Fluid filtration system with single use filter and integrated integrity test device and method of using same

Abstract

The fluid filtration system includes a disposable filter removablely mounted in a cabinet of the workstation. The upstream end of the disposable filter is fluidly connected to a pump through a fluid supply conduit containing a test joint. An integrity testing device is supported by the cabinet and is fluidly connected to the upstream end of the disposable filter through a test conduit fluidly connected to the disposable filter through the test joint of the fluid supply conduit. The integrity testing device is connected to a source of pressurized gas and is adapted to perform a test operation on the disposable filter by selectively inducing the flow of pressurized gas through the test conduit and the disposable filter.

Description

Technology Field

[0001] Cross-reference regarding related applications

[0002] This patent application claims priority to U.S. Non-Provisional Patent Application No. 17 / 937,690, filed on October 3, 2022, with the invention titled "Fluid Filtration System with Single Use Filter and Integrated Integrity Test Device and Method of Using Same," and U.S. Non-Provisional Patent Application No. 63 / 295,830, filed on December 31, 2021, with the invention titled "Fluid Filtration System with Single Use Filter and Integrated Integrity Test Device and Method of Using Same," the full text of which is incorporated herein by reference. Background Technology

[0003] The use of single-use systems (SUS) is becoming increasingly widespread in biopharmaceutical applications. 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, for example, tangential flow filtration (TFF). Examples of downstream SUS applications include, for example, chromatographic concentration, diafiltration, and buffer preparation.

[0004] One aspect of biopharmaceutical processing involves managing the movement of liquids through numerous elements, including tubes, valves, filters, and sensors. The adoption of SUS can provide several advantages over conventional reusable stainless steel systems. Disposable technology can increase process flexibility and reduce the risk of cross-contamination; reduce or even eliminate the need for cleaning; reduce the requirements for in-house sterilization of products, such as autoclaving and chemical inventory cleaning; and lower process downtime.

[0005] Filter integrity testing ("FIT") is frequently required in many applications to ensure filtration performance. In conventional systems, the FIT process is frequently performed manually and ex-situ. Manual ex-situ FIT techniques can lead to misuse, insufficient testing, product loss, and wasted time.

[0006] There is a continuing need in the industry for single-use applications related to fluid filtration. For example, there is a continuing need in the industry to provide additional solutions for sterile fluid filtration under conditions that can be proven to meet a predetermined FIT.

[0007] This description of the background art is written to assist the reader, and it should be understood that any of the problems described should not be construed as an indication that they have been recognized in the art. While the principles described may mitigate problems inherent in other systems in some aspects 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 specific problem mentioned herein.

[0008] In one aspect, the present disclosure relates to an embodiment of a fluid filtration system. In one embodiment, the fluid filtration system comprises a workstation, a pump, a disposable filter, a fluid supply conduit, an integrity test device, a test conduit, and a control unit.

[0009] The workstation includes a cabinet. The pump is supported by the cabinet and is adapted to selectively generate fluid flow. The disposable filter has an upstream end and a downstream end. The disposable filter is removablely mounted on the workstation. The upstream end of the disposable filter is fluidly connected to the pump through a fluid supply conduit. The fluid supply conduit includes a test junction.

[0010] The integrity testing device is supported by a cabinet and fluidly communicates with the upstream end of a disposable filter through a test conduit. The test conduit is fluidly connected to the disposable filter through a test joint of the fluid supply conduit. The integrity testing device is connected to a source of pressurized gas and is configured to selectively direct the flow of pressurized gas through the test conduit and the disposable filter.

[0011] The control unit includes a non-transitory computer-readable medium having an integrity test program and a processor. The processor is arranged with the computer-readable medium to execute the integrity test program. The processor communicates with the integrity test device to selectively operate the integrity test device to perform a test operation on a disposable filter using a flow of pressurized gas based on instructions from the integrity test program.

