TW201607607A - Assembly for agitating or mixing material - Google Patents

Abstract

An assembly for agitating or mixing material. The assembly includes 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. In some aspects the flexible bag may include at least one geometric feature formed in the wall of the bag.

Description

Assembly for agitating or mixing materials

The present application claims the benefit of U.S. Provisional Patent Application Serial No. 62/020, filed on Jan. 2, 2014, the entire content of which is hereby incorporated by reference.

Field of invention

The present disclosure relates generally to assemblies for agitating or mixing materials, and more particularly to flexible bag assemblies for agitating or mixing materials.

Background of the invention

Drug manufacture is primarily carried out by mixing materials in batches in reusable stainless steel containers and similar reusable equipment. One of the drawbacks of using this type of production is that this type of production requires a large initial investment in materials and equipment, as well as expensive cleaning and sterilization systems and agreements. In some cases, drug manufacturing is achieved by a single use technique. For example, materials are mixed by using equipment designed for single use (usually made of different types of plastic). Equipment can be manufactured, sterilized, and assembled in a clean room environment to provide a production assembly that is used as part of the pharmaceutical manufacturing process. After production, the equipment is cleaned and disposed of as waste. Use disposable or single use Using equipment can result in lower initial investment and a more adaptive manufacturing process.

One goal in the manufacture of pharmaceuticals is to ensure that the added components, such as drugs, pharmaceuticals, and other materials combined in the 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, the powder can be added to the liquid solution with or without other materials and with or without ventilation. For another example, living cells that are generally sensitive to shear may need to be mixed and combined with other materials without damage. And other components may all require variable mixing in a single batch, for example, low shear, high shear, vortex, no vortex mixing to provide a suitable end result and satisfactory mixing. Additionally, materials and other materials may be heated or cooled or include chemical or biological treatment during the mixing process. Another goal in the manufacture of drugs is timely, efficient and complete mixing. In general, the faster and more efficient the mixing of a substance or compound into a homogenous blend, the less time required for the manufacturing process.

In some mixer arrangements, the drive shaft must be sealed within an opening in the mixing vessel, for example, in a stainless steel (multiple use) or flexible bag (single use) system. In such cases, there is a risk that the seal will contaminate the material within the container by leaching of the sealing material itself or by leakage of contaminants into the container via the seal or leaking out of the container. Additionally, one or more of the materials within the mixing vessel can be detrimental, and there is a risk that the seal will cause hazardous materials (eg, steam or liquid) to leak out of the container and leak into the surrounding environment. This exposure can be harmful to workers. In addition, some components may still be embedded in the cavity formed within the seal after mixing and emptying the mixed components from the container. These cavities collect and trap materials that can be difficult to clean.

The disclosed hybrid assembly is directed to overcoming one or more of the above mentioned disadvantages and/or other disadvantages in the art.

Summary of invention

In accordance with one aspect of the present disclosure, a flexible bag assembly for mixing materials is disclosed. The assembly includes a flexible bag having a wall and defining an interior for receiving the material. The assembly also includes a rigid carrier disposed on the exterior of the bag and a bearing abutting the interior of the bag adjacent 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 adjacent the carrier and on the exterior of the bag for rotating the mixing element.

According to other aspects of the present disclosure, the flexible bag can include at least one geometric feature formed in the wall of the bag. The geometric features can include a preformed structural indentation that defines a cavity that projects toward the exterior or interior of the bag. The geometric feature can include a creping arrangement formed in one of the pockets and assembled to transition from the creping arrangement into the tensioning arrangement to define a cavity that projects toward the exterior or interior of the pocket. In other aspects, the carrier can include at least one geometric feature formed in the wall of the carrier and defining a cavity that projects toward the interior of the bag. In other aspects, the geometric features formed in the walls of the bag have a substantially complementary shape associated with geometric features in the walls of the carrier. In other aspects, the geometric features formed in the walls of the carrier are disposed within the geometric features of the bag during assembly. In other aspects, the bag may include a plurality of geometric features formed in the wall of the bag, thereby A plurality of cavities projecting away from the interior of the bag. In a further aspect, the flexible bag can include a plurality of geometric features formed in the wall of the bag, thereby defining a plurality of cavities that protrude away from the interior of the bag.

According to a further aspect of the present disclosure, the film can be attached to the bag Internal to cover one or more of the geometric features. In other aspects, the film can be attached to the exterior of the bag and cover one or more geometric features. In other aspects, a plurality of films can be attached to the interior or exterior of the bag to cover one or more of the geometric features. In some aspects, the film can be attached to the interior of the bag adjacent to and covering: (i) a geometric feature having a preformed structural indentation that defines the exterior of the bag Or an internally projecting cavity, and/or (ii) a geometric feature having a creping arrangement formed in one of the pockets and assembled to transition from the creping arrangement into the tensioning arrangement to define the orientation a cavity that protrudes outside or inside the pocket, and/or (iii) a plurality of geometric features having a preformed structural indentation, and/or (iv) has a creped configuration, and/or a geometric formation formed in the pocket Any combination and/or any number of geometric features of the geometric configurations.

