Homogenizer and methods for controlling the same

Abstract

The invention relates to a homogenizing apparatus (200) for processing fluids and methods for controlling the same The apparatus features a high-pressure plunger pump (202) with fixed geometry orifices (204, 206), a control unit (300), and a Variable Frequency Drive (VFD) (304) for precise pressure control. It includes a PID controller (302) to regulate motor (210) speed based on real-time pressure data from sensors (308), ensuring consistent product quality. The system integrates with a Human-Machine Interface (HMI) for user-friendly operation and remote access. The apparatus is designed for high-pressure applications, improving reliability, reparability, and efficiency. The apparatus develop control architecture for unique combination of fixed geometry Microfluidic interaction chambers with High pressure plunger pump. It is suitable for various industrial applications, including pharmaceuticals and food processing, by achieving precise control over process variables like temperature, pressure, and flow.

Description

“HOMOGENIZER AND METHODS FOR CONTROLLING THE SAME”FIELD OF INVENTION

[0001] The present invention relates to the field of pumping devices, and more particularly to a pumping apparatus for processing of fluids, and methods for controlling the same.BACKGROUND OF THE INVENTION

[0002] The subject matter discussed in the background section should not be assumed to be prior art merely because of its mention in the background section. Similarly, a problem mentioned in the background section or associated with the subject matter of the background section should not be assumed to have been previously recognized in the prior art. The subject matter in the background section merely represents different approaches, which in and of themselves may correspond to implementations of the claimed technology.

[0003] In high-pressure fluid processing for applications such as cell disruption, homogenization, cell-lysis, nano-emulsification, particle size reduction, chemical mixing, high shear processing, etc., a high-pressure equipment of a sanitary nature in design and construction is required. Such applications typically involve generation of a shearing action in a fluid, with the help of high pressure. High-pressure pumping devices are often used for a variety of pharmaceutical applications, which involves pumping a biological fluid at high pressure into interaction chambers having small orifices to cause the shearing action in the biological fluid. However, such high-pressure pumping devices typically generate the shearing action with the help of valves. This severely affects reliability and availability of the pumping devices. Such valves are also required to be frequently replaced for optimal operation of the pumping devices.

[0004] Use of the valves for generating the shearing action in the biological fluid limits an operating pressure rating of the pumping devices. The operating pressure rating of conventional pumping devices is generally rated below 1500bar, thereby reducing yield as well as efficiency of the pumping devices. Also, such pumping devices require large and bulky heat exchangers to heat the biological fluid for a longer time interval, which reduces quality of the pumped fluid.

[0005] Furthermore, conventional high-pressure pumps often encounter issues with maintaining consistent pressure due to the wear and tear on valves and seals, leading to frequent maintenance and downtime. This not only increases operational costs but also affects the overall efficiency and productivity of the fluid processing operations. There is also a significantchallenge in achieving precise control over process variables such as temperature, pressure, and flow rate, which are critical for ensuring the quality and consistency of the processed fluid.

[0006] Fig. 1 illustrates a schematic representation of a conventional intensifier pumping device 100 which includes a directional control valve 102 having a plurality of valve openings. An electric motor 104 is connected to a valve opening of the directional control valve 102 through a hydraulic pump 106. A Programmable Logic Controller (PLC) 108 is also connected to the directional control valve 102. The valve openings of the directional control valve 102 are also connected to an intensifier 110 configured to regulate and control pressure of a fluid passed into the directional control valve 102 from a fluid reservoir 112 designed to store a pre-defined volume of the fluid. The intensifier 110 includes a plunger 114 connected to a piston 116 to imparting and regulating the pressure of the fluid. The fluid reservoir 112 may receive the fluid from a chiller unit 118 adapted to control temperature of the fluid. The chiller unit 118 has a drain inlet end for receiving waste fluid from a valve opening of the directional control valve 102, and a drain outlet end for draining the waste fluid. The intensifier 110 received water from an inlet port thereof to control the temperate of the fluid passing therethrough. An outlet port of the intensifier 110 transfers the fluid to one or more interaction chambers 120 for further processing. The fluid flowing through the interaction chambers 120 passes to a heat exchanger for regulating temperature of the fluid, which leads to a reduction in the quality of the pumped fluid.

[0007] The directional control valve 102 employed in the conventional intensifier pumping device 100 reduces availability of the pumping devices, and also affects reparability of other components of the conventional intensifier pumping device 100. The directional control valve 102 also severely restricts operating pressure of the conventional intensifier pumping device 100.

[0008] Conventional Intensifier is complex system due to higher number of components and requirement of sensors and PLC to move piston back and forth to generate high pressure. Further, the conventional pumping devices employ pressure transducers to capture operating pressures of the fluid. The pressure transducer is employed in lieu of a gauge or other mechanical device to improve cleanliness of the pumping device, reduce internal volume, and increase accuracy of the pressure measurement. Such pressure transducers, however, generate a huge amount of data since their response times may range between millisecond or microsecond range, resulting in thousands to millions points of data for an operator of pumping device to look at, per second, in order to determine an actual operating pressure the pumping devices is attaining.

[0009] The pressure fluctuation in the conventional pumping devices may quickly fluctuate between 0 psi to a maximum operating pressure. This results in millions of data points that are practically impossible to interpret. Control over operating pressure in the pumping device is a critical parameter which directly affects shear rates within the interaction chambers used to generate shear in the fluid. Inefficient control over the operating pressure in turn severely impacts the quality of the product being produced by the pumping device.

[0010] There is therefore a need in the art for simplifying and improving reliability of a pumping apparatus, while addressing the aforesaid shortcomings of the conventional pumping devices.OBJECTS OF THE INVENTION

[0011] An object of the present invention is to provide a simplified and low-cost pumping apparatus for processing of fluids in high-pressure applications, and methods for controlling the same.

