WO2016001847A1

WO2016001847A1 - Assembly for agitating or mixing material

Info

Publication number: WO2016001847A1
Application number: PCT/IB2015/054931
Authority: WO
Inventors: Alf Löfving; Håkan Samuelsson; Lennart Myhrberg; Sten Johansson
Original assignee: Alf Löfving; Håkan Samuelsson; Lennart Myhrberg; Sten Johansson
Priority date: 2014-07-02
Filing date: 2015-06-30
Publication date: 2016-01-07
Also published as: TW201607607A

Abstract

An assembly (100) for agitating or mixing material. The assembly (100) includes a flexible bag (110) having a wall and defining an interior for containing the material. The assembly also includes a rigid carrier (120) disposed on an exterior of the bag (110) and a bearing disposed on the interior of the bag adjacent to the carrier. The assembly also includes a mixing element (130) disposed on the interior of the bag (110) and rotatably supported on the bearing. The assembly further includes a motor drive unit (140) disposed on the exterior of the bag (110) adjacent to the carrier (120) for rotating the mixing element (130). In some aspects the flexible bag (110) may include at least one geometric feature formed in the wall of the bag.

Description

ASSEMBLY FOR AGITATING OR MIXING MATERIAL

This application claims priority to U.S. Provisional Patent Application No.

62/020, 105, filed July 2, 2014, the entire contents of which are incorporated herein by reference.

Description

Technical Field

[0001] This disclosure generally relates an assembly for agitating or mixing material and, more particularly, to a flexible bag assembly for agitating or mixing material.

Background

[0002] Pharmaceutical manufacturing is primarily done by mixing material in batches in reusable stainless-steel vessels and similar reusable equipment. One drawback with this type of production is that it requires significant initial investments in materials and equipment, as well as a costly cleaning and sterilization systems and protocols. In some instances, pharmaceutical manufacturing is accomplished through single use technologies. For example, materials are mixed by using equipment (often made from different types of plastics) that are designed for a single use. The equipment may be fabricated, sterilized, and assembled in a clean room environment to provide a production assembly for use as part of a pharmaceutical manufacturing process. After production, the equipment is cleaned and disposed of as waste. Using disposable or single use equipment may result in lower initial investment and a more adaptive manufacturing process.

[0003] One goal in pharmaceutical manufacturing is ensuring the added components, e.g., the pharmaceuticals, drugs, and other materials combined in a formulation, are uniformly blended. This is usually done with a mixer. Different materials and formulations have different requirements and often require different mixing methods. For example, a powder may be brought into liquid solution with or without other materials and with or without aeration. For another example, living cells that are typically sensitive to shear may require mixing and combination with other materials without damage. And other components may need variable mixing, e.g., low shear, high shear, vortex, non-vortex mixing, all in a single batch to provide suitable end results and satisfactory mixing. Additionally, the materials and other substances may be heated or cooled, or include a chemical or biological processing, during the mixing process. Another goal in pharmaceutical manufacturing is timely, efficient, and complete mixing. Generally, the quicker and more efficient a substance or compound is mixed into homogenous blend, the less time required for the manufacturing process.

[0004] In some mixer arrangements, a drive shaft must be sealed within an opening in the mixing vessel, e.g., within a stainless-steel (multi-use) or flexible bag (single-use) system. In such instances, there is a risk that the seals will contaminate the materials inside the vessel, either by leaching of the seal material itself or by leakage of contaminants into or out of the vessel through the seal. In addition, one or more of the materials within the mixing vessel may be hazardous and there is a risk that the seals will leak hazardous material (e.g., vapors or liquids) out of the vessel and into the surrounding environment. Such exposure may be harmful to workers. Furthermore, after mixing and emptying the mixed components from the vessel, some components may remain lodged cavities that are formed within the seal. These cavities may collect and trap material which may be difficult to clean.

[0005] The disclosed mixing assembly is directed to overcoming one or more of the shortcomings mentioned above and/or other shortcomings in art.

Summary of the Disclosure

[0006] According to one aspect of the disclosure, a flexible bag assembly for mixing a material is disclosed. The assembly comprises a flexible bag having a wall and defining an interior for containing the material. The assembly also includes a rigid carrier disposed on an exterior of the bag and a bearing disposed on the interior of the bag adjacent to the carrier. The assembly also includes a mixing element disposed on the interior of the bag and rotatably supported on the bearing. The assembly further includes a motor drive unit disposed on the exterior of the bag adjacent to the carrier for rotating the mixing element.

[0007] According to other aspects of the disclosure, the flexible bag may include at least one geometric feature formed in the wall of the bag. The geometric feature may include a pre-formed structural indentation defining a cavity projecting toward the exterior or interior of the bag. The geometric feature may include a rumpled arrangement formed in a portion of the bag and configured to transition from a rumpled arrangement into a taut arrangement defining a cavity projecting toward the exterior or interior of the bag. In other aspects, the carrier may include at least one geometric feature formed in the wall of the carrier and defining a cavity projecting toward the interior of the bag. In other aspects, the geometric features formed in the wall of the bag have a substantially complimentary shape to a shape of geometric features in the wall of the carrier. In other aspects, the geometric feature formed in the wall of the carrier is disposed within the geometric feature of the bag when assembled. In other aspects, the bag may include a plurality of geometric features formed in the wall of the bag, defining a plurality of cavities projecting away from the interior of the bag. In further aspects, the flexible bag may include a plurality of geometric features formed in the wall of the bag, thereby defining a plurality of cavities projecting away from the interior of the bag

