Centrifuges and carriages for separating biological components and their usage.

Abstract

The present invention discloses a carriage (700) for separating biological components, comprising: a housing (701) defining a compartment (708) partially defined by a mounting platform (709); and a loading assembly (800) fixed to the housing for communication with the compartment. The loading assembly (800) includes an alignment plate (808) having a top surface with a recessed cavity (814) therein communicating with the compartment; a drive rotor (15) rotatably disposed below the alignment plate and at least partially surrounding the cavity, the drive rotor including one or more magnets; a motor (169) coupled to the drive rotor for selectively rotating the drive rotor about the cavity; and a mounting member at least partially surrounding the drive rotor and communicating with the compartment, the mounting member including a mounting plate having one or more mounting elements erected therefrom, the mounting member being movable between a raised position in which the mounting plate is aligned with the alignment plate, and a second lower position in which the mounting plate is disposed at a height lower than the alignment plate.

Description

[0001] Cross-reference of related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 63 / 115,938, filed November 19, 2020, and U.S. Provisional Application No. 63 / 219,339, filed July 7, 2021, which are incorporated herein by reference in their entirety. Background Technology 1. Technical Field

[0004] This disclosure relates to centrifuges used in the bioproduction industry, and more specifically, to single-use continuous flow centrifuges for separating biological fluids, solids, mixtures, solutions and suspensions, and to modular carriages into which the separators can be incorporated. 2. Background Technology

[0006] Bioreactors and fermenters are used to grow various types of biological suspensions. These suspensions are broadly defined as liquid cultures containing cells or microorganisms suspended therein. Once the suspension has grown sufficiently, it is typically separated into components, and the separated components are then harvested for subsequent analysis or use. Centrifugation is a technique frequently used during the isolation or analysis of various cells, organelles, and biopolymers, including proteins, nucleic acids, lipids, and carbohydrates dissolved or dispersed in biological suspensions.

[0007] In one centrifugation method, a large volume of suspension is dispensed from a bioreactor or fermenter into open-top bottles. The bottles are then closed by manually applying a cap and subsequently rotated using a centrifuge rotor. The centrifugal force generated by the rotor's rotation causes solids (e.g., cells or microorganisms) within the suspension to precipitate towards the bottom of the bottle, while the lighter components collect towards the top. Once the bottles are removed from the centrifuge rotor, the lighter components are poured out for harvesting, followed by the solids.

[0008] While the above method is effective, it has several drawbacks. For example, the bottles are reused. Therefore, each bottle needs to be cleaned and sterilized after each use. This process is time-consuming, labor-intensive, and requires specialized sterilization equipment, such as an autoclave. Furthermore, although the bottles are cleaned and sterilized between uses, they are still used as open-top containers. Therefore, when the suspension is initially dispensed into the bottle, both the suspension and the interior of the bottle are exposed to the surrounding environment. Subsequently, when the separated components are removed from the bottle, the separated components are again exposed to the environment. This open exposure increases the likelihood of contamination of the suspension and / or the separated components. Therefore, subsequent purification steps may be required to remove any contaminants from one or both of the separated components. In addition to the above, it may be difficult to effectively separate lighter components from heavier components from the bottle in a conventional system without any mixing between them.

[0009] Furthermore, because the above method operates by continuously separating discrete portions of a given volume of suspension, it cannot be used in situations requiring a continuous flow perfusion system. Similarly, when harvesting cells / microbes for reuse, such as in inoculum, extending the removal of cells / microbes from the reactor for separation would stress the cells / microbes and reduce their activity.

[0010] In one alternative embodiment of the above, a centrifuge rotor with a cavity having an inlet and an outlet is provided. As the centrifuge rotor rotates, the suspension is delivered into the cavity through the inlet. The heavier components of the suspension are collected within the cavity against the outer wall of the rotor, while the lighter components flow out of the cavity through the outlet. Once a determined amount of the heavier components has been collected within the cavity, the inflow of the suspension is stopped and a portion of the heavier components is removed from the cavity. Inflow is then resumed, and this process is repeated until the entire batch of suspension has been adequately separated. The cavity of the centrifuge rotor is then cleaned and sterilized for use with the next batch of suspension.

[0011] While the latter method is more efficient than the first, it still has several drawbacks. For example, it still collects heavier components in batches, making it unsuitable for continuous flow perfusion systems. Additionally, because the cells / microbes are collected inside the rotor, they are again kept outside the reactor for an extended period, which reduces their activity. Centrifuge rotors are typically very robust machines, primarily made of metal and composed of many different assembled parts. Once the rotor is finished with its use, it must be cleaned and sterilized for subsequent use. Therefore, centrifuge rotors are both expensive to manufacture and require a significant labor force for maintenance.

[0012] Therefore, there is a need in the art for improved separators, systems, and methods that address all or some of the above and other existing disadvantages. Summary of the Invention

[0013] A first independent aspect of this disclosure includes a slide for separating biological components, the slide comprising:

[0014] A housing that defines a compartment, which is partially defined by a mounting platform; and

[0015] Loading assembly, which is fixed to the housing for communication with the compartment, includes:

[0016] Alignment plate having a top surface having a recessed cavity therein, the cavity communicating with a compartment;

[0017] A drive rotor, rotatably disposed below the alignment plate and at least partially surrounding the cavity, the drive rotor comprising one or more magnets;

[0018] An electric motor, coupled to a drive rotor, for selectively rotating the drive rotor about the cavity; and

[0019] The mounting component, which at least partially surrounds the drive rotor and communicates with the compartment, includes a mounting plate having one or more mounting elements erected therefrom. The mounting component is movable between a raised position and a second lowered position, in which the mounting plate is aligned with an alignment plate, and in the second lowered position, the mounting plate is positioned at a height lower than the alignment plate.

[0020] An alternative implementation plan also includes:

[0021] A passageway, formed in the shell and communicating with a compartment; and

[0022] A door, mounted on the housing, is movable between an open position and a closed position, in which the doorway is exposed and in which the doorway is covered.

[0023] In another embodiment, the notch is recessed into the outer surface of the housing and extends between the side of the housing and the doorway, defining a passageway that communicates with the compartment regardless of whether the door is in the open or closed position.

[0024] Another implementation plan also includes:

[0025] An installation platform having an opening extending through it; and

[0026] The loading assembly is fixed to the housing so that the alignment plate is aligned with an opening extending through the mounting platform.

[0027] In another embodiment, when the mounting component is in the raised position, at least a portion of the top surface of the mounting platform, the top surface of the alignment plate, and the top surface of the mounting plate are horizontally aligned.

[0028] In another embodiment, the loading component further includes:

[0029] An annular inner sleeve surrounds an opening and has an upper end on which an alignment plate is mounted.

[0030] A receiving portion extending from the bottom surface of the alignment plate and protruding into the opening of the annular sleeve, the receiving portion defining a cavity; and

[0031] A drive rotor is at least partially disposed within the opening of the inner sleeve.

[0032] Another embodiment also includes a loading assembly that further includes an annular outer sleeve surrounding the inner sleeve, the outer sleeve having an upper end on which a mounting plate is mounted, the outer sleeve and the mounting plate being movable relative to the inner sleeve.

[0033] Another implementation plan also includes:

[0034] A support member from which the inner sleeve stands upright;

[0035] A pivot mounting block that is fixed to a support at a position spaced apart from the inner sleeve;

[0036] A pair of pivoting arms, each having a first end pivotally mounted to a pivoting mounting block, such that the pair of pivoting arms extend along opposite sides of the outer sleeve; and

[0037] A pair of support pins that protrude outward from opposite sides of the outer sleeve and are connected to a corresponding pivot arm of a pair of pivot arms.

[0038] Another embodiment also includes a linear actuator positioned to selectively raise and lower the outer sleeve relative to the inner sleeve.

[0039] In another embodiment, one or more mounting elements include one or more L-shaped clips that stand upright from the mounting plate and face the cavity.

[0040] Another embodiment also includes one or more peristaltic pumps mounted on the outer surface of the housing.

[0041] Another embodiment also includes one or more pinch valves mounted on the outer surface of the housing.

[0042] Another embodiment also includes one or more of a pressure sensor, conductivity sensor, flow meter sensor, pH sensor, temperature sensor, or turbidity sensor mounted on the outer surface of the housing.

[0043] Another independent aspect of this disclosure includes a system for separating biological components, the system comprising:

[0044] The carriage as described above, which may or may not have any of the above-described or alternative features contained in this application; and

[0045] A centrifugal separator, which is detachably mounted in the compartment of the carriage, is supported on the mounting plate of the loading assembly.

[0046] Another embodiment also includes a first fluid line fluidly connected to a centrifugal separator within the compartment of the carriage, the first fluid line exiting the compartment and being detachably secured to the outer surface of the housing.

[0047] In another embodiment, the first fluid line is detachably connected to a peristaltic pump and / or a pinch valve fixed to the outer surface of the housing.

[0048] Another embodiment also includes a sensor mounted on the first fluid line, which can be detachably inserted into a power socket formed on the outer surface of the housing.

[0049] In another embodiment, the centrifugal separator is at least partially secured to the mounting plate by magnetic force generated by one or more magnets driving the rotor.

[0050] Another implementation plan also includes:

[0051] Centrifuge, the centrifuge comprising:

[0052] A separating stator, the separating stator defining a chamber, the separating stator having a base plate having a receiving portion projecting outward therefrom, the receiving portion defining a groove communicating with the chamber of the separating stator;

[0053] A separating rotor, which is rotatably mounted in the chamber of the separating stator;

[0054] A drive coupling that is coupled to and extends from the separating rotor so as to protrude into a recess in the receiving portion; and

[0055] A drive sleeve that protrudes outward from the base plate of the split stator and at least partially surrounds the receiving portion of the split stator;

[0056] The centrifugal separator is positioned such that the receiving portion of the separator rotor is aligned with the cavity of the alignment plate, and one or more mounting elements engage the drive sleeve.

[0057] In another embodiment, when the mounting plate is moved to the lowered position, the receiving portion of the decoupled stator is received in the cavity of the alignment plate, and when the mounting plate is moved to the raised position, the receiving portion of the decoupled stator is removed from the cavity of the alignment plate.

[0058] In another embodiment, the drive sleeve has one or more openings or recesses, in which a portion of one or more mounting elements is received.

[0059] In another embodiment, with one or more mounting elements engaging the drive sleeve, moving the mounting plate to a lowered position rigidly locks the centrifugal separator to the carriage housing.

[0060] Another independent aspect of this disclosure includes a method for separating biological components, the method comprising:

[0061] The centrifugal separator is positioned on the top surface of the mounting platform of the carriage as described above, which may or may not have any of the above-described or alternative features in this application;

[0062] The centrifugal separator is moved laterally within the compartment of the housing, such that the centrifugal separator is supported on the mounting plate of the mounting element, and the mounting element engages the centrifugal separator.

[0063] The mounting plate is moved to the lowered position, causing the centrifuge to lower relative to the alignment plate. When the mounting plate is moved to the lowered position, the centrifuge's drive coupling is received within the cavity of the alignment plate; and

[0064] Start the motor to rotate the drive rotor, which magnetically rotates the centrifugal separator's separating rotor.

[0065] In another embodiment, the lateral moving centrifugal separator includes a centrifugal separator that slides laterally on a mounting platform near a magnetic field generated by one or more magnets driving a rotor, wherein the magnetic field assists in the positioning of the centrifugal separator.

[0066] In another embodiment, moving the mounting plate to a lowered position rigidly locks the centrifugal separator to the carriage housing.

[0067] In another embodiment, the step of positioning the centrifuge on the top surface of the mounting platform includes:

[0068] The centrifuge is passed through a doorway formed on the shell and into the compartment; and

[0069] Close the door covering the passageway after the centrifuge is in the compartment.

[0070] In another embodiment, the centrifugal separator is positioned on the top surface of the mounting platform such that a first fluid line connected to the centrifugal separator exits from a compartment of the housing. The method also includes detachably securing the first fluid line to a clamp valve and / or a peristaltic pump mounted on an outer surface of the housing.

[0071] Another independent aspect of this disclosure includes a centrifugal separator comprising:

[0072] A separation stator, the separation stator defining a chamber, the separation stator having an inlet opening, a first outlet opening and a second outlet opening;

[0073] A separating rotor, defining a compartment, is at least partially disposed within the compartment of the separating stator and is rotatable about a rotation axis within the compartment. The separating rotor has a base plate having an inner surface and an opposing bottom surface. A cup-shaped member is formed on and protrudes outward from the bottom surface of the base plate, defining a groove formed on the inner surface of the base plate and communicating with the compartment of the separating rotor.

[0074] An annular bearing assembly extending between a separate stator and a separate rotor to allow the separate rotor to rotate relative to the separate stator, the annular bearing assembly being disposed around and directly against the outer surface of the bowl-shaped member to surround at least a portion of the groove.

[0075] In another embodiment, during operation, fluid flowing between the inlet opening and the first and second outlet openings is passed through a groove in the bowl-shaped member to form a radiator for the bearing.

[0076] Another embodiment also includes a plurality of fins that protrude downward from the bottom surface of the base plate and radially outward away from the bowl-shaped member.

[0077] Another independent aspect of this disclosure includes a centrifugal separator comprising:

[0078] A separating stator, the separating stator defining a chamber, the separating stator having an inlet opening, a first outlet opening, and a second outlet opening; and

[0079] A separating rotor defines a compartment, which is at least partially disposed within the compartment of the separating stator and is rotatable about a rotation axis within the compartment. Heavy component collection grooves and light component collection grooves are spaced apart between the separating stator and the separating rotor. The heavy component collection groove communicates with a first outlet opening, and the light component collection groove...

[0080] The separating rotor, connected to the second outlet opening, includes:

[0081] Base plate;

[0082] A sidewall assembly, erected from the base plate and surrounding the compartment, includes multiple heavy component separation fluid paths, each communicating upstream with an inlet opening and downstream with a heavy component collection recess; and

[0083] Multiple upper partitions project radially inward from the sidewall assembly into the compartment to at least partially divide the compartment into multiple separate light component fluid paths, each of which communicates upstream with an inlet opening and downstream with a light component collection recess.

[0084] Each light component fluid path is connected to at least two of the heavy component fluid paths, but is isolated from at least some of the heavy component fluid paths.

[0085] In another embodiment, each of the multiple separation light component fluid paths extends along its length and is isolated from each other along its length.

[0086] In another embodiment, at least some of the multiple heavy component separation fluid paths are isolated from other heavy component separation fluid paths upstream of the heavy component collection groove.

[0087] In another embodiment, each light component fluid path is connected to two or three of the heavy component separation fluid paths, but is isolated from the rest of the multiple heavy component separation fluid paths.

[0088] In another embodiment, the sidewall assembly includes an annular outer sidewall and an annular inner sidewall surrounded by the outer sidewall, with multiple fluid paths for separating heavy components defined between the inner and outer sidewalls.

[0089] Another embodiment also includes multiple separators extending between the inner and outer sidewalls, which separate the heavy component fluid paths from each other.

[0090] In another embodiment, the outer sidewall extends to the bottom plate, and the inner sidewall is spaced apart from the bottom plate.

[0091] In another embodiment, at least a portion of the outer wall has a truncated conical configuration.

[0092] In another embodiment, at least a portion of the inner sidewall has a truncated conical configuration.

[0093] In another embodiment, a plurality of upper partitions protrude radially inward from the outer and inner sidewalls.

[0094] Another embodiment also includes a tubular conduit disposed along the axis of rotation within the compartment of the separating stator, the tubular conduit having a first end connected to the inlet opening of the separating stator and an opposing second end.

[0095] Another embodiment also includes a dispersing member disposed in the compartment of the separating rotor, the dispersing member having a main body position located above the base plate, such that a space is formed between the base plate and the main body of the dispersing member.

[0096] In another embodiment, the dispersing member has a centrally located opening therethrough, and a second end of a conduit is connected to or passes through the opening of the dispersing member. The conduit is configured such that fluid passing through the conduit from the inlet opening exits the conduit in a space formed between the base plate and the body of the dispersing member.

[0097] In another embodiment, a plurality of upper separators extend radially outward from the conduit and along the top surface of the body of the dispersing member.

[0098] In another embodiment, the body of the dispersion component has a flat plate configuration or a truncated conical configuration.

[0099] Another embodiment also includes a plurality of lower partitions extending between the body of the dispersion member and the base plate, the plurality of lower partitions extending radially outward from the opening of the dispersion member.

[0100] In another embodiment, the lower partition extends to the sidewall assembly and is aligned with a corresponding upper partition among a plurality of upper partitions.

[0101] In another embodiment, the second end of the conduit is disposed outside the separating rotor and can be rotatably fixed to the separating stator via a bearing assembly.

[0102] Another implementation plan also includes:

[0103] A drive coupling, which is fixed to the base plate of the separate rotor so as to protrude outward from the base plate; and

[0104] A drive rotor surrounds a drive coupling, and the drive rotor generates a magnetic field on the drive coupling, such that the rotation of the drive rotor promotes the rotation of the drive coupling.

[0105] In another embodiment, the drive coupling is disposed inside the separate stator, and the drive rotor is disposed outside the separate stator.

[0106] In another embodiment, the separating rotor further includes a rod assembly coupled to a first end of the sidewall assembly, the rod assembly including a rod comprising:

[0107] A tubular orifice having an inner surface and an opposing outer surface, the inner surface defining a light collection channel that provides fluid communication between each light component fluid path in the light component fluid path and a light component collection recess; and

[0108] Multiple separator segments protrude radially outward from the outer surface of the tubular orifice and at least partially define multiple heavy collection channels that are in fluid communication with the heavy component fluid path.

[0109] In another embodiment, the rod assembly further includes a tubular sleeve surrounding the rod, the tubular sleeve having an inner surface and an opposing outer surface, wherein a plurality of radially spaced openings pass through the tubular sleeve between the inner and outer surfaces, each of the plurality of openings providing fluid communication between the heavy collection channel and the heavy component collection recess.

[0110] In another embodiment, the sleeve and rod are made of different materials.

[0111] In another embodiment, the sleeve is made of a material that is more thermally conductive than the rod.

[0112] In another embodiment, the sleeve comprises metal and the rod comprises polymer.

[0113] Another embodiment also includes one or more seals disposed between the separating stator and the sleeve.

[0114] Another embodiment also includes a first end of a tubular opening that opens radially outward away from the axis of rotation and terminates at an annular end face, with a sleeve disposed against the annular end face of the opening.

[0115] Another embodiment also includes one or more bearing assemblies disposed between the separate stator and the separate rotor.

[0116] In another embodiment, the chamber of the separation stator extends between a first end and an opposite second end, with an inlet opening, a first outlet opening and a second outlet opening each disposed at or toward the first end.

[0117] In any independent aspect of this disclosure, the centrifugal separator includes:

[0118] A separating stator, the separating stator defining a chamber, the separating stator having an inlet opening, a first outlet opening, and a second outlet opening; and

[0119] A separating rotor defining a compartment, the separating rotor being at least partially disposed within the compartment of the separating stator and capable of rotating about a rotation axis within the compartment, the separating rotor comprising:

[0120] Base plate;

[0121] A sidewall assembly, erected from the base plate and surrounding the compartment, includes multiple heavy component fluid paths, each of which communicates upstream with an inlet opening and downstream with a first outlet opening; and

[0122] Multiple upper partitions project radially inward from the sidewall assembly into the compartment to at least partially divide the compartment into multiple separate light component fluid paths, each of which communicates upstream with an inlet opening and downstream with a second outlet opening; and

[0123] The rod assembly, which is connected to a first end of the sidewall assembly, includes:

[0124] A rod, made of a material and including a tubular orifice having an inner surface and an opposing outer surface, the inner surface defining at least one light collection channel providing fluid communication between a light component fluid path and a second outlet opening; and

[0125] A tubular sleeve surrounds a rod and has an inner surface and an opposing outer surface. At least one heavy collection channel is disposed between the rod and the sleeve and provides fluid communication between multiple heavy component fluid paths and a first outlet.

[0126] In another embodiment, the tubular sleeve includes a first heat dissipation section having an inner surface and an opposing outer surface, the inner surface of the first heat dissipation section directly defining a portion of at least one recollection channel.

[0127] Another embodiment also includes a seal disposed between the separate stator and the tubular sleeve, the seal being offset directly against the inner surface of the first heat dissipation section of the sleeve.

[0128] In another embodiment, the tubular sleeve includes a second heat dissipation section having an inner surface and an opposing outer surface, the inner surface of the second heat dissipation section directly defining a portion of at least one light collection channel.

[0129] Another embodiment also includes a seal disposed between the separate stator and the tubular sleeve, the seal being offset directly against the inner surface of the second heat dissipation section of the sleeve.

[0130] In another embodiment, the tubular sleeve is made of a material that is more thermally conductive than the material of the rod.

[0131] In another embodiment, the tubular sleeve has a thickness of less than 2.5 mm extending between its inner and outer surfaces.

[0132] Another implementation plan also includes:

[0133] The rod also includes: a plurality of partition segments that project radially outward from the outer surface of the tubular opening; and

[0134] At least one recollection channel, which includes multiple recollection channels separated by multiple separator segments.

[0135] Another embodiment also includes a tubular sleeve having a first end and an opposing second end and having a plurality of radially spaced openings that pass through the tubular sleeve between an inner surface and an outer surface to be positioned between the first end and the second end, each of the plurality of openings being aligned with a corresponding recollection channel in a plurality of recollection channels to provide fluid communication between the recollection channel and the first outlet.

[0136] Another implementation plan also includes:

[0137] A first seal is disposed between the separating stator and the tubular sleeve, the first seal being disposed directly against the outer surface of the tubular sleeve at a first end of the tubular sleeve to provide a liquid-proof seal between the separating stator and the tubular sleeve; and

[0138] A second seal is disposed between the separator stator and the tubular sleeve, and the second seal is disposed at the second end of the tubular sleeve directly abutting against the outer surface of the tubular sleeve.

[0139] This is to provide a liquid-proof seal between the separating stator and the tubular sleeve.

[0140] Another embodiment also includes a heavy component collection groove disposed between the separating stator and the separating rotor, the heavy component collection groove being in fluid communication upstream with each of the multiple separating heavy component fluid paths and in fluid communication downstream with a first fluid outlet.

[0141] Another embodiment also includes a light component collection groove disposed between the separating stator and the separating rotor, the light component collection groove being in fluid communication upstream with each of the multiple separating light component fluid paths and in fluid communication downstream with a second fluid outlet.

[0142] In another embodiment, multiple light component fluid paths are separated from multiple heavy component fluid paths and are arranged radially inside the multiple heavy component fluid paths.

[0143] In any independent aspect of this disclosure, the centrifugal separator includes:

[0144] A separating stator, the separating stator defining a chamber, the separating stator having an inlet opening, a first outlet opening, and a second outlet opening; and

[0145] A separating rotor defining a compartment, the separating rotor being at least partially disposed within the compartment of the separating stator and capable of rotating about a rotation axis within the compartment, the separating rotor comprising:

[0146] Base plate;

[0147] A sidewall assembly, erected from the base plate and surrounding the compartment, includes an annular outer sidewall and an annular inner sidewall surrounded by the outer sidewall. Multiple heavy component separation fluid paths are defined between the inner and outer sidewalls. The outer sidewall includes an upper sidewall portion having an internal surface with a truncated conical configuration. The internal surface of the upper sidewall portion is inclined relative to the axis of rotation at an angle ranging from 40° to 50°. Each of the multiple heavy component separation fluid paths communicates upstream with an inlet opening and downstream with a first outlet.

[0148] Multiple upper partitions protrude radially inward from the sidewall assembly into the compartment to at least partially divide the compartment into multiple separate light component fluid paths, each of which communicates with an inlet opening upstream and a second outlet downstream.

[0149] In another embodiment, the outer sidewall extends to the bottom plate, and the inner sidewall is spaced apart from the bottom plate.

[0150] In another embodiment, at least a portion of the inner sidewall has a truncated conical configuration.

[0151] Another embodiment also includes a tubular conduit disposed along the axis of rotation within the compartment of the separating stator, the tubular conduit having a first end connected to the inlet opening of the separating stator and an opposing second end.

[0152] Another embodiment also includes a dispersing member disposed above the base plate within the compartment of the separating rotor, thereby creating a space between the base plate and the dispersing member.

[0153] In another embodiment, the dispersing member has an opening centrally located therethrough, and a second end of a conduit is connected to or passes through the opening of the dispersing member. The conduit is configured such that fluid passing through the conduit from the inlet opening exits the conduit in a space formed between the base plate and the dispersing member.

[0154] In any independent aspect of this disclosure, the centrifugal separator includes:

[0155] A separating stator, the separating stator defining a chamber, the separating stator having an inlet opening, a first outlet opening, and a second outlet opening; and

[0156] A separating rotor defining a compartment, the separating rotor being at least partially disposed within the compartment of the separating stator and capable of rotating about a rotation axis within the compartment, the separating rotor comprising:

[0157] Base plate;

[0158] A sidewall assembly that stands upright from the base plate and surrounds the compartment includes an annular outer sidewall and an annular inner sidewall surrounded by the outer sidewall. The outer sidewall extends to the base plate and the inner sidewall is spaced apart from the base plate. Multiple heavy component fluid paths are defined between the inner and outer sidewalls. Each of the multiple heavy component fluid paths is connected to an inlet opening upstream and to a first outlet downstream.

[0159] A dispersing member is disposed in the compartment of the separating rotor above the base plate, such that a space including part of the compartment is formed between the base plate and the dispersing member. The dispersing member has a top surface and an opposing bottom surface, and an opening passes through the dispersing member centrally between the top surface and the bottom surface.

[0160] A tubular conduit is disposed at least partially within the compartment of the separating stator along the axis of rotation. The tubular conduit has a first end connected to an inlet opening of the separating stator and an opposite second end connected to or passing through an opening of a dispersing member. The conduit is configured such that fluid passing through the conduit from the inlet opening exits the conduit in a space formed between the base plate and the dispersing member.

[0161] Multiple upper partitions extend between the inner wall and the upper surface of the dispersing member and project radially outward from the tubular conduit, dividing at least a portion of the compartment into multiple separate light component fluid paths, each of which communicates upstream with an inlet opening and downstream with a second outlet; and

[0162] Multiple lower partitions extend between the base plate and the lower surface of the dispersion member and project radially inward from the outer side wall aligned with the axis of rotation. The multiple lower partitions at least partially divide the space into multiple separation inlet fluid paths, each of which communicates with an inlet opening upstream and with multiple separation light component fluid paths and multiple separation heavy component fluid paths downstream.

[0163] In another embodiment, each of the plurality of separation inlet fluid paths is connected to at least two of the plurality of separation heavy component fluid paths, but is isolated from at least some of the plurality of separation heavy component fluid paths.

[0164] In another embodiment, at least a portion of the outer sidewall has a truncated conical configuration, and at least a portion of the inner sidewall has a truncated conical configuration.

[0165] In another embodiment, at least some of the upper partitions extend to the outer sidewall and intersect with the corresponding lower partitions in the lower partitions.

[0166] In another embodiment, a tubular conduit passes through the bottom plate of the separator rotor, and multiple lower separators protrude radially outward from the conduit.

[0167] In another independent aspect of this disclosure, a method for separating biological suspensions includes:

[0168] Biological cells or microorganisms growing in a suspension within a reactor vessel, the suspension also including a growth culture medium; and

[0169] The inlet flow of the suspension is passed from the container of the reactor to the inlet opening of the centrifuge as described in claim 1, 30, 43 or 49, the centrifuge separating the inlet flow into a first outlet flow exiting the centrifuge through a first outlet opening and a second outlet flow exiting the centrifuge through a second outlet opening, the first outlet flow having a higher density or solids percentage than the second outlet flow.

[0170] Another implementation also includes returning the first outlet stream to the reactor's container.

[0171] Another implementation also includes transferring the first outlet stream to a collection container separate from the reactor.

[0172] Another embodiment also includes continuously operating the centrifuge to separate the suspension into a first outlet stream and a second outlet stream for a period of at least 20 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, or 48 hours.

[0173] Another implementation plan also includes:

[0174] The first pump is used to control the flow rate of the first outlet flow leaving the first outlet opening;

[0175] as well as

[0176] A second pump is used to control the flow rate of the second outlet stream leaving the second outlet opening.

[0177] Another implementation plan also includes:

[0178] The first control valve is used to control the flow rate of the first outlet flow leaving the first outlet opening; and

[0179] A second control valve is used to control the flow rate of the second outlet flow leaving the second outlet opening.

[0180] Another implementation also includes mixing the suspension within the reactor vessel while operating the centrifuge.

[0181] In another embodiment, as the inlet flow enters the centrifugal separator, the first outlet flow and the second outlet flow simultaneously exit the centrifugal separator.

[0182] Another implementation also includes passing the second outlet stream to a second centrifugal separator.

[0183] In another independent aspect of this disclosure, a method for separating biological suspensions includes:

[0184] Biological cells or microorganisms growing in a suspension within a reactor vessel, the suspension also including a growth culture medium; and

[0185] The inlet flow of the suspension is passed from the container of the reactor to the inlet opening of the centrifuge, which separates the inlet flow into a first outlet flow that exits the centrifuge through a first outlet opening and a second outlet flow that exits the centrifuge through a second outlet opening. The first outlet flow has a higher density or solids percentage than the second outlet flow.

[0186] In another independent aspect of this disclosure, a modular system for separating biological components includes:

[0187] A carriage, comprising a base, sidewalls, and a top forming a housing with housing compartments;

[0188] An electric motor, which is at least partially located in a housing compartment;

[0189] A magnetic actuator comprising a drive rotor mechanically coupled to a motor, the drive rotor including an internal surface defining a cavity and at least one magnet mounted to the internal surface, the magnet generating a magnetic field; and

[0190] Centrifuge assembly, the centrifuge assembly comprising:

[0191] The stator includes a base, sidewalls and top forming a stator chamber, and the stator includes a fluid inlet port and at least two fluid outlet ports;

[0192] A separating rotor is rotatably coupled to the stator chamber and in fluid communication with the stator's inlet port and at least two outlet ports, forming a separating container;

[0193] A drive coupling comprising a first end mechanically coupled to and extending from a separating rotor and a second magnetic end magnetically coupled to a drive rotor, the second magnetic end being positioned near a magnetic field to generate an alignment force aligning the central axis of the separating rotor with the central axis of the drive rotor; and

[0194] The stator chamber forms a sterile and airtight seal around the separate rotor and drive coupling.

[0195] In another embodiment, at least a portion of the magnetic actuator and the drive coupling are arranged within the housing compartment.

[0196] In another embodiment, the stator further includes a groove forming a receiving shroud that extends from the bottom surface of the stator to receive and accommodate the drive coupling.

[0197] In another embodiment, the stator includes a mounting surface, and the housing includes a mounting clip that extends from a surface of the housing and engages the mounting surface to mechanically attach the stator to the housing.

[0198] In another embodiment, the mounting clip is positioned to apply a downward force to the mounting surface and the stator.

[0199] In another embodiment, the mounting surface is a flange, slot, cavity, or bend.

[0200] Another embodiment also includes a loading component, which includes:

[0201] An installation platform is coupled to a housing compartment and extends laterally across the housing compartment. The installation platform includes a recess and a movable mounting plate coupled to the installation platform and at least partially positioned within the recess.

