WO2005037658A2 - A flexible mixing bag for mixing solids, liquids and gases - Google Patents
A flexible mixing bag for mixing solids, liquids and gases Download PDFInfo
- Publication number
- WO2005037658A2 WO2005037658A2 PCT/US2004/032997 US2004032997W WO2005037658A2 WO 2005037658 A2 WO2005037658 A2 WO 2005037658A2 US 2004032997 W US2004032997 W US 2004032997W WO 2005037658 A2 WO2005037658 A2 WO 2005037658A2
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- WO
- WIPO (PCT)
- Prior art keywords
- mixing tank
- mixing
- sleeve
- fibers
- components
- Prior art date
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Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/02—Form or structure of the vessel
- C12M23/14—Bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
- B01F27/88—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with a separate receptacle-stirrer unit that is adapted to be coupled to a drive mechanism
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/10—Maintenance of mixers
- B01F35/145—Washing or cleaning mixers not provided for in other groups in this subclass; Inhibiting build-up of material on machine parts using other means
- B01F35/146—Working under sterile conditions; Sterilizing the mixer or parts thereof
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/50—Mixing receptacles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/50—Mixing receptacles
- B01F35/513—Flexible receptacles, e.g. bags supported by rigid containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/50—Mixing receptacles
- B01F35/514—Mixing receptacles the mixing receptacle or conduit being transparent or comprising transparent parts
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/28—Constructional details, e.g. recesses, hinges disposable or single use
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M27/00—Means for mixing, agitating or circulating fluids in the vessel
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M27/00—Means for mixing, agitating or circulating fluids in the vessel
- C12M27/02—Stirrer or mobile mixing elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/06—Mixing of food ingredients
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/2202—Mixing compositions or mixers in the medical or veterinary field
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/58—Mixing semiconducting materials, e.g. during semiconductor or wafer manufacturing processes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F31/00—Mixers with shaking, oscillating, or vibrating mechanisms
- B01F31/80—Mixing by means of high-frequency vibrations above one kHz, e.g. ultrasonic vibrations
Definitions
- This invention generally relates to mixing of components and more particularly to a flexible bag for mixing of solids, liquids, gases and combinations thereof.
- the components that are mixed may be hazardous, dangerous, infectious and/or require high levels of purity.
- the components that are to be mixed may be toxic.
- the handling of powders may be dangerous because of the possibilities of inhalation of such powders.
- individuals that handle body fluids, such as fluids that are HlV-infected do so without attempting direct contact of these fluids.
- handling of chemicals is avoided to reduce potential for particulate formation and introduction of impurities.
- a recirculation loop may be employed to regenerate mixtures, such as emulsions or suspensions, whereby liquid, separated from the bulk mixture is repeatedly drained from the foot or base of the storage bag and refilled through the top of the bag.
- mixtures such as emulsions or suspensions
- liquid, separated from the bulk mixture is repeatedly drained from the foot or base of the storage bag and refilled through the top of the bag.
- an alternative requires opening and resealing of the container.
- Figure 1 illustrates a 3 -dimensional view of a disposable mixing tank, according to one embodiment of the present invention.
- Figure 2 illustrates a 3 -dimensional view of the substantially parallelepiped shaped mixing tank of Figure 1.
- Figures 3A and 3B illustrate a 3-dimensional view of the substantially cylindrical sealed sleeve 140, of the mixing tank of Figure 1.
- Figures 4A and 4B illustrate a disposable mixing tank comprising a mixing means according to a further embodiment of the present invention.
- FIGS 5A - 5C illustrate a disposable mixing tank according to a preferred embodiment of the present invention.
- Figure 6 illustrates a 2-dimensional view of a disposable mixing tank according to a further embodiment of the present invention.
- Figure 7 illustrates a disposable mixing tank comprising mixing means according to a further embodiment of the present invention.
- Figure 8 illustrates a flow diagram for mixing components, according to a further embodiment of the invention.
- the present invention relates to a disposable, mixing and storage bag. More particularly, the present invention relates to a disposable bag, useful for mixing, storing, reconstituting and/or dispensing of materials.
- the present invention relates to an apparatus comprising a disposable mixing tank having a sealed sleeve therein.
- the present invention relates to an apparatus comprising a disposable mixing tank having a sealed sleeve therein and an interior volume that is defined by an interior wall of the mixing tank and an interior wall of the sleeve.
