Fluid filtration system with single-use filter and integrated integrity test device and method of use thereof

Abstract

The fluid filtration system includes a disposable filter removably mounted on a cabinet within a workstation. The upstream end of the disposable filter is in fluid communication with a pump via a fluid supply conduit including a test junction. An integrity testing unit, supported by the cabinet, is in fluid communication with the disposable filter via a test conduit connected to the upstream end of the disposable filter via a test junction in the fluid supply conduit. The integrity testing unit is adapted to connect to a pressurized gas source and selectively direct a flow of pressurized gas through the test conduit and the disposable filter to perform testing operations on the disposable filter.

Description

[0001] Cross-references to related applications

[0002] This patent application claims the benefit of U.S. non-provisional patent application 17 / 937,690, filed October 3, 2022, entitled "Fluid Filtration System with Single Use Filter and Integrated Integrity Test Device and Method of Using Same", which claims priority to U.S. provisional patent application 63 / 295,830, filed December 31, 2021, entitled "Fluid Filtration System with Single Use Filter and Integrated Integrity Test Device and Method of Using Same", the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a fluid filtration system and a method of using thereof, which includes a disposable filter and an integrated integrity testing device. Background Technology

[0004] In biopharmaceutical applications, the use of single-use systems (SUS) is becoming increasingly widespread. SUS can be used in systems such as bioreactors and mixing systems. Exemplary upstream SUS applications include media preparation processes, such as mixing and filtration, including tangential flow filtration (TFF). Examples of downstream SUS applications include, for example, chromatographic concentration and dual filtration, as well as buffer preparation.

[0005] One aspect of biopharmaceutical processing involves managing the movement of liquids through a vast number of components, including tubing, valves, filters, and sensors. Compared to conventional reusable stainless steel systems, SUS (Stainless Steel) offers several advantages. Single-use technology increases process flexibility, reduces the risk of cross-contamination, reduces or even eliminates the need for cleaning, reduces the requirement for internal sterilization (e.g., autoclaving) and cleaning chemical inventories, and minimizes process downtime.

[0006] Filter integrity testing ("FIT") is frequently required in many applications to ensure filtration performance. In conventional systems, the FIT process is often performed manually and in-situ. Manual, in-situ FIT techniques can lead to misuse, inadequate testing, product loss, and wasted time.

[0007] There is a persistent need in the art for single-use applications related to fluid filtration. For example, there is a continued need for additional solutions to filter liquids aseptically under conditions that can be verified to meet a predetermined FIT (Fitness Intake).

[0008] It should be understood that this background description has been created to assist the reader and should not be considered as an indication that any problem indicated is itself understood in the art. While the principles described may mitigate problems inherent in other systems in some respects and embodiments, it should be understood that the scope of the protected innovation is defined by the appended claims, and not by the ability of any disclosed feature to solve any of the problems described herein. Summary of the Invention

[0009] In one aspect, this disclosure relates to embodiments of fluid filtration systems. In one embodiment, the fluid filtration system includes a workstation, a pump, a disposable filter, a fluid supply line, an integrity testing device, a test line, and a control unit.

[0010] The workstation includes a cabinet. The pump is supported by the cabinet and is adapted to selectively generate fluid flow. A disposable filter has upstream and downstream ends. The disposable filter is removably mounted to the workstation. The upstream end of the disposable filter is in fluid communication with the pump via a fluid supply line. The fluid supply line includes a test junction.

[0011] The integrity testing unit is supported by a cabinet and is in fluid communication with the upstream end of a disposable filter via a test conduit. The test conduit is fluidly connected to the disposable filter via a test junction of the fluid supply conduit. The integrity testing unit is adapted to connect to a pressurized gas source and selectively direct the pressurized gas flow through the test conduit and the disposable filter.

[0012] The control unit includes a processor and a non-transitory computer-readable medium carrying an integrity test program. The processor, together with the computer-readable medium, is arranged to execute the integrity test program. The processor is in electrical communication with the integrity test apparatus to selectively operate the integrity test apparatus based on instructions from the integrity test program to perform test operations on the disposable filter using a pressurized gas flow.

[0013] In another aspect, this disclosure relates to embodiments of techniques for in-situ integrity testing of single-use filters. In one embodiment, a method for in-situ integrity testing of a single-use filter includes removably mounting the single-use filter to a workstation. The workstation includes a cabinet. The upstream end of the single-use filter is fluidly connected to a pump via a fluid supply conduit and to an integrity testing apparatus via a test conduit. The pump and the integrity testing apparatus are supported by the cabinet. The integrity testing apparatus is fluidly connected to a pressurized gas source. The integrity testing apparatus is operated to direct a flow of pressurized gas through the test conduit to perform a test operation on the single-use filter.

[0014] Further and alternative aspects and features of the disclosed principles will be understood from the following detailed description and accompanying drawings. It will be understood that the fluid filtration system and method for in-situ integrity testing of disposable filters disclosed herein can be implemented in other and different embodiments and can be modified in various ways. Therefore, it should be understood that the foregoing general description and the following detailed description are merely exemplary and illustrative and do not limit the scope of the appended claims. Attached Figure Description

[0015] Figure 1 This is a perspective view of one embodiment of a filter skid constructed according to the principles of this disclosure, which includes an embodiment of a fluid filtration system constructed according to the principles of this disclosure.

[0016] Figure 2 yes Figure 1 Another perspective view of the filter skid, with its cabinet indicated by dashed lines for illustration.

[0017] Figure 3 yes Figure 1 Side front view of the filter skid.

[0018] Figure 4 yes Figure 1 A schematic front view of the three sides of the filter skid.

[0019] Figure 5 This is a schematic diagram of an embodiment of a fluid filtration system constructed according to the principles of this disclosure, illustrating a filter integrity test operation.

[0020] Figure 6 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the fluid recovery operation.

[0021] Figure 7 This is a view of an embodiment of a graphical user interface suitable for use with an integrity testing procedure, constructed in accordance with the principles of this disclosure.

[0022] Figure 8 and Figure 9 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the upstream filter filling operation.

[0023] Figure 10 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the downstream filter filling operation.

[0024] Figure 11 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the filter flushing operation.

[0025] Figure 12 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the upstream filter pressurization operation used to enhance filter membrane wetting.

[0026] It should be understood that the accompanying drawings are not necessarily drawn to scale, and the disclosed embodiments are shown in the form of illustrations and partial views. In some cases, details that are not essential for understanding this disclosure or that make other details difficult to understand may have been omitted. It should be understood that this disclosure is not limited to the specific embodiments shown herein. Detailed Implementation

[0027] Embodiments of the fluid filtration system constructed according to the principles of this disclosure are suitable for use with embodiments of the method for performing in-situ integrity testing of single-use filters according to the principles of this disclosure. In an embodiment, the fluid filtration system is incorporated into a filter skid including at least one single-use filter mounted thereon and a filter integrity testing (“FIT”) device incorporated into the skid.