[0202] The mounting clip extends from the surface of the mounting plate; and

[0203] A linear actuator includes an arm having a first end coupled to a movable mounting plate; wherein the linear actuator is configured to move the arm and the movable mounting plate to move a mounting clip into a locked position and an unlocked position.

[0204] Another embodiment also includes an inlet pump that is coupled to the housing compartment and in fluid communication with the fluid inlet port of the stator.

[0205] In another embodiment, the inlet pump is a centrifugal pump.

[0206] Another embodiment also includes at least one outlet pump, which is coupled to the housing compartment and in fluid communication with at least two fluid outlet ports.

[0207] In another embodiment, the outlet pump is a peristaltic pump.

[0208] In another embodiment, the centrifugal separator assembly is detachably attached to the housing via a magnetic field.

[0209] Another embodiment also includes a programmable power supply that communicates with the controller via wired or wireless communication. The controller includes a memory, a processor, and a non-transitory computer-readable medium containing instructions executed by the processor to control the programmable power supply to supply power to the motor.

[0210] Another embodiment also includes a programmable power supply that communicates with the controller via wired or wireless communication. The controller includes a memory, a processor, and a non-transitory computer-readable medium containing instructions executed by the processor to control the programmable power supply to supply power to the inlet and outlet pumps.

[0211] In another independent aspect of this disclosure, a method for separating biological components includes:

[0212] The culture containing culture medium and cells or microorganisms is pumped from the bioprocess reservoir to the centrifuge via the inlet pump and inlet line.

[0213] The centrifugal separator includes: a stator having an inlet port, a light outlet port, and a heavy outlet port; and a separating rotor rotatably connected to the stator and in fluid communication with the inlet port, the light outlet port, and the heavy outlet port.

[0214] The inlet pump is located downstream of the bioprocess reservoir and upstream of the centrifuge, and is in fluid communication with both the bioprocess reservoir and the centrifuge.

[0215] The gas is discharged from the inlet line, inlet pump, and centrifuge using a culture medium;

[0216] The turbidity downstream of the centrifuge was measured using a turbidity sensor; and

[0217] The separation rotor is rotated and a rotational force is applied to the culture based on the turbidity downstream of the centrifuge.

[0218] Another implementation also includes using a pressure sensor to measure the pressure downstream of the centrifugal separator and providing a first electrical input to the inlet pump based on the pressure downstream of the centrifugal separator.

[0219] Another implementation plan also includes:

[0220] The first electrical input is provided to the light outlet pump, which is in fluid communication with the light outlet port, based on the turbidity downstream of the centrifugal separator; and

[0221] A second power input is provided to the heavy outlet pump, which is in fluid communication with the heavy outlet port, based on the turbidity downstream of the centrifugal separator.

[0222] Another implementation plan also includes:

[0223] A second electrical input is provided to the light outlet pump, which is in fluid communication with the light outlet port, based on the turbidity and pressure downstream of the centrifugal separator; and

[0224] A third electrical input is provided to the heavy outlet pump, which is in fluid communication with the heavy outlet port, based on the turbidity and pressure downstream of the centrifugal separator.

[0225] Another implementation also includes detachably mounting the centrifugal separator onto a carriage that houses the inlet pump.

[0226] In another embodiment, detachably mounting the centrifuge includes moving the centrifuge to the vicinity of a magnetic field at the surface of the carriage, the magnetic field providing a magnetic force to attach the centrifuge to the carriage.

[0227] Another implementation includes using an inlet pressure sensor to measure the inlet pressure at the inlet of the centrifuge, and stopping the operation of the centrifuge when the inlet pressure reaches a predetermined shut-off inlet pressure.

[0228] In another embodiment, the inlet pump is a centrifugal pump.

[0229] In another independent aspect of this disclosure, the controller includes a memory, a processor, and a non-transitory computer-readable medium containing instructions executable by the processor to perform the following operations:

[0230] The culture containing culture medium and cells or microorganisms is pumped from the bioprocess reservoir to the centrifuge via the inlet pump and inlet line.

[0231] The centrifugal separator includes: a stator having an inlet port, a light outlet port, and a heavy outlet port; and a separating rotor rotatably connected to the stator and in fluid communication with the inlet port, the light outlet port, and the heavy outlet port.

[0232] The inlet pump is located downstream of the bioprocess reservoir and upstream of the centrifuge, and is in fluid communication with both the bioprocess reservoir and the centrifuge.

[0233] The gas is discharged from the inlet line, inlet pump, and centrifuge using a culture medium;

[0234] The turbidity downstream of the centrifuge was measured using a turbidity sensor; and

[0235] The separation rotor is rotated and a rotational force is applied to the culture based on the turbidity downstream of the centrifuge.

[0236] It should be understood that each of the independent aspects described herein may include any features, options, and possibilities described in relation to the other independent aspects described herein or as described elsewhere in this document. Attached Figure Description

[0237] Various embodiments of this disclosure will now be discussed with reference to the accompanying drawings. It should be understood that these drawings depict only typical embodiments of this disclosure and should therefore not be considered as limiting its scope.

[0238] Figure 1 This is a schematic diagram of a system combining a reactor and a continuous flow centrifugal separator;

[0239] Figure 2 For can Figure 1 Front elevation view of the manifold components used in the system;

[0240] Figure 3 For those with modified flow control components Figure 1 The diagram shown is a schematic of the system.

[0241] Figure 4 for Figure 1 A cross-sectional view of one embodiment of the centrifugal separator shown;

[0242] Figure 5 for Figure 1 A schematic diagram of the modified version of the system is shown;

[0243] Figure 6 For can Figure 1 , Figure 3 and Figure 5 Top perspective view of the centrifugal separator used in the system;

[0244] Figure 7 for Figure 6 The image shows a bottom perspective view of the centrifuge.

[0245] Figure 8 for Figure 6 A partial exploded view of the centrifuge shown;

[0246] Figure 9 for Figure 6 The image shows a front sectional view of the centrifuge.

[0247] Figure 10 for Figure 9 The diagram shows a front view of the centrifugal separator's separation stator separated from the rotor assembly.

[0248] Figure 11 for Figure 10 An exploded perspective view of the separated rotor shown;

[0249] Figure 12 for Figure 11 The bottom perspective view of the cap of the separated rotor shown;

[0250] Figure 13for Figure 9 An enlarged cross-sectional view of the first end of the centrifuge shown;

[0251] Figure 14 for Figure 13 A partial exploded view of the first end of the centrifuge shown;

[0252] Figure 15 for Figure 14 An exploded view of the rod assembly shown;

[0253] Figure 16 for Figure 14 A perspective view of the assembled parts shown;

[0254] Figure 17 for Figure 11 Bottom perspective view of the insert shown;

[0255] Figure 18 for Figure 6 The image shows a front sectional view of the centrifuge.

[0256] Figure 19 For the section taken along line 19-19 Figure 18 A cross-sectional view of the separated rotor shown;

[0257] Figure 20 A front sectional view of an alternative embodiment of the centrifugal separator;

[0258] Figure 21 for Figure 20 Top perspective view of the dispersed components shown;

[0259] Figure 22 Top perspective view of an alternative embodiment of the centrifugal separator;

[0260] Figure 23 for Figure 22 The image shows a bottom perspective view of the centrifuge.

[0261] Figure 24 for Figure 22 The cross-sectional view of the centrifuge shown is shown.

[0262] Figure 25 for Figure 22 A partial exploded view of the centrifuge shown;

[0263] Figure 26 for Figure 25 An exploded view of the separated rotor shown;

[0264] Figure 27 for Figure 26 An internal perspective view of the base of the split rotor shown;

[0265] Figure 28 for Figure 27 A perspective view of the base shown;

[0266] Figure 29 for Figure 26 Top perspective view of the dispersed components shown;

[0267] Figure 30 for Figure 29 Bottom perspective view of the dispersed components shown;

[0268] Figure 31 for Figure 26 Top perspective view of the disk shown;

[0269] Figure 32 for Figure 31 The bottom perspective view of the disk shown;

[0270] Figure 33 for Figure 26 The bottom perspective view of the hat shown;

[0271] Figure 34 for Figure 22 An enlarged cross-sectional side view of the peripheral edge of the separated rotor shown;

[0272] Figure 35 for Figure 26 The top perspective view of the insert shown;

[0273] Figure 36 for Figure 35 Bottom perspective view of the insert shown;

[0274] Figure 37 for Figure 22 An enlarged sectional view of the upper end of the centrifuge shown;

[0275] Figure 38 for Figure 22 Another cross-sectional view of the centrifuge shown;

[0276] Figure 39 for Figure 22 The image shows a cross-sectional view of the centrifuge.

[0277] Figure 40 An enlarged cross-sectional side view of the peripheral edge of the alternatively separated rotor;

[0278] Figure 41 An enlarged cross-sectional side view of the peripheral edge of another alternatively selected separate rotor;

[0279] Figure 42 To and Figure 22 Front perspective view of the carriage used with the centrifugal separator;

[0280] Figure 43 for Figure 42 Rear perspective view of the carriage shown;

[0281] Figure 44 for Figure 42 The elevation side view of the carriage shown;

[0282] Figure 45 for Figure 42 The rear elevation view of the carriage shown;

[0283] Figure 46 The door was removed Figure 42 The front perspective view of the carriage shown;

[0284] Figure 47 For centrifuges that have been removed Figure 46 The front perspective view of the carriage shown;

[0285] Figure 48 for Figure 45 The sectional view of the carriage shown;

[0286] Figure 49 For those in a lower position Figure 42 Front perspective view of the loading assembly of the carriage shown;

[0287] Figure 50 For those in an elevated position Figure 49 The front perspective view of the loading components shown;

[0288] Figure 51 for Figure 49 Rear perspective view of the loading components shown;

[0289] Figure 52 for Figure 49 A cross-sectional view of the loading assembly shown;

[0290] Figure 53 For connection to centrifuges Figure 49 An enlarged cross-sectional view of the loading components;

[0291] Figure 54 A schematic diagram of an exemplary centrifuge carriage integrated into an exemplary bioproduction process;

[0292] Figures 55A to 55C A process flow diagram illustrating an exemplary process for operating an exemplary centrifugal separator carriage is shown.

[0293] Figure 56 A process flow diagram illustrating an exemplary process for operating an exemplary centrifugal separator carriage is shown.

[0294] Figure 57Bar graphs showing process performance parameters generated from an exemplary separation process operating using an exemplary centrifuge mounted on a carriage; and

[0295] Figure 58 An exemplary pressure-volume deep filtration curve is shown. Detailed Implementation

[0296] Before describing the invention in detail, it should be understood that the invention is not limited to the specifically illustrated apparatus, systems, methods, or process parameters, which may, of course, be modified. It should also be understood that the terminology used herein is for the purpose of describing specific embodiments of the disclosure only and is not intended to limit the scope of the disclosure in any way.

[0297] All publications, patents and patent applications cited in this article, whether above or below, are hereby incorporated in their entirety by reference as if each individual publication, patent or patent application were explicitly and individually identified as incorporated by reference.

[0298] The term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional unlisted elements or method steps.

[0299] It should be noted that in this specification and the appended claims, unless expressly specified otherwise, the singular forms “a,” “an,” and “the” include plural references. Therefore, for example, a reference to “separator” includes one, two, or more separators.

[0300] As used in the specification and appended claims, directional terms such as “top,” “bottom,” “left,” “right,” “upper,” “lower,” “upper,” “lower,” “near,” “farer,” etc., are used only to indicate relative directions and are not intended to otherwise limit the scope of this disclosure or the claims.

[0301] Where possible, similar reference numerals are used in all the figures. Furthermore, multiple instances of an element and / or a sub-element of a parent element may each include a separate letter appended to the element number. For example, two instances of a specific element "10" or two alternative embodiments of a specific element may be designated as "10A" and "10B". In such cases, the element designation without the appended letter (e.g., "10") may be used to generally refer to the element or an instance of any of these elements. The element designation including the appended letter (e.g., "10A") may be used to refer to a specific instance of the element or to distinguish or emphasize multiple uses of the element. Furthermore, the element designation with the appended letter may be used to refer to alternative designs, structures, functions, embodiments, and / or implementations of elements or features without the appended letter. Similarly, the element designation with the appended letter may be used to represent a sub-element of a parent element. For example, element "12" may include sub-elements "12A" and "12B".

[0302] Various aspects of the apparatus and system of the present invention can be described by describing components that are joined, attached, and / or engaged together. As used herein, the terms “joint,” “attach,” and / or “engage” are used to indicate a direct connection between two components, or, where appropriate, an indirect connection to each other via an intermediary or intermediate component. In contrast, when a component is referred to as “directly joined,” “directly attached,” and / or “directly engaged” to another component, no intermediary element is present. Furthermore, as used herein, the terms “connection” and the like do not necessarily imply direct contact between two or more components.

[0303] Various aspects of the apparatus, system, and method of the present invention may be illustrated with reference to one or more exemplary embodiments. As used herein, the term "implementation" means "serving as an example or instance" and should not necessarily be construed as preferred or advantageous compared to other embodiments disclosed herein.

[0304] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. While various methods and materials similar to or equivalent to those described herein may be used in practice with respect to this disclosure, preferred materials and methods are described herein.

[0305] Generally, this disclosure relates to centrifuge systems for separating biological components in the bioproduction industry. More specifically, this disclosure relates to centrifuges for separating biological components, such as biofluids, solids, mixtures, solutions, and suspensions, which include, for example, culture media, cells, blood, plasma, organelles, proteins, nucleic acids, lipids, plasmids, viral vectors, and / or carbohydrates dissolved or dispersed in biological mixtures, solutions, and suspensions. The centrifuge can be a manually operated, portable, single-use, continuous-flow, and / or closed system centrifuge for separating biological components. This disclosure also relates to methods, systems, and modular carriages that can be incorporated into such centrifuges.

[0306] Although the apparatus and methods disclosed herein are primarily designed for use with bioprocesses, they can also be used with non-biological processes where the separation of solids and liquids using centrifuges is desired. Such applications can be found in the production of chemicals, pharmaceuticals, food products, and other products. Therefore, the discussion and examples described herein regarding the separation of biological components and the harvesting of the separated biological components also apply to and should be considered as disclosures regarding the separation of non-biological components and the harvesting of their separated components.

[0307] Exemplary centrifuge systems / carriers provide an airtight and sterile environment for continuous flow separation and mixed-phase separation of biological components in liquids, solids, and gases. The embodiments disclosed herein can be modular, sterile, portable, and continuous-flow centrifuge systems, including centrifuge carriages, which improve process efficiency, product purification, and yield.

[0308] Exemplary centrifuge systems / carriers can also be portable and easily transported to bioproduction facilities and integrated into bioproduction processes (typically downstream) for the purification of bioproducts. To address a diverse range of bioproduction processes, equipment, and control requirements, exemplary centrifuge systems / carriers can combine installation arrangements with single-use, disposable, and modular separators, along with other easily installable and removable components, to increase the versatility, efficiency, and throughput of continuous flow centrifugation. For example, in one embodiment, exemplary installation arrangements may include controller mounts, pump mounts, sensor ports, valve ports, terminals and manifolds, through-plate connectors, motor mounts, pipe sockets, and cable management systems. These mounts facilitate portability, universal compatibility, and easy installation on a wide range of bioproduction process equipment, piping, cables, controllers, motors, pumps, sensors, and valves.

[0309] Additionally, the exemplary centrifuge system / carriage may be equipped with a loading assembly that can magnetically, mechanically, and / or releasably load, mount, center, and lock the centrifuge to the carriage. Preferably, the centrifuge is a single-use, disposable component that can be easily and quickly removed, discarded, and replaced with a sterile separator to increase efficiency in continuous flow processes.

[0310] Figure 1 The description depicts an exemplary embodiment of a system incorporating features of this disclosure and used for separating biological suspensions or other mixtures and harvesting one or more components thereof. More specifically, Figure 1 A bioproduction reservoir 10 is depicted in fluid connection with a continuous flow centrifuge 12. The bioproduction reservoir 10 is configured for growing biological suspensions and may include one or more bioreactors, fermenters, storage tanks, fluid management systems, cell culture equipment, or any other equipment designed for growing or producing cells and / or other biological products. An example of such other equipment may include the Cell Factory multiplate growth chamber manufactured by Thermo Fisher Scientific. It should also be understood that the bioproduction reservoir 10 may include any conventional type of bioreactor, fermenter, or cell culture equipment, such as stirred tank reactors, rocker arm reactors, paddle mixer reactors, etc.

[0311] In the depicted exemplary embodiment, the bioproduction reservoir 10 includes a container 14 defining a chamber 16. The container 14 is supported by a rigid support shell 15. A liquid suspension 18 is disposed within the chamber 16. The suspension 18 typically comprises a biological suspension including cells or microorganisms and a growth medium in which the cells or microorganisms are suspended and grown. As an example and without limitation, the suspension 18 may include one or more biological components, including bacteria, fungi, algae, plant cells, animal cells, protozoa, nematodes, plasmids, viral vectors, etc. Examples of some common bioproducts grown include *Escherichia coli*, yeast, *Bacillus*, and CHO cells. The suspension 18 may also include cell therapy cultures and may include aerobic or anaerobic and adhesive or non-adhesive cells and microorganisms. Various culture medium compositions known in the art can be used to adapt the growth of specific cells or microorganisms and the desired end product. In some applications, the bioproduction reservoir 10 is used primarily for cell growth and cell recovery for subsequent use (e.g., preparing vaccine material from the cells themselves). However, in many applications, the ultimate purpose of growing cells in the bioproduction reservoir 10 is to produce and later recover biological products (such as recombinant proteins) from the cells exported to the growth medium. The bioproduction reservoir 10 is also typically used to grow cells in a masterbatch to prepare aliquots of cells for use as inoculum for subsequent growth of multiple batches of cells as recovered biological products.

[0312] In one exemplary embodiment, container 14 comprises a flexible, collapseable bag. For example, container 14 may contain one or more flexible, waterproof polymer membrane (such as low-density polyethylene) sheets. The thickness of the polymer membrane may be at least or less than 0.02 mm, 0.05 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, or within any two of the aforementioned thicknesses. Other thicknesses may also be used. The membrane is sufficiently flexible to be rolled into a tube without plastic deformation and can be folded at angles of at least 90°, 180°, 270°, or 360° without plastic deformation.

[0313] The membrane may comprise a single layer of material or may comprise two or more layers, which are sealed together or separated to form a double-walled container. When the layers are sealed together, the material may comprise a laminated or extruded material. A laminated material comprises two or more separately formed layers that are subsequently bonded together by an adhesive. One example of an extruded material that can be used in this disclosure is the Thermo Scientific CX3-9 membrane, available from Thermo Fisher Scientific. The Thermo Scientific CX3-9 membrane is a three-layer, 9-mil cast film manufactured in a cGMP facility. The outer layer is a polyester elastomer co-extruded with an ultra-low density polyethylene product contact layer. Another example of an extruded material that can be used in this disclosure is the Thermo Scientific CX5-14 cast film, also available from Thermo Fisher Scientific. The Thermo Scientific CX5-14 cast film comprises a polyester elastomer outer layer, an ultra-low density polyethylene contact layer, and an EVOH barrier layer disposed between them.

[0314] The material may be approved for use in direct contact with living cells and to maintain the sterility of the solution. In such embodiments, the material may also be sterilized, for example, by ionizing radiation. Examples of materials that can be used in various situations are disclosed in U.S. Patent No. 6,083,587, published July 4, 2000, and U.S. Patent Publication No. US 2003-0077466 A1, published April 24, 2003, both of which are incorporated herein by reference in their specific instances.

[0315] In one embodiment, container 14 comprises a two-dimensional pillow-like bag in which two material sheets are placed in an overlapping relationship and the two sheets are defined together at their periphery to form a chamber 16. Alternatively, a single material sheet may be folded and sewn around its periphery to form an internal compartment. In another embodiment, container 14 may be formed from a continuous tubular extrusion of polymer material cut to length and sewn closed at the ends. In still some embodiments, container 14 may comprise a three-dimensional bag having not only annular sidewalls but also two-dimensional top walls and two-dimensional bottom walls.

[0316] It should be understood that container 14 can be manufactured to have virtually any desired size, shape, and configuration. For example, container 14 can be formed to have a chamber 16 with a size set to 0.5 liters, 1 liter, 5 liters, 10 liters, 30 liters, 50 liters, 100 liters, 250 liters, 500 liters, 750 liters, 1,000 liters, 1,500 liters, 3,000 liters, 5,000 liters, 10,000 liters, or other desired volumes. The size of chamber 16 can also be within the range of any two of the aforementioned volumes. In other embodiments, chamber 16 can have larger or smaller volumes. Although container 14 is described as a flexible, collapsible bag in the embodiments discussed above, in alternative embodiments, it should be understood that container 14 can comprise any form of collapsible container or semi-rigid container. In some embodiments, container 14 can comprise a rigid container, such as one containing metal, molded plastic, or a composite. In this embodiment, because container 14 is self-supporting, the support shell 15 can be eliminated.

[0317] As needed, sensor 20 and probe 22 can be coupled to container 14 for detecting the properties of suspension 18. By way of example and without limitation, sensor 20 and probe 22 may include temperature probes, pH probes, CO2 sensors, oxygen sensors, pressure sensors, etc. If desired, bubbler 24 can be coupled to container 14 for delivering gas to suspension 18 within chamber 16.

[0318] In one exemplary embodiment of this disclosure, an apparatus is provided for mixing a suspension 18 within a container 14. In the depicted embodiment, a movable mixing element 26 is disposed within a chamber 16 and is used to mix the suspension 18. In one exemplary embodiment, the mixing element 26 may include an impeller coupled to a drive shaft 28. The drive shaft 28 is coupled to the container 14 via a dynamic seal 30. A motor may be coupled to the drive shaft 28 for rotating the mixing element 26 to facilitate mixing of the suspension 18.

[0319] In another embodiment, the drive shaft 28 may protrude into the container 14 through a flexible tube having one end rotatably connected to the container 14 and an opposing second end connected to the mixing element 26. The drive shaft 28 passes through the flexible tube and is removably coupled to the mixing element 26 such that the drive shaft 28 can rotate the mixing element 26 without direct contact with the suspension 18. Examples of such mixing systems are disclosed in U.S. Patent No. 7,384,783, published June 10, 2008, and U.S. Patent No. 7,682,067, published March 23, 2010, both of which are incorporated herein by specific reference. In another alternative embodiment, the drive shaft 28 may be configured to repeatedly raise and lower the mixing element 26 located within the container 14 for mixing the suspension 18. Alternatively, the mixing element 26 may comprise a magnetic stirring rod or impeller disposed within a chamber 16 of the container 14 and rotated by a magnetic mixer disposed outside the container 14. In other embodiments, the mixing element 26 may include a stirring rod, paddle, etc., protruding into a chamber 16 of container 14 and pivotable, rotatable, agitable, or otherwise movable to mix the suspension 18. Alternatively, mixing may be achieved by circulating fluid through chamber 16, such as by using a peristaltic pump to move fluid in and out of chamber 16 through a tube having a seal to opposite ends of container 14. Air bubbles may also be passed through the suspension 18 to achieve desired mixing. Finally, the support housing 15 and container 14 may pivot, rock, rotate, or otherwise move to mix the suspension 18 within container 14. Other conventional mixing techniques may also be used. Specific examples of how a mixer can be incorporated into a flexible bag (such as container 14) are disclosed in U.S. Patent No. 7,384,783, published June 10, 2008; U.S. Patent No. 7,682,067, published March 23, 2010; and U.S. Patent Publication No. 2006 / 0196501, published September 7, 2006, all of which are incorporated herein by reference.

[0320] Multiple ports 34 are connected to container 14 for delivering material into or removing material from chamber 16. Port 35 is located at the lower end of container 14 and is fluidly connected to centrifuge 12. It should be noted that reactor 10 is not necessarily drawn to scale with respect to centrifuge 12. The fluid capacity of chamber 16 of reactor 10 will typically be at least 3, 5, 10, 20, 50, 100, 200, or more times the fluid capacity of centrifuge 12.

[0321] exist Figure 1In the depicted system, container 14 is fluidly connected to centrifuge 12 via a fluid line 36 extending from port 35 to inlet port 38 of centrifuge 12. Fluid line 36 and other fluid lines discussed herein typically comprise flexible polymer tubing that can be coiled without plastic deformation. However, in other embodiments, the fluid line may comprise other flexible or rigid conduits. Centrifuge 12 also has a first outlet port 40 and a second outlet port 42. Fluid line 44 has a first end 46 connected to the first outlet port 40 of centrifuge 12 and an opposing second end 48 fluidly connected to chamber 16 of container 14, such as via port 50 mounted on container 14. Similarly, fluid line 52 has a first end 54 connected to the second outlet port 42 of centrifuge 12 and an opposing second end 56 fluidly connected to collection container 58. Collection container 58 typically comprises a collapsible bag made of one or more polymer films. Collection container 58 may be made of the same material and using the same methods as container 14 described above and have the same properties as container 14 described above. For example, collection container 58 may include a two-dimensional pillow-shaped bag or a larger three-dimensional bag. The volume of collection container 58 may be the same as, smaller than, or larger than that of container 14. For example, the volume of collection container 58 may be less than 0.7 times, 0.5 times, or 0.2 times the volume of container 14, or greater than 1.2 times, 1.5 times, 2 times, or 3 times the volume of container 14. When collection container 58 is a flexible bag, it may be supported within a rigid support housing. In other embodiments, collection container 58 may include a rigid or semi-rigid container.

[0322] In an alternative implementation, it can be used as follows Figure 2 The depicted manifold system 62 replaces a single collection container 58. Generally, the manifold system 62 includes a manifold 64 fluidly connected to a plurality of collection containers 58A, 58B, 58C, and 58D. In one embodiment, the manifold 64 includes multiple separate sections of a fluid line 66 (such as a flexible conduit) connected together by fittings 68 (such as Y-connectors) such that fluid flowing from the fluid line 52 can be delivered along a sterile path to each of the collection containers 58A-58D.

[0323] Each collection container 58A-58D may include a flexible, collapsible bag 70 defining a compartment 72. Each collection container 58A-58D also includes a first port 74A and a second port 74B coupled to the bag 70 and communicating with the compartment 72. Although two ports 74A and 74B are shown, other numbers of ports, such as one, three, four, or more, may be used. The size of the bag 70 is typically set such that, when fully inflated, the volume of the compartment 72 is at least or less than 0.5 liters, 1 liter, 1.5 liters, 2 liters, 2.5 liters, 3 liters, 5 liters, 10 liters, or within the range of any two of the aforementioned volumes. Other volumes may also be used.

[0324] Fluid lines 66 include inlet lines 80A-80D that are fluidly connected to port 74A on bag 70. Clamps 82A-82D are respectively mounted on inlet lines 80A-80D. Clamps 82A-82D can be manually adjusted to regulate the flow rate of fluid through inlet lines 80A-80D, and inlet lines 80A-80D can be sealed to prevent fluid from flowing through them. Additionally, outlet lines 84A-84D are connected to port 74B on bag 70. Each outlet line 84 has a terminal that can be sealed, for example by welding or crimping, or by means of a fitting (such as a sterile connector) mounted thereon, which can be selectively connected to another fluid line.

[0325] During use, once bag 70 has been filled with the desired amount of fluid, a portion of the inlet line 80 upstream of clamp 82 is sealed off and then cut, thereby separating each bag 70 from manifold 64. Collection containers 58A-58D are connected to manifold 64 in parallel, rather than in series. Therefore, the transfer of fluid from container 14 can be controlled to select collection containers 58A-58D by selectively opening and closing clamp 82. For example, all clamps 82 can be opened simultaneously to allow all collection containers 58A-58D to fill at the same time. Alternatively, collection containers 58A-58D can be filled sequentially by successively closing all clamps 82 and then opening clamp 82. It should be understood that clamps 82, valves, or other flow control devices may also be positioned at other locations on manifold 64 to control the flow rate of fluid through it.

[0326] In the depicted embodiment, manifold 64 is fluidly connected to four collection containers 58A-58D. In an alternative embodiment, manifold 64 may be fluidly connected to or fluidly coupled to at least two, three, five, six, eight, twelve, sixteen, or any other number of collection containers 58. In yet another alternative embodiment, collection containers 58A-D may be fluidly connected to manifold 64 in series, rather than in parallel.

[0327] exist Figure 1 In another alternative to the described implementation, the collection container 58 can be eliminated, and the fluid line 52 can be directly connected to downstream process equipment, such as a filtration system, for example a depth or sterile filter.

[0328] return Figure 1 The first pump 100A is connected to fluid line 44, while the second pump 100B is connected to fluid line 52. As discussed in more detail below, pump 100 is used to control the flow rate of suspension 18 through centrifugal separator 12. In one embodiment, pump 100 may include a peristaltic pump that pumps fluid through fluid lines 44 and 52 but does not directly contact the fluid. Therefore, pump 100 can be reused without cleaning. However, other types of pumps, such as positive displacement pumps, may also be used.

[0329] In one exemplary embodiment, controller 98 can be used to automatically and individually control the operation of pumps 100A and 100B to selectively and individually control and adjust the flow rate of fluid within fluid lines 44 and 52. Controller 98 may include a programmable processor and non-transitory memory. Figure 3 In an alternative embodiment shown, the flow rate of fluid through centrifugal separator 12 can be controlled by a single pump 100C connected to fluid line 36 and a control valve 96A connected to fluid line 44 and / or a control valve 96B connected to fluid line 52. Pump 100C and control valves 96A and 96B can also be controlled by controller 98. In another alternative, container 14 can be pressurized or raised to allow flow of suspension 18 into centrifugal separator 12, while control valves 96 on one or both fluid lines 44 and 52 can be used to control the flow rate through fluid lines 44 and 52. In yet another alternative, pumps 100A and 100B can be as follows: Figure 1 The fluid is retained as described above, while pump 100C is added to fluid line 36. Fluid flow is then controlled by three pumps regulated by controller 98.

[0330] like Figure 1 and Figure 3 As shown, the controller 98 can control the operation of the pump 100 and / or valve 98 based on inputs from sensors 94 mounted to fluid lines 44 and / or 52, or by otherwise sensing the characteristics of the outlet flow through the fluid lines. Depending on the intended operation method, the sensors 94 may include pressure sensors, flow rate sensors, turbidity sensors, capacitance sensors, conductivity sensors, online spectral sensors, etc.

[0331] In one operating method, the centrifuge 12 functions to continuously separate a suspension 18 received from a container 14 into a first outlet stream and a second outlet stream, wherein the first outlet stream has a higher concentration of cells or microorganisms than the second outlet stream, and therefore has a greater density or a higher percentage of solids. More specifically, in such... Figure 1 During a single use, as shown, pump 100 can be operated such that the inlet flow of suspension 18, indicated by arrow 102, flows from container 14 through fluid line 36 and into centrifuge 12 through inlet port 38. Centrifuge 12 then separates the inlet flow 102 into a first outlet flow, indicated by arrow 104, which exits centrifuge 12 through outlet port 40. Centrifuge 12 also separates the inlet flow 102 into a second outlet flow, indicated by arrow 106, which exits centrifuge 12 through outlet port 42 and is delivered to fluid line 52. As discussed above, the first outlet flow 104 has a higher concentration or volume of cells or microorganisms than the second outlet flow 106, i.e., a higher percentage of solids per unit volume.