[0012] In another aspect, the present disclosure relates to an embodiment of a technique for in-situ integrity testing of a disposable filter. In one embodiment, a method for performing in-situ integrity testing of a disposable filter includes the step of removingly mounting the disposable filter in a workstation. The workstation includes a cabinet. The upstream end of the disposable filter is fluidly connected to a pump via a fluid supply conduit and to an integrity testing device via a test conduit. 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. The integrity testing device is operated to perform a test operation on the disposable filter by inducing a flow of pressurized gas through the test conduit.

[0013] Additional and alternative aspects and features of the disclosed principles will be known from the following detailed description and the attached drawings. As will be known, the fluid filtration system and method for performing field integrity testing of a disposable filter disclosed herein may be performed in other and different embodiments and may be modified in various aspects. Accordingly, it should be understood that both the above general description and the following detailed description are merely illustrative and for illustrative purposes and do not limit the scope of the appended claims. Brief explanation of the drawing

[0014] FIG. 1 is a perspective view of one embodiment of a filtration skid constructed according to the principles of the present disclosure, including one embodiment of a fluid filtration system constructed according to the principles of the present disclosure. FIG. 2 is another perspective view of the filter skid of FIG. 1, and its cabinet is illustrated with dashed lines for illustrative purposes. Figure 3 is a side elevational view of the filtration skid of Figure 1. Figure 4 is a schematic elevation view of three sides of the filtration skid of Figure 1. FIG. 5 is a schematic diagram of one embodiment of a fluid filtration system configured according to the principles of the present disclosure and illustrates a filter integrity test operation. Figure 6 is a schematic diagram of a fluid filtration system as in Figure 5, illustrating a fluid recovery operation. FIG. 7 is a view of one embodiment of a graphical user interface suitable for use with an integrity test program configured according to the principles of the present disclosure. Figures 8 and 9 are schematic diagrams of a fluid filtration system as in Figure 5 and illustrate an upstream filter priming operation. Figure 10 is a schematic diagram of a fluid filtration system as in Figure 5, illustrating a downstream filter priming operation. Figure 11 is a schematic diagram of a fluid filtration system as in Figure 5 and illustrates a filter flushing operation. FIG. 12 is a schematic diagram of a fluid filtration system as in FIG. 5 and illustrates an upstream filter pressurization operation for enhanced filter membrane wetting. It should be understood that the drawings are not necessarily to scale and that the disclosed embodiments are illustrated schematically and in partial views. In certain cases, details that are not necessary for understanding the disclosure or that make it difficult to perceive other details may be omitted. It should be understood that the disclosure is not limited to the specific embodiments illustrated herein. Specific details for implementing the invention

[0015] An embodiment of a fluid filtration system constructed according to the principles of the present disclosure is adapted for use with an embodiment of a method for performing a field integrity test of a disposable filter according to the principles of the present disclosure. In the embodiment, the fluid filtration system is integrated into a filtration skid, said filtration skid comprising at least one disposable filter mounted thereon and a filter integrity test ("FIT") device integrated into said filtration skid.

[0016] Embodiments of a fluid filtration system constructed according to the principles of the present disclosure may be used in biopharmaceutical environments, but may also be used in other industrial applications where different fluids, solutions, reagents, and / or chemicals are filtered. For example, embodiments of a fluid filtration system constructed according to the principles of the present disclosure are adapted for use in bioprocessing systems where a fluid feed is separated and filtered in bioprocessing applications (e.g., chromatography / tangential flow filtration (TFF) applications). Embodiments of a fluid filtration system constructed according to the principles of the present disclosure may be used to perform applications related to formulation, filling, and other applications related to filtering liquids in a sterile manner.

[0017] An embodiment of a fluid filtration system configured according to the principles of the present disclosure is configured to have a FIT device integrated into the control unit of a filtration skid, enabling repeatable and reliable fully automated filter integrity testing through seamless processing of field, pre-use, and post-use integrity tests. An embodiment of a fluid filtration system configured according to the principles of the present disclosure is configured to perform real-time testing executed by the integrated FIT device according to a predetermined test protocol without additional manual interaction required to perform FIT.

