Single-use mixing and bioreactor systems
AssigneeGE Healthcare Bio-Science AB
InventorsThomas Erdenberger, Richard L. Damren, Coln R. Tuohey, Michael Fisher, Parrish M. Galliher, Jonathan A. Kenney
Life of this patent
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Abstract
Disclosed are magnetic agitation mixing systems for use with flexible container reaction vessels. In one aspect of the invention, the orientation of magnetic coupling between the impeller magnets and the external driver magnets is modified such that the coupling is neither strictly axial nor strictly radial. Also disclosed are “receiver-less” retainer configurations whereby the single-use container need not have a rigid base that defines a cup or post to engage of rotatable agitator.
Claims98
A mixing system comprising:
- a flexible bag (128) for containing a fluid;
- a magnetic agitator (142) disposable in the bag (128) for mixing the fluid, the agitator (142) configured to rotate about an axis of rotation when magnetically coupled to an external magnetic drive system (121);
- wherein the flexible bag is configured to be supported by a bag support structure (104) including a bag support structure wall (106) that at least partially surrounds, supports or contains the bag (128) during use and the flexible bag (128) is further adapted for deformation by a shaped portion of the bag support structure (104) to define a receiverless retainer for the agitator (142) within the bag (128) when the agitator (142) is magnetically coupled to the external magnetic drive system (121).
A method of mixing a fluid, comprising:
- providing a flexible bag (128) for containing the fluid;
- inserting an agitator (142) comprising a supporting structure (210) and a rotatable magnetic agitator (142) into the flexible bag (128);
- installing the flexible bag (128) in a bag support structure (104);
- positioning the agitator (142) against a shaped portion of the support structure (104) containing the flexible bag, wherein the flexible bag (128) is sandwiched in between the agitator (142) and the shaped portion of the support structure (104);
- placing the supporting structure (210) in contact with an inner wall of the flexible bag (128) such that it engages with the shaped portion to facilitate magnetically coupling of the agitator (142) with an external magnetic drive system (121);
- and
- activating the external magnetic drive system (121) to mixing the fluid within the flexible bag (128) by magnetically rotating the agitator (142).
A mixing system for mixing a fluid, comprising:
- a flexible bag (128) for containing the fluid;
- a magnetic agitator (142) located within the flexible bag (128) and configured for mixing the fluid, the magnetic agitator (142) comprising a rotatable hub (204) and at least one vane or blade (206A), wherein
- an agitator bearing structure (213) is attached to the magnetic agitator (142) for allowing the hub (204) to rotate around its central axis and for supporting the hub (204)
- a supporting structure (210) is provided in contact with an inner surface of the flexible bag (128) for spacing the rotatable hub (204) away from the flexible bag (128), wherein the supporting structure (210) is attached to the agitator bearing structure (213);
- and
- an external magnetic drive system (121) for magnetically coupling with and driving rotation of the magnetic agitator (142).
A method of mixing a fluid, comprising:
- providing a flexible bag (128) for containing the fluid;
- inserting a magnetic agitator (142) into the flexible bag (128), the magnetic agitator comprising at least one vane or blade (206A) attached to the magnetic agitator (142), a rotatable hub (204) and a bearing structure (213) for supporting the hub (204);
- providing a supporting structure (210) in contact with an inner wall of the flexible bag (128) attached to the bearing structure (213) for spacing the hub (204) and bearing structure (213) away from the flexible bag (128);
- providing a magnetic drive system (121) external to the flexible bag (128) for magnetically coupling with and driving rotation of the magnetic agitator (142);
- and
- mixing the fluid within the flexible bag (128) by the drive system (121) magnetically rotating the agitator (142).
A mixing system for a fluid, comprising:
- a flexible bag (128) for containing the fluid wherein the flexible bag (128) has an upper portion and a lower portion;
- an agitator (706) for mixing the fluid having an agitator shaft (708) and at least one impeller (710) attached to the agitator shaft (708), wherein the agitator shaft (708) has an upper end and a lower end;
- a lower magnetic stabilizer (702) having a first core magnetic support (712) and located within the flexible bag (128), and a magnetic drive system (714), the lower end of the agitator shaft (708) is attached to the first core magnetic support (712) causing rotation of the agitator (706) as the magnetic drive system (714) rotates;
- and
- an upper magnetic stabilizer (704) having a magnetic coupling (718) and located within the flexible bag (128), and a second core magnetic support (716), wherein the upper end of the agitator shaft (708) is attached to the second core magnetic support (716).