[0028] Embodiments of fluid filtration systems constructed according to the principles of this disclosure can be used in biopharmaceutical environments, but also in other industrial applications involving the filtration of various fluids, solutions, reagents, and / or chemicals. For example, embodiments of fluid filtration systems constructed according to the principles of this disclosure are suitable for use in biological processing systems, where supplied fluids are separated and filtered (e.g., chromatographic / tangential flow filtration (TFF) applications) in biological processing applications. Embodiments of fluid filtration systems constructed according to the principles of this disclosure can be used to perform applications related to formulation and filling, as well as other applications related to the aseptic filtration of liquids.

[0029] Embodiments of the fluid filtration system constructed according to the principles of this disclosure are equipped with a FIT (Filter Integrity Testing) device integrated into the control unit of the filter skid to enable repeatable, reliable, fully automated filter integrity testing, seamlessly handling in-situ, pre-use, and post-use filter integrity testing. Embodiments of the fluid filtration system constructed according to the principles of this disclosure are configured to perform field tests together with the integrated FIT device according to a predetermined test protocol, without requiring additional human interaction to perform the FIT.

[0030] Embodiments of fluid filtration systems constructed according to the principles of this disclosure include a FIT device incorporated into a filter skid and configured to aid in the recovery of filtered product from an exhaust duct by directionally applying a pressurized gas flow (e.g., pressurized air or nitrogen) through the filter via the FIT device. The product recovered as fluid can be forced through the filter and into the product outlet of the exhaust duct via the operation of the FIT device, following a predetermined operating procedure.

[0031] Now turn to the attached diagram. Figure 1-4 An embodiment of a fluid filtration system 20 constructed according to the principles of this disclosure is shown, which is incorporated into a workstation in the form of a filter skid 22 constructed according to the principles of this disclosure. In the embodiment, the filter skid 22 includes at least one disposable filter 25 and an integrity testing device 30 (e.g., see...). Figure 2 The integrity testing device is selectively fluidly connected to a disposable filter 25 to perform at least one FIT.

[0032] refer to Figure 1-3 The illustrated filter skid 22 includes a cabinet 32, a pump 34, multiple pre-filters 35, a pair of disposable filters 25, a fluid supply line 37, a discharge line 38, an integrity testing device 30, a test line 40, a control unit 45, and a display device 50. Those skilled in the art will understand upon review of this disclosure that the system may have different configurations in other embodiments. For example, in embodiments, the pre-filters 35 may be omitted, and / or only one disposable filter 25 may be provided.

[0033] In an embodiment of the fluid filtration system 20 constructed according to the principles of this disclosure, the upstream end 52 of each disposable filter 25 is fluidly connected to a pump 34 via a fluid supply conduit 37 and to an integrity testing device 30 via a test conduit 40. The pump 34 and the integrity testing device 30 are supported by a cabinet 32. The integrity testing device 30 is adapted to be fluidly connected to a pressurized gas source. The integrity testing device 30 is operable to guide a pressurized gas flow through the test conduit 40 to perform a test operation on each disposable filter 25. In embodiments, the test operation includes one of a forward flow test, a water intrusion test, a bubble point test, a leak test, and a pressure decay test. In embodiments, the fluid filtration system 20 can be used with any suitable fluid, which can be stored in a suitable container (e.g., a tank) in fluid communication with the pump 34.

[0034] refer to Figure 1 The filter skid 22 includes a trolley 55. A cabinet 32 ​​is mounted on top of the trolley 55 and configured to house the hydraulic and automated equipment of the fluid filtration system 20. The trolley 55 includes a base 57 and a plurality of wheels 58 rotatably attached to the base 57. In the illustrated embodiment, the base 57 is rectangular, and a wheel 58 is rotatably attached to each corner of the base 57. In another embodiment, the base 57 may be generally square.

[0035] The cabinet 32 ​​is mounted to the base 57 of the trolley 55. In an embodiment, the cabinet 32 ​​includes storage units for automated and hydraulic equipment and is made of a suitable metal such as stainless steel. The cabinet 32 ​​defines an internal cavity that can be suitably configured to store and support components of a liquid filtration system, including an integrity testing device 30. (Reference) Figure 2 In one embodiment, the cabinet 32 ​​houses at least one pump 34, an integrity testing device 30, and a control unit 45.

[0036] Pump 34 is supported by housing 32 and is adapted to selectively generate a fluid flow. Pump 34 is configured to draw fluid from a fluid supply device (not shown) and deliver that fluid to a filter. Pump 34 is operatively coupled to control unit 45, allowing control unit 45 to selectively operate pump 34. Pump 34 is adapted to selectively generate a fluid flow to supply fluid to the filter. In embodiments, pump 34 can be any suitable pump capable of generating a liquid flow through the filter that meets the specifications of the intended application. In embodiments, pump 34 includes a variable displacement pump. In embodiments, fluid filtration system 20 includes a plurality of pumps 34 that can be used to deliver one or more types of fluid to filters 35, 25.

[0037] refer to Figure 1 and Figure 2The pre-filter 35 is fluidly connected to the pump 34 in parallel via a fluid supply line 37. (Reference) Figure 1 The disposable filter 25 is fluidly connected in parallel to the pre-filter group 35 via a fluid supply conduit 37. The parallel pre-filter group 35 is connected in series with the parallel pair of disposable filters 25.

[0038] refer to Figure 1 In the illustrated embodiment, each conduit 37, 38, 40 includes a pipe arrangement that fluidly interconnects the various components of the fluid filtration system 20. In this embodiment, the pipe arrangement includes multiple flexible conduits adapted to be selectively shut off by externally mounted pinch valves. In this embodiment, the flexible conduits can be made of any suitable material, such as silicone, thermoplastic elastomers (TPE), etc. In this embodiment, the conduits include flexible, plastic-based hoses (e.g., PVC, PP, PE). In this embodiment, the conduits include any of a range of suitable materials and components readily known to those skilled in the art, such as silicone tubing, plastic injection-molded adapters, and commercially available connectors and disconnectors (e.g., the Kleenpack® Presto sterile connector and Kleenpack® sterile disconnector from Parr Corporation, Port of Washington, NY), as well as those disclosed in U.S. Patent Application Publication US2017 / 0284584.

[0039] In one embodiment, the filter skid 22 may have several valve arrangements associated with piping. In another embodiment, each piping 37, 38, 40 may be associated with a control valve that is electrically in communication with a control unit 45, which is then configured to control the operating conditions of the valve between open and closed conditions to direct fluid flow through the valve. These valves may include any suitable valves adapted to selectively close the associated piping.

[0040] In the illustrated embodiment, the valves include pinch valves adapted to control fluid flow within the system by blocking the pipe of the pipe, thereby effectively blocking the associated pipe. The valves are secured to skid 22, and means for removably mounting pipes 37, 38, 40 to skid 22 can be provided. These valves are supported by a housing 32 such that a clamping portion of each valve extends from the outer surface of the housing 32 to be associated with a pipe, respectively. In other embodiments, different types of valves, readily familiar to those skilled in the art, such as solenoid valves, can be used. In embodiments, the valves can be operated by a suitable source, such as a pneumatic or electric source. In embodiments, the operation of the valves on the filter skid 22 can be coordinated via a control unit 45, which is appropriately programmed to operate one or more desired fluid distribution sequences.

