Fluid flow control valve, systems, and methods for using and producing the same

Abstract

The disclosure relates to fluid flow control valves for use in a fluid processing system, preferably a pharmaceutical fluid processing system, and methods for using the same.

Description

FLUID FLOW CONTROL VALVE, SYSTEMS, AND METHODS FOR USING AND PRODUCING THE SAME

[0001] Related Applications

[0002] This application claims priority to U. S. Ser. No. 63 / 713,629 filed on October 30, 2024, which is incorporated herein in its entirety.

[0003] Field of the Disclosure

[0004] The disclosure relates to fluid flow control valves for use in a fluid processing system, such as a chemical and / or biological fluid processing system, as well as methods for using and producing the same.

[0005] Background of the Disclosure

[0006] Fluid processing systems (e.g., industrial fluid processing systems) typically include multiple valves and associated piping system. It can be difficult to manage the flow of fluids through, and to sanitize and / or sterilize such systems. For instance, some systems require the combination of multiple reactants and / or intermediary products from different containers and / or parts of the system (e.g., sequentially) during processing, and the reactants, intermediates, or final products can require additions of reactants or combinations to be made under precisely controlled conditions (e.g., flow rates, pressures). The fluid flow control valves of this disclosure provide for the adjustment of flow rates between containers and / or parts into which the combined reactants, intermediates and / or products are contained. Challenges associated with controlling the flow from particular types of balls valves in a system has been addressed using, e.g., flow' bore, reduced bore, segmented, cavity filled, multi-port, three-way ball valves, and / or the use of acuators (e.g., automated actuators). These components do not address the complexity of such systems, however Difficulties associated with cleaning and / or sterilization of valves cleaning / sterilization of the valve without removing it from the system into which it is incorporated have been addressed using top entry that provide access to its internal components by removing the bonnet from the top of the valve or sanitary ball valves that use materials amenable to cleaning processes (e.g., seals, O-rings, and seats made from inert, abrasion-resistant materials such as polytetrafluoroethylene (PTFE or Teflon), cavity filled seats, and / or high finishpolish to eliminate peaks and crevices). The flow control, complexity, and cleaning-related problems, among others, encountered using such ball valves can be avoided using the fluid flow control valves of this disclosure. As discussed below, the fluid flow control valves of this disclosure provide for controlled combinations of reactants as well as cleaning and / or sterilization of the valve and associated piping without removing it from the system into which it is incorporated.

[0007] Conventional fluid control systems commonly rely on variable-position valves, throttling valves, or replaceable orifices to achieve different flow rates through a conduit. Such arrangements often require fine manual adjustment, multiple separate valve components, or external flow-restricting devices, increasing both complexity and cost. In systems that alternate between high-flow and low-flow operation — such as filling, rinsing, or metering processes — these traditional approaches can result in inconsistent flow characteristics, mechanical wear, and increased maintenance demands. Ball valves and plug valves are sometimes used to provide on / off control, but they typically offer only a single flow passage and do not permit precise, repeatable selection between distinct flow capacities without complex modulation mechanisms. Accordingly, there remains a need for a compact valve assembly and associated system capable of reliably selecting between predetermined high-flow and low-flow conditions using simple rotational actuation, with compatibility for both manual and automated operation.Brief Description of the Drawings

[0008] Figure 1. Comparison of currently available valve configuration and the configuration of the exemplary preferred flow control valve of this disclosure in an industrial fluid processing system.

[0009] Figure 2. Exemplary' preferred flow control valve in the high flow’ (“open”) configuration.

[0010] Figure 3. Exemplary preferred flow7control valve in the low flow (“closed”) configuration.

[0011] Figure 4. Exemplary preferred flow control valve including stem and actuator in the high flow (“open”) configuration.

[0012] Figure 5. Exemplary preferred flow control valve in the low flow (“closed”) configuration.

[0013] Figure 6. Top view of exemplary preferred flow control valve in the high flow (“open”) configuration

[0014] Figure 7. Top view7of exemplary preferred flow control valve in the low flow (“closed”) configuration.

[0015] Figure 8. Front view of exemplary' preferred flow control valve in the high flow (“open”) configuration.

[0016] Figure 9. Front view exemplary preferred flow control valve in the low flow (“closed”) configuration.

[0017] Figure 10. Isometric view of exemplary preferred flow control valve in the low flow (“open”) configuration.

[0018] Figure 11. Isometric view of exemplary preferred flow control valve in the low flow (“closed”) configuration.

[0019] Figure 12. Isometric view of exemplary preferred flow control valve in the high flow (“open”) configuration.

[0020] Figure 13. Isometric view of exemplary’ preferred flow control valve in the high flow (“open”) configuration.

[0021] Figure 14. Exploded view of exemplary7preferred flow control valve.

[0022] Figure 15. Exemplary, preferred, rotatable valve member Fig. 15A. Top view. Fig.15B. Isometric view. Fig. 15C. First alternative view. Fig. 15D. Second alternative view. Fig.15E. Front view. Fig. 15F. Ri ht side view.Summary of the Disclosure

[0023] Disclosed herein are fluid flow control valves allowing controlled flow of a fluid through a fluid control system (e.g., a. Systems comprising such ball valves and methods for using the same are also provided. Methods for constructing and using such ball valves and systems are described herein.

[0024] This disclosure provides flow control valves, components thereof, systems, and methods for selectively controlling fluid flow between discrete flow conditions within a conduit or fluid process line. In some embodiments, a valve assembly is provided that includes a rotatable valve member having at least two flow passages of different effective flow capacities. The valve member is supported within a valve housing defining a fluid passageway and is coupled to an actuator that rotates the valve member between predetermined orientations. In a first orientation, a high-flow passage of the valve member is aligned with the fluid passageway to permit substantially unrestricted fluid flow. In a second orientation, a low-flow passage that includes a metering orifice or other restriction is aligned with the passageway to limit flow to a reduced rate. Rotation between these orientations enables rapid and repeatable selection of flow rate without the need for variable-aperture throttling mechanisms.

[0025] In another aspect, a fluid movement system is provided that integrates such a valve assembly within one or more conduits and may include a pump, sensors, or a controller configured to actuate the valve member automatically in response to process conditions such as pressure or flow rate. The actuator may be manually operated or may comprise an electric, pneumatic, or hydraulic drive mechanism. The valve member may be generally spherical, cylindrical, or plug-shaped, and may be fabricated from metals, polymers, or composite materials suitable for the intended fluid environment. In certain embodiments, the system maintains sealing engagement between the valve member and valve seats in both high-flow and low-flow positions.

[0026] In a further aspect, methods are provided for manufacturing and operating the valve assembly. The manufacturing methods include forming a body having at least two through-bores of different diameters and positioning the bores to permit selective alignment with the valve housing during rotation. The operational methods include rotating the valve member between orientations to select between flow states, either manually or under automated control.Collectively, the disclosed systems and methods provide a compact, reliable, and easily controlled means of toggling between distinct flow rates in a variety of liquid or gas handling applications.

[0027] Other embodiments are also contemplated by this disclosure as will be understood by those of ordinary' skill int hea rt.Detailed Description

[0028] The present disclosure relates to a fluid movement system configured to selectively regulate fluid flow between distinct flow conditions using a compact, rotatable valve assembly. The system generally includes one or more fluid conduits defining a fluid passageway, a valve disposed within the passageway, and an actuator operatively coupled to the valve The valve includes a rotatable valve member having at least two flow passages of different effective flow capacities — typically a high-flow passage and a low-flow passage with a metering restriction. Rotation of the valve member by the actuator selectively aligns one of the passages with the fluid passageway, thereby permitting an operator or control system to switch between flow states such as full-flow operation and restricted-flow operation without replacing components or introducing external throttling devices. The actuator may be manually operated (for example, a lever or handle) or powered (for example, an electric motor, solenoid, or pneumatic driver), enabling integration into automated process-control environments. The system is suitable for use in liquid or gas transport, chemical and bioprocessing, and other industrial applications requiring rapid, repeatable flow-rate selection. Thus, this disclosure relates to fluid flow control valves (that may also be referred to as “ball valves”), preferably of sanitary design, that can be actuated to provide at least two distinct and different flow rates within or through a conduit in systems for industrial process, such as chemical and biological processing systems (eg., chemical synthesis, oil and gas, bioreactor, fermenter, and the like). The fluid flow control valves of this disclosure can be used to manage the flow of any suitable fluid (e g., liquid, gas, and / or vapor within a piping system). In some embodiments, one of such flow rates is suitable for controlled additions to a bioreactor / fermenter and another such flow rate can be suitable for cleaning / sterilization (e.g., dean-in-place (CIP), steriiize-in-place (SIP)) of the fluid flow control valve without removing it from the system into which it is incorporated. Currently those functions are accomplished using multiple valves (including but not limited to ball valves) and associated extra piping (see, e g.,Fig. 1). As illustrated in Fig. 1, existing valve configurations within fluid processing systems include multiple components including, e.g., flow control valves (F1C), line reducers, flow transmitters (FT), and flow elements (FE), can be replaced with the fluid flow control valve and associated control elements (programming) of this disclosure. Advantages provided by the system of this disclosure (e.g., new valve configuration shown in Fig. 1 and further described herein) include but are not limited to simpler and more efficient cleaning and maintenance, capital cost, and manufacturing documentation provided to regulatory agencies such as The Food and Drug Administration (FDA).