[0012] Another object of the present invention is to develop control architecture for unique combination of fixed geometry Microfluidic interaction chambers with High Pressure triplex / Multiplex plunger pump.

[0013] Another object of the present invention is to achieve precise control over operating pressure of the fluid in the pumping apparatus.

[0014] Another object of the present invention is to provide a pumping apparatus having high reliability and product yield characteristics, and methods for controlling the same.

[0015] Another object of the present invention is to provide a compact pumping apparatus and methods for fluid processing with reduced complexity by using a mechanical drive.

[0016] Another object of the present invention is to provide techniques capable of precisely measuring and evaluating operating pressures of the pumping apparatus.

[0017] Another object of the present invention is to enhance the ease of maintenance and reduce the frequency of component replacements, thereby increasing the operational uptime and efficiency of the pumping apparatus.SUMMARY OF THE INVENTION

[0018] The summary is provided to introduce aspects related to a pumping apparatus and methods for controlling the same, and the aspects are further described below in the detaileddescription. This summary is not intended to identify essential features of the claimed subject matter, nor is it intended for use in determining or limiting the scope of the claimed subject matter.

[0019] The pumping apparatus may be used as a homogenizer for processing of a biological fluid, and may include a plunger pump having an inlet end and an outlet end, and a plunger configured to reciprocate along a longitudinal direction. The plunger is operatively connected to an output shaft of a motor, to enable reciprocating motion thereof in a pump chamber of the plunger pump. The plunger pump pressurizes an unprocessed fluid passing through the inlet end in the pump chamber. The outlet end of the plunger pump is connected to one or more interaction chambers configured to process the pressurized fluid to produce a processed fluid having uniform nanoparticles for high-pressure applications. The plunger pump includes a control unit for controlling speed of the output shaft of the motor based on an operating pressure of the fluid present in the pump chamber. The control unit is configured to regulate speed of the output shaft of the motor based on the operating pressure of the fluid, to enable efficient control over pressure of the fluid passing to the one or more interaction chambers. The control unit receives input of a pressure sensor installed at the outlet end, and compares the operating pressure of the fluid present in the pump chamber with a pre-define threshold value. The control unit regulates speed of the motor based on the comparison of the operating pressure of the fluid and the pre-define threshold value. The motor includes a Variable Frequency Drive (VFD) for regulating speed and torque of the output shaft by varying frequency of an input electric voltage. The control unit includes a Proportional-Integral-Derivative (PID) controller.

[0020] The inlet end and the outlet end of the plunger pump include orifices having fixed geometry as compared to valves of conventional pumping devices, which typically include orifices of variable geometry. This simplifies design requirements of the pumping apparatus and also leads to cost reduction during manufacturing thereof. The pumping apparatus has improved reparability and availability, since pressure of the fluid passing through the fixed geometry orifice of the outlet end is efficiently controlled by the control unit.

[0021] The control unit is equipped with advanced algorithms that enable adaptive control based on real-time data, ensuring optimal performance and energy efficiency under varying operational conditions. The use of a Variable Frequency Drive (VFD) further enhances the precision and responsiveness of the control system, making it suitable for high-precision applications in pharmaceutical and other critical industries.

[0022] The control system is also designed to integrate seamlessly with existing manufacturing execution systems (MES) and enterprise resource planning (ERP) systems, enabling real-timedata exchange and process optimization across the production chain. This integration ensures that the pumping apparatus can be monitored and controlled remotely, providing flexibility and scalability in modern manufacturing environments.

[0023] In a preferred embodiment, the present invention provides a homogenizing apparatus for processing fluids, comprising: a high-pressure plunger pump having an inlet end and an outlet end with fixed geometry orifices; a plunger located within a pump chamber of the high- pressure plunger pump configured to reciprocate along a longitudinal axis, the plunger operatively connected to an output shaft of a motor for inducing reciprocal motion to pressurize a fluid within the pump chamber; one or more interaction chambers connected to the outlet end of the plunger pump, configured to homogenize the fluid under pressure to produce a processed fluid having the desired process result; a control unit configured to receive signals from one or more pressure sensors located on the high pressure line at the outlet end of the pump to detect the operating pressure of the fluid and to regulate the speed of the motor output shaft based on the detected pressure; a variable frequency drive (VFD) integrated with the motor to adjust motor speed by varying the frequency of an input electric voltage, wherein the VFD (304) is controlled by said control unit.

[0024] In an embodiment, wherein the plunger pump increases the fluid pressure to extreme high pressure (upto 50000 psi) in order to push the fluid through fixed geometry microfluidic interaction chamber which homogenizes the process fluid, enhancing fluid consistency.

[0025] In an embodiment, wherein developing control architecture for unique combination of fixed geometry microfluidic interaction chambers (214) with high pressure triplex / multiplex plunger pump.

[0026] In an embodiment, wherein the control unit includes a Programmable Logic controller (PLC) with Proportional-Integral-Derivative (PID) controller that adjusts the motor speed by analyzing deviations between the detected pressure and a predefined threshold pressure.

[0027] In an embodiment, wherein the PID controller adjusts the motor speed by sending a frequency adjustment signal to the VFD based on real-time pressure sensor data.

[0028] In an embodiment, wherein the one or more interaction chambers include structures for mechanical shearing of the fluid to achieve the desired process result, such as nanoemulsification, cell lysis, particle size reduction, and others.

[0029] In an embodiment, the homogenizing comprising a heat exchanger positioned downstream of the interaction chambers to regulate the temperature of the processed fluid.

