WO2024252428A1

WO2024252428A1 - Pumping apparatus

Info

Publication number: WO2024252428A1
Application number: PCT/IN2024/050706
Authority: WO
Inventors: Rahul KHARCHE; Anand Shah; Joe RAMINA; Nilabh VISHWAKARMA; Marco CATALANI; Jimit VYAS; John Michael BERNARD; David HARNEY; Mihir Modi; Michael RATIGAN; Kartikeya Mahalatkar; Daljit Singh
Original assignee: Idex India Pvt Ltd; Idex Mpt Inc; Idex MPT Inc
Current assignee: Idex India Pvt Ltd; Idex Mpt Inc; Idex MPT Inc
Priority date: 2023-06-07
Filing date: 2024-06-07
Publication date: 2024-12-12
Anticipated expiration: 2025-12-07

Abstract

The present invention relates to a pumping apparatus (100) designed for high-pressure applications The apparatus includes a drive end (120) and a fluid end (150) that can be easily coupled and uncoupled for maintenance. The fluid end features high-pressure plunger cylinder assemblies (152) equipped with U-cup seals (204) and bellows (162) to prevent leakage and ensure sanitary operation. An external seal flushing unit with inlet (220) and outlet flush lines (222) facilitates thorough cleaning, maintaining hygienic conditions. The apparatus can process fluids at pressures exceeding 50,000 psi and incorporates features like temperature sensors, interchangeable seals, and a digital interface for monitoring operational parameters. The design allows for quick replacement of components, reducing downtime and ensuring the apparatus meets the stringent cleanliness requirements of any pharmaceutical processes.

Description

“PUMPING APPARATUS”

FIELD OF INVENTION

[0001] The present invention relates to fluid pumping devices and more particularly to a pumping apparatus having improved availability and reparability for high-pressure applications, specifically in the pharmaceutical industry.

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., high-pressure equipment of a sanitary nature in design and construction is required. Such applications typically involve the 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 involve pumping a biological fluid at high pressure into diamond-type interaction chambers having small orifices to cause the shearing action in the biological fluid. Such high-pressure pumping devices generally include a power end and a fluid end. The power end uses a drive shaft to convert rotational motion into reciprocation of one or more plungers located in a pump housing or the fluid end. The fluid end includes high-pressure cylinders configured to pressurize the biological fluid.

[0004] The fluid end of conventional high-pressure pumping devices also includes suction valves for receiving the biological fluid to be pumped and corresponding discharge valves for discharging the biological fluid at high pressure. Through the reciprocal motion of the plungers, the biological fluid is pressurized and flows into and out of the fluid end. [0005] The high-pressure pumping devices employed in the pharmaceutical industry are required to have components that are extremely sanitary and easily cleanable. However, commercially available pumping devices currently used in pharmaceutical applications include components in a pre-fitted configuration and do not allow easy replacement and/or repair of individual components such as seals used for preventing leakage of the biological fluid. This severely affects high-pressure applications and proper sealing of the fluid end of pumping devices. Also, since such pumping devices are used to process biological fluids containing bacterial cells like E. coli, yeast cells from which protein extraction takes place for pharmaceutical applications ., it is of utmost importance that the components of the pumping devices are easily replaceable and cleanable with zero leak. The design of the pumping devices are free from dead zone, crevices where biological fluid cannot stagnates during operation (design eliminating bio burden). All fluids in the pumping devices have continuous flow from inlet to outlet.

[0006] It is therefore desirable to provide a pumping apparatus capable of addressing the aforesaid shortcomings of conventional high-pressure pumping devices.

OBJECT OF THE INVENTION

[0007] The object of the present invention is to provide a pumping apparatus suitable for pharmaceutical applications.

[0008] Another object of the present invention is to provide a pumping apparatus capable of processing biological fluids in an extremely sanitary manner.

[0009] Another object of the present invention is to provide a pumping apparatus in which components present in a fluid end thereof are easily cleanable and removable.

[0010] Another object of the present invention is to provide a pumping apparatus capable of efficiently eliminating bio-burden and improving accessibility to the components for easy and convenient sealing and sanitization thereof.