[0029] The fluid flow control valves (e.g., “ball valves”), and fluid control systems including the same, of this disclosure eliminate the need for such multiple valves (including but not limited to ball valves) and associated piping, thereby improving the efficiency and efficacy of such system. In preferred embodiments, the fluid flow control valves of this disclosure are what are commonly referred to in the art as “ball valves”, as those may be understood to those of ordinary skill in the art. When the bore cross-section of a typical ball valve is aligned perpendicularly to the direction of flow of fluid through the associated piping, the valve blocks the fluid. Conversely, when the bore of a typical ball valves is aligned with the flow of fluid through the associated piping, the fluid passes through, with the flow rate determined by the exposed area of the bore. The fluid flow control valves (e.g, ball valves) of this disclosure provide both a pathway through which fluid can flow at a high flow rate and a pathway through which fluid can flow only at a flow rate (a low flow rate), lower than the high flow rate (e.g., measured as ml / cm, pressure, etc.) In preferred embodiments, this disclosure provides a ball valve, also referred to herein as a rotatable valve member, positioned within a fluid passageway and coupled to an actuator, the valve member including (i) a first through-bore defining a high-flow passage having a first diameter, and (ii) a second through-bore defining a low-flow passage including a metering orifice of smaller diameter than the first diameter, wherein rotation of the rotatably valve member by the actuator selectively aligns either the high-flow passage or the low-flow passage with the fluid passageway to regulate flow through the valve.

[0030] In certain embodiments, the fluid movement system includes a valve having a rotatable valve member disposed within a valve housing that defines a fluid passageway. The valve member is generally spherical and configured to rotate about a stem or actuator axis between discrete rotational orientations. The valve member includes at least two through-bores: a firstthrough-bore forming a high-flow passage having a relatively large diameter, and a second through-bore forming a low-flow passage that includes a metering orifice or restriction having a smaller diameter than the high-flow passage. Rotation of the valve member selectively aligns one of the through-bores with the housing passageway so that, in a first orientation, the high-flow passage is aligned to permit substantially unrestricted flow through the valve, and in a second orientation, the low-flow passage is aligned to restrict flow to a predetermined reduced rate. The valve member may be coupled to a manual handle, lever, or a powered actuator, such as a motor or solenoid, that controls the rotational orientation of the valve member. In use, the system may include sensors configured to monitor flow rate or pressure and to signal the actuator to rotate the valve member between the high-flow and low-flow orientations to maintain desired operating conditions. The spherical external surface of the valve member may seat against complementary valve seats in the housing to provide fluid sealing in each position.

[0031] In some preferred embodiments, the actuator comprises a handle mechanically coupled to the valve member, the handle being rotatable between at least two detented positions corresponding respectively to alignment of the high-flow passage and the low-flow passage with the fluid passageway.

[0032] In some preferred embodiments, the high-flow passage is aligned with the fluid passageway when the valve member is in a first rotational orientation, and the low-flow passage is aligned with the fluid passageway when the valve member is in a second rotational orientation offset by approximately 90 degrees from the first orientation.

[0033] In some preferred embodiments, the low-flow passage includes a metering orifice having a diameter dimensioned to produce a volumetric flow rate less than one-tenth of that through the high-flow passage under an equal pressure differential.

[0034] In some preferred embodiments, the system comprises a valve housing that defines the fluid passageway, the valve member being rotatably retained within a spherical cavity of the housing and sealed by opposing valve seats.

[0035] In some preferred embodiments, this disclosure provides the following aspects a rotatable valve member for a fluid flow7control valve, the rotatably valve member comprising a generally spherical body configured to be received within a valve housing and to rotate about an axis; a firstthrough-bore extending through the body to define a high-flow passage having a first diameter, and, a second through-bore extending through the body to define a low-flow passage including a metering orifice of smaller diameter than the first diameter; wherein the first and second through-bores are positioned such that rotation of the valve member about the axis selectively aligns one of the high-flow passage or the low-flow passage with a fluid passageway of the valve housing. In some preferred embodiments, the first and second through-bores are oriented approximately ninety degrees apart around the rotational axis. In some preferred embodiments, the body comprises stainless steel, brass, or a polymeric material resistant to corrosion and wear. In some preferred embodiments, the body comprises a stem or actuator interface extending from the body for engagement with a manual or motorized actuator. In some preferred embodiments, the metering orifice is dimensioned to provide a volumetric flow rate less than one-tenth that of the high-flow passage under equal inlet pressure. In some preferred embodiments, an external surface of the body is polished or coated wdth a low-friction material to reduce torque during rotation within the valve housing.

[0036] In some preferred embodiments, this disclosure provides a fluid movement system comprising: a fluid conduit defining a fluid passageway; a valve disposed within the fluid passageway, the valve including a rotatable valve member coupled to an actuator, the valve member comprising: (i) a first through-bore defining a high-flow7passage having a first diameter, and, (ii) a second through-bore defining a low-flow passage including a metering orifice of smaller diameter than the first diameter; wherein rotation of the valve member by the actuator selectively aligns either the high-flow7passage or the low-flow passage with the fluid passageway to regulate flow through the system. In some embodiments, the actuator comprises a handle rotatable between detented positions corresponding respectively to the high-flow7and low-flow7passages. In some embodiments, the actuator comprises a motor or solenoid configured to rotate the valve member in response to an electronic control signal. In some embodiments, the system further comprises a pump configured to drive fluid through the conduit, the pump being downstream of the valve. In some embodiments, the system comprises a flow sensor operatively coupled to a controller that adjusts the actuator to select the high-flow7or low7-flow passage based on a measured flow7rate or pressure differential. In some embodiments, the valve member is spherical and rotatably retained within a valve housing having opposed valve seats that seal against the valve member when rotated. In some embodiments, the low-flow passage isconfigured to pass a volumetric flow rate less than one-tenth that of the high-flow passage under equal inlet pressure.

[0037] In some preferred embodiments, this disclosure provides methods for regulating fluid flow through a fluid movement system, the system comprising a fluid conduit and a valve disposed within the fluid conduit, the valve including a rotatable valve member having a high-flow passage and a low-flow passage, the method comprising rotating the valve member between a first orientation in which the high-flow passage is aligned with the fluid conduit to permit a high flow of fluid, and a second orientation in which the low-flow' passage is aligned with the fluid conduit to restrict the flow' of fluid. In some embodiments, the low-flow passage comprises a metering orifice having a diameter smaller than that of the high-flow passage. In some preferred embodiments, the methods comprise sensing a parameter of the fluid selected from flow rate, pressure, or temperature, and rotating the valve member between the first and second orientations in response to the sensed parameter. In some preferred embodiments, the method comprises rotating the valve member comprises manually turning a handle between detented positions corresponding to the first and second orientations. In some preferred embodiments, rotating the valve member comprises actuating a motor or solenoid under control of an electronic controller. In some preferred embodiments, the method comprises the valve member is spherical and rotatably retained w'ithin a valve housing having opposed valve seats. In some preferred embodiments, the method comprises the controller maintains the valve member in the low-flow orientation until a predetermined flow-rate threshold is exceeded, and then rotates the valve member to the high-flow orientation.