[0030] In an embodiment, wherein the heat exchanger utilizes a cooling fluid circulated in counterflow to the processed fluid to enhance thermal exchange efficiency.

[0031] In another aspects of the present invention, a method for controlling a homogenizing apparatus, comprising: providing a high-pressure plunger pump with an inlet check valve and an outlet check valve , wherein the inlet check valve and the outlet check valve are equipped with fixed geometry microfluidic interaction chamber; operating a plunger within a pump chamber of the high-pressure plunger pump to reciprocate along a longitudinal axis, wherein the plunger is operatively connected to an output shaft of a motor , thereby inducing reciprocal motion to pressurize a fluid within the pump chamber; passing the pressurized fluid to one or more interaction chambers connected to the outlet end of the plunger pump, wherein the interaction chambers are configured to homogenize the fluid under pressure to produce a processed fluid having desired process result, such as nano -emulsification, cell lysis, particle size reduction, and others; detecting the operating pressure of the fluid using one or more pressure sensors located after the outlet of the pump; regulating the speed of the motor's output shaft based on the detected pressure using a control unit, wherein the speed adjustment is facilitated by a variable frequency drive (VFD) integrated with the motor that varies the frequency of an input electric voltage as controlled by the control unit.

[0032] In an embodiment, wherein regulating the speed of the motor involves varying the frequency of an electric voltage supplied to the motor using a Variable Frequency Drive (VFD).

[0033] In an embodiment, wherein further developing control architecture for unique combination of fixed geometry microfluidic interaction chambers (214) with high pressure triplex / multiplex plunger pump.

[0034] In an embodiment, wherein the frequency of the electric voltage is adjusted continuously based on real-time feedback from the pressure sensors to maintain the operating pressure within a predetermined range.

[0035] In an embodiment, the method comprising the step of processing the fluid in the one or more interaction chambers to form a fluid with the desired process result, such as nanoemulsification, cell lysis, particle size reduction, and others.

[0036] In an embodiment, wherein processing the fluid involves passing the fluid through fixed geometry orifices in the interaction chambers to mechanically shear the fluid.

[0037] In an embodiment, the method including the step of cooling the processed fluid using a heat exchanger immediately after it exits the interaction chambers.

[0038] In an embodiment, wherein cooling the processed fluid involves circulation of a cooling fluid relative to the direction of the processed fluid flow to optimize heat transfer.

[0039] In another aspects of the present invention, a method for evaluating operating pressures in a homogenizing apparatus, comprising: acquiring data inputs from a pressuretransducer configured to measure instantaneous operating pressures within a pump chamber of a homogenizer; sampling these data inputs into a dataset structured for analysis over a predefined time interval; selecting, from the dataset, data inputs representing either maximum or average pressure values over each predefined time interval; and displaying a chronological series of the selected pressure values to provide a real-time or near-real-time visualization of pressure trends.

[0040] In an embodiment, wherein the data inputs are acquired at a high-data rate capable of capturing fluctuations in the pressure from millisecond to millisecond.

[0041] In an embodiment, wherein the sampling step includes organizing the data inputs into sets according to not only time intervals but also according to the magnitude of pressure changes.

[0042] In an embodiment, the method including filtering out data inputs that do not exceed a predefined variance threshold to reduce noise and enhance the relevance of the data displayed.

[0043] In an embodiment, wherein the displaying step includes using graphical user interfaces that graph the pressure values over time, providing controls for zooming and scrolling through the data.

[0044] In an embodiment, the method comprising an alert generation step if the pressure exceeds or drops below critical thresholds, notifying system operators to take corrective actions.

[0045] In another aspects of the present invention, a control system for multi-mode batch processing in a homogenizing apparatus, comprising: a programmable logic controller (PLC) and an industrial personal computer (IPC) configured to interact through an operator interface terminal; multiple operational modes programmed within the PLC including idling, priming, running, cleaning-in-place (CIP), and steaming-in-place (SIP); a set of control unit that define process parameters for each mode to ensure consistent product quality and system performance; a human-Machine Interface (HMI) designed to provide a user-friendly interface that displays real-time system data, process parameters, and operational status, enabling operators to monitor and control the homogenizer effectively; and remote access capabilities allowing operators to adjust settings or monitor operations from a distance.

[0046] In an embodiment, wherein the PLC uses a series of sensors to automatically switch between operational modes based on real-time data inputs.

[0047] In an embodiment, where the operator interface terminal displays both current and historical data on system performance, includes alarms, and allows operators to input or modify process parameters.

[0048] In an embodiment, wherein remote access is secured through end-to-end encryption and multi-factor authentication to ensure secure operations.

[0049] In an embodiment, wherein the interface terminal is equipped with customizable settings for different users, allowing adjustments to display language, units of measure, and alarm thresholds.

[0050] In an embodiment, the system comprising a data logging function that records all operational parameters during each batch process for quality control and process validation purposes.BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS

[0051] The accompanying drawings constitute a part of the description and are used to provide a further understanding of the present invention. Such accompanying drawings illustrate the embodiments of the present invention used to describe the principles of the present invention. The embodiments are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings in which references indicate similar elements. It should be noted that references to “an” or “one” embodiment in this invention are not necessarily to the same embodiment, and they mean at least one. In the drawings:

[0052] Fig. 1 illustrates a schematic representation of a conventional intensifier pumping device in accordance with prior art;

[0053] Fig. 2 illustrates a schematic representation of a pumping apparatus in accordance with an embodiment of the present invention;

[0054] Fig. 3 illustrates a schematic representation of a system of the pumping apparatus, in accordance with an embodiment of the present invention;

[0055] Fig. 4 illustrates a schematic representation of a control unit of the pumping apparatus, in accordance with an embodiment of the present invention;