[0011] Still another object of the present invention is to provide a pumping apparatus capable of being easily retrofitted into existing pumping devices. SUMMARY OF THE INVENTION

[0012] The summary is provided to introduce aspects related to a pumping apparatus for processing a fluid, 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.

[0013] The pumping apparatus includes a drive end and a fluid end. The drive end may include a drive unit adapted for efficient operation of the pumping apparatus. Additionally, or alternatively, the drive end may include a conventional drive unit capable of drive the pumping apparatus for high-pressure applications. The fluid end is properly fitted with the drive end to carry out the pumping operation. The fluid end includes one or more seals placed at various locations in a sanitary area of the fluid end, to effectively seal the fluid passing to high-pressure cylinder assembly of the pumping apparatus by reciprocating action of high-pressure plungers. In a preferable embodiment, at least one seal is coupled with the plunger to prevent leakage of the fluid during operation of the pumping apparatus. The seals may have a U-cup shape. The seals have a simple design, and are formed by a single elastomeric ring. The seals are capable of being easily replaced and clean, thereby reducing costs associated with cleaning and disposal of the leakage fluid. The fluid end may include a plurality of bellows to protect any spillage of the fluid in the sanitary area thereof. One end of a bellow may be fitted with the drive end while the other end is fitted with a corresponding plunger. The seals have zero leakage and the simple design is free from Dead zone, crevices where biological fluid cannot stagnate during operation (design eliminating bio burden). The Fluid flowing have continuous flow from inlet to outlet.

[0014] The combination of the drive end and the fluid end of the pumping apparatus provides flexibility to easily and efficiently service/repair the s sanitary area of the fluid end, while allowing generation of the desired shearing action in the fluid with a desired constant flow rate at high pressure. The fluid end of the pumping apparatus is cost-effective, and may be adapted/configured in accordance with a suitable drive end to cater to different high-speed applications and piston-diameter configurations of the pumping apparatus.

[0015] With the pumping apparatus of the present invention, the seals installed in the fluid end thereof can be easily replaced or repaired, without the requirement of removing or detaching any other component, such as check valves, cylinder and pump block. Also, the time required for replacement of the seal is substantially reduced as compared to a conventional pumping device. The pumping apparatus of the present invention is capable of processing fluids at high pressure of more than 50,000 psi.

[0016] In a preferred embodiment, the present invention provides a pumping apparatus for processing biological fluids at high pressures, comprising: a drive end, including a drive unit adapted for efficient operation of the pumping apparatus; a fluid end, removably coupled to the drive end, comprising: a plurality of high-pressure plunger cylinder assembly configured to pressurize the biological fluid by reciprocating action of one or more plungers driven by the drive unit; a plurality of seals placed at various locations within the fluid end to prevent leakage of the biological fluid, each seal having a U-cup shape and formed by a single elastomeric ring, wherein at least one seal is coupled with each plunger; a plurality of bellows to protect against spillage of the fluid within a sanitary area of the fluid end to separate red zone and green zone and to prevent oil from red zone to green zone, wherein one end of each bellow is fitted with the drive end and the other end is fitted with the corresponding plunger; the high pressure plunger cylinder assembly houses an external seal flushing unit, wherein the external seal flushing unit include a flush line having an inlet flush line and outlet flush line for cleaning and quenching of high pressure bearings and seals; wherein the pumping apparatus is configured to process fluids at pressures exceeding 50,000 psi, and the components of the fluid end are easily cleanable and replaceable to maintain sanitary conditions suitable for pharmaceutical applications.

[0017] In an embodiment, wherein the drive unit comprises a variable speed controller to adjust the flow rate and pressure of the biological fluid, facilitating precise control over the shearing action required for different pharmaceutical applications.

[0018] In an embodiment, wherein the high-pressure cylinder assembly are equipped with temperature sensors to monitor and control the temperature of the biological fluid, ensuring that the fluid's properties remain consistent during processing.

[0019] In an embodiment, wherein the U-cup seals are interchangeable with seals of different materials to accommodate a variety of biological fluids with differing chemical properties. [0020] In an embodiment, the pumping apparatus comprising a diagnostic system capable of monitoring the wear and tear of the seals and bellows, providing alerts for preventative maintenance and replacement to avoid unexpected downtime.