[0041] refer to Figure 1The pre-filter 35 and the disposable filter 25 are removably mounted to the cabinet 32. In the illustrated embodiment, the filter skid 22 includes four pre-filters 35 and two disposable filters 25. In other embodiments, the filter skid 22 may include different numbers of pre-filters 35 and / or disposable filters 25, including one pre-filter 35 and / or one disposable filter 25. In some embodiments, the pre-filters 35 may be omitted.

[0042] refer to Figure 1 Each disposable filter 25 is removably mounted to workstation 22. Each disposable filter 25 has an upstream end 52 and a downstream end 54. The upstream end 52 of each disposable filter 25 is in fluid communication with pump 34 via fluid supply conduit 37 (see also...). Figure 2 Each disposable filter 25 is in fluid communication with the downstream end 54 of the discharge pipe 38.

[0043] In the illustrated embodiment, each disposable filter 25 includes a replaceable portion that is installed once in the filter skid 22 for use in a biological treatment application and then removed for further processing. After its intended use in the biological treatment application is complete, the corresponding disposable filter 25 can be detached from the filter skid 22 and replaced with another disposable filter 25 having a similar structure. In the embodiment, the filter 25 comprises any of a range of suitable materials and components, which will be readily apparent to those skilled in the art.

[0044] Various commercially available filters, filter media (e.g., fiber media, membranes, and / or composites), filter elements, filter modules, and filter sizes are suitable for use as pre-filter 35 and disposable filter 25 in embodiments of fluid filtration systems constructed according to the principles of this disclosure. Suitable filters include, for example, Pegasus Prime filters available from Parr Corporation in Port Washington, New York. Exemplary filters and filter elements include pleated filters and “LOP” filter configurations.

[0045] In embodiments, the pre-filter 35 and the single-use filter 25 comprise filters and filter elements having any suitable pore structure, such as pore size (e.g., as demonstrated by bubbling point, or by KL as described, for example, in U.S. Patent 4,340,479, or by capillary condensation flow method), pore grade, pore diameter (e.g., when characterized using, for example, the modified OSU F2 test described in U.S. Patent 4,925,572), or removal rate that reduces or allows one or more target substances to pass through as fluid flows through the element. The pore structure used depends on the composition of the fluid to be treated and the desired effluent level of the fluid being treated.

[0046] In embodiments, the pre-filter 35 and the single-use filter 25 comprise filters and filter elements having any desired critical wetting surface tension (CWST, such as that defined in, for example, U.S. Patent 4,925,572). The porous membrane may have any desired critical wetting surface tension (CWST, such as that defined in, for example, U.S. Patent 4,925,572). The CWST can be selected as is known in the art, for example, as otherwise disclosed in U.S. Patents 5,152,905, 5,443,743, 5,472,621, and 6,074,869. The surface properties of the element (e.g., influencing the CWST, including surface charge (e.g., positive or negative charge), and / or altering the polarity or hydrophilicity of the surface) can be modified by wet or dry oxidation, by coating or depositing a polymer on the surface, or by grafting reactions. Modifications include, for example, radiation, polar or charged monomers, coating and / or curing the surface with a charged polymer, and chemical modification to attach functional groups to the surface.

[0047] In embodiments, the pre-filter 35 and the disposable filter 25 may include additional elements, layers, or components that may have different structures and / or functions, such as at least one of the following: pre-filtration, support, discharge, spacing, and buffering. Illustratively, in embodiments, the pre-filter 35 and the disposable filter 25 may also include at least one additional element, such as a mesh and / or screen.

[0048] In an embodiment, the pre-filter 35 and the disposable filter 25 include multiple filter elements (typically, filters are arranged between the outer cage and the inner core to provide a filter module) disposed within a housing that includes an inlet and an outlet and defines a fluid flow path between the inlet and the outlet, wherein the filter spans the fluid flow path. Preferably, as is known in the art, the pre-filter 35 and the disposable filter 25 are sterilizable (e.g., autoclaved, irradiated with gamma rays, etc.). Any housing with a suitable shape and providing an inlet and an outlet can be used.

[0049] refer to Figure 1 The discharge conduit 38 is in fluid communication with the downstream end 54 of each disposable filter 25. The discharge conduit 38 includes a first outlet 61 and a second outlet 62, and a first outlet valve 63 and a second outlet valve 64 associated with the first outlet 61 and the second outlet 62, respectively. The first outlet 61 is adapted to be in fluid connection with a product container, and the second outlet 62 is adapted to be in fluid connection with a waste storage area.

[0050] refer to Figure 2 The integrity testing device 30 is supported by a cabinet 32 ​​and is in fluid communication with the upstream end 52 of each disposable filter 25 via a test pipe 40 (see also...). Figure 1 The integrity testing device 30 is adapted to connect to a pressurized gas source (e.g., pressurized air or nitrogen) and selectively direct the pressurized gas flow through a corresponding test conduit 40 to each disposable filter 25. The test conduit 40 may include a high-pressure manifold section located upstream of the disposable filter 25, configured to selectively deliver pressurized gas to one or both disposable filters 25. The test conduit 40 may include a stainless steel gas line from the integrity testing device 30 to the manifold section.

[0051] In this embodiment, any integrity testing apparatus 30 suitable for performing the desired integrity tests can be used. In this embodiment, a commercially available integrity testing apparatus configured to perform pre-use and post-use integrity tests can be used. In this embodiment, various integrity testing instruments are suitable for use, such as the PALLTRONIC Flowstar IV filter integrity tester, PALLTRONIC Flowstar IV filter integrity tester MUX Extension, PALLTRONIC Flowstar LGR tester, or PALLTRONIC AquaWIT IV filter integrity test system, all commercially available from PALLTRONIC Corporation, Port Washington, New York.

[0052] In this embodiment, the integrity testing device 30 is configured to perform various filter integrity tests (FITs), which are familiar to those skilled in the art, including pre-use sterilization and post-use tests. In this embodiment, the integrity testing device 30 is configured to perform FITs designed to ensure consistent filtration performance according to regulatory agencies (e.g., the FDA). In this embodiment, the integrity testing device 30 is configured to perform at least one FIT according to a regulatory protocol to ensure that the filter performance meets regulatory performance specifications. In this embodiment, the integrity testing device 30 is configured to perform each of the following tests according to at least one predetermined protocol: forward flow test, water ingress test, bubble point test, leak test, and pressure decay test.

[0053] refer to Figure 2 In this embodiment, the control unit 45 may include any suitable device configured to control the operation of at least one component of the liquid filtration system 20 during the execution of a filtration operation. In this embodiment, the control unit 45 includes a processor 71, a non-transitory computer-readable medium 72 carrying a fluid filtration program, a data storage device 73, and a display device 50. The processor 71 is arranged together with the computer-readable medium 72 to execute the fluid filtration program. The processor 71 and the display device 50 are operatively arranged to selectively display output information from the fluid filtration program and / or receive input information from a graphical user interface displayed on the display device 50.

[0054] In one embodiment, the processor 71 of the control unit 45 includes both a separate processor and a processor included in the integrity testing apparatus 30. In another embodiment, the fluid filtration process includes an integrity testing program. In yet another embodiment, the integrity testing apparatus 30 includes a non-transitory computer-readable medium carrying the integrity testing program. The processor 71, together with the computer-readable medium 72, is arranged to execute the integrity testing program. The processor 71 is in electrical communication with the integrity testing apparatus 30 to selectively operate the integrity testing apparatus 30 based on instructions from the integrity testing program to perform a test operation on each disposable filter 25 using a pressurized gas flow.

