A sanitary homogenizer with cleanable and drainable components

Abstract

The present disclosure relates to a sanitary homogenizer apparatus (100) designed for high- pressure fluid processing applications The apparatus includes a high-pressure intensifier pump (102) located in a sanitary area (108), capable of internal surface steam sterilization and controlled by a variable speed drive. An electrically or air-driven feed pressure pump (116) directs fluid through a series of high capacity external valves (110, 310) to a positive displacement plunger pump (106). A novel seal assembly (204) with a U-cup seal design enhances sterilization efficiency and prevents contamination. The system features an integrated Steam-in-Place (SIP) drainage assembly (150) with a sophisticated piping and instrumentation layout (P&ID), ensuring thorough cleaning and effective sterilization. An integrated control and data acquisition system dynamically adjusts operational parameters, ensuring optimal performance. This invention streamlines sanitary processes, enhancing efficiency and maintaining strict hygiene standards.

Description

“A SANITARY HOMOGENIZER WITH CLEANABLE AND DRAINABLE COMPONENTS”FIELD OF INVENTION

[0001] The present invention relates to the field of pumping devices, and more particularly to a sanitary homogenizer having cleanable and drainable components.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, nano-emulsification, particle size reduction, chemical mixing, high shear processing, etc., a high pressure pumping device of a sanitary nature in design and construction is required. The pumping device is utilized in chemical processing, food processing, pharmaceutical applications, and biotechnology operations. The pumping device includes pumps, such as, single intensifier pumps, dual intensifier pumps, triplex pumps, and multiplex pumping systems, etc. capable of operating at a high pressure up to 340 MPa (50,000 psi). The applications of the high pressure pumping device generally involve generation of a shearing action in a fluid, with the help of high pressure.

[0004] In the realm of high-pressure fluid processing, the need for equipment that can maintain a high level of cleanliness and sterility is paramount, especially in industries like pharmaceutical manufacturing, where the risk of contamination must be minimized. Traditional homogenizing and pumping devices, while effective in their basic function of fluid processing, often fall short when it comes to ease of cleaning and maintenance. These devices typically incorporate multiple components that are susceptible to contamination due to fluid retention and are challenging to access and clean thoroughly.

[0005] The 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 pumpingdevice typically include components that are easily contaminated by the biological fluid. Such components are often required to be frequently replaced for optimal operation of the pumping device, since use of such components may lead to contamination of the biological fluid. This limits functionality of the pumping device for repeated use, and increases the risk of contamination of the biological fluid.

[0006] Existing systems often use high-pressure pumps and valves that, despite their effectiveness in processing fluids, have intricate designs with internal crevices and complex assemblies. These designs make complete draining and cleaning difficult, often requiring extensive disassembly or the use of specialized cleaning processes that can be time-consuming and costly. Additionally, the materials and surface finishes of these components frequently fail to meet the highest standards required for certain sanitary applications, thereby posing risks of biofilm formation and microbial growth.

[0007] The limitations of current designs underscore the need for a homogenizer that not only performs efficiently under high-pressure conditions but also embodies a construction that facilitates easy and thorough cleaning, sterilization, and draining, thereby enhancing the overall hygiene and operational efficiency of the process.

[0008] There is, therefore, a need in the art to provide a homogenizer including components that are easily cleanable and drainable, while addressing the aforesaid shortcomings of the conventional high pressure pumping devices. The present invention provides high-pressure fluid processing equipment, specifically designed for applications requiring stringent cleanliness and sterility standards, such as those found in the pharmaceutical, biotechnological, and food processing industries. This invention specifically addresses the need for equipment that can be easily and effectively cleaned and sterilized, thereby reducing downtime and ensuring compliance with industry standards.OBJECTS OF THE INVENTION

[0009] An object of the present invention is to provide a sanitary homogenizer for processing of fluids in high-pressure applications.

[0010] Another object of the present invention is to provide a low-cost homogenizer which includes components that are easily cleanable and drainable.

[0011] Another object of the present invention is to provide a homogenizer utilizing steam to easily sanitize or sterilize the components, so as to reduce the risk of biological contamination of a fluid passing through the components.

[0012] Still another object of the present invention is to provide a homogenizer having high reliability and product yield characteristics.SUMMARY OF THE INVENTION

[0013] The summary is provided to introduce aspects related to a pumping apparatus for processing of fluids, and the aspects are further described below in the detailed description. 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.

[0014] The pumping apparatus is a homogenizer that includes components that are easily cleanable and drainable. The components of the pumping apparatus, such as, pumps, strainers, heat exchangers, etc. may be made of polished stainless steel to ensure better cleanability of their internal as well as exterior surfaces. The internal and exterior surfaces of the components may be formed to be smooth to reduce friction and retention of any residual matter, during operation of the pumping apparatus. The present invention provides a sanitary homogenizer designed to meet the rigorous demands of high-pressure applications requiring maximum cleanliness and sterility.

[0015] The key aspects of the pumping apparatus is integration of a high-pressure intensifier pump and a uniquely designed feed pressure pump assembly, both of which are constructed with materials and surface treatments optimized for easy cleaning and resistance to contamination. The present invention also introduces a seal assembly that incorporates a U- cup seal design, enhancing the apparatus's ability to prevent contamination and facilitating its cleaning and sterilization. This seal is specifically adapted to work under the high-pressure conditions prevalent in the homogenizer’s operational environment, providing an effective barrier against leakage and contamination while being easy to replace and maintain.