[0021] In an embodiment, wherein the fluid end includes a modular design, allowing for the quick exchange of high-pressure plunger cylinder assembly to adapt the apparatus for different volumes or types of biological fluids

[0022] In an embodiment, wherein the bellows are constructed of a material that is resistant to a wide range of biological fluids, ensuring durability and longevity in various pharmaceutical processing environments

[0023] In an embodiment, comprising a digital interface for programming and monitoring operational parameters, such as pressure, flow rate, and seal integrity, enhancing the ease of use and precision in processing.

[0024] In an embodiment, wherein the external seal flushing unit includes a recycling system for the flushed fluid, reducing waste and environmental impact.

[0025] In an embodiment, wherein the cleaning fluid is introduced into the cylinder assembly through the inlet flush line positioned at an upper section of the cylinder assembly to ensure thorough coverage of the internal surfaces, particularly around the seals.

[0026] In an embodiment, wherein the cleaning fluid containing a dislodged contaminant exits the cylinder assembly through the outlet flush line positioned at the lower section of the cylinder assembly.

[0027] In an embodiment, the pumping apparatus comprising vibration damping components to minimize the transfer of vibrations from the drive end to the fluid end, ensuring the stability and reliability of high-pressure fluid processing.

[0028] In another aspect of the present invention, a method for processing biological fluids at high pressures using a pumping apparatus, comprising: driving one or more plungers in a reciprocating motion using a drive unit of the pumping apparatus to pressurize the biological fluid within a plurality of high-pressure plunger cylinders assembly located in a fluid end of the apparatus; sealing the pressurized biological fluid within the fluid end using a plurality of U- cup shaped seals placed at various locations within the fluid end, wherein each seal is formed by a single elastomeric ring and at least one seal is coupled with each plunger to prevent leakage of the biological fluid; protecting against spillage of the fluid within a sanitary area of the fluid end using a plurality of bellows, wherein one end of each bellow is fitted with the drive end of the apparatus and the other end is fitted with a corresponding plunger; utilizing an external seal flushing unit within the high-pressure plunger cylinder assembly, wherein the external seal flushing unit includes a flush line having an inlet flush line and an outlet flush line for cleaning and quenching the high-pressure bearings and seals; wherein the method facilitates the processing of biological fluids at pressures exceeding 50,000 psi, maintaining sanitary conditions suitable for pharmaceutical applications by enabling the components of the fluid end to be easily cleanable and replaceable.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS

[0029] 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:

[0030] Figs. 1A and IB illustrate perspective views of a pumping apparatus having a drive end and a fluid end in accordance with an embodiment of the present invention;

[0031] Fig. 2 illustrates a perspective view of a high-pressure plunger cylinder assembly located in the fluid end in accordance with an embodiment of the present invention;

[0032] Fig. 3 illustrates a perspective view of the fluid end separated from the drive end by a separator wall in accordance with an embodiment of the present invention;

[0033] Figs. 4A and 4B illustrate front view representations of external check valves installed at the fluid end in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0034] 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.

[0035] The present invention provides a pumping apparatus for pumping a fluid in high- pressure applications while allowing the processing of the fluid in a sanitary manner. The pumping apparatus may be a multiplex plunger pump configured to eliminate bio-burden and improve accessibility to its components for easy and convenient sealing and sanitization. Figs. 1A and IB illustrates the pumping apparatus 100 that includes a drive end 120 and a fluid end 150. The drive end 120 includes a drive unit adapted for efficient operation of the pumping apparatus 100. The fluid end 150 includes a plurality of high-pressure plunger cylinder assembly 152 configured to receive the fluid pumped by the reciprocating motion of one or more plungers 154 driven by the drive unit. Multiple cylinders may be fitted into a pump block 156 acting as a housing for the cylinders. The fluid end 150 also includes a fork 158 to ensure accurate alignment of the cylinders with the pump block 156 with precision tolerances for high- pressure applications. The fork 158 may be aligned with the drive end 120 with the help of fasteners such as bolts, pins, or dowels. Once the fork 158 is aligned with the drive end 120, the fasteners are torqued with proper bolts for accurate fitment of the fork 158 with the drive end 120.