- the present invention relates to an apparatus comprising a disposable mixing tank having a sealed sleeve therein and an interior volume that is defined by an interior wall of the mixing tank and an interior wall of the sleeve, wherein the sleeve defines a passageway for arrangement of mixing means.
- the present invention relates to a storage system comprising, a disposable mixing tank having a sealed sleeve therein and an interior volume that is defined by an inner wall of the mixing tank and an inner wall of the sleeve; at least one component in the interior volume; and mixing means arranged inside the sleeve.
- the present invention relates to a mixing process comprising, adding two or more components of a mixture to an interior volume of a disposable mixing tank having a sealed sleeve arranged therein, the interior volume being defined by an inner wall of the mixing tank and an inner wall of the sleeve; mixing the two or more components using mixing means arranged inside the sleeve to form a mixture; and storing the mixture inside the disposable mixing tank.
- the present invention is based on an apparatus, method, and system for mixing solids, liquids and/or gases, having the potential to reduce labor, lower production costs, and improve product quality in mixing applications. It allows disposable bags to be used to replace mixing tanks in many laboratory and pilot scale operations eliminating cleaning, sterilization, and product contamination concerns.
- Embodiments of the invention are described to include a disposable and flexible mixing tank having a sealed sleeve arranged therein.
- the mixing tank and sleeve may be manufactured from any suitable material.
- the mixing tank and sleeve are made of any suitable material having a property where upon removal of an extending force, it is capable of substantially recovering its original size and shape and/or exhibits a significant retractive force.
- the mixing tank and sleeve may be made of any suitable type of stretchable, collapsible, pliable and/or elastic material.
- the disposable mixing tank is manufactured from a fully transparent film to allow for visual inspection of the tank's contents before and after use.
- colladible refers to a material that may fold down into a more compact shape.
- the term “pliable” refers to a material that is supple or adjustable enough to bend freely without breaking.
- the term "elastic,” or “elastomeric” refers to that property of a material where upon removal of an extending force, it is capable of substantially recovering its original size and shape and/or exhibits a significant retractive force.
- the term “stretch,” or “stretchable” refers to a material that is either elastic or extensible. That is, the material is capable of being extended, deformed, or the like, without breaking, and may or may not significantly retract after removal of an extending force.
- the stretchable material can optionally be biaxial stretchable.
- the term “biaxial stretch” or “biaxial stretchable” refers to a material having stretchability in two directions perpendicular to one another, e.g. stretchability in a machine direction and in a cross machine direction, or in a longitudinal direction (front to back) and a lateral direction (side to side).
- the mixing tank and sleeve may be manufactured from any suitable material. Suitable materials include, e.g., films, polymers, thermoplastic pblymers, homopolymers, copolymers, block copolymers, graft copolymers, random copolymers, alternating copolymers, terpolymers, metallocene polymers, nonwoven fabric, spunbonded fibers, meltblown fibers, polycellulose fibers, polyester fibers, polyurethane fibers, polyolefin fibers, polyamide fibers, cotton fibers, copolyester fibers, open cell foam, polyurethane, polyvinyl chloride, polyethylene, metals, alloys, fiberglass, glass, plastic (e.g., polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyethylene terephtalate (PET), polyetheretherketone (PEEK) and polytetrafluoroethylene (PTFE) and polyfluoroalkoxy (PFA) and poly
- film refers to a thermoplastic film made using a film extrusion and/or foaming process, such as a cast film or blown film extrusion process.
- the term includes nonporous films as well as microporous films. Films may be vapor permeable or vapor impermeable, and function as liquid barriers under normal use conditions.
- thermoplastic refers to uncrosslinked polymers of a thermally sensitive material, which flow under the application of heat or pressure.
- polymers includes, but is not limited to, homopolymers, copolymers, such as for example, block, graft, random and alternating copolymers, terpolymers, etc. and blends and modifications thereof.
- polymer shall include all possible geometrical configurations of the material. These configurations include, but are not limited to isotactic, syndiotactic and atactic symmetries.
- metallocene polymers refers to those polymer materials that are produced by the polymerization of at least ethylene using metallocenes or constrained geometry catalysts, a class of organometallic complexes, as catalysts.
- nonwoven and nonwoven web refer to fibrous materials and webs of fibrous material, which are formed without the aid of a textile weaving or knitting process.
- spunbonded fibers refers to small diameter fibers, which are formed by extruding molten thermoplastic material as filaments from a plurality of fine capillaries of a spinnerette having a circular or other configuration, with the diameter of the extruded filaments then being rapidly reduced.