[0018] An embodiment of a fluid filtration system constructed according to the principles of the present disclosure comprises a FIT device integrated into a filtration skid and configured to assist in recovering a filtered product from a discharge conduit, for example, through the induced application of a flow of pressurized gas, such as pressurized air or nitrogen, through a filter by a FIT device. The product recovered as a fluid can be pressed into a product outlet of a discharge conduit through a filter via the operation of the FIT device through an established work routine.

[0019] Now, looking at the drawings, FIGS. 1 through 4 illustrate an embodiment of a fluid filtration system (20) configured according to the principles of the present disclosure, which is integrated into a workstation in the form of a filtration skid (22) configured according to the principles of the present disclosure. In the embodiment, the filtration skid (22) includes an integrity testing device (30) (e.g., see FIG. 2) that is optionally fluidly connected to a disposable filter (25) to perform at least one FIT, and at least one disposable filter (25).

[0020] Referring to FIGS. 1 through 3, the illustrated filtration skid (22) comprises a cabinet (32), a pump (34), a plurality of pre-filters (35), a pair of disposable filters (25), a fluid supply conduit (37), a discharge conduit (38), an integrity test device (30), a test conduit (40), a control unit (45), and a display device (50). A person skilled in the art will understand, after reviewing the present disclosure, that in other embodiments, the system may have different configurations. For example, in an embodiment, the pre-filters (35) may be omitted, and / or only one disposable filter (25) may be provided.

[0021] In an embodiment of a fluid filtration system (20) configured according to the principles of the present 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 source of pressurized gas. The integrity testing device (30) is operable to perform a test operation on each disposable filter (25) by inducing a flow of pressurized gas through the test conduit (40). 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 drop test. In an embodiment, the fluid filtration system (20) can be used with any suitable fluid that can be stored in a suitable container, such as a tote that communicates with the pump (34), for example.

[0022] Referring to FIG. 1, the filtration skid (22) includes a trolley (55). A cabinet (32) is mounted on the trolley (55) and configured to accommodate hydraulic and automation 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 an illustrated embodiment, the base (57) is rectangular, and there are wheels (58) rotatably attached to each corner of the base (57). In an embodiment, the base (57) may be substantially square in shape.

[0023] The cabinet (32) is mounted on the base (57) of the trolley (55). In an embodiment, the cabinet (32) includes a storage unit for automation and hydraulic equipment and is manufactured 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). Referring to FIG. 2, in an embodiment, the cabinet (32) accommodates at least one pump body (34), an integrity testing device (30), and a control unit (45).

[0024] The pump (34) is supported by the cabinet (32) and is adapted to selectively generate a fluid flow. The pump (34) is configured to draw fluid from a supply (not shown) of fluid(s) and deliver it to the filter. The pump (34) is in an operable relationship with the control unit (45) so that the control unit (45) can selectively operate the pump (34). The pump (34) is adapted to selectively generate a fluid flow to deliver the fluid supply to the filter. In an embodiment, the pump (34) may be any suitable pump capable of generating a fluid flow through the filter and meeting the specifications of the intended application. In an embodiment, the pump (34) includes a variable displacement pump. In an embodiment, the fluid filtration system (20) includes a plurality of pumps (34) that can be used to deliver one or more types of fluid to the filter (35, 25).

[0025] Referring to FIGS. 1 and 2, the pre-filter (35) is fluidly connected in parallel to the pump (34) through the fluid supply conduit (37). Referring to FIG. 1, the disposable filter (25) is fluidly connected in parallel to the bank of the pre-filter (35) through the fluid supply conduit (37). The bank of the parallel pre-filters (35) is connected in series to the parallel pair of disposable filters (25).