[0332] Figure 4 The present invention depicts a simplified embodiment of a centrifuge 12 incorporating features of this disclosure. Generally, the centrifuge 12 includes a separation stator 114 defining a chamber 116. A separation rotor 118 is rotatably disposed within the chamber 116 of the separation stator 114. Devices (such as magnetic actuators) are provided for rotating the separation rotor 118 within the separation stator 114. Ports 38, 40, and 42 are mounted on the separation stator 114 for communication with the chamber 116. As the inlet flow 102 flows into the chamber 116 through inlet port 38, the rotation of the separation rotor 118 causes the suspension 18 to rotate within the chamber 116, subjecting the suspension 18 to centrifugal force. Due to the centrifugal force, the heavier components of the suspension 18 collect toward the inner surface of the separation stator 114 and exit as a first outlet flow 104 through outlet port 40. The lighter components of the suspension 18 collect toward the outer surface of the separation rotor 114 and exit as a second outlet flow 106 through outlet port 42.

[0333] It should be understood that in some embodiments, the second outlet stream 106 may not contain cells or microorganisms that have been separated from the first outlet stream 104. However, typically, some cells or microorganisms remain in the second outlet stream 106 when the suspension 18 is passed through a single centrifuge. The remaining cells or microorganisms can then be removed from the second outlet stream 106 by passing the second outlet stream 106 through one or more additional centrifuges (discussed in more detail below) and / or by passing the second outlet stream 106 through other conventional filtration systems.

[0334] exist Figure 1 In the depicted embodiment, the first outlet stream 104 is pumped back into container 14 via fluid line 44 to help retain cells or microorganisms within container 14, while the second outlet stream 106 is harvested via collection container 58 for subsequent use. Therefore, Figure 1 The system described is a perfusion system in which cells or microorganisms are retained within container 14 for continued growth, while culture medium and byproducts from the cells or microorganisms are continuously harvested. To compensate for the loss of culture medium caused by harvesting, new culture medium is continuously or as needed added to container 14 through port 34.

[0335] Turning Figure 5 Instead of returning the first outlet flow 104 to container 14, the first outlet flow 104 can be harvested by collecting it within collection container 110. Collection container 110 typically comprises a collapsible bag made of one or more polymer films. Collection container 110 can be made of the same material and using the same methods as collection container 58 described above, and has the same properties, size, and alternatives as collection container 58. For example, collection container 110 may comprise a two-dimensional pillow-like bag or a larger three-dimensional bag. In the case where collection container 110 is a flexible bag, collection container 110 can be supported in a rigid support housing. In other embodiments, collection container 110 may comprise a rigid or semi-rigid container.

[0336] In an alternative implementation, the method described above is applicable. Figure 2 The manifold system 62 under discussion replaces the single collection container 110. Therefore, the first effluent 104 can be collected in separate collection containers 58A-58D. All the uses and alternatives of the manifold system 62 discussed above regarding the harvesting of the second effluent 106 also apply to the harvesting of the first effluent 104. Furthermore, in addition to the first effluent 104 being harvested instead of returned to container 14, Figure 5 The system in the text is related to the above. Figure 1 The system operates in the same way as the one discussed in the article.

[0337] exist Figure 5 In another alternative to the depicted system, container 14 does not need to form part of a reactor for growing the biopharmaceutical. Instead, container 14 may simply comprise a rigid or flexible container for storing only the previously prepared suspension 18.

[0338] exist Figure 6 and Figure 7 The diagram depicts a detailed exemplary embodiment of a continuous flow centrifugal separator 12A, which can be used as described above regarding... Figures 1 to 5The centrifuge 12 in the discussed system and alternatives. Generally, centrifuge 12A includes a main body assembly 130 and a drive sleeve 132, which is integrally formed with, releasably attached to, or otherwise interacts with the main body assembly 130. During operation, the magnetic actuator 148 ( Figure 8 The centrifuge is received within and rotates within the drive sleeve 132 to facilitate operation of the centrifuge 12A during use. As discussed in more detail below, the main assembly 130 / centrifuge 12A includes an inlet port 38, a first outlet port 40, and a second outlet port 42.

[0339] Go to Figure 8 The actuator sleeve 132 includes an outer surface 134 and an inner surface 136 surrounding an opening 138. The actuator sleeve 132 has a first end 140 through which the opening 138 extends, and in one embodiment, the first end is releasably engageable with a body assembly 130. For example, the first end 140 can be releasably engaged with the body assembly 130 by fasteners (such as screws or bolts), clamps, threaded connections, or torsion connections (such as bayonet connections). In other exemplary embodiments, the actuator sleeve may be integrally formed with the body assembly 130 and may be positioned only against or adjacent to the body assembly 130. For example, one purpose of the actuator sleeve 132 is to serve as a protective cover for the magnetic actuator 148. Therefore, the actuator sleeve 132 may be formed as part of the separator 12A interacting with the magnetic actuator 148, or may be formed as part of the magnetic actuator 148 interacting with the separator 12A. In other embodiments, the actuator sleeve 132 may be eliminated.

[0340] In one embodiment, the actuator sleeve 132 may include a tubular sleeve body 142 having a flange 144 projecting outwardly from a first end 140. The flange 140 can be used for engagement with the body assembly 130. In an exemplary embodiment, the sleeve body 142 may have a second end 141 opposite the first end 140, from which a flange 145 projecting outwardly. The flange 145 can be used to secure the separator 12A to a separation structure, such as a carriage or other frame supporting the magnetic actuator 148. In other embodiments, the actuator sleeve 132 need not be in the form of a tubular sleeve.

[0341] The magnet actuator 148 includes a drive rotor 150 aligned with the body assembly 130 as discussed below and rotatably disposed within an opening 138 of an actuator sleeve 132. The drive rotor 150 includes a sleeve 152 having an inner surface 154 extending between a first end 158 and an opposing second end 160, and an opposing outer surface 156. The inner surface 154 defines a cavity 162. For example, in one embodiment, the sleeve 152 is annular and surrounds the cavity 162. In other embodiments, the sleeve 152 does not need to completely surround the cavity 162. The first end 158 of the sleeve 152 terminates at an end face 164, which defines an opening 166 leading to the cavity 162. A magnet 168 is attached to the inner surface 154 of the sleeve 152. In the depicted embodiment, magnet 168 includes a plurality of magnet segments 170 spaced apart and secured to the inner surface 154 of sleeve 152 to surround cavity 162. In one embodiment, magnet 168 may include at least 2, 4, 6, 12, 18, 24, or 30 separate magnet segments 170, or may include a range of separate magnet segments between any two of the foregoing values. Magnetic segments 170 may be oriented perpendicular to the axis of rotation such that the magnetic poles of the magnetic segments are axially oriented. In this embodiment, the magnetic poles of each magnetic segment 170 are preferably alternately axially oriented.

[0342] In other embodiments, magnet 168 may include a magnetic ring fixed to an inner surface 154 to surround cavity 162. In this embodiment, the magnetic ring may be a dipole, quadrupole, hexapole, or octupole. In such a magnetic ring, the magnetic poles are preferably arranged radially. Magnetic coupling may include any magnetic pair that provides sufficient torque to overcome power losses and rotor and fluid acceleration requirements. For example, in one exemplary embodiment, the torque requirement ranges from 10 in-lb. f up to 70 in-lb f The magnet may include a material capable of carrying a permanent magnetic field on the rotor side and a permanent magnet or electromagnet on the motor side of the coupling. In one embodiment, the magnet may include neodymium.

[0343] Go to Figure 9 The magnet actuator 148 also includes a motor 169 coupled to the drive rotor 150 / sleeve 153 and selectively rotates them. For example, in one embodiment, the drive rotor 150 further includes a rod 172 projecting from a second end 160 of the sleeve 152 and coupled to the motor 169 for driving the rotation of the rotor 150. The motor 169 may be housed within or at least partially housed within the housing 134. As previously mentioned, the actuator sleeve 132 is optional and may partially serve as a protective cover for the drive rotor 150 and / or the motor 169.

[0344] Continue to refer to Figure 9 The separator 12A / main assembly 130 typically includes a separation stator 180 and a rotor assembly 182 rotatably disposed within the separation stator 180. The rotor assembly 182 includes a separation rotor 184 rotatably disposed within the separation stator 180 and a drive coupling 186 coupled to the separation rotor 184 and also rotatably disposed within the separation stator 180. A central axis 230 passes centrally through the separation stator 180 and the rotor assembly 182 and coincides with a rotation axis, also identified by reference numeral 230, about which the rotor assembly 182 rotates. Therefore, "central axis 230" and "rotation axis 230" are used synonymously herein.

[0345] like Figure 9 and Figure 10 As depicted, in one embodiment, the split stator 180 includes a base 190 and a head 192 joined together before use. The split stator 180 has an inner surface 202 and an opposing outer surface 203. The inner surface 202 defines a chamber 194 in which the rotor assembly 182 is at least partially received. The assembled split stator 180 has a first end 196 where the head 192 is disposed and an opposing second end 198 where the base 190 is disposed. A central axis 230 extends between the first end 196 and the second end 198. The split stator 180 includes an inlet port 38, a first outlet port 40, and a second outlet port 42, each located on the head 192 at the first end 196.

[0346] Continue to refer to Figure 9 The base 190 (or the second end 198 of the separate stator 180) includes a base plate 200 extending radially outward to an annular sidewall 204. The sidewall 204 stands upright from the base plate 200 and projects toward the first end 196. An annular mounting flange 205 projects outward from the sidewall 204. In one embodiment, the inner surface 202 of the sidewall 204 is cylindrical. In other embodiments, the inner surface 202 of the sidewall 204 may be outwardly inclined. A receiving portion 206 is centrally located on the base plate 200 and projects outward from its outer surface 203. The receiving portion 206 defines a recess 212 forming a portion of the chamber 194. In one embodiment, the receiving portion 206 includes a sidewall 208 projecting from the base plate 200 and terminating at an end wall 210. In one embodiment, the sidewall 208 and the recess 212 each have a cylindrical configuration. Figure 9 As depicted and discussed below, the receiving portion 206 is configured such that it can be received within the opening 166 of the drive rotor 150.

[0347] Reference Figure 10The base 190 (or the first end 198 of the separating stator 180) also includes a plurality of fins 226 that project outwardly from the outer surface of the base plate 200 and are equidistantly spaced around the receiving portion 206, aligned parallel to the central axis 230. The fins 226 extend longitudinally from the mounting flange 205 to or toward the receiving portion 206. In one embodiment, the centrifuge 12A is designed to be discarded after a single use. For this purpose, the separating stator 180, and more specifically, the base 190 and head 192, are typically made of polymeric materials such as polyvinylidene fluoride or polyvinylidene(di)fluoride (PVDF), high-density polyethylene (HDPE), polyetherimide (PEI), polyetheretherketone (PEEK), etc., and are typically molded, for example, by injection molding or rotational molding. These materials and manufacturing methods make it possible to produce the separating stator 180 at a lower cost compared to cases where the separating stator 180 is made of metal. To some extent, when the split stator 180 is made of a lower-strength polymer material, the fins 226 serve to increase the strength and stability of the split stator 180. However, in an alternative embodiment, the split stator 180 may be made of a higher-strength metal (such as aluminum or stainless steel) or alternatively, a higher-strength polymer (such as liquid crystal polymer or polycarbonate). In this case, the fins 226 can be eliminated.

[0348] return Figure 9 The head 192 of the separate stator 180 includes a nose 214 disposed at a first end 196. The nose 214 has a sidewall 216 terminating at an end wall 218. The nose 214 defines a recess 213. In one embodiment, the inner surface 202 of the recess 213 defining the sidewall 216 may have a cylindrical configuration. An inlet port 38 projects outwardly from the end wall 218. A first outlet port 40 and a second outlet port 42 project outwardly from the sidewall of the nose 214. The head 192 also includes an annular mounting flange 228 and an annular transition wall 220 extending between the mounting flange 228 and the sidewall 216 of the nose 214. In one embodiment, at least a portion of the transition wall 220 has a truncated conical configuration, wherein its inner surface 202 is generally set at an angle of at least or less than 30°, 40°, 50°, or 60° relative to the central axis 230, or within a range of any two of the aforementioned angles. In the depicted embodiment, a portion of the transition wall 220 extending from the mounting flange 228 may be cylindrical or have a configuration different from the rest of the transition wall 220. Like the base 190, the head 192 is also shown with fins 229 formed. Figure 10The fins project outward from the transition wall 220 to extend between the mounting flange 228 and the nose 214. Fins 229 also extend parallel to each other along the central axis 230 and are equidistantly spaced around the transition wall 220. As discussed above, when the separate stator 180 is made of a plastic material, fins 229 increase structural strength and stability while minimizing material and cost. When the separate stator 180 is made of a higher-strength material, fins 229 can be eliminated.

[0349] During assembly, mounting flanges 205 and 228 are joined together such that rotor assembly 182 / separate rotor 184 is contained within separate stator 180. Mounting flanges 205 and 228 may be joined together by welding, clamps, fasteners (such as screws or bolts) or by using other fastening techniques.

[0350] The rotor assembly 182 is rotatably positioned within chamber 194 of the separation stator 180 and is used to direct the inlet flow 102 of the biological suspension. Figures 1 to 5 It is separated into a first outlet flow 104 and a second outlet flow 106. (Refer to...) Figure 10 As previously mentioned, rotor assembly 182 includes a separate rotor 184 and a drive coupling 186 extending therefrom. More specifically, the separate rotor 184 has a first end 240 and an opposing second end 242, with a central axis / rotation axis 230 extending centrally between the first and second ends. The drive coupling 186 is centrally mounted to and projectes outward from the second end 242 of the separate rotor 184, such that the central axis 230 passes centrally through the drive coupling. The drive coupling 186 typically has a surrounding side 244 terminating at an end face 246. In one embodiment, the drive coupling 186 has a cylindrical configuration, and as... Figure 9 As depicted, it is configured such that it can be rotatably received within the groove 212 of the receiving portion 206. A gap 248 is formed between the side surface 244 of the drive coupling 186 and the side wall 208 of the receiving portion 206, allowing the drive coupling 186 to rotate freely within the receiving portion 206.

[0351] In one embodiment, the gap 248 is less than 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, or within any two of the aforementioned values. Minimizing the size of the gap 248 is generally desirable to facilitate the magnetic rotation of the drive coupling 186. The drive coupling 186 comprises a material and is configured such that it can be controlled by a magnetic field generated by the magnet 168. For example, the drive coupling 186 may comprise another magnet or a material attracted to a magnet, such as iron or an iron composite. During operation, the drive coupling is positioned within a receiving portion 206, which is received within a cavity 162 of the drive rotor 150. The rotation of the drive rotor 150 by the motor 169 facilitates the simultaneous rotation of the drive coupling 186 due to the magnetic force generated by the magnet 168 on it. The rotation of the drive coupling 186, in turn, facilitates the simultaneous rotation of the attached separate rotor 184. In an alternative embodiment, it should be understood that the receiving portion 206, which typically serves as a protective cover, may be eliminated. In this case, the drive coupling 186 will be directly received within the cavity 162 of the drive rotor 150.

[0352] Turning Figure 11 The separating rotor 184 includes a base 250 to which a drive coupling 186 is attached, a dispersing member 252 located on the base 250, a cap 254 connected to the base 250, an insert 256 captured between the cap 254 and the base 250, and a rod assembly 258 disposed on the cap 254. The various elements of the separating rotor 184 will now be discussed in more detail.

[0353] like Figure 9 More preferably, the base 250 has an inner surface 260 that partially defines the compartment 261 and an opposing outer surface 262. The base 250 includes a base plate 264 and an annular sidewall 266 that projects upward from the outer periphery of the base plate 264 toward the cap 254. The sidewall 266 is referred to below as the lower sidewall 266. The mounting member 268 projects outward from the outer surface 262 of the base plate 264, aligned with the central axis 230. The drive coupling 186 is secured to the mounting member 268, such as by adhesives, press fits, fasteners, threaded connections, etc. An annular bearing assembly 270 (such as a race bearing) extends between the mounting member 268 and the base 190 of the separate stator 180. The bearing assembly 270 serves to center and stabilize the separate rotor 184 relative to the separate stator 180 and to allow the separate rotor 184 to rotate easily relative to the separate stator 180.

[0354] return Figure 11A plurality of spacers 272A-F protrude upward from the inner surface 260 of the base plate 264. The spacers 272 are evenly spaced and project radially outward in alignment with the central axis 230. Spacers 272A, 272C, and 272E also have elongated slots 273 formed along their length. As will be discussed in more detail below, the spacers 272 serve to space the dispersing member 252 from the inner surface 260 of the base plate 264 and to secure the dispersing member 252 to the base 250, such that the base 250 and the dispersing member 252 rotate simultaneously. The inner surface 260 of the lower sidewall 266 has an annular truncated conical configuration that slopes outward from the outer peripheral edge of the base plate 264 to an annular lip 274. In one embodiment, the lower sidewall 266 is sloped outward at an angle of at least or less than 10°, 15°, 20°, 25°, 30°, 35°, or within any two of the aforementioned angles, relative to the central axis 230. The annular slot 276 is recessed into the lip 275 and, as will be discussed in more detail below, is used to attach the cap 254 to the base 250.

[0355] As discussed herein, the dispersing member 252 can have a variety of different configurations. In the currently depicted embodiment, the dispersing member 252 includes a body 280 in the form of a circular plate having a top surface 282 and an opposing bottom surface 284, each extending to an outer peripheral edge 286. An opening 290 extends centrally through the body 280 aligned with a central axis 230 to pass between the opposing surfaces 282 and 284. Protruding from the bottom surface 284 of the body 280 are generally equidistant lower separators 288A, B, and C. The lower separators 288 are linear and project radially outward from the opening 290. The lower separators 288 are configured to be received within slots 273 of the spacers 272A, C, and E and terminate at a terminal 291 that protrudes beyond the peripheral edge 286. During assembly, the dispersing member 252 is placed on top of the spacer 272 of the base 250, such that the lower spacers 288A, B, and C are received within the slot 273, and the terminal 291 abuts against or is positioned directly adjacent to the inner surface 260 of the lower sidewall 266 of the base 250. This assembly centers the dispersing member 252 on the base plate 264 to ensure that the peripheral edges 286 are uniformly spaced from the lower sidewall 266, and also interlocks the dispersing member 252 with the base 250, such that rotation of the base 250 promotes simultaneous circumferential rotation of the dispersing member 252. Furthermore, as will be discussed in more detail below, the lower spacers 288 and spacers 272 serve to form an inlet fluid channel through which fluid flows radially outward from between the dispersing member 252 and the base plate 264 to aid in the separation of the biological suspension. It should be understood that various other structural designs can be used to fix and center the dispersive member 252 on the base plate 264 while forming an inlet fluid channel. However, the embodiment depicted here is uniquely configured to enable quick and easy positioning of the dispersive member 252 without the need for separate fasteners.

[0356] Similarly, Figure 11 As shown, the dispersing member 252 also includes retaining rails 292A-C, which are equidistantly spaced on the top surface 282 of the body 280 and project radially outward from the opening 290 to the peripheral edge 286. Each retaining rail 292 has a slot 294 extending along its length.

[0357] Reference Figure 9 , Figure 11 and Figure 12The cap 254 has an inner surface 300 extending between a first end 307 and an opposing second end 308, and an opposing outer surface 302. The cap 254 includes an annular sidewall 304 extending from an annular lip 306 formed at the second end 308 to an annular lip 310 disposed at the first end 307. The sidewall 304 is hereinafter referred to as the "upper sidewall 304". The upper sidewall 304 and its inner surface 300 have a frustoconical configuration that tapers inward from the annular lip 306 to the annular lip 310. In one embodiment, the sidewall 304 is configured such that its inner surface 300 is inclined at an angle between 35° and 55° relative to the central axis 230, and more commonly between 40° and 50° or between 42° and 48°. A plurality of spaced-apart guides 309 project radially inward from the inner surface 300 at the second end 308. Each guide 309 defines a slot 311, which is configured to engage with an insert 256 as discussed below.

[0358] like Figure 9 As best seen, the lip 306 may have a cylindrical configuration configured to fit within a slot 276 formed on the base 250 and have a configuration complementary to the slot. This configuration helps to promote a liquid-proof seal between the base 250 and the cap 254. Fastener 312 ( Figure 11 (Such as screws or bolts) extend from the outer surface 262 into the sidewall of the base 250 and through the lip 306 to facilitate a firm engagement. Figure 13 As best depicted in the image, the annular lip 310 at the first end 196 of the cap 254 has an annular first shoulder 314 recessed in the outer surface 302 and an annular second shoulder 315 recessed in the outer surface 302, wherein the shoulder 315 is spaced apart from the shoulder 314.

[0359] Reference Figure 14 and Figure 15 The rod assembly 258 is coupled to the lip 310 at the first end 307 of the cap 254. The rod assembly 258 includes a rod 358 and a sleeve 390 mounted thereon. Specifically, in the depicted embodiment, the rod 358 has a substantially cylindrical configuration and projects outward from the annular lip 310, such that a central axis 230 passes centrally through the rod. In the depicted embodiment, the rod 358 is integrally formed with the cap 254 as a single, integral component. However, in other embodiments, the rod 358 may be installed separately and secured to the cap 254. (See also...) Figure 13 and Figure 15The rod 358 includes a tubular opening 360 having an inner surface 362 and an outer surface 364 extending between a first end 366 and an opposing second end 368. The inner surface 362 defines a light collection channel 379 centrally passing through the opening 360. As discussed below, the second end 368 of the opening 360 is connected to the insert 256. The first end 366 of the opening 360 flares radially outward and terminates at an annular end face 370. The end face 370 is arranged around a central axis 230 and generally parallel to the central axis. Separating segments 372A-F project outward from the outer surface 364 of the opening 360 and are equidistantly spaced around the opening 360. The separating segments 372 are generally parallel to the central axis 230 and extend longitudinally between the annular end face 370 and the annular lip 310 of the cap 254.

[0360] Extending between the orifice 360 ​​and the annular lip 310 of the cap 254 are redistribution channels 382A-F separated by partitions 372. For example, redistribution channel 382A passes between the annular lip 310 of the cap 254 and the outer surface 364 of the orifice 360 ​​at the first end 366, and is also defined between partitions 372A and 372B. As redistribution channel 382A extends upward toward the first end 366, it communicates with an opening 384A formed on the outer side of the rod 358. Opening 384A is defined between partitions 372A and 372B, and is also defined between the annular lip 310 and the end face 370. Redistribution channels 382B-F are similarly constructed and communicate with corresponding openings 384B-F. In an alternative embodiment, it should be understood that other numbers of partitions 372 and redistribution channels 382 may be formed. For example, in one embodiment, the dividing section 372A may be eliminated, so that only a single collection channel 382 is formed, which is partially defined between the outer surface 364 of the port 360 and the sleeve 390.

[0361] In one embodiment, a plurality of struts 376A-F project inwardly from the inner surface 362 of the orifice 360 ​​and extend between a first end 366 and a second end 368. The struts 376A-F are equidistantly spaced around the orifice 360 ​​and generally extend linearly and parallel to the central axis 230. Each strut 376 terminates at an inner surface 378 spaced apart from the central axis 230. In one embodiment, the struts 376 may divide the light collection channel 379 into multiple separate light collection channels 379. In other embodiments, the struts 376 may be eliminated, such that only a single integral light collection channel 379 is formed.

[0362] Although rod 358 is shown as having six dividing sections 372, six openings 384, six heavy collection channels 382 and six struts 376, other numbers may be used in alternative embodiments, such as those discussed in more detail below, such as at least 2, 3, 4, 5, 6, 7, 8, 9 or 10 or any two of the foregoing numbers.

[0363] The sleeve 390 has an outer surface 394 extending between a first end 391 and an opposing second end 392, and an opposing inner surface 395. The inner surface 395 defines a channel 396 extending through it, which is configured to receive a rod 358. Specifically, the sleeve 390 is configured to receive the rod 358 such that the second end 392 of the sleeve 390 is located on a shoulder 315, flush with and across an annular lip 310 and an annular end face 370. The sleeve 390 spans an opening 384 of the rod 358, which is located between the annular lip 310 and the annular end face 370. A plurality of equidistant partial openings 398A-F extend through the sleeve 390 around its circumference and are configured such that each opening 398A-F is aligned with a corresponding opening 384A-F / recollection channel 382A-F. However, the opening 398 of the sleeve 390 is smaller than the opening 384 of the rod 358. Therefore, a portion of the sleeve 390 directly defines a portion of the heavy collection channel 382. Specifically, the sleeve 390 includes an annular heat dissipation section 388 that surrounds the nozzle 360 ​​and extends between the annular lip 310 and the opening 398 of the sleeve 390. The inner surface 395 of the heat dissipation section 388 directly defines a portion of the heavy collection channel 382. The sleeve 390 also includes an annular heat dissipation section 389, which is disposed on the side of the annular end face 370 of the nozzle 360 ​​opposite to the opening 398. That is, the annular heat dissipation section 389 protrudes beyond the nozzle 360 ​​and surrounds the central axis 230. The heat dissipation section 389 extends between the annular end face 370 and the end of the sleeve 390. The inner surface 395 of the heat dissipation section 389 directly surrounds and defines a portion of the light collection channel 379. The function of the heat dissipation sections 388 and 389 will be discussed below. Segment 400 of sleeve 390 is disposed between each pair of adjacent openings 398 and aligned with the corresponding separating segment 372, such as Figure 14 The description.

[0364] The rod 358, base 250, dispersing member 252, insert 256, and cap 254 are each typically made of a polymeric material (such as liquid crystal polymer, polycarbonate, PVDF, HDPE, PEI, PEEK, etc.). Different parts may be made of the same or different materials. As previously mentioned, manufacturing parts with polymeric materials minimizes the cost of the centrifuge, allowing it to be economically discarded after a single use, thus avoiding the need for subsequent sterilization or other cleaning. However, in an alternative embodiment, one or more parts may also be made of a metal (such as aluminum or stainless steel). For reasons discussed in more detail below, in one embodiment, the sleeve 390 is made of a material that is more thermally conductive than the material used to form the rod 358. For example, in one embodiment, the rod 358 is formed of a polymeric material, while the sleeve 390 is formed of a metal (such as aluminum, copper, brass, stainless steel, or alloys thereof) that is more thermally conductive than the polymer used to form the rod 358. In other embodiments, the sleeve 390 may be formed of a non-metal (such as a composite, polymer, or other material that is more thermally conductive than the material used to form the rod 358).

[0365] The rod assembly 258 and the cap 254 rotate simultaneously, thereby forming part of the separating rotor 184. The centrifugal separator 12A also includes elements disposed between the separating rotor 184 and the separating stator 180. For example, such as... Figure 13 , Figure 14 and Figure 16 As depicted, such elements include an annular bearing assembly 404, such as a race bearing or other bearing assembly, surrounding an annular lip 310 and located on a shoulder 314. Annular seals 406A and 406B (such as lip seals or other types of annular seals) surround a rod 358 above the bearing assembly 404. Seals 406 typically seal directly against the outer surface 394 of the sleeve 390 at a second end 392 below the opening 398. More specifically, one or both seals 406 are typically positioned directly against the outer surface 394 of the heat dissipation section 388.

[0366] An annular seal 408 (such as a lip seal or other type of annular seal) surrounds the rod 358 and seals directly against the outer surface 394 of the sleeve 390 at a first end 391 above the opening 398. More specifically, the seal 408 is typically disposed directly against the outer surface 394 of the heat dissipation section 389. A cylindrical ring 410 has an inner surface 412 and an opposing outer surface 414 and surrounds the sleeve 390 aligned with the opening 398. The ring 410 is disposed between the seal 408 and the seal 406A and has a channel 416 extending laterally through the ring between the inner surface 412 and the opposing outer surface 414.

[0367] As will be discussed further below, the centrifuge 12A also includes a tubular conduit 420 having an inner surface 412 and an outer surface 414 extending between a first end 426 and an opposing second end 428. The inner surface 422 defines a passage 430 extending therethrough. Surrounding the first end 426 of the conduit 420 is a dynamic seal 432. The dynamic seal 432 provides a liquid-proof seal with respect to the conduit 420 while allowing the conduit 420 to rotate relative to the seal 432.

[0368] Reference Figure 11 and Figure 17 The insert 256 includes an annular truncated conical sidewall 320, referred to herein as the inner sidewall 320. The inner sidewall 320 has an inner surface 322 and an opposing outer surface 324 that tapers inward from a second end 326 to an opposing first end 238. The second end 326 of the inner sidewall 320 terminates at a peripheral edge 330, while the first end 328 terminates at an annular lip 332. The lip 332 surrounds an opening 334 that centrally passes through the insert 256 along a central axis 230. In one embodiment, the inner surface 322 of the inner sidewall 320 may be set at the same angle as the inner surface 300 of the sidewall 304. For example, the inner surface 322 of the inner sidewall 320 may be inclined at an angle between 35° and 55° relative to the central axis 230, and more commonly between 40° and 50° or in the range of 42° and 48°. Other angles may also be used.

[0369] The insert 256 also includes three radially spaced upper dividers 336A-C that are equidistant from each other. The upper dividers 336A-C project away from the inner surface 322 and extend radially outward, aligned with the central axis 230, to and beyond the peripheral edge 330. More specifically, each divider 336 has a top edge extending along the inner surface 322 from the peripheral edge 330 to the opening 334, an inner edge 340 extending along the opening 334 parallel to the central axis 230, and projecting downward below the inner sidewall 320 and configured to be received in the slot 294 of the dispersing member 252. Figure 11 The bottom edge 342 of the upper partition 336 and the outer edge 344 of the inner surface 260 of the sidewall 266 of the base 250 are aligned to abut against the base 250. The upper partitions 336B and 336C have the same configuration and elements as the upper partition 336A, and thus the same elements between each upper partition in the upper partition 336 are identified by the same reference numerals.

[0370] Protruding outward from the outer surface 324 of the inner sidewall 320 are a plurality of radially spaced separators 350A-F. The separators 350 are in the form of linear guides, which extend radially outward from the annular lip 332 to the peripheral edge 330 and are equidistantly spaced.

[0371] During assembly, refer to Figure 9 and Figure 11 The dispersing member 252 is disposed on and interlocked with the spacer 272 of the base 250 by means of a lower spacer 288 received within the slot 276. In this configuration, the dispersing member 252 is fixed to the base 250 such that rotation of the base 250 about the central axis 230 promotes rotation of the dispersing member 252. However, the body 280 of the dispersing member 252 is spaced apart from the base plate 264 of the base 250, thereby forming a space 448 between them.

[0372] Insert 256 passes through the bottom edge 342 of the upper separator 336. Figure 17 The insert 256 is received within the slot 294 of the retaining guide 292 and is positioned on and interlocked with the dispersing member 252. Therefore, rotation of the base 250 also facilitates the current rotation of the insert 256. As discussed above, the cap 254, on which the rod assembly 258 is disposed, is secured to the base 250 by fixing the lip 306 of the cap 254 within the slot 276 of the base 250, as previously discussed. The slot 311 of the guide 309 ( Figure 12 The corresponding separator 350 receives the insert 256 to help ensure proper centering, alignment, and engagement between the cap 254 and the insert 256. As a result of assembly, the insert 256 and the separator 252 are enclosed between the base 250 and the cap 254. When the base 250 is secured to the cap 254, the lip 332 at the first end 328 of the insert 256 is secured to the second end 368 of the nozzle 360. Figure 13 For example, in the depicted embodiment, an annular slot 436 is formed at the second end 368 of the port 360, and a lip 332 can be securely received in the annular slot. In other embodiments, the second end 368 of the port 360 can be secured to the lip 332 of the insert 256 by adhesive, threaded engagement, press-fit connection, snap-fit ​​connection, or by using fasteners or other conventional mechanisms.