According to a further aspect, the carrier can include a geometric feature formed in the wall of the carrier and defining a cavity that projects away from the interior of the bag. In other aspects, the geometric features formed in the walls of the carrier are disposed within geometric features formed in the walls of the bag. The geometric features formed in the carrier may be disposed in a preformed structural indentation defining a cavity that protrudes toward the exterior of the bag, or geometric features formed in the carrier may be disposed in a creping arrangement having a portion formed in the pocket In the geometric feature, the creping arrangement is transitioned from the creping arrangement into the tensioning arrangement to define an empty space that protrudes toward the exterior or interior of the bag Cavity.

In still further aspects, the present disclosure includes any combination of the features described above or described in greater detail below.

100‧‧‧Mixed assembly/assembly

110‧‧‧Flexible bag/bag

120‧‧‧Rigid carrier/carrier

122‧‧‧Removable carrier segment/carrier segment/removable portion

124‧‧‧Geometric features

130‧‧‧Mixed components

132‧‧‧Bearing components/bearings

134‧‧‧Mixer/mixing components

140‧‧‧Drive unit

210, 216, 222, 226‧‧‧ geometric features

212, 214, 224‧‧‧ Geometric features/preformed structural indentations

228‧‧‧Uplifted general ridged lip/lip

218, 304‧‧‧ films or sheets of material

1 is a schematic view of an exemplary assembly for mixing materials; FIG. 2A is a schematic view of an exemplary flexible bag of the exemplary assembly of the mixed material of FIG. 1; FIG. 2B is a mixed material of FIG. 3 is a schematic view of another exemplary flexible bag of the exemplary assembly; FIG. 3 is a schematic view of the flexible bag of the exemplary assembly of FIG. 1 for mixing materials; FIG. 4A is a schematic view of an exemplary mixing element; FIG. Figure 1 is a schematic cross-sectional view of an exemplary assembly for mixing materials.

Detailed description of the preferred embodiment

FIG. 1 schematically illustrates an exemplary hybrid assembly 100. Assembly 100 includes a flexible bag, such as flexible bag 110, which may be formed, arranged, and/or adjusted into one or more different shapes or configurations, depending on the particular application. As explained in more detail below, the pouch 110 includes a wall and generally defines an interior and an exterior with respect to the wall. Assembly 100 also includes a rigid carrier 120 disposed external to the bag and assembled to support at least a portion of bag 110. The rigid carrier 120 can include a removable carrier section 122. Assembly 100 also includes a mixing element 130 that is disposed on the interior of bag 110. Mixing element 130 includes A mixer 134 is rotatably supported on the bearing member 132. Assembly 100 also includes a drive unit 140 that is disposed on the exterior of bag 110. Drive unit 140 can be disposed generally adjacent to mixing element 130.

When included, the removable carrier section 122 is a rigid carrier 120 The modular assembly can be detached and repositioned from the remainder of the rigid carrier 120, such as at one or more various locations around the rigid carrier 120. The rigid carrier 120 can have one, two, three, four or more locations that are assembled to accommodate the removable carrier section 122. One or more removable carrier segments 122 can be used in the rigid carrier 120 and can be disposed in one or more locations that are assembled to accommodate the removable carrier segments. As described in more detail below, the removable carrier section 122 allows the drive unit 140 and the mixing element 130 to be moved to different positions. The removable carrier section 122 can be attached or fastened to the rigid carrier 120 by any suitable coupling method. For example, the rigid carrier 120 can have one or more geometric features that are substantially complementary in shape to the carrier to accommodate the removable carrier segment 122 and secure the removable carrier segment thereto. One or more geometric features.

The drive unit 140 can be attached or fastened by any suitable coupling To the carrier 120, and in particular to the removable carrier section 122. Drive unit 140 can be attached or fastened to rigid carrier 120 by any type of suitable coupling. For example, the drive unit 140 can be by one or more brackets, and/or one or more locks, and/or one or more fasteners such as bolts, screws, rivets, and/or one or more clips, And/or any other suitable coupler is coupled to carrier 120 and/or carrier section 122. The coupler is constructed and/or arranged to permit drive unit 140 relative to carrier 120 and/or bag 110 and/or mixing elements The adjustability of the position and allows for adjustability of the angle and/or orientation of the drive unit 140 relative to the carrier 120 and/or the pouch 110 and/or the mixing element 130. For example, the drive shaft of the drive unit 140 can be oriented substantially perpendicular (eg, approximately 90°) to the walls of the rigid carrier 120 and/or the flexible bag 110. Alternatively, the drive shaft of the drive unit 140 can be oriented at a non-perpendicular angle, such as 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 can be at any angle between 0° and 90°, and the drive shaft and/or drive unit 140 of the drive unit 140 can be mixed prior to mixing, during mixing, and/or after mixing. Adjust or change to any angle.

Drive unit 140 and/or drive shaft as described in more detail below The different angles allow for variable and different mixing dynamics of the material used in the flexible bag 110 prior to mixing of the materials, during mixing of the materials, and/or after mixing of the materials. In particular, the angle of the drive unit 140 and/or the drive shaft can be varied during active mixing of the material, for example, when the drive unit 140 is actively driving the mixer 134 to change the mixing characteristics of the material. An exemplary sequence of mixing can include starting the mixing element substantially vertically, 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 be substantially vertical.