[0056] Fig. 5 illustrates a flow chart depicting a method for controlling the pumping apparatus, in accordance with an embodiment of the present invention;

[0057] Fig. 6 illustrates a flow chart depicting a method for evaluating operating pressures of the pumping apparatus, in accordance with an embodiment of the present invention;

[0058] Fig. 7 illustrates a schematic representation of a system for evaluating operating pressures of the pumping apparatus, in accordance with an embodiment of the present invention;

[0059] Fig. 8 illustrates a schematic representation of a control system for multi-mode batch processing for the pumping apparatus, in accordance with an embodiment of the present invention.DETAILED DESCRIPTION OF THE INVENTION

[0060] The detailed description set forth below in connection with the appended drawings is intended as a description of various embodiments of the present invention and is not intended to represent the only embodiments in which the present invention may be practiced. Each embodiment described in this disclosure is provided merely as an example or illustration of the present invention and should not necessarily be construed as preferred or advantageous over other embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without these specific details.

[0061] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. In addition, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0062] The terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. Therefore, “A, B or C” or “A, B and / or C” mean “any of the following: A; B; C; A and B; A and C; B and C; A, B and C.” An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.

[0063] The present invention relates to a simplified pumping apparatus (also referred to as “homogenizer” hereinafter) for processing of fluids, and methods for controlling the same. The pumping apparatus is capable of processing the fluid for high-pressure applications, while precisely controlling process variables such as temperature, pressure, and flow of the fluid, to improve reliability and product yield characteristics of the pumping apparatus. The pumping apparatus may be provided with a heat exchanger located in vicinity of a pump to efficiently control temperature of the fluid, thereby obtaining a better quality of processed fluid. The pumping apparatus is compact and includes components having simple configurations, thereby improving reparability and availability thereof.

[0064] The present invention provides a method for controlling the pumping apparatus. The method includes receiving, by the control unit, an operating pressure of unprocessed fluid present in the pump chamber, and comparing the operating pressure with a pre-defined threshold value. Based on this comparison, speed of the motor is controlled by the control unit.The operating pressure of the unprocessed fluid is received by the control unit through one or more pressure sensors installed in a high pressure line of the pump chamber at the outlet end. The pumping apparatus develop a control architecture for unique combination of fixed geometry Microfluidic interaction chambers with High pressure Triplex / Multiplex plunger pump.

[0065] Another aspect of the present invention relates to a system and a method for evaluating operating pressures in the pumping apparatus. The method allows efficient collection, organization, interpretation and display of data related to operating pressures of the pumping apparatus in a form which provides an operator with an easy to understand assessment of the current operating condition of the pumping apparatus. The system is capable of providing more accurate information regarding operating pressures in the pumping apparatus, while preventing erroneous pressure values to be shown to an operator.

[0066] Yet another aspect of the present invention relates to a control system for multi-mode batch processing for the pumping apparatus. The control system reduces the risk of errors that may result in product loss, while facilitating ease of use and operation for the pumping apparatus. The control system is an automated process for controlling processes for various modes of operation, such as, idling, priming, running, Cleaning-in-Place (CIP), draining and Steaming-in-Place (SIP), etc. of the pumping apparatus. The control system allows production of consistent product quality by defining operation modes and appropriate control parameters for production, CIP, and draining operations.

[0067] The design of the pumping apparatus ensures minimal downtime due to maintenance, as the key components are designed for easy access and replacement. This is particularly important in high-demand industrial applications where prolonged downtime can lead to significant losses.

[0068] Fig. 2 illustrates a schematic representation of the pumping apparatus 200 which includes a high-pressure plunger pump 202 having an inlet end 204 and an outlet end 206. The plunger pump 202 includes a plunger 208 configured to reciprocate along a longitudinal direction of the plunger pump 202. The plunger 208 may be operatively connected to an output shaft of a motor, to enable reciprocating motion of the plunger 208 with rotation of the output shaft. The plunger 208 is located in a pump chamber 212 of the plunger pump 202. The inlet end 204 and the outlet end 206 of the plunger pump 202 may include orifices having fixed geometry to simplify construction thereof while reducing costs associated with manufacturing of the plunger pump 202. The pumping apparatus 200 is capable of processing the fluid for high-pressure applications in the order of 2000bar.

[0069] The high-pressure capability of the plunger pump ensures that it can handle a wide range of fluid viscosities and compositions, making it versatile for various industrial applications. The fixed geometry of the orifices also contributes to a more stable and predictable flow rate, enhancing the overall performance and reliability of the apparatus.

[0070] The plunger pump 202 is configured to pressurize or de-pressurize an unprocessed fluid passing through the inlet end 204 into the pump chamber 212. The outlet end 206 of the plunger pump 202 is connected to one or more interaction chambers 214 configured to process the pressurized fluid to produce a processed fluid having uniform nanoparticles for further processing. The pumping apparatus 200 employs a mechanical drive including the plunger pump 202 and the motor having simple construction for processing of the fluid, thereby reducing costs and complexity in design and manufacturing thereof.

[0071] In an illustration embodiment as shown in Fig- 3, the plunger pump 202 includes a control unit 300 for controlling the speed of the output shaft of the motor 210 based on an operating pressure of the fluid present in the pump chamber 212. The control unit may include a Proportional-Integral -Derivative (PID) controller 302 configured to regulate the speed of the motor 210 based on the operating pressure of the fluid, to enable efficient control over the pressure of the fluid passing to the one or more interaction chambers 214. The motor 210 may include a Variable Frequency Drive (VFD) 304 for regulating speed and torque of the output shaft by varying frequency of an input electric voltage provided by a power supply unit 306.