- meltblown fiber refers to fibers formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten threads or filaments into converging high velocity heated gas (e.g., air) streams which attenuate the filaments of molten thennoplastic material to reduce their diameter, which may be to microfiber diameter (the average microfiber diameter is not greater than about 100 microns, for example, having an average diameter of from about 0.5 microns to about 50 microns, more particularly, microfibers may have an average diameter of from about 4 microns to about 40 microns).
- heated gas e.g., air
- references in the specification to "one embodiment”, “an embodiment”, “an example embodiment”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
- Embodiments of the invention include features, methods or processes embodied within machine-executable instructions provided by a machine-readable medium.
- a machine-readable medium includes any mechanism, which provides (i.e., stores and/or transmits) information in a form accessible by a machine (e.g., a computer, a network device, a personal digital assistant, manufacturing tool, any device with a set of one or more processors, etc.).
- a machine-readable medium includes volatile and/or non-volatile media (e.g., read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; etc.), as well as electrical, optical, acoustical or other form of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.).
- volatile and/or non-volatile media e.g., read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; etc.
- electrical, optical, acoustical or other form of propagated signals e.g., carrier waves, infrared signals, digital signals, etc.
- Such instructions are utilized to cause a general or special purpose processor, programmed with the instructions, to perform methods or processes of the embodiments of the invention.
- the features or operations of embodiments of the invention are performed by specific hardware components, which contain hard-wired logic for performing the operations, or by any combination of programmed data processing components and specific hardware components.
- Embodiments of the invention include software, data processing hardware, data processing system- implemented methods, and various processing operations, further described herein.
- the disposable mixing tank as described herein provides a closed system for use in all phases of processing, reconstitution or revalidation of mixtures.
- the mixing tank is flexible.
- the mixing tank may be manufactured from pyrogen free, sterile materials, to reduce risks associated with cross contamination.
- the flexible bag may comprise one or more ports for filling, spiking, adding and/or draining to reduce the amount of human contact with the various components (which maybe hazardous, dangerous and/or infectious) that are to be mixed as part of and during the mixing of such components.
- the present invention provides a disposable and flexible mixing tank having a sealed sleeve arranged therein.
- the mixing tank being a single-use apparatus may be used to mix two or more components and store the two or more components before or after mixing. Accordingly, the mixing tank may be discarded after a single use, thereby eliminating washing/sterilizing operations as well as maintenance associated with conventional mixing devices.
- a number of inlet and outlet openings may be further incorporated into the mixing tank
- FIG. 1 illustrates a 3 -dimensional view of a disposable mixing tank, 100, according to one embodiment of the present invention.
- the tank is useful for storage and/or mixing of liquids, solids, and/or gases, having a volume of 5 liters or more, of a collapsible type, that assumes when filled a substantially parallelepiped shape.
- a support frame 115 may support the mixing tank 100, to maintain a sufficient tension during loading of components into the mixing tank as well as during a mixing step.
- Mixing tank 100 comprises a bottom wall, 110, a top wall 120, and four lateral walls 130.
- the mixing tank may further comprise inlet(s) 160 and optional outlet(s) 170.
- Figure 1 illustrates a 3 -dimensional view of a flexible mixing tank (apparatus/device) that includes a sealed sleeve or compartment, 140, which is defined by wall, 150.
- the sealed sleeve may be located on any wall of the mixing tank. Preferably however, the sealed sleeve is arranged on the upper or top wall and centrally located.
- the disposable mixing tank, 100 may include any number of inlet openings 160 and outlet opening(s) 170. A more detailed description of the different components of the mixing tank, 100, will be described below in conjunction with the description of the various components thereof.
- the flexible mixing tank may be manufactured to assume any shape and volume when filled. Preferably the shape of the mixing tank is cylindrical or parallelpiped and the volume is between 5 and 10,000 liters. More preferably the volume of the flexible mixing tank is between about 10 and 3000 liters.
- Figure 2 illustrates a 3-dimensional view of the substantially parallelepiped shaped mixing tank of Figure 1.
- the bottom, top, and lateral walls, 110, 120 and 130 respectively, having interior portions, 210, 220 and 230 respectively and exterior portions, 211, 221, 231, respectively, may be of any suitable thickness readily determined by one skilled in the art.
- each wall may be manufactured from one or more, same or different materials.
- each wall may be manufactured from one or more, same or different materials.