[0038] In some preferred embodiments, this disclosure provides methods for manufacturing a rotatable valve member for a fluid flow' control valve, the method comprising: forming a generally spherical body configured for rotation within a valve housing; machining or otherwise forming a first through-bore extending through the body to define a high-flow passage having a first diameter; and, machining or otherwise forming a second through-bore extending through the body to define a low-flow passage including a metering orifice of smaller diameter than the first diameter, wherein the first and second through-bores are oriented such that rotation of the valve member within the valve housing selectively aligns one of the high-flow and low-flow passages with a fluid passageway of the valve. In some embodiments, the step of forming the body comprises casting, sintering, or molding a metal or polymeric material and subsequentlymachining the first and second through-bores. In some embodiments, the metering orifice is formed by precision drilling, laser machining, or electrical discharge machining to achieve a predetermined orifice diameter. In some embodiments, polishing or coating at least a portion of the spherical surface of the body to reduce frictional resistance during rotation within the valve housing. In some embodiments, the first and second through-bores are positioned at an angular offset of approximately 90 degrees relative to one another about the rotational axis of the body. In some embodiments, the system further comprises attaching a stem or actuator interface to the body to enable rotation of the valve member within the valve housing.

[0039] In alternative embodiments, the valve member need not be spherical. The valve member may instead comprise a generally cylindrical or plug-shaped body configured for rotation or translation within a corresponding bore or cavity of the valve housing. The body may include a first passage sized and oriented to provide a high-flow path and a second passage including a metering orifice or restriction to provide a low-flow path. Rotation or axial movement of the body selectively aligns either passage with the fluid passageway of the housing to achieve the desired flow' condition. The plug-type valve member may be fabricated from metal, polymeric, or composite materials suitable for the operating fluid and may include surface treatments or coatings to reduce friction and enhance sealing. The actuator used to reposition the valve member may be mechanical, pneumatic, electric, or hydraulic Such non-spherical valve members function analogously to the spherical embodiments described above, permitting controlled selection between discrete flow' rates within a compact flow-control assembly.

[0040] Thus, in preferred embodiments, such as in systems in which multiple reactants and / or intermediary products from different containers and / or parts of the system are combined together (e.g., sequentially) during processing, the fluid control ball valves of this disclosure provide for the adjustment of flow rates between containers and / or parts into which the combined reactants and / or products are contained. The fluid control ball valves of this disclosure can be used to control the flow rate of solutions between containers comprising such reactants and / or products. The fluid control ball valves of this disclosure also provide the advantages described above, including but not limited to the cleaning / sterilization of the valve without removing it from the system into which it is incorporated. As mentioned above, typical designs and processes used to clean and / or sterilize valves in a fluid control system can be very complicated, such as a top entry ball valve that provides access to its internal components by removing the bonnet from the top ofthe valve. Such intensive processes can be avoided using the fluid flow control valves designed as disclosed herein. Even so, in some embodiments, however, the fluid control ball valves of this disclosure can include top entry access feature and provide the other advantages disclosed herein.

[0041] In some preferred embodiments, the present disclosure provides a fluid flow valve comprising: a rotatable ball comprising first and second fluid flow passageways, the first fluid flow passageway being a high flow fluid flow passageway, the second fluid flow passageway being a low flow fluid passageway and comprising at least one critical size orifice that determines the rate of flow therethrough; a body comprising an interior cavity enclosing the rotatable ball; and, a stem extending into the ball along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball into a high flow (i.e., high flow fluid flow passageway open, low flow fluid flow passageway closed) or low flow configuration (i.e., high flow fluid flow passageway closed, low flow fluid flow passageway open). When the high flow fluid flow passageway is open and the low flow fluid flow passageway is closed, fluid flows through the fluid flow valve at a first flow rate. When the high flow fluid flow passageway is closed and the low flow fluid flow passageway is open, fluid flows through the fluid flow7valve at a second flow rate, preferably lower than the first flow rate.

[0042] In preferred embodiments, the fluid flow passageway is included in a system for processing fluids. In some such embodiments, the fluid flow passageway provides a transition point between an upstream flow7conduit and a downstream fluid conduit. In preferred embodiments, the flow7of fluid through the fluid flow passageway is at least in part regulated by the fluid flow control valve.

[0043] In preferred embodiments, this disclosure provides a fluid flow control valve comprising: a body including an upstream flow passage and a downstream flow passage in fluid communication with an interior cavity of the body; a ball disposed within the interior cavity, the ball being rotatable within the interior cavity on an axis to adjust the valve from a closed position (low flow7) to an open (high flow) position, the ball including a first fluid conduit of a first, diameter extending along a first axis therethrough (the high flow fluid passageway), and a second fluid conduit (the low flow fluid passageway including the critical orifice) of a second lesser diameter extending along a second axis, the first and second fluid conduits preferably being positioned perpendicular to one another, each or the other conduit being mutually exclusivelyalignable with the upstream flow passage and the downstream flow passage In the ‘"open” configuration, the first fluid conduit is aligned with the upstream flow passage and the downstream flow passage while the second fluid conduit is not. In the “closed’’ configuration, the second fluid conduit is aligned with the upstream flow passage and the downstream flow passage while the first fluid conduit is not. The open and closed configurations are actuated by a stem that is operably fixed to the body (e.g., by insertion therein or as a functional part of the body ).

[0044] In preferred embodiments, a system may include multiple flow control valves of this disclosure. In some embodiments, the multiple flow control valves can be aligned and operate in series to adjust the flow of fluid in conjunction with one another

[0045] In preferred embodiments, this disclosure provides a fluid flow7valve comprising: a rotatable ball comprising first and second fluid flow7passageways, the first fluid flow passageway being a high flow fluid flow passageway, the second fluid flow passageway being a low flow fluid passageway and comprising at least one critical size orifice: a body comprising an interior cavity enclosing the rotatable ball; and, a stem extending into the ball (or being a single piece constructed as part of the ball body) along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball.

[0046] The body, in preferred embodiments, can be a cylindrical body (or substantially cylindrical) such that an interior cavity of the body is substantially cylindrical in shape. In some embodiments, the body may be a spherical body such that the interior cavity of the body is substantially spherical. In some embodiments, the body may be a octagonal body such that the interior cavity of the body is substantially octagonal (see, e.g., Fig. 2). In any embodiment, however, the valve body provides the fluid passages through which fluid can flow7and be regulated thereby. The fluid passages includes a fluid inlet and a fluid outlet.

[0047] The stem can generally a cylindrical rod extending through one or more components of the fluid flow control valve, preferably the body. Alternatively, the stem may be an integral (not separate) part of the body. In preferred embodiments, the axis of rotation extends through a centerline of the stem and, generally, provides a reference axis about which the stem and the ball may rotate as the fluid flow control valve is adjusted from 0-degrees rotation from an open (i.e., high flow) to a closed (i.e., low flow) position w'ith 90-degrees of rotation and back to the open position. A rotational force may be supplied to the stem by an actuator (e.g., a handle) coupled tothe stem. The actuator may supply rotational force to the stem via a variety of actuator power sources, such as hydraulic, pneumatic, or electric, and the like, and may be automated.

[0048] In some preferred embodiments, this disclosure provides such a fluid flow valve wherein the stem, via the actuator, effectuates rotation of the ball: into a high flow configuration in which the flow of fluid into a downstream fluid conduit is at a high flow rate and pressure, and, into a low flow configuration in which the flow of fluid into a downstream fluid conduit is at low flow rate and pressure that is less than the high flow rate and pressure