[0008] According to further aspects of the disclosure, a membrane may be attached to the interior of the bag to cover one or more of the geometric features. In other aspects, the membrane may be attached to the exterior of the bag and cover one or more geometric features. In other aspects, a plurality of membranes may be attached to the interior or exterior of the bag to cover one or more of the geometric features. In some aspects, a membrane may be attached to the interior of the bag adjacent to and covering: (i) a geometric feature having a pre-formed structural indentation defining a cavity projecting toward the exterior or interior of the bag, and/or (ii) a geometric feature having a rumpled arrangement formed in a portion of the bag and configured to transition from a rumpled arrangement into a taut arrangement defining a cavity projecting toward the exterior or interior of the bag, and/or (iii) a plurality of a geometric features having a pre-formed structural indentation, and/or (iv) a plurality of geometric features having a rumpled configuration, and/or any combination and/or any number of geometric formations formed in the bag.

[0009] According to further aspects, the carrier may include a geometric feature formed in a wall of the carrier and defining a cavity projecting away from the interior of the bag. In other aspects, the geometric features formed in the wall of the carrier is disposed within a geometric feature formed in the wall of the bag. The geometric feature formed in the carrier may be disposed in a pre-formed structural indentation defining a cavity projecting toward the exterior of the bag or the geometric feature formed in the carrier may be disposed in a geometric feature having a rumpled arrangement formed in a portion of the bag transition it from a rumpled arrangement into a taut arrangement defining a cavity projecting toward the exterior or interior of the bag. [0010] In yet further aspects, the present disclosure includes any combination of features described above or described in more detail below.

Brief Description of the Drawings

[0011] Figure 1 is a schematic diagram of an exemplary assembly for mixing material;

[0012] Figure 2A is a schematic diagram of an exemplary flexible bag of the exemplary assembly for mixing material of Figure 1 ;

[0013] Figure 2B is a schematic diagram of another exemplary flexible bag of the exemplary assembly for mixing material of Figure 1 ;

[0014] Figure 3 is a schematic diagram of flexible bag of the exemplary assembly for mixing material of Figure 1 ;

[0015] Figure 4A is a schematic diagram of an exemplary mixing element;

[0016] Figure 4B is a schematic cross sectional diagram of the exemplary assembly for mixing material of Figure 1.

Detailed Description

[0017] Figure 1 schematically illustrates an exemplary mixing assembly 100. The assembly 100 includes a flexible bag, e.g., flexible bag 1 10, that may be formed, arranged, and/or adjusted into one or more different shapes or configurations depending on the specific application. As explained in more detail below, the bag 1 10 includes a wall and generally defines an interior and an exterior with respect to the wall. The assembly 100 also includes a rigid carrier 120 disposed on the exterior of the bag and configured to support at least a portion of the bag 1 10. The rigid carrier 120 may include a removable carrier section 122. The assembly 100 also includes a mixing element 130 disposed on the interior of the bag 1 10. The mixing element 130 includes a mixer 134 rotatably supported on a bearing element 132. The assembly 100 also includes a drive unit 140 disposed on the exterior of the bag 1 10. The drive unit 140 may be disposed substantially adjacent the mixing element 130.

[0018] When included, the removable carrier section 122 is a modular component of the rigid carrier 120 that may be removed from the remainder of the rigid carrier 120 and relocated, e.g., placed, at one or more various locations around rigid carrier 120. Rigid carrier 120 may have one, two, three , four, or more locations configured to accommodate the removable carrier section 122. One or more removable carrier section 122 may be used in rigid carrier 120 and may be disposed in one or more locations configured to accommodate the removable carrier sections. As described in more detail below, the removable carrier section 122 permits the drive unit 140 and the mixing element 130 to be moved to different locations. The removable carrier section 122 may be attached or secured to rigid carrier 120 by any suitable coupling method. For example, the rigid carrier 120 may have one or more geometric features that are substantially complimentary in shape to the carrier to

accommodate and secure the removable carrier section 122 therein.

[0019] The drive unit 140 may be attached or secured by any suitable coupling to the carrier 120 and, in particular, to the removable carrier section 122. Drive unit 140 may be attached or secured by any type of suitable coupling to rigid carrier 120. For example, the drive unit 140 may be coupled to the carrier 120 and/or the carrier section 122 by one or more brackets, and/or one or more locks, and/or one or more fasteners, e.g., bolts, screws, rivets, and/or one or more clamps, and/or any other suitable coupling. The coupling is constructed and/or arranged to permit adjustability in the location of the drive unit 140 relative to the carrier 120 and/or the bag 1 10 and/or the mixing element, as well as permit adjustability of the angle and/or orientation of the drive unit 140 relative to the carrier 120, and/or the bag 110, and/or the mixing element 130. For example, a drive shaft of the drive unit 140 may be oriented substantially perpendicular, e.g., approximately 90°, to the wall of rigid carrier 120 and/or flexible bag 1 10. Or the drive shaft of the drive unit 140 may be orientated at a non- perpendicular angle, e.g., approximately 89°, 88°, 87°, 86°, 85°, 80°, 75°, 60°, 50°, 45°, 40°, 35°, 30°, 25°, 20°, 15°, 10°, 5°, 4°, 3° ,2°, 1°, or any other suitable angle. It is contemplated that the drive shaft of the drive unit 140 may be at any angle between 0° and 90° and that the drive shaft of the drive unit 140 and/or the drive unit 140 may be adjusted or varied to any angle before, during, and/or after mixing.