- Figures 3A and 3B illustrate a 3-dimensional view of the substantially cylindrical sealed sleeve 140, of the mixing tank of Figure 1.
- the wall 150, of sealed sleeve 140 having both interior, 351, and exterior, 352, portions respectively, may be manufactured from materials same as or different from the mixing tank walls.
- the interior portions of mixing tank walls 210, 220 and 230 and exterior portion 352, of sealed sleeve, 140 serve to define an interior volume, 180, of mixing tank 100, configured to house components of a mixture, before or after a mixing process.
- the sealed sleeve 140 may be of any suitable thickness readily determined by one skilled in the art. Moreover, the sealed sleeve, 140, may comprise multiple sections, such as a side wall(s) and or a single article of manufacture.
- the sleeve 140 which is preferably flexible, is sealably coupled to disposable mixing tank, 100, at a seam or juncture, 190, by any process readily available to one skilled in the art, including but not limited to joining, welding heat shrinking, shrink down plastic tubing, or combinations thereof.
- a sleeve cavity 353, is defined by the interior portion of sleeve wall, 351, having length or height and diameter or width dimensions.
- the sleeve may be of a regular or irregular shape (i.e. cylindrical vs. tapered respectively).
- the sleeve may be form fitting so as to directly contact an object arranged therein, much like a hand in a glove.
- the sleeve defines a sealed passageway for insertion or arrangement of mixing means therein.
- the mixing means is isolated from the interior of the mixing tank, by the interior sleeve wall and hence does not contact the interior of the tank, 180, or components therein.
- the mixing means which when placed in a mixing mode, serves to mix components in the tank.
- the mixing means serves to create turbulence and mixing while presenting no risk of contact with the mixture inside the vessel.
- FIGs 4A and 4B illustrate the sealed sleeve 140 of mixing tank 100 comprising a mixing means 400, As shown by Figure 4B, sealed sleeve 140, serves as a cavity for arrangement of mixing means 400.
- mixing means 400 comprises a mixing paddle 410, having coupling means 420 for coupling to, for example, a shaft of a mixer (not shown).
- the term "mixing means” relates to a mechanical system or components thereof, capable of transferring energy of motion to the materials housed in the mixing bag.
- the mixing means which is isolated from the interior of the mixing tank by the exterior sleeve wall, serves to create turbulence and mixing while presenting no risk of contact with the mixture inside the vessel.
- Useful mechanical system components readily insertable into the sealed sleeve for transfer of energy to the components include but are not limited to, piezoelectric actuators, ultrasonic, rotation, swaying, blending, vibration, eductor, stirring, agitation, turbine, static, stator/rotor, impeller, helical, and vortex.
- the mechanical system may be portable, or fixed mounted.
- a component of the mechanical system comprises a rigid, detachable, support rod or shaft, which is insertable into the sealed sleeve.
- the support rod or shaft having a proximal end, closest to the upper wall 120, of mixing tank 100, and distal end, farthest from upper wall 120, of mixing tank 100, may be enhanced by additional feature(s) such as paddles and/or blades.
- the additional feature(s) such as paddle and or blade, may be form fitted into the sleeve during a manufacturing process.
- FIGS 5A - 5C illustrate the sealed sleeve 140 of mixing tank 100 according to a preferred embodiment of the present invention.
- Sealed sleeve 140 comprises paddle, 510, hollow cavity 520, mixing shaft 530, and coupling guide 540. More specifically, Figure 5A shows sealed sleeve 140, having form fitted therein, during a manufacturing step, a paddle type device 510.
- a hollow cavity 520, in the interior of sealed sleeve 140 provides for arrangement and coupling of a shaft or rod type component 530, to the paddle type device 510.
- the support rod or shaft 530 having a proximal end, 531, closest to the upper wall 120, of mixing tank 100, and distal end, 532, farthest from upper wall 120, of mixing tank 100, couples to paddle 510 at distal end 532, by any means readily available to one skilled in the art, at any time prior to a mixing step in a manufacturing process.
- the proximal end of support rod 530 may couple, for example, to a mixer motor driver (not shown).
- the interior of hollow cavity 520 may be defined by the interior wall of sealed sleeve 140. Alternatively, the interior of hollow cavity 520, may be defined by a separate integrated sleeve to provide additional protection and/or guard against potential punctures from a misfed or faulty rod or shaft.
- Coupling guide 540 sealed to sleeve 140, serves as a rigid guide for insertion, arrangement and coupling of support rod or shaft 530.