The rigid carrier 120 and/or the removable portion 122 includes at least a few The feature 112, the at least one geometric feature forms a cavity that extends generally toward the exterior of the flexible bag 110 when assembled. See Figure 4B. The geometric features 124 generally protrude outwardly from the walls of the rigid carrier 120 and/or the removable portion 122 and are There is a shape that is substantially complementary to one or more of the geometric features 210. It is contemplated that the carrier 120 and/or the removable portion 122 can include any number of geometric features 112 and can include multiple geometric features having different shapes and/or configurations. The carrier 120 can include legs or other supports (not referenced) to support the carrier 120 and the entire assembly relative to a surface or other structure. It is contemplated that the carrier 120 may not include a foot or support structure and may alternatively include other suitable support members for supporting the carrier 122 and the entire assembly relative to the machine.

FIG. 2A illustrates various embodiments of a flexible bag 110. Flexible bag 110 One or more geometric features 210, such as a plurality of geometric features, formed in the wall of the flexible bag 110 can be included. The geometric features 210 are assembled to define one or more cavities that protrude toward the interior of the flexible bag 110 or toward the exterior of the flexible bag 110.

In some aspects, the geometric feature 210 can be pre-formed to be flexible In the wall of the bag 110. For example, the geometric features 212, 214, 224 are pre-formed structural indentations formed in the walls of the flexible bag 110 that extend toward the interior of the bag and form a cavity that projects toward the exterior of the bag. As explained in more detail below, the outwardly extending cavity can accommodate substantially complementary indentations formed on the removable portion 122 of the carrier 120 and/or carrier. It is contemplated that the preformed structural indentations 212, 214, 224 can be sufficiently resilient such that the pre-formed structural indentations can be folded into a generally flat arrangement and/or retained in a fold with a cover, film or other mechanism and In a generally flat arrangement. When uncovered, the preformed structural indentations are sufficiently elastic and assembled to return (eg, automatically return) to the preformed shape.

In another aspect, the wall of the flexible bag 110 can be sufficiently flexible To allow geometric features to be made by moving the wall of the flexible bag 110 toward the flexible bag The interior of the 110 extends or projects toward the exterior of the flexible bag 110. That is, the geometrical features formed on the removable portion 122 of the carrier 120 and/or the carrier can be extended, for example, to extend a portion of the wall of the bag toward the interior of the bag, or by inserting a geometry formed on the bearing 132. The feature is such that a portion of the wall of the bag extends toward the exterior of the bag to partially extend one of the walls or walls of the flexible bag 110, rather than a pre-formed structural indentation.

In another aspect, the geometric feature 210 can be utilized in the flexible bag 110 Additional material is included in the wall portion to form. For example, geometric feature 216 is a portion of flexible bag 110 that includes, for example, a wrinkle arrangement, a crease arrangement, a crease arrangement, a pleat arrangement, a roll arrangement, a fold arrangement, a grooved arrangement, or other arrangement of additional material, each of which Formed in the wall of the flexible bag 110. The geometric features 216 are assembled to transition from a creping (or other arrangement) portion, a relaxed arrangement, into a tensioning arrangement to define a cavity that projects toward the exterior or interior of the flexible bag 110 and that is adapted to be formed on the carrier 120 or carrier. The indentation on the portion 122 can be removed. For example, the additional material will allow for geometrical features that are similar in size and shape to the preformed structural indentations 212, 214 or any other shape that would push the wrinkle of the flexible bag 110 toward the interior or exterior of the flexible bag 110 (or other Arrange) materials to produce. It is contemplated that the creping (or other arrangement) portion can be assembled to transition from the relaxed arrangement to the tensioning arrangement to define a cavity that projects toward the exterior of the bag, the interior of the bag or the interior of the bag, and the exterior of the bag. That is, the creped portions can be assembled to extend inwardly and outwardly depending on the particular configuration. Alternatively, it is contemplated that the creping (or other arrangement) portion can be assembled to extend only inwardly or only outwardly such that the creped portion can transition to a taut configuration in only a single direction.

There may be any number of geometric shapes formed in the flexible bag 110 Sign 210. For example, one, two, three, four, five, ten or more geometric features may be present in the flexible bag 110. Geometric feature 210 can be any number of different types of geometric features and/or any combination of different types of geometric features. It is contemplated that the flexible bag 110 can include a pre-formed structural indentation that projects toward the interior of the flexible bag 110 or that projects toward the exterior of the flexible bag 110, and a wrinkle (or other arrangement) portion. It is also contemplated that the flexible bag 110 can include two pre-formed structural geometric features and a wrinkle (or other arrangement) portion together. Geometric feature 212 can be any shape. For example, the geometric features can be cylindrical, pyramidal, spherical, hemispherical, conical, frustoconical, toroidal, circular, elliptical, square, triangular, or any other suitable shape. The geometric features 212 can be disposed in any suitable location in the wall of the flexible bag 110 and can abut or move away from other geometric features and/or can be disposed in one or more configurations. For example, a series of geometric features can be arranged in a line, triangle, square, diamond, cross, x, figure, or any other suitable configuration. The flexible bag 110 can include geometric features formed in the walls of the flexible bag 110 that define a cavity that projects toward the exterior of the flexible bag. The resulting geometric features can have cavities of any size or shape. The cavity can be relatively shallow or relatively deep. The depth can be 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or any suitable depth. The entire geometric feature width can be 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or any suitable width.