[0020] As described in more detail below, different angles of the drive unit 140 and/or the drive shaft allow for variable and different mixing dynamics for the materials inside the flexible bag 1 10 before, during and/or after mixing of materials. In particular, the angle of the drive unit 140 and/or the drive shaft may be varied during active mixing of materials, e.g., when the drive unit 140 is actively driving the mixer 134, to dynamically vary the mixing characteristics of the materials. An exemplary sequence of mixing may include starting with the mixing element substantially perpendicular, changing the angle of the drive unit 140 and mixing element 134 to approximately 75°, and changing the angle of the drive unit 140 and mixing element 134 to substantially perpendicular.

[0021] The rigid carrier 120 and/or removable portion 122 includes at least one geometric feature 1 12 that forms a cavity generally extending toward the exterior of the flexible bag 1 10 when assembled. See Figure 4B. The geometric feature 124 generally projects outward from a wall of the rigid carrier 120 and/or removable portion 122 and may have a shape that is substantially complimentary to one or more of the geometric features 210. It is contemplated that the carrier 120 and/or removable portion 122 may include any number of geometric features 1 12 and may including a plurality of geometric features having different shapes and/or configurations. The carrier 120 may include legs or other supports (not referenced) to support the carrier 120 and overall assembly relative to a surface or other structure. It is contemplated that carrier 120 may not include legs or support structures and may instead include other suitable support means to support the carrier 122 and the overall assembly relative to a table.

[0022] Figure 2A illustrates various embodiments of the flexible bag 1 10. The flexible bag 1 10 may include one or more, e.g., a plurality, of geometric features 210 formed in the wall of the flexible bag 1 10. The geometric features 210 are configured to define one or more cavities projecting toward the interior or toward the exterior of the flexible bag 110.

[0023] In some aspects, the geometric features 210 may be preformed in the wall of the flexible bag 1 10. For example, geometric features 212, 214, 224 are preformed structural indentations formed in the wall of the flexible bag 1 10 that extend toward the interior of the bag and form a cavity projecting toward the exterior of the bag. As explained in more detail below, the outward extending cavity may accommodate a substantially complimentary shaped indentation formed on the carrier 120 and/or the removable portion 122 of the carrier. It is contemplated that the preformed structural indentations 212, 214, 224 may be sufficiently elastic such that they can be collapsed into a generally flat arrangement and/or held in a collapsed and generally flat arrangement with a covering, membrane, or other mechanism. When uncovered, the preformed structural indentations are sufficiently elastic and configured to return, e.g., automatically return, to a preformed shape.

[0024] In another aspect, the walls of flexible bag 1 10 may be sufficiently elastic to allow for geometric features to be formed by stretching the walls of flexible bag 1 10 in toward the interior of flexible bag 1 10 or out toward the exterior of flexible bag 1 10. That is, instead of a preformed structural indentation, the wall, or a portion of the wall, of the flexible bag 1 10 may be stretched, e.g., by inserting a geometric feature formed on the carrier 120 and/or the removable portion 122 of the carrier to extend a portion of the wall of the bag toward the interior of the bag or by inserting a geometric feature formed on the bearing 132 to extend a portion of the wall of the bag toward the exterior of the bag.

[0025] In another aspect, the geometric features 210 may be formed by including extra material in portion of the wall of the flexible bag 1 10. For example, geometric feature 216 is portion of the flexible bag 1 10 that includes, e.g., rumpled, crumpled, wrinkled, creased, rolled, folded, furrowed, or other arrangement of extra material, formed in the wall of the flexible bag 1 10. The geometric feature 216 is configured to transition from a rumpled (or other arrangement) portion, slack arrangement into a taut arrangement to define a cavity projecting toward the exterior or interior of the flexible bag 1 10 and accommodate an indentation formed on the carrier 120 or the removable portion 122 of the carrier. For example, the extra material would permit geometric features, similar in size and shape to the preformed structural indentations 212, 214, or any other shape, to be created by pushing the rumpled (or other arrangement) material of the flexible bag 1 10 toward the interior or exterior of the flexible bag 1 10. It is contemplated that the rumpled (or other arrangement) portion may be configured to transition from a slack arrangement to a taut arrangement to define either a cavity projecting toward the exterior of the bag, the interior of the bag, or both. That is, a rumpled portion may be configured to extend both inward and outward depending on the particular configuration. Alternatively, it is contemplated that the rumpled (or other arrangement) portion may be configured to extend inward only or extend outward only such that it can transition to a taut configuration in only a single direction.