- the paddle type device, 510, support rod or shaft 530, and coupling guide 540 are preferably rigid, and may be formed from any material readily available to one skilled in the art, including but not limited to metals, alloys, composites, ceramics, composition(s) and material(s) described herein, and/or mixtures thereof.
- the paddle device is absent sharp edges.
- Figure 5B shows insertion of support rod 530, through coupling guide 540, and into hollow cavity 520 and Figure 5C shows support rod 530 coupled to paddle 510.
- the sealed sleeve comprises a range of motion similar to an arm and hand in a glove of a glove or dry box.
- the glove which is form fitted, couples to the wall of the dry box, and isolates a user from an interior environment of the box. Although an interior portion of the glove contacts the contents in the box, the user is isolated from therein while providing a wide range of mobility to the user's arm(s) and hand(s).
- FIG. 6 serves to illustrate, in 2-dimensions, mixing tank, 100, and sealed sleeve 140, having a paddle, 600, arranged therein, by a form-fitting means.
- the paddle may include one or more sections of manufacture.
- the interior portions of bottom, top, and lateral walls, 210, 220 and 230 respectively, and exterior portion of sealed sleeve wall, 352 serve to define the interior volume, 180, of mixing tank 100, for housing components of a mixture, before or after a mixing process.
- Sealed sleeve, 140, comprising paddle 600 moves within mixing tank 100, though a 360° range of motion in the plane of mixing tank base 110, whereby through mechanical motion, the paddle at least partially combines the components housed therein.
- the disposable mixing tank may be used for containment and storage of at least one component of the mixture, whereby the disposable mixing tank may store at least a first component for a period of time until at least a second component is added to the mixing tank for subsequent combining and mixing with the at least first component.
- the first and second components may comprise multiple compositions as in a mixture or blend, or the first and second components may consist essentially of single compositions. Each component may be introduced into the mixing tank by one or more inlet openings.
- the present invention relates to a method of remixing, regenerating and/or revalidating a mixture, which over time, has separated into two or more phases or components.
- the mixture having been stored in a disposable mixing tank having a sealed sleeve therein, comprises two or more components prone to phase separations, including but not limited to emulsions, blends and suspensions, (e.g. biological solutions such as plasma, red cells, virus etc. or CMP slurries used in semiconductor manufacturing processes).
- the sleeve defines a sealed passageway for insertion or arrangement of mixing means therein, which when placed in a mixing mode, serves to remixing, regenerate, and/or revalidate the mixture in the mixing tank.
- the present invention serves to reduce the time required to regenerate a mixture because there is no downtime due to revalidating, as there is no transfer of materials required.
- the present invention relates to a kit including a disposable and collapsible tank having a sealed, and collapsible sleeve therein.
- the collapsible tank having a storage area defined by an interior wall of the collapsible tank and an exterior wall of the sleeve is configured to house components prior to, during and/or after a mixing process.
- the collapsible sleeve defines a sealed passageway for insertion or arrangement of mixing means therein.
- the mixing means is isolated from the interior of the mixing tank, by the exterior sleeve wall and hence does not contact the interior of the tank or components therein.
- the mixing means which when placed in a mixing mode, serves to mix components in the mixing tank.
- the flexible sleeve includes a mixing rod shaft or other mixing componentry, prearranged therein, during a manufacturing process.
- the kit may further include packaging material and instructions or indicia located on the packaging material or inside the packaging material and may optionally include ancillary componentry such as couplers, connectors and filters.
- the tank and sleeve walls 110, 120, 130 and 150 respectively may be any type of flexible material for providing a flexible mixing apparatus (e.g., different types of plastics).
- the walls, 110, 120, 130 and 150 may be heat-welded plastic films.
- the walls 110, 120, 130 and 150 are plastic films with a thickness in range of 5 microns to 500 microns, (depending on the type of application).
- the walls, 110, 120, 130 and 150 may be made from a number of different plastics
- the walls, 110, 120, 130 and 150 are made from a plastic that includes at least one material from the following group: polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyethylene terephtalate (PET), polyetheretherketone (PEEK) polytetrafluoroethylene (PTFE) and polyfluoroalkoxy (PFA) derivates thereof.
- the mixing tank walls are manufactured from materials including at least one of, ethylene vinyl acetate and metallocene polyethylene.
- the walls 110, 120, 130 and 150 are a stretchable material, having a deformation, e.g., of less than approximately five percent when subjected to a tensile force of 100 gmf per inch (per 2.54 cm) of width.