The flexible bag 110 can be made of any suitable material. For example, materials A substantially flexible polymer such as polyethylene or polypropylene can be included. The flexible bag 110 can comprise a single layer or a composite of two or more layers. The layers may be adapted to hold various materials including gases, solids or liquids in or out of the bag. The material may be impermeable to a particular type or to a particular gas, liquid or solid, and the material may be permeable to a particular type or to a particular gas, liquid or solid. Materials can be formulated to block certain types of light or radiation, such as ultraviolet, visible, infrared, and/or x-rays.

In an example, the flexible bag 110 can include at least three layers, The invention includes an inner layer adjacent to an inner surface of the flexible bag 110 and forming the inner surface, the inner layer being inert to the material being mixed within the flexible bag 110; the outer layer being adjacent to the exterior of the flexible bag 110 And forming the outer surface; and one or more intermediate layers disposed between the inner layer and the outer layer. The inert inner layer may be formed of a material that helps prevent or reduce contamination of the material to be mixed or otherwise disposed within the interior of the bag. One or more of the intermediate layers may be one or more gas impermeable materials to further prevent or reduce contamination of materials that are to be mixed or otherwise disposed within the interior of the bag. For example, a gas impermeable house may reduce or prevent gases, vapors, or other fluids that are part of the material or produced by the mixed material from escaping the interior of the flexible bag 110 and leaking to the external environment. In addition, the gas impermeable layer can reduce or prevent gases, vapors, and other fluids present in the surrounding environment from passing through and into the interior of the flexible bag. The outer layer can be a material that is inert to the conditions outside the flexible bag 110. The outer layer can provide a third barrier to the contamination protection of the mixture in the flexible bag 110.

It is envisaged that any of the individual layers can be formed by: Such as polyethylene, linear low density polyethylene, polyethylene vinyl acetate, polypropylene, ethylene tetrafluoroethylene, polyvinylidene fluoride, polyethylene terephthalate, polyamine, ethylene vinyl alcohol, styrene ethylene Butadiene styrene, polyparaphenylene Ethylene glycol dicarboxylate, polyvinylidene fluoride or other suitable materials. In general, suitable materials for any of the individual layers may be biodegradable, non-biodegradable, opaque, transparent, translucent, may or may not block ultraviolet light or radiation, and may or may not block or Blocking x-rays, with or without insulating properties, may or may not be electrically conductive, and may include any combination of such properties. It is also contemplated that any of the individual layers can be of any thickness and the entire wall of the flexible bag can be of any thickness. It is further contemplated that the individual layers can each have the same thickness, can have different thicknesses, and/or one or more of the same materials can have the same or different thickness throughout the walls of the bag.

It is contemplated that any of the walls of the flexible bag 110 include any number of layers. For example, the wall of the flexible bag 110 can include three layers, such as an inner layer, an outer layer, and a single intermediate layer disposed between the inner layer and the outer layer. Additionally or alternatively, the wall of the flexible bag 110 can include any number of intermediate layers, for example, two, three, four, five, or six layers. It is also contemplated that the flexible bag 110 can comprise any number of different layers or can include one or more layers of the same material disposed between the other layers. The layers can be combined in any order and include any material, including any of the materials described above.

The flexible bag 110 can be used to produce a polymer film (including examples) Any method such as coextruding a polymer sheet) is formed. Alternatively, the polymer sheets may be welded together or formed by injection molding. The flexible bag 110 can include one or more turns or connections (not shown) to allow material to be inserted into or removed from the flexible bag 110 prior to mixing, during mixing, and/or after mixing. . For example, one or more materials may be delivered to the flexible bag 110 via one or more inlet ports prior to operation of the mixing element 130, which may be mixed in operation Element 130, that is, when the material in the bag is actively mixing, one or more materials are delivered to the flexible bag 110 via one or more inlet ports and/or outlet ports and/or from the flexible bag 110 is removed, and/or material may be removed from the flexible bag 110 via one or more outlet ports after operation of the mixing element 130. The shackles or connections in the flexible bag can be assembled into inlets, outlets, vents for drainage, inhalation or any other suitable purpose. It is contemplated that the flexible bag 110 can include any number of turns, including any number of inlets, outlets, vents, or other ports, and any combination of turns or other connections can be present in the flexible bag 110. It is contemplated that the flexible bag may comprise any combination of the following: a luer valve, a lock and/or an assembly; a file; a quick connect, a barbed flange and/or a bayonet connection; a clip, a cap, an upper cover, Snap-fit lids and/or other covers; inserts, pipes, gaskets, seals, and/or any other components for connection to upstream and/or downstream containers, tubing, tubing, and/or other equipment or devices.