[0036] In an illustrated embodiment of the high-pressure plunger cylinder assembly 152, as shown in Fig. 2, includes a casing/body 202 designed to facilitate high-pressure applications. The casing 202 includes a seal housing and a bearing housing in which the fluid to be processed passes through the seal housing before passing through the bearing housing. The seal housing is designed to accommodate one or more U-cup seals 204 which are adapted to eliminate bioburden in gaps between the plungers 154 and the seals. The U-cup seals 204 are capable of withstanding high pressure and are inserted into the inner diameter of the cylinder casing 202 with a U-cup seal installation tool. As a backup for the U-cup seal 204, one or more ceramic bearings 206 may be placed in the bearing housing to reach a rear face of the U-cup seal 204. The U-cup seals 204 are specially made of Ultra-high-molecular- weight polyethylene (UHMPE) which assures zero leakage during high-pressure operations. The serviceability and replacement of the U-cup seals 204 are easy and convenient.

[0037] One or more low-pressure U-cup seals 210 may be positioned in a groove of the end cap 212. The low-pressure U-cup seals 210 may be fitted by a spacer 214 in the end cap 212. The end cap 212 containing the low-pressure U-cup seal 210 and the spacer 214 is fastened to the cylinder 152 using fasteners such as bolts, screws, or pins. The plunger 154 may be inserted into the inner diameter of the cylinder 152. The plunger 154 may be made of high strength wear-resistant material like ceramic. Movement of the plunger 154 may be locked with a cylinder coupling 216. The cylinder coupling 216 may be fastened with the driveline- side coupling 160. The driveline- side coupling 160 may be placed on a driveline located in the drive end 120 of the high-pressure pumping apparatus 100 and fastened with bolts 218.

[0038] The end cap 212 is designed to guide pistons coupled with the plungers 154 in the high- pressure cylinders 152. The end cap 212 is provided with low-pressure U-cup seals 210 to prevent the fluid from leaking out of the cylinders 152. These low-pressure seals 210 may be removed or installed without removing the cylinders 152 and the pump block 156 from the drive end 120. This reduces the time required for the repair or replacement of the low-pressure seals 210 during batch processing in high-pressure applications.

[0039] In an illustrated embodiment of Fig. 1A and IB, the fluid end 150 may also include couplings 160, each adapted to couple or connect a plunger 154 to a corresponding output shaft or spindle of the drive unit. The fluid end 150 includes an external seal flushing unit and a set of cooling guides/lines for taking away any leaked fluid therefrom. In accordance with an embodiment of Figure 2, the high-pressure plunger cylinder assembly 152 is equipped with an external seal flushing unit designed to maintain the sanitary conditions of the pumping apparatus by effectively cleaning and quenching the high-pressure bearings 206 and seals 204 of the pumping apparatus 100. The external seal flushing unit includes a flushing line in 220 and a flushing line out 222 i.e., inlet flush line 220 and outlet flush line 222. The external seal flushing unit includes flushing in and flushing out mechanisms as indicated in Figure 2 to ensure efficient cleaning and flushing of the fluid end. Specifically, the flushing in mechanism introduces a cleaning fluid into the fluid end, while the flushing out mechanism ensures the removal of any residual biological fluid or cleaning fluid, maintaining the sanitary conditions of the apparatus.

[0040] In accordance with an exemplary embodiment of Figure 2, the high-pressure plunger cylinder assembly 152 with the designated flushing in and flushing out mechanism. In the flushing in mechanism, the inlet flush line 220 is positioned at an upper section of the cylinder assembly 152 to introduce cleaning fluid into the seal housing area of the cylinder assembly 152. The flushing in mechanism ensures that any contaminants or residues around the seals 204 and the surrounding surfaces are washed away.

[0041] The inlet flush line 220 directs the cleaning fluid through the internal pathways of the cylinder casing 202, targeting areas where biological fluids may accumulate and cause contamination.

[0042] In The flushing out mechanism, the outlet flush line 222 positioned at the lower section of the cylinder assembly 152 to remove the cleaning fluid from the seal housing area after it has performed the cleaning function. This mechanism ensures that the used cleaning fluid, along with any dislodged contaminants and residues, is efficiently removed from the cylinder assembly 152. The flushing out mechanism ensures the cleanliness of the internal components and prevents the buildup of contaminants.