[0373] During further assembly, such as Figure 14 and Figure 16 As depicted, bearing assembly 404, seals 406 and 408, and ring 410 are disposed on rod assembly 258, as previously discussed. Conduit 420 is also positioned. Specifically, refer to... Figure 9The second end 428 of the conduit 420 is secured within the opening 290 that extends centrally through the dispersing member 252. This connection can be made by press-fit, threaded connection, adhesive, or other forms of connection. The remainder of the conduit 420 protrudes centrally along the central axis 230 through the opening 334 of the insert 256 and centrally extends upward through the light collection channel 379 of the orifice 360. In this position, the conduit 420 is laterally supported by the inner surface 378 of the strut 376. Figure 16 During operation, the conduit 420 and the rest of the separating rotor 184 rotate simultaneously relative to the separating stator 180.

[0374] The assembled separate rotor 184 is enclosed within the separate stator 180. Specifically, see... Figure 13 An inlet port 38 protrudes outward from the end wall 218 of the nose 214 and defines a channel 45 aligned with the central axis 230. The channel 45 extends through the end wall 218 to the inner surface 202. An annular groove 438 is recessed in the inner surface 202 of the end wall 218 to surround the channel 45. A dynamic seal 432 is received and secured within the groove 438. A rod assembly 258 having a bearing assembly 404, seals 406 and 408, and a ring 410 disposed thereon is received within a recess 213 of the nose 214, thereby rotatably fluidly connecting the first end 426 of the conduit 420 to the channel 45 of the inlet port 38 via the dynamic seal 432.

[0375] Continue to refer to Figure 13 The annular upper shoulder 440 protrudes inward from the inner surface 202 of the side wall 216 of the nose 214 toward the end wall 218. A lightweight component collection groove 444 is formed between the upper shoulder 440 and the end wall 218. The second outlet port 42 ( Figure 6 A channel 47 is defined, communicating with the light component collection groove 444. A seal 408 abuts against the upper shoulder 440, while each of seals 408, ring 410, and seals 406A and 406B abuts against the inner surface 202 of the sidewall 216 of the nose 214. Thus, each of seals 408, ring 410, and seals 406A and 406B is trapped between the sidewall 216 of the nose 214 and the sleeve 390. More specifically, seals 406 and 408 form a dynamic, liquid-impermeable seal directly abutting the sleeve 390, allowing the sleeve 390 and the remainder of the separating rotor 184 to rotate relative to the separating stator 180 and relative to seals 406 and 408 while maintaining the liquid-impermeable seal therebetween.

[0376] An annular heavy component collection groove 446 surrounds the sleeve 390 and is defined between the sleeve 390 and the ring 410, and is also defined between seals 408 and 406A. First outlet port 42 ( Figure 6A channel 49 is defined, aligned with the channel 416 of the ring 410, to communicate with the heavy component collection recess 446. In an alternative embodiment, the ring 410 may be eliminated, such that the heavy component collection recess 446 is defined directly between the nose 214 of the separator stator 180 and the sleeve 390. The heavy component collection recess 446 is aligned with and communicates with the opening 398 and the heavy collection channel 382 of the sleeve 390.

[0377] The annular lower shoulder 442 protrudes inward from the inner surface 202 of the sidewall 216 of the nose 214. The bearing assembly 404 sits abutting the shoulders 442 and 314 and is held between the lip 310 of the cap 254 and the head 192 of the separate stator 180. (With bearing assembly 270...) Figure 9 Similarly, bearing assembly 404 is used to center and stabilize the separate rotor 184 within the separate stator 180, so that the separate rotor 184 can rotate freely within the separate stator 180.

[0378] Turning Figure 18 During operation, motor 169 is active to rotate drive rotor 150 about central axis 230 relative to separate stator 180. Subsequently, as previously discussed, magnetic force generated by magnet 168 acts on drive coupling 186 to simultaneously rotate drive coupling 186 and separate rotor 184 about central axis 230 and relative to separate stator 180. During operation, separate rotor 184 typically rotates at a rate of at least 1,000 rpm, 2,000 rpm, 2,500 rpm, 3,000 rpm, or 3,500 rpm, or within any two of the aforementioned values. Other speeds may also be used depending on the application.

[0379] Once the rotation of the separator rotor 184 is started, the inlet flow of the suspension 18 is 102 ( Figure 1 , Figure 3 and Figure 5The inlet flow 102 is delivered to the inlet port 38 and travels along the central axis 230 through the conduit 420 and through the opening 290 of the dispersing member 252 to enter the space 448 between the dispersing member 252 and the base plate 264 of the separating rotor 184. The inlet flow 102 flows radially outward in all directions toward the peripheral edge 286 of the dispersing member 252 within the space 448. To some extent, the dispersing member 252 serves to force the inlet flow 102 radially outward away from the central axis 230 to maximize the rate and force at which the inlet flow 102 begins to separate into heavier and lighter components. Specifically, as the inlet flow 102 moves radially outward away from the central axis 230, it experiences a greater centrifugal force due to the increased rotation of the separating rotor 184. Therefore, as the inlet flow 102 passes around the peripheral edge 286 of the dispersing member 252, the centrifugal force causes the inlet flow 102 to separate into a heavier component traveling radially outward and a lighter component traveling radially inward.

[0380] Additionally, the radially extending spacer 272 and the lower spacer 288 ( Figure 11 The inlet fluid path 460 extends between the dispersing member 252 and the base plate 264 to divide the space 448 into multiple inlet fluid paths 460 extending from the conduit 420 to the peripheral edge 286 of the dispersing member 252. Each inlet fluid path 460 is defined between a pair of adjacent spacers 272 / lower spacers 288 to force the inlet flow 102 to flow radially outward along a generally linear path, rather than swirling in circles around the central axis 230 within the space 448. This linear, radial flow of the inlet flow 102 again helps the inlet flow 102 move rapidly away from the central axis 230 to increase the rate at which the inlet flow 102 is separated into heavier and lighter components. In addition, the linear radial flow helps to keep the inlet flow laminar rather than turbulent, which further helps to separate the inlet flow 102 into heavier and lighter components. In the depicted embodiment, six inlet fluid paths 460 are formed. Figure 11 In an alternative embodiment, other numbers of inlet fluid paths 460 may be formed, such as at least 3, 4, 5, 6, 7, 8, 9, or 10, or a number of inlet fluid paths within any two of the aforementioned values.

[0381] The lower sidewall 266 of the base 250 and the upper sidewall 304 of the cap 254 combine to form the outer sidewall 450 of the separating rotor 184, while the inner sidewall 320 of the insert 256 forms the inner sidewall 320 of the separating rotor 184. The outer sidewall 450 and the inner sidewall 320 combine to form a sidewall assembly 452 of the separating rotor 184, which surrounds the compartment 454, and the space 448 forms part of the compartment.

[0382] like Figure 19As better depicted in the cross-sectional view, the lower partition 288 protrudes radially outward within space 448 from or toward the opening 290 of the dispersing member 252 to the sidewall assembly 452, and more specifically, radially outward to the outer sidewall 450 / lower sidewall 216. Thus, the lower partition 288 also extends between the body 280 of the dispersing member 252 and the base plate 264, creating three isolated inlet fluid paths 460 that do not openly connect to the downstream of the opening 290.

[0383] Similarly, the upper partition 336 protrudes radially outward from the conduit 420 along the top surface 282 of the dispersing member 252 to the sidewall assembly 452, and more specifically, radially outward to the inner sidewall 320 and along its length to the outer sidewall 450 (lower sidewall 266) below the inner sidewall 320. Thus, the upper partition 336, in combination with the guide rail 292, divides the compartment 454 above the dispersing member 252 into multiple light component fluid paths 456A-C. In one embodiment, the light component fluid paths 456A-C are substantially isolated from each other, preventing free flow of fluid between the light component fluid paths 456A-C.

[0384] Furthermore, each upper separator 336 extends radially from the conduit 420 along the top surface 282 of the dispersing member 252 to the peripheral edge 286, and then aligns with and intersects with the corresponding lower separator in the lower separator 288 as the upper separator 336 extends from the peripheral edge 286 to the sidewall assembly 452. Thus, each inlet fluid path 460 defined between adjacent lower separators 288 is aligned with the corresponding light component fluid path 456, and the fluids do not mix as they pass between them. That is, the fluid traveling along the inlet fluid path 460 to the corresponding light component fluid path 456 does not mix with the separated fluid traveling along the separating inlet fluid path 460 to the separating corresponding light component fluid path 456. Again, this configuration facilitates continuous fluid flow along a generally linear path, rather than swirling in circles around the conduit 420 / central axis 230, and helps maintain a stronger laminar flow rather than a turbulent flow, both of which contribute to the separation of the fluid into heavy and light components. In the depicted embodiment, three upper partitions 336 and three lower partitions 288 are shown. In an alternative embodiment, the separator rotor 184 may be formed with at least 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21 or more upper partitions 336 and lower partitions 288, or with upper and lower partitions in the range between any two of the foregoing values.

[0385] Again, as previously mentioned, due to the centrifugal force generated by the rotation of the separating rotor 184, the lighter component of the inlet flow 102 passing around the peripheral edge 286 of the dispersing member 252 flows radially inward into the corresponding light component fluid path 456 at the second end 242 of the separating rotor 184. Figure 13 and Figure 18 As depicted, the separated light components flow through a light component fluid path 456, through a light collection channel 379 defined between the port 360 and the conduit 420, and into a light component collection recess 444, toward the first end 240 of the separating rotor 184. The light components from each light component fluid path 456 combine within the light component collection recess 444. Finally, the light components exit as a second outlet flow 106. Figure 1 , Figure 3 and Figure 5 The lightweight component collection groove 444 is discharged through the second outlet port 42 and can be further processed or transferred as previously discussed.

[0386] Continue to refer to Figure 13 During operation, the seal 408 is fixed and rests against the sleeve 390, which rotates with the rest of the separator rotor 184. Frictional engagement between the seal 408 and the sleeve 390 can heat the seal 408 and reduce its effective life. To help minimize heating of the seal 408 and thus extend its effective life, the seal 408 is biased directly against the heat dissipation section 389 of the sleeve 390. As previously discussed, the inner surface 395 of the heat dissipation section 389 defines a portion of the light collection channel 379. Therefore, as the light components of the fluid flow through the light collection channel 379 and into the light component collection recess 444, the fluid flows across the inner surface 395 of the heat dissipation section 389 to cool the heat dissipation section 389 / sleeve 390, thereby also cooling the seal 408. Furthermore, as previously discussed, by manufacturing the sleeve 390 with a material having relatively high thermal conductivity, the heat from the sleeve 390 dissipates more quickly, thereby further improving the cooling of the sleeve 390 and the seal 408.

[0387] In contrast to the light components flowing radially inward into the light component fluid path 456, heavier components, typically including cells, microorganisms, their particles, and other solids, flow radially outward toward the sidewall assembly 452 / outer sidewall 450. Because the separator 350 protrudes outward from the outer surface 324 of the insert 256, an annular truncated conical gap 462 is formed between the insert 256 and the cap 254. The outer edge of the separator 350 rests against the inner surface 300 of the cap 254, such that the separator 350 divides the annular truncated conical gap 462 into multiple separated heavy component fluid paths 464A-F. That is, the sidewall assembly 452 defines multiple separated heavy component fluid paths 464. Each heavy component fluid path 464 has an opening 466 located at the peripheral edge 330 of the insert 256 / inner sidewall 320.

[0388] During operation, once the inlet flow 102 exits through the inlet fluid path 460 between the base plate 264 and the dispersing member 252, the heavier components of the fluid flow radially outward toward the sidewall assembly 452 / outer sidewall 450 and flow through the opening 466 into the corresponding heavy component fluid path 464. The heavy components then flow toward the first end 196 of the separating rotor 184 within the heavy component fluid path 464. (Refer to...) Figure 13 and Figure 18 When the heavy component reaches the rod assembly 258, it flows into the corresponding heavy component collection channel 382, ​​exits through the opening 398 on the sleeve 390, and flows into the heavy component collection groove 446. The heavy components from each of the different heavy component fluid paths 464 are combined together within the heavy component collection groove 446. Finally, the heavy component is transferred through the channel 416 on the ring 410 and then flows out as the first outlet flow 104. Figure 1 , Figure 3 and Figure 5 It exits through the first outlet port 40, where the heavy components can be further processed or transferred as previously discussed.

[0389] Continue to refer to Figure 13During operation, the seal 406 is fixed and rests against the sleeve 390, which rotates with the rest of the separator rotor 184. Frictional engagement between the seal 406 and the sleeve 390 can heat the seal 406 and reduce its effective life. To help minimize heating of the seal 406 and thus extend its effective life, the seal 406 is biased directly against the heat dissipation section 388 of the sleeve 390. As previously discussed, the inner surface 395 of the heat dissipation section 388 defines a portion of the heavy component collection channel 382. Therefore, as the heavy component of the fluid flows through the heavy component collection channel 382 and into the heavy component collection recess 446, the fluid flows across the inner surface 395 of the heat dissipation section 388 to cool the heat dissipation section 388 / sleeve 390, thereby also cooling the seal 406. Furthermore, as previously discussed, by manufacturing the sleeve 390 with a material having relatively high thermal conductivity, the heat from the sleeve 390 dissipates more quickly, thereby further improving the cooling of the sleeve 390 and the seal 406.

[0390] Furthermore, using separators 350 to form and isolate the heavy component fluid paths 464 helps the heavy components flowing into and along these paths to flow continuously along a generally linear path, rather than swirling in circles around the central axis 230. It also helps maintain a stronger laminar flow rather than turbulent flow for the heavy components. Both types of flow facilitate fluid separation and limit the application of excessive forces, which could be destructive or harmful, to the separated cells or microorganisms. In the depicted embodiment, six separators 350 are used to form six heavy component fluid paths 464. In an alternative embodiment, the separator rotor 184 may be formed with at least 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 26, 32, 38 or more separators 350 and / or heavy component fluid paths 464, or may be formed with separators and / or heavy component fluid paths within the range of any two of the foregoing values.

[0391] like Figure 19 As depicted, the aligned upper separator 336 and lower separator 288 are also radially aligned with the corresponding separator 350. Therefore, fluid flowing from the inlet fluid path 460 to the corresponding aligned light component fluid path 456 can only communicate with the corresponding aligned heavy component fluid path 464. For example, as... Figure 19As shown, inlet fluid paths 460A, light component fluid paths 456A, and heavy component fluid paths 464A and 464B are aligned and interconnected. However, they are restricted by upper separator 336, lower separator 288, and separator 350 from freely communicating with other inlet fluid paths 460B and C, other light component fluid paths 456B and C, and other heavy component fluid paths 464C-F. This configuration and isolation of the fluid paths facilitates the separation of heavy and light components.

[0392] The developments disclosed herein have also revealed surprising and unexpected results. For example, as discussed herein, when using upper separator 336, lower separator 288, and separator 350 to isolate the fluid communication between the selected inlet fluid path 460, the light component fluid path 456, and the heavy component fluid path 464, it has been found that fluid communication between each light component fluid path 456 and an increased number of heavy component fluid paths 464 improves the solids separation efficiency. For example, the following table illustrates the parameters and results of three tests operating three different separation rotor designs.

[0393]

[0394] In each of the three tests described above, the rotation of the separating rotor was set to 2500 rpm, the feed rate delivering the inlet stream to the centrifuge was set to 3 L / min, and the solids percentage in the inlet stream was maintained at 10%. Furthermore, in each of the three tests, the separating rotor was designed similarly to the separating rotor 184 previously disclosed herein, having three separate light component fluid paths 456A-C separated by three spaced-apart upper separators 336A-C. However, the number of heavy component fluid paths 464 communicating with each light component fluid path 456 varied for each test.

[0395] In Test 1, the separating rotor 184 was designed such that the sidewall assembly 452 included only three separators 350, each aligned with a corresponding upper separator 336. Therefore, each light component fluid path 456 communicates only with a single heavy component fluid path 464. In this test, 78.2% of the solids were collected in the first outlet stream 104 collecting the heavier components, and 21.8% of the solids were collected in the second outlet stream 106 collecting the lighter components.

[0396] In Test 2, with all other variables kept constant, the separating rotor 184 was designed identically to that in this disclosure, wherein the sidewall assembly 452 includes six separators 350, with every other separator aligned with a corresponding separator 336. Thus, each light component fluid path 456 communicates with two heavy component fluid paths 464. In this test, 88.9% of the solids were collected in the first outlet stream 104 collecting the heavier components, and 11.1% of the solids were collected in the second outlet stream 106 collecting the lighter components.

[0397] Finally, in Test 3, with all other variables kept constant, the separating rotor 184 was designed similarly to this disclosure, except that the sidewall assembly 452 includes twelve separators 350 (with every four separators aligned with corresponding upper separators 336). Thus, each light component fluid path 456 communicates with four heavy component fluid paths 464. In this test, 96.6% of the solids were collected in the first outlet stream 104 for collecting heavier components, and 3.4% of the solids were collected in the second outlet stream 106 for collecting lighter components.

[0398] Test results support increasing the number of heavy component fluid paths 464 relative to the aligned light component fluid path 456 to improve solids separation efficiency. Therefore, although in one embodiment of this disclosure the separation rotor 184 may be configured such that the ratio of heavy component fluid path 464 to light component fluid path 456 is 1:1 in other embodiments, to further improve solids separation efficiency, the separation rotor 184 may be designed such that the ratio is at least 2:1, 3:1, 4:1, 5:1, 6:1, 8:1, 10:1, 20:1, 40:1, or within any two of the aforementioned ratios.

[0399] In addition, some common centrifuges employ angled sidewalls to aid separation. Typically, the angle of the sidewalls serves two purposes: 1) to facilitate the transport of heavy components to a co-located volume for collection and potential discharge, and 2) to shorten the separation time of heavy components by reducing the radial distance that the separated material must travel for separation. However, this disclosure also employs angled upper and / or lower sidewalls for the additional purpose of mitigating inertial fluid flow effects that can disrupt separation.

[0400] Fluid flowing radially through a rotating chamber is subject to the Coriolis effect (i.e., the inertial effect). The Coriolis effect affects the flowing fluid primarily perpendicular to the axis of rotation. For example, as the fluid flows radially inward, its radial velocity relative to the chamber's radial velocity is accelerated due to the fluid's inertia at a larger radius of the rotating chamber. This velocity difference can cause the fluid to overtake the chamber at a radius smaller than the outermost radius, which then drives the fluid back towards the outermost radius. In short, the Coriolis (inertial) effect imparts a flow dynamic that results in the formation of vortices in a plane perpendicular to the axis of rotation. Such vortices can create flows that are detrimental to centrifugal separation. In chambers with upper and lower sidewalls that maintain axial equidistant spacing, such as in one embodiment of this disclosure, the radial cross-sectional area changes linearly with respect to the radius. Therefore, the radially flowing fluid in such a chamber is accelerated to maintain a flow rate through a given radial cross-sectional area of ​​the chamber. In such a chamber, the radial acceleration of the fluid exacerbates the Coriolis effect and amplifies and increases the fluid flow rate as vortices form.

[0401] To help mitigate these aforementioned effects, embodiments of this disclosure may employ an upper sidewall, a lower sidewall, or both, wherein the upper and lower sidewalls extend the axial distance between them as the radius decreases. In one embodiment, the upper sidewall (e.g., the inner surface 322 of the inner sidewall 320) Figure 17 and Figure 18 The chamber can be angular with respect to the central axis 230 (i.e., the axis of rotation) between 40° and 50°, and more commonly between 42° and 48° or between 43° and 47°. This resulting truncated conical shape helps mitigate the aforementioned flow effects. That is, the expanded chamber height counteracts the change in the radial cross-sectional area through which the fluid flows radially, thereby reducing, eliminating, or reversing the acceleration of the fluid as it flows radially. Thus, the additional axial dimension of the chamber can be used to interrupt the formation of vortices from the Coriolis effect by causing the fluid to flow out of a plane perpendicular to the axis of rotation. This combination mitigates and prevents the mixing acceleration of the fluid, which leads to the formation of strong vortices capable of disrupting separation within the chamber.

[0402] Figure 20 The image depicts another alternative embodiment of centrifuge 12B, which can be used as described above regarding... Figures 1 to 5 Centrifuge 12 is discussed in the system and alternatives. Centrifuge 12B is substantially similar to centrifuge 12A, and similar elements are identified by similar reference numerals in the figures. Furthermore, unless otherwise described and / or depicted, it should be understood that similar elements in centrifuge 12B function in the same manner and may have the same alternatives as their counterparts in centrifuge 12A.

[0403] like Figure 20As depicted, the centrifuge 12B includes a separating rotor 184 that rotates within a separating stator 180 and is used to separate the inlet flow 102 into heavy and light components. The separating rotor 184 includes a base 250, a dispersing member 252A, an insert 256, a cap 254, and a rod assembly 258. Compared to the dispersing member 252 having a body 470 in the form of a flat plate, as... Figure 20 and Figure 21 As shown, the dispersing member 252A includes a body 280 with a truncated conical configuration and an opening 290 extending centrally through the body. The body 470 has a top surface 282 that slopes outward from the opening 290 to an outer peripheral edge 286 and an opposing bottom surface 284. Three upper separators 474A-C project outward from the top surface 282. The upper separators 474A-C extend radially outward from the opening 290 and terminate at a free end 484 extending beyond the peripheral edge 286. The free end 484 is designed to abut against an outer side wall 450. Each upper separator 474 has an outer edge 476 configured to sit against the inner surface of the insert 256, such that a lightweight component fluid path 456A-C is formed between each pair of adjacent upper separators 474 through which the lightweight component is transferred to the rod assembly 258. In the depicted embodiment, a plurality of elongated separators 486 also project outward from the top surface 282 of the dispersing member 252A between each pair of adjacent upper separators 474. The separators extend radially outward from the opening 290 to the peripheral edge 286. However, the separators 486 do not extend to the outer sidewall 450. The separators 486 partially subdivide each light component fluid path 456A-C. However, a small amount of fluid communication is allowed between the subdivisions of each light component fluid path 456A-C. In contrast, fluid communication is restricted between the different light component fluid paths 456A-C. In the depicted embodiment, three separators 486 are formed between each pair of upper separators 474. Other numbers of separators 486 may also be used, such as at least one, two, four, five, six, eight, or ten.

[0404] Centrifuge 12B also forms a conduit 420A. A first end 426 of conduit 420A is rotatably sealed to the end wall 218 of nose 214 by a pair of dynamic seals 432A and 432B. A second end 428 of conduit 420A, centered through base plate 264 and drive coupling 186, is rotatably secured to the end wall 210 of receiving portion 206 by an annular bearing assembly 478 (such as a seat ring bearing). A seal 482 is formed between conduit 420A and base plate 264 to prevent liquid leakage between them. Bearing assembly 270 has been eliminated, so bearing assemblies 404 and 478 now serve to support and stabilize the separating rotor 184 within separating stator 180. Multiple openings 480 extend radially through conduit 420A between base plate 264 and dispersing member 252A to communicate with passageway 430. Three equidistant lower separators 490 extend between the base plate 264 and the dispersion member 252A, and project radially outward from the conduit 420A to the outer sidewall 450. The lower separators 490 are aligned with and intersect with the corresponding upper separators 474. The lower separators 490 divide the space into separate and isolated inlet fluid paths 460A-C that communicate with the corresponding lightweight component fluid paths 456A-C.

[0405] It should be noted that the outer peripheral edge 330 of the insert 256 is arranged radially outward from the outer peripheral edge of the dispersing member 252A. During operation, the separating rotor 184 rotates with the separating stator 180 via the drive coupling 186, as previously discussed. An inlet flow 102 is delivered at the inlet port 38, where it is passed downward through the conduit 420A and exits through the opening 480 into the inlet fluid path 460. The fluid flow flows radially outward toward the outer wall 450. Lighter components flow into the light component fluid path 456, pass through the orifice 360 ​​of the rod assembly 258, flow into the light component collection recess 444, and exit through the second outlet port 42, as previously discussed with respect to centrifuge 12A. Similarly, heavier components flow radially outward to flow into the heavy component fluid path 464, pass through the heavy component collection channel 382, ​​flow into the heavy component collection recess 446, and exit through the first outlet port 40, as previously discussed with respect to centrifuge 12A.

[0406] Figure 22 and Figure 23 The diagram depicts an exemplary embodiment of another alternative continuous flow centrifugal separator 12C, which can be used as described above regarding... Figures 1 to 5Centrifugal separator 12 is discussed in the system and alternatives. Separator 12C has components similar to those of separator 12A and operates in a similar manner to separator 12A. Therefore, similar elements between separators 12A and 12C are identified by similar reference numerals in the accompanying drawings. Furthermore, unless otherwise expressly or inherently understood, the alternatives, modifications, operations, characteristics, and functions discussed above with respect to existing separators also apply to separator 12C.

[0407] Generally, the centrifugal separator 12C includes a main body assembly 130C and a drive sleeve 132C projecting outward therefrom. In the exemplary embodiment depicted, the drive sleeve 132C is integrally formed with a portion of the main body assembly 130C as a single integral component. However, in other embodiments, the drive sleeve 132C may be configured as previously described regarding the drive sleeve 132 ( Figure 8 The same method discussed above is used to fix it to the main assembly 130C. Again, as will be discussed in more detail below, during the operation of the centrifuge 12A, the magnet actuator 148 ( Figure 8 It can be positioned and rotated within the drive sleeve 132. As will be discussed in more detail below, the main assembly 130C / centrifuge 12C includes an inlet port 38, a first outlet port 40, and a second outlet port 42.

[0408] Continue to refer to Figure 23 The actuator sleeve 132C includes an outer surface 134C and an inner surface 136C surrounding an opening 138C. The actuator sleeve 132C has a first end 140C extending from the body assembly 130C and an opposing second end 141C. In an exemplary embodiment, the actuator sleeve 132C includes a cylindrical sleeve body 142C and a plurality of spaced-apart reinforcing fins 143C that project radially inward from the inner surface 136C and outward along the base plate of the body assembly 130C. The fins 143C increase the reinforcement and structural stability of both the actuator sleeve 132C and the body assembly 130C.

[0409] Spaced-apart openings 146A-C extend through the actuator sleeve 132C between the outer surface 134C and the inner surface 136C, and can be used to releasably secure the separator 12C to a carriage or other structure, as will be discussed in more detail below. In this embodiment, all three openings 146A-C are formed on one half of the actuator sleeve 132C. In other embodiments, openings 146A-C may be replaced with two or four or more openings. In still other embodiments, one or more recesses extending into the outer surface 134C or one or more flanges (such as flange 145) projecting outward from the outer surface 134C may be used. Figure 8 Replace the 146A-C opening.

[0410] Reference Figure 24 The separator 12C / main assembly 130C typically includes a separator stator 180C and a rotor assembly 182C rotatably disposed within the separator stator 180C. The rotor assembly 182C includes a separator rotor 184C rotatably disposed within the separator stator 180C and a drive coupling 186C coupled to the separator rotor 184C and rotatably disposed within the separator stator 180C. A central axis 230C passes centrally through the separator stator 180C and the rotor assembly 182C and coincides with a rotation axis also identified by reference numeral 230C about which the rotor assembly 182C rotates. Therefore, "central axis 230C" and "rotation axis 230C" are used synonymously herein.

[0411] like Figure 24 and Figure 25 As depicted, in one exemplary embodiment, the split stator 180C includes a base 190C and a head 192C joined together before use. In one exemplary embodiment, the head 192C includes a tapered neck 174C having a nose 214C connected thereto. The split stator 180C has an inner surface 202C and an opposing outer surface 203C. The inner surface 202C defines a chamber 194C in which the rotor assembly 182C is at least partially received. The assembled split stator 180C has a first end 196C with the head 192C / nose 214C disposed and an opposing second end 198C with the base 190C disposed. A central axis 230C extends between the first end 196C and the second end 198C. The split stator 180C includes an inlet port 38, a first outlet port 40, and a second outlet port 42, each located on the head 192 / nose 214C at the first end 196C.

[0412] Continue to refer to Figure 24The base 190C (or the second end 198C of the separator stator 180C) includes a base plate 200C extending radially outward to an annular sidewall 204C. The sidewall 204C stands upright from the base plate 200C and projects toward the first end 196C. An annular mounting flange 205C projects outward from the sidewall 204C. A pair of handles 199A and 199B project radially outward from opposite sides of the flange 205C. The handles 199A and 199B are used for manually lifting and conveying the separator 12C. In one embodiment, the inner surface 202C of the sidewall 204C is cylindrical. In other embodiments, the inner surface 202C of the sidewall 204C may be inclined outward. The drive sleeve 132C is generally centered on the base plate 200C and projects outward from it. A receiving portion 206C is centrally located on the base plate 200C and projects outward from its outer surface 203C. A receiving portion 206C is disposed within an opening 138C of a drive sleeve 132C so as to be surrounded by the drive sleeve 132C. In an exemplary embodiment, the receiving portion 206C is concentrically disposed within the drive sleeve 132C. The receiving portion 206C defines a recess 212C forming a portion of a chamber 194C. In one embodiment, the receiving portion 206C includes a sidewall 208C projecting from a base plate 200C and terminating at an end wall 210C. In one embodiment, the sidewall 208C and the recess 212C each have a cylindrical configuration. An annular notch 211C may be recessed into the sidewall 208C at its intersection with the base plate 200C for receiving a bearing assembly 270C, as will be discussed in more detail below. The receiving portion 206C is configured such that it can be received within the magnetic actuator 148 / drive rotor 150 ( Figure 8 The magnetic actuator 148 / drive rotor 150 is received in the opening 138C of the actuator sleeve 132C.

[0413] return Figure 23 The base 190C (or the first end 198C of the separated stator 180C) also includes fins 143C projecting outward from the outer surface of the base plate 200C, as previously discussed. The fins 143C can be aligned parallel to the central axis 230C. Figure 24 ), and are equidistant from each other around the receiving part 206C.

[0414] In one embodiment, the centrifugal separator 12C is designed to be discarded after a single use. For this purpose, the separator stator 180C, and more specifically, the base 190C, head 192C, and drive sleeve 132C, are typically made of polymeric materials such as polyvinylidene fluoride or polyvinylidene (PVDF), high-density polyethylene (HDPE), polyetherimide (PEI), polyetheretherketone (PEEK), etc., and are typically molded, for example, by injection molding or rotational molding. These materials and manufacturing methods make it possible to produce the separator stator 180C at a lower cost compared to cases where the separator stator 180C is made of metal. To some extent, when made of a lower-strength polymeric material, the fins 143C are used to increase the strength and stability of the separator stator 180C and drive sleeve 132C. However, in alternative embodiments, the separator stator 180C may be made of a higher-strength metal (such as aluminum or stainless steel) or alternatively of a higher-strength polymer (such as liquid crystal polymers or polycarbonate). In this case, fin 143C can be eliminated.