FIG. 2B shows another view of the flexible bag 110. Geometric feature 212 And 214 are shown at exemplary unrestricted locations within the wall of the flexible bag 110. It is contemplated that the geometric features 210 can be located at any number of locations in the wall of the flexible bag 110. FIG. 2B also illustrates an exemplary geometric feature 216 that is in a generally flat configuration and that is covered by a film or sheet 218 of material. The film or sheet 218 of material can be made of any suitable material, such as tantalum resin, and assembled to cover the geometric features 216. For example, a film or sheet 218 of material can be attached to the inner surface of the wall of the pouch 110 and assembled to cover the geometric features 216 and maintain the geometric features 216 in a generally flat arrangement. The film or sheet 218 of material may be sufficiently elastic to allow the film or sheet of the material to be placed over the fixed geometric features 216 and/or other geometric features (eg, geometric features 212 or 214). The other geometric features include geometric features disposed within the flexible pocket 110 but not currently in use, for example, the mixing element 130, the carrier 120, and the drive unit 140 are not located at the geometric features, but may be expanded as needed use. While the geometric features 210 are generally shown on the bottom of the flexible bag 110, it is contemplated that there may be geometric features on any general surface, side or portion of the bag. Arranging the mixing elements 134 at such locations can provide the ability to achieve additional and/or different mixing characteristics of the materials.

Referring to Figure 3, a film or sheet 304 of material can be attached to the flexible bag The inner surface of the wall of 110 covers the geometric features 212, 214 and retains the geometric features 212, 214 in a first substantially flat arrangement, as described in more detail above. Alternatively, the film or sheet 304 of material may cover only one of the geometric features 212, 214. A film or sheet 218 of material or alternatively a film or sheet of another separate material (not shown) may be attached to the interior surface of the wall of the flexible bag 110 to cover the geometric feature 214 and retain the geometric feature 214 at the first In a generally flat arrangement.

It is contemplated that any number of films or sheets of material (eg, films or sheets 218, 304 of material) may be attached to the interior surface of the wall of the pouch 110 to cover one or more of the geometric features. The film or sheet 218, 304 of material may be formed from any type of material, in any suitable shape or contour, having any suitable or desired thickness, and may or may not affect the mixing dynamics of the material. In an exemplary embodiment, the additional film or material is made of tantalum resin. By covering and maintaining geometric features, the film or sheet 218, 304 of material can reduce turbulence in the flexible bag 110 by providing a substantially smooth interior surface, which is provided by covering surface irregularities, These surface irregularities The property may be when the geometric feature is in the first arrangement of the geometric feature, such as when the preformed structural indentation (214) is folded into a substantially flat arrangement or when the wrinkle (or other arrangement) feature (216) does not extend to The creping (or other arrangement) feature is formed in the flexible bag wall when it is tensioned. Smoothing the interior can help promote uniform mixing, reduce or eliminate eddy currents, and/or substantially promote laminar flow. It is contemplated that when the flexible bag 110 includes a plurality of geometric features, all but one of the geometric features will be covered by a film or other sheet (218, 304) of material such that when assembling the mixer, bearing, carrier and/or drive unit Only one geometric feature transitions to the second arrangement. It is also contemplated that the film or sheet of material may be sufficiently elastic to stretch and extend to accommodate the carrier and/or bearing during assembly without tearing or otherwise breaking. Alternatively, the film or sheet of material can be assembled to tear or otherwise break when the carrier and/or bearing is assembled. By being configured to tear or otherwise rupture, the film can provide a visual indication that the flexible bag has been used and/or that a particular mixing operation has been completed. It is contemplated that the film can be attached to the pouch 110 via any suitable method including, for example, a glue or fusion, and can be attached continuously or intermittently. It is further contemplated that a film or sheet of material covering two or more geometric features can be assembled to allow one of two or more overlay geometric features to transition to a second arrangement while still two or two The other of the more than one coverage geometric features remains in a substantially flat arrangement. For example, a film or other sheet (218, 304) of material can be attached to the wall of the bag substantially around each individual geometric feature.

In addition to or as described above As an alternative to the described geometric configuration, the flexible bag 110 can include one or more apertures or other openings formed in the wall and The assembly is configured to receive and receive a portion of the carrier and/or bearing during assembly. As described above, a film or sheet of material can be included to cover the aperture and be assembled to stretch and accommodate portions of the carrier and/or bearing during assembly. The aperture can be any shape or size. The edge of the aperture may be surrounded by a raised generally ridged lip 228 (eg, a generally circular ring that encloses a generally circular aperture). The lip 228 can have any suitable material and can be attached or fastened to the interior surface of the wall of the flexible bag 110 by any suitable means including, for example, adhesive or fusion welding. The lip 228 can be any suitable shape or size, and in an exemplary embodiment can be circular, square, triangular, elliptical, shaped as a figure eight, a diamond, or any other suitable shape. It is contemplated that the lip 228 or an additional lip formed in the interior of the pocket and/or attached to the interior of the pocket may be disposed at any geometric feature in the geometric feature 210 and substantially encompass any geometric feature in the geometric feature 210. It is also contemplated that the lip 228 and/or other lips may substantially enclose two or more geometric features 210. It is further contemplated that the lip 228 and/or other lip may be attached directly to the pouch 110 and, if included, a film or other sheet of material may be attached to the lip 228 and/or other lips rather than directly attached To the bag 110. The lip 228 and other lips, if included, provide additional support and rigidity to the walls of the flexible pocket at the geometric features. This can reduce tearing or other damage to the bag when assembling the mixer, bearing, carrier, and/or drive unit, and can improve component alignment and support during assembly and/or after assembly.