[0016] In a preferred embodiment, the present invention provides a sanitary homogenizer apparatus for processing fluids in high-pressure applications, the apparatus comprising: a high- pressure intensifier pump installed in a sanitary area of the homogenizer, fabricated from materials resistant to high temperatures to enable internal surface steam sterilization, equipped with a variable speed drive, the high-pressure positive displacement pump receiving fluid from a feed pressure pump assembly and connected to a series of high capacity external valves, an electrically or air-driven feed pressure pump assembly for drawing fluid and directing it to a positive displacement plunger pump, the assembly positioned within a designated pump drive area of the homogenizer, facilitating direct fluid flow without necessitating disconnection for drainage purposes, a seal assembly with a single simple cup design comprising high-pressureplunger seals positioned in the sanitary area, wherein each seal having a U-cup seal shape and one end of the seal in coupled with plunger to eliminate contamination and aid in the steamability of the equipment, wherein: the seal single simple cup design eliminates contamination and aid in the steamability of the equipment, the single simple cup design eliminates multiple crevices that retain contamination in a traditional multi-element seal pack typically employed in other traditional equipment designs, the high-pressure plunger seals engineered for the implementing characteristics of cleanability, high-pressure operation, steamability, long operational life needed for this application, the seal assembly provides application of steam on both sides of the plunger seal to ensure sterilization of this cavity, an alternate design may employ using hot condensate to sterilize equipment as opposed to the usage of steam and the hot condensate approach requires longer time periods to achieve sterility due to usage of lower temperatures, the series of high capacity external valves, wherein the external valves comprise one-way valves or check valves, each arranged vertically to enhance the drainability and prevent fluid retention within the sanitary environment, wherein each check valve is designed to incorporate gravity drainage of condensate, ensuring proper sterilization of surfaces by preventing condensate puddling and retention and the usage of a fixed orifice design to reduce complexity during sterilization as differentiated from traditional complex multi-component homogenizing valves, a drainage assembly employing a Steam-in-Place (SIP) technique, integrated within the apparatus with a configured piping architecture to allow for the passage and condensation management of steam for the sterilization of components, including a flush inlet line for steam introduction and a flush drain line for expelling steam, ensuring efficient cleaning and drainage across all sterilizable components, wherein the application of steam on both sides of the plunger seal ensures sterilization of the homogenizer equipments, an integrated control and data acquisition system, strategically positioned within the apparatus and linked to a plurality of temperature and pressure sensors dispersed throughout the piping architecture, tasked with collecting and analyzing operational data to adjust process variables and steam sterilization parameters.

[0017] In an embodiment, wherein the high-pressure intensifier pump includes a variable frequency electronic drive, facilitating adjustable operational speeds through the use of belts or pulleys.

[0018] In an embodiment, wherein the high- pressure positive displacement plunger pump assembly incorporates internal surfaces capable of being steamed to achieve required sanitization or sterilization temperatures efficiently.

[0019] In an embodiment, wherein the integrated control and data acquisition system further includes a graphical user interface for real-time monitoring and adjustment of the homogenizer operational parameters.

[0020] In an embodiment, wherein the materials that come into contact with the processed fluid, including the feed pressure pump, high-pressure positive displacement plunger pump, and heat exchanger, are made from polished stainless steel with surfaces smoothed to minimize friction and prevent residue adherence.

[0021] In an embodiment, wherein the integrated control and data acquisition system is strategically situated within the apparatus to collect and analyze data from temperature and pressure sensors, facilitating the adjustment of process variables and steam sterilization parameters for optimal performance and hygiene.

[0022] In an embodiment, wherein the polished stainless-steel components are characterized by having both internal and external surfaces meticulously finished to a specified surface roughness to enhance cleanability and maintain the apparatus hygiene standards.

[0023] In an embodiment, wherein the high-pressure positive displacement plunger pump is equipped with a variable speed drive to precisely regulate fluid pressure through the system up to 340 MPa (50,000 psi).

[0024] In an embodiment, wherein the apparatus comprises: a piping and instrumentation diaphragm (P&ID) configured to regulate fluid flow and sterilization processes throughout the system.

[0025] In another aspect of the present invention, a method for processing fluids in high- pressure applications using a sanitary homogenizer apparatus, comprising: drawing fluid using an electrically or air-driven feed pressure pump, positioned within a designated pump drive area of the homogenizer, to direct fluid to a high- pressure positive displacement plunger pump, thereby facilitating direct fluid flow without necessitating disconnection for drainage purposes, passing the fluid to the high-pressure intensifier pump, installed in a sanitary area of the homogenizer, where the pump is fabricated from materials resistant to high temperatures for internal surface steam sterilization and equipped with a variable speed drive to accurately regulate fluid pressure, using a seal assembly with a single simple cup design comprising high- pressure plunger seals positioned in the sanitary area, wherein: eliminating contamination and aiding in the steamability of the equipment by seal single simple cup design, the single cup design eliminates multiple crevices that retain contamination in a traditional multi-element seal pack typically employed in other traditional equipment designs, the high-pressure plunger seals engineered to implement cleanability, high-pressure operation, steamability, long operationallife needed for this application, the usage of the seal assembly provides application of steam on both sides of plunger seal to ensure sterilization of this cavity, providing an alternate designs that may employ using hot condensate to sterilize equipment as opposed to usage of steam and the hot condensate approach requires longer time periods to achieve sterility due to usage of lower temperatures, directing the fluid through a series of high capacity external valves, comprising one-way valves or check valves, each arranged vertically within the sanitary environment to enhance drainability and prevent fluid retention, wherein: the check valve is designed to incorporate gravity drainage of condensate, ensuring proper sterilization of surfaces by preventing condensate puddling and retention and use of a fixed orifice design to reduce complexity during sterilization as differentiated from traditional complex multicomponent homogenizing valves, employing a Steam-in-Place (SIP) technique via a drainage assembly integrated within the homogenizer, with a configured piping architecture that includes a flush inlet line for steam introduction and a flush drain line for steam expulsion, to ensure efficient cleaning and sterilization of components, adjusting process variables and steam sterilization parameters based on data collected and analyzed by an integrated control and data acquisition system strategically positioned within the homogenizer and linked to a plurality of temperature and pressure sensors dispersed throughout the piping architecture.