[0049] In preferred embodiments, this disclosure provides such a fluid flow valve wherein the critical size orifice of the fluid flow valve comprises a diameter provides for the flow of a fluid through the valve at a pre-determined rate and volume In the preferred embodiment shown in Figs. 3 and 4, for instance, the low flow fluid passageway 5 / 5A has a diameter of approximately 20-25% of the diameter of the high flow fluid passageway, or the ratio of the diamter of the low flow fluid passageway to the diameter of the high flow fluid passageway is approximately 4:1 or approximately 5.1. Any suitable relationship of these diameters can be used, however, as long as the relative flow rates in the high flow fluid passageway and the low flow fluid passageway are as desired, and as can be determined using standard techniques in the field (e.g., sufficiently lower through the low flow fluid passageway as compared to the high flow fluid passageway). In some embodiments, this relationship between the flow rates provided by the low flow and high flow fluid fluid passageways can be determined using standard formulas that can include several calculations relating to flow7rates, pipe diameters, pressure drops, and pump requirements. For complex systems, computational fluid dynamics (CFD) software may be used for detailed analysis and design. Exemplary equations that can be used to make such determinations for water and other liquid fluids are shown below:Exemplary equations that can be used for steam are shown below:An exemplary structured approach to performing flow calculations in the system disclosed herein is provided by the calculations shown below:1. Determine the fluid properties of the fluid being transported (e.g., viscosity (p):Resistance to flow, affecting the friction in the pipes; density (p): mass per unit volume, important for calculating pressure drops and flow rates; temperature (T): affects viscosity and density).2. The flow rate (Q) is typically expressed in units such as liters per minute (LPM), liters per second (L / s), cubic meters per hour (m3 / h), and can be calculated using the following equation:Q — A - iJwhere:A = Cross-sectional area of the pipe (m2); and.v = Flow velocity (m / s).Once the flow rate is known, the required pipe diameter (D) using the cross-sectional area equation for a circular pipe can be determined using the formula:which can be rearranged to provide:The flow regime (i.e., whether the flow is laminar or turbulent) can be determined using the Reynolds number (Re):where D Pipe diameter (m); and, an Re < 2000 indicates laminar flow (use the Hagen-Poiseuille equation) and Re > 4000 indicates turbulent flow (use the Darcy-Weisbach equation)Calculate the pressure drop (AP) due to friction in the pipe using the Darcy-Weisbach equation:where:f= Darcy friction factor (depends on flow regime and pipe roughness) and L = Length of the pipe (m); and,the friction factor can be calculated by:for laminaror,for turbulent flow, the Moody chart (see, e.g., Moody, 1. 1 “Friction factors for pipe flow”, Trans. ASME (1944)) or the Colebrook-White equation(Zeghadnia, et al. Explicit solutions for turbulent flow friction factor: A review, assessment and approaches classification. Ain Shams Eng’g J., 10(1): 243-252 (2019)) can be employed to determine6. In addition to friction loss, consider other possible losses in the system due to fittings, bends, valves, etc. that can be calculated as shown below:where K is the loss coefficient for the fitting.7. If a pump is needed to maintain the desired flow rate, the required pump head (IP) can bed etermined using the formula:Elevation Headwhere g = Acceleration due to gravity (9.81 m / s2).8. If flow control devices such as valves are used, calculate the flow coefficient (CvC vCv) to ensure adequate flow regulation using the formula:Q - APwhere PP is the pressure drop across the valve.Other calculations for determining flow rates in the low flow and high flow fluid passageways, and the relationship between the two for use in the systems disclosed herein, are also suitable as would be understood by those of ordinary skill in the art, e g., as is described in standard textbooks (e.g., An Introduction to Fluid Dynamics (Batchelor, G. K., 1967; Physical Fluid Dynamics (Tritton, F. J., 1988); Fluid Mechanics: An Intermediate Approach (Sultanian, B. K., 2015)).

[0050] In some preferred embodiments, this disclosure provides such a fluid flow valve wherein the second (low flow) fluid flow' passageway comprises an entry and / or exit at which fluid is received or discharged, respectively, in which one or both comprise a resected region (e.g., 4 in Figs. 2-5, 10, 14, 15). The resected region can be of any suitable size but preferably does not include any sharp edges that could interfere with and / or disrupt the flow' of fluid into or out of thethe low flow fluid passageway. Sharp edges can also interfere with cleaning and / or sterlization of the valve and should be avoided for this additional reason.

[0051] In some preferred embodiments, this disclosure provides such a fluid flow valve wherein the high flow fluid flow passageway has a diameter sufficient for clea -in -pl ace (CIP) and / or sterilize-in-place (SIP) processes. Cleaning and / or sterilizing (i.e., production reactor) can be achieved using standard procedures including acid / caustic washes and clean water rinses In preferred embodiments, the system could comprise piping (e.g., tubing) that can be independently cleaned and sterilized from other sections of the system to allow a container to sterilely accept liquid additions into the product stream. In some embodiments, an “empty” sterilization process utilizing clean steam (i.e., steam prepared from a purified water source) or culinary grade stream as the same is known in the field, can also be used to clean and / or sterilize. Time and temperature can also be adjusted to align with desired sterilization requirements. For example, a suitable sterilization can include heating an empty container and supply lines (including the fluid flow control valve of this disclosure) and the sterile boundaries thereof up to 125°C and hold this temperature for 30 minutes. Steam would be replaced with clean air and the vessel would cool down to allow for media addition. Other suitable CIP and SIP processes are known in the art and would be applicable to the systems disclosed herein, as would be understood by those of ordinary skill in the art.

[0052] In some preferred embodiments, this disclosure provides a system comprising the fluid flow valve of any preceding claim wherein: the fluid flow valve is in fluid communication with an upstream fluid conduit and a downstream fluid conduit; the fluid flow valve is positioned to receive fluid from the upstream fluid conduit and to supply fluid to the downstream fluid conduit; and, the diameter reduces the high flow rate and and pressure of the fluid to the low flow rate and pressure.

[0053] In some embodiments, this disclosure provides such fluid flow control system comprising the fluid flow valve of any preceding claim, the system comprising: an upstream fluid conduit and a downstream flow fluid conduit in fluid communication with the flow control valve; the flow' control valve being positioned between the upstream fluid conduit and the downstream flow fluid conduit; wherein: the flow control valve receives fluid from the upstream fluid conduit at a first flow rate and first pressure; and, the low flow fluid passageway has a diameter less than theupstream fluid conduit and supplies the fluid to the downstream flow fluid conduit at a second flow rate and pressure lower than the first low rate and pressure.

[0054] In some embodiments, this disclosure provides such a flow control system wherein the high flow fluid flow passageway, in the open configuration, comprises a first opening adjacent to the upstream fluid conduit and a second opening adjacent to the downstream fluid conduit, optionally wherein the openings have the same diameter.

[0055] In some embodiments, this disclosure provides such a flow control system wherein the fluid traverses the low flow fluid passageway at a calculated rate (Iph) determined by the first flow rate, first pressure, and the diameter of the critical size orifice.

[0056] In some embodiments, this disclosure provides such a flow control system wherein the high flow fluid flow passageway has a diameter sufficient for clean-in-place (CIP) and / or sterilize-in-place (SIP) processes.

[0057] Figs. 2-15 illustrate preferred embodiments of the fluid flow control valve (1) of this disclosure. The various parts are labeled with numerals. To the extent the same are not explicitly repeated in each of Figs. 2-15, one of ordinary skill in the are can easily correspond each part in one illustration to that of another by a simple comparison In the preferred embodiment shown in Figs. 2-15, the fluid flow control valve (1) includes valve body (1A) and associated sub-parts (e.g., end connections (7), ball seat gasket 8 (also referred to as valve seat in Fig. 13)) enclosing a rotatable member (or valve member, preferably in the form of a sphere or ball) (2) that, in preferred embodiments (see, e g.. Figs. 14-15), includes ball body (3) (the solid portion of the rotatable member or ball), resected portion (4), low flow fluid passageway (5) (providing the critical orifice (5A)), high flow fluid passageway (6), upstream fluid conduit (11) from which fluid enters the fluid flow control valve, the low flow fluid passageway (5) and high flow fluid passageway (6) (the presence of which depending on whether the fluid flow control valve is in the high flow (or “open”) configuration (as shown in Fig. 2) or the low flow (or “closed”) configuration (as shown in Fig. 3)), and downstream fluid conduit (12) into which fluid flows from the fluid flow control valve positioned in the high flow or low flow configuration. Fig. 4 illustrates additional features of a preferred embodiment of the fluid flow control valve of this disclosure, including an actuator (13) that typically includes a handle (14) for rotating the stem of the actuator (15) that is incorporated into ball body (3), preferablythrough valve stem attachment point (10) (for rotating the ball into the high flow (or ‘"open”) configuration or low7flow (or “closed”) configuration). The actuator may also be automated with or without a handle. The parts can be connected by any suitable mechanism such as using the nut and bolt embodiment shown in Fig. 14 (see, e.g., the combination of components 9 and 10 therein). As mentioned herein, the actuator can in some preferred embodiments, be automated and may therefore be present in a configuration different from what is presented one figure or another (e.g., lacking an actuator handle), but able to rotate the rotatable member (e g., ball) into the the high flow (or “open”) configuration or low flow (or “closed”) configuration. The components of the fluid flow control valve of this disclosure can comprise any material suitable for clean-in-place or sterlize-in-pl ce processes (e.g., acid, base and / or heat resistant material(s)) such as stainless steel, ethylene propylene diene monomer (EPDM), or a combination of such materials.