[0026] Referring to FIG. 1, in an illustrated embodiment, each conduit (37, 38, 40) comprises a tube array that fluidically interconnects various components of a fluid filtration system (20). In an embodiment, the tube array comprises a plurality of flexible tube lines adapted to be selectively blocked by a pinch valve mounted externally thereto. In an embodiment, the flexible tubes may be made of any suitable material, such as silicone, thermoplastic elastomer (TPE), etc. In an embodiment, the conduit comprises a flexible plastic-based (e.g., PVC, PP, PE) hose. In an embodiment, the conduit comprises any one of a range of suitable materials and assemblies that would be readily known to a person skilled in the art, such as those disclosed in U.S. Patent Application No. US 2017 / 0284584.

[0027] In an embodiment, the filter skid (22) may have a plurality of valve arrays associated with a conduit. In an embodiment, each conduit (37, 38, 40) may be associated with a control valve that communicates electrically with a control unit (45), and the control unit is configured to induce fluid flow through the conduit by controlling the operating conditions of the valve between an open state and a closed state. The valve may include any suitable valve adapted to selectively block the associated conduit.

[0028] In the illustrated embodiment, the valve comprises a pinch valve adapted to control the flow of fluid within the system by blocking the tube of the conduit to effectively block the combined conduit. The valve is fixed to the skid (22) and may provide means for removingly mounting the conduits (37, 38, 40) to the skid (22). The valve is supported by the cabinet (32) such that the clamping portion of each valve protrudes from the outer surface of the cabinet (32) to be connected to each conduit. In other embodiments, different types of valves that would be readily familiar to a person of ordinary skill in the art, such as solenoid valves, may be used. In an embodiment, the valve may be actuated by a suitable power source, such as a pneumatic power source or an electric power source. In an embodiment, the actuation of the valve of the filtration skid (22) may be coordinated through a control unit (45) suitablely programmed to actuate one or more desired fluid distribution sequences.

[0029] Referring to FIG. 1, the pre-filters (35) and disposable filters (25) are removablely mounted in the cabinet (32). In the illustrated embodiment, the filtration skid (22) includes four pre-filters (35) and two disposable filters (25). In another embodiment, the filtration skid (22) may include a different number of pre-filters (35) and / or disposable filters (25), including one pre-filter (35) and / or one disposable filter (25). In an embodiment, the pre-filters (35) may be omitted.

[0030] Referring to FIG. 1, each disposable filter (25) is removablely mounted on a 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 fluidly connected to a pump (34) through a fluid supply conduit (37) (see FIG. 2 as well). The downstream end (54) of each disposable filter (25) is fluidly connected to a discharge conduit (38).

[0031] In the illustrated embodiment, each disposable filter (25) comprises a replaceable part that is once installed on the filtration skid (22) for use in a bioprocessing application and then removed for disposal. After completing its intended use in a bioprocessing application, each disposable filter (25) can be detached from the filtration skid (22) and replaced with another disposable filter (25) having a similar configuration. In the embodiment, the filter (25) comprises any one of a range of suitable materials and assemblies that would be readily known to a person skilled in the art.

[0032] Various commercially available filters, filter media (e.g., fibrous media, membranes and / or composites), filter elements, filter modules, and filter sizes are suitable for use as pre-filters (35) and disposable filters (25) in embodiments of fluid filtration systems constructed according to the principles of the present disclosure. Suitable filters include, for example, the Pegasus Prime filter commercially available from Pall Corporation (Port Washington, New York). Exemplary filters and filter elements include pleated filters and “laid-over-pleat (LOP)" filter configurations.

[0033] In an embodiment, the pre-filter (35) and the disposable filter (25) comprise a filter and a filter element, which have any suitable pore structure, for example, pore size (e.g., by bubble point, or as demonstrated by KL as described in Patent No. 4,340,479, or as demonstrated by capillary condensation flow porometry), pore class, pore diameter (e.g., when characterized using a modified OSU F2 test (e.g., as described in U.S. Patent No. 4,925,572), or a removal class that reduces or allows the passage of one or more materials of interest when a fluid passes through the element. The pore structure used depends on the composition of the fluid to be treated and the desired effluent level of the treated fluid.