[0026] In an embodiment, wherein adjusting operational speeds of the high- pressure intensifier pump with a variable frequency electronic drive, facilitated through the use of belts or pulleys.

[0027] In an embodiment, including steaming internal surfaces of the high- pressure positive displacement plunger pump to achieve required sanitization or sterilization temperatures efficiently.

[0028] In an embodiment, comprising a graphical user interface included in the integrated control and data acquisition system for real-time monitoring and adjustment of the homogenizer operational parameters.

[0029] In an embodiment, wherein components that come into contact with the processed fluid, including the feed pressure pump, high-pressure positive displacement plunger pump, and heat exchanger, are made from polished stainless steel with surfaces smoothed to minimize friction and prevent residue adherence.

[0030] In an embodiment, comprising strategic collection and analysis of data from temperature and pressure sensors by the integrated control and data acquisition system to facilitate the adjustment of process variables and steam sterilization parameters for optimal performance and hygiene.

[0031] In an embodiment, comprises the polished stainless- steel components are characterized by having both internal and external surfaces meticulously finished to a specified surface roughness to enhance cleanability and maintain the apparatus hygiene standards.

[0032] In an embodiment, wherein regulating fluid pressure through the system up to 340 MPa (50,000 psi) is achieved by equipping the high-pressure intensifier pump with a variable speed drive.

[0033] In an embodiment, wherein a piping and instrumentation diaphragm (P&ID) configured to regulate fluid flow and sterilization processes throughout the system.BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS

[0034] 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:

[0035] Figs. 1A to ID illustrates various perspective views of a sanitary homogenizer pumping apparatus, in accordance with an embodiment of the present invention;

[0036] Figures 2 to 2E illustrates detailed views of the seal assembly of the sanitary homogenizer pumping apparatus, in accordance with an embodiment of the present invention;

[0037] Figs. 3 A and 3B illustrate perspective views of vertical arrangement of a plurality of high capacity external valves of a plunger pump of the pumping apparatus, in accordance with an embodiment of the present invention; and

[0038] Figure 4 illustrates the Piping and Instrumentation Diagram (P&ID) providing a detailed graphical representation of the mechanical and instrumentation details of the sanitary homogenizer pumping apparatus, in accordance with an embodiment of the present invention.DETAILED DESCRIPTION OF THE INVENTION

[0039] 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 overother 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.

[0040] 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.

[0041] 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.

[0042] The present invention relates to a sanitary and low-cost pumping apparatus for processing of fluids. The pumping apparatus (also referred to as “homogenizer” hereinafter) 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 homogenizer. The key aspects of the pumping apparatus is integration of a high-pressure intensifier pump and a uniquely designed feed pressure pump assembly, both of which are constructed with materials and surface treatments optimized for easy cleaning and resistance to contamination. The present invention also introduces a seal assembly that incorporates a U-cup seal design, enhancing the apparatus's ability to prevent contamination and facilitating its cleaning and sterilization. This seal is specifically adapted to work under the high-pressure conditions prevalent in the homogenizer’s operational environment, providing an effective barrier against leakage and contamination while being easy to replace and maintain.

[0043] Further, the present invention includes a drainage assembly which utilizes Steam- in-Place (SIP) sterilisation technique for cleaning and drainage of the components and pathways between the same. This assembly is carefully designed to ensure that all components, particularly those in direct contact with the processed fluids, can be thoroughly steamed and sterilized without disassembly. The design ensures that steam reaches all parts of the homogenizer, including those typically difficult to clean, thereby guaranteeing a high level of sterility.

[0044] The detailed configuration of valves and the strategic placement of sensors and control systems within the homogenizer facilitate precise control over the processingconditions and enable real-time monitoring and adjustment of operational parameters to optimize performance and ensure compliance with sanitary standards. The drainage assembly has provisions for cleaning and steaming the components of the pumping apparatus. The drainage assembly includes a piping architecture consisting of a plurality of pipes connected together so as to easily pass the steam in vicinity of the components to be sterilised. The piping architecture may be configured to control and manage condensation of the steam, to achieve sterilisation of the components.

[0045] The sanitary homogenizer apparatus 100 is comprised of multiple key components engineered to function synergistically. The primary components include a high-pressure intensifier pump 102, an electrically or air-driven feed pressure pump assembly 116, a novel seal assembly 204 with a U-cup seal design, a series of high capacity external valves 110, 310 a sophisticated drainage assembly 150 and an integrated control and data acquisition system. Each component is designed and positioned within the apparatus to optimize the processing of fluids under high-pressure conditions while ensuring that the system remains cleanable and drainable to maintain sterility.

[0046] In an illustrated embodiment of the sanitary homogenizer apparatus 100, as shown in Fig. 1A and 1C is the high-pressure intensifier pump 102, located within a sanitary area 108 of the apparatus. This pump is fabricated from materials such as polished stainless steel, chosen for their resistance to high temperatures and corrosive conditions, which are prevalent in sterilization processes. The pump is equipped with a variable speed drive, allowing precise control over fluid pressures, which is crucial for achieving effective homogenization, particle size reduction, and cell disruption in various applications.