[0058] As illustrated, low flow fluid passageway (5), critical orifice (5 A), and high flow fluid passageway (6) each have a circular shape, providing a tubular passageway for fluid. However, these features may take any shape, the same or different, allowing for the flow of fluid through the same at a suitable rate. For instance, the shape could be, for instance, circular (as shown), square, rectangular, triangular, rhomboidal, pentagonal, hexagonal, octagonal, star-shaped, or any other suitable shape (meaning the desired flow rate through the passageway is sufficient for the intended use). Each end of the low7flow fluid passageway (5) (i.e., critical orifice (5A)) and high flow fluid passageway (6), respectively, may be the same or different. Figs. 2, 3, 5, 10, 12, and 15 illustrate low7flow fluid passageway (5) (including the critical orifice (5A) therein) traversing high flow fluid passageway (6). In preferred embodiments, high flow fluid passageway (6) has a larger diameter than low flow fluid passageway (5) which allows are greater amount of fluid to flow through high flow7fluid passageway (6) as compared to low flow fluid passageway (5). The flow of fluid through high flow fluid passageway (6) is not significantly impeded by the presence of low flow7fluid passageway (5) therein, meaning the flow therethrough is sufficient for an intended use. In preferred embodiments, low flow fluid passageway (5) traverses high flow fluid passageway (6) in a perpendicular manner as shown in Fig. 15 (e.g., along the respective axes labeled as 5B1 and 5B2). However, the low flow fluid passageway (5) can traverse high flow7fluid passageway (6) in any suitable relative manner, meaning the flow therethrough is sufficient for an intended use. Other embodiments can also besuitable as would be understood by those of ordinary skill in the art.

[0059] As shown in the embodiment illustrated in Fig. 14, rotatable ball (2) can be enclosed within valve body includes the fluid flow control valve (1) includes valve body (1A) and associated sub-parts (e.g., end connections (7), ball seat gasket 8 (also referred to as valve seat in Fig. 13)) enclosing rotatable member (e.g., ball) (2) including rotatable member (e.g., ball) body (3) (the solid portion of the rotatable member (e.g., ball)), resected portion (4), low flowfluid passageway (5) (providing the critical orifice (5A)), high flow fluid passageway (6), upstream fluid conduit connector (11 A) for connection to upstream fluid conduit (11), the low flow fluid passageway (5) (provding critical orifice (5A)) and high flow fluid passageway (6) (the presence of which depending on whether the fluid flow control valve is in the high flow (or “open”) configuration (as shown in Fig. 1) or the low flow (or “closed”) configuration (as shown in Fig. 2)), downstream fluid conduit connector (12A) for connection to downstream fluid conduit, valve actuator (13) that typically includes a handle (14) for rotating the stem of the actuator (15) that is incorporated into ball body (3), preferably through valve stem attachment point (10 (within valve body), 10A (within ball body)), as well as the exemplary nut and bolt embodiment (9, 10).

[0060] Figs. 15A-F illustrate embodiments of the rotatable member (e.g., ball) (2) in additional detail. As shown in this embodiment, ball includes ball body (3) including low flow pathway (5) and critical orifice (5 A), high flow pathway (6), resected area (4) within low flow pathway (5) and leading to critical orifice (5A), as well as valve stem attachment point (10). In preferred embodiments, rotatable ball (2) has a generally spherical shape (e.g., as a bead or ball), the low flow pathway (5), critical orifice (5A), high flow pathway (6) and valve stem attachment point introduced into valve body starting material (e.g., a spherical component comprised of a suitable material) by a technique such as drilling and / or grinding. However, rotatable member (e.g., ball) (2) can be made using any technique available to those of ordinary skill in the art including for instance 3D printing, etching (e.g., water, laser), and the like, including but not limited to the methods disclosed herein.

[0061] As can be ascertained from Figs. 2-15, the rotatable member (e.g., ball) includes a body of material (e.g., any clean-in-place or sterlize-in-place material, preferably a corrosion-, heat-, and / or hydraulic-resistant material, a metal such as nickel alloy or stainless steel, a polyamide / Nylon material, elastomeric material, or a plastic polymer such as Teflon (PTFE), polyether ether ketone (PEEK), UMHW polyethylene, acetal urethane, TFM, or ethylene propylene (EP), ethylene propylene diene monomer (EPDM), and / or a combination of such materials) that only allows from fluid to flow through the fluid flow control valve by traversing the low flow passageway of the rotatable ball (critical orifice (5); the low flow configuration or “closed” position), or through the high-flow passageway (6) in the high-flow configuration (or “open”). The flow of fluid into the downstream fluid conduit, and therefore any fluidly connected container, from the flow control valve is thereby restricted (e.g., lower flow rate / volume, slower speed and / or pressure). In the high flow (closed) configuration, fluid can flow through high flow passageway (6) of the fluid flow control valve and can flow from the upstream fluid conduit into the downstream fluid conduit in a relatively unimpeded manner (e.g., approximately the same flow rate through the fluid flow control valve and into the downstream fluid conduit and any fluidly connected container).

[0062] The fluid flow control valve (e.g., ball valve) disclosed herein can be manufactured as a one-, two-, three- (or more) piece valve, synthesized using any techniques known in the art (e.g., manufacturing and assembly of individual parts, 3D printing, and the like). For instance, the fluid flow control valve may be prepared as a single, cast body that encases all internal components. The fluid flow control valve (ball valve) can also be manufactures as a two-piece version including a housing divided into two sections that are assembled together. The fluid flow control valve of this disclosure can also be manufactured as a split-body version including a housing divided into two sections that are assembled together, where a housing is divided into two sections that are assembled together (e.g., one section houses the ball and provides a connection at one end, while the other section contains the internal components and connects at the opposite end). The fluid flow control valve of this disclosure can also be manufactured as a three-piece valve including a housing that encloses the internal components, with the housing sections connected and secured by bolts at each end, where the ends are typically threaded or welded to the main pipe (commonly used in systems requiring cleaning, typically an intensive process that can be avoided using the fluid flow control valves designed as dislcosed herein; however, the ball valves can nonetheless be designed in this way if desired). The fluid flow control valves of this disclosure can also be manufactured as a top entry ball valve that provides access to its internal components by removing the bonnet from the top of the valve (anothersystem commonly used in systems requiring cleaning and, again, this intensive process that can be avoided using the fluid flow control valves designed as dislcosed herein; however, the fluid flow control valves can nonetheless be designed in this way if desired).

[0063] In preferred embodiments, the systems described herein may also include one or more manual, electrical, motorized, pneumatic, air acuated and / or automated control systems (i.e., not requiring continuous direct human intervention, or constant direct human intervention), including but not limited to one or more remotely controlled control systems, for actuating the fluid flow control valve to the high or low flow configuration. For instance, a control system may continuously monitor one or more conditions occurring within any of the components of the system, preferably between at least any two components of the system. Such control systems typically comprise one or more general purpose computers including software for processing such information and manually or automatically adjusting the desired parameters of the reaction as required by a particular process. Thus, in some preferred embodiments, the control system is automated (e.g., using software). In some preferred embodiments, the systems described herein can include one or more automation system(s) for control and monitoring of process conditions and process sequencing. In some preferred embodiments, the automation system includes hardware (automation system hardware) including but not limited to commercially-available Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), and / or one or more Human-Machine Interfaces (HMI). In preferred embodiments, the automation system hardware is programmed for control and monitoring of process conditions and process sequencing. Process control and monitoring parameters that can be controlled by such manual and / or preferably automated systems include but are not limited to dissolved oxygen, pCOz, temperature, liquid level, foam detection / control, gassing / mass flow, headspace pressure, pH, agitator speed, viable cell density, exhaust gas analysis and spectroscopy methods including Ultraviolet (UV) and Raman, and can incorporate specific control algorithms such as exponential feeding. Sequences that can be controlled can include clean-in-place (CIP), sterilization-in-place (SIP), pressure hold testing, vessel charging, cell growth, reagent addition and / or cell harvest processes. Process control and monitoring can also include integration / interfacing of external process systems supplying or servicing one or more containers, including reagent addition tanks, clean-in-place (CIP) systems, sterlize-in-place (SIP) systems, liquid sterilization systems and harvest systems. Process control, monitoring and9?sequencing data, may be collected and stored as a batch record. Exemplary automatically-controlled systems preferably include Ethernet-based Redundant Plant Control Network connection to two redundant network switches (not shown) in each remote I / O panel and redundant ethernet connection from switches to HMI and to Ethernet 170 (shown) inside remote I / O panel.