[0055] The processor 71 can be configured as a controller to selectively operate at least one component of the fluid filtration system 20, such as the pump 34 and the valve arrangement. In an embodiment, the processor 71 is in electrical communication with the pump and valve arrangement to selectively operate the valves based on instructions from the fluid filtration program.

[0056] In embodiments, the controller and processor 71 may comprise separate devices, and the controller may be operatively communicatively arranged with the processor 71. In embodiments, the controller may include a user input and / or interface device having one or more user-actuated mechanisms (e.g., one or more buttons, sliders, rotatable knobs, keyboards, and mice) adapted to generate one or more user-actuated input control signals. In embodiments, the controller may be configured to include one or more other user-activated mechanisms to provide various other control functions for the fluid filtration system, as will be understood by those skilled in the art. The controller may be associated with a display device 50 adapted to display a graphical user interface. In embodiments, the graphical user interface may be configured to function as both a user input device and a display device. In embodiments, the display device 50 may include a touchscreen device adapted to receive input signals from a user touching different portions of the display screen. In embodiments, the controller may be in the form of a smartphone, tablet computer, personal digital assistant (e.g., a wireless mobile device), laptop computer, desktop computer, or other types of device.

[0057] In embodiments, processor 71 may include any suitable computing device, such as a microprocessor, mainframe computer, digital signal processor, portable computing device, personal electronic memo pad, device controller, logic device (e.g., a programmable logic device configured to perform processing functions), digital signal processing (DSP) device, or computing engine within a home appliance. In embodiments, processor 71 may also include one or more additional input devices (e.g., a keyboard and mouse).

[0058] The processor 71 may have one or more associated storage devices for storing data and information. The one or more storage devices may include any suitable type, including volatile and non-volatile storage devices, such as RAM (Random Access Memory), ROM (Read-Only Memory), EEPROM (Electrically Erasable Programmable Read-Only Memory), flash memory, etc.

[0059] In one embodiment, the control unit 45 is in electrical communication with each pump 34 for supplying fluid to filters 35, 25 and with each valve in the valve arrangement. The control unit 45 is configured to selectively operate the pumps 34 and valves according to logic and operating parameters included in the fluid filtration procedure. In another embodiment, the control unit 45 is configured to control at least one of the pump speed and the volumetric displacement of the pump 34 to control the amount of fluid delivered to the disposable filter 25. In the illustrated embodiment, the control unit 45 is configured to independently operate each valve of the different valve arrangement.

[0060] In one embodiment, processor 71 includes a specially programmed processor that facilitates the control and operation of the fluid filtration system 20. In another embodiment, processor 71 may be configured to receive input signals from a controller, send input control signals to the controller, and / or send output information to the controller. In the illustrated embodiment, the controller and processor 71 include the same device, and the integrity testing device 30 includes its own processor that can be controlled by processor 71.

[0061] In one embodiment, processor 71 is adapted to execute a program stored on a non-transitory computer-readable medium 72 to perform various methods, processes, and modes of operation in accordance with the principles of this disclosure. In an embodiment, the non-transitory computer-readable medium 72 may include a fluid filtration program configured to implement embodiments of a method for filtering fluids according to the principles of this disclosure. In an embodiment, the fluid filtration program is configured to perform at least one fluid filtration operation. In an embodiment, the fluid filtration program is configured to perform at least one fluid recovery operation.

[0062] In one embodiment, the fluid filtration program includes a graphical user interface that can be displayed by the display device 50. The graphical user interface can be used to facilitate the user inputting commands and data into the fluid filtration program and to display the output generated by the fluid filtration program.

[0063] The fluid filtration program can be stored on any suitable computer-readable storage medium. For example, in embodiments, a fluid filtration program following the principles of this disclosure can be stored on a hard disk drive, floppy disk drive, CD-ROM drive, magnetic tape drive, zip drive, flash memory drive, optical storage device, magnetic storage device, and similar devices.

[0064] In one embodiment, processor 71 is operatively in communication with data storage device 73, which includes at least one database containing fluid filtration data. In another embodiment, the fluid filtration program can be configured to store fluid filtration data generated during system operation in data storage device 73. In yet another embodiment, the fluid filtration data can be logically associated with time data in the data storage device, such that various data can be retrieved within a given time period.

[0065] The display device 50 and the processor 71 are operatively arranged. In an embodiment, the integrity test procedure is configured to perform the following steps as part of a test operation when executed by the processor 71: determining whether each disposable filter 25 satisfies the test operation; generating a graphical display containing a graphical indication of whether the disposable filter 25 satisfies the test operation; and displaying the graphical display on the display device 50 (e.g., see...). Figure 7 ).

[0066] In one embodiment, the processor 71 is configured to display fluid filtration data received from the integrity testing device 30 and from at least one sensor electrically communicating with the control unit 71 on the display device 50. The fluid filtration data may also be stored in a data storage device 73 operatively arranged with the processor 71.

[0067] Figure 5 This is a schematic diagram of one embodiment of a fluid filtration system 20 constructed according to the principles of this disclosure, illustrating a filter integrity test operation. The illustrated arrangement includes a single-use filter 25. It should be understood that this arrangement (and...) Figure 6 and Figure 8-12 The description of those shown applies to each disposable filter 25 included in a particular embodiment of a fluid filtration system constructed in accordance with the principles of this disclosure.

[0068] The fluid supply line 37 includes a fluid supply valve 81 and a test junction 82. The test line 40 is fluidly connected to the disposable filter 25 via the test junction 82 of the fluid supply line 37.

[0069] Test line 40 includes an air filter 85, a test line valve 86, and a liquid sensor 87. The air filter 85 is configured to filter particles from the fluid passing through it. The air filter 85 is positioned between the integrity testing device 30 and the disposable filter 25, such that pressurized gas supplied from the integrity testing device 30 to the disposable filter 25 is filtered through the air filter 85. Test line 40 includes the liquid sensor 87 and the test line valve 86 to protect the air filter 85 from exposure to liquid.

[0070] Liquid sensor 87 is configured to generate a liquid detection signal in response to detecting liquid in test pipe 40. Control unit 45 is in electrical communication with liquid sensor 87 to receive the liquid detection signal from the liquid sensor. Test pipe valve 86 is arranged together with test pipe 40 to selectively close test pipe 40.

[0071] Liquid sensor 87 is disposed between integrity testing device 30 and test node 82, particularly between air filter 85 and test node 82. Test pipeline valve 86 is disposed between air filter 85 and liquid sensor 87.

[0072] The test line valve 86 is operatively arranged with the control unit 45 such that the control unit 45 can operate the test line valve 86 in response to receiving a liquid detection signal. In an embodiment, the control unit 45 is configured to stop the operation of the pump 34 and / or close the test line valve 86 in response to receiving a liquid detection signal to prevent the air filter 85 from being wetted by liquid.

[0073] In one embodiment, the fluid filtration system 20 may include means for removing trapped gas within the ductwork to enhance the accuracy and consistency of the fluid filtration process. In the illustrated embodiment, the test duct 40 also includes a ventilation junction 88 for fluid communication with a ventilation duct 90. The ventilation duct 90 is in fluid communication with the test duct 40 via the ventilation junction 88.