[0043] During the operation of the pumping apparatus 100, the flushing in and flushing out mechanisms work in tandem to maintain the sanitary conditions of the high-pressure plunger cylinder assembly 152. During flushing in and out mechanism, the cleaning fluid is introduced into the cylinder assembly 152 through the inlet flush line 220. This is positioned to ensure thorough coverage of the internal surfaces, particularly around the seals 204. The cleaning fluid flows through the internal pathways of the cylinder casing 202, reaching the seal housing and bearing housing areas. The fluid dislodges any biological residues, contaminants, or debris that may have accumulated during the high-pressure processing of the biological fluids.

[0044] The used cleaning fluid, now containing the dislodged contaminants, exits the cylinder assembly 152 through the outlet flush line 222. This ensures that the internal components are left clean and free of any residues that could compromise the sanitary conditions of the apparatus. The flushing line ensures that the temperature of the pumping apparatus as the flushing line includes valve that maintain the cooling flow rate and strategically positioned to monitor the temperature of the pumping apparatus to provide cooling of the cylinder assembly (152).

[0045] A plurality of bellows 162, as shown in Fig. IB, may be located in the fluid end 150 to protect against any spillage of the fluid in a sanitary area thereof to separate red zone and green zone and to prevent oil from red zone to green zone. One end of a bellow 162 may be fitted with the drive end 120 while the other end is fitted with a corresponding plunger 154.

[0046] In accordance with an embodiment disclosed in Fig. 3, the fluid end 150 is separated from the drive end 120 by a separator wall 310 to prevent interference of the drive unit installed in the drive end 120 with the operation of the components installed in the fluid end 150. The separator wall 310 efficiently prevents the transfer of undue vibrations and movement of the drive unit to the plungers 154 of the fluid end 150. The separator wall prevents the drive unit oil or other non-sanitary grade parts, such as cast-iron parts/steel parts, rubber, belts etc., creating contamination in sanitary area (green zone as depicted in Fig. 1A). The drive unit may include one or more motors or linear actuators configured to enable the reciprocating motion of the plungers 154 to allow efficient operation of the pumping apparatus.

[0047] Figs. 4 A and 4B illustrate front view representations of the external check valves 166 installed at the fluid end 150 of the pumping apparatus 100. Inlets 402 of the external check valves 166 receive the fluid to be processed from the fluid inlet line 164. The external check valves 166 are vertically arranged with each other and include an inlet check valve 404 and a discharge check valve 406 separated by a tee valve fitting 408 having two outlets and one main connection line. The tee valve fitting 408 may have adjacent outlets used to connect pipes at any desired angles. The tee valve fittings 408 connect the outlets of the cylinders 152 with the inlet check valve 404 and the discharge check valve 406. The arrangement of the external check valves 166 may also include cross-valve fittings 410 used to connect four pipes of adjacent check valves. An outlet of the external check valves 166 conveys the processed fluid to a collection tank. The vertical arrangement of the external check valves 166 also contributes to the easy drainability of any residual matter.

[0048] Thus, the present invention relates to a pumping apparatus having improved availability and reparability in which components, such as seals installed in a fluid area thereof, are easily cleanable and replaceable. The pumping apparatus allows high-pressure applications exceeding 50,000 psi and is suitable for pharmaceutical applications which involve processing of biological fluids such as containing bacterial cells like E. coli, yeast cells from which protein extraction takes place for pharmaceutical applications.

[0049] 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.

Claims

We claim

1. A pumping apparatus (100) for processing biological fluids at high pressures, comprising: a drive end (120), including a drive unit adapted for efficient operation of the pumping apparatus (100); a fluid end (150), removably coupled to the drive end (120), comprising: a plurality of high-pressure plunger cylinder assembly (152) configured to pressurize the biological fluid by reciprocating action of one or more plungers (154) driven by the drive unit; a plurality of seals (204) placed at various locations within the fluid end (150) to prevent leakage of the biological fluid, each seal having a U-cup shape and formed by a single elastomeric ring, wherein at least one seal is coupled with each plunger (154); a plurality of bellows (162) to protect against spillage of the fluid within a sanitary area of the fluid end (150) to separate red zone and green zone and to prevent oil from red zone to green zone, wherein one end of each bellow is fitted with the drive end (120) and the other end is fitted with the corresponding plunger (154); the high pressure plunger cylinder assembly houses an external seal flushing unit, wherein the external seal flushing unit include a flush line (164) having an inlet flush line (220) and outlet flush line (222) for cleaning and quenching of high pressure bearings (206) and seals (204); wherein the pumping apparatus (100) is configured to process fluids at pressures exceeding 50,000 psi, and the components of the fluid end (150) are easily cleanable and replaceable to maintain sanitary conditions suitable for pharmaceutical applications.