[0047] As shown in Figs. 1A to ID, the homogenizer 100 including a high-pressure intensifier pump 102 driven by a variable frequency electronic drive. The variable frequency electronic drive may include belts or pulleys for driving the high-pressure intensifier pump 102. The homogenizer 100 may include a screen or strainer for filtering undesired particles from the fluid to be processed. The high-pressure intensifier pump 102 configured to drain cavities of components of the homogenizer 100, without the requirement of disconnecting the high-pressure intensifier pump 102. The high-pressure intensifier pump 102 is configured to undergo drainage of any residual matter or condensation. This is achieved without disconnecting inlet or outlet connections of the high-pressure intensifier pump 102.

[0048] The design and material selection for the high-pressure intensifier pump 102 facilitate its internal surface sterilization using steam, ensuring that the pump can be maintainedin a sterile condition without the need for disassembly. This capability is vital for applications requiring stringent regulatory compliance regarding cleanliness and sterility.

[0049] In an embodiment of the present invention as shown in Fig. 1A and 1C, a feed pressure pump 116 assembly is positioned within a designated pump drive area 104 of the homogenizer 100, the feed pressure pump 116 assembly is configured to be either electrically or air-driven. This flexibility allows the apparatus to be adapted to different operational settings and energy availability scenarios. The feed pressure pump 116 assembly is crucial for drawing the fluid into the homogenizer and directing it towards the high-pressure intensifier pump 102. This initial step is crucial as it sets the stage for the subsequent high-pressure processing that occurs within the apparatus 100. The design of this assembly facilitates direct fluid flow and supports easy connection and disconnection, thereby aiding in the maintenance and cleaning processes without compromising the sterility of the fluid path.

[0050] In an exemplary embodiment, the key features of the feed pressure pump 116 assembly is its design to be either electrically or air-driven. This dual capability allows the homogenizer to be adaptable to various operational environments and energy sources, enhancing its applicability across different industries and geographical locations. The choice between electric and pneumatic drive systems also allows operators to select the most appropriate energy-efficient solution for their specific needs, considering factors such as energy costs, availability, and environmental impact. A significant design consideration for the feed pressure pump 116 assembly is facilitating ease of connection and disconnection for maintenance and cleaning purposes. The assembly is equipped with quick-connect features that allow it to be easily detached from the rest of the system without compromising the sterility of the process. This feature is particularly important in pharmaceutical and food processing applications, where any breach in sterility can lead to contamination and product loss.

[0051] The feed pressure pump 116 is constructed from materials that are resistant to corrosion and easy to clean, such as polished stainless steel. These materials are capable of withstanding the harsh sanitizing agents and steam used during cleaning cycles. The smooth surface finish of the pump components ensures that there are minimal crevices where bacteria or contaminants could lodge, thereby simplifying the cleaning process and reducing the risk of biofilm formation. The feed pressure pump 116 assembly is designed with precision engineering to maintain a steady and controlled flow of fluid into the high-pressure intensifier pump 102. This controlled flow is crucial for preventing surges or drops in pressure that could affect the efficiency and safety of the homogenizing process. The pump’s variable speed control, facilitated by either its electrical or pneumatic drive, allows for fine-tuning the flowrate according to the specific requirements of the processed fluid and the operational parameters set by the integrated control and data acquisition system.

[0052] The feed pressure pump 116 assembly works in tandem with the other components of the sanitary homogenizer apparatus 100, such as the high-pressure intensifier pump 102 and the seal assembly 204. This integration ensures that the entire system operates cohesively, with each component’s function complementing the others. The design of the feed pressure pump 116 assembly particularly supports the function of the high-pressure intensifier pump by preconditioning the fluid to the correct pressure and flow rate necessary for effective high- pressure processing.

[0053] The homogenizer 100 also includes a high pressure positive displacement plunger pump 106 provided with a variable speed drive to accurately control pressure of the fluid passing therethrough. The plunger pump 106 is installed in a sanitary area 108 of the homogenizer 100. The high-pressure intensifier pump 102 draws in the fluid to be processed and pumps it through the strainer to the high pressure positive displacement plunger pump 106. The positive displacement plunger pump 106 may be constructed of high temperature materials that allow its internal surfaces to be steamed, to achieve the necessary sanitization or sterilization temperatures for efficient cleaning and drainage thereof. The positive displacement plunger pump 106 located in the sanitary area 108 utilizes a plurality of high capacity external valves 110, 310, as clearly shown in Figs. IB and 3B, to develop the high pressure required to promote drainage in the homogenizer 100, in order to improve efficiency of the positive displacement plunger pump 106. The external valves 110, 310 may include oneway valves or check valves that are vertically arranged to prevent retention of the fluid passing therethrough. The vertical arrangement of the external valves 110, 310 contribute to improved drainability of components of the homogenizer 100 in a sanitary environment. The high pressure developed by the external valves 110, 310 may be varied between 2 to 340 MPa (300 to 50,000 psi). One or more seals may be used to reduce complexity and increase cleanability inside the positive displacement plunger pump 106. The seals may include high temperate polymeric cup seals designed to reduce the possibility of contamination and loss of the fluid. The cup seals are simple in design, and include a single ring capable of preventing leakage of the fluid during its service life. The seals prevent leakage of the fluid during its service life, even after being subjected to high temperatures during steaming. The cup seals prevent any biological or chemical hazard due to exposure of components of the homogenizer 100 to a leaked fluid. The cup seals are easily cleanable and replaceable, thereby reducing disposal costs thereof. The cup seal was tested at high pressures for hundreds of hours. The cup seal was ableto be steam- sterilized or sanitized, and was observed to successfully withstand high pressure conditions without any leakage.