4A and 4B schematically illustrate an exemplary mixing element 130. The mixing element 130 can be disposed on the interior of the flexible bag 110 and can be any type of mixer suitable for mixing, agitating or agitating materials within the flexible bag 110. In an exemplary embodiment, the mixing element 130 includes Mix of four blades The combiner 134. However, it is contemplated that the mixer 134 can include any number of blades in any arrangement. The mixer is rotatably supported on the bearing 132 and is driven by a drive shaft (not shown) of the drive unit 140 to agitate, mix or agitate the material. Mixer 134 can be supported on bearing 132 in any suitable manner. For example, the bearing 132 can include a snug fit connection with the mixer 134 such that the interior surface of the mixer 134 is in sliding relationship with the outer surface of the bearing 132. For another example, the bearing 132 can include a magnet or other member for generating a magnetic force that applies an upwardly directed force to the mixer 134. The mixer may or may not include a magnet or other member for generating a magnetic force. This magnetic force applies a force of downward guiding force to the bearing 132. It is contemplated that the mixer 134 can be fully or partially magnetically supported on the bearing 132. For example, the magnitude and direction of the magnetic force can be adjusted and/or dynamically adjusted to provide or modify the extent to which the mixer 134 is magnetically supported or directly supported by the bearing 132. It is contemplated that the mixer 134 can be fully magnetically supported, fully supported directly, or magnetically and directly supported, depending on any relative percentage of the support. For another example, the drive unit can include a non-rotating drive shaft having a plurality of individual electrical coils mounted therein, the plurality of individual electrical coils being energized alternately and sequentially to produce a movement (eg, rotation) The magnetic field magnetically supports and rotates the mixer. It is envisaged that in this arrangement, the mixer and/or the bearing may or may not have a series of magnets formed in the mixer and/or bearing that are assembled to be produced by the non-rotating drive shaft of the drive unit Alternating magnetic fields interact.

FIG. 4B shows an exemplary cross-sectional view of the mixing element 130. Bearing 132 can be located on any geometric feature. For example, Figure 1 exemplarily illustrates a hybrid Element 130, the mixing element and thus mixer 134 and bearing 132 are disposed adjacent to geometric feature 212. As shown, the bearing 132 includes a cavity that projects toward the exterior of the flexible bag 110 that, when assembled, substantially encloses a portion of the geometric feature 212 and thus a portion of the wall of the flexible bag 110. Carrier 120 and/or removable portion 122 are disposed on the exterior of flexible bag 110 and include projections, such as indentations, to form a cavity that projects toward the exterior of the bag. The indentations are placed in a cavity formed by geometric features 212 that are formed in the walls of the flexible bag 110. Thus, the geometric features 212 generally surround the indentations formed on the carrier 120 and/or the removable portion 122. Additionally, the bearing 132 generally surrounds a portion of the indentation on the carrier 120 and/or the 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 features 212 in the walls of the flexible bag 110 have geometric features 124 (eg, indentations) associated with the walls formed in the rigid carrier 120 and are formed in the bearing 132. The substantially complementary shape of the cavity. As shown in FIG. 4B, the walls of the flexible bag 110 can be completely continuous and disposed entirely between the bearing 132 and the carrier 120 when assembled.

Alternatively, the bearing may include a protrusion (not shown) that is oriented The exterior of the flexible bag 110 protrudes such that geometric features, such as geometric features 216, substantially surround the protrusions during assembly. In this arrangement, the carrier and/or the removable portion that is again disposed on the exterior of the flexible bag 110 includes a cavity that forms a cavity that projects toward the interior of the bag. Geometric features 216 are disposed within cavities formed in the carrier and/or the removable portion. Thus, the geometric feature 216 generally surrounds the protrusion formed on the bearing, and the cavity formed in the carrier and/or the removable portion 122 substantially encloses the geometric feature 216. In addition, the carrier and / or The removable portion substantially surrounds a portion of the protrusion on the bearing. As in the embodiment shown in Figure 4, in this alternative arrangement, the geometric features 216 in the wall of the flexible bag 110 have substantially complementary to the cavity of the bearing and the cavity of the carrier and/or the removable portion. The shape, the wall of the flexible bag 110 can be completely continuous and fully disposed between the bearing and the carrier when assembled.

The driving unit 140 can be disposed on the outer side of the flexible bag 110 and adjacent Attached to the rigid carrier 120. Drive unit 140 can be assembled to rotate, such as to drive mixer 134. For example, the drive unit 140 can be assembled for rotational contact to the contactless transfer of the mixer 134. For example, drive unit 140 can include a drive shaft (not referenced), one or more magnets can be disposed in the drive shaft, and one or more magnets can be disposed in mixer 134. The individual magnets can be arranged such that when the drive shaft rotates, for example, when driven by a motor, mutual attraction and/or repulsive forces of the magnets transfer the rotation of the drive shaft to the mixer 134. As shown in FIG. 4B, the drive shaft and mixer 134 rotate about an axis generally defined by the geometric features 212, the bearings 132, and the carrier 120 and/or the removable portion 122. As explained in more detail herein, the axis of rotation can be oriented at any angle relative to the flexible bag 110 and can be dynamically changed and adjusted during mixing.