- the tank and sleeve walls 110, 120, 130 and 150 respectively, define the storage and/or mixing compartment that isolates components therein from the outside medium/environment.
- the films 110, 120, 130 and 150 also have a mechanical resistance such that the disposable mixing tank 100, may be used under pressure from the outside medium/environment.
- the walls of the disposable mixing tank and sleeve are manufactured from similar materials, having similar thicknesses. In a preferred embodiment the wall thickness of the mixing tank and sleeve is about 200 microns.
- the mixing tank walls 110, 120 and 130 are approximately clear to allow for the viewing of the components and the mixture thereof, such that one skilled in the art may determine when the mix operation is complete based on viewing of the components.
- the mixing tank walls include volumetric indicia for measuring the volume of the components therein.
- the disposable mixing tank 100 is a single-use apparatus.
- the mixing tank 100 is used to mix, at least partially, components contained therein. More preferably, the mixing tank is used to at least partially mix and store components therein. The result of the mixing of the components may be removed from the mixing tank 100 (as described in more detail below). Thereafter, the mixing tank 100 is discarded. Accordingly, there is no need to wash/sterilize the mixing tank 100 in preparation for subsequent uses.
- the mixing tank 100 is a single-use apparatus, the mixing tank 100 does not have the ongoing maintenance costs associated with conventional mixing devices.
- the at least one, outlet opening, 170 allows for draining disposable mixing tank 100, of its contents. While the mixing tank 100 is illustrated with separate inlets 160, and outlets 170, embodiments of the invention are not so limited. For example, in an embodiment, a single opening could be used for both loading and draining of components and/or mixtures.
- the inlet opening(s) 160, and the outlet opening(s) 170 include a base plate welded onto the internal or external face of the mixing tank walls 120, and 130, respectively, such that one end of the opening emerges inside the wall and the other end emerges outside the wall.
- the number of inlet openings 160, and the outlet openings 170 may be closed using a number of devices, such as tight plugs.
- the diameters of the number of inlet openings 160, and the outlet openings 170 is dependent on the flow rate that a particular component is to be introduced into the mixing tank 100, and/or the admix operation that is to occur by movement of the mixing device arranged in sealed sleeve 140.
- the gas inlet and outlet rate (or pressure) may be such that there is a sufficient homogenization of the components in the disposable mixing tank 100.
- inlet opening(s) 160, and outlet opening(s) 170 may be used to introduce different types of probes into the mixing tank 100.
- pH, p0 2 , temperature or pressure probes can be introduced into the mixing tank 100 through a number of inlet 160 and/or outlet 170 openings to check the status of the components and/or the result of the mixing of such components within the mixing tank 100.
- the components to be stored in and the components that are to be admixed (mixed), at least partially together, during motion of the mixing device inside the flexible sleeve 140 may be in different phases (different types of solids, liquids and/or gases).
- the solid components may be different types of powders.
- the liquid components may be in different organic phases and/or aqueous phases.
- the gases may include oxygen, air, nitrogen, argon, carbon dioxide, etc.
- the components are substantially homogenized.
- the different components may or may not be soluble in reference to each other.
- any of a number of combinations of different components in different phases can be admixed in accordance with embodiments of the invention.
- a first component in a solid phase may be mixed with a second component in a solid phase.
- a first component in a solid phase may be mixed with a second component in a liquid phase.
- a powder is suspended in a liquid component when the powder may be partially or totally insoluble in the liquid component.
- the operation of the mixing tank 100 is such that the result is a homogenized solution of the powder and the liquid.
- a first component in a liquid phase may be mixed with a second component in a liquid phase.
- the first liquid component may be partially soluble, totally soluble or totally insoluble with reference to the second liquid component. If at least one liquid component is at least partially insoluble in at least another liquid component, an emulsion is obtained after the mixing/stirring of the mixing tank 100. In an embodiment, if the liquid components are soluble in reference to each other, the operation of the mixing tank 100 is such that the result is a homogenized solution of the two different liquid components.
- a first component in a liquid phase may be mixed with a second component in a gas phase.
- the gas may be inert or may react with at least one component of the liquid component.
- a gas that is relatively reactive under the desired conditions
- the width/diameter of sealed sleeve 140, and the width/diameter of inlet(s) 160, and outlet(s) 170, are dependent on the size of the mixing tank 100, and components to be mixed and/or transferred.