[0072] The integration of the PID controller with the VFD provides a highly responsive and precise control mechanism, ensuring that the motor operates within optimal parameters. This integration helps in maintaining consistent product quality by minimizing variations in pressure and flow rate during the fluid processing.

[0073] The PID controller 302 receives input from one or more pressure sensors 308 installed in the high-pressure line at the outlet end 206 of the pump chamber 212, and compares the operating / instantaneous pressure of the unprocessed fluid present in the pump chamber 212 with a pre-defined threshold value set by a user. The PID controller 302 is configured to transmit a motor speed signal to the VFD unit for regulating the speed of the motor 210 based on the comparison of the operating pressure of the fluid and the pre-defined threshold value. The homogenizer 200 has improved reparability and availability, since the pressure of the pressurized fluid passing through the fixed geometry orifice of the outlet end 206 is efficiently controlled by the control unit 300 before the pressurized fluid is passed to the interaction chambers 214. The processed fluid may be passed from the interaction chambers 214 to a heat exchanger installed in the vicinity thereof to control the temperature of the processed fluid. Thepresence of the heat exchanger near the interaction chambers 214 helps the homogenizer 200 in obtaining a better quality of processed fluid. According to an embodiment, the homogenizer 200 is used for homogenization of various types of biological fluids, such as containing bacterial cells like E. coli, yeast cells from which protein extraction takes place for pharmaceutical applications.

[0074] The placement of the heat exchanger in close proximity to the interaction chambers ensures rapid temperature adjustments, which is crucial for maintaining the integrity and quality of heat-sensitive biological fluids during processing.

[0075] In an embodiment of the present invention, Fig. 4 illustrates a schematic representation of the PID controller 302 of the control unit 300 for controlling the speed of the motor 210 based on the operating pressure of the unprocessed fluid present in the pump chamber 212. The PID controller 302 utilizes a closed-loop PID logic architecture based integrator algorithm for comparison of the operating pressure of the unprocessed fluid with the pre-defined threshold value detected by the pressure sensors 308. The output of the integrator algorithm is provided as an input to the VFD unit 304 of the motor to regulate or change the speed and torque of the output shaft of the motor 210 by varying the frequency of an input electric voltage supplied by the power (mains) supply unit 306.

[0076] Fig. 5 illustrates a flow chart depicting a method 500 for controlling the homogenizer 200. The method 500 includes a step S 502 of receiving, by the control unit 300, the operating pressure of the unprocessed fluid present in the pump chamber 212. The operating pressure of the unprocessed fluid is detected by the one or more pressure sensors 308 located in the high- pressure line at the outlet end 206 of the pump chamber 212. The PID controller 302 of the control unit 300 receives the operating pressure detected by the pressure sensors 308 as an input. Thereafter, at step S504, the method includes comparing the operating pressure detected by the pressure sensors 308 with a pre-defined threshold value set by a user. The pre-defined threshold value may be provided as an input to the PID controller 302. Additionally or alternatively, a set of pre-defined threshold values may be provided as the input to the PID controller 302. The method includes, at step S506, controlling the speed of the motor 210 by varying the frequency of an electric voltage supplied to the VFD unit 304 of the motor 210, based on the comparison of the operating pressure of the unprocessed fluid with the pre-defined threshold value performed in step S504. The control unit 300 is configured to increase or decrease the speed of the motor 210 by appropriately varying the frequency of the electric voltage supplied to the VFD unit 304 according to the requirement of an increase or a decrease in the operating pressure of the unprocessed fluid when compared to the pre-defined threshold value set by the user.

[0077] This method ensures that the homogenizer operates within the desired pressure range, reducing the risk of over-pressurization and potential damage to the system. By continuously monitoring and adjusting the motor speed, the control unit maintains a stable processing environment, which is essential for achieving consistent product quality.

[0078] Fig. 6 illustrates a flow chart depicting a method 600 for evaluating operating pressures of the homogenizer 200. The method 600 allows efficient collection, organization, interpretation, and display of data related to operating pressures of the homogenizer 200 in a form which provides an operator with an easy-to-understand assessment of the current operating condition of the homogenizer 200. The method 600 includes at step S602, acquiring a plurality of data inputs from one or more pressure transducers, as shown in Fig. 7, appropriately positioned in the homogenizer 200 over a specific time period. The pressure transducers are configured to continuously detect an instantaneous operating pressure in the homogenizer 200. The data inputs correspond to pressure values detected by the pressure transducer.

[0079] The method 600 also includes a step S604 of sampling the data inputs received from the pressure transducer into a data set for a pre-defined time interval. The sampling involves distribution and organization of the data inputs in various data sets in accordance with the predefined time interval set by a user. Thereafter, at step S604, the method 600 involves selecting a data input from the sampled data set having a maximum value or an average value of the sampled data set. Thereafter, the method 600 includes a step S608 of plotting or displaying a series of the selected data inputs for the consecutive pre-defined time intervals. This ensures that the operator of the homogenizer 200 has access to the selected data inputs rather than the huge amount of data inputs directly transmitted from the pressure transducers.

[0080] By aggregating and displaying the most relevant data points, the system helps operators quickly identify trends and anomalies, facilitating timely interventions and adjustments to the processing parameters.