[0415] Reference Figure 24 and Figure 25 The nose portion 214C of the head 192C has a sidewall 216C that terminates at an upper end at an end wall 218C and has an annular outwardly projecting flange 219C at the opposite lower end. The nose portion 214C defines a groove 213C. In one embodiment, the inner surface 202C of the groove 213C defining the sidewall 216C may have a substantially cylindrical configuration. An inlet port 38 projects outwardly from the end wall 218C. A first outlet port 40 and a second outlet port 42 project outwardly from the sidewall of the nose portion 214C. The inlet port 38 defines a channel 45, while the outlet ports 40 and 42 define channels 47 and 49, respectively. Recessed in the end wall 218C to surround the channel 45 and communicating with the groove 213C is an annular lightweight component collection groove 444C. The lightweight component collection groove 444C communicates directly with the channel 47 of the second outlet port 42.

[0416] The neck 174C of the head 192C includes an annular transition wall 220C extending between an annular mounting flange 227C at the upper end and an annular mounting flange 228C at the opposite lower end. The flanges 219C and 227C are joined together by fasteners 221C (such as screws, bolts, clamps, etc.), with an O-ring 223C disposed between them to form an airtight seal between the nose 214C and the neck 174C. In one embodiment, at least a portion of the transition wall 220C has a truncated conical configuration, wherein its inner surface 202C is typically set at an angle of at least or less than 30°, 40°, 50°, or 60° relative to the central axis 230C, or within a range of any two of the aforementioned angles. In the depicted embodiment, a portion of the transition wall 220C extending from the mounting flanges 227C and / or 228C may be cylindrical or have a different configuration than the rest of the transition wall 220. Forming the nose 214C and neck 174C as two separate components secured together by fasteners simplifies the production of the head 192C and its assembly with the separator 12C. However, in other embodiments, the nose 214C and neck 174C can be integrally formed as a single component, thereby eliminating the need for fasteners.

[0417] During assembly, mounting flanges 205C and 228C are joined together, such that rotor assembly 182C / separated rotor 184C is contained within separate stator 180C. Mounting flanges 205C and 228C are joined together by fasteners 233C (such as screws, bolts, clamps, or other fasteners or fastening techniques). An O-ring 235C is disposed between flanges 205C and 228C to form an hermetically tight seal between them.

[0418] The rotor assembly 182C is rotatably positioned within chamber 194C of the separating stator 180C and is used for the inlet flow 102 of the biological suspension or other mixture. Figures 1 to 5 It is separated into a first outlet flow 104 and a second outlet flow 106. (Refer to...) Figure 25 As previously mentioned, rotor assembly 182C includes a separate rotor 184C and a drive coupling 186C extending therefrom. More specifically, the separate rotor 184C has a first end 240C and an opposing second end 242C, with a central axis / rotation axis 230 extending centrally between the first and second ends. The drive coupling 186C is centrally mounted to and projectes outward from the second end 242C of the separate rotor 184C, such that the central axis 230 passes centrally through the drive coupling. Steering Figure 24The drive coupling 186C typically has a surrounding side 244C terminating at an end face 246C. Fasteners 247C (such as screws, bolts, etc.) may extend through an opening formed in the drive coupling 186C and engage with the separator rotor 184C (e.g., via a threaded connection or other technique) to secure the drive coupling 186C to the separator rotor 184C. In an exemplary embodiment, a shear pin 249C protrudes from the separator rotor 184C into an opening 251C formed in the drive coupling 186C. The engagement between the shear pin 249C and the drive coupling 186C helps ensure that the separator rotor 184C and the drive coupling 186C rotate simultaneously. In an alternative embodiment, the shear pin 249C may protrude outwardly from the drive coupling 186C and into an opening 251C formed in the separator rotor 184C.

[0419] The drive coupling 186C typically has a cylindrical configuration, and as... Figure 24 As depicted, it is configured such that it can be rotatably received within the groove 212C of the receiving portion 206C. A gap 248C is formed between the side surface 244C of the drive coupling 186C and the side wall 208C of the receiving portion 206C, allowing the drive coupling 186C to rotate freely within the receiving portion 206C.

[0420] In one exemplary embodiment, the gap 248C is less than 10 mm, 8 mm, 6 mm, 4 mm, 2 mm, or within any two of the aforementioned values. Minimizing the size of the gap 248C is typically desired to facilitate the magnetic rotation of the drive coupling 186C. The drive coupling 186C comprises a material and is configured such that it can be driven by the magnetic actuator 148 (… Figure 8 The magnetic field generated by the magnet 168 is controlled by the drive coupling 186. For example, the drive coupling 186 may include another magnet or a material attracted to the magnet, such as iron or an iron composite. During operation, the drive coupling 186C is positioned within the receiving portion 206C, which is received within the cavity 162 of the drive rotor 150. Figure 8 The drive rotor 150, driven by the rotation of the motor 169, promotes the simultaneous rotation of the drive coupling 186C due to the magnetic force generated on the drive coupling 186C by the magnet 168. Subsequently, the rotation of the drive coupling 186C promotes the simultaneous rotation of the attached separate rotor 184C. In an alternative embodiment, it should be understood that the receiving portion 206C, which is typically used as a protective cover, can be eliminated. In this case, the drive coupling 186C will be directly received within the cavity 162 of the drive rotor 150.

[0421] Turning Figure 26The split rotor 184C typically includes: a base 250C to which a drive coupling 186C is attached; a dispersing member 252C located on the base 250C; a disk stack 253C disposed on the dispersing member 252C; a cap 254C coupled to the base 250C; and an insert 256C held between the cap 254C and the disk stack 253C. The various elements of the split rotor 184C will now be discussed in more detail.

[0422] like Figure 27 and Figure 28 As depicted, base 250C has an inner surface 260C that partially defines compartment 261C and an opposing outer surface 262C. Base 250C includes a base plate 264C and an annular sidewall 266C projecting upward from the outer periphery of base plate 264C toward cap 254C. Sidewall 266C is hereinafter referred to as lower sidewall 266. Mounting flange 265C surrounds upper sidewall 266 and projects radially outward therefrom. Recess 267C is centrally formed on the inner surface 260C of base plate 264C and communicates with compartment 261C. More specifically, in an exemplary embodiment, bowl 269C is centrally formed on the outer surface 262C of base plate 264C and projects outward therefrom. Recess 167C is formed in bowl 269C. In one embodiment, both bowl 269C and recess 267C may be circular. Mounting member 268C protrudes outward from the outer surface 262C of cup-shaped member 269C, aligned with the central axis 230A. Cup-shaped member 269C and recess 167C are optional and can be eliminated. When not in use, mounting member 268C may protrude directly from the outer surface 262C of base plate 264C, aligned with the central axis 230C. Drive coupling member 186C is secured to mounting member 268C, such as by fasteners 247C as previously discussed, or by other fastening techniques such as adhesives, press fits, threaded connections, etc.

[0423] Multiple optional cooling fins 271C are formed on and project outward from the base plate 264C. In one exemplary embodiment, the fins 271C are spaced apart and project radially outward away from the cup-shaped member 269C. The fins 271C may be linear or curved. Without the cup-shaped member 269C, the fins 271C may project radially outward away from the central axis 230C. The base 250C may be formed with at least one, three, five, six, eight, or more fins 271C, or with a number of fins within any two of the aforementioned values.

[0424] return Figure 24An annular bearing assembly 270C (such as a race bearing) is received within an annular recess 211C and extends between the base 250C of the separating rotor 184C and the base 190C of the separating stator 180C. The bearing assembly 270C supports, centers, and stabilizes the separating rotor 184C relative to the separating stator 180C, and allows the separating rotor 184C to rotate easily relative to the separating stator 180C. In one exemplary embodiment, the bearing assembly 270C is fixed externally to or directly adjacent to a bowl-shaped member 269C. As discussed in more detail below, one function of the bowl-shaped member 269C / recess 267C is that, during operation, when the separating rotor 184C rotates relative to the separating stator 180C using the bearing assembly 270C, the treated biological suspension or other mixture can flow through the recess 267C, thereby aiding in the cooling of the adjacent bearing assembly 270C. That is, the bowl-shaped member 269C / groove 267C serves as a heat sink. In one embodiment, the bearing assembly 270C is horizontally aligned with and / or surrounds a portion of the groove 276C and / or the bowl-shaped member 269C.

[0425] Cooling fins 271C ( Figure 28 This also helps cool the bearing assembly 270C. Specifically, when the separate rotor 184C is rotated relative to the separate stator 180C using the bearing assembly 270C, the fins 271C rotate within the gap between the separate rotor 184C and the separate stator 180C. The fins 271C cause the air within the gap to move above the bearing assembly 270C, thereby contributing to the cooling of the bearing assembly 270A.

[0426] return Figure 27 A plurality of spacers 272A-F protrude upward from the inner surface 260C of the base plate 264C. The spacers 272 are evenly spaced and project radially outward in alignment with the central axis 230 and / or the groove 267C. Spacers 272A, 272C, and 272E are also formed with elongated slots 273 along their length. As will be discussed in more detail below, the spacers 272 serve to space the dispersing member 252C from the inner surface 260C of the base plate 264C and to secure the dispersing member 252C to the base 250C, such that the base 250C and the dispersing member 252C rotate simultaneously. The inner surface 260C of the lower sidewall 266C may have an annular truncated conical configuration that slopes outward from the outer peripheral edge of the base plate 264C to the annular flange 265C. In one embodiment, the inner surface of the lower sidewall 266C is inclined outward at an angle of at least or less than 10°, 15°, 20°, 25°, 30°, 35° or within any two of the aforementioned angles relative to the central axis 230.

[0427] Turning Figure 29 and Figure 30 As discussed herein, the dispersing member 252C can have a variety of different configurations. In the embodiment described herein, the dispersing member 252C includes a body 280C in the form of a circular plate having a top surface 282C and an opposing bottom surface 284C, each extending to an outer peripheral edge 286C. An opening 290C extends centrally through the body 280C aligned with a central axis 230C, passing between the opposing surfaces 282C and 284C. Protruding from the bottom surface 284C of the body 280C are generally equidistant lower spacers 288A, B, and C. The lower spacers 288 are linear and project radially outward away from the opening 290C. The lower spacers 288 are configured to be received within slots 273C of spacers 272A, C, and E, and terminate at a terminal 291C that protrudes beyond the peripheral edge 286C.

[0428] During assembly, the dispersion component 252C passes through the lower separator 288A-C ( Figure 30 ) is received in slot 273C of spacers 272A, C and E ( Figure 27 ) and set in the base 250C ( Figure 26 The terminal 291C is disposed abutting against or directly adjacent to the inner surface 260C of the lower sidewall 266C of the base 250C. This assembly centers the dispersing member 252C on the base plate 264C to ensure that the peripheral edge 286C is evenly spaced from the lower sidewall 266C, and also interlocks the dispersing member 252C with the base 250C, such that rotation of the base 250C about the central axis 230C promotes simultaneous circumferential rotation of the dispersing member 252C. Furthermore, the body 280C of the dispersing member 252C is spaced from the base plate 264C of the base 250C, forming a space 448C between them. As will be discussed in more detail below, the lower separator 288 and the spacer 272 serve to form an inlet fluid channel that flows radially outward through the space 448C between the dispersing member 252C and the base plate 264C to aid in facilitating the separation of the biological suspension. It should be understood that various other structural designs can be used to fix and center the dispersive member 252C on the base plate 264C while forming an inlet fluid channel. However, the currently depicted embodiment is uniquely configured to enable quick and easy positioning of the dispersive member 252C without the need for separate fasteners.

[0429] Similarly, Figure 29As shown, the dispersing member 252C also includes a tubular rod portion 289C that protrudes outward from the top surface 282C of the body 280C, aligned with the opening 290C. Specifically, the rod portion 289C defines a channel 293C communicating with the opening 290C. Retaining rails 296A-C extend upward from the top surface 282C and radially outward from the rod portion 289C, respectively aligned with the lower separators 288A-C. Each retaining rail 296A-C intersects with the corresponding lower separator 288A-C outside the peripheral edge 286C and extends to a terminal 291C. Each retaining rail 296 includes a support portion 297C with a triangular shape and an extension portion 299C protruding outward from the support portion 297C beyond the peripheral edge 286C, the support portion having a top edge 298C that slopes upward toward the rod portion 289C.

[0430] 253C disk stacking ( Figure 26 This includes multiple nested disks (500C). For example... Figure 31 and Figure 32 As depicted, each disk 500C includes a disk body 502C having a top surface 504C and an opposing bottom surface 506C, each having a complementary truncated conical configuration. The disk body 502C extends between a central inner edge 508C and an outer peripheral edge 510C. The inner edge 508C is rounded and surrounds an opening 512C through which an axis 230C is centrally located. The peripheral edge 510C is also generally rounded. Protruding outward from the top surface 504C are a plurality of spaced-apart spacers 514C. The spacers 514C are used to keep the disks 500C spaced apart when nested together in a disk stack 253C, and especially when the disk stack 253C rotates at high speed.

[0431] Three radially spaced guides 516A-C are formed on the disc body 502C. Each guide 516A-C is radially aligned with axis 230C and is disposed between inner edge 508C and peripheral edge 510C. More specifically, each guide 516A-C is elongated, having a first end 518C facing the inner edge 508C and an opposing second end 520C facing the peripheral edge 510C. An upper notch 522C passes through the disc body 502C and extends from the first end 518C to the inner edge 508C, while a lower notch 524C extends from the second end 520C to the peripheral edge 510C. Each guide 516A-C has an inner surface 526 formed on the bottom surface 506C of the disc body 502C and an outer surface 528C formed on the top surface 504C of the disc body 502C. A guide slot 530C is recessed into the inner side 526 and extends between opposite ends 518C and 520C. A guide rail 532C protrudes outward from the outer side 528C and extends between opposite ends 518C and 520C. When the discs 500C are nested together, the guide rail 532C of one disc 500C is received within the guide slot 530C of the adjacent disc 500C. The coupling between the guide rail 532C and the guide slot 530C partially helps to interlock each disc in the discs 500C so that they rotate simultaneously. Additionally, the size of the guide rail 532C and the guide slot 530C is set to help achieve and maintain an appropriate spacing between the discs 500C, allowing fluid to flow between them. Although the spacing between the discs 500C can vary based on intended use and operation, in one embodiment, the spacing between each pair of adjacent nested discs 500C is typically less than 1.5 cm, 1 cm, 0.8 cm, 0.6 cm, or 0.4 cm, or within any two of the aforementioned values. The number of discs 500C can also vary depending on intended use. In some embodiments, the number of discs 500C used in the separator can be at least 1, 3, 5, 7, 10, 12, 15, or 20, or within any two of the aforementioned values. Finally, the interlocking between the guides 516 (i.e., the interlocking between the guide rails 532C and the guide slots 530C) forms a continuous wall portion along the nested discs 500C that prevents fluid from flowing radially around the discs 500C. For example, Figure 24 Stacked guides 516A and 516B are shown, which form wall portions 534A and 534B, respectively.

[0432] like Figure 31As depicted, each disc 500C also includes elongated flow guides 536A-C. Each flow guide 536A-C is positioned between a pair of adjacent guides 516A-C and radially aligned with the opening 512C / axis 230C. Flow guides 536A-C extend partially between the inner edge 508C and the peripheral edge 510C, but not fully between them. In one exemplary embodiment, the linear radial distance from the inner edge 508C to the peripheral edge 510C is “D”. Each flow guide 536A-C extends between 20% and 90% of the radial distance D, and more commonly, between 30% and 80% or 40% and 70% of the radial distance D. Other sizes may also be used. Flow guides 536A-C are typically spaced apart from the peripheral edge 510C and extend to the inner edge 508C. However, in other embodiments, flow guides 536A-C may also be spaced apart from the inner edge 508C. As will be discussed in more detail below, during operation, the liquid flows radially in opposite directions between the peripheral edge 510C and the inner edge 508C along the separation channel defined between the guides 516. The formation of the flow guides 536 (which is optional) helps to limit or eliminate fluid vortices in the separation channel. Vortices in the fluid can enhance turbulent flow, which reduces fluid settling and separation. In other words, the flow guides 536 help maintain radial and laminar flow that contributes to separation. Separating the flow guides 536A-C back from the peripheral edge 510C allows fluid to flow freely into each separation guide in the separation channel.

[0433] During assembly, disk 500C is stacked on top of the distributive component 252C for interlocking. Disks 500C can be stacked incrementally or as a group, i.e., disk stack 253C. (See reference...) Figure 29 and Figure 32 The disks 500C are stacked such that the top edge 298C of the support portion 297C of the retaining rail 296 is received within a corresponding guide slot 530 on the bottom disk 500C, and the extension portion 299C of the retaining rail 296 is received within a recess 524C of the bottom disks 500C. This positioning interlocks the disks 550C with the dispersing member 252C, causing them to rotate simultaneously and also causing the retaining rail 296 to extend vertically downwards from the wall formed by the stacked guides 516C to the body 280C of the dispersing member 252C.

[0434] Reference Figure 26 , Figure 35 and Figure 36The insert 256C includes an annular sidewall 320C, referred to herein as the inner sidewall 320C. The inner sidewall 320C has an inner surface 322C extending between a first end 238C and an opposing second end 326C, and an opposing outer surface 324C. The inner sidewall 320C includes an annular first portion 560C at the first end 238, which has a generally cylindrical configuration configured to be received within a cap 254C. The inner sidewall 320C also includes an annular second portion 562C at the second end 326C, which has a generally frustoconical configuration tapering inward toward the first portion 560C. In one embodiment, the inner surface 322C of the second portion 562C of the inner sidewall 320C may be tilted relative to the central axis 230 at an angle between 35° and 55°, and more commonly between 40° and 50°, or within a range of 42° and 48°. Other angles may also be used. The second end 326C of the inner sidewall 320C terminates at the peripheral edge 330C, while the first end 328 terminates at the annular lip 332C. The lip 332C surrounds the opening 334C, which passes centrally through the insert 256C along the central axis 230C. An annular flange 563C surrounds the first end 238C and projects radially outward from the sidewall 320C. An annular groove 564C surrounds the flange 563C just below the lip 332C and is recessed into the flange. The annular groove 564C is configured to receive an O-ring 566C.

[0435] The insert 256C also includes a tubular conduit portion 570C disposed within an opening 334C of the insert 256C to extend along at least a section of a first portion 560C and a second portion 562C of the inner sidewall 320C. A free end 571C of the conduit portion 570C protrudes from the opening 334C at a first end 238C. The conduit portion 570C defines a passage portion 572C through which an axis 230C extends. Three upper separators 574A-C project radially outward along the length of the conduit portion 570C to an inner surface 322C of the inner sidewall 320C. The upper separators 574A-C partially serve to secure the conduit portion 570C to the inner sidewall 320C and to divide the opening 334C through the first portion 560C into three separate channels. The strut 576C also extends radially between each pair of adjacent upper partitions 574A-C, between the conduit portion 570C and the sidewall 320C. The strut 576C is used to further support the conduit portion 570C at the first end 238C, but typically does not extend the length of the conduit portion 570C and is typically not as long as the upper partitions 574A-C. Figure 36As shown, the outer partition 578A-C is radially aligned with but spaced apart from the upper partition 574A-C. The outer partition 578A-C protrudes outward from the inner surface 322C at its second end 326C on the inner sidewall 320C, thus protruding beyond the peripheral edge 330C. The outer partition 578A-C is radially aligned with the upper partition 574A-C.

[0436] Protruding outward from the outer surface 324C of the inner sidewall 320D are a plurality of radially spaced dividers 350A-F. Dividers 350 are in the form of linear guides, which extend radially outward from the outer surface of the inner sidewall 320C aligned with axis 230C and longitudinally from flange 563C at the first end 326C to peripheral edge 330C at the second end 238C. Dividers 350A, C, and E are aligned with upper dividers 574A-C and outer dividers 578A-C, respectively, and also intersect with outer dividers 578A-C.

[0437] During assembly, insert 256C is positioned on and interlocked with disk 500 and dispersion member 252. Specifically, see [reference needed]. Figure 29 , Figure 31 and Figure 36 Insert 256C is nested on top of disk stack 253C, such that upper separators 574A-C pass through corresponding upper recesses 522 of disk 500C and engage with the upper ends of retaining guides 296A-C of dispersing member 252C, respectively. Simultaneously, the lower end of conduit portion 570C passes through opening 512 of disk 500C and connects to the upper end of rod portion 289C of dispersing member 252C. Conduit portion 570C and rod portion 289C combine to form conduit 568C defining channel 569C. Figure 24 The outer separators 578A-C of the insert 256C pass downward through the recess 524C of the disk 500C and engage with the extensions 299C of the retaining rails 296A-C, respectively. In this nested configuration, rotation of the base 250C also facilitates the current rotation of each of the dispersing member 252C, the disk 500C, and the insert 256C.

[0438] Reference Figure 26 and Figure 33The cap 254C has an inner surface 300C extending between a first end 307C and an opposing second end 308C, and an opposing outer surface 302C. The cap 254 includes a tubular rod 358C disposed at the first end 308C and an annular sidewall 304C disposed at the second end 307C. The sidewall 304C is hereinafter referred to as the "upper sidewall 304C". The upper sidewall 304C and its inner surface 300C have a truncated conical configuration that tapers inward from an annular flange 305C at a lower end to the rod 358C. In one embodiment, the sidewall 304C is configured such that its inner surface 300C is inclined at an angle between 35° and 55° relative to the central axis 230C, and more commonly between 40° and 50° or within the range of 42° and 48°. Other angles may also be used.

[0439] like Figure 34 As best seen, during assembly, the cap 254C is connected to the base 250C via cap flanges 256C and 305C. To help ensure proper alignment and centering, an annular ridge 540C erected from flange 305C can be received within an annular slot 542C formed on flange 265C. In an alternative embodiment, ridge 540C and slot 542C can be inverted. With flanges 256C and 305C overlapping, a threaded hole 546C extends through it. Figure 26 The annular mounting ring 544C can be positioned against the bottom surface of flange 265C. Fasteners 548 (such as screws, bolts, etc.) can then be pushed down through alignment openings in flanges 305C and 265C and screwed into holes 546 on the mounting ring 544. The mounting ring 544C is typically made of metal (such as aluminum or stainless steel) and provides enhanced uniform compression between flanges 256C and 305C, while also increasing structural stability. Formed between flanges 256C and 305C is an annular slot 550C that tapers in a triangular or wedge shape. An O-ring 552C is received and compressed within the slot 550C to form an airtight seal between the cap 254C and the base 250C. Because the slot 550C is tapered, the O-ring 552C is further pressed into the constricting slot 550C when the fluid pressure inside the separating rotor 184C increases, which further enhances the sealing effect of the O-ring 552C.

[0440] return Figure 26The rod 358C has a generally cylindrical configuration and projects outward from the upper sidewall 304C, such that the central axis 230 passes centrally through the rod. In the depicted embodiment, the rod 358C and the cap 254C are integrally formed as a single, monolithic component. However, in other embodiments, the rod 358C may be mounted separately and fixed to the cap 254C. As will be discussed in more detail below, the rod 358C terminates at an end face 544C having an end opening 556C extending through it in alignment with the axis 230C. Extending laterally through the rod 358C between the inner surface 300C and the outer surface 302C are a plurality of radially spaced side openings 558C. In one embodiment, six side openings 558C are formed, wherein all side openings 558C are disposed in a common plane orthogonal to the axis 230C. Other numbers of side openings 558C may also be formed.

[0441] Turning Figure 21 As previously discussed, when the cap 254C is placed above the insert 256C and secured to the base 250C, the first portion 560C of the insert 256C is received within the rod 358C of the cap 254C. The free end 571C of the conduit 568C extends through the end opening 556C of the rod 348C, while the O-ring 566C forms a seal between the first portion 560C of the insert 256C and the inner surface of the rod 358C above the side opening 556C. In the assembled state, the base 250C, the dispersing member 252C, the insert 256C, the disc 500C, and the cap 254C are fixed together and rotate simultaneously with the base 250C.

[0442] The assembled split rotor 184C is enclosed within the split stator 180C. Specifically, as previously discussed, the base 250C of the split rotor 184C is located within the base 190C of the split stator 180C, and is thus supported on the bearing assembly 270C. In this position, the drive coupling 186C is freely disposed within the receiving portion 206C. As previously discussed, the neck 174C of the head 192C is secured to the base 190C using fasteners 233C and O-rings 235C. As previously discussed, the nose 214C of the head 192C is secured to the neck 174C using fasteners 221C and O-rings 223C simultaneously or subsequently with the neck 174C.

[0443] The base 250C, dispersing member 252C, disc 500C, insert 256C, and cap 254C are each typically made of a polymeric material (such as liquid crystal polymer, polycarbonate, PVDF, HDPE, PEI, PEEK, etc.). Different parts may be made of the same or different materials. As previously mentioned, manufacturing parts with polymeric materials minimizes the cost of the centrifuge, allowing it to be economically discarded after a single use, thus avoiding the need for subsequent sterilization or other cleaning. However, in an alternative embodiment, one or more parts may also be made of metal (such as aluminum or stainless steel).

[0444] Turning Figure 37 During assembly, the bearing assembly and various seals are positioned between the nose 214C / head 192C and the upper end of the rotor assembly 182C. Specifically, during assembly, the free end 571C / conduit portion 570C of the conduit 568C is received within the channel 45 of the inlet port 38. A dynamic seal 580C is used to form a seal between the conduit 568C and the head 192C / nose 214C, which allows the conduit 568C to rotate relative to the head 192C / nose 214C. In one exemplary embodiment, the dynamic seal 580C may be spring-loaded. For example, in the depicted embodiment, the dynamic seal 580C includes a spring-loaded rotating face seal. Other types of dynamic seals may also be used.

[0445] The dynamic seal 580A includes an annular mount 582A, which is received and secured within an annular recess 584A surrounding the channel 45 of the inlet port 38. Attached to the mount 582A to surround the free end of the conduit 568C is an annular static seal element 586A. In one embodiment, the static seal element 586A comprises a ceramic ring. Attached to the exterior of the conduit 570C is an annular mount 588A. Attached to the mount 588A to sit abut the static seal element 586A is an annular dynamic seal element 590A. The dynamic seal element 590A is made of a material that will form a wear-resistant seal with the static seal element 590A when the dynamic seal element 586A rotates over the static seal element 586A. The materials used for the static seal element 586A and the dynamic seal element 590A can be the same as those used for conventional rotary pump seals. Mounting element 582A and / or mounting element 588A are typically made of a flexible elastomer material and are generally more flexible than static sealing element 586A and dynamic sealing element 590A. One end of spring 592A is disposed in a groove 594C formed at the end of insert 256C to seat support rod 576C and / or upper separator 574. Figure 35The opposite ends of spring 594A elastically press against dynamic sealing element 590A to load or press dynamic sealing element 590A against static sealing element 586A. The flexibility of mounting member 588A allows dynamic sealing element 590A to float or move along axis 230A while being pressed by spring 592A, in order to accommodate the expansion and / or contraction of rotor assembly 182C during use and to account for wear of dynamic sealing element 590A and / or static sealing element 586A, while still achieving an impermeable seal between them. Given dynamic seal 580C, fluid forced into inlet port 38 and traveling along channel 45 enters channel 569C of conduit 568C and travels downward along that channel.

[0446] Bearing assembly 596C (such as a race bearing) extends between the cap 254C and the head 192C / nose 214C of the separated rotor 184C. Bearing assemblies 596C and 270C ( Figure 24The rotor assembly 182C / separate rotor 184C is supported and stabilized within the separate stator 180C, while allowing the rotor assembly 182C / separate rotor 184C to rotate within the separate stator 180A. A dynamic seal 580B extends below the side opening 558C between the head 192C / nose 214C and the separate rotor 184C, while a dynamic seal 580C extends above the side opening 558C between the head 192C / nose 214C and the separate rotor 184C. In one embodiment, dynamic seals 580B and 580C may also be spring-loaded and include a spring-loaded rotating surface seal. Other types of dynamic seals may also be used. Dynamic seals 580B and 580C are depicted having substantially the same elements as dynamic seal 580A. Therefore, similar elements are identified by similar reference numerals, but the reference numerals have the letters corresponding to the seals. For example, the dynamic seal 580B includes an annular mount 582B fixed to the head 192C / nose 214C and an annular static seal element 586B fixed to the mount 582B. An annular spacer 582B may extend between the bearing assembly 596C and the mount 586C. Subsequently, the annular mount 588B is fixed to the separate rotor 184C, wherein the annular dynamic seal element 590B is fixed to the mount 588B. The dynamic seal element 590B is disposed against the static seal element 586B to form a seal between them. Again, the mounts 582B and / or 588B may be made of a flexible elastomer material that is more flexible than the dynamic seal element 590B or the static seal element 586B, thereby allowing the dynamic seal 580B to float or move. A dynamic seal 580C is similarly constructed on the opposite side of the side opening 558C. A single spring 592B has one end biased against abutment mount 588B and a second end mounted against abutment mount 588C for loading or pressing against dynamic seals 580B and 580C. Thus, a single spring 592B can operate with two separate dynamic seals. Spring 592B is positioned within an annular heavy component collection groove 446C surrounding cap 254C and extending between dynamic seals 580B and 580C. A first outlet port 40 is aligned with and communicates with the heavy component collection groove 446C, which in turn is aligned with and communicates with a side opening 558C. Therefore, fluid flowing through the side opening 558C is forced to flow out through channel 49 of the first outlet port 40.

[0447] Turning Figure 38During operation, motor 169 is active, causing drive rotor 150 to rotate relative to separate stator 180C about central axis 230C. Subsequently, as previously discussed, magnetic force generated by magnet 168 acts on drive coupling 186C to simultaneously rotate drive coupling 186C and separate rotor 184C about central axis 230 and relative to separate stator 180. During operation, separate rotor 184C typically rotates at a rate of at least 1,000 rpm, 2,000 rpm, 2,500 rpm, 3,000 rpm, or 3,500 rpm, or within any two of the aforementioned values. Other speeds may also be used depending on the application.

[0448] Once the rotation of the separator rotor 184C is started, the inlet flow of the suspension 18 is 102 ( Figure 1 , Figure 3 and Figure 5 The inlet flow 102 is delivered to the inlet port 38 and travels along the central axis 230C through the conduit 568C and through the opening 290C of the dispersing member 252C to enter the space 448C between the dispersing member 252C and the base plate 264C of the separating rotor 184C. Within the space 448C, the inlet flow 102 flows radially outward in all directions toward the peripheral edge 286C of the dispersing member 252C. To some extent, the dispersing member 252D serves to force the inlet flow 102 radially outward away from the central axis 230C, thereby maximizing the rate and force at which the inlet flow 102C begins to separate into heavy and light components. Specifically, as the inlet flow 102 moves radially outward away from the central axis 230C, it experiences a greater centrifugal force due to the increased rotation of the separating rotor 184C. Therefore, as the inlet flow 102 passes around the peripheral edge 286C of the dispersing member 252C, the centrifugal force causes the inlet flow 102 to separate into a heavier component traveling radially outward and a lighter component traveling radially inward.