[0064] In some exemplary' embodiments, the fluid flow control valves of this disclosure can be incorporated into reaction systems for including multiple containers holding fluids that are reagents and / or comprise and / or serve as reagents for reactions. For instance, in the pharmaceutical industry, relevant processes can include, e.g., and without limitation, the culturing of cells for use per se or in the production of pharmaceutical products such as proteins (e.g., antibodies, cytokines) or recombinant viruses. One or several containers can comprise reactants that are combined in various processes to provide a reaction mixture (e.g., a starting material, intermediate reaction mixtures and / or product, and / or a final product). Exemplary fluids can be, for instance, cell culture media or its individual components, cell culture fluid for inoculation, basic or acidic solutions to control pH, glucose or another sugar for cell growth, antifoam, and / or the like. In some embodiments, each of these liquid additions could be fed from a previous container (e.g., bioreactor) as in a train of containers, other containers of a proper size for reaction, and / or a header system that could supply multiple of such containers. In some embodiments, the systems can include multiple containers fluidly connected in series of, for instance, 10, 50, 100, 250, 500, 1,000, 5,000, 10,000, 20,000, 25,000, 32,000, 40,000, 50,000, 125,000, and / or 250,000 L, arranged into various subsystems. The containers and other components of the system can be comprised of any suitable material (e.g., a corrosion-resistant material, a metal such as nickel alloy or stainless steel, a polyamide / Nylon material, elastomeric material, or a plastic polymer such as Teflon® (PTFE), polyether ether ketone (PEEK), UMHW polyethylene, acetal urethane, TFM, or ethylene propylene (EP), and / or the like and / or combinations thereof) and can comprise disposable containers therein in which the reactions take place. A suitable material is one that is able to withstand the forces applied thereto and to be cleaned- and / or sterilized-in-place without being damaged. The flow of fluids at the transition between such containers and components can be controlled using the flow control valves of this disclosure.

[0065] In some exemplary cell culture-related processes, for example, one or more containers typically include a liquid cell culture media suitable for maintaining the viability and growth of the cells of interest (e.g., bacterial, mammalian, fish, avian, and / or insect cells). For instance, a system can include containers holding a media preparation (“Media Prep”) that is connected to a nutrient preparation container (“Nutrient Prep”) and / or a large media preparation subsystem (“Large Media Prep”). Exemplary cell culture medias would be any of those typically used for culturing such cells and modified as needed to allow for viability and growth within the container (e.g., at a growth rate and / or to the densities required). Typically, the cell culture media and any other liquids introduced into the container during the cell growth / expansion process is sterile. The cell expansion process could take different forms such as batch (i.e,, in which the entire volume of media is introduced at a single time), fed-batch (in which media and nutrients are added throughout the growth time) or in a process intensification form (i.e., in which an external device such as a filter is used to exchange media / nutrients to allow higher cell densities). Following an initial reaction (e.g., growth to 50 million cells / ml), cell harvesting can be performed that transports the cells from the culture container (e g., to minimize the risk of contamination) through a sterile transfer line into another container. In some embodiments, an additional reagent may be introduced into the culture container to facilitate growth of the cells therein. In some embodiments, the entire contents of the culture container can be harvested simultaneously, or in some embodiments only a portion could be harvested, and then additional cell culture media can be introduced into the system to continue cell expansion in a manner known as draw and fill. Certain processes require the supply of a reactant from one container in the system require movement from one container to another at different speeds (e.g., flow rates) and / or pressures. This movement typically involves a series of fluid conduits (e.g., transport lines), valves and pumps operating in conjunction with one another. It can be critical to control the flow rate and / or pressure by which fluid is moved from one container and into another. For instance, while cell culture media can be moved through the system at a high flow rate without detrimentally affecting the same, the rate at which that cell culture media is introduced into a container including live cells may need to be performed at a lower flow rate to avoid damage to the cells (e.g., protect the cells from rotational or vibrational stress). Currently available systems can provide some such control, but the fluid flow valves and systems disclosed herein provide precise and customized solutions to such problems. Thus, the fluid flow valves and systemsdisclosed herein provide for the adjustment of flow rates and / or pressure as fluid moves from one container to another. As such, the fluid flow valves disclosed herein provide transition points in the flow of fluid from one container to another within a system designed to move and process fluids.

[0066] In certain embodiments, sufficient mixing and gas dispersion within a container are important for the maintaining optimal cell viability and growth in a container (e.g,, in a bioreactor vessel). The addition of reactants and / or components such as cell media (e.g., fresh cell media) requires, in some instances, controlled addition to the container. The fluid flow' control valve of this disclosure can be used to control the flow of such reactants and / or components to a container, such as one including cells. Mixing of such reactants, components, and / or cells can be accomplished using an agitation system comprising an agitator including one or more impellers.

[0067] This disclosure also provides methods for regulating the flow of a fluid by providing a fluid flow control valve of this disclosure in fluid communication with an upstream flow passage and a downstream flow passage. In one embodiment, the method includes providing a fluid to the upstream fluid passage; rotating the ball in the body to align the first flow conduit with the upstream flow passage and the downstream flow passage in an open position; and directing fluid communication from the upstream flow conduit through the high flow passageway of the ball to the downstream fluid conduit. In one embodiment, the method includes providing a fluid to the upstream fluid passage, rotating the ball in the body to align the low flow passageway with the upstream flow conduit and the downstream flow conduit in a closed position; and directing fluid communication from the upstream flow conduit through the low flow passageway (i.e., the critical orifice) of the ball to the downstream flow conduit. In preferred embodiments, the stem and actuator are used to engage the ball and move it into the open and closed positions.

[0068] This disclosure also provides methods for making a fluid flow control valve of this disclosure, the method comprising assembling a rotatable ball comprising first and second fluid flow passageways, the first fluid flow passageway having a first diameter, the second fluid flow comprising at least one critical size orifice having a diameter less than that of the first diameter; a body comprising an interior cavity enclosing the rotatable ball; and, a stem extending into theball along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball. “Assembling” can be accomplished by any method available to those of ordinary skill in the art, including for instance, manufacturing the individual components using a process such as a mold and / or 3D printing and then connecting the components to provide a fluid flow control valve. Assembling could also be accomplished, for instance, using a process such as 3D printing in which the components are manufactured together as a single functional unit. Other methods of manufacturing would also be suitable as would be understood by those of ordinary skill in the art,