It is contemplated that any number described above with respect to a particular embodiment Features may be combined with one or more of the features described with respect to other embodiments, and/or combined in any suitable arrangement in the additional embodiments.

Industrial applicability

The disclosed embodiments can provide improved mixing processes for materials, and particularly for mixing pharmaceutical materials. The disclosed embodiments can be used for mixed application in the pharmaceutical, food or biotechnology industries and can be suitable for mixing or production Any type of material, including, for example, liquids, gases, solids, slurries, particulate materials, transporting gases, creating a suspension, aerating the solid-solid mixture, aerating the solid-liquid mixture, and/or any other type of operation.

The disclosed embodiments can be produced by allowing different mixing characteristics to be produced The improved mixing device and process are created by allowing and facilitating multiple and selectable locations for the mixing elements within the flexible bag. The mixing element can be located at any geometric feature formed in the flexible bag. When the wall of the flexible bag is stretched, the mixing element can also be located at any other location within the flexible bag. Different locations of the mixing elements allow for different mixing characteristics. For example, if the mixing element 130 is placed offset from the center of the flexible bag, for example, as shown in Figure 1, it is compared to the flow produced by the mixer 132 when the mixing element 130 is generally disposed at the center of the flexible bag. The mixer 134 will create a different flow within the flexible bag. Additionally, the mixing element 130 can be moved during a particular processing batch to allow for two or more different types of flow without the use of two different bags. For example, the particular positional sequence combined with the mixing time can produce the desired mixed distribution for the various materials and mixtures. One disadvantage of conventional hybrid assemblies is that such conventional mixing assemblies include a single location for the mixing elements, and where it is not permitted or convenient to change the position of the mixing elements or to reposition the mixing elements. Thus, such conventional mixing assemblies provide a single predetermined mixing characteristic.

The disclosed embodiments can also be enabled by allowing different mixing characteristics This is provided to provide an improved mixing device and process that is enabled by allowing and facilitating dynamic adjustment of the angle of rotation of the mixer. The rotating shaft of the mixer can be adjusted by changing the orientation and position of the drive unit and, in particular, the drive shaft. Different angles of rotation provide different flow and different mixing characteristics in the material. For example, a substantially vertical orientation can provide a generally circular rotational flow rather than a vertical orientation, such as a skew angle that can create turbulence in the material, creating one or more eddies that can inflate the material. Not only can the drive shaft and drive unit be coupled to the carrier in any given orientation, thus providing variability in initial flow characteristics, the drive shaft and the drive unit can also be dynamically adjusted during mixing to provide dynamic variability. Another disadvantage of conventional assemblies is that such conventional assemblies include a single orientation and therefore do not allow or facilitate changing orientation. Thus, such conventional mixing assemblies provide a single predetermined mixing characteristic.

The disclosed embodiments can also be assembled and mixed by allowing flexible bags The components, carrier and drive unit will be continuous, i.e., without openings or cracks, to reduce or eliminate the risk of contamination and/or leakage. For example, the nature of the bag, such as that provided by the particular material of the wall of the bag, can be homogenous and uninterrupted, and the properties of the bag are substantially constant throughout the bag. Similarly, the disclosed embodiments may also reduce or eliminate the risk of leaking into or out of the interior of the bag by eliminating or reducing the number of seals. Another disadvantage of conventional hybrid assemblies is that such conventional hybrid assemblies typically comprise a rigid bearing, typically of a different material, welded to a wall formed in the pocket and/or comprising a leakable additional seal. In the hole.

In addition, the mixing element can be extinguished in both the mixing element and the flexible bag The bacteria were previously positioned in a flexible bag. This condition allows the bag and mixing elements to be sterile prior to any mixing process and to prevent the need to open the flexible bag prior to mixing to add mixing elements that may introduce contaminants, compromise the sterility of the system and/or Re-sterilization is required after assembly.

It will be apparent to those skilled in the art that various modifications and changes can be made in the assembly of the disclosure. Those skilled in the art will recognize other embodiments from the consideration of the specification and the practice of the flexible bag assembly disclosed herein. The specification and examples are intended to be illustrative only, and the scope of the claims

100‧‧‧Mixed assembly/assembly

110‧‧‧Flexible bag/bag

120‧‧‧Rigid carrier/carrier

122‧‧‧Removable carrier segment/carrier segment/removable portion

124‧‧‧Geometric features

130‧‧‧Mixed components

140‧‧‧Drive unit

Claims (35)