[0074] Ventilation duct 90 includes ventilation valve 91. Ventilation valve 91 is operatively arranged with control unit 45 such that control unit 45 can selectively operate ventilation valve 91.

[0075] In one embodiment, the integrity test procedure is configured to perform the following steps as part of a test operation when executed by the processor 71: closing the fluid supply valve 81 to block the fluid supply pipe 37; opening the test pipe valve 86 to open the test pipe 40; opening the second outlet valve 64 to allow airflow through the disposable filter 25; and operating the integrity test device 30 to guide pressurized gas flow through the test pipe 40 and through the disposable filter 25. In one embodiment, the test operation includes one of a forward flow test, a water intrusion test, a bubble point test, a leak test, and a pressure decay test. In another embodiment, the integrity test procedure is configured to perform the following steps as part of a test operation when executed by the processor: closing the vent valve 91 to block the vent pipe 90.

[0076] In one embodiment, the integrity test procedure may be configured to perform the following steps as part of a test operation when executed by the processor: closing the first outlet valve 63 to block the first outlet 61; and opening the second outlet valve 64 to open the second outlet 62. In another embodiment, the integrity test procedure may omit the execution of these steps, but they help to avoid unwanted fluid at the product outlet (which could cause unnecessary / undesirable dilution). In other embodiments, the integrity test procedure may be configured to perform the reverse steps as part of a test operation when executed by the processor, i.e., opening the first outlet valve 63 to open the first outlet 61, and closing the second outlet valve 64 to close the second outlet 62.

[0077] The discharge pipe 38 includes a pressure sensor 93. The pressure sensor 93 is configured to generate a pressure signal indicating the pressure measured in the discharge pipe 38. The control unit 45 is in electrical communication with the pressure sensor 93 to receive the pressure signal from the pressure sensor. In an embodiment, the pressure sensor 93 can be used to confirm that the discharge pipe 38 is unpressurized.

[0078] In one embodiment, the FIT device 30 includes an internal pressure sensor that can operate independently to sense pressure in the test conduit 40. In another embodiment, the integrity test procedure is configured to determine whether test conditions for the test operation are met based on pressure measured by the pressure sensor of the FIT device 30 in the upstream portion of the disposable filter 25 within the area of ​​test node 82.

[0079] In an embodiment, the fluid filtration system 20 may include means for recovering fluid from a single-use filter that would otherwise be retained in the single-use filter or not discharged during the filtration operation. Figure 6 This is a schematic diagram of the fluid filtration system 20, illustrating fluid recovery operation. After use, the fluid filtration system 20 can be operated to recover fluid from the disposable filter 25 by guiding pressurized gas through the filter 25. The fluid supply valve 81 can be closed to prevent fluid from flowing from the fluid supply line 37 to the upstream end 52 of the disposable filter 25. The fluid supply valve 81 can be closed to ensure that the pressure (air) provided by the FIT device 30 is used to recover product from the disposable filter 25 (rather than flowing / flowing through the fluid supply line 37). The integrity testing device 30 can supply pressurized gas through the disposable filter 25. The product outlet of the discharge line 38 can be opened to allow fluid driven from the disposable filter 25 to exit from the downstream end 54 of the filter 25 through the discharge line 38 from the first outlet 61. In other embodiments, a separate pressurized gas source can be provided for the fluid recovery operation.

[0080] Figure 7 This is a view of one embodiment of a graphical user interface 95 constructed according to the principles of this disclosure and suitable for use with an integrity testing procedure. In this embodiment, the integrity testing procedure is configured to determine whether a single-use filter 25 satisfies a test operation, generate a graphical display containing a graphical indication of whether the single-use filter 25 satisfies the test operation, and display this graphical display on a display device 50. The graphical user interface 95 is an example of such a graphical display.

[0081] In other embodiments, the fluid filtration system may include different and additional devices configured to maintain a supply of fluid for delivery to a single-use filter. For example, in other embodiments, a fluid filtration system constructed according to the principles of this disclosure may include at least one tower configured to hold one or more tanks filled with fluid for use with the fluid filtration system. In other embodiments, a fluid filtration system constructed according to the principles of this disclosure may include at least one tank filled with fluid used in the system.

[0082] In other embodiments of the fluid filtration system constructed according to the principles of this disclosure, the fluid filtration system may be constructed in alternative forms. For example, in other embodiments, the fluid filtration system may be scaled up for larger volumes or reduced in size for laboratory use. In embodiments, the fluid filtration system constructed according to the principles of this disclosure can be used to process a variety of liquids to meet the requirements of a desired application.

[0083] In embodiments of the method of using a fluid filtration system in accordance with the principles of this disclosure, any suitable embodiment of the fluid filtration system based on the principles discussed herein may be used. In embodiments, the method of using a fluid filtration system in accordance with the principles of this disclosure includes using a filter skid having a FIT device integrated into the fluid filtration system in accordance with the principles of this disclosure. In specific implementations, the method of using a fluid filtration system in accordance with the principles of this disclosure includes performing an in-situ integrity test on a single-use filter.

[0084] In one embodiment, a method for performing in-situ integrity testing on a single-use filter includes removably mounting the single-use filter to a workstation. The workstation includes a cabinet. The upstream end of the single-use filter is fluidly connected to a pump via a fluid supply line and to an integrity testing device via a test line. The pump and the integrity testing device are supported by the cabinet. The integrity testing device is fluidly connected to a source of pressurized gas (e.g., pressurized air or nitrogen). The integrity testing device is operated to guide a flow of pressurized gas through the test line to perform a test operation on the single-use filter. In an embodiment, the test operation includes one of a forward flow test, a water intrusion test, a bubble point test, a leak test, and a pressure decay test. In an embodiment, operating the integrity testing device to perform the test operation includes determining whether test conditions for the test operation are met based on pressure measured within the discharge line. In an embodiment, the FIT device 30 is configured to determine whether the test passes or fails based on a selected test method (forward flow, bubble point, pressure decay, etc.) and associated test parameters (e.g., pressure, flow rate, etc.).

[0085] In one embodiment, the integrity testing apparatus performs a test operation by using a processor to execute an integrity test program stored on a non-transitory computer-readable medium. In this embodiment, the processor executes the integrity test program to determine whether a single-use filter satisfies the test operation. A graphical display containing a graphical indication of whether the single-use filter satisfies the test operation is generated. The graphical display is displayed on a display device.

[0086] In one embodiment, the fluid supply conduit includes a fluid supply valve and a test junction. The test conduit includes a test conduit valve and is fluidly connected to a disposable filter via the test junction of the fluid supply conduit. In another embodiment, the method further includes closing the fluid supply valve to block the fluid supply conduit during a test operation. The test conduit valve is then opened to open the test conduit during the test operation.

[0087] In one embodiment, the test conduit includes a ventilation junction. In another embodiment, the method further includes closing a ventilation valve to block the ventilation conduit during a test operation. The ventilation conduit is in fluid communication with the test conduit via the ventilation junction. In yet another embodiment, the method further includes opening the ventilation valve to open the ventilation conduit after the test operation is completed, thereby allowing pressurized gas upstream of the disposable filter to escape from the test conduit and enter the ventilation conduit.