[0069] Thus, this disclosure provides the following aspects, in addition to other aspects disclosed herein or as would otherwise be understood by those of ordinary' skill in the art:1. A rotatable valve member (e.g., as illustrated in Figs. 15A-F) for a fluid flow control valve, comprising:a generally spherical body configured to be received within a valve housing and to rotate about an axis;a first through-bore extending through the body to define a high-flow passage having a first diameter; anda second through-bore extending through the body to define a low-flow passage including a metering orifice of smaller diameter than the first diameter;wherein the first and second through-bores are positioned such that rotation of the valve member about the axis selectively aligns one of the high-flow passage or the low-flow passage with a fluid passageway of the valve housing.2. The valve member of aspect 1, wherein the first and second through-bores are oriented approximately ninety degrees apart around the rotational axis.3. The valve member of aspect 1, wherein the body comprises stainless steel, brass, or a polymeric material resistant to corrosion and wear.4. The valve member of aspect 1, further comprising a stem or actuator interface extending from the body for engagement with a manual or motorized actuator.The valve member of aspect 1, wherein the metering orifice is dimensioned to provide a volumetric flow rate less than one-tenth that of the high-flow passage under equal inlet pressure.The valve member of aspect 1, wherein an external surface of the body is polished or coated with a low-friction material to reduce torque during rotation within the valve housing.A fluid flow’ control valve (see, e g., Figs. 4-14) comprising:a) a rotatable ball comprising first and second fluid flow passageways,the first fluid flow passageway being a high flow fluid flow passageway having a first diameter,the second fluid flow passageway being a low flow fluid passageway and comprising at least one critical size orifice having a diameter less than the first diameter: and, b) a body comprising an interior cavity enclosing the rotatable ball; and,c) a stem extending into the ball along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball.The fluid flow' control valve of aspect 7 w'herein the stem, via the actuator, effectuates rotation of the ball:into a high flow configuration in which the flow' of fluid into a downstream fluid conduit is at a high flow rate and / or pressure, and,into a low flow configuration in which the flow' of fluid into a downstream fluid conduit is at low' flow rate and pressure that is less than the high flow rate and / or pressure.The fluid flow control valve of aspect 7 or 8 wherein the critical size orifice comprises a diameter provides for the flow of a fluid through the valve at a pre-determined rate and volume,The fluid flow control valve of any one of aspect 7-9 wherein the second fluid flow passageway comprises a terminus at which fluid is received, the terminus comprising a resected region.The fluid flow control valve of any one of aspect 7-10 that is suitable for clean-in-place (OP) and / or sterilize-in-place (SIP) processes, the fluid flow' control valve being positioned within a fluid flow s stem, wherein the CIP and / or SIP process can be performed without changingthe position of the fluid flow control valve, exposing the fluid flow control valve or any part thereof to an external environment, or removing the fluid flow control valve from the system. A fluid flow system comprising the fluid flow control valve of any preceding claim wherein:the fluid flow control valve is in fluid communication with an upstream fluid conduit and a downstream fluid conduit;the fluid flow control valve is positioned to receive fluid from the upstream fluid conduit at a first flow rate and / or pressure, and to supply fluid to the downstream fluid conduit; and,the fluid flow control valve can be actuated to reduce the flow rate and / or pressure of fluid to below the first fluid flow rate and / or pressure.A fluid flow control system comprising the fluid flow control valve of any one of aspects 1-11, the system comprising:an upstream fluid conduit and a downstream flow fluid conduit in fluid communication with the flow control valve,the flow control valve being positioned between the upstream fluid conduit and the downstream flow fluid conduit;wherein:the flow control valve receives fluid from the upstream fluid conduit at a first flow rate and / or first pressure;the flow control valve comprises low flow fluid passageway having a diameter less than the upstream fluid conduit and supplies the fluid to the downstream flow fluid conduit at a second flow rate and / or pressure lower than the first low rate and pressure.The fluid flow control system of aspect 13 wherein the fluid flow control valve can be actuated into an open configuration only provding for the flow of fluid through the low flow fluid passageway.The fluid flow control system of aspect 13 or 14 wherein the fluid traverses the low flow fluid passageway at a calculated rate (Iph) lower than the first flow rate, first pressure, the Iph being determined by the diameter of the low flow fluid passageway.The fluid flow control system of any one of aspects 11-15 wherein the high flow fluid flow passageway has a diameter sufficient for clean-in-place (CIP) and / or sterilize-in-place (SIP) processes.A fluid movement system comprising:a fluid conduit defining a fluid passageway; and,a fluid flow control valve disposed within the fluid passageway, the valve including a rotatable valve member (see, e.g., Figs. 15A-F) coupled to an actuator,the valve member comprising:(i) a first through-bore defining a high-flow passage having a first diameter, and (ii) a second through-bore defining a low-flow passage including a metering orifice of smaller diameter than the first diameter;wherein rotation of the valve member by the actuator selectively aligns either the high-flow passage or the low-flow passage with the fluid passageway to regulate flow through the system.The system of aspect 17, wherein the actuator comprises a handle rotatable between detented positions corresponding respectively to the high-flow and low-flow passages.The system of aspect 17, wherein the actuator comprises a motor or solenoid configured to rotate the valve member in response to an electronic control signal.The system of aspect 17, further comprising a pump configured to drive fluid through the conduit, the pump being downstream of the valveThe system of aspect 20, further comprising a flow sensor operatively coupled to a controller that adjusts the actuator to select the high-flow or low-flow passage based on a measured flow rate or pressure differential.The system of aspect 17, wherein the valve member is spherical and rotatably retained within a valve housing having opposed valve seats that seal against the valve member when rotated.The system of aspect 17, wherein the low-flow passage is configured to pass a volumetric flow rate less than one-tenth that of the high-flow passage under equal inlet pressure.A method for processing a fluid using the fluid flow control valve or system of any one of aspects 1-23.A method for regulating fluid flow through a fluid movement system, the system comprising a fluid conduit and a valve disposed within the fluid conduit, the valve including a rotatable valve member having a high-flow passage and a low-flow passage, the method comprising: rotating the valve member between a first orientation in which the high-flow passage is aligned with the fluid conduit to permit a high flow of fluid, anda second orientation in which the low-flow passage is aligned with the fluid conduit to restrict the flow of fluid.The method of aspect 25, wherein the low-flow passage comprises a metering orifice having a diameter smaller than that of the high-flow passage.The method of aspect 25, further comprising sensing a parameter of the fluid selected from flow rate, pressure, or temperature, and rotating the valve member between the first and second orientations in response to the sensed parameter.The method of aspect 25, wherein rotating the valve member comprises manually turning a handle between detented positions corresponding to the first and second orientations.The method of aspect 25, wherein rotating the valve member comprises actuating a motor or solenoid under control of an electronic controller.The method of aspect 29, wherein the controller maintains the valve member in the low-flow orientation until a predetermined flow-rate threshold is exceeded, and then rotates the valve member to the high-flow orientation.The method of aspect 25, wherein the valve member is spherical and rotatably retained within a valve housing having opposed valve seats.A method for making a fluid flow control valve, the method comprising assembling:a rotatable ball comprising first and second fluid flow passageways, the first fluid flow passageway having a first diameter, the second fluid flow comprising at least one critical size orifice having a diameter less than that of the first diameter; and, comprising an interior cavity enclosing the rotatable ball; and,a stem extending into the ball along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball.? X method of manufacturing a rotatable valve member for a fluid flow control valve, the method comprising:forming a generally spherical body configured for rotation within a valve housing; machining or otherwise forming a first through-bore extending through the body to define a high-flow passage having a first diameter; andmachining or otherwise forming a second through-bore extending through the body to define a low-flow passage including a metering orifice of smaller diameter than the first diameter,wherein the first and second through-bores are oriented such that rotation of the valve member within the valve housing selectively aligns one of the high-flow and low-flow passages with a fluid passageway of the valve.The method of aspect 33, wherein the step of forming the body comprises casting, sintering, or molding a metal or polymeric material and subsequently machining the first and second through-bores.The method of aspect 33, wherein the metering orifice is formed by precision drilling, laser machining, or electrical discharge machining to achieve a predetermined orifice diameter The method of aspect 33, further comprising polishing or coating at least a portion of the spherical surface of the body to reduce frictional resistance during rotation within the valve housingThe method of aspect 33, wherein the first and second through-bores are positioned at an angular offset of approximately 90 degrees relative to one another about the rotational axis of the body.38. The method of aspect 33, further comprising attaching a stem or actuator interface to the body to enable rotation of the valve member within the valve housing.Other aspects are also provided by this disclosure as would be understood by those of ordinary' skill in the art.

[0070] The terms “about”, “approximately”, and the like, when preceding a list of numerical values or range, refer to each individual value in the list or range independently as if each individual value in the list or range was immediately preceded by that term. The terms mean that the values to which the same refer are exactly, close to, or similar thereto. Optional or optionally means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where the event or circumstance occurs and instances where it does not. Ranges may be expressed herein as from about one particular value, and / or to about another particular value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent about or approximately, it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. Ranges (e.g., 90-100%) are meant to include the range per se as well as each independent value within the range as if each value was individually listed.

[0071] All references cited within this application are incorporated by reference A better understanding of the present invention and of its many advantages will be had from the following examples, given by way of illustration

[0072] All documents cited in this disclosure are hereby incorporated into this disclosure in their entirety. While the present invention has been described in terms of the preferred embodiments, it is understood that variations and modifications will occur to those skilled in the art. Therefore, it is intended that the appended claims cover all such equivalent variations that come within the scope of the invention as claimed.