[0026] There may be any number of geometric features 210 formed the flexible bag 1 10. For example, there may be one, two, three, four, five, ten, or more geometric features in flexible bag 1 10. The geometric features 210 may be any number and/or combination of the different types of geometric features. It is contemplated that the flexible bag 1 10 may include one pre-formed structural indentation, either projecting towards to the interior of flexible bag 1 10 or projecting toward the exterior of the flexible bag 1 10, and one rumpled (or other arrangement) portion. It is also contemplated that the flexible bag 1 10 may include two preformed structural geometric features and one rumpled (or other arrangement) portion. The geometric features 212 may be any shape. For example, the geometric feature may be cylindrical, pyramidal, spherical, hemispherical, conical, frustroconical, torroidal, round, elliptical, square, triangular, or any other suitable shape. The geometric features 212 may be arranged in any suitable location in the wall of flexible bag 1 10 and, may be adjacent or apart from other geometric features, and/or may be arranged in one or more configurations. For example, a series of geometric features may be arranged in a line, a triangle, a square, a diamond, a cross, an x-shape, a figure-eight, or any other suitable configuration. The flexible bag 1 10 may include geometric features that are formed in the wall of the flexible bag 1 10 defining a cavity projecting toward the exterior of the flexible bag. The geometric features created may have a cavity of any size or shape. The cavity may be relatively shallow or deep. The depth may be 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or any suitable depth. The overall geometric feature width may be 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or any suitable width.

[0027] The flexible bag 1 10 may be made out of any suitable material. For example, the material may include generally flexible polymers such as polyethylene or polypropylene. The flexible bag 1 10 may include a single layer or a composition of two or more layers. The layers may be suitable to keep various materials including gases, solids or liquids in or out of the bag. The material may be impermeable to particular types or specific gases liquids or solids and the material may be permeable to particular types or specific gases, liquids or solids. The material may be configured to block certain types of light or radiation such as ultraviolet, visible light, infrared light, and/or x-rays.

[0028] In one example, flexible bag 1 10 may include at least three layers, including an inner layer, adjacent to and forming the interior surface of the flexible bag 1 10, that is inert to the materials being mixed inside the flexible bag 1 10, an outer layer, adjacent to and forming the exterior surface of the flexible bag 1 10, and one or more middle layers disposed between the inner and outer layers. The inert inner layer may be formed from a material that helps prevent or reduce contamination of the materials to be mixed or otherwise disposed in the interior of the bag. One or more of the middle layer may be materials that are impermeable to one or more gasses to further prevent or reduce contamination of the materials to be mixed or otherwise disposed in the interior of the bag. For example, the gas impermeable layer may reduce or prevent gases, vapors, or other fluids that are part of or result from mixing the material from escaping the interior of the flexible bag 1 10 and leaking to an exterior environment. In addition, the gas impermeable layer may reduce or prevent gases, vapors, or other fluids present in a surrounding environment from passing through and entering the interior of the flexible bag. The outer layer may be a material that is inert to the conditions outside the flexible bag 1 10. The outer layer may provide a third barrier of protection against contamination of the mixture in the flexible bag 1 10.

[0029] It is contemplated that any of the respective layers may be formed from, for example, polyethelylene, linear low-density polyethylene, polyethylene vinyl acetate, polypropylene, ethylene tetrafuoroethylene, polyvinylidene fluoride, polyethylene terephthalate, polyamide, ethylene vinyl alcohol, styrene ethylene butadiene styrene, polyethylene terephthalate glycol, polyvinylidene fluoride, or other suitable materials. In general, suitable materials for any of the respective layers may be biodegradable, non- biodegradeable, opaque, transparent, translucent, may or may not block ultraviolet light or radiation, may or may not block x-rays, may or may not have insulative properties, may or may not be conductive, and may include any combination of such properties. It is also contemplated that any of the respective layers may be any thickness, and the overall wall of the flexible bag may be any thickness. It is further contemplated that the respective layers may each have the same thickness, may have different thicknesses, and/or one or more layers of the same material may have the same or different thicknesses throughout the wall of the bag.

[0030] It is contemplated that the wall of the flexible bag 1 10 any include any number of layers. For example, the wall of the flexible bag 1 10 may include three layers, e.g., an inner layer, an outer layer, and a single middle layer disposed between the inner and outer layers. In addition, or as an alternative, the wall of the flexible bag 1 10 may include any number of middle layers, e.g., two, three, four, five, or six layers. It is also contemplated that flexible bag 1 10 may include any number of different layers or may include a one or more layers of the same material inter-disposed between other layers. The layers may be configured in any order and include any material, including any of the materials described hereinabove.

[0031] The flexible bag 1 10 may be formed using any method suitable to create polymer films, including, for example, co-extruding polymer sheets. Alternatively, the polymer sheets may be welded together or formed by injection molding. The flexible bag 1 10 may include one or more ports or connections (not shown) to permit material to be inserted into or removed from the flexible bag 1 10 before, during, and/or after mixing. For example, one or more materials may be delivered into the flexible bag 1 10 via one or more inlet ports before the mixing element 130 is operated, one or more materials may be delivered into and/or removed from the flexible bag 1 10 via one or more inlet and/or outlet ports when the mixing element 130 is operated, i.e., while material inside the bag is actively being mixed, and/or material may be removed from the flexible bag 1 10 after the mixing element 130 is operated via one or more outlet ports. The ports or connections in flexible bag may be configured as inlets, outlets, vents, for drainage, suction, or any other suitable purpose. It is contemplated that the flexible bag 1 10 may include any number of ports, including any number of inlets, outlets, vents, or other ports, and there may be any combination of ports or other connections in flexible bag 1 10. It is contemplated that the flexible bag may include any combination of luer valves, locks, and/or assemblies; needle ports; quick-connect, barbed flange, and/or bayonet connections; clamps, caps, lids, snap-fit covers, and/or other coverings; inserts, tubing, gaskets, seals, and/or any other component for connecting with upstream and/or downstream vessels, piping, tubing, and/or other equipment or apparatus.