[0088] In one embodiment, the discharge conduit is in fluid communication with the downstream end of a disposable filter. The discharge conduit includes first and second outlets and first and second outlet valves associated with the first and second outlets, respectively. In another embodiment, the method further includes closing the first outlet valve to block the first outlet, which is in fluid communication with a product container. The second outlet valve is then opened to open the second outlet. The second outlet is in fluid communication with a waste storage area.

[0089] In one embodiment, the method further includes measuring the pressure within the discharge conduit. In another embodiment, operating the FIT device does not include measuring the pressure within the discharge conduit 38 (downstream of the disposable filter 25). The discharge conduit 38 is understood to be unpressurized because the waste outlet 62 is unpressurized.

[0090] In one embodiment, the FIT device 30 has an internal flow sensor and internal pressure, which can be operated to determine the pressure in the region of test node 82 upstream of test pipe 40 and disposable filter 25. In another embodiment, the method includes measuring the pressure within the test pipe upstream of the disposable filter. In yet another embodiment, the operational integrity testing device, in order to perform a test operation, includes determining whether test conditions for the test operation are met based on the pressure measured within the test pipe.

[0091] In one embodiment, the discharge conduit 38 is in fluid communication with the downstream end of the disposable filter 25. The discharge conduit 38 includes a first outlet and a second outlet, and a first outlet valve and a second outlet valve associated with the first outlet and the second outlet, respectively. In another embodiment, the method further includes closing the first outlet valve to block the first outlet. The first outlet is in fluid connection to a product container for receiving filtered fluid for final use. The second outlet valve is opened to open the second outlet. The second outlet is in fluid connection to a waste storage area. In other embodiments, the method further includes opening the first outlet valve to open the first outlet. The first outlet is in fluid connection to the product container. The second outlet valve is closed to block the second outlet. The second outlet is in fluid connection to a waste storage area.

[0092] refer to Figure 8-12 This shows a series of filter adjustment sequences. Figure 8 and Figure 9 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the upstream filter prime operation.

[0093] refer to Figure 8 The upstream end 52 of the disposable filter 25 is in fluid communication with the pump 34 via a fluid supply conduit 37. The ventilation duct 90 is in fluid communication with the junction 82 of the fluid supply conduit 37, such that the upstream end 52 of the disposable filter 25 is in fluid communication with the ventilation duct 90 via the junction 82 and a common branch 97 extending between the junction 82 and the upstream end 52 of the disposable filter 25. The ventilation duct 90 includes an outlet 98, a liquid sensor 87, and a ventilation valve 91. The liquid sensor 87 is disposed between the junction 82 and the outlet 98. The ventilation valve 91 is disposed between the liquid sensor 87 and the outlet 98. The liquid sensor 87 is configured to generate a liquid detection signal in response to the detection of liquid in the ventilation duct 90.

[0094] Control unit 45 is electrically connected to liquid sensor 87 to receive liquid detection signals from the liquid sensor. In an embodiment, control unit 45 is programmed to have a filter conditioning program that includes a filter filling module. Processor 71 is electrically connected to pump 34, fluid supply valve 81, vent valve 91, and liquid sensor 87 to perform filling operations on disposable filter 25 based on instructions from the filter filling module.

[0095] In an embodiment, the filter filling module is configured to perform the following steps when executed by the processor 71: opening the fluid supply valve 81 to open the fluid supply conduit 37; opening the vent valve 91 to open the vent 90; closing the first outlet valve 63 to block the first outlet 61 of the discharge conduit 38; opening the second outlet valve 64 to open the second outlet 62 of the discharge conduit 38; operating the pump 34 to deliver a fluid flow to the upstream end 52 of the disposable filter 25, causing air in the fluid supply conduit 37 to be displaced into the vent 90; and stopping the operation of the pump 34 and / or closing the vent valve 91 in response to receiving a liquid detection signal.

[0096] refer to Figure 9 The liquid has risen above node 82 and extends toward liquid sensor 87, indicating that the air upstream of disposable filter 25 has been removed through ventilation duct 90.

[0097] Figure 10 yes Figure 5 The schematic diagram of the fluid filtration system shown illustrates the downstream filter filling operation. In response to the presence of liquid detected by the liquid sensor 87, the control unit 45 has closed the vent valve 91.

[0098] In an embodiment, the filter filling module is configured to perform a downstream filter filling operation including the following steps when executed by the processor 71: closing vent valves 86, 91; opening fluid supply valve 81 to open fluid supply conduit 37; closing first outlet valve 63 to block first outlet 61 of discharge conduit 38; opening second outlet valve 64 to open second outlet 62 of discharge conduit 38; operating pump 34 to deliver fluid flow through disposable filter 25 to upstream end 52 of disposable filter 25 and out from second outlet 62 of discharge conduit 38; and stopping operation of pump 34 after a predetermined amount of time or in response to pressure in discharge conduit 38 reaching a predetermined value based on pressure signal from pressure sensor 93.

[0099] Figure 11 yes Figure 5 The schematic diagram of the fluid filtration system illustrates the filter flushing operation. In this embodiment, the control unit 45 is programmed to have a filter conditioning program that includes a filter flushing module.

[0100] In this embodiment, the filter flushing module is configured to perform the following steps as part of a flushing operation when executed by the processor 71: Vent valve 91 is closed in response to receiving a liquid detection signal from liquid sensor 87. First outlet valve 63 is closed to block the first outlet 61 of discharge conduit 38. Second outlet valve 64 is partially opened to partially open the second outlet 62 of discharge conduit 38. Fluid supply valve 81 is opened to open fluid supply conduit 37. Pump 34 is operated to deliver a fluid flow to disposable filter 25, such that the fluid flow passes through disposable filter 25 and discharge conduit 38 and exits from the second outlet 62, thereby creating back pressure in discharge conduit 38. Pressure sensor 93 may be used as a feedback loop for control unit 45 to monitor the generation of a defined back pressure in discharge conduit 38, thereby improving the wetting of the filter membrane.

[0101] In one embodiment, the filter flushing module is configured to sequentially open and close the second outlet valve 64 to sequentially open and close the second outlet 62, thereby generating a pulse effect in the discharge duct 38. This pulse effect can be modulated to help improve the wetting of the filter membrane.

[0102] Figure 12 yes Figure 5 The schematic diagram of the fluid filtration system illustrates the upstream filter pressurization operation. In an embodiment, test conduit 40 includes a pressurized air supply conduit for supplying pressurized air to the upstream end 52 of the disposable filter 25 to pressurize the upstream of the disposable filter 25.

[0103] The upstream end 52 of the disposable filter is in fluid communication with a pressurized air supply duct 40. The pressurized air supply duct 40 is adapted to connect to a pressurized air source and selectively direct pressurized air flow through the pressurized air supply duct to the upstream end 52 of the disposable filter 25.

[0104] In the illustrated embodiment, the pressurized air supply conduit 40 includes an integrity testing device 30 adapted to connect to a pressurized air source and selectively direct pressurized air flow through the pressurized air supply conduit 40 to an upstream end 52 of the disposable filter 25. The processor 71 is in electrical communication with the integrity testing device 30 to selectively operate it. In other embodiments, the integrity testing device 30 may be omitted, and the pressurized air supply conduit 40 may be in fluid communication with another device delivering pressurized air (e.g., a pressure tank and / or compressor).