[0054] The pumping apparatus 100 may include a priming valve positioned at an outlet of the positive displacement plunger pump 106. The priming valve is used to prime the high pressure plunger pump 106 and aid in air removal in the high-pressure intensifier pump 102. As clearly shown in Figs. IB and 3A, the fluid to be processed is then fed into one or more interaction chambers 112, 312 to mix and impinge the fluid and generate high shear in the fluid to produce a proceed fluid. The interaction chambers 112, 312 may include a single orifice or multiple orifices having fixed geometry. The orifices may be made of a hard material to resist wear and tear. The positive displacement plunger pump 106 may be operated at higher pressures to reduce fluid processing time and achieve better process results with the interaction chambers 112, 312. After passing through the interaction chambers 112, 312 the fluid enters a sanitary heat exchanger, where the fluid is cooled to a desired temperature. The heat exchanger is made of stainless steel. The homogenizer 100 may include a plurality of bellows 114 to protect any spillage of the fluid in the sanitary area 108.

[0055] The pumping apparatus 100 allows any internal valves of the high-pressure intensifier pump 102 or the positive displacement plunger pump 106 to be controlled externally. This allows internal passages of the high-pressure intensifier pump 102 and the positive displacement plunger pump 106 to be cleaned and drained, to prevent build-up of the residual matter or condensate during steaming that would prevent the internal surfaces to achieve temperatures necessary for sanitization or sterilization.

[0056] The components of the homogenizer 100, such as, the high-pressure intensifier pump 102, the strainer, and the positive displacement plunger pump 106, heat exchanger etc. may be made of polished stainless steel to ensure better cleanability of their internal as well as exterior surfaces. The internal and exterior surfaces of the components are formed to be smooth to reduce friction and retention of any residual matter, during operation of the homogenizer 100.

[0057] In a preferred embodiment of the present invention as shown in Fig. 2 and 2A-2E, the sanitary homogenizer 100 houses a seal assembly 204 featuring for example a U-cup seal design. This seal assembly is positioned within the sanitary area 108 and is integral to maintaining the integrity and sterility of the fluid processing zone. The U-cup seal design is specifically tailored to prevent any leakage that could lead to contamination. Each seal is directly coupled with a plunger 220, enhancing the seal’ s effectiveness under varying pressures and ensuring that it can withstand the rigors of high-pressure operation.

[0058] In the embodiment of the sanitary homogenizer apparatus 100 as shown in Fig. 2A- 2B, the design of the seal assembly significantly enhances the sterility and operational efficiency of the device. The seal assembly 204, incorporates a single simple cup (U-cup) design as shown in Fig. 2C-2E. This design is pivotal in eliminating contamination risks and facilitating the effective steam sterilization of the equipment. The simplicity of the U-cup seal design facilitates easy replacement and maintenance. This design allows the seal to be quickly accessed and replaced without the need for extensive disassembly, significantly reducing downtime and maintenance costs. The single cup design of the seal assembly 204 is engineered to replace traditional multi-element seal packs, which are commonly used in other high- pressure fluid processing equipment. Traditional seals often include multiple crevices and interfaces between different components of the seal pack. These crevices can retain contaminants and make thorough cleaning and sterilization challenging. In contrast, the single simple cup design of the present invention eliminates such crevices, significantly reducing areas where contaminants might accumulate.

[0059] In a preferred embodiment of the present invention as shown in Fig. 2A-2E, the seal single simple cup design to eliminate contamination and aid in the steamability of the equipment. This single cup design eliminates multiple crevices that retain contamination in a traditional multi-element seal pack typically / commonly employed in other traditional equipment designs. The high-pressure plunger seals engineered for the following characteristics: cleanability, high-pressure operation, steamability, long operational life needed for this application and provides application of steam on both sides of plunger seal to ensure sterilization of this cavity.

[0060] In an exemplary embodiment of the present invention, an alternate designs may employ using hot condensate to sterilize equipment as opposed to our proposed usage of steam. This hot condensate approach requires longer time periods to achieve sterility due to usage of lower temperatures. The high-pressure plunger seals within the seal assembly 204 are specifically engineered for high-pressure operation, which is a critical requirement for effective homogenization. These seals are capable of operating under pressures necessary to achieve the fine particle sizes required in pharmaceutical and food processing applications. The robustness of the seal design ensures that the seal integrity is maintained even under these extreme conditions, thereby preventing any breach that could lead to contamination. Moreover, the seal assembly is designed to allow the application of steam on both sides of the plunger seal. This feature is crucial for ensuring the complete sterilization of the cavity surrounding the seal. By allowing steam to envelop the seal fully, all potential microbial life and contaminants areeffectively eradicated, thus maintaining the sterility of the process environment. While the preferred method for sterilizing the seal assembly involves the use of steam, alternative designs may employ hot condensate for sterilization. It is important to note that the use of hot condensate typically requires longer periods to achieve sterility due to the lower temperatures involved compared to steam. This longer duration can increase downtime and reduce the efficiency of the sterilization process, making steam a more effective choice in applications where time and operational efficiency are critical.

[0061] In an embodiment of the present invention, the seal assembly is used in conjunction with a fixed orifice design. This design approach reduces complexity during sterilization compared to traditional complex multi-component homogenizing valves. The fixed orifice provides a consistent and unobstructed path for fluid flow, which not only simplifies cleaning and maintenance but also ensures more reliable and predictable performance during operation. Additionally, the check valve design incorporated in the homogenizer is specifically configured to facilitate gravity drainage of condensate. This design is in stark contrast to traditional homogenizers that employ a bottom-up flow, which often results in condensate puddling and retention in the valves. Such retention can restrict and reduce the effectiveness of steam sterilization by preventing the steam from reaching all surfaces at the required temperatures. The gravity drainage feature in the new design ensures that all internal surfaces are properly exposed to sterilization processes, thereby enhancing the overall cleanliness and sterility of the homogenizer.