[0032] Figure 2B shows another view of the flexible bag 1 10. The geometric features 212 and 214 are shown at exemplary non-limiting locations within the wall of the flexible bag 1 10. It is contemplated that the geometric features 210 may be located at any number of locations in the wall of the flexible bag 1 10. Fig. 2B also illustrates exemplary geometric feature 216 in a generally flat configuration and covered by a membrane or piece of material 218. The membrane or piece of material 218 may be made out of any material suitable, such as silicone, and configured to cover geometric feature 216. For example, the membrane or piece of material 218 may be attached to the interior surface of the wall of the bag 1 10 and configured to cover and maintain the geometric feature 216 in substantially flat arrangement. The membrane or piece of material 218 may be sufficiently elastic to permit it to be placed over a fixed geometric feature 216, and/or other geometric features (e.g. 212 or 214) including geometric features that are disposed within the flexible bag 1 10 but that are not currently in use, e.g., the mixing element 130, carrier 120, and drive unit 140 are not located at the geometric feature, but may be expanded and used when needed. Although the geometric features 210 are shown generally on the bottom of the flexible bag 1 10, it is contemplated that possible to have geometric features on any general surface, side, or portion of the bag. Arranging the mixing element 134 at such locations may provide the ability to achieve additional and/or different mixing characteristics of the material.

[0033] Referring to Figure 3, a membrane or piece of material 304 may be attached to the interior surface of the wall of the flexible bag 1 10 to cover geometric features 212, 214 and hold the geometric features 212, 214 in a first generally flat arrangement, as described in more detail above. Alternatively, the membrane or piece of material 304 may cover just one of the geometric features 212, 214. The membrane or piece of material 218, or alternatively another, separate membrane or piece of material (not shown), may be attached to the interior surface of the wall of the flexible bag 1 10 to cover geometric feature 214 and hold the geometric feature 214 in a first generally flat arrangement.

[0034] It is contemplated that any number of membranes or pieces of material (e.g., 218, 304) may be attached to the interior surface of the wall of the bag 1 10 to cover one or more of the geometric features. The membranes or pieces of material 218, 304 may be formed from any type of material, be any suitable shape or contour, have any suitable or desired thickness, and may, or may not, affect the mixing dynamics of the material. In an exemplary embodiment, the additional membrane or material is made of silicone. By covering and holding the geometric features, the membranes or pieces of material 218, 304 may reduce turbulence in the flexible bag 1 10 by providing a substantially smooth interior surface by covering surface irregulatarites that may form in the flexible bag wall when the geometric feature is in its first arrangement, e.g., when a preformed structural indentation (214) is collapsed to a generally flat arrangement or when a rumpled (or other arrangement) feature (216) is not extended to its taut arrangement. A smooth interior may help promote uniform mixing, reduce or eliminate vortices, and/or generally promote laminar flow. It is

contemplated that, when the flexible bag 1 10 includes a plurality of geometric features, all but one of the geometric features will be covered by a membrane or other piece of material (218, 304) such that only one geometric feature is transitioned to a second arrangement when the mixer, bearing, carrier, and/or drive unit are assembled. It is also contemplated that the membrane or piece of material may be sufficiently elastic to stretch and extend so as to accommodate the carrier and/or bearing when assembled without tearing or otherwise breaking. Alternatively, the membrane or piece of material may be configured to tear or otherwise break when the carrier and/or bearing are assembled. By being configured to tear or otherwise break, the membrane may provide a visible indication that the flexible bag has been used and/or that a particular mixing operation has been completed. It is contemplated that the membrane may be attached to the bag 110 via any suitable method including, for example, adhesive or welding, and may be attached with a continuous or intermittent attachment joint. It is further contemplated that a membrane or piece of material that covers two or more geometric features may be configured to permit one of two or more covered geometric features to transition to a second arrangement while still holding the other of the two or more covered geometric features in a generally flat arrangement. For example, the membrane or other piece of material (218, 304) may be attached to the wall of the bag substantially around each individual geometric feature.

[0035] In addition or as an alternative to the geometric formations described above, the flexible bag 1 10 may include one or more apertures or other openings formed in the wall and configured to accept and receive a portion of the carrier and/or bearing when assembled. As described above, a membrane or piece of material may be included to cover the aperture and configured to stretch and accommodate portions of the carrier and/or bearing when assembled. The aperture may be any shape or size. The edge of the aperture may be surrounded by a raised substantially ridged lip 228 (e.g. a substantially round ring surrounding a substantially round hole). The lip 228 may be of any suitable material and may be attached or secured to the interior surface of the wall of the flexible bag 1 10 by any suitable manner including, for example, adhesive or welding. The lip 228 may be any suitable shape or size and may, in exemplary embodiments, be round, square, triangular, elliptical, shaped like a figure 8, a diamond or any other suitable shape. It is contemplated that lip 228, or additional lips formed in and/or attached to the interior of the bag, may be disposed at and substantially surround any of the geometric features 210. It is also contemplated that lip 228 and/or other lips may substantially surround two or more geometric features 210. It is further contemplated that lip 228 and/or other lips may be directly attached to the bag 1 10 and that, if included, the membrane or other piece of material may be attached to the lip 228 and/or other lips instead of being directly attached to the bag 1 10. The lip 228 and other lips (if included) may provide additional support and rigidity to the wall of the flexible bag at a geometric feature. This may reduce tearing or other damage to the bag when the mixer, bearing, carrier, and/or drive unit are assembled, may improve component alignment and support during and/or after assembly.