- the width/diameter and height of sealed sleeve 140 must allow for the arrangement of mixing means therein.
- the dimensions of the sealed sleeve 140 are based on the size of mixing tank 100, and physical characteristics of the components to be mixed. Examples of the type of characteristics that the diameter of the sleeve 140 is dependent include viscosity, granulometry, density, thixotropy and rheoscopy.
- the mixing tank 100 also includes one to a number of valves to allow for a release mechanism in the event that pressure builds up within the mixing tank 100, because of the mixing/rotation operation.
- the disposable mixing tank 100 may comprise a support frame 115, as shown, in Figure 1.
- the support frame may enclose the disposable mixing tank 100 and can couple to the mixing bag 100, through one of a number of connection apparatus (e.g., a clip, a hook, etc., not shown).
- the frame may additionally function as support for mixing means and related ancillaries. Accordingly, the support frame supports the mixing tank 100, so as to maintain a sufficient tension during loading of components into the mixing tank as well as during the mixing of the components contained therein.
- Figure 7 illustrates disposable mixing tank 100, comprising mixing means 700, whereby both mixing tank 100 and mixing means 700 are supported by frame 115.
- Motor - wheel driver 710 couples to rotation wheel 720, which couples to mixing stick 730 through bearings 740 and 750.
- the motor - wheel driver 710 may communicate directly with a processor to execute machine- readable instructions for controlling the rotation of the mixing stick 730, including the number of turns, the rate of rotation, the angle of rotation, how far to turn for a given rotation, (as described in more detail below in conjunction with the description of the flow diagram 800 of Figure 8).
- the disposable mixing tank of the present invention may further comprise a secondary containment system for containment of materials, which may leak from the tank during storage, processing, and/or transfer of same into and/or out of the mixing tank.
- the secondary containment system may be fixed or portable. Further, the appropriate secondary containment system for use with the disposable mixing tank may be readily determined by one skilled in the art.
- the disposable mixing tank of the present invention may further comprise external heating and/or cooling means for controlling the temperature of components in the disposable mixing tank.
- the secondary containment system may serve as housing for a fluid, which conducts heat into or out of the disposable mixing tank, such as heating and cooling baths.
- the heating and/or cooling means may envelope the exterior of the disposable mixing tank or a portion thereof as in for example, heating jackets, heating and cooling tanks, heat exchangers, chillers, and fluid cooling systems.
- the mixing tank may comprise a liner, exterior to the outer walls of sealed cavity 140 and mixing tank 100.
- the liner preferably envelops at least a portion of the mixing tank and provides a sealed gap or space between the liner and exterior walls of sealed cavity 140 and mixing tank 100.
- the gap or space is useful for containing fluids having heat and/or cooling capacities.
- the heating and/or cooling fluid contained therein is circulatable in the gap or space by circulation means.
- Figure 8 illustrates a flow diagram for mixing components, according to a further embodiment of the invention.
- components are loaded into mixing tank 100, through inlet 160.
- Inlet 160, or multiple inlets (not shown) may be opened in an order that is in accord with a mixing protocol for the components to be loaded into mixing tank 100. For example, a more homogenous solution may be derived for three components if a first component and a second component are mixed, followed by the mixing of the third component into the mixture of the first component and the second component.
- the components may be loaded simultaneously or based on a mixing protocol or instructions from a CPU.
- the number of inlet openings 160 allow for the introduction of components ("raw materials” or “reactants") to be mixed within the mixing tank 100.
- Control continues at block 804.
- different inlets may be opened at different times during the mixing of the components in order to follow a mix protocol for a given set of components. Accordingly, the opening of an inlet for filling, may follow a first mix operation, which is followed by a second mix operation.
- the components loaded into the mixing tank 100 are mixed, at least partially, based on rotation of the mixing device as shown in Figure 7.
- the mixing of the components may be performed by an individual and/or a control apparatus (not shown).
- the mixing of the components may be carried out by a number of rotations of the mixing means 700, wherein one rotation includes rotating at least a 360° turn.
- the range of motion through the 360° rotation is in the plane of mixing tank base 110.
- the rotation of mixing means 700, in the mixing tank 100 continues until the components are approximately homogenized.
- the rotation of mixing means 700 continues until the powder is suspended in the liquid.
- the at least partially mixed components are drained from the mixing tank 100.
- the mixing tank 100 is positioned such that when a plug type device is removed or a valve is opened, mixed components drain from outlet 170.
- the drain operation may be facilitated.