[0062] In a preferred embodiment of the present invention, the check valve is designed to incorporate gravity drainage of condensate, ensuring proper sterilization of surfaces by preventing condensate puddling and retention and use of a fixed orifice design to reduce complexity during sterilization as differentiated from traditional complex multi-component homogenizing valves.

[0063] In an embodiment of the present invention of the sanitary homogenizer apparatus 100, as shown in Figs. 1C and 3A, the homogenizer 100 incorporates a series of high capacity external valves 110, 310, which are strategically arranged to optimize fluid flow and enhance the system’s cleanliness. These valves are designed as one-way or check valves and are arranged vertically within the sanitary area 108 to facilitate the gravity-assisted drainage of fluids and condensates. This arrangement ensures that there are no retention areas where fluids or contaminants could accumulate, thus maintaining the cleanliness and sterility of the system.

[0064] The homogenizer 100 includes a drainage assembly 150 to drain any residual matter from its components, and ensure minimal retention of the fluid. The homogenizer 100employs sanitary diaphragm valves made of stainless steel to facilitate in efficient cleaning and drainage of pathways between the components. The drainage assembly 150 utilizes Steam- inPlace (SIP) sterilisation technique for cleaning and drainage of the components and pathways between the same. The drainage assembly 150 uses a superheated steam to remove or sterilise any residual matter from the components and the pathways. The drainage assembly 150 has provisions for cleaning and steaming the pumps, pipes, orifices, seals, heat exchanger, or other components of the pumping apparatus 100. The drainage assembly 150 includes a piping architecture consisting of a plurality of pipes connected together so as to easily pass the steam in vicinity of the components to be sterilised. The piping architecture of the drainage assembly 150 may include a flush inlet line 152 through which the steam is introduced in the pipes or conduits, and a flush drain line 154 through which the steam flowing through the pipes is drained out of the drainage assembly 150. The piping architecture is configured to achieve flow velocities required for efficient cleaning and sterilisation of the components. The piping architecture may also be configured to control and manage condensation of the steam, to achieve sterilisation of the components. A plurality of temperature sensors and pressure sensors may be disposed at various locations in the pipes of the drainage assembly 150 to verify critical areas, process results and adequate temperature exposure of the steam passing therethrough.

[0065] The piping architecture provides various passages for flow of the fluid, steam and air to various components, while allowing Cleaning-in-Place (CIP) and Steam-in-Place (SIP). The piping architecture may employ a plurality of flow control valves, such as, check valves, ball valves, diaphragm valves, needle valves, etc., to efficiently regulate flow of the fluid and the steam. The fluid to be processed may be provided at an inlet of the piping architecture. Subsequently, the steam may be passed to the inlet, through a ball valve, to prevent reverse flow thereof. The steam passing through the piping architecture may be drained through drain pipes. The piping architecture may also include strainers for filtering undesired particles from the fluid to be processed, flow regulators and steam regulators configured to restrict and reduce the amount of fluid and the steam flowing through respective pipes of the piping architecture. Steam traps may be placed in the piping architecture to discharge condensates and noncondensable gases present in the steam. Temperature and pressure sensors are also arranged throughout the piping architecture to detect temperature and pressure of respective pipes or conduits. The pumping apparatus 100 also includes a control and data acquisition unit configured to acquire and collect data from the temperature and pressure sensors disposed in the pipes. The control and data acquisition unit acquires and collects data from the temperature and pressure sensors located throughout the piping architecture to efficiently control theprocess variables of the multiplex pumping system. The control and data acquisition unit is also configured to control flow and temperature characteristics of the superheated steam to be supplied to the piping architecture of the drainage assembly 150.

[0066] In an embodiment of the present invention as shown in Fig. 4, illustrates the Piping and Instrumentation Diagram (P&ID) providing a detailed graphical representation of the mechanical and instrumentation details of the sanitary homogenizer pumping apparatus 100. In an embodiment, Fig. 4 provides the process flow, component arrangement, and control architecture of the system, facilitating both operational efficacy and compliance with engineering standards. The P&ID illustrates the layout of pipes, the placement of key equipment such as pumps, valves, sensors, and controllers, and the interconnections between these components. Each element in the diagram is identified by standardized symbols and labelling conventions, which are consistent with industry standards to ensure clarity and universal understanding. The diagram includes several pumps which are essential for moving fluids through the system at required pressures and flow rates. These pumps are depicted with specific symbols indicating their type (e.g., centrifugal, diaphragm) and are annotated with unique identifiers for easy reference. Various types of valves are shown, including control valves, check valves, and possibly diaphragm valves, each chosen for specific functions such as controlling flow rates, preventing backflow, and isolating sections of the system for maintenance, temperature and pressure sensors are strategically placed throughout the system to monitor critical parameters. Controllers use this data to adjust the operation of the pumps and valves automatically, ensuring optimal process conditions are maintained. The diagram distinctly outlines the flow paths of the product and steam (for cleaning and sterilization), illustrating how these mediums traverse through different system components. This layout helps in understanding the system’s operational logic and the sequence of actions during normal operation and cleaning cycles. The P&ID also integrates with the homogenizer’s control system by detailing the connections between physical components and their corresponding control logic. This integration is crucial for automating the homogenizer operations, allowing for real-time adjustments based on sensor feedback, which optimizes the system’s performance and reliability.