[0036] Figures 4A and 4B schematically illustrate an exemplary mixing element 130. The mixing element 130 may be disposed on an interior of the flexible bag 1 10 and may be any type of mixer suitable for mixing, agitating, or stirring material inside the flexible bag 1 10. In an exemplary embodiment, the mixing element 130 includes mixer 134 with four blades. It is contemplated, however, that the mixer 134 may include any number of blades in any arrangement. The mixer is rotatably supported on the bearing 132 and driven by the drive shaft (not shown) of the drive unit 140 to agitate, mix, or stir the material. The mixer 134 may be supported on the bearing 132 in any suitable manner. For example, the bearing 132 may include a snug-fit connection with the mixer 134 such that an internal surface of the mixer 134 is in sliding relationship with an external surface of the bearing 132. For another example, the bearing 132 may include magnets or other means for generating a magnetic force exerting an upwardly directed force on the mixer 134. The mixer may, or may not, include magnets or other means for generating a magnetic force exerting a downwardly directed force on bearing 132. It is contemplated that the mixer 134 may be completely or partially magnetically supported on the bearing 132. For example, the magnitude and direction of the magnetic forces may be configured and/or dynamically adjusted to provide or modify the degree to which the mixer 134 is magnetically supported or directly supported by the bearing 132. It is contemplated that the mixer 134 may be completely magnetically supported, completely directly supported, or supported both magnetically and directly according to any relative percentage of support. For a further example, the drive unit may include a non-rotating drive shaft having a plurality of separate electrical coils mounted therein that can be alternatively and sequentially electrified to produce a moving, e.g., revolving, magnetic field to magnetically support and rotate a mixer. It is contemplated that in such an arrangement, the mixer and/or the bearing may or may not have a series of magnets formed therein configured to interact with the alternating magnetic field produced by the non-rotating drive shaft of the drive unit.

[0037] Figure 4B shows an exemplary cross sectional view of the mixing element 130. The bearing 132 may be located at any geometric feature. For example, Figure 1 exemplary illustrates the mixing element 130, and thus mixer 134 and bearing 132, disposed adjacent geometric feature 212. As shown, the bearing 132 includes a cavity projecting toward the exterior of the flexible bag 1 10 that substantially surrounds a portion of the geometric feature 212 and thus a portion of the wall of the flexible bag 1 10 when assembled. The carrier 120 and/or removable portion 122 is disposed on the exterior of the flexible bag 1 10 and includes a projecting portion, e.g., indentation, forming a cavity projecting toward the exterior of the bag. The indentation is disposed within the cavity formed by the geometric feature 212 formed in the wall of the flexible bag 1 10. Thus, the geometric feature 212 substantially surrounds the indentation formed on the carrier 120 and/or removable portion 122. In addition, the bearing 132 substantially surrounds a portion of the indentation on the carrier 120 and/or removable portion 122. The mixing element 130 at least partially surrounds the bearing 132 and the bearing 132 partially surrounds the wall of the flexible bag 110. As shown in an exemplary embodiment, the geometric feature 212 in the wall of flexible bag 1 10 has a substantially complimentary shape to a geometric feature 124, e.g., indentation, formed in the wall of the rigid carrier 120 and the cavity formed in the bearing 132. As shown in Figure 4B, the wall of the flexible bag 1 10 may be completely continuous and disposed completely between the bearing 132 and the carrier 120 when assembled.

[0038] Alternatively, the bearing may include a projection (not shown) projecting toward the exterior of the flexible bag 1 10 such that a geometric feature, e.g., geometric feature 216 substantially surrounds the projection when assembled. In such an arrangement, the carrier and/or removable portion, again disposed on the exterior of the flexible bag 1 10, includes cavity forming a cavity projecting toward the interior of the bag. The geometric feature 216 is disposed within the cavity formed in the carrier and/or removable portion. Thus, the geometric feature 216 substantially surrounds the projection formed on the bearing and the cavity formed in the carrier and/or removable portion 122 substantially surrounds the geometric feature 216. In addition, the carrier and/or removable portion substantially surrounds a portion of the projection on the bearing. Like the embodiment shown in Figure 4, in this alternative arrangement, the geometric feature 216 in the wall of flexible bag 1 10 has a substantially complimentary shape to projection of the bearing and the cavity of the carrier and/or removable portion, the wall of the flexible bag 1 10 may be completely continuous and disposed completely between the bearing and the carrier when assembled.

[0039] A drive unit 140 may be disposed on the exterior of the flexible bag 1 10 and adjacent the rigid carrier 120. The drive unit 140 may be configured to rotate, e.g., drive, the mixer 134. For example, the drive unit 140 may be configured for contactless transfer of rotational movement to the mixer 134. For example, the drive unit 140 may include a drive shaft (not referenced), one or more magnets may be disposed in the drive shaft, and one or more magnets may be disposed in the mixer 134. The respective magnets may be arranged such that when the drive shaft rotates, e.g., when driven by an electrical motor, the mutual attracting and/or repelling forces of the magnets transfer the rotation of the drive shaft to the mixer 134. As shown in Figure 4B, the drive shaft and mixer 134 rotate about an axis generally defined by the geometric feature 212, the bearing 132, and the carrier 120 and/or the removable portion 122. As explained in more detail herein, the rotational axis may be oriented at any angle relative to the flexible bag 1 10, and may be dynamically changed and adjusted during mixing. [0040] It is contemplated that any number of the features described above with respect to a particular embodiment may be combined with one or more of the features described with respect to the other embodiments, and/or combined in any suitable arrangement in additional embodiments.

