Mixing of the content of a flexible container for biopharmaceutical use

Patent metadata

Field	Value
Publication number	US-9440206-B2
Application number	US-201113997535-A
Country	US
Kind code	B2
Filing date	Dec 21, 2011
Priority date	Dec 22, 2010
Publication date	Sep 13, 2016
Grant date	Sep 13, 2016

Abstract

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 ).

First claim

The invention claimed is:

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 ( 28 a ) adjoining the inside space ( 5 ) and able to displace the content,
drive means ( 23 ) for driving the movable displacement means ( 28 a ),
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 ( 28 a ) is mounted to slide alternately forwards and backwards axially,
a suction-discharge cavity ( 29 ), delimited by the lateral inside face ( 30 a ) of the sleeve ( 24 ) and the front inside face ( 31 a ) 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 ( 28 a ) 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 ( 28 a ) 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 ( 35 a ) 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 ( 35 b ) 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 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 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 ( 36 a ) external to the sleeve ( 24 ) and to the given part ( 21 ) of the flexible wall ( 4 ) by a part ( 36 b ) 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 ( 22 a ) 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 ( 30 a ) of the sleeve ( 24 ), delimited at a back by the front inside face ( 31 a ) 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 ( 30 a ) 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 ( 28 b ) attached to the lateral inside face ( 30 a ) of the sleeve ( 24 ) and a central movable part ( 28 a ).

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 ( 26 a ) 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, wh

Assignees

• Cuting Jonathan
• Sartorius Stedim Fmt Sas

Inventors

• Cuting Jonathan

Classifications

• B01F15/0085

  Operations & Transport · mapped topic

• B01F11/0065 Primary

  Operations & Transport · mapped topic

• B01F11/0045

  Operations & Transport · mapped topic

• B01F15/00831

  Operations & Transport · mapped topic

• B01F11/0071

  Operations & Transport · mapped topic