An assembly for agitating a material, the assembly comprising: a flexible bag having a wall and defining an interior for receiving the material; a rigid carrier disposed on an exterior of the bag; a bearing disposed adjacent to the carrier on the interior of the bag; a mixing element disposed on the interior of the bag and rotatably supported on the bearing; and a motor drive member abutting the carrier Disposed on the exterior of the bag for rotating the mixing element. The assembly of claim 1 wherein the bag comprises at least one geometric formation formed in the wall of the bag, the at least one geometric configuration being assembled to define a cavity. The assembly of claim 2, wherein the geometric configuration is a pre-formed indentation defining a cavity that projects toward the exterior of the bag. The assembly of claim 3, wherein the carrier comprises at least one indentation formed in one of the walls of the carrier and defining a cavity that projects toward the exterior of the bag. The assembly of claim 4, wherein the at least one indentation formed in the wall of the bag has a shape that is substantially complementary to one of the at least one indentations formed in the wall of the carrier. The assembly of claim 4, wherein the at least one indentation formed in the wall of the carrier is disposed at the assembly to be formed in the wall of the bag Less one indentation. The assembly of claim 2, wherein the geometric configuration is a preformed indentation defining a cavity that projects toward the interior of the pocket. The assembly of claim 7, wherein the carrier comprises at least one indentation formed in one of the walls of the carrier and defining a protrusion that projects toward the interior of the bag. The assembly of claim 8 wherein the at least one indentation formed in the wall of the bag has a shape that is substantially complementary to one of the at least one indentations formed in the wall of the carrier. The assembly of claim 9, wherein the at least one indentation formed in the wall of the bag is disposed in the at least one indentation formed in the wall of the carrier during assembly. The assembly of claim 1, wherein the bag includes a plurality of geometric configurations formed in the wall of the bag, the plurality of geometric configurations being assembled to define a plurality of cavities. The assembly of claim 11, wherein the carrier comprises at least one indentation formed in a wall of the carrier, the at least one indentation defining a cavity that projects toward the outer pocket. The assembly of claim 11, wherein: the carrier comprises an indentation formed in a wall of the carrier, the indentation defining a cavity projecting toward the exterior of the bag; and forming in the wall of the carrier The indentation is assembled during assembly into one of the plurality of geometric configurations formed in the bag. As in the assembly of claim 11, 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. The assembly of claim 14, wherein the mixing element is disposed on the bearing when assembled and at least partially encloses the bearing. 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 bag The portion of the wall 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 in the bag One of the portions of the wall is on a first side and the carrier is disposed on a second side of the portion of the wall of the bag opposite the first side. The assembly of claim 16, wherein, when assembled, the motor is driven adjacent the carrier such that the carrier is disposed between the drive member and the portion of the wall of the bag. The assembly of claim 1, wherein the wall of the bag is homologous. The assembly of claim 1, wherein the bag includes a preformed indentation formed in the wall of the bag, the pre-formed indentation being assembled to transition from a first substantially folded arrangement to a second substantially Upright arrangement. The assembly of claim 19, further comprising a film that substantially covers the preformed indentation to maintain the preformed indentation in the first arrangement. The assembly of claim 20, wherein the preformed indentation is assembled to automatically transition from the first arrangement to the second arrangement when the film is removed to expose the preformed indentation. The assembly of claim 1 wherein the bag includes a corrugated portion formed in the wall of the bag, the creped portion being assembled to transition from a first substantially folded arrangement to a second substantially upright arrangement . The assembly of claim 22, further comprising a film that substantially covers the preformed indentation to maintain the preformed indentation in the first arrangement. The assembly of claim 23, wherein the preformed indentations are assembled to transition from the first arrangement to the second arrangement when the carrier and bearing are assembled relative to the bag. The assembly of claim 20 or claim 23, wherein the film is sealed to the interior of the bag. The assembly of claim 20 or claim 23, wherein the film is sealed to the exterior of the bag. The assembly of claim 1, wherein the bag includes a plurality of creped portions formed in the wall of the bag, the plurality of creped portions being assembled to transition from a first substantially folded arrangement to a first The two are generally upright. The assembly of claim 27, further comprising a plurality of films, each film attached to an interior of the bag adjacent one of the plurality of creped portions and substantially covering the creped portion. The assembly of claim 27, further comprising a film adjoining at least two of the plurality of creped portions and substantially covering the two The creped portion is attached to the interior of the bag. An assembly for agitating a material, the assembly comprising: a flexible bag having a wall defining an interior of one of the materials, the bag including at least one pressure formed in the wall of the bag a plurality of indentations defining a cavity projecting toward an 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, At least one indentation defining a cavity projecting away from the interior of the bag; a bearing disposed adjacent the carrier for the interior of the bag; a mixing element disposed on the interior of the bag and rotatable Ground support on the bearing. 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. The assembly of claim 30, further comprising at least a wrinkle portion formed in the wall of the bag. A method for agitating a material, the method comprising the steps of: delivering a material to a flexible bag having a wall defining and defining an interior of the material, the bag comprising a bag formed in the bag At least one indentation in the wall, the at least one indentation 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 The bearing is disposed on the interior of the bag on a bearing; wherein the bearing is disposed adjacent to a rigid carrier, the rigid carrier Placed on an exterior of one of the pockets; wherein the bearing includes at least one indentation formed in the bearing, the at least one indentation defining a cavity that substantially surrounds the at least one of the walls formed in the pocket An indentation; and wherein the carrier comprises at least one indentation formed in a wall of the carrier, the at least one indentation being substantially disposed on the at least one indentation formed by the wall formed in the pocket Inside the cavity. The method of claim 33, wherein the bearing comprises a direction, the method further comprising changing the at least one mixing characteristic by changing the orientation of the bearing. The method of claim 34, further comprising changing the orientation of the bearing during active mixing of the material.