[0067] The P&ID for the sanitary homogenizer apparatus 100 demonstrates a complex system designed to ensure efficient processing, cleaning, and sterilization of fluids in high- pressure applications. The system is outlined with several interconnected components including pumps, valves, sensors, and piping that facilitate the movement, control, and monitoring of both product fluid and cleaning / sterilizing agents such as steam. At the heart ofthe homogenizer apparatus are two main pumps (marked with a "P" in circles), which are essential for the fluid movement through the system. These pumps draw the product fluid from the source and propel it through the system under controlled pressures necessary for the homogenization process. The first pump, situated near the system's inlet, is responsible for the initial pressure and flow rate control, preparing the fluid for further processing.

[0068] The fluid then travels through various control valves, which regulate the flow and direct the fluid to necessary areas of the system. These valves are crucial for managing the operational dynamics of the apparatus and are integrated with sensors that provide real-time data on pressure and temperature. This data is fed back to a central control system which adjusts the valves and pumps accordingly to maintain optimal processing conditions. In the course of its journey, the fluid encounters several check valves and a series of more complex valve arrangements. These are specifically designed to prevent backflow and ensure that the fluid remains within the desired pathways. Check valves play a critical role in maintaining the integrity of the fluid flow in one direction, preventing contamination and ensuring efficiency.

[0069] Temperature control is achieved through strategically placed temperature controllers ("TC") along the fluid lines. These controllers monitor the temperature of the fluid, crucial for processes that require specific temperatures to ensure product quality and safety. The control system adjusts the fluid temperature by modulating the operation of the pumps and the opening or closing of various valves. Steam lines are also depicted in the diagram, indicating the paths for steam to enter the system for cleaning and sterilization purposes. The steam is introduced into the system through designated inlets and is directed to envelop all internal surfaces of the pumps, pipes, and other components. This Steam-in-Place (SIP) system is essential for ensuring the sterility of the apparatus between batches or when a changeover is required.

[0070] Fig 4 also shows a series of drainage paths, critical for the removal of condensate and other waste materials from the system. Proper drainage ensures that no contaminants remain within the system that could affect the next batch of product. Gravity drainage paths are designed to utilize natural forces to aid in the effective removal of these materials, minimizing the need for mechanical assistance. Finally, the overall P&ID as shown in Fig. 4 illustrates a well-integrated system where all components are connected via a series of pipes and control links that ensure smooth operation and high reliability. Each component is marked with specific identifiers that correspond to a detailed list of equipment, aiding in maintenance and troubleshooting processes.

[0071] This comprehensive setup as depicted in Fig. 4, the P&ID ensures that the sanitary homogenizer apparatus 100 operates efficiently, maintaining the high standards required for the processing of fluids in sensitive applications like pharmaceuticals, biotechnology, and food processing. The graphical representation in the P&ID not only serves as a blueprint for constructing the system but also as a guide for operation and maintenance, ensuring long-term reliability and compliance with stringent industry standards.

[0072] The present invention provides a simplified and low-cost homogenizer for processing of a fluid for high-pressure applications. The homogenizer is capable of withstanding high-pressure operations, while providing for sanitization or sterilization of its components for continued operation. The components are design and integrated to improve cleanability and reparability of the homogenizer, while reducing the occurrence of any contamination to the fluid to be processed. The capability to steam the pipes, and other components of the homogenizer reduces the risk of bioburden and product cross contamination. The sanitary drainable configuration of the pumping apparatus greatly contributes to effectiveness of the steamability.

[0073] 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.

[0074] 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 embodiment may be combined together to form a further embodiment of the disclosure.

Claims

We claim:

1. A sanitary homogenizer apparatus (100) for processing fluids in high-pressure applications, the apparatus comprising: a high-pressure intensifier pump (102) installed in a sanitary area (108) of the homogenizer (100), fabricated from materials resistant to high temperatures to enable internal surface steam sterilization, equipped with a variable speed drive, the high-pressure positive displacement pump (106) receiving fluid from a feed pressure pump (116) assembly and connected to a series of high capacity external valves (110); an electrically or air-driven feed pressure pump (116) assembly for drawing fluid and directing it to a positive displacement plunger pump (106), the assembly positioned within a designated pump drive area (104) of the homogenizer (100), facilitating direct fluid flow without necessitating disconnection for drainage purposes; a seal assembly (204) with a single simple cup design comprising high-pressure plunger seals positioned in the sanitary area (108), wherein each seal having a U-cup seal shape and one end of the seal in coupled with plunger (220) to eliminate contamination and aid in the steamability of the equipment, wherein: the seal single simple cup design eliminates contamination and aid in the steamability of the equipment, the single simple cup design eliminates multiple crevices that retain contamination in a traditional multi-element seal pack typically employed in other traditional equipment designs, the high-pressure plunger seals engineered for the implementing characteristics of cleanability, high-pressure operation, steamability, long operational life needed for this application, the seal assembly (204) provides application of steam on both sides of the plunger seal to ensure sterilization of this cavity, an alternate design may employ using hot condensate to sterilize equipment as opposed to the usage of steam and the hot condensate approach requires longer time periods to achieve sterility due to usage of lower temperatures; the series of high capacity external valves (110, 310), wherein the external valves (110, 310) comprise one-way valves or check valves, each arranged vertically to enhance the drainability and prevent fluid retention within the sanitary environment, wherein:each check valve is designed to incorporate gravity drainage of condensate, ensuring proper sterilization of surfaces by preventing condensate puddling and retention and the usage of a fixed orifice design to reduce complexity during sterilization as differentiated from traditional complex multi-component homogenizing valves, a drainage assembly (150) employing a Steam-in-Place (SIP) technique, integrated within the apparatus with a configured piping architecture to allow for the passage and condensation management of steam for the sterilization of components, including a flush inlet line (152) for steam introduction and a flush drain line (154) for expelling steam, ensuring efficient cleaning and drainage across all sterilizable components, wherein the application of steam on both sides of the plunger seal ensures sterilization of the homogenizer equipment; an integrated control and data acquisition system, strategically positioned within the apparatus and linked to a plurality of temperature and pressure sensors dispersed throughout the piping architecture, tasked with collecting and analyzing operational data to adjust process variables and steam sterilization parameters.

2. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the high- pressure intensifier pump (102) includes a variable frequency electronic drive, facilitating adjustable operational speeds through the use of belts or pulleys.

3. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the high- pressure positive displacement plunger pump (106) assembly incorporates internal surfaces capable of being steamed to achieve required sanitization or sterilization temperatures efficiently.

4. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the integrated control and data acquisition system further includes a graphical user interface for real-time monitoring and adjustment of the homogenizer’s operational parameters.

5. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the materials that come into contact with the processed fluid, including the feed pressure pump (116), high- pressure positive displacement plunger pump (106), and heat exchanger, are made from polished stainless steel with surfaces smoothed to minimize friction and prevent residue adherence.

6. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the integrated control and data acquisition system is strategically situated within the apparatus to collect and analyze data from temperature and pressure sensors, facilitating the adjustment of process variables and steam sterilization parameters for optimal performance and hygiene.

7. The sanitary homogenizer apparatus (100) as claimed in claim 5, wherein the polished stainless-steel components are characterized by having both internal and external surfaces meticulously finished to a specified surface roughness to enhance cleanability and maintain the apparatus hygiene standards.

8. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the high- pressure positive displacement plunger pump (106) is equipped with a variable speed drive to precisely regulate fluid pressure through the system up to 340 MPa (50,000 psi).

9. The sanitary homogenizer apparatus (100) as claimed in claim 1, wherein the apparatus comprises: a piping and instrumentation diaphragm (P&ID) configured to regulate fluid flow and sterilization processes throughout the system;10. A method for processing fluids in high-pressure applications using a sanitary homogenizer apparatus (100), comprising: drawing fluid using an electrically or air-driven feed pressure pump (116), positioned within a designated pump drive area (104) of the homogenizer (100), to direct fluid to a high- pressure positive displacement plunger pump (106), thereby facilitating direct fluid flow without necessitating disconnection for drainage purposes; passing the fluid to the high-pressure intensifier pump (102), installed in a sanitary area (108) of the homogenizer (100), where the pump is fabricated from materials resistant to high temperatures for internal surface steam sterilization and equipped with a variable speed drive to accurately regulate fluid pressure; using a seal assembly (204) with a single simple cup design comprising high-pressure plunger seals positioned in the sanitary area (108), wherein: eliminating contamination and aiding in the steamability of the equipment by seal single simple cup design,the single cup design eliminates multiple crevices that retain contamination in a traditional multi-element seal pack typically employed in other traditional equipment designs, the high-pressure plunger seals engineered to implement cleanability, high- pressure operation, steamability, long operational life needed for this application, the usage of the seal assembly (204) provides application of steam on both sides of plunger seal to ensure sterilization of this cavity, provide an alternate designs that may employ using hot condensate to sterilize equipment as opposed to usage of steam and the hot condensate approach requires longer time periods to achieve sterility due to usage of lower temperatures, directing the fluid through a series of high capacity external valves (110, 310), comprising one-way valves or check valves, each arranged vertically within the sanitary environment to enhance drainability and prevent fluid retention, wherein: the check valve is designed to incorporate gravity drainage of condensate, ensuring proper sterilization of surfaces by preventing condensate puddling and retention and use of a fixed orifice design to reduce complexity during sterilization as differentiated from traditional complex multi-component homogenizing valves, employing a Steam- in-Place (SIP) technique via a drainage assembly (150) integrated within the homogenizer, with a configured piping architecture that includes a flush inlet line (152) for steam introduction and a flush drain line (154) for steam expulsion, to ensure efficient cleaning and sterilization of components; and adjusting process variables and steam sterilization parameters based on data collected and analyzed by an integrated control and data acquisition system strategically positioned within the homogenizer (100) and linked to a plurality of temperature and pressure sensors dispersed throughout the piping architecture.

11. The method as claimed in claim 10, wherein adjusting operational speeds of the high- pressure intensifier pump (102) with a variable frequency electronic drive, facilitated through the use of belts or pulleys.

12. The method as claimed in claim 10, including steaming internal surfaces of the high- pressure positive displacement plunger pump (106) to achieve required sanitization or sterilization temperatures efficiently.

13. The method as claimed in claim 10, comprising a graphical user interface included in the integrated control and data acquisition system for real-time monitoring and adjustment of the homogenizer’s (100) operational parameters.

14. The method as claimed in claim 10, wherein components that come into contact with the processed fluid, including the feed pressure pump (116), high-pressure positive displacement plunger pump (106), and heat exchanger, are made from polished stainless steel with surfaces smoothed to minimize friction and prevent residue adherence.

15. The method as claimed in claim 10, comprising strategic collection and analysis of data from temperature and pressure sensors by the integrated control and data acquisition system to facilitate the adjustment of process variables and steam sterilization parameters for optimal performance and hygiene.

16. The method as claimed in claim 14, wherein the polished stainless-steel components are characterized by having both internal and external surfaces meticulously finished to a specified surface roughness to enhance cleanability and maintain the apparatus (100) hygiene standards.

17. The method as claimed in claim 10, wherein regulating fluid pressure through the system up to 340 MPa (50,000 psi) is achieved by equipping the high-pressure intensifier pump (102) with a variable speed drive.

18. The method as claimed in claim 10, wherein a piping and instrumentation diaphragm (P&ID) configured to regulate fluid flow and sterilization processes throughout the system.

Images