[0081] In an embodiment of the present invention as shown in Fig. 7 illustrates a schematic representation of a system 700 for peak pressure smoothing, and evaluating operating pressures of the homogenizer 200. The system 700 performs the method 600 for evaluating operating pressures of the homogenizer 200. The pressure transducer 702 is used to directly detect the instantaneous operating pressure of the fluid in the homogenizer 200. The system 700 includes a control and acquisition unit 704 for acquiring and recording the data inputs from the pressure transducer 702. The control and acquisition unit 704 is also configured to collate the data inputs in different samples (data sets) for the pre-defined time interval, and evaluate the sampled data sets to obtain a maximum value or an average value from the sampled data set. The control andacquisition unit 704 is connected to a display unit 706 configured to display the maximum values or average values of the selected data inputs for consecutive time intervals. The display unit 706 may be configured to display the maximum values or average values of the selected data inputs in the form of a graph or a curve. The data inputs may be recorded by the control and acquisition unit 704 on the basis of a user-specified parameter, to select the most relevant datum for the user-specified time interval. The inclusion of the user-defined time interval allows for the process to be adjusted for pressure transducers 702 having different response rates, or for homogenizer having different stroke rates and operational characteristics.

[0082] The pressure transducer 702 may be configured to transmit a set of data inputs having high-data rate 708, which includes a huge amount of undesired data inputs received from the pressure transducer 702. The control and acquisition unit 704 executes a comparison operation to select the most relevant and pertinent data for the set of data inputs having the high-data rate 708. This information is then processed by the control and acquisition unit 704 to capture high pressure points, and obtain optimal data inputs with a meaningful data rate 710 evaluated by the control and acquisition unit 704. The obtained optimal data inputs with the meaningful data rate 710 may then be displayed by the display unit 706, thereby preventing the operator from being shown misleading information regarding the operating pressures in the homogenizer 200. The control and acquisition unit 704 may form part of a fluid processor installed in the homogenizer 200. The fluid processor is a hardware component containing a printed circuit board (PCB) interfaced with the control and acquisition unit 704, and may be connected to an output of the pressure transducers 702 with the help of electrical leads or wires. The fluid processor may be equipped with a plurality of pumps connected with the fixed geometry interaction chamber 120, to enable pressurization of the fluid at high pressure up to 50,000 psi.

[0083] The system 700 for peak pressure smoothing does not select a random point of data input received from the pressure transducer 702 for every “x” seconds, as done by conventional systems. The system 700 is configured to evaluate every data input received from the pressure transducer 702, and selects optimal data inputs to be displayed on the display device 706 based on the sampling process and based on the user-specified parameter, so as to return the most relevant datum for a particular time period. The function of the system 700 was verified by comparing the result transmitted from the control and acquisition unit 704 to the display device 706, with the output of a temporary mechanical gauge temporarily installed along with the pressure transducer 702. It was observed that the maximum pressure shown by the display device 706 and the mechanical gauge for a particular time interval, were close to each other. To this effect, the system 700 is capable of providing more accurate information regardingoperating pressures in the homogenizer 200, while preventing erroneous pressure values to be shown to the operator. This approach to pressure monitoring and control significantly enhances the reliability of the homogenizer, reducing the likelihood of process disruptions due to inaccurate pressure readings. The ability to smooth peak pressures ensures a more stable and consistent processing environment, which is critical for high-precision applications.

[0084] In an embodiment of the present invention as shown in Fig. 8, where a flowchart depicting a control system (as referred to as “Enhanced Homogenizer Control System with SIP” hereinafter) 800 for multi-mode batch processing for the homogenizer 200 is shown. The control system 800 reduces the risk of errors that may result in product loss, while facilitating ease of use and operation for the homogenizer 200, such as, a high pressure homogenizer. The control system 800 includes all hardware and software components within the bounds of a skidmounted enclosure which houses a programmable logic controller (PLC) with local input and output (VO) modules, an industrial personal computer (IPC) with an operator interface terminal (OIT), and a power distribution equipment. The control system 800 also incorporates a Human- Machine Interface (HMI) to enhance user interaction and system control. The HMI is designed to provide a user-friendly interface that displays real-time system data, process parameters, and operational status, enabling operators to monitor and control the homogenizer more effectively. The Enhanced Homogenizer Control System with SIP 800 is an automated process for controlling processes for various modes of operation, such as, idling, priming, running, Cleaning-in-Place (CIP), draining and Steaming-in-Place (SIP), etc. of the homogenizer 200. The control system 800 provides a single validated and verified control technique for use across various pumping models, the control system 800 configured to be updated for different configurations of pumping models. The control system 800 allows production of consistent product quality by defining operation modes and appropriate control parameters for production, CIP, and draining operations, and facilitates compliance with cGMP and 21 CFR Part 11 regulations outlining administration of electronic records in a medical device’s quality management system, including audit trail tracking and reporting process parameters. The control system 800 may be accessed remotely by a user with an appropriate permission level.

[0085] The control system 800 is configured to control batch processing of various operation modes, such as, production, CIP, and drain modes of the homogenizer 200. For instance, the operation modes may be controlled by batch-specific set points and batch start / stop commands provided by the control system 800. The Enhanced Homogenizer Control System with SIP 800 is configured to generate semi-automated batch sequences for the operation modes, for example, by automatically proceeding from the priming mode to the running mode during operation ofthe homogenizer 200. The control system 800 also provides an open-loop control of process variables, such as, pressure, temperature, flow characteristics, etc., and optionally open or closed-loop control of auxiliary process variables like back-pressure, and temperature of the processed (product) fluid. The control system 800 uses faceplates, user-defined functions, function blocks, and functions to enhance code readability, reuse, and maintenance thereof. The control system 800 includes an operator interface terminal (OIT) having a configuration unit that presents users with configuration options appropriate to corresponding permission level. Configuration options include, but are not limited to, system language, system units, manual commands, and PID settings. The OIT is operatively connected with a plurality of storage devices including Universal Serial Bus (USB) storage devices and database s / servers, such as, Recipe database, Audit trail database, batch history database, alarm logging database and tag logging database, etc. to simultaneously store and fetch information from respective databases.