Industrial Applicability

[0041] The disclosed embodiments may provide an improved mixing process for materials and, in particular, for mixing pharmaceutical materials. The disclosed embodiments may be used for mixing applications in the medical, food, or biotech industries and may be suitable for mixing or producing any type of material including, for example, liquids, gases, solids, slurries, granular materials, entraining gases, creating suspensions, aerating solid-solid mixtures, aerating solid-liquid mixtures, and/or any other type of operation.

[0042] The disclosed embodiments may provide an improved mixing apparatus and process by allowing for different mixing characteristics to be created by permitting and facilitating multiple and selectable locations for the mixing element inside the flexible bag. The mixing element may be located at any of the geometric features formed in the flexible bag. The mixing element may also be located at any other location inside the flexible bag when stretching the wall of the flexible bag. The different locations of the mixing element allow for different mixing characteristics. For example, if the mixing element 130 is disposed off- center of the flexible bag, e.g., as shown in Figure 1, the mixer 134 will generate a different flow inside the flexible bag as compared to the flow generated by the mixer 132 when the mixing element 130 is disposed at substantially at the center of the flexible bag. Moreover, the mixing element 130 can be moved during a particular processing batch to allow for two or more different types of flows without having to use two different bags. For example, a specific sequence of locations, combined with mixing times, may produce desired mixing profiles for various materials and mixtures. One shortcoming of conventional mixing assemblies is that they include a single location for the mixing element and thus do not allow or facilitate varying the location of or relocating the mixing element. Thus they provide a single predetermined mixing characteristic.

[0043] The disclosed embodiments may also provide an improved mixing apparatus and process by allowing for different mixing characteristics to be created by permitting and facilitating dynamic adjustment of the rotational angle of the mixer. The rotational axis of the mixer may be adjusted by varying the orientation and location of the drive unit and, in particular, of the drive shaft. Different rotational angles provided different flows and different mixing characteristics in the material. For example, a substantially perpendicular orientation may provide a substantially circular rotational flow, whereas a non-perpendicular orientation, e.g., an askew angle, may create turbulence in the material creating one or more vortexes that may aerate the material. Not only can the drive shaft and drive unit be connected to the carrier at any given orientation, thus providing variability in the initial flow characteristic, they may be dynamically adjusted during mixing to provide dynamic variability. Another shortcoming of conventional assemblies is that they include a single orientation and thus do not allow or facilitate varying the orientation. Thus they provide a single predetermined mixing characteristic.

[0044] The disclosed embodiments may also reduce or eliminate the risk of contamination and/or leakage by allowing the flexible bag to be continuous, i.e., no openings or breaks, when the mixing element, carrier, and drive unit are assembled. For example, the properties of the bag, e.g., provided by the particular materials of the wall of the bag, can be

consanguineous and are not interrupted and the properties of the bag are substantially constant throughout the entire bag. Similarly, the disclosed embodiments may also reduce or eliminate the risk of leakage into or out of the interior of the bag by eliminating or reducing the number of seals. Another shortcoming of conventional mixing assemblies is that they often include a rigid bearing, often of a disparate material, welded into a hole formed in the wall of a bag and/or including additional seals that can leak.

[0045] In addition, the mixing element may be located in the flexible bag before both are sterilized. This allows for the bag and mixing element to be sterile before any mixing process and prevents the need from opening the flexible bag prior to mixing to add the mixing element which may introduce contaminants, compromise the sterility of the system, and/or require resterilization after assembly.

[0046] It will be apparent to those skilled in the art that various modifications and variations can be made to assembly of the present disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the flexible bag assembly for mixing disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope being indicated by the following claims and their equivalents.

Claims

Claims What is claimed is:

1. An assembly for agitating a material, comprising:

a flexible bag having a wall and defining an interior for containing the material; a rigid carrier disposed on an exterior of the bag;

a bearing disposed on the interior of the bag adjacent the carrier;

a mixing element disposed on the interior of the bag and rotatably supported on the bearing; and

a motor drive element disposed on the exterior of the bag adjacent the carrier for rotating the mixing element.

2. The assembly of claim 1 , wherein the bag includes at least one geometric formation formed in the wall of the bag configured to define a cavity.

3. The assembly of claim 2, wherein the geometric formation is a preformed indentation defining a cavity projecting toward the exterior of the bag.

4. The assembly of claim 3, wherein the carrier includes at least one indentation formed in a wall of the carrier and defining a cavity projecting toward the exterior of the bag.

5. The assembly of claim 4, wherein the at least one indentation formed in the wall of the bag has a shape substantially complimentary to a shape of the at least one indentation formed in the wall of the carrier.

6. The assembly of claim 4, wherein the at least one indentation formed in the wall of the carrier is disposed within the at least one indentation formed in the wall of the bag when assembled.

7. The assembly of claim 2, wherein the geometric formation is a preformed indentation defining a cavity projecting toward the interior of the bag.