2. The pumping apparatus (100) as claimed in claim 1, wherein the drive unit comprises a variable speed controller to adjust the flow rate and pressure of the biological fluid, facilitating precise control over the shearing action required for different pharmaceutical applications.

3. The pumping apparatus (100) as claimed in claim 1, wherein the high-pressure cylinder assembly (152) are equipped with temperature sensors to monitor and control the temperature of the biological fluid, ensuring that the fluid's properties remain consistent during processing.

4. The pumping apparatus (100) as claimed in claim 1, wherein the U-cup seals (204) are interchangeable with seals of different materials to accommodate a variety of biological fluids with differing chemical properties.

5. The pumping apparatus (100) as claimed in claim 1, further comprising a diagnostic system capable of monitoring the wear and tear of the seals (204) and bellows (162), providing alerts for preventative maintenance and replacement to avoid unexpected downtime.

6. The pumping apparatus (100) as claimed in claim 1, wherein the fluid end (150) includes a modular design, allowing for the quick exchange of high-pressure plunger cylinder assembly (152) to adapt the apparatus for different volumes or types of biological fluids.

7. The pumping apparatus (100) as claimed in claim 1, wherein the bellows (162) are constructed of a material that is resistant to a wide range of biological fluids, ensuring durability and longevity in various pharmaceutical processing environments.

8. The pumping apparatus (100) as claimed in claim 1, further comprising a digital interface for programming and monitoring operational parameters, such as pressure, flow rate, and seal integrity, enhancing the ease of use and precision in processing.

9. The pumping apparatus (100) as claimed in claim 1, wherein the external seal flushing unit includes a recycling system for the flushed fluid, reducing waste and environmental impact.

10. The pumping apparatus (100) as claimed in claim 1, wherein the cleaning fluid is introduced into the cylinder assembly (152) through the inlet flush line (220) positioned at an upper section of the cylinder assembly to ensure thorough coverage of the internal surfaces, particularly around the seals (204).

11. The pumping apparatus (100) as claimed in claim 10, wherein the cleaning fluid containing a dislodged contaminant exits the cylinder assembly (152) through the outlet flush line (222) positioned at the lower section of the cylinder assembly (152).

12. The pumping apparatus (100) as claimed in claim 1, further comprising vibration damping components to minimize the transfer of vibrations from the drive end (120) to the fluid end (150), ensuring the stability and reliability of high-pressure fluid processing.

13. A method for processing biological fluids at high pressures using a pumping apparatus (100), comprising: driving one or more plungers (154) in a reciprocating motion using a drive unit of the pumping apparatus (100) to pressurize the biological fluid within a plurality of high-pressure plunger cylinders assembly (152) located in a fluid end (150) of the apparatus; sealing the pressurized biological fluid within the fluid end (150) using a plurality of U- cup shaped seals (204) placed at various locations within the fluid end, wherein each seal is formed by a single elastomeric ring and at least one seal is coupled with each plunger (154) to prevent leakage of the biological fluid; protecting against spillage of the fluid within a sanitary area of the fluid end (150) using a plurality of bellows (162) to separate red zone and green zone and to prevent oil from red zone to green zone, wherein one end of each bellow is fitted with the drive end (120) of the apparatus and the other end is fitted with a corresponding plunger (154); utilizing an external seal flushing unit within the high-pressure plunger cylinder assembly (152), wherein the external seal flushing unit includes a flush line (164) having an inlet flush line (220) and an outlet flush line (222) for cleaning and quenching the high-pressure bearings (206) and seals (204); wherein the method facilitates the processing of biological fluids at pressures exceeding 50,000 psi, maintaining sanitary conditions suitable for pharmaceutical applications by enabling the components of the fluid end (150) to be easily cleanable and replaceable.