[0086] Control ideologies of the Enhanced Homogenizer Control System with SIP 800 work based on recipes or routines that provide a single point where all parameters for a batch in production mode, CIP mode, or drain mode, can be simultaneously specified, e.g., set points and timer durations. This also facilitates audit trail tracking of user-selected parameters. The control system 800 includes a display unit to allow users to view real-time process values and system status information. The display unit may be an integrated touch screen as shown in Fig. 8. The HMI further enhances the operator's ability to manage the system by offering intuitive graphics and visualizations, touch-based navigation, and customizable dashboards that display key performance indicators (KPIs) and critical alerts. The Enhanced Homogenizer Control System with SIP 800 also enables control over alarm / warning management. All alarms, warnings, and system messages are displayed in a single screen of the display unit to allow the user to readily identify and respond accordingly. The display unit allows the users to view alarm details for any alarm. The display unit is configured to indicate specific alarm statuses. The control system 800 allows the user with an appropriate authentication / permission level to reset one or more alarms.

[0087] The Enhanced Homogenizer Control System with SIP 800 is also configured to facilitate troubleshooting and maintenance of the homogenizer 200 by a user, with an appropriate permission level. The control system 800 protects product quality by managing user permission level through a plurality of user groups, and allows for end-user configuration of process control parameters, including set points and alarm / warning settings. The control system 800 monitors and displays process information, such as, current process values and alarms, and provides archival storage and data access of the process values, set points, and alarms. The control system800 also allows generation of batch reports, calibration of analog inputs, and manual control of components of the homogenizer 200 where appropriate, such as manual control of PLC- controlled valves or retract / extend control of plunger or intensifier pumps.

[0088] Operation capability of the control system 800 was evaluated by capturing and executing results or output of the control system 800 in a Software Site Acceptance (SSAT) document. It was found that the control system 800 improves ease of use experience for navigating through various operation modes of the homogenizer 200. The control system 800 is improved over conventional control techniques, since the control system 800 removes a large amount of human error and reduces manual intervention, while improving product quality by ensuring repeatability in the processing of the product (processed fluid). The control system 800 reduces the number of manual operations to be carried out and permits highly reproducible batch-processing suitable for process validation, as per Food and Drug Administration (FDA) general guidelines. The control system 800 is also configured to record and archive process data required to facilitate the process validation and quality assurance processes. The inclusion of the HMI within the control system 800 not only improves operational efficiency but also enhances the user experience by providing a seamless interface for monitoring and control. This advanced interface supports various languages and units of measurement, making it adaptable for global use and ensuring that operators can interact with the system in their preferred language and measurement units.

[0089] Thus, the present invention provides a simplified homogenizer for processing of a fluid for high-pressure applications, and methods for controlling the same. The homogenizer and the methods described above are capable of achieving precise control over process variables such as temperature, pressure, and flow characteristics of the fluid to be processed. The methods control the homogenizer by facilitating the pumping operation, to obtain a better quality of the processed fluid. The homogenizer is compact and has a higher operating pressure rating when compared to conventional pumping devices.

[0090] The homogenizer is also designed to be scalable, allowing for adjustments in capacity and pressure ratings to suit different industrial requirements. This scalability makes it a versatile solution for various fluid processing needs across multiple sectors, including pharmaceuticals, chemicals, and food processing.

[0091] It would be appreciated by a person skilled in the art that the pumping apparatus described above may be used for emulsifying, suspending, grinding, dispersing, dissolving, mixing various fluids in the pharmaceutical, beverage, chemical industries, and the like.

[0092] In view of the present disclosure, which describes the present invention, all changes, modifications and, variations within the meaning and range of equivalency are considered within the scope of the invention. It is to be understood that the aspects and embodiment of the disclosure described above may be used in any combination with each other. Several of the aspects and embodiments may be combined together to form a further embodiment of the disclosure.

Claims

We claim:

1. A homogenizing apparatus (200) for processing fluids, comprising: a high-pressure plunger pump (202) having an inlet end (204) and an outlet end (206) with fixed geometry orifices in microfluidic interaction chamber (214); a plunger (208) located within a pump chamber (212) of the high-pressure plunger pump (202) configured to reciprocate along a longitudinal axis, the plunger operatively connected to an output shaft of a motor (210) for inducing reciprocal motion to pressurize a fluid within the pump chamber (212); one or more interaction chambers (214) connected to the outlet end (206) of the plunger pump (202), configured to homogenize the fluid under pressure to produce a processed fluid having the desired process result; a control unit (300) configured to receive signals from one or more pressure sensors (308) located on the high pressure line at the outlet end (206) of the pump to detect the operating pressure of the fluid and to regulate the speed of the motor (210) output shaft based on the detected pressure; a variable frequency drive (VFD) (304) integrated with the motor (210) to adjust motor speed by varying the frequency of an input electric voltage, wherein the VFD (304) is controlled by said control unit (300).

2. The apparatus as claimed in claim 1, wherein the plunger pump (202) increases the fluid pressure to extreme high pressure (upto 50000 psi) in order to push the fluid through fixed geometry microfluidic interaction chamber (214) which homogenizes the process fluid, enhancing fluid consistency.

3. The apparatus as claimed in claim 1 , wherein developing control architecture for unique combination of fixed geometry microfluidic interaction chambers (214) with high pressure triplex / multiplex plunger pump.

4. The apparatus as claimed in claim 1, wherein the control unit (300) includes a Programmable Logic controller (PLC) with Proportional-Integral-Derivative (PID) controller (302) that adjusts the motor speed by analyzing deviations between the detected pressure and a predefined threshold pressure.