- the drain operation may be facilitated through a number of operations.
- the drain operation is facilitated by an increase in pressure initiated by introducing a gas into an inlet opening(s) 160. Control continues at block 808.
- the mixing tank 100 is discarded.
- the mixing tank 100 is discarded after a single use. Accordingly, the washing/sterilizing operations as well as the maintenance associated with conventional mixing devices are not needed.
- embodiments of the invention reduce the amount of human contact with the components (which may be hazardous, dangerous and/or infectious) that are to be mixed as part of and during the mixing of such components.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2004800302449A CN1867395B (en) | 2003-10-14 | 2004-10-07 | Flexible mixing bag for mixing solids, liquids and gases |
EP04794370A EP1678040B1 (en) | 2003-10-14 | 2004-10-07 | Mixing apparatus comprising a flexible mixing bag, and related method |
JP2006535556A JP4931592B2 (en) | 2003-10-14 | 2004-10-07 | Mixing container, mixing apparatus and mixing method |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/684,932 | 2003-10-14 | ||
US10/684,932 US7249880B2 (en) | 2003-10-14 | 2003-10-14 | Flexible mixing bag for mixing solids, liquids and gases |
Publications (2)
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WO2005037658A2 true WO2005037658A2 (en) | 2005-04-28 |
WO2005037658A3 WO2005037658A3 (en) | 2005-09-15 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2004/032997 WO2005037658A2 (en) | 2003-10-14 | 2004-10-07 | A flexible mixing bag for mixing solids, liquids and gases |
Country Status (5)
Country | Link |
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US (4) | US7249880B2 (en) |
EP (1) | EP1678040B1 (en) |
JP (2) | JP4931592B2 (en) |
CN (2) | CN102989351B (en) |
WO (1) | WO2005037658A2 (en) |
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- 2004-10-07 CN CN201210378113.6A patent/CN102989351B/en active Active
- 2004-10-07 JP JP2006535556A patent/JP4931592B2/en active Active
- 2004-10-07 WO PCT/US2004/032997 patent/WO2005037658A2/en active Application Filing
- 2004-10-07 CN CN2004800302449A patent/CN1867395B/en active Active
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2007
- 2007-07-31 US US11/831,735 patent/US7431494B2/en not_active Ceased
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2010
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2011
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2012
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Cited By (7)
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US8182137B2 (en) | 2000-10-09 | 2012-05-22 | Atmi Packaging, Inc. | Mixing bag or vessel with a fluid-agitating element |
US8282269B2 (en) | 2000-10-09 | 2012-10-09 | Atmi Packaging, Inc. | Mixing bag or vessel having a fluid-agitating element |
US8123199B2 (en) * | 2004-01-07 | 2012-02-28 | Atmi Packaging, Inc. | Bioreactor |
US10632433B2 (en) | 2006-05-13 | 2020-04-28 | Pall Life Sciences Belgium Bvba | Disposable bioreactor |
US8282267B2 (en) | 2006-10-03 | 2012-10-09 | Artelis S.A. | Mixing system including a flexible bag, specific flexible bag and locating system for the mixing system |
US8292491B2 (en) | 2006-10-03 | 2012-10-23 | Artelis S.A. | Flexible bag, mixing system and method for fixing a flexible bag inside a rigid container |
EP2788468A4 (en) * | 2011-12-09 | 2015-09-16 | Pall Technology Uk Ltd | Filtration apparatus for continuous perfusion |
Also Published As
Publication number | Publication date |
---|---|
USRE43418E1 (en) | 2012-05-29 |
CN102989351B (en) | 2015-10-07 |
US7249880B2 (en) | 2007-07-31 |
JP5656801B2 (en) | 2015-01-21 |
JP4931592B2 (en) | 2012-05-16 |
US7431494B2 (en) | 2008-10-07 |
EP1678040A2 (en) | 2006-07-12 |
JP2007511337A (en) | 2007-05-10 |
US20080031082A1 (en) | 2008-02-07 |
US20050078552A1 (en) | 2005-04-14 |
JP2012024767A (en) | 2012-02-09 |
US20130003488A1 (en) | 2013-01-03 |
CN1867395B (en) | 2012-11-28 |
EP1678040B1 (en) | 2012-05-30 |
WO2005037658A3 (en) | 2005-09-15 |
CN102989351A (en) | 2013-03-27 |
CN1867395A (en) | 2006-11-22 |
EP1678040A4 (en) | 2010-07-21 |
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