8. The assembly of claim 7, wherein the carrier includes at least one indentation formed in a wall of the carrier and defining a cavity projecting toward the interior of the bag.

9. The assembly of claim 8, wherein the at least one indentation formed in the wall of the bag has a shape substantially complimentary to a shape of the at least one indentation formed in the wall of the carrier.

10. The assembly of claim 9, wherein the at least one indentation formed in the wall of the bag is disposed within the at least one indentation in the wall of the carrier when assembled.

1 1. The assembly of claim 1 , wherein the bag includes a plurality of geometric formations formed in the wall of the bag, configured to define a plurality of cavities.

12. The assembly of claim 1 1, wherein the carrier includes at least one indentation formed in a wall of the carrier, defining a cavities projecting toward the exterior the bag.

13. The assembly of claim 1 1 , wherein:

the carrier includes an indentation formed in a wall of the carrier, defining a cavity projecting toward the exterior of the bag; and

the indentation formed in the wall of the carrier is disposed within one of the plurality of geometric formations formed in the bag when assembled.

14. The assembly of claim 1 1, wherein:

the bearing includes a cavity formed in the bearing; and

the geometric feature formed in the wall of the bag is disposed within the cavity in the bearing when assembled.

15. The assembly of claim 14, wherein the mixing element is disposed on and at least partially surrounds the bearing when assembled.

16. The assembly of claim 1 , wherein, when assembled: the mixing element is disposed on a first side of the bearing;

the bearing is disposed between the mixing element and a portion of the wall of the bag such that the portion of the wall of the bag is disposed on a second side of the bearing opposite the first side;

the portion of the wall of the bag is disposed between the bearing and the carrier such that the bearing is disposed on a first side of the portion of the wall of the bag and the carrier is disposed on a second side of the portion of the wall of the bag, opposite the first side.

17. The assembly of claim 16, wherein, when assembled, the motor drive is disposed adjacent the carrier such that the carrier is disposed between the drive element and the portion of the wall of the bag.

18. The assembly of claim 1, wherein the wall of the bag is consanguineous.

19. The assembly of claim 1, wherein the bag includes a preformed indentation formed in the wall of the bag configured to transition from a first substantially collapsed arrangement to a second substantially erect arrangement.

20. The assembly of claim 19, further including a membrane substantially covering the preformed indentation to maintain the preformed indentation in the first arrangement.

21. The assembly of claim 20, wherein the preformed indentation is configured to automatically transition from the first arrangement to the second arrangement when the membrane is removed to uncover the preformed indentation.

22. The assembly of claim 1, wherein the bag includes a rumpled portion formed in the wall of the bag configured to transition from a first substantially collapsed arrangement to a second substantially erect arrangement.

23. The assembly of claim 22, further including a membrane substantially covering the preformed indentation to maintain the preformed indentation in the first arrangement.

24. The assembly of claim 23, wherein the preformed indentation is configured to transition from the first arrangement to the second arrangement when the carrier and bearing are assembled relative to the bag.

25. The assembly of either claim 20 or claim 23, wherein the membrane is sealed to the interior of the bag.

26. The assembly of either claim 20 or claim 23, wherein the membrane is sealed to the exterior of the bag.

27. The assembly of claim 1 , wherein the bag includes a plurality of rumpled portions formed in the wall of the bag configured to transition from a first substantially collapsed arrangement to a second substantially erect arrangement.

28. The assembly of claim 27, further including a plurality of membranes, each membrane attached to the interior of the bag adjacent a respective one of the plurality of rumpled portions and substantially covering the rumpled portion.

29. The assembly of claim 27, further including a membrane attached to the interior of the bag adjacent at least two of the plurality of rumpled portions and substantially covering the two rumpled portions.

30. An assembly for agitating a material, comprising:

a flexible bag having a wall and defining an interior for containing the material, the bag including at least one indentation formed in the wall of the bag defining a cavity projecting toward the exterior of the bag;

a rigid carrier disposed on an exterior of the bag, the carrier including at least one indentation formed in a wall of the carrier defining a cavity projecting away from the interior of the bag;

a bearing disposed on the interior of the bag adjacent the carrier;

a mixing element disposed on the interior of the bag and rotatably supported on the bearing.

31. The assembly of claim 30, wherein the at least one indentation formed in the wall of the bag is one of a plurality of indentations formed in the bag.

32. The assembly of claim 30, further including at least one rumpled portion formed in the wall of the bag.

33. An method for agitating a material, comprising:

delivering material into a flexible bag, the flexible having a wall and defining an interior for containing the material, the bag including at least one indentation formed in the wall of the bag defining a cavity projecting toward the exterior of the bag;

mixing the material with a mixing element disposed on the interior of the bag and rotatably supported on a bearing disposed on the interior of the bag;

wherein the bearing is disposed adjacent a rigid carrier disposed on an exterior of the bag;

wherein the bearing includes at least one indentation formed in the bearing defining a cavity substantially surrounding the at least one indentation formed in the wall of the bag; and

wherein the carrier includes at least one indentation formed in a wall of the carrier substantially disposed within the cavity defined by the at least one indentation formed in the wall of the bag.

34. The method of claim 33, wherein the bearing includes an orientation, the method further including varying at least one mixing characteristic by varying the orientation of the bearing.

35. The method of claim 33, further including varying the orientation of the bearing during active mixing of the material.