Claims

CLAIMSWhat is claimed is:

1. A rotatable valve member for a fluid flow control valve, comprising:a generally spherical body configured to be received within a valve housing and to rotate about an axis;a first through-bore extending through the body to define a high-flow passage having a first diameter; anda second through-bore extending through the body to define a low-flow passage including a metering orifice of smaller diameter than the first diameter;wherein the first and second through-bores are positioned such that rotation of the valve member about the axis selectively aligns one of the high-flow passage or the low-flow passage with a fluid passageway of the valve housing.

2. The valve member of claim I, wherein the first and second through-bores are oriented approximately ninety degrees apart around the rotational axis.

3. The valve member of claim 1, wherein the body comprises stainless steel, brass, or a polymeric material resistant to corrosion and wear,4. The valve member of claim 1, further comprising a stem or actuator interface extending from the body for engagement with a manual or motorized actuator.

5. The valve member of claim 1, wherein the metering orifice is dimensioned to provide a volumetric flow rate less than one-tenth that of the high-flow passage under equal inlet pressure.

6. The valve member of claim 1, wherein an external surface of the body is polished or coated with a low-friction material to reduce torque during rotation within the valve housing.

7. A fluid flow control valve comprising:d) a rotatable ball comprising first and second fluid flow passageways,the first fluid flow passageway being a high flow fluid flow passageway having a first diameter,the second fluid flow passageway being a low flow fluid passageway and comprising at least one critical size orifice having a diameter less than the first diameter; and,e) a body comprising an interior cavity enclosing the rotatable ball; and,f) a stem extending into the ball along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball.

8. The fluid flow control valve of claim 7 wherein the stem, via the actuator, effectuates rotation of the ball:into a high flow configuration in which the flow of fluid into a downstream fluid conduit is at a high flow rate and / or pressure, and,into a low flow configuration in which the flow of fluid into a downstream fluid conduit is at low flow rate and pressure that is less than the high flow rate and / or pressure.

9. The fluid flow valve of claim 7 or 8 wherein the critical size orifice comprises a diameter provides for the flow of a fluid through the valve at a pre-determined rate and volume.

10. The fluid flow valve of any one of claims 7-9 wherein the second fluid flow passageway comprises a terminus at which fluid is received, the terminus comprising a resected region 11. The fluid flow valve of any one of claims 7-10 that is suitable for clean-in-place (CIP) and / or sterilize-in-place (SIP) processes, the fluid flow' control valve being positioned within a fluid flow system, wherein the CIP and / or SIP process can be performed without changing the position of the fluid flow control valve, exposing the fluid flow control valve or any part thereof to an external environment, or removing the fluid flow control valve from the system.

12. A fluid flow system comprising the fluid flow valve of any preceding claim wherein:the fluid flow control valve is in fluid communication with an upstream fluid conduit and a downstream fluid conduit;the fluid flow control valve is positioned to receive fluid from the upstream fluid conduit at a first flow rate and / or pressure, and to supply fluid to the downstream fluid conduit; and,the fluid flow control valve can be actuated to reduce the flow rate and / or pressure of fluid to below the first fluid flow rate and / or pressure.

13. A fluid flow control system comprising the fluid flow valve of any one of claims 1-11, the system comprising:an upstream fluid conduit and a downstream flow fluid conduit in fluid communication with the flow control valve,the flow control valve being positioned between the upstream fluid conduit and the downstream flow fluid conduit;wherein:the flow control valve receives fluid from the upstream fluid conduit at a first flow rate and / or first pressure;the flow control valve comprises low flow fluid passageway having a diameter less than the upstream fluid conduit and supplies the fluid to the downstream flow fluid conduit at a second flow rate and / or pressure lower than the first low rate and pressure.

14. The fluid flow control system of claim 13 wherein the flow control valve can be actuated into an open configuration only provding for the flow of fluid through the low flow fluid passageway.

15. The fluid flow control system of claim 13 or 14 wherein the fluid traverses the low flow fluid passageway at a calculated rate (Iph) lower than the first flow rate, first pressure, the Iph being determined by the diameter of the low flow fluid passageway,16. The fluid flow control system of any one of claims 11-15 wherein the high flow fluid flow passageway has a diameter sufficient for clean-in-place (CIP) and / or sterilize-in-place (SIP) processes.

17. A fluid movement system comprising:a fluid conduit defining a fluid passageway; and,a valve disposed within the fluid passageway, the valve including a rotatable valve member coupled to an actuator,the valve member comprising:(iii) a first through-bore defining a high-flow passage having a first diameter, and(iv) a second through-bore defining a. low-flow passage including a metering orifice of smaller diameter than the first diameter;wherein rotation of the valve member by the actuator selectively aligns either the high-flow passage or the low-flow passage with the fluid passageway to regulate flow through the system.

18. The system of claim 17, wherein the actuator comprises a handle rotatable between detented positions corresponding respectively to the high-flow and low-flow passages.

19. The system of claim 17, wherein the actuator comprises a motor or solenoid configured to rotate the valve member in response to an electronic control signal.

20. The system of claim 17, further comprising a pump configured to drive fluid through the conduit, the pump being downstream of the valve21. The system of claim 20, further comprising a flow sensor operatively coupled to a controller that adjusts the actuator to select the high-flow or low-flow passage based on a measured flow rate or pressure differential.

22. The system of claim 17, wherein the valve member is spherical and rotatably retained within a valve housing having opposed valve seats that seal against the valve member when rotated.

23. The system of claim 17, wherein the low-flow passage is configured to pass a volumetric flow rate less than one-tenth that of the high-flow passage under equal inlet pressure.

24. A method for processing a fluid using the fluid flow control valve or system of any one of claims 1-23.

25. A method for regulating fluid flow through a fluid movement system, the system comprising a fluid conduit and a valve disposed within the fluid conduit, the valve including a rotatable valve member having a high-flow passage and a low-flow passage, the method comprising: rotating the valve member between a first orientation in which the high-flow passage is aligned with the fluid conduit to permit a high flow of fluid, anda second orientation in wdiich the low-flow passage is aligned with the fluid conduit to restrict the flow of fluid.

26. The method of claim 25, wherein the low-flow passage comprises a metering orifice having a diameter smaller than that of the high-flow passage.

27. The method of claim 25, further comprising sensing a parameter of the fluid selected from flow rate, pressure, or temperature, and rotating the valve member between the first and second orientations in response to the sensed parameter.

28. The method of claim 25, wherein rotating the valve member comprises manually turning a handle between detented positions corresponding to the first and second orientations.

29. The method of claim 25, wherein rotating the valve member comprises actuating a motor or solenoid under control of an electronic controller.

30. The method of claim 29, wherein the controller maintains the valve member in the low-flow orientation until a predetermined flow-rate threshold is exceeded, and then rotates the valve member to the high-flow orientation.

31. The method of claim 25, wherein the valve member is spherical and rotatably retained within a valve housing having opposed valve seats.

32. method for making a fluid flow control valve, the method comprising assembling:a rotatable ball comprising first and second fluid flow passageways, the first fluid flow passageway having a first diameter, the second fluid flow comprising at least one critical size orifice having a diameter less than that of the first diameter; and, comprising an interior cavity enclosing the rotatable ball; and,a stem extending into the ball along a rotatable axis thereof and being operably linked to an actuator, wherein the stem, via the actuator, effectuates rotation of the ball.

33. A method of manufacturing a rotatable valve member for a fluid flow control valve, the method comprising:forming a generally spherical body configured for rotation within a valve housing; machining or otherwise forming a first through-bore extending through the body to define a high-flow passage having a first diameter; andmachining or otherwise forming a second through-bore extending through the body to define a low-flow passage including a metering orifice of smaller diameter than the first diameter,wherein the first and second through-bores are oriented such that rotation of the valve member within the valve housing selectively aligns one of the high-flow and low-flow passages with a fluid passageway of the valve.

34. The method of claim 33, wherein the step of forming the body comprises casting, sintering, or molding a metal or polymeric material and subsequently machining the first and second through-bores.

35. The method of claim 33, wherein the metering orifice is formed by precision drilling, laser machining, or electrical discharge machining to achieve a predetermined orifice diameter.

36. The method of claim 33, further comprising polishing or coating at least a portion of the spherical surface of the body to reduce frictional resistance during rotation within the valve housing.

37. The method of claim 33, wherein the first and second through-bores are positioned at an angular offset of approximately 90 degrees relative to one another about the rotational axis of the body.

38. The method of claim 33, further comprising attaching a stem or actuator interface to the body to enable rotation of the valve member within the valve housing.

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