A mixing system (1000) for a fluid, comprising:
- a flexible bag (128) for containing the fluid and adapted for positioning with a support structure (104);
- an agitator assembly (1706) for mixing the fluid having an agitator shaft (1013) and at least one impeller (710) attached to the agitator shaft (1013);
- and
- at least one wall stabilizer (1002) configured to provide a linkage between the agitator shaft (1013) and the support structure (104).
A method of mixing a fluid, comprising:
- providing a flexible bag (128) for containing a fluid;
- inserting an agitator assembly (1706) into the flexible bag (128), the agitator assembly (1706) having an agitator shaft (1013) and at least one impeller (710) attached to the agitator shaft (1013) arranged at a lower end for coupling with an external magnetic drive system (714), such that the agitator assembly (1706) can rotate about its shaft axis within the bag (128) in response to a motive exerted by the external magnetic drive system (714);
- installing the flexible bag (1128) in a bag support structure (104);
- and
- stabilizing the agitator assembly (1706) with at least one stabilizer (1002) configured to provide a linkage between the agitator assembly (1706) and the support structure (104).
A mixing system for a fluid, comprising:
- a flexible bag (128) having an upper portion and a lower portion for containing the fluid;
- an agitator (712) for mixing the fluid having an agitator shaft (708) having a lower and an upper end, and at least one impeller (710) attached to the agitator shaft (708);
- and
- at least one stabilizer (1110) configured to provide a linkage between the upper end of the agitator shaft (708) and a top portion of a support structure (104A).
A mixing system comprising:
- a flexible bag (128) for containing a fluid;
- a magnetic agitator disposable in the flexible bag (128) and configured to rotate about an axis of rotation when magnetically coupled to an external magnetic drive system (1200);
- wherein the magnetic agitator comprises a hub assembly (1240) that comprises at least one magnet (1226) configured to magnetically couple with a drive magnet (1206) of opposite polarity associated with the external magnetic drive system (1200), and further configured such that the coupling between the agitator magnet (1226) and the drive magnet (1206) occurs in a generally radial direction relative to the axis of rotation.
A method of mixing a fluid, comprising:
- providing a flexible bag (128) for containing the fluid;
- inserting a magnetic agitator into the flexible bag (128);
- providing a magnetic drive system (1200) external to the flexible bag for magnetically coupling agitator magnets (1226) with driver magnets (1206), the coupling being in a radial direction relative to the axis of rotation;
- and
- activating the drive system (1200) to mix the fluid within the flexible bag (128) by magnetically rotating the agitator.
A bioreactor system, comprising:
- a flexible bag (128) for containing a fluid, the flexible bag (128) having at least one aperture (311;
- 734);
- at least one bulkhead unit (138) comprising a sparger unit (138A), the at least one bulkhead unit (138;
- 138A;
- 138B;
- 138C) sealing against the at least one aperture (311;
- 734) and providing a fluid-tight passageway;
- a magnetic agitator (142) in contact with an inner wall of the flexible bag (128) and configured for mixing the fluid, the magnetic agitator (142) comprising:
- at least one vane (306;
- 206) attached to the magnetic agitator (142),
- a rotatable hub (304;
- 804),
- an agitator bearing (313;
- 813) supporting the hub (304;
- 804),
- a supporting structure (310;
- 210) attached to the bearing (313;
- 813) for spacing the hub (304;
- 804) and bearing (313;
- 813) away from the flexible bag (128);
- and
- an external magnetic drive system (121) for magnetically coupling with and driving rotation of the magnetic agitator (142).
The bioreactor system of any one of claims 82-95, wherein the supporting structure (310;
- 210) comprises a bearing system (313;
- 813) coupling the hub (304;
- 804) to the flexible bag (128).
A bulkhead disposable sensor assembly (2300) comprising:
- a bulkhead fitting for attaching the sensor assembly (2300) to a flexible or semi-rigid container or tubing (32);
- a bulkhead body (40) comprising a monitoring sensor (30;
- 64);
- wherein the sensor (30) is mounted on one side of the flexible or semi-rigid container or tubing (32) and a plate (42) is mounted on the external side of the container or tubing (32) wall;
- and wherein the sensor body (30) is seated through the plate (42) and positioned such that the container or tubing wall (32) is sandwiched between the plate (42) and the bulkhead body (40).
A bulkhead disposable sensor assembly (2400;
- 2500;
- 2600;
- 2700) comprising:
- bulkhead base (70;
- 72) that fits within a bag or a tubing wall (32) for attaching a disposable sensor (30) through the bag or tubing wall (32), wherein the bulkhead base (70) comprises a sensor housing (54) surrounding the sensor (30), and threads or grooves (52) for allowing a bulkhead fastener (60) to screw or rotate into the bulkhead base (70).
Dependencies are inferred from the claim text.