) for biopharmaceutical use according to claim 1, wherein it additionally comprises aeration means (54) able to deliver aeration gas to the content, comprising aeration gas supply means (55) having at least one tubular element extending in a fluid communication from outside the flexible container (2) to aeration gas distribution means (56) located within the inside space (5) of the flexible container (2) and rigidly supported by a part forming a fixed peripheral support which is part of the mixing means (20) or of the rigid and leaktight connection means (22), in particular with the aeration gas distribution means (56) arranged at the periphery of the mixing means (20) or of the rigid and leaktight connection means (22), in an adjoining manner or at a distance away. 20. Receptacle (1) for biopharmaceutical use according to claim 1, wherein it additionally comprises means (57) for collecting a sample of the content of the inside space (5), opening into the suction-discharge cavity (29). 21. Receptacle (1) for biopharmaceutical use according to claim 1, wherein it constitutes a mixing vessel or a bioreactor or a freezing/thawing vessel. 22. A method for making use of the receptacle for biopharmaceutical use according to claim 1, wherein: biopharmaceutical product is provided which is generally liquid or pasty at least when it is to be mixed, or one or more components of such a product,the inside space (5) of the flexible container (2) is filled with said biopharmaceutical product or with said one or more components, thus forming the content of the flexible container (2), the suction-discharge cavity (29), in communication with the inside space (5), being filled with said content,when the content of the flexible container (2) is to be mixed, the drive means (23) are used such that:the movable part (28a) of the suction-discharge part (28) is displaced in at least one sequence of axially sliding alternately forwards and backwards,the volume of the suction-discharge cavity (29) follows at least one sequence of alternately compressing and expanding, and, in alternation, the content located in the suction-discharge cavity (29) is discharged into the inside space (5) through the suction-discharge opening (26) and the content of the inside space (5) is sucked into the cavity through the suction-discharge opening (26),the content of the flexible container (2) adjacent to the suction-discharge opening (26) is displaced,and in this manner the content of the flexible container (2) is mixed, and optionally comprising the following feature:when stopping the use of the drive means (23), the suction-discharge part (28) is brought to its extreme forward position where it closes off the suction-discharge opening (26) and/orthe drive means (23) are controlled as a function of a control parameter such as time or the degree of homogeneity/heterogeneity of the content of the flexible container (2) and/orsaid receptacle is used as a mixing vessel or as a bioreactor or as a freezing/thawing vessel. 23. Receptacle for biopharmaceutical use according to claim 5, wherein the transverse face (22a) is part of a rigid wall. 24. Receptacle for biopharmaceutical use according to claim 5, wherein the transverse face (22a) is rigidly secured, to lie flat, in a leaktight manner, to the flexible wall (4) by welding or adhesive bonding.