[0034] In an embodiment, the pre-filter (35) and the disposable filter (25) comprise a filter and a filter element having any desired critical wet surface tension (CWST; as defined, for example, in U.S. Patent No. 4,925,572). The porous membrane may have any desired critical wet surface tension (CWST; as defined, for example, in U.S. Patent No. 4,925,572). The CWST may be selected as known in the art, for example, as additionally disclosed in U.S. Patent Nos. 5,152,905, 5,443,743, 5,472,621 and 6,074,869. The surface properties of the element may be modified by wet or dry oxidation, by coating or depositing a polymer on the surface, or by a grafting reaction (e.g., to include a surface charge, e.g., positive or negative charge, to affect the CWST, and / or to change the polarity or hydrophilicity of the surface). Modification includes, for example, irradiation, coating and / or curing of the surface with a polar or charged monomer or charged polymer, and performing chemical modification to attach functional groups on the surface.

[0035] In an embodiment, the prefilter (35) and the disposable filter (25) may include at least one additional element, layer, or component having a different structure and / or function, for example: prefiltration, support, drainage, spacing, and cushioning. For example, in an embodiment, the prefilter (35) and the disposable filter (25) may also include at least one additional element such as a mesh and / or screen.

[0036] In an embodiment, the pre-filter (35) and the disposable filter (25) comprise a plurality of filter elements disposed in a housing (typically, the filters are arranged between an outer cage and an inner core to provide a filter module), the housing comprising an inlet and an outlet, defining a fluid flow path between the inlet and the outlet, wherein the filter crosses the fluid flow path. Preferably, the pre-filter (35) and the disposable filter (25) are sterilizable as is known in the art (e.g., autoclaved, gamma irradiated, etc.). Any housing of a suitable shape providing an inlet and an outlet may be used.

[0037] Referring to FIG. 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 for fluid connection to a product container, and the second outlet (62) is adapted for fluid connection to a waste repository.

[0038] Referring to FIG. 2, the integrity test device (30) is supported by a cabinet (32) and fluidly communicates with the upstream end (52) of each disposable filter (25) through a test conduit (40) (see FIG. 1 as well). The integrity test device (30) is connected to a source of pressurized gas, such as pressurized air or nitrogen, and is adapted to selectively direct the flow of pressurized gas to each disposable filter (25) through each test conduit (40). 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 of the disposable filters (25). The test conduit (40) may include a stainless steel gas line from the integrity test device (30) to the manifold section.

[0039] In an embodiment, any integrity testing device (30) suitable for performing the intended integrity test may be used. In an embodiment, a commercially available integrity testing device configured to perform integrity tests before and after use may be used. In an embodiment, various integrity testing devices 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 commercially available from Pall Corporation (Port Washington, New York).

[0040] In an embodiment, the integrity testing device (30) is configured to perform various filter integrity tests (FITs) that would be familiar to a person of ordinary skill in the art, including post-use sterilization and post-use testing. In an embodiment, the integrity testing device (30) is configured to perform FITs designed to ensure consistent filtration performance according to regulatory agencies (e.g., FDA). In an embodiment, the integrity testing device (30) is configured to perform at least one FIT according to a regulatory protocol to ensure filter performance according to regulated performance specifications. In an 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, immersion test, bubble point test, leak test, and pressure drop test.

[0041] Referring to FIG. 2, in an embodiment, the control unit (45) may include any suitable equipment configured to control the operation of at least one component of the liquid filtration system (20) when performing a filtration operation. In an embodiment, the control unit (45) includes a processor (71), a non-transient computer-readable medium (72) having 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) is operably arranged with the display device (50) to optionally display output information from the fluid filtration program and / or receive input information from a graphical user interface displayed by the display device (50).

[0042] In an embodiment, the processor (71) of the control unit (45) includes both a separate processor and a processor included in the integrity test device (30). In an embodiment, the fluid filtration program includes an integrity test program. In an embodiment, the integrity test device (30) includes a non-transient computer-readable medium having an integrity test program. The processor (71) is arranged together with the computer-readable medium (72) to execute the integrity test program. The processor (71) communicates with the integrity test device (30) to selectively operate the integrity test device (30) to perform a test operation on each disposable filter (25) using a flow of pressurized gas based on instructions from the integrity test program.