[0105] The fluid supply conduit 37 includes a first node at its junction 82, and the pressurized air supply conduit 40 includes a second node (ventilation node 88). The ventilation conduit 90 is in fluid communication with the second node 88, such that the upstream end 52 of the disposable filter 25 is in fluid communication with the ventilation conduit 40 via the first node 82 and the second node 88, and such that a common branch 99 extends between the second node 88 and the upstream end 52 of the disposable filter 25.

[0106] The pressurized air supply duct 40 includes an air supply valve 86 and an air filter 85. A liquid sensor 87, air supply valve 86, and air filter 85 are disposed in a common branch 99. The liquid sensor is disposed between the first node 82 and the air supply valve 86. The air supply valve 86 is disposed between the liquid sensor 87 and the air filter 85.

[0107] In one embodiment, the filter conditioning procedure includes a filter pressurization module configured to perform the following steps as part of a pressurization operation when executed by the processor 71: Closing the fluid supply valve 81 to block the fluid supply conduit 37; closing the vent valve 91 to block the vent conduit 90; closing the first and second outlet valves 63, 64 to block the first and second outlets 61, 62 of the discharge conduit 38, respectively; and directing pressurized airflow through the pressurized air supply conduit 40 to the upstream end 52 of the disposable filter 25. In another embodiment, the filter pressurization module may be configured to, when executed by the processor 71, sequentially open and close the air supply valve 86 to sequentially open and close the pressurized air supply conduit 40, thereby creating a pulse effect in the pressurized air supply conduit 40.

[0108] All references cited in this article, including publications, patent applications and patents, are incorporated herein by reference as if each reference were individually and specifically indicated as incorporated herein by reference and described in its entirety.

[0109] In the context of describing the invention (particularly in the context of the appended claims), the terms “a,” “the,” and “the,” and similar designations, should be interpreted as encompassing both singular and plural aspects, unless otherwise stated herein or obviously contradicted by the context. Unless otherwise stated, the terms “comprising,” “having,” “including,” and “with” should be interpreted as open-ended terms (i.e., meaning “including but not limited to”). Unless otherwise indicated herein, the enumeration of numerical ranges herein is intended only as a way of abbreviating each individual value falling within that range, and each individual value is incorporated into the specification as if it were separately described herein. Unless otherwise indicated herein or obviously contradicted by the context, all methods described herein may be performed in any suitable order. Unless otherwise required, the use of any and all examples or exemplary language (e.g., “such as”) provided herein is intended only to better illustrate the invention and does not constitute a limitation on the scope of the invention. No language in the specification should be construed as indicating that any unclaimed element is essential for carrying out the invention.

[0110] This document describes preferred embodiments of the invention, including the best modes known to the inventors for carrying out the invention. Variations of those preferred embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors expect those skilled in the art to appropriately employ such variations, and the inventors wish to practice the invention in ways other than those specifically described herein. Therefore, the invention includes all modifications and equivalents of the subject matter set forth in the appended claims as permitted by applicable law. Moreover, unless otherwise indicated herein or clearly contradicted by the context, the invention covers any combination of the foregoing elements in all possible variations.

Claims

1. A fluid filtration system comprising: The workstation includes a cabinet; A pump, which is supported by a cabinet and is adapted to selectively generate a fluid flow; A disposable filter and a fluid supply line, the disposable filter having an upstream end and a downstream end, the disposable filter being removably mounted to a workstation, the upstream end of the disposable filter being in fluid communication with a pump via the fluid supply line, the fluid supply line including a test node; Integrity testing device and test pipeline, wherein the integrity testing device is supported by a cabinet and is in fluid communication with the upstream end of a disposable filter via a test pipeline, the test pipeline being in fluid connection with the disposable filter via a test node of a fluid supply pipeline, and the integrity testing device being adapted to be connected to a pressurized gas source and selectively guide pressurized gas flow through the test pipeline and the disposable filter; The control unit includes a processor and a non-transitory computer-readable medium carrying an integrity test program. The processor, together with the computer-readable medium, is arranged to execute the integrity test program. The processor is in electrical communication with an integrity test apparatus to selectively operate the integrity test apparatus based on instructions from the integrity test program to test a single-use filter using a pressurized gas flow.

2. The fluid filtration system of claim 1, wherein the fluid supply conduit includes a fluid supply valve, the test conduit includes a test conduit valve, and the integrity test procedure is configured to perform the following steps as part of a test operation when executed by a processor: Close the fluid supply valve to block the fluid supply line. Open the test pipeline valve to open the test pipeline. The operational integrity test apparatus directs a pressurized gas flow through a test pipeline and through a single-use filter.

3. The fluid filtration system according to claim 1 or 2, wherein the test conduit includes an air filter disposed between the integrity testing device and the disposable filter.

4. The fluid filtration system according to any one of claims 1 to 2, wherein the test pipeline includes a liquid sensor disposed between the integrity testing device and the test node.

5. The fluid filtration system according to claim 1, wherein the test pipeline includes an air filter disposed between the integrity testing device and the disposable filter, a liquid sensor disposed between the air filter and the test node, and a test pipeline valve disposed between the air filter and the liquid sensor.

6. The fluid filtration system according to any one of claims 1 to 2, wherein the test conduit includes a ventilation junction, and the fluid filtration system further comprises: A ventilation duct, which is in fluid communication with a test duct via a ventilation node, includes a ventilation valve; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the ventilation valve to block the ventilation duct.

7. The fluid filtration system according to any one of claims 1 to 2, further comprising: The discharge pipe is in fluid communication with the downstream end of a disposable filter. The discharge pipe includes a first outlet and a second outlet, as well as a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet. The first outlet is adapted to be in fluid connection with a product container, and the second outlet is adapted to be in fluid connection with a waste storage area. The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the first outlet valve to block the first outlet. Open the second outlet valve to open the second outlet.

8. The fluid filtration system of claim 7, wherein the discharge conduit includes a pressure sensor configured to measure pressure within the discharge conduit, the pressure sensor being configured to generate a pressure signal indicating the measured pressure within the discharge conduit, and the processor being in electrical communication with the pressure sensor to receive the pressure signal from the pressure sensor.

9. The fluid filtration system of claim 8, wherein the integrity testing device includes a FIT pressure sensor configured to generate a pressure signal indicating a pressure measured in a test pipe upstream of the disposable filter, the processor electrically communicating with the FIT pressure sensor to receive the pressure signal from the FIT pressure sensor, and wherein the integrity testing procedure is configured to perform the following steps as part of a test operation when executed by the processor: Receive pressure signal from FIT pressure sensor, The test conditions for the test operation are determined based on the pressure signal.

10. The fluid filtration system according to any one of claims 1 to 2, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

11. The fluid filtration system of claim 3, wherein the test conduit includes a liquid sensor disposed between the integrity testing device and the test node.

12. The fluid filtration system of claim 3, wherein the test conduit includes a ventilation junction, and the fluid filtration system further includes: A ventilation duct, which is in fluid communication with a test duct via a ventilation node, includes a ventilation valve; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the ventilation valve to block the ventilation duct.