5. The apparatus as claimed in claim 4, wherein the PID controller (302) adjusts the motor speed by sending a frequency adjustment signal to the VFD (304) based on real-time pressure sensor data.

6. The apparatus as claimed in claim 1, wherein the one or more interaction chambers (214) include structures for mechanical shearing of the fluid to achieve the desired process result, such as nano-emulsification, cell lysis, particle size reduction, and others.

7. The apparatus as claimed in claim 1, further comprising a heat exchanger positioned downstream of the interaction chambers (214) to regulate the temperature of the processed fluid.

8. The apparatus as claimed in claim 6, wherein the heat exchanger utilizes a cooling fluid circulated in counterflow to the processed fluid to enhance thermal exchange efficiency.

9. A method for controlling a homogenizing apparatus (200), comprising: providing a high-pressure plunger pump (202) with an inlet check valve (204) and an outlet check valve (206), wherein the inlet check valve (204) and the outlet check valve (206) are equipped with fixed geometry microfluidic interaction chamber (214); operating a plunger (208) within a pump chamber (212) of the high-pressure plunger pump (202) to reciprocate along a longitudinal axis, wherein the plunger (208) is operatively connected to an output shaft of a motor (210), thereby inducing reciprocal motion to pressurize a fluid within the pump chamber (212); passing the pressurized fluid to one or more interaction chambers (214) connected to the outlet end (206) of the plunger pump (202), wherein the interaction chambers (214) are configured to homogenize the fluid under pressure to produce a processed fluid having desired process result, such as nano-emulsification, cell lysis, particle size reduction, and others; detecting the operating pressure of the fluid using one or more pressure sensors (308) located after the outlet of the pump (206); regulating the speed of the motor's (210) output shaft based on the detected pressure using a control unit (300), wherein the speed adjustment is facilitated by a variable frequency drive (VFD) (304) integrated with the motor (210) that varies the frequency of an input electric voltage as controlled by the control unit (300).

10. The method as claimed in claim 9, wherein regulating the speed of the motor (210) involves varying the frequency of an electric voltage supplied to the motor (210) using a Variable Frequency Drive (VFD) (304).

11. The method as claimed in claim 9, wherein further developing control architecture for unique combination of fixed geometry microfluidic interaction chambers (214) with high pressure triplex / multiplex plunger pump.

12. The method as claimed in claim 10, wherein the frequency of the electric voltage is adjusted continuously based on real-time feedback from the pressure sensors (308) to maintain the operating pressure within a predetermined range.

13. The method as claimed in claim 9, further comprising the step of processing the fluid in the one or more interaction chambers (214) to form a fluid with the desired process result, such as nano-emulsification, cell lysis, particle size reduction, and others.

14. The method as claimed in claim 13, wherein processing the fluid involves passing the fluid through fixed geometry orifices in the interaction chambers (214) to mechanically shear the fluid.

15. The method as claimed in claim 9, further including the step of cooling the processed fluid using a heat exchanger immediately after it exits the interaction chambers (214).

16. The method as claimed in claim 15, wherein cooling the processed fluid involves circulation of a cooling fluid relative to the direction of the processed fluid flow to optimize heat transfer.

17. A method for evaluating operating pressures in a homogenizing apparatus (200), comprising: acquiring data inputs from a pressure transducer (308) configured to measure instantaneous operating pressures within a pump chamber (212) of a homogenizer; sampling these data inputs into a dataset structured for analysis over a predefined time interval;selecting, from the dataset, data inputs representing either maximum or average pressure values over each predefined time interval; and displaying a chronological series of the selected pressure values to provide a real-time or near-real-time visualization of pressure trends.

18. The method as claimed in claim 17, wherein the data inputs are acquired at a high-data rate capable of capturing fluctuations in the pressure from millisecond to millisecond.

19. The method as claimed in claim 17, wherein the sampling step includes organizing the data inputs into sets according to not only time intervals but also according to the magnitude of pressure changes.

20. The method as claimed in claim 18, including filtering out data inputs that do not exceed a predefined variance threshold to reduce noise and enhance the relevance of the data displayed.

21. The method as claimed in claim 17, wherein the displaying step includes using graphical user interfaces that graph the pressure values over time, providing controls for zooming and scrolling through the data.

22. The method as claimed in claim 17, further comprising an alert generation step if the pressure exceeds or drops below critical thresholds, notifying system operators to take corrective actions.

23. A control system for multi-mode batch processing in a homogenizing apparatus (200), comprising: a programmable logic controller (PLC) and an industrial personal computer (IPC) configured to interact through an operator interface terminal; multiple operational modes programmed within the PLC including idling, priming, running, cleaning-in-place (CIP), and steaming-in-place (SIP); a set of control unit that define process parameters for each mode to ensure consistent product quality and system performance; a human-machine interface (HMI) designed to provide a user-friendly interface that displays real-time system data, process parameters, and operational status, enabling operators to monitor and control the homogenizer effectively; andremote access capabilities allowing operators to adjust settings or monitor operations from a distance.

24. The control system as claimed in claim 23, wherein the PLC uses a series of sensors to automatically switch between operational modes based on real-time data inputs.

25. The control system as claimed in claim 23, where the operator interface terminal displays both current and historical data on system performance, includes alarms, and allows operators to input or modify process parameters.

26. The control system as claimed in claim 23, wherein remote access is secured through end-to-end encryption and multi-factor authentication to ensure secure operations.

27. The control system as claimed in claim 25, wherein the interface terminal is equipped with customizable settings for different users, allowing adjustments to display language, units of measure, and alarm thresholds.

28. The control system as claimed in claim 23, further comprising a data logging function that records all operational parameters during each batch process for quality control and process validation purposes.

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