[0449] Additionally, radially extending spacers 272 and lower spacers 288 extend between the dispersing member 252C and the base plate 264C to divide the space 448 into multiple inlet fluid paths 460C extending from the conduit 420C to the peripheral edge 286C of the dispersing member 252C. Each inlet fluid path 460C is defined between a pair of adjacent spacers 272C / lower spacers 288C to force the inlet flow 102 to flow radially outward along a generally linear path, rather than swirling in circles around the central axis 230 within the space 448C. This linear, radial flow of the inlet flow 102 again helps the inlet flow 102 move rapidly away from the central axis 230C to increase the rate at which the inlet flow 102 is separated into heavier and lighter components. Furthermore, the linear radial flow helps to maintain the inlet flow 102 in a laminar rather than turbulent flow, which further contributes to the separation of the inlet flow 102 into heavier and lighter components. In the depicted implementation, six inlet fluid paths 460C are formed. Figure 27 In an alternative embodiment, other numbers of inlet fluid paths 460C may be formed, such as at least 3, 4, 5, 6, 7, 8, 9, or 10, or a number within any two of the aforementioned values. Furthermore, as the inlet flow 102 flows radially outward along the inlet fluid path 460C, the fluid also flows through a groove 267C formed on the base plate 264C. As previously discussed, the fluid flowing through the groove 267C helps to cool the adjacent bearing assembly 270C.

[0450] The lower sidewall 266C of the base 250C and the upper sidewall 304C of the cap 254C combine to form the outer sidewall 450C of the separating rotor 184C, while the inner sidewall 320C of the insert 256C forms the inner sidewall 320C of the separating rotor 184C. The outer sidewall 450C and the inner sidewall 320C combine to form the sidewall assembly 452C of the separating rotor 184C, which surrounds the compartment 454C, and the space 448C forms part of the compartment.

[0451] like Figure 39 As better depicted in the sectional view, the lower separator 288C protrudes radially outward within the space 448C from or toward the opening 290C of the dispersing member 252C to the sidewall assembly 452C, and more specifically, radially outward to the outer sidewall 450C / lower sidewall 216C. Thus, the lower separator 288 creates three isolated inlet fluid paths 460 below the dispersing member 252C.

[0452] Similarly, such as Figure 24 and Figure 29As depicted, three walls 600A-C are formed within compartment 454C. These walls extend radially outward from conduit 568C to inner wall 320C and lower wall 266C, and longitudinally from top surface 282C of base 280C to first end 238C of insert 256C, generally extending above side opening 558C. Walls 600A-C define multiple light component fluid paths 456A-C that extend longitudinally along separator rotor 184C, and a portion of the fluid travels through these paths. Walls 600A-C prevent or restrict the radial flow of fluid traveling within fluid paths 456A-C around conduit 568C. Figure 24 The figure depicts a side view of wall 600A. As shown, wall 600A is formed by a combination of retaining guide rail 296A, outer separator 578A, upper separator 574A, and stacking guide 516A. Similarly, other walls 600B and C are formed by corresponding retaining guide rail 296, outer separator 578, upper separator 574, and stacking guides 516B and C, respectively.

[0453] Walls 600A-C are also aligned with and intersect with lower separators 288A-C, respectively. Therefore, each inlet fluid path 460 defined between adjacent lower separators 288 is aligned with a corresponding light component fluid path 456, and the fluids do not mix as they pass between them. That is, fluid traveling along inlet fluid path 460 to the corresponding light component fluid path 456 does not mix with the separated fluid traveling along the separating inlet fluid path 460 to the separating corresponding light component fluid path 456. Again, this configuration facilitates continuous fluid flow along a generally linear path, rather than swirling in circles around duct 568C / central axis 230C, and helps maintain a stronger laminar flow rather than turbulent flow, both of which contribute to separating the fluid into heavy and light components. In the depicted embodiment, three walls 600 and three lower separators 288 are shown. In an alternative embodiment, the separator rotor 184 may have at least 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21 or more walls 600 and lower separators 288, or have walls and lower separators within the range of any two of the aforementioned values.

[0454] Reference Figure 33 , Figure 35 , Figure 38 and Figure 39Multiple heavy component fluid paths are formed between the insert 256C and the cap 254C. Specifically, since the separators 350A-F protrude outward from the outer surface 324C of the insert 256C, an annular truncated conical gap 462C is formed between the inner sidewall 320C of the insert 256C and the inner surface 300C of the cap 254C. The outer edge of the separators 350A-F sits against the inner surface 300C of the cap 254C, such that the separators 350A-F divide the annular truncated conical gap 462C into multiple separated heavy component fluid paths 464A-F. That is, the sidewall assembly 452C defines multiple separated heavy component fluid paths 464A-F. Each heavy component fluid path 464 has an opening 466C provided at the peripheral edge 330C / inner sidewall 320C of the insert 256C. For example, Figure 38 The heavy component fluid path 464A is shown. Walls 600A-C are typically aligned with separators 350A, C, and E, respectively.

[0455] Using separators 350C to form and isolate heavy component fluid paths 464A-F helps the heavy components flowing into and along the heavy component fluid paths 464 to flow continuously along a generally linear path, rather than swirling in circles around the central axis 230C. It also helps maintain a stronger laminar flow rather than turbulent flow for the heavy components. Both types of flow facilitate fluid separation and limit the application of excessive forces, which could be destructive or harmful, to the separated cells or microorganisms. In the depicted embodiment, six separators 350A-F are used to form six heavy component fluid paths 464A-F. In an alternative embodiment, the separator rotor 184C may be formed with at least 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 26, 32, 38 or more separators 350 and / or heavy component fluid paths 464, or may be formed with separators and / or heavy component fluid paths within the range of any two of the foregoing values.

[0456] Go to Figure 38Due to the centrifugal force generated by the rotation of the separating rotor 184C, the lighter component of the inlet flow 102 initially flows radially outward from the opening 290C, bypassing the peripheral edge 286C of the dispersing member 252C, and then radially inward into the corresponding light component fluid path in the light component fluid path 456 at the second end 242C of the separating rotor 184C. As the lighter component flows into the fluid path 456, the fluid travels between the discs 500C, where it can be further separated. Specifically, as the fluid travels between the discs 500C, the heavier aspect of the light component separates towards the bottom surface 506C of the discs 500C and flows downward and radially outward towards one of the heavy component fluid paths 464, while the lighter aspect separates towards the top surface 504C of the discs 500C and flows radially inward towards the conduit 568C. As the lighter component flows out from between the discs 500C, it flows along the channel between the conduit 568C and the insert 256C toward the first end 196C, flows past the end of the insert 256C, flows past the light component collection groove 444C, and serves as the second outlet flow 106. Figure 1 , Figure 3 and Figure 5 The flow exits through the second exit port 42. The second exit flow 106 can then be further processed or transferred as previously discussed.

[0457] In contrast to the light component flowing radially inward into the light component fluid path 456, heavier components, typically including cells, microorganisms, their particles, and other solids, flow radially outward toward the sidewall assembly 452C / outer sidewall 450C, and more specifically, the heavier component of the fluid flows into the corresponding heavy component fluid path 464 through opening 466C. The heavy component then flows toward the first end 196C of the separating rotor 184C within the heavy component fluid path 464. Upon reaching the first end 196C, the heavy component flows out through the side opening 558C, through the heavy component collection groove 446C, and then out through the first outlet port 40 as the first outlet flow 104. Figure 1 , Figure 3 and Figure 5 The first effluent stream 104 can then be further processed or transferred as previously discussed.

[0458] return Figure 34As previously discussed, the heavy component is transferred through opening 466C into the heavy component fluid path 464. Opening 466C and heavy component fluid path 464 are defined between an outer wall 450C and an inner wall 320C. During operation, particles of the heavy component may collect at the constricted opening 466C and form precipitates. These precipitates may block or restrict the flow of the heavy component through opening 466C and into the heavy component fluid path 464. Separator 12C and other separators disclosed herein may be operated in different ways and / or modified into different designs to help minimize precipitate formation and / or remove precipitates after formation. For example, such as Figure 5 The pump 100A shown can be applied to the first outlet flow 104 to draw heavy component fluid through the heavy component fluid path 464. Increasing the flow rate of the pump 100A can minimize the formation of precipitates and / or draw out the formed precipitates through the opening 466 and remove them from the first outlet port 40. For example, the pump 100A can operate at a first flow rate and then periodically operate at a second flow rate higher than the first flow rate. Periodic operation at the higher flow rate can minimize the formation of precipitates and / or draw out the formed precipitates through the opening 466 and remove them from the first outlet port 40. The operation of the pump 100A at the higher flow rate can be based on a set time interval or on sensed operating parameters such as flow rate and / or pressure readings. The operation at the higher flow rate can be sustained for only a short time interval to avoid significantly disrupting the natural separation process. For example, the pump 100A can operate at a high flow rate for periodic time intervals of less than 30 seconds, 20 seconds, 10 seconds, 5 seconds, or within any two of the aforementioned time intervals.

[0459] The shape of the inner wall 320C can also be modified to help control the formation and / or removal of precipitates. For example, in Figure 34 In the depicted embodiment, the second end of the inner sidewall 320C has an annular tip 612A terminating at a circular end face 614C. In the depicted embodiment, the opposite sides 322C / 324C of the tip 612A remain parallel and are aligned with the opposite sides 322C / 324C of the central portion of the inner sidewall 320C. Figure 40 In an alternative embodiment depicted, the inner sidewall 320C may be formed with an annular tip 612B that is radially curved or bent toward the axis 230C. For example, an inner corner or curve may be formed at the tip 612B on the inner surface 322C of the inner sidewall 320C. This configuration results in the tip 612B having an orientation similar to that of the adjacent outer sidewall 450C and facilitates the supply of larger particles and / or deposits through the opening 466C.

[0460] exist Figure 41In another alternative embodiment depicted, the inner sidewall 320C may have an annular tip 612C formed at its second end, radially outwardly curved or bent away from the axis 230C. For example, an inner bend or curve may be formed at the tip 612C on the outer surface 324C of the inner sidewall 320C. This configuration results in a narrowing of the width of the opening 466C. The narrowing of the opening 466C directly increases the flow rate at the opening 466C, which helps to draw in larger solid particles and / or precipitates through the opening 466C, which then travel downwards.

[0461] In addition to the benefits discussed previously, centrifuges 12A, 12B, and / or 12C offer several unique advantages. For example, many prior art centrifuges used for separating cells from culture media can only operate in batch mode, not in continuous flow mode. That is, the centrifuge is loaded with a defined batch of suspension, operated to facilitate the separation of the defined batch, then stopped and reloaded with a new batch of suspension for separation. In other prior art centrifuges, the centrifuge must be temporarily stopped after a period of operation to backwash the system or remove the components collected therein. In contrast, the centrifuges 12A-C of the present invention can operate continuously without needing to stop to reload a new suspension, remove collected components, or rinse the system. Therefore, as used in the specification and appended claims, a “continuous flow” centrifuge is one that can continuously separate fluid flows without needing to stop the centrifuge to remove collected components or rinse the separator. For example, centrifuges 12A-C are operable to continuously separate the inlet stream 102 of suspension 18 into two outlet streams 104 and 106 for extended periods of at least 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 48 ​​hours, or longer, without requiring a stop to remove collected components or flush the system. Therefore, one benefit of this disclosure is that outlet streams 104 and 106 can exit centrifuges 12A-C simultaneously, while inlet stream 102 is flowing into centrifuges 12A-C.

[0462] Furthermore, because centrifuges 12A-C operate in a continuous flow process, the suspension 18 is processed more quickly due to less downtime. Therefore, cells and microorganisms experience less stress. For example, in Figure 1In the infusion system, centrifuges 12A-C can quickly and continuously separate the inlet flow 102 into outlet flows 104 and 106 and return outlet flow 104 to container 14, thereby minimizing the time required for cells and microorganisms to separate from the injected gas and nutrients within container 14, and thus minimizing stress on cells and microorganisms. Furthermore, due to the configuration of centrifuges 12A-C, minimal mechanical stress is applied to cells and microorganisms as they pass through the separators.

[0463] An additional benefit of centrifuge implementations is that they have few parts and are simple and inexpensive to manufacture, allowing them to be discarded after a single use. For example, the material cost of producing the main assembly 130 is relatively low because the separating stator 180 and separating rotor 184 can be simply molded from a polymer. Therefore, once the suspension 18 has been completely processed from the container 14, the main assembly 130 can be easily disposed of, for example, by recycling, thus avoiding any need for cleaning or sterilization. A new main assembly 130 can then be used with a magnetic actuator 132 to process a new container 14 for storing a new amount of suspension 18. Because the magnetic actuator 132 never comes into direct contact with the suspension 18, it can be reused repeatedly without the need for sterilization or cleaning.

[0464] Another advantage of centrifuges 12A-C is that the main assembly 130 can be easily sterilized before transport and use. For example, as discussed above, once the main assembly 130 is assembled, it can be sealed and then sterilized by irradiation (such as gamma irradiation). Depending on the materials used, some embodiments may also be sterilized by autoclave. As used in the specification and appended claims, the terms "sterile" and "sterilized" mean free from bacteria or other living microorganisms. Because the main assembly 130 comprises a minimal number of metal parts, there is minimal interference with the irradiation process.

[0465] Finally, the unique configuration of centrifuges 12A-C enables efficient separation of solids. Other benefits also exist.

[0466] The centrifuges and components disclosed herein can be incorporated into portable and modular carriages, which will be described in detail below. Figure 42 and Figure 43Front and rear perspective views of an exemplary centrifuge carriage 700 are depicted. The carriage 700 may include a platform or base 702 with a wheel assembly 703 that provides portability, ease of movement, and positioning of the carriage 700, such as positioning it to a bioproduction facility or within a bioproduction device and / or during processing. The wheel assembly 703 may have red polyurethane casters with bearings and mounting plates for mounting the wheel assembly 703 to the base 702. In other embodiments, the wheel assembly 703 may be eliminated.

[0467] The carriage 700 also includes a housing 701 supported on a base 702. The housing 701 may include opposing side panels 704A and 704B extending between a front panel 705 and an opposing rear panel 706. Panels 704, 705, and 706 extend between the base 702 at its lower end and a top panel 707 at its upper end to form a closed, receptacle-like unit within the carriage 700 / housing 701 having one or more compartments 708. Panels 704, 705, 706, and 707 may be made of one or more pieces of metal, plastic, or other rigid material that form the walls of the one or more compartments 708 of the carriage 700.

[0468] The buffer and / or handle 710 may be mounted on one or both side panels 704A and 704B of the housing 701 or on other panels, so that the operator or automation system can grip the handle 710 while moving the carriage 700 into an optimal position for integration into the bioproduction process.

[0469] like Figure 46 As shown, the mounting platform 709 can be disposed within the housing 701 and can extend laterally between the panels 704, 705, and 706 of the carriage 700 / housing 701 for mounting the centrifuge 12 on the mounting platform. Although any of the centrifuges disclosed herein can be used on the carriage 700, the separator 12C is depicted and discussed together with the carriage 700. The mounting platform 709 divides the compartment 708 into a top compartment 708A and a bottom compartment 708B. Figure 43 The top compartment 708A and / or the bottom compartment 708B may be hermetically sealed to the environment, but this is not required. In one exemplary embodiment, the top compartment 708A and the bottom compartment 708B are hermetically sealed to each other and to the environment.

[0470] Similarly, Figure 46As shown, a doorway 710 is formed in the housing 701 and provides communication and access to the top compartment 708A. The doorway 710 is sized and configured such that the separator 12C can be manually inserted into and removed from the top compartment 708A. The doorway 710 is shown as a portion extending through the front panel 705 and the top panel 707. In other embodiments, the doorway 710 may extend only through the front panel 705 or the top panel 707, or it may extend through other panels. (See reference...) Figure 42 Door assembly 711 may be disposed on housing 701 to selectively open and close doorway 710. More specifically, in an exemplary embodiment, door assembly 711 includes door 716 movably mounted to housing 701 (e.g., hingedly mounted to housing 701) such that door 716 can be in an open position where doorway 710 is open. Figure 46 ) and the closing position of doorway 710 ( Figure 42 The separator 12C can be moved between the two locations. In the open position, the mounting platform 709 is exposed, allowing the separator 12C to be mounted on or removed from the platform within the top compartment 708A, or otherwise accessed within the top compartment 708A. In the closed position, the doorway 710 is covered by door 716 to act as a shield or cover in the event of a malfunction of the separator 12C during operation. In one embodiment, door assembly 711 / door 716 can be automatically locked during operation of the centrifugal separator 12C; for example, door assembly 711 can be self-locking or programmed to lock automatically.

[0471] In an exemplary implementation, such as Figure 45 As shown, door assembly 711 may include switch block 715, latch 713, locking protection switch 719, and actuation locking key 720, which interact with door 716. Switch block 712 and locking protection switch 719 communicate wired or wirelessly with controller 798, which includes a programmable processor and non-transitory memory programmed to actuate switch block 715 and locking protection switch 719 and move latch 713 from a locked position to an unlocked position. In an exemplary embodiment, switch block 712 and locking protection switch 719 form a key or tongue-operated solenoid interlock switch with a key entry slot. Actuation locking key 720 may be inserted into one or more key entry slots to unlock door 716, or door 716 may be automatically unlocked using controller 798. Door assembly 711 may also include hinges, bearings, bushings, and / or radial dampers 762 (in... Figure 48(As shown in the diagram), these features facilitate rotation of door 716 about the axis of rotation, radially and upward to open the door assembly and radially and downward to close the door assembly. Radial dampers 762 also prevent door 716 from opening or closing with excessive speed or force, thereby preventing damage. Door assembly 711 / door 716 acts as a containment shield capable of withstanding the maximum forces associated with a failure of centrifuge 12C at maximum speed or rpm.

[0472] In an exemplary embodiment, controller 798 is programmed to automatically lock door assembly 711 / door 716 when centrifuge 12C is in operation, and to automatically unlock door assembly 711 / door 716 when centrifuge 12C is not in operation. Controller 798 is also programmed to prevent locking of centrifuge 12C (described in detail with respect to loading assembly 800) and actuation of mounting clip 804 if door 716 is open.

[0473] The centrifuge carriage 700 is a modular and portable unit comprising single-use process equipment and components that can be easily installed, mounted, and removed from the carriage 700 / housing 701 via quick-release and easily connectable ports and mounting components. Therefore, the exemplary carriage 700 can be fully equipped with different sets of processing components and equipment required for the efficient integration of the centrifuge 12C into various bioproduction processes. The exemplary carriage 700 can also be configured without process equipment but with ports and mounting components, allowing an operator or end-user to select a customized set of processing components and equipment to be mounted via the quick-release and easily connectable ports and mounting components of the carriage 700.

[0474] Exemplary quick-release and easy-connect ports and mounting assemblies include pipes and pipe supports, cable management systems, mounting hardware, connectors and ports for centrifuges, controllers, sensors, valves, power supplies, and pumps. Exemplary process equipment and components include pipes, tubes, cables and electronics, controllers, pumps, power supplies, sensors, probes, valves, and centrifuges. In a preferred embodiment, one or more exemplary processing components are single-use and / or disposable components. Exemplary quick-release and easy-connect ports and mounting assemblies, process equipment, and components can be mounted and installed on any surface of the carriage 700 / housing 701 (including the side panels 704, front panel 705, rear panel 706, and top panel 707 of the carriage 700 / housing 701), in a compartment 708 of the carriage 700 / housing 701, or on a mounting platform 709 of the carriage 700.

[0475] In an exemplary embodiment, power supply 733 ( Figure 45The power supply 733 is located on the rear panel 706 of the slide 700 / housing 701. The power supply 733 provides power to all process equipment mounted on the slide 700, including centrifuges, centrifuge motors, controllers, door assemblies, fieldbuses, fieldbus nodes and switches, linear actuators, linear actuator motors, pumps, pump motors, sensors, switches, valves, and valve control systems. The power supply 733 can be a single power supply, multiple power units, a programmable power supply, a DC power supply, a variable AC power supply, a switch-mode power supply (SMPS), or an uninterruptible power supply (UPS). In an exemplary embodiment, the power supply 733 is a variable AC 240V power supply.

[0476] Reference Figure 22 A. One or more tube seats 722 (and typically multiple tube seats) are mounted on the housing 701, and in an exemplary embodiment, are mounted to a side wall panel 704A of the carriage 700. The tube seats 722 may be formed as clips configured to retain conduits and / or pipes for flowing biological fluids and solids to and from process equipment mounted on and from the carriage 700.

[0477] like Figure 46 As shown, separator 12C is detachably fixed within top compartment 708A. Installed into and protruding outwards from separator 12C are fluid lines 36, 44, and 52, as previously described. Figures 1 to 5 The fluid line 36 at the inlet port is used to deliver an inlet flow, such as from the bioproduction reservoir 10, to the separator 12C. Fluid line 44 is connected to the first outlet port 40 and is used to deliver a downstream heavy component outlet flow. Finally, fluid line 52 is connected to the second outlet port 42 and is used to deliver a downstream light component outlet flow. Each of the fluid lines 36, 44, and 52 passes through a recess 764 that extends through the side panel 704A and / or the top panel 707 to communicate with the top compartment 708A. Erected within the recess 764 are guide rails 766 for separation channels 768. Typically, three separation channels 768 are formed. The size of each channel 768 is configured to receive the corresponding fluid line among the fluid lines 36, 44, and 52. The notch 764 is configured such that when the door 716 is moved to the open position, the separator 12, with the fluid lines previously connected thereto, can be positioned within the top compartment 708A, and the fluid lines 36, 44, and 52 are located within their respective channels 768. The door 716 can then be moved to the closed position to operate the separator 12C, while the fluid lines 36, 44, and 52 exit the top compartment 708A through the notch 764. To some extent, the guide rail 766 is configured to minimize any open space between the fluid lines 36, 44, and 52 passing through the notch 764, thereby minimizing the risk of any material being ejected from the top compartment 708A in the event of a failure of the separator 12.

[0478] like Figure 44 As depicted, fluid lines 36, 44, and 52 (which may also be referred to as line assemblies) are detachably mounted along the height of side panel 704A via pipe fittings 722. As previously discussed, fluid lines 36, 44, and 52 are typically formed of flexible piping, but may also include rigid piping. Fluid line 36, carrying inlet fluid, is detachably coupled to side panel 704A, on which a pinch valve 726 is mounted. Pinch valve 726 can selectively clamp fluid line 36 shut to prevent fluid flow, or release fluid line 36 to allow fluid flow. Connected to fluid line 36 are inlet pump 721 and one or more sensors 730.

[0479] An inlet pump 721 is detachably mounted to the housing 501 / sidewall panel 504A of the carriage 700 to pump biofluids, solids, mixtures, solutions, and suspensions to the centrifuge 12 via inlet line 36. The inlet pump 721 may include a pump assembly housing with a quick-release connector that connects to the inlet port 721A and outlet port 721B of the pump 721, as well as a motor interface for driving the pump 721. The pump assembly housing may be enclosed around the pump 721 and provide an hermetically sealed environment. Inlet port 721A may be fluidly connected to a bioproduction reservoir 10. The bioproduction reservoir 10 may be any bioproduction reservoir, including but not limited to mixers, cell factories, bioreactors, fermenters, laboratory and laboratory-scale reservoirs, and other reservoirs that can supply solid, fluid, or mixed-phase biological components to the carriage 700 for separation.

[0480] The inlet pump 721 can be a centrifugal pump or a positive displacement pump, such as a peristaltic pump. Preferably, the inlet pump 721 is a single-use, disposable centrifugal pump without bearings or seals. The inlet pump 721 can be enclosed in a sterile, sealed housing (such as a pump assembly box) and equipped with a suspended impeller driven by the magnetic field of the inlet pump motor. The inlet pump 721 is typically a centrifugal pump to provide high-flow-rate fluid to and through separator 12C for efficient processing. However, other types of pumps may be used in other applications. The pump 721 is detachably coupled to housing 701. This allows separator 12C, fluid lines 36, 44, and 52, and pump 721 to be pre-assembled and sterilized, for example by irradiation, and subsequently mounted as a single unit on carriage 700.

[0481] One or more sensors 730 may include one or more of a pressure sensor, conductivity sensor, flow meter sensor, pH sensor, temperature sensor, or turbidity sensor that may be spaced apart along a fluid line 36. One or more sensors 730 may be detachably inserted into a corresponding power socket 723 via a cable 765. In various embodiments, the sensors 730 may be equipped with quick-release through-plate connectors for easy connection and release for single-use. The power socket 723 may provide power to one or more sensors 730 and may couple one or more sensors 730 to a controller 798 for operation and monitoring of one or more sensors 730. The controller 798 may convert electrical signals from the sensors into measurable process parameters. In other embodiments, one or more sensors 730 may be wireless.

[0482] A fluid line 44 carrying the outlet flow of the heavy component is detachably coupled to a pump 749, typically a peristaltic pump, mounted on a housing 701 / side panel 704A. One or more sensors 758 are coupled to the fluid line 44. The one or more sensors 758 may include one or more of a pressure sensor, conductivity sensor, flow meter sensor, pH sensor, temperature sensor, or turbidity sensor spaced apart along the fluid line 44. The one or more sensors 758 are detachably plugged into a power socket 759 via a cable 767. In various embodiments, the sensors 758 may be equipped with quick-release through-plate connectors for easy connection and release for single use. The power socket 759 provides power to the one or more sensors 758 and couples the one or more sensors 758 to a controller 798 for operation and monitoring of the one or more sensors 758. The controller 798 converts electrical signals from the sensors into measurable process parameters. In other embodiments, the one or more sensors 758 may be wireless. The lower end of fluid line 44 branches at a tee joint 761, from which fluid lines 44A and 44B extend. Fluid lines 44A and 44B are each detachably connected to pinch valves 728A and 728B, respectively, mounted to housing 701. Therefore, by controlling the operation of pinch valves 728A and 728B, the heavy component outlet flow can be delivered to different locations, such as back to bioproduction reservoir 10 or to collection containers, waste containers, or other downstream process equipment. In other embodiments, tee joint 761 can be eliminated, and fluid line 44 can be coupled to a single pinch valve 728.

[0483] A fluid line 52 carrying the outlet flow of a light component is detachably connected to a pump 748 mounted on a housing 701 / side panel 704A, which is typically peristaltic. Connected to the fluid line 52 are a flow meter sensor 763, a pressure sensor 731, a turbidity sensor 729, and a sensor 735. Sensor 735 may include one or more of a pressure sensor, a conductivity sensor, a flow meter sensor, a pH sensor, a temperature sensor, or a turbidity sensor. Sensors 763, 731, 729, and 735 can each be detachably inserted via a cable into a power socket located on the housing 701. The power socket provides power to sensors 763, 731, 729, and 735 and couples them to a controller 798 for operation and monitoring of the sensors. In other embodiments, sensors 763, 731, 729, and 735 may be wireless. The lower end of fluid line 52 branches at a tee joint 761, from which fluid lines 52A and 52B extend. Fluid lines 52A and 52B are each detachably connected to pinch valves 727A and 727B, respectively, mounted to housing 701. Therefore, by controlling the operation of pinch valves 727A and 727B, the heavy component outlet flow can be delivered to different locations, such as back to bioproduction reservoir 10 or to collection containers, waste containers, or other downstream process equipment. In other embodiments, tee joint 737 can be eliminated, and fluid line 52 can be coupled to a single pinch valve 727.

[0484] The various sensors discussed above regarding fluid lines 36, 44, and 52 can measure and provide signals indicating pressure, flow rate, turbidity, density, motor power, rotor rpm, temperature, pH, O2 concentration, CO2 concentration, and other process parameters at various locations throughout the process flow lines, within the centrifuge, and in other pipes and equipment upstream and downstream of centrifuge 12.

[0485] One or more cable management modules 753 may also be mounted at various desired locations on the housing 701 / sidewall panel 704A of the carriage 700. The one or more cable management modules 753 may be low-profile, through-hole, multi-wire cable management systems that provide spools or other surfaces for winding and retaining cables. One or more impermeable sealing grommets may also be used with or independently of the cable management module 753 and the tube seat 722. The grommets form an impermeable seal around conduits, wires, cables, and cords that are routed to and from the process equipment mounted on and from the carriage 700. One or more ports may be provided to allow the tube seat 722 and cable management module 753 to extend out of the port during installation, during retraction into the port (e.g., flush with the sidewall panel 704A / housing 701 of the carriage 700), or during storage. The exemplary tube seat 722 and cable management module 753 provide enhanced equipment access, operational efficiency, and safety for the operator of the carriage 700.

[0486] The carriage 700 can also be equipped with a valve control system 760, which includes a flow control valve 726A and a pipe 725 (also in...). Figure 48 (As shown in the diagram), a series of operating valves 726, 727, 728, 744, valve terminals 739, and fieldbus node 747. The valve control system 760 can be an electric or pneumatic control system, and the valves 726, 727, 728, 744 can be electrically or pneumatically actuated. In an exemplary embodiment, valves 726, 727, 728, 744 are pneumatic pinch valves or spring-loaded throttle clamps. Valves 726, 727, 728, 744 can also be gate valves, ball valves, check valves, plug valves, ball valves, butterfly valves, needle valves, pinch valves, or solenoid valves equipped with solenoid elements for opening and closing the valve. Valves 726, 727, 728, 744 can also be equipped with optical digital position feedback sensors for detecting whether the valve is open or closed. An exemplary pneumatic valve control system may include a conduit 725 and a flow control valve 726A, through which air or other gas or hydraulic fluid is distributed via a manifold to each of valves 726, 727, 728, and 744 for valve actuation. Valves 726, 727, 728, and 744 may communicate wirelessly with a controller 98. The valves may also be self-actuated or manually operated.

[0487] Valves 726, 727, 728, and 744 can be arranged on and mounted to any surface of carriage 700 (including the sidewall panel 704A of carriage 700) to control the flow of biological fluids, solids, mixtures, solutions, and suspensions through flow lines to and from centrifuge assembly 12C and through other process equipment. Valves 726, 727, 728, and 744 may also include snap-fit ​​grooves for quickly loading and unloading tubing into and from the valve. In an exemplary embodiment, valves 726, 727, 728, and 744 are single-use valves made of disposable material to allow for inexpensive and easy replacement after use.

[0488] Valve terminal 739 may be mounted to the base 702, panels 704, 705, 706, 707, or mounting platform 709 of carriage 700. In an exemplary embodiment, valve terminal 739 is mounted in the bottom compartment 708B of carriage 700. Valve terminal 739 may include a communication port, a communication link, a circuit board, and a manifold with multiple pneumatic ports pneumatically connected to the inlet and outlet ports of valves 726, 727, 728, and 744. In one embodiment, gas or hydraulic fluid may be supplied via conduit 725 and flow control valve 726A and the manifold to distribute the gas or hydraulic fluid to and actuate each of valves 726, 727, 728, and 744.

[0489] In an exemplary embodiment, the communication port and link may be an I / O port and link coupled to the fieldbus node 747. The valve terminal 739 and the fieldbus node 747 may communicate wiredly or wirelessly with a controller 798, which controls the actuation of valves 726, 727, 728, and 744 using electrical signals, pneumatic pressure, or hydraulic pressure applied through the valve terminal 739 and the manifold. The valve control system 760 may use specific communication protocols to facilitate the transmission of data and electrical signals between the valve terminal 739, the fieldbus node 747, the valves 726, 727, 728, 744, and the controller 798. Exemplary industrial fieldbus and Ethernet protocols include, but are not limited to, Profibus, Modbus, DeviceNET, Profinet, Ethernet / IP, Ethernet CAT, and Modbus TCP. In an exemplary embodiment, the communication protocol used by the valve control system 760 is Profinet.