13. The fluid filtration system of claim 4, wherein the test conduit includes a ventilation junction, and the fluid filtration system further includes: A ventilation duct, which is in fluid communication with a test duct via a ventilation node, includes a ventilation valve; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the ventilation valve to block the ventilation duct.

14. The fluid filtration system of claim 5, wherein the test conduit includes a ventilation junction, and the fluid filtration system further includes: A ventilation duct, which is in fluid communication with a test duct via a ventilation node, includes a ventilation valve; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the ventilation valve to block the ventilation duct.

15. The fluid filtration system according to claim 3, further comprising: The discharge pipe is in fluid communication with the downstream end of a disposable filter. The discharge pipe includes a first outlet and a second outlet, as well as a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet. The first outlet is adapted to be in fluid connection with a product container, and the second outlet is adapted to be in fluid connection with a waste storage area. The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the first outlet valve to block the first outlet. Open the second outlet valve to open the second outlet.

16. The fluid filtration system of claim 4, further comprising: The discharge pipe is in fluid communication with the downstream end of a disposable filter. The discharge pipe includes a first outlet and a second outlet, as well as a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet. The first outlet is adapted to be in fluid connection with a product container, and the second outlet is adapted to be in fluid connection with a waste storage area. The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the first outlet valve to block the first outlet. Open the second outlet valve to open the second outlet.

17. The fluid filtration system according to claim 5, further comprising: The discharge pipe is in fluid communication with the downstream end of a disposable filter. The discharge pipe includes a first outlet and a second outlet, as well as a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet. The first outlet is adapted to be in fluid connection with a product container, and the second outlet is adapted to be in fluid connection with a waste storage area. The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the first outlet valve to block the first outlet. Open the second outlet valve to open the second outlet.

18. The fluid filtration system of claim 6, further comprising: The discharge pipe is in fluid communication with the downstream end of a disposable filter. The discharge pipe includes a first outlet and a second outlet, as well as a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet. The first outlet is adapted to be in fluid connection with a product container, and the second outlet is adapted to be in fluid connection with a waste storage area. The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Close the first outlet valve to block the first outlet. Open the second outlet valve to open the second outlet.

19. The fluid filtration system according to claim 3, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

20. The fluid filtration system according to claim 4, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

21. The fluid filtration system according to claim 5, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

22. The fluid filtration system according to claim 6, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

23. The fluid filtration system according to claim 7, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

24. The fluid filtration system of claim 8, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

25. The fluid filtration system according to claim 9, further comprising: A display device, wherein the display device is operatively arranged with a processor; The integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

26. A method for in-situ integrity testing of a disposable filter in a fluid filtration system according to any one of claims 1 to 25, the method comprising: A disposable filter is removably installed into a workstation, which includes a cabinet; The upstream end of the disposable filter is fluidly connected to the pump via a fluid supply pipe and to the integrity testing device via a test pipe. The pump and the integrity testing device are supported by a cabinet. Connect the integrity testing device to a pressurized gas source fluid; The operational integrity test apparatus guides a pressurized gas flow through a test pipeline to test a single-use filter.

27. The method of claim 26, wherein the operation integrity testing apparatus for performing test operations comprises using a processor to execute an integrity test program stored on a non-transitory computer-readable medium.

28. The method of claim 27, further comprising: Using the processor to: Determine if the single-use filter meets the test procedure. Generate a graphical display that includes a graphical indication of whether the one-time use filter satisfies the test operation. Display the graphic on the display device.

29. The method according to any one of claims 26 to 28, wherein the test operation includes one of a forward flow test, a water intrusion test, a bubble point test, a leak test, and a pressure decay test.

30. The method according to any one of claims 26 to 28, wherein the fluid supply conduit includes a fluid supply valve and a test junction, the test conduit includes a test conduit valve, and the test conduit is fluidly connected to a disposable filter via the test junction of the fluid supply conduit, the method further comprising: During the test operation, the fluid supply valve was closed to shut off the fluid supply line; Open the test pipeline valve to open the test pipeline during the test operation.

31. The method according to any one of claims 26 to 28, wherein the test conduit includes a ventilation joint, the method further comprising: During the test operation, the ventilation valve is closed to block the ventilation duct, which is in fluid communication with the test duct via a ventilation node.

32. The method of claim 31, further comprising: After the test is completed, open the ventilation valve to open the ventilation duct, allowing the pressurized gas upstream of the disposable filter to be discharged from the test duct and enter the ventilation duct.

33. The method according to any one of claims 26 to 28, further comprising: Measure the pressure in the test pipe upstream of the disposable filter; The operational integrity testing apparatus performs test operations, including determining whether test conditions for the test operation are met based on pressure measurements within the test pipeline.

34. The method of claim 33, wherein the discharge conduit is in fluid communication with the downstream end of the disposable filter, the discharge conduit including a first outlet and a second outlet and a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet, the method further comprising: The first outlet valve is closed to shut off the first outlet, which is in fluid connection with the product container. Open the second outlet valve to open the second outlet, which is fluidly connected to the waste storage area.

35. The method of claim 33, wherein the discharge conduit is in fluid communication with the downstream end of the disposable filter, the discharge conduit including a first outlet and a second outlet and a first outlet valve and a second outlet valve respectively associated with the first outlet and the second outlet, the method further comprising: Open the first outlet valve to open the first outlet, which is fluidly connected to the product container; The second outlet valve is closed to shut off the second outlet, which is fluidly connected to the waste storage area.

36. The method of claim 29, wherein the fluid supply conduit includes a fluid supply valve and a test junction, the test conduit includes a test conduit valve, and the test conduit is fluidly connected to a disposable filter via the test junction of the fluid supply conduit, the method further comprising: During the test operation, the fluid supply valve was closed to shut off the fluid supply line; Open the test pipeline valve to open the test pipeline during the test operation.

37. The method of claim 29, wherein the test conduit includes a ventilation joint, the method further comprising: During the test operation, the ventilation valve is closed to block the ventilation duct, which is in fluid communication with the test duct via a ventilation node.

38. The method of claim 30, wherein the test conduit includes a ventilation joint, the method further comprising: During the test operation, the ventilation valve is closed to block the ventilation duct, which is in fluid communication with the test duct via a ventilation node.

39. The method of claim 29, further comprising: Measure the pressure in the test pipe upstream of the disposable filter; The operational integrity testing apparatus performs test operations, including determining whether test conditions for the test operation are met based on pressure measurements within the test pipeline.

40. The method of claim 30, further comprising: Measure the pressure in the test pipe upstream of the disposable filter; The operational integrity testing apparatus performs test operations, including determining whether test conditions for the test operation are met based on pressure measurements within the test pipeline.

41. The method of claim 31, further comprising: Measure the pressure in the test pipe upstream of the disposable filter; The operational integrity testing apparatus performs test operations, including determining whether test conditions for the test operation are met based on pressure measurements within the test pipeline.

42. The method of claim 32, further comprising: Measure the pressure in the test pipe upstream of the disposable filter; The operational integrity testing apparatus performs test operations, including determining whether test conditions for the test operation are met based on pressure measurements within the test pipeline.

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