[0490] One or more process lines (including inlet line 36 and outlet lines 44, 52) and valves 726, 727, 728, 744 may be configured and actuated to route biological components to centrifuge assembly 12C for separation. In an exemplary embodiment, inlet line 36 and inlet valve 726, located upstream of inlet pump 721, may be configured and actuated by controller 798 to bypass centrifuge assembly 12C during startup and to deliver air, other gases, liquids, solids, or biological components downstream of inlet pump assembly 721 and centrifuge assembly 12C. This operation may be used to flush the air and gas system before or after use. Inlet line 36 and inlet valve 726, located upstream of inlet pump 721, may also be configured and actuated by controller 798 to transfer biological components from the bioproduction reservoir to centrifuge assembly 12C for separation.

[0491] Light outlet line 52 and a light outlet valve 727 may be configured and controlled via controller 798 to allow the light biological components separated from centrifuge assembly 12C to flow downstream and be conveyed for processing, while another light outlet valve 727 may be configured to recycle and convey the light biological components separated from centrifuge assembly 12C back to the bioproduction reservoir of the supply system.

[0492] Similarly, the heavy outlet line 44 and a heavy outlet valve 728 may be configured and controlled via controller 798 to allow the heavy biological components separated from centrifuge assembly 12C to flow downstream and be conveyed for processing, while another heavy outlet valve 728 may be configured to recycle the heavy biological components separated from centrifuge assembly 12C and convey them back to the bioproduction reservoir of the supply system.

[0493] Recycled biological components leaving the bioprocess reservoir can flow through and be conveyed via inlet pump 721 and reach centrifuge 12C or bypass centrifuge 12C via a crack in the inlet line assembly.

[0494] The carriage 700 can be equipped with an emergency shut-off valve 744. Figure 45 The emergency shut-off valve closes one or more outlet lines 44, 52 of the centrifugal separator assembly 12C during emergencies, leaks, or other situations. Each of valves 726, 727, 728, and 744 can be used as an emergency shut-off valve.

[0495] like Figure 42As shown, carriage 700 may include user input and digital display 756, switch block 717, switch reset button 74, and emergency stop button 714, which can be used to start, stop, and otherwise control the operation of centrifuge 12C and / or components of carriage 700. In one embodiment, if emergency stop button 714 is actuated to stop centrifuge 12C, the user may need to actuate switch reset button 774 to reset switch block 717 for operation. User input and digital display 756 allows the operator to provide process parameter inputs and read process parameter outputs, which control and indicate process parameters such as pressure, flow rate, turbidity, density, temperature, pH, motor power, rotor rmp, and other process parameters in flow lines and process equipment throughout carriage 700.

[0496] In exemplary embodiments, process equipment and components, including pipes, tubes, cables, and electronics, controllers, motors, pumps, power supplies, sensors, probes, valves, and centrifuges, can be mounted at various locations on the carriage 700, depending on the specific requirements and configuration of the bioprocess in which the carriage 700 is integrated. For example, process equipment and components can be mounted and installed on any surface of the carriage 700 (including the side panels 704, front panel 705, rear panel 706, and top panel 707 of the carriage 700), in a compartment 708 of the carriage 700, or on a mounting platform 709 of the carriage 700.

[0497] Figure 48 and Figure 49 A front sectional view and a side sectional view of an exemplary centrifugal separator carriage 700 are depicted. Additional components and functionality of the carriage 700 are shown in the sectional views.

[0498] Mounting platform 709 is used to mount centrifuge 12C to carriage 700. Mounting platform 709 may be a flat workbench with a recess 812 that receives and interfaces with loading assembly 800. Loading assembly 800 can releasably load, mount, center, and lock centrifuge assembly 12C to carriage 700. Carriage 700 houses centrifuge assembly 12C within top compartment 708A. The housed centrifuge may be any centrifuge disclosed and described herein or in connection with U.S. Provisional Patent Serial No. 63 / 115,938, which is incorporated herein by reference in its entirety for all purposes.

[0499] As previously discussed, centrifuge assembly 12C may include a separation stator 180C forming a stator chamber 188C and a separation rotor 184C rotatably mounted and / or coupled to the stator chamber 188C. The separation rotor 184C forms a separation container 190C within which biological components are separated during rotation of the separation rotor 184C. A mounting surface 804 may be fixed to or integral with the separation stator 180C and serves to mount and / or lock the separation stator 180C and centrifuge 12C to the carriage 700. The mounting surface 804 may be a flange, cavity, bend, groove, or slot on the separation stator 180C. A drive coupling 186C having two ends, preferably with a magnet at one end, is coupled at one end to the separation rotor 184C and magnetically coupled at the other end to a magnetic actuator 148. The magnetic actuator 148 may include a housing 134 and a drive rotor 150, one end of which is coupled to a motor 169. The drive rotor 150 includes a magnet that generates a magnetic field capable of interacting with the drive rotor and magnetically coupling the drive rotor to a drive coupling 186C and / or a magnet on the drive coupling 186C. When the motor 169 rotates the drive rotor 150, the rotation of the drive rotor 150 and the magnetic field causes the drive coupling 186C and the disconnect rotor 184C to rotate. A stator chamber 188C may form a sterile seal and an airtight seal around the disconnect rotor 184C and the drive coupling 186C to provide a sterile chamber sealed to the environment.

[0500] Centrifuge 12C is preferably housed in the top compartment 708A of the carriage 700, where the door assembly 711 is located. An airtight seal may be formed around all components of centrifuge assembly 12C in the top compartment 708A of the carriage 700. Separating stator 180C acts as a containment shield and can withstand the maximum force associated with a failure of separating rotor 180C at maximum speed or rpm. Top compartment 708A and door assembly 711 act as a second containment shield and can also withstand the maximum force associated with a failure of separating rotor 180C at maximum speed or rpm. Therefore, the carriage 700 and centrifuge 12C together provide dual containment with two containment shields for enhanced safety. Dual containment is particularly suitable when handling potentially hazardous materials such as viruses, vaccines, and clinical-stage products and compositions.

[0501] The drive coupling 186C has one end connected to the separate rotor 184C and the other end magnetically centered and connected to the magnetic actuator 148. The drive coupling 186C may be mechanically attached to the separate rotor 184C at one end. The drive coupling 186C may be made of metal, magnetic material, or a magnetic material similar to that attached to the magnetic actuator 148, such that the magnetic field generated by the magnet on the magnetic actuator 148 can interact with the drive coupling 186C, magnetically couple to the drive coupling, and cause the drive coupling to rotate, which in turn causes the separate rotor 184C to rotate.

[0502] The drive coupling 186C can be disposed within or outside the separating stator 180C. The drive coupling 186C can also be disposed within a drive coupling sleeve 187C mounted to the separating stator 180C. The drive coupling sleeve 187C and / or the separating stator 184C can partially or completely form a sterile and airtight seal around the drive coupling 186C, the separating rotor 184C, and the separating container 190C, such that no seals are required to form airtight and watertight seals around the separating rotor 184C and the drive coupling 186C. The separating rotor 184C can then be magnetically driven by the drive coupling 186C and the magnetic actuator 148 without requiring a seal between the drive coupling 186C and the magnetic actuator 148 or a seal between the top compartment 708A and the bottom compartment 708B of the carriage 700. This configuration prevents contamination of the contents of the separation container 190C and the components of the centrifuge assembly 12C, and allows the operator to easily discard all or part of the centrifuge assembly 12C after use.

[0503] One or more magnets (not shown) may be mounted and attached to the drive coupling 186C. In an exemplary embodiment, the drive coupling 186C is annular and partially or completely surrounds the annular cavity. One or more magnets are fixed to the inner surface of the cavity. The magnets may be multiple magnet segments spaced apart and fixed to the inner surface to surround the cavity. In an exemplary embodiment, the magnets may include at least 2, 4, 6, 12, 18, 24, or 30 separate magnet segments. The magnetic segments may be oriented perpendicularly to the axis of rotation, such that the magnetic poles of the magnetic segments are axially oriented. The magnetic poles of each magnetic segment are preferably alternately axially oriented. The magnets may also be magnetic rings fixed to and surrounding the cavity. The magnetic rings may be dipole, quadrupole, hexapole, or octupole, and these poles may preferably be radially arranged. One or more magnets may be made of one or more magnetic materials, including neodymium.

[0504] Further details of the exemplary centrifugal separator assembly 12, including the drive coupling 186C, are described in relation to U.S. Provisional Patent Serial No. 63 / 115,938, which is incorporated herein by reference in its entirety for all purposes.

[0505] The carriage 700 is equipped with a loading assembly 800 to releasably load, install, and lock the centrifugal separator assembly 12C to the carriage 700. (See reference...) Figures 49 to 52 The loading assembly 800 includes a housing 802 having a support 804 projecting outward from its upper end. In one embodiment, the support 804 may be annular and project radially outward from the housing 802. Aligned with the housing 802 and erected vertically from the support 804 is a tubular inner sleeve 806. An alignment plate 808 is fixed to the upper end of the inner sleeve 806 and surrounds a central opening 810. Figure 52 As best depicted, the receiving portion 812 is aligned with and fixed to the inner surface of the alignment plate 808 and protrudes downward from that inner surface. The receiving portion 812 defines a cavity 814 communicating with the opening 810. In one embodiment, the alignment plate 808 and the central opening 810 are circular, while the cavity 814 has a cylindrical configuration.

[0506] At least partially surrounding the inner sleeve 806 is a mounting member 816. In one embodiment, the mounting member 816 includes an outer sleeve 818 having an annular mounting plate 820 disposed at its upper end. Both the outer sleeve 818 and the mounting plate 820 may completely or at least partially surround the inner sleeve 806 and may be circular. The mounting plate 820 may surround the outer sleeve 818 and project radially outward from the outer sleeve by a certain distance. One or more mounting elements 822 are disposed on and project upward from the top surface of the mounting plate 820. In the depicted embodiment, the one or more mounting elements 822 include three radially spaced clips 822A-C, each having a substantially L-shaped configuration. As will be discussed in more detail below, in alternative embodiments, the one or more mounting elements 822 may have a variety of different configurations. The mounting member 816 is slidable relative to the inner sleeve 806. Furthermore, the mounting member 816 / outer sleeve 118 has a shorter height than the inner sleeve 806. Therefore, the mounting member 816 / outer sleeve 118 may be slidable as... Figure 49 The lowering position shown is similar to... Figure 50 The mounting plate 820 can be moved between the raised and lowered positions. In the lowered position, the mounting plate 820 is positioned at a lower height. In the raised position, the top surfaces of the mounting plate 820 and the alignment plate 808 can be positioned in substantially the same plane.

[0507] Lifting assembly 824 is used to selectively move mounting member 816 between a lowered position and a raised position. Lifting assembly 824 includes a pivot mounting block 826 fixed to and erected on support member 804. A pair of pivot arms 828A and 828B each have a first end hinged to the opposite end of mounting block 826. Pivoting arms 828A and 828B protrude from mounting block 826 to extend beyond the opposite sides of mounting member 816 / outer sleeve 118 to a second end. A strut 830 extends between the second ends of pivot arms 828A and 828B. In this configuration, pivot arms 828A and 828B are positioned on opposite sides of mounting member 816 / outer sleeve 118, while pivot mounting block 826 and strut 830 are positioned on opposite opposite sides of mounting member 816 / outer sleeve 118. Openings 834A and 834B are centrally formed on or extend through pivot arms 828A and 828B. Support pins 832A and 832B protrude outward from opposite sides of mounting member 816 / outer sleeve 118 and are received within openings 834A and 834B, respectively. The size of openings 834A and 834B is set / configured such that pivot arms 828A and 828B can be supported by support pins 832A and 832B, but pivot about these support pins. In one embodiment, openings 834A and 834B are elongated such that support pins 832A and 832B can also slide laterally a certain distance within openings 834A and 834B.

[0508] A mounting bracket 836 protrudes downward from the support member 804, aligned with the strut 803. Extending between the lower end of the mounting bracket 836 and the strut 803 is a linear actuator 838. The linear actuator 838 typically includes a housing 840, a linear actuator rod 842, and a motor 844. The linear actuator rod is extendable outward from and retractable into the housing 840, and the motor controls the movement of the linear actuator rod 842 relative to the housing 840. The housing 840 is fixed to the mounting bracket 836, while the linear actuator rod 842 is fixed to the strut 836. The linear actuator 838 is electrically connected to a controller 798, which can control the operation of the linear actuator 838 automatically or manually or through sensor prompts.

[0509] During operation, linear actuator 838 can be activated to raise linear actuator rod 842, which in turn raises strut 830 and the second ends of pivot arms 828A and 828B. Pivot arms 828A and 828B pivot on pivot mounting block 826 and simultaneously raise mounting member 816 by engaging support pin 832. Mounting member 816 is raised to an elevated or unlocked position, in which mounting plate 820 is flush with alignment plate 808. When needed, linear actuator 838 can be activated to lower linear actuator rod 842, which then lowers mounting member 816 to a lowered or locked position, in which mounting plate 820 is positioned at a height below alignment plate 808.

[0510] The proximity sensor 846, mounted via the proximity sensor mount 848, can be positioned close to the pivot arm 828 and / or the strut 830 to sense whether the linear actuator 838 is actuated upwards or downwards and whether the loading assembly 800 is in the locked or unlocked position.

[0511] Turning Figure 51 The pivot mounting block 826 can be spring-loaded to allow for elastic movement. Specifically, in one embodiment, the pivot mounting block 826 is slidably secured to a pair of guide pins 850, which are secured to the support member 804 and pass through the pivot mounting block 826. A retaining pin 852 is also secured to the support member 804 and freely passes through a portion of the pivot mounting block 826. An enlarged head 854 is formed at the upper end of the retaining pin 852, with a spring 856 surrounding the retaining pin 852 and extending between the enlarged head 854 and the pivot mounting block 826. Thus, as needed, during movement of the lifting assembly 824, such as to prevent binding and overloading, the pivot mounting block 826 can elastically slide upward along pins 850 and 852 and subsequently elastically return to its initial position under the force of the spring 856. Thus, the pivot mounting block 826 moves according to elastic stiffness, tension, and force, which provides clearance between the mounting plate 820 and other components of the loading assembly 800 during locking of the centrifuge.

[0512] return Figure 47 and Figure 48 An opening 858 extends through a mounting platform 709 within the top compartment 708A to communicate with a bottom compartment 708B. A loading assembly 800 is secured within the bottom compartment 708B, for example, by one or more brackets 860 extending between a support 804 and the platform 709 or some other part of the housing 701. The loading assembly 800 is positioned to align with the opening 858 and such that the top surface of the alignment plate 808 is substantially flush with the top surface of the platform 709 within the top compartment 708A. In this mounted position, the linear actuator 838 can be reactivated to, for example... Figure 47 The raised or unlocked position is shown as follows: Figure 49 The loading component 800 is moved between the lowered and locked positions shown.

[0513] return Figure 52 Contained within the loading assembly 800 is the previously discussed magnetic actuator 148. More specifically, the magnetic actuator 148 includes an actuator rotor 150 rotatably housed within an opening 864 surrounded by an inner sleeve 806. The actuator rotor 150 may include a sleeve 152 having one or more magnets 168 attached thereto, as previously discussed. A rod 172 protrudes from the sleeve 152 and is coupled to a motor 169 disposed within the housing 802. In an exemplary embodiment, the motor 169 is a 2HP, 3-phase, 230 / 460VAC, 3600RPM induction motor. The motor 169 may be housed, or at least partially housed, within a bottom compartment 708B of the carriage 700. The bottom compartment 708B may form an airtight and sterile seal around the motor 169, the magnetic actuator 148, or both. The motor 169 may be electrically coupled to and operated by a controller 798, or may be manually controlled in other ways. Therefore, the operation of the magnetic actuator 150 facilitates the rotation of the rotor 150 / one or more magnets 168 around the receiving portion 812.

[0514] One or more magnets 168 may be mounted and attached to the drive rotor 150 or the sleeve 152 of the drive rotor 150. As will be described in more detail, one or more magnets 168 are configured to generate a magnetic field around a component of the carriage 700, which interacts with the separate rotor 184C and the drive coupling 186C to magnetically couple the rotor 184C, center the rotor, and rotate the rotor during loading and operation. An exemplary embodiment of the magnetic actuator 148 is described in U.S. Provisional Patent Serial No. 63 / 115,938 (e.g., Figure 8 The U.S. Provisional Patent is disclosed and described in its entirety and is incorporated herein by reference for all purposes.

[0515] In an exemplary embodiment, the drive rotor 150 and / or sleeve 152 are annular and partially or completely surround the annular cavity or cup 162. The cavity of cup 162 may form a partially or completely hermetically sealed barrier to prevent water from entering the components of the magnetic actuator 148. One or more magnets are attached to the inner surface of the cavity 162. One or more magnets 168 may be multiple spaced-apart magnetic segments attached to the inner surface of the drive rotor 150 and / or sleeve 152. In an exemplary embodiment, one or more magnets 168 may include at least 2, 4, 6, 12, 18, 24, or 30 separate magnetic segments. The magnetic segments may be oriented perpendicularly to the axis of rotation, such that the magnetic poles of the magnetic segments are axially oriented. The magnetic poles of each magnetic segment are preferably alternate in axial orientation. One or more magnets 168 may also be magnetic rings attached to and surrounding the cavity 162 of the drive rotor 150 and / or sleeve 152. The magnetic ring can be a dipole, quadrupole, hexapole, or octupole, and these poles can preferably be arranged radially. One or more magnets 168 can be made of one or more magnetic materials (including neodymium).

[0516] In an exemplary embodiment, a plurality of magnets are circumferentially spaced and mounted in an annular cavity 162 of the drive rotor 150. In this configuration and all other exemplary configurations, the magnets are arranged around a portion of the magnetic actuator 148, mounting member 816, mounting plate 820, cavity 814, and / or mounting platform 709 to generate a magnetic field. When the drive coupling 186 is positioned near the magnetic field, magnetic pull and / or vertical load-assisted forces load the centrifugal separator assembly 12C, including the separating rotor 184C and the drive coupling 186C, onto the carriage 700 and center the separating rotor 184C onto the drive rotor 150.

[0517] One or more magnets 168, mounted and attached to the drive rotor 150 or the sleeve 152 of the drive rotor 150, provide optimal centering of the separated rotor 184C during loading and provide torque during operation. The magnetic coupling between the drive rotor 150 and the drive coupling 186C may include any magnetic pairing that provides sufficient torque to meet process torque requirements. For example, in one exemplary embodiment, the torque requirement ranges from 10 in-lb. f up to 70 in-lb f The magnet may include a material capable of carrying a permanent magnetic field on the rotor side and a permanent magnet or electromagnet on the motor side of the coupling. In an exemplary embodiment, the magnet may include neodymium.

[0518] Magnetic actuator 148 is coupled to motor 844 and can be mounted to carriage 700 via motor 169 / housing 802, support 804, or via another surface of loading assembly 800. Magnetic actuator 148, motor 169, and / or loading assembly 800 can be mounted to any surface of carriage 700, including base 7022, panels (704, 705, 706, 707), or mounting platform 709. In a preferred embodiment, the coupled magnetic actuator 148 and motor 169 are mounted to the bottom of mounting platform 709 or to support 804 attached to mounting platform 9. Motor 169 may be partially or completely disposed within bottom compartment 708B of carriage 700. A portion of mounting plate 820 and / or drive rotor 150 may be mounted to extend through and beyond opening 858 in mounting platform 709. A portion of mounting plate 820 and / or drive rotor 150 may also be mounted flush with opening in mounting platform 709.

[0519] One or more magnets 168 attached to the drive rotor 150 and / or the sleeve 152 of the drive rotor 150 generate a magnetic field in the vicinity and / or around the drive rotor 150, opening 810, mounting plate 820, receiving portion 812, cavity 814, and / or mounting platform 709. The strength and position of the magnetic field near and / or around the opening 810, mounting plate 820, receiving portion 812, cavity 814, and / or mounting platform 709 of the drive rotor 150 can vary to produce a load-assisted effect that pulls the centrifuge assembly 12C, and specifically the drive coupling 186C, toward the cavity 814 and mounting plate 820.

[0520] In an exemplary method for loading centrifuge assembly 12C onto carriage 800, loading assembly 800 is moved to a raised, unlocked position, such as... Figure 47 As shown. Mounting plate 820 is now flush with mounting platform 709, from which mounting element 822 stands upright. An operator or automated control system can open door assembly 711 and place centrifuge 12C on mounting platform 709 near mounting plate 820 (accessible through opening 885 in mounting platform 9). Specifically, as Figure 23 As depicted, the lower end of the drive sleeve 132C is positioned on the mounting platform 709 and serves to support the separator assembly 12C. The mounting platform 709 provides a horizontal surface that allows the centrifugal separator assembly 12C / drive sleeve 132C to translate / slide horizontally across the platform 709 and toward the cavity 814 and mounting plate 820. When the centrifugal separator assembly 12C moves horizontally across the mounting platform 709 and / or is positioned sufficiently close to the drive rotor 150, opening 858, or mounting plate 820 to encounter the magnetic field of the drive rotor 150, a horizontal and / or downward vertical load-assisted force will drive the coupling 186C (…). Figure 24The centrifugal separator 12C is pulled toward the cavity 814, mounting plate 820, and drive rotor 150. As the separator assembly 12C moves toward the mounting plate 820, it can be oriented such that the opening 146 on the drive sleeve 132C ( Figure 23 Oriented toward the mounting element 822 that is erected from the mounting plate 820.

[0521] The magnetic field applies a downward vertical force to the drive coupling 186 and the centrifuge 12C, which helps to self-position and magnetically locate the centrifuge assembly 12C for locking. Specifically, the centrifuge 12C is manipulated and moved laterally on the mounting platform 709 until the mounting element 822 is received within the corresponding opening 146 on the drive sleeve 132C. The magnetic field facilitates horizontal movement and centering. The magnetic field and load-assisted force also automatically and magnetically align the rotational center axis of the separator rotor 184C with the rotational center axis of the drive rotor 150. The drive sleeve 132C supports and mitigates the downward vertical force on the drive coupling 186 caused by the magnetic field during loading and as the centrifuge 12C moves horizontally across the mounting platform 709.

[0522] Reference Figure 53 After the mounting element 822 is received within the corresponding opening 146 on the drive sleeve 132C and the separating rotor 184C is self-aligned with the drive rotor 150 via magnets and a magnetic field, the centrifugal separator 12C can be locked. Specifically, the linear actuator 838 is actuated to move the loading assembly 800 / mount 816 to a lowered locked position, as previously discussed. This lowers the mounting plate 820, on which the mounting element 822 and the centrifugal separator 12C are disposed, below the mounting platform 709, causing the drive coupling 186 to be directly received within the cavity 814 of the receiving portion 812. The drive coupling 186 is then attached to one or more magnets 168 of the drive rotor 150 and aligned laterally with it. This positioning optimizes the magnetic force of the one or more magnets 168 on the drive coupling 186 to optimize the rotation of the separating rotor 184C. Furthermore, when the loading assembly 800 / mount 816 is moved to the lowered locked position, the base 190C of the separating stator 180C abuts against a portion of the mounting platform 709 to effectively lock the centrifugal separator 12C to the carriage 700. Specifically, as the mounting platform 709 is pushed upward against the base 190C of the separating stator 180C, the mounting element 822 received in the opening 146 is pulled downward onto the drive sleeve 132C. During operation of the centrifugal separator 12C, the linear actuator 838 holds the loading assembly 800 in this lowered locked position. Here, it is understood again that, as previously discussed, the spring loading of the pivot mounting block 826 prevents overloading of the centrifugal separator 12C during the locking process and operation.

[0523] It should be understood that various alternative structures can be used to facilitate engagement between the mounting element 822 and the actuator sleeve 132C. For example, the mounting element 822 can be replaced by a single semi-circular L-shaped member received within a corresponding recess in the actuator sleeve 132C. In other embodiments, one or more extensions may extend outward from the actuator sleeve 132C and be received within recesses or openings formed in one or more mounting elements 822. In other embodiments, different types of fasteners or clamps may be used to secure the mounting element 822 to the actuator sleeve 132C. Thus, the actuator sleeve 132C may be formed with one or more flanges, bends, cavities, slots, or grooves for engagement with the mounting element 822. However, this design has a unique advantage because it facilitates and allows for easy lateral sliding connection.

[0524] Once the centrifuge 12C has been operated, the linear actuator 838 can be used to move the loading assembly 800 back to the raised unlocked position, and to allow the centrifuge 12C to be removed from the carriage 700 in a reverse process of attachment. It should be understood that manual separation of the centrifuge 12C from the drive rotor 150 is difficult due to strong magnetic forces, as the drive coupling 186 is received within the receiving portion 812 and engaged with one or more magnets 168. Therefore, the carriage 700 and loading assembly 800 have the unique advantage of using mechanical force to at least partially separate the centrifuge 12C from the drive rotor 150 before manual manipulation of the centrifuge 12C is necessary.

[0525] Figure 54 This is a schematic diagram of an exemplary centrifuge carriage 900 integrated into an exemplary bioproduction process including a bioproduction reservoir 901. The bioproduction reservoir 901 can be any bioproduction reservoir, including but not limited to mixers, cell factories, bioreactors, fermenters, laboratory and laboratory-scale reservoirs, and other containers that can supply fluid, solid, or mixed-phase biological components to the carriage 900 for separation. The carriage 900 may include an inlet pump 902, a centrifuge assembly 904, an inlet line assembly 912, a light outlet line assembly 914, a heavy outlet line assembly 916, a light outlet pump 918, a heavy outlet pump 920, a recirculation line assembly 922, a series of valves 924, 926, 928, a series of sensors 930-948, 960, a controller 950, a programmable power supply 956, and related information. Figures 43 to 46 Other process equipment and components described.

[0526] Centrifuge assembly 904 may be the same centrifuge 12 and alternatives discussed herein, including all components and devices described herein or any centrifuge disclosed and described in relation to U.S. Provisional Patent Serial No. 63 / 115,938, which is incorporated herein by reference in its entirety for all purposes. As previously described, centrifuge assembly 904 may have an inlet port 906, a light outlet port 908, and a heavy outlet port 910. Ports 906, 908, and 910 are fluidly coupled to the separator rotor 184C (in Figure 48 The inner chamber or separation container 190C (shown in the figure) is connected to the biological components and the biological components are separated in the inner chamber or separation container.

[0527] An inlet line or line assembly 912 connects to the inlet port 906 of the bioproduction reservoir 901, inlet line valve 952, inlet pump 902, and centrifuge assembly 904. Inlet line valve 952 may be positioned upstream or downstream of inlet pump 902 and may be actuated to block or allow biological components to flow to inlet port 910 of centrifuge assembly 904 for separation. Inlet pump 902 is used to pump and flow liquid, solid, gaseous, and mixed-phase biological components from bioproduction reservoir 901 through inlet line assembly 912 and inlet line valve 952, and to pump or flow them to centrifuge assembly 904. Inlet pump 902 may be a centrifugal pump or a positive displacement pump, such as a peristaltic pump. Preferably, inlet pump 902 is a single-use, disposable centrifugal pump.

[0528] Light outlet line assembly 914 connects the light outlet port 908, light outlet pump 918, light recirculation valve 924, and recirculation line assembly 922 of centrifuge assembly 904. The lighter components separated in centrifuge assembly 904 flow naturally and are routed through light outlet port 908 and light outlet line assembly 914 during operation of centrifuge assembly 904. Light outlet line assembly 914 may include light recirculation valve 924 located at a slit in light outlet line assembly 914. Light recirculation valve 924 can be actuated to allow the light biological components separated in centrifuge assembly 904 to flow downstream of carriage 900 and be conveyed for further processing, harvesting, and removal. Light recirculation valve 924 can also be actuated to allow the light biological components separated in centrifuge assembly 904 to flow through and be conveyed through recirculation line assembly 922 and return to bioproduction reservoir 901.

[0529] The light outlet pump 918 can be driven (by an electric motor or other means) to pump the light biological components separated in the centrifugal separator assembly 904 downstream of the carriage 900 for further processing, or to pump them through the recirculation line assembly 922 for recirculation to the bioproduction reservoir 901. The light outlet pump 918 can also act as a shut-off valve for the light outlet line assembly 914 by reversing the operation and flow through the pump 918, preventing any biological components from flowing through the pump 918. The light outlet pump 918 can be a centrifugal pump or a positive displacement pump, such as a peristaltic pump. Preferably, the light outlet pump 918 is a single-use, disposable peristaltic pump.

[0530] The heavy mass outlet line assembly 916 connects the heavy mass outlet port 910, heavy mass outlet pump 920, heavy mass recirculation valve 928, and recirculation line assembly 922 of the centrifuge assembly 904. The heavier components separated in the centrifuge assembly 904 flow naturally and are routed through the heavy mass outlet port 910 and heavy mass outlet line assembly 916 during operation of the centrifuge assembly 904. The heavy mass outlet line assembly 916 may include a heavy mass recirculation valve 928 located at a slit in the heavy mass outlet line assembly 916. The heavy mass recirculation valve 928 can be actuated to allow the heavy biomass separated in the centrifuge assembly 904 to flow downstream of the carriage 900 and be conveyed for further processing, harvesting, and removal. The heavy mass recirculation valve 928 can also be actuated to allow the heavy biomass separated in the centrifuge assembly 904 to flow through and be conveyed through the recirculation line assembly 922 and return to the bioproduction reservoir 901.

[0531] The heavy outlet pump 920 can be driven (by an electric motor or other means) to pump the heavy biological components separated in the centrifuge assembly 904 downstream of the carriage 900 for further processing, or to pump them through the recirculation line assembly 922 for recirculation to the bioproduction reservoir 901. The heavy outlet pump 920 can also act as a shut-off valve for the heavy outlet line assembly 916 by reversing the operation and flow through the pump 920, preventing any biological components from flowing through the pump 920. The heavy outlet pump 920 can be a centrifugal pump or a positive displacement pump, such as a peristaltic pump. Preferably, the heavy outlet pump 920 is a single-use, disposable peristaltic pump.

[0532] The exemplary centrifuge carriage 900 and line assemblies 918, 920, 922, 958 may be equipped with and coupled to a series of sensors 930-948, 960 for measuring process parameters at different locations within the carriage 900. For example, inlet pressure sensor 930 can measure the pressure in inlet line assembly 912 upstream or downstream of inlet pump 902 and upstream of centrifuge assembly 904. Inlet flow sensor 932 can measure the flow rate of biological components upstream or downstream of inlet pump 902 and upstream of centrifuge assembly 904.

[0533] The light outlet pipeline assembly 914 is equipped with sensors that measure process parameters and send signals to the controller 950 for process control functions. For example, the light pipeline assembly pressure sensor 934 measures the pressure downstream of the centrifuge assembly 904 and upstream of the light outlet pump 918. The light pipeline assembly turbidity sensor 936 measures the turbidity downstream of the centrifuge assembly 904 and upstream of the light outlet pump 918. The light pipeline assembly flow sensor 938 measures the flow rate of the biological components in the light outlet pipeline assembly 914, downstream of the centrifuge assembly 904 and upstream of the light outlet pump 918.

[0534] The heavy mass outlet line assembly 916 is also equipped with sensors that measure process parameters and send signals to the controller 950 for process control functions. For example, the heavy mass line pressure sensor 940 measures the pressure downstream of the centrifuge assembly 904 and upstream of the heavy mass outlet pump 920. The heavy mass line turbidity sensor 942 measures the turbidity downstream of the centrifuge assembly 904 and upstream of the heavy mass outlet pump 920. The heavy mass line flow sensor 944 measures the flow rate of the biological components in the heavy mass outlet line assembly 916, downstream of the centrifuge assembly 904 and upstream of the heavy mass outlet pump 920.

[0535] The recirculation line assembly 922 is also equipped with sensors that measure process parameters and send signals to the controller 950 for process control functions. For example, a recirculation line pressure sensor 946 measures the pressure in the recirculation line assembly 922. A recirculation line flow sensor 948 measures the flow rate of the biological components in the recirculation line assembly 922. A recirculation line turbidity sensor 960 measures the turbidity in the recirculation line assembly 922. A series of exemplary sensors 930-948, 960 can be located at multiple locations along the line assemblies 918, 920, 922 and upstream and downstream of the process equipment (including pumps 902, 918, 920 and centrifuge assembly 904) of the carriage 900. Preferably, the exemplary sensors 930-948, 960 are single-use, disposable sensors that are easy to install, remove, and replace on the carriage 900. In addition to pressure sensors, flow sensors, and turbidity sensors, carriage 900 may also be equipped with conductivity sensors, O2 sensors, CO2 sensors, pH sensors, temperature sensors, proximity sensors, rpm sensors, and other sensors selected by the operator and necessary for the bioproduction process.

[0536] The carriage may also be equipped with one or more emergency shut-off valves 926 throughout the carriage 900 (including upstream of the inlet pump 902, downstream of the centrifuge assembly 904 via the light outlet line group 914 or the heavy outlet line group 916, downstream of the light outlet pump 918 and the heavy outlet pump 920, downstream of the recirculation line group 922, or elsewhere) to prevent biological components from flowing through the lines and process equipment.

[0537] Exemplary valves 924, 926, 928, and 952 equipped on the carriage can be referenced. Figure 48 The valve control system 760 described is controlled by [the system]. The valve control system 760 may include a flow control valve 726, a conduit 725, a valve terminal 739, and a fieldbus node 747. The valve control system 760 may be a pneumatic control system, and valves 924, 926, 928, and 952 may be equipped with pneumatic pinch valves or spring-loaded throttling clamps. The valve control system 760 may also be an electronic control system, and valves 924, 926, 928, and 952 may have solenoid elements for opening and closing various ports on the valve, and optical digital position feedback sensors for detecting whether a port is open or closed. In an exemplary embodiment, valves 924, 926, 928, and 952 include snap-fit ​​grooves for quickly loading and unloading conduit into and from the valve.

[0538] Valve terminal 739 (in) Figure 48 (As shown in the diagram) may include communication ports, communication links, circuit boards, and manifolds having multiple ports electrically or pneumatically connected to inlet and outlet ports of valves 924, 926, 928, and 952. In an exemplary embodiment, the communication ports and links may be I / O ports and links coupled to fieldbus node 747. Valve terminal 739 and fieldbus node 747 may communicate wiredly or wirelessly with controller 950, which controls the actuation of valves 924, 926, 928, and 952 based on process parameters measured by sensors 930-948 and 960 using electrical signals or pneumatic pressure applied through valve terminal 739 and the manifold. Valve control system 60 and controller 950 may use specific communication protocols to facilitate the transmission of data and electrical signals between valve terminal 739, fieldbus node 747, valves 924, 926, 928, 952, and controller 950. In an exemplary embodiment, the communication protocol is Profinet.

[0539] The controller 950, mounted on the carriage 900, may include a programmable processor and non-transitory memory programmed to actuate valves 924, 926, 928, and 952 via a programmable power supply 956 based on process parameters measured by sensors 930-948, 960, and to power pumps 902, 918, 920, centrifuge assembly 904, valve control system 760, and other process equipment. The controller 950 may be compatible with exemplary sensors 930-948, 960, and valve terminals 739 (in... Figure 48 (shown in the diagram), pumps 902, 918, 920 and associated motors, and motor 169 driving centrifugal separator assembly 904 (in... Figure 48 (As shown in the diagram) Wired or wireless communication is possible. Controller 950 can receive signals from sensors 930-948, 960 and convert those signals into readable process parameters. The signals indicate process parameters such as pressure, flow rate, turbidity, density, temperature, pH, motor power, rotor rpm, O2 concentration, and / or CO2 concentration in the process equipment throughout carriage 900, pipeline assemblies 912, 914, 916, 922, and carriage 900. Controller 950 can automatically actuate, open, and close exemplary valves 924, 926, 928, 952 equipped on carriage 900 based on process parameter signals measured and transmitted by sensors 930-948, 960 and read and converted by controller 950. The controller 950 can also automatically control the programmable power supply 956 to increase or decrease the power to pumps 902, 918, 920, centrifugal separator assembly 904 and / or associated motors based on process parameter signals measured and transmitted by sensors 930-948, 960 and read and converted by the controller 950.

[0540] In an exemplary embodiment, the centrifugal separator assembly 904 has a separating rotor 184C (in... Figure 48 (As shown in the diagram) An rpm sensor (e.g., an accelerometer) is connected near the separating rotor 184C to measure the revolutions per minute and / or rotational speed of the separating rotor 184C. The controller 950 can automatically control the programmable power supply 956 to increase or decrease power to the motor 169 (in... Figure 48 The power (shown in the figure) is used to increase or decrease the rotational speed of the separate rotor 184C based on process parameter signals measured and transmitted by sensors 930-948, 960 and received, read and converted by controller 950.

[0541] Figures 55A to 55CA process flow diagram is shown for exemplary operations of loading and locking the centrifuge carriages (700, 900), initialization valves (924, 926, 928, 952), interlock door assembly (711), and performing an emergency system shutdown operation. The exemplary operations and processes can be operated by a controller (798, 950) including a programmable processor and non-transitory memory programmed to automatically run the start-up, separation, discharge, recirculation, and downstream operations of the exemplary process. Various aspects of the process can also be operated manually. See reference... Figure 45 and Figure 54 As described, the controller (798, 950) can communicate wired or wirelessly with a programmable power supply (733), valves (924, 926, 928, 952), a valve control system (760), sensors (930-948, 960), pumps (721, 748, 749, 902, 918, 920), motors (108, 169), and actuators (838) mounted on an exemplary centrifuge carriage (700, 900). The controller (798, 950) is programmed to perform the start-up, separation, discharge, recirculation, and downstream operations of the exemplary process by actuating, opening, closing, and moving valves, motors, pumps, centrifuges, linear actuators, and other devices on the carriage (700, 900) and / or supplying them with signals or power.

[0542] The controller (798, 950) is programmed to request data and signals from all sensors in the system, including proximity sensors located at and connected to the centrifuge carriage (700, 900), valves (924, 926, 928, 952), and door assembly (711), to determine whether the equipment has been loaded, locked, and properly configured for operation.

[0543] Centrifuge loading and locking operations

[0544] Reference Figure 55A , Figures 42 to 44 and Figure 54 The centrifuge carriage (700, 900) and controller (798, 950) are programmed to perform centrifuge loading operations by performing the following steps.

[0545] In step 971, the controllers (798, 950) are programmed to run control logic that triggers a proximity sensor to sense whether the linear actuator (838) is actuated in the up and unlocked position or the down and unlocked position. If the linear actuator (838) is in the down and locked position, the control logic may display an error message and prompt the user or automatically close and lock the door assembly (711). The control logic may also send a signal to the linear actuator (838) to actuate it to the up and unlocked position, thereby triggering an output or notification indicating that the linear actuator (838) is in the unlocked and up position via the digital display unit (762). At this time, the control logic initiated by the controllers (798, 950) may unlock the door assembly (711) to load the centrifuge assembly (12, 904).

[0546] In step 972, the door assembly (711) can be opened manually or automatically and the centrifuge assembly (12, 904) can be loaded, which triggers the proximity sensor to sense whether the centrifuge assembly (12, 904) is properly loaded and centered. The centrifuge assembly (12, 904) can be as follows: Figures 49 to 53 The centrifuge assembly (12, 904) is magnetically loaded and centered. If the centrifuge assembly (12, 904) is not properly loaded, the controller (798, 950) may display an error message on the digital display unit (762) and prompt the user to adjust the centrifuge assembly (12, 904). When the assembly (12, 904) is properly loaded, notifications and displays may be provided.

[0547] Reference Figure 55B In step 973, the operator may be prompted to close the door assembly (711), or the door assembly (711) may be automatically closed, which triggers a proximity sensor to sense whether the door assembly (711) is properly interlocked. If the door assembly (711) is not properly interlocked, the digital display unit (762) may provide a notification that the door is open or unlocked and prompt the user or automatically adjust the door assembly (711) to achieve proper interlocking. Once proper interlocking is achieved, the digital display unit (762) may provide a notification that interlocking has been achieved.

[0548] In step 974, once the door assembly (711) is locked, the controller (798, 950) initiates control logic that moves the linear actuator downwards and into a locked position to lock the centrifugal separator assembly (12, 904) to the carriage (700, 900). This triggers a proximity sensor to sense whether the linear actuator (838) is in the downward and locked position, and if not, provides an indication that the linear actuator is upwards. The controller (798, 950) can actuate the linear actuator (838) to continue moving it downwards. Once the centrifugal separator assembly (12, 904) is locked to the carriage (700, 900), the control logic can provide an indication that the separator is locked and ready for start-up, separation, discharge, recirculation, and downstream operations.

[0549] Reference Figure 55C In step 975, the valve initialization process can be executed by control logic initiated by the controller (798, 950), which triggers proximity sensors associated with the light recirculation valve and the heavy recirculation valve (924, 928) to sense whether the valve is actuated to recirculate the biological components back to the bioproduction reservoir (901). If the recirculation valve (924, 928) is not actuated to recirculate the biological components back to the bioproduction reservoir (901), the digital display unit (762) can provide notification that the valve is not open or not configured for recirculation. The control logic initiated by the controller (798, 950) can automatically actuate the recirculation valve (924, 928) to recirculate the biological components back to the bioproduction reservoir (901). Once the recirculation valve (924, 928) is actuated into recirculation mode, the digital display unit (762) can provide notification that the valve is open or in recirculation mode.

[0550] Figure 56 A process flow diagram is shown for an exemplary process for operating an exemplary centrifuge carriage (700, 900). The exemplary process can be operated by a controller (798, 950) described herein, which includes a programmable processor and nontransitory memory programmed to automatically execute the initiation, separation, discharge, recirculation, and downstream operations of the exemplary process. See reference... Figure 45 and Figure 54As discussed, the controller (798, 950) can communicate wired or wirelessly with a programmable power supply (733, 956), valves (924, 926, 928, 952), a valve control system (760), sensors (930-948, 960), pumps (721, 748, 749, 902, 918, 920), motors (108, 169), and actuators (838) mounted on an exemplary centrifuge carriage (700, 900). The controller (798, 950) is programmed to perform the start-up, separation, discharge, recirculation, and downstream operations of the exemplary process by actuating, opening, closing, and moving valves, pumps, centrifuges, linear actuators, and other devices on the carriage (700, 900) and / or supplying them with signals or power. (See also...) Figures 42 to 54 The centrifugal separator carriage (700, 900) and controller (798, 950) are programmed to perform the startup operation by performing the following steps.

[0551] Centrifuge start-up operation

[0552] In step 601, the operator can use the user input and digital display unit 762 of the carriage (700, 900) which communicates with the controller (798, 950) via wired or wireless communication. Figure 42 (as shown in the diagram) to supply the RUN or START input, or the operator can actuate the on / off switch of the carriage (700, 900).

[0553] In step 602, the controller (798, 950) may provide an equipment ready output or notification indicating that the inlet pump (721, 902) can be started via the user input and digital display unit (762).

[0554] In step 603, the controller (798, 950) initiates control logic that starts the inlet pumps (721, 902) by supplying power to their motors. If the appropriate ports of the valves (924, 926, 928, 952) are not already open, the controller (798, 950) can be programmed to open and / or actuate the valves (924, 926, 928, 952) and create a fluid path from the bioprocess reservoir (901) to the centrifuge assembly (12, 904) and downstream of the centrifuge assembly (12, 904) through the light and heavy outlet line groups (36, 44, 52, 914, 916, 958). The controller (798, 950) can be programmed to arrange the valves (924, 926, 928, 952) according to default valve start positions and modes. In an exemplary embodiment, valves (924, 926, 928, 952) create a flow path from the bioprocess reservoir (901) to the centrifuge assembly (12, 904), through the light outlet line group and the heavy outlet line group (36, 44, 52, 914, 916), and through the recirculation line group (922) returning to the bioprocess reservoir (901) in their default positions prior to startup. Startup of the inlet pumps (721, 902) causes fluid (which may or may not include the biological components and / or solids for separation) to flow from the bioprocess reservoir 901 and through the inlet pumps (721, 902) to start the inlet pumps (721, 902). The controller can be programmed to actuate valves (924, 926, 928, 952) to deliver fluid through the centrifuge assembly (12, 904) and through the recirculation line group 922 (in Figure 54 (As shown in the diagram). The flow of fluid in the system starts the pump and pushes the gas out of the system. Fluid, gas, or biological components can be recirculated back to the bioprocess reservoir 901 during the start-up of the inlet pumps (521, 902).

[0555] In step 604, the controller (598, 950) initiates control logic that delays the start-up of the light and heavy outlet pumps (36, 44, 52, 918, 920) for a short duration (e.g., 2 to 10 seconds) or until the inlet pump (721, 902) is started. The delay and / or logic in the next process steps 605 and / or 606 can be used to ensure that the inlet pump (721, 902) is started. If pressure measurements are used to determine whether the inlet pump (721, 902) has been started, the time delay can be increased. Once the time delay has reached the minimum time limit, the control logic can proceed to the next process step.

[0556] In step 605, the controller (798, 950) initiates control logic that starts the outlet pumps (748, 749, 918, 920) and puts the inlet pumps (721, 902) into automatic mode, in which a constant power is applied to the inlet pumps (721, 902). In automatic mode, the controller (798, 950) initiates control logic that applies power from the programmable power supply (733) to the motor of the inlet pumps (721, 902) and adjusts the power to maintain the pressure downstream of the inlet pumps (721, 902) or downstream of the centrifuges (12, 904) at the setpoint pressure.

[0557] In step 606, the controller (798, 950) initiates control logic that triggers one or more of the light pipeline turbidity sensor (936) or the heavy pipeline turbidity sensor (942) to measure the turbidity in the light outlet pipeline and / or heavy outlet pipeline (36, 44, 52, 914, 916) downstream of the centrifuge assembly (12, 904), respectively. The light pipeline turbidity sensor (936) and / or heavy pipeline turbidity sensor (942) send signals to the controller (98, 950) indicating the turbidity downstream of the centrifuge assembly (12, 904). The controller (798, 950) receives, converts, reads the turbidity measurement, and compares it with the setpoint turbidity in the light outlet pipeline and / or heavy outlet pipeline (914, 916) downstream of the centrifuge assembly (12, 904). If the turbidity measurement matches the desired setpoint turbidity, startup is complete and the inlet pumps (721, 902) continue operating, pumping the biological components from the bioproduction reservoir (910) through the system and back via the recirculation loop. The setpoint turbidity in the light and heavy outlet line groups (36, 44, 52, 914, 916) downstream of the centrifuge assembly (12, 904) can be set to a minimum turbidity. In an exemplary embodiment, the setpoint turbidity in both the light and heavy outlet line groups (36, 44, 52, 914, 916) downstream of the centrifuge assembly (12, 904) is greater than 0 FTU. One or more turbidity measurements can be performed over time to confirm that the turbidity does not fluctuate over time and to ensure that the inlet pumps (721, 902) are started and the outlet pumps (748, 749, 918, 920) and the system have reached a steady state. The controller (798, 950) can provide “pump started” or “start-up complete” output or notification via user input and digital display unit (762), which indicates that the inlet pump (721, 902) has been started.

[0558] In step 606, alternatively or in addition to measuring the turbidity in the light outlet line group and / or the heavy outlet line group (36, 44, 52, 914, 916), the controller (798, 950) initiates control logic that triggers one or more of the inlet pressure sensor (930), the light line group pressure sensor (934), or the heavy line group pressure sensor (940) downstream of the inlet pump (721, 902) to measure the pressure downstream of the inlet pump (721, 902) or the pressure in the light outlet line group and / or the heavy outlet line group (36, 44, 52, 914, 916) downstream of the centrifuge assembly (12, 904). Inlet pressure sensor 930, light pipeline group pressure sensor (934), and / or heavy pipeline group pressure sensor (940) send signals to controllers (798, 950) indicating the pressure downstream of the inlet pump (721, 902) or centrifuge assembly (12, 904). Controllers (798, 950) receive, convert, read the pressure measurement, and compare it with the setpoint pressure in the light and / or heavy outlet pipeline groups (36, 44, 52, 914, 916) downstream of the inlet pump (721, 902) and / or centrifuge assembly (12, 904). If the pressure measurement matches the desired setpoint pressure, startup is complete, the system has reached steady state, and the inlet pump (721, 902) continues to operate, pumping biological components from the bioproduction reservoir (910) through the system and returning via the recirculation loop. The setpoint pressure can be set to a minimum pressure. One or more pressure measurements can be performed over time to confirm that the pressure does not fluctuate over time and to ensure that the inlet pump (721, 902) has been started and the system has reached a steady state. If pressure measurements are used to confirm startup and steady state, a time delay in step 604 can be added to ensure that steady state has been reached and startup has been completed. In an exemplary embodiment, the setpoint pressure is a minimum pressure greater than or equal to 2 psi. The controller (798, 950) can provide a “pump started” output or notification via user input and digital display unit (62) indicating that the inlet pump (721, 902) has been started.

[0559] In step 607, after the inlet pumps (721, 902) are started and the outlet pumps (748, 749, 918, 920) and the system have reached a steady state, the controller (798, 950) initiates control logic that applies power from the programmable power supply (733) to the motor (169), which magnetically drives and rotates the separation rotor (184) of the centrifugal separator assembly (12, 904). The start-up of the separation rotor (184) can affect process parameters, including system pressure, turbidity, and flow rate, resulting in disturbances away from the steady state achieved prior to the start-up of the centrifugal separator assembly (12, 904).

[0560] In step 608, the controller (798, 950) initiates control logic that triggers one or more of the following: light pipeline group turbidity sensor (936), heavy pipeline group turbidity sensor (942), light pipeline group pressure sensor (934), or heavy pipeline group pressure sensor (940) (all located upstream of the light and heavy outlet pumps (36, 44, 52, 918, 920)) to measure the pressure and / or turbidity in the light and heavy outlet pipeline groups (36, 44, 52, 914, 916) downstream of the centrifuge assembly (12, 904). One or more sensors (934, 936, 940, 942) send signals to the controller (98, 950) indicating the pressure or turbidity in the light and heavy outlet line groups (36, 44, 52, 914, 916) downstream of the centrifuge assembly (12, 904). The controller (798, 950) receives, converts, reads the turbidity and / or pressure measurements and compares them to the outlet pump setpoint turbidity and / or pressure requirements that must be met at the location downstream of the centrifuge assembly (12, 904). If the turbidity and / or pressure measurements match the required outlet pump setpoint turbidity and / or pressure, the system has reached a safe steady state. The pressure and turbidity setpoints can be set to minimum or maximum pressure or turbidity. For example, the outlet pump setpoint pressure is set to the minimum pressure requirement measured at the light line group pressure sensor (934) or the heavy line group pressure sensor (940).

[0561] In an exemplary embodiment, the light outlet setpoint turbidity measured at the light pipeline group turbidity sensor (936) is set as a predetermined maximum turbidity. The heavy outlet setpoint turbidity measured at the heavy pipeline group turbidity sensor (942) is set as a predetermined minimum turbidity. The maximum and minimum turbidity setpoints measured by the light pipeline group turbidity sensor and the heavy pipeline group turbidity sensor (934, 940) in the light outlet pipeline group and the heavy outlet pipeline group (36, 44, 52, 914, 916), respectively, must be satisfied to achieve a safe steady state and before the control logic can proceed to the next process step.

[0562] One or more pressure and / or turbidity measurements can be performed over time downstream of the centrifuge assembly (12, 904) to confirm that the pressure or turbidity does not fluctuate over time and to ensure that the system has reached a safe steady state with all pumps and centrifuges running. The controller (98, 950) can provide a “steady state” output and notification via user input and a digital display unit (762) indicating that the system has reached a safe steady state with all pumps and centrifuges running. Once one or more steady state setpoint requirements governing this step have been met, the control logic can proceed to the next process step, including a downstream process mode in which the biological components are delivered downstream of the centrifuge assembly (12, 904) and the carriage (700, 900).

[0563] Alternatively, in step 608, the controllers (798, 950) initiate control logic that delays the initiation of a downstream process mode in which the biological components are transferred downstream of the centrifuge assemblies (12, 904) and carriages (700, 900), instead of transferring the biological components from the bioprocess reservoir (901) through the recirculation line assembly (922) and back to the bioprocess reservoir (901). The initiation of the downstream process mode is delayed until a confirmed steady state has been reached after the centrifuge assemblies (12, 904) and all pumps have started. The time delay and / or other logic in process step 613 can be used to ensure that the system has reached a safe steady state after the centrifuge assemblies (12, 904) have started. If pressure measurements are used to determine whether a steady state has been reached, the time delay can be increased. Once the time delay has reached its minimum time limit, the control logic can proceed to the next process step.

[0564] After steady state has been reached in step 609 with all pumps and centrifuges turned on, the controller (798, 950) initiates control logic that actuates one or more valves to deliver the separated biological components downstream of the centrifuge assemblies (12, 904) and carriages (700, 900), instead of delivering the biological components from the bioprocess reservoir (901) through the recirculation line assembly (922) and back to the bioprocess reservoir (901). In an exemplary embodiment, the controller (798, 950) is programmed to operate logic that causes actuation of the light recirculation valve (924) and the heavy recirculation valve (928) (e.g., using valve control system 760) to deliver the separated biological components downstream of the centrifuge assemblies (12, 904) and carriages (700, 900).

[0565] In step 610, another set of pressure and turbidity measurements may be performed as discussed with respect to the previous steps to verify that the system has not been disturbed out of steady state or that the system has reached steady state again after the downstream process mode is initiated. Once steady state is reached and confirmed after the downstream process mode is initiated, the controller (798, 950) initiates control logic to enter cascade mode. Cascade mode may also be initiated simultaneously with the downstream process mode. In cascade mode, the controller (798, 950) continuously applies power from the programmable power supply (733) to the inlet pump (721, 902), the light outlet pump (748, 918), and the heavy outlet pump (749, 920) and adjusts this power to maintain steady-state setpoints, including the operating setpoints for pressure, turbidity, and flow rate upstream and downstream of the centrifuge assembly (12, 904).

[0566] Reference Figure 5 C. In step 506, if equipment malfunctions, process parameters are not optimized, or the separation process is not operating properly, the controller (798, 950) may initiate an emergency stop event. During an E-STOP event, control logic initiated by the controller (798, 950) may display and / or issue alarms and error messages indicating that an E-STOP event needs to occur or will occur. The controller (798, 950) may then cut off all power and stop all pumps and centrifuge components (12, 904). The controller (798, 950) may also close all valves (924, 926, 928, 952) to ensure that no biological components leave the system or carriage (700, 900).

[0567] Example

[0568] Example 1: Separation

[0569] Following the loading, locking, and startup operations performed according to this disclosure, the CHO cell culture suspension is pumped at 8 liters / minute to the inlet of an exemplary centrifuge mounted on a carriage. The centrifuge separates the cell culture suspension into a centrifuged fraction of light components exiting the light outlet and a concentrated fraction of heavy components exiting the heavy outlet of the centrifuge. Figure 57 Bar graphs are shown that include the percentage reduction in turbidity; the percentage reduction in hematocrit (PCV); the PCV enriched in the concentrate stream; and the theoretical yield of soluble products (in this case, secretory proteins) measured from the inlet to the outlet of the centr...

Claims

1. A slide for separating biological components, the slide comprising: A housing that defines a compartment, the compartment being partially defined by a mounting platform; and A loading assembly, fixed to the housing for communication with the compartment, the loading assembly comprising: An alignment plate having a top surface having a recessed cavity therein, the cavity communicating with the compartment; A drive rotor, rotatably disposed below the alignment plate and at least partially surrounding the cavity, the drive rotor comprising one or more magnets; An electric motor, coupled to the drive rotor, for selectively rotating the drive rotor about the cavity; and A mounting component, at least partially surrounding the drive rotor and communicating with the compartment, comprising a mounting plate having one or more mounting elements erected therefrom, the mounting component being movable between a raised position and a second lowered position, in which the mounting plate is aligned with the alignment plate, and in the second lowered position, the mounting plate is positioned at a height lower than the alignment plate.

2. The carriage according to claim 1, further comprising: A doorway, which is formed on the housing and communicates with the compartment; and A door, mounted on the housing, is movable between an open position and a closed position, in which the doorway is exposed and in which the doorway is covered.

3. The carriage according to claim 2, further comprising a notch recessed into the outer surface of the housing and extending between the side of the housing and the doorway, the notch defining a passageway communicating with the compartment regardless of whether the door is in the open or closed position.

4. The carriage according to claim 1, The mounting platform includes an opening extending through it; and The loading assembly is secured to the housing such that the alignment plate is aligned with the opening extending through the mounting platform.

5. The carriage of claim 4, wherein when the mounting member is in the raised position, at least a portion of the top surface of the mounting platform, the top surface of the alignment plate, and the top surface of the mounting plate are horizontally aligned.

6. The carriage of claim 1, wherein the loading assembly further comprises: An annular inner sleeve surrounds an opening, the inner sleeve has an upper end on which the alignment plate is mounted; A receiving portion extending from the bottom surface of the alignment plate and protruding into the opening of the annular sleeve, the receiving portion defining the cavity; and The drive rotor is at least partially disposed within the opening of the inner sleeve.

7. The carriage of claim 6, wherein the loading assembly further comprises an annular outer sleeve surrounding the inner sleeve, the outer sleeve having an upper end on which the mounting plate is mounted, the outer sleeve and the mounting plate being movable relative to the inner sleeve.

8. The carriage according to claim 7, further comprising: Support member, the inner sleeve is erected from the support member; A pivoting mounting block, which is fixed to the support at a position spaced apart from the inner sleeve; A pair of pivoting arms, each having a first end pivotally mounted to the pivoting mounting block such that the pair of pivoting arms extend along opposite sides of the outer sleeve; and A pair of support pins, the pair of support pins protruding outward from the opposite sides of the outer sleeve and connected to the corresponding pivot arm of the pair of pivot arms.

9. The carriage of claim 7, further comprising a linear actuator positioned to selectively raise and lower the outer sleeve relative to the inner sleeve.

10. The carriage of claim 1, wherein the one or more mounting elements comprise one or more L-shaped clips that are erected from the mounting plate and face the cavity.

11. The carriage of claim 1, further comprising one or more peristaltic pumps mounted on the outer surface of the housing.

12. The carriage of claim 1, further comprising one or more clamp valves mounted on the outer surface of the housing.

13. The carriage according to claim 1, wherein the carriage further comprises one or more of a pressure sensor, a conductivity sensor, a flow meter sensor, a pH sensor, a temperature sensor or a turbidity sensor mounted on the outer surface of the housing.

14. A system for separating biological components, the system comprising: The carriage according to claim 1; and A centrifugal separator, which is detachably mounted in the compartment of the carriage and supported on the mounting plate of the loading assembly.

15. The system of claim 14, further comprising a first fluid line fluidly connected to the centrifugal separator in the compartment of the carriage, the first fluid line exiting the compartment and detachably secured to an outer surface of the housing.

16. The system of claim 15, wherein the first fluid line is detachably coupled to a peristaltic pump and / or a pinch valve fixed to the outer surface of the housing.

17. The system of claim 15, further comprising a sensor mounted on the first fluid line, the sensor being detachably insertable into a power socket formed on the outer surface of the housing.

18. The system of claim 14, wherein the centrifugal separator is at least partially secured to the mounting plate by magnetic force generated by one or more magnets driving the rotor.

19. The system according to claim 14, The centrifuge includes: A separating stator, the separating stator defining a chamber, the separating stator having a base plate, the base plate having a receiving portion projecting outward therefrom, the receiving portion defining a groove communicating with the chamber of the separating stator; A separating rotor, which is rotatably disposed within the chamber of the separating stator; A drive coupling member is coupled to and extends from the separating rotor so as to protrude into the groove of the receiving portion; and A driver sleeve that protrudes outward from the base plate of the split stator and at least partially surrounds the receiving portion of the split stator; The centrifugal separator is positioned such that the receiving portion of the separating rotor is aligned with the cavity of the alignment plate, and one or more mounting elements engage the drive sleeve.

20. The system of claim 19, wherein when the mounting plate is moved to the lowered position, the receiving portion of the separating stator is received in the cavity of the alignment plate, and when the mounting plate is moved to the raised position, the receiving portion of the separating stator is removed from the cavity of the alignment plate.

21. The system of claim 19, wherein the driver sleeve has one or more openings or recesses, and a portion of the one or more mounting elements is received in the one or more openings or recesses.

22. The system of claim 19, wherein, with the one or more mounting elements engaged with the drive sleeve, moving the mounting plate to the lowered position rigidly locks the centrifugal separator to the housing of the carriage.

23. A method for separating biological components, the method comprising: Position the centrifugal separator on the top surface of the mounting platform of the carriage according to claim 1; The centrifugal separator is moved laterally within the compartment of the housing such that the centrifugal separator is supported on the mounting plate of the mounting element, and the mounting element engages the centrifugal separator. The mounting plate is moved to the lowered position, so that the centrifuge is lowered relative to the alignment plate. When the mounting plate is moved to the lowered position, the drive coupling of the centrifuge is received in the cavity of the alignment plate. as well as Start the motor to rotate the drive rotor, which magnetically rotates the separation rotor of the centrifugal separator.

24. The method of claim 23, wherein laterally moving the centrifuge comprises laterally sliding the centrifuge on the mounting platform near a magnetic field generated by one or more magnets of the drive rotor, wherein the magnetic field assists in positioning the centrifuge.

25. The method of claim 23, wherein moving the mounting plate to the lowered position rigidly locks the centrifugal separator to the housing of the carriage.

26. The method of claim 23, wherein the step of positioning the centrifuge on the top surface of the mounting platform comprises: The centrifugal separator is allowed to pass through a doorway formed on the housing and enter the compartment; as well as After the centrifuge is inside the compartment, close the door covering the passageway.

27. The method of claim 23, wherein the centrifugal separator is positioned on the top surface of the mounting platform such that a first fluid line coupled to the centrifugal separator exits from the compartment of the housing, the method further comprising detachably securing the first fluid line to a clamp valve and / or a peristaltic pump mounted on an outer surface of the housing.

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