[0043] The processor (71) may be configured to act as a controller for selectively operating at least one component of the fluid filtration system (20), such as, for example, a pump (34) and a valve array. In an embodiment, the processor (71) communicates electrically with the pump(s) and the valve array to selectively operate the valve based on instructions from a fluid filtration program.

[0044] In an embodiment, the controller and the processor (71) may include separate devices, and the controller may be arranged to communicate operablely with the processor (71). In an embodiment, the controller may include a user input and / or interface device having one or more user-operation mechanisms (e.g., one or more push buttons, slide bars, rotatable knobs, keyboards, and mice) adapted to generate one or more user-operation input control signals. In an embodiment, as will be known to a person skilled in the art, the controller may be configured to include one or more other user-activation mechanisms to provide various other control functions for the fluid filtration system. The controller may be coupled with a display device (50) adapted to display a graphical user interface. In an embodiment, the graphical user interface may be configured to function as both a user input device and a display device. In an embodiment, the display device (50) may include a touch screen device adapted to receive input signals from a user touching different parts of the display screen. In an embodiment, the controller may be in the form of a smartphone, tablet, personal digital assistant (e.g., wireless, mobile device), laptop computer, desktop computer, or other type of device.

[0045] In an embodiment, the processor (71) may include any suitable computing device(s), such as a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a personal organizer, a device controller, a logic device (e.g., a programmable logic device configured to perform processing functions), a digital signal processing (DSP) device, or a computing engine within the device. In an embodiment, the processor (71) also includes one or more additional input devices (e.g., a keyboard and a mouse).

[0046] The processor (71) may have one or more memory devices associated with it for storing data and information. One or more memory devices may include any suitable type of volatile and non-volatile memory devices such as RAM (Random Access Memory), ROM (Read-Only Memory), EEPROM (Electrically-Erasable Programmable Read-Only Memory), flash memory, etc.

[0047] In an embodiment, the control unit (45) communicates electrically with each pump (34) and each valve of the valve array used to deliver fluid(s) to the filter (35, 25). The control unit (45) is configured to selectively operate the pump (34) and the valve according to logic and operating parameters included in the fluid filtration program. In an embodiment, the control unit (45) is configured to control the amount of fluid delivered to the disposable filter (25) by controlling at least one of the pump speed and the volume displacement of the pump (34). In an illustrated embodiment, the control unit (45) is configured to independently operate each valve of the different valve array.

[0048] In an embodiment, the processor (71) includes a specially programmed processor that can be used to facilitate the control and operation of the fluid filtration system (20). In an embodiment, the processor (71) may be configured to receive an input signal from a controller, transmit an input control signal to the controller, and / or transmit output information to the controller. In an illustrated embodiment, the controller and the processor (71) include the same device, and the integrity test device (30) includes its own processor that can be controlled by the processor (71).

[0049] In one embodiment, the processor (71) is adapted to perform various methods, processes, and modes of operation in a manner consistent with the principles of the present disclosure by executing a program stored on a non-transient computer-readable medium (72). In one embodiment, the non-transient computer-readable medium (72) may include a fluid filtration program configured to implement one embodiment of a method for filtering a fluid in accordance with the principles of the present disclosure. In one embodiment, the fluid filtration program is configured to perform at least one fluid filtration operation. In one embodiment, the fluid filtration program is configured to perform at least one fluid recovery operation.

[0050] In an embodiment, the fluid filtration program includes a graphical user interface that can be displayed by a display device (50). The graphical user interface can be used to facilitate the user in inputting commands and data into the fluid filtration program and to display the output generated by the fluid filtration program.

[0051] A fluid filtration program may be stored on any suitable computer-readable storage medium. For example, in an embodiment, a fluid filtration program following the principles of the present disclosure may be stored on a hard drive, a floppy disk, a CD-ROM drive, a tape drive, a zip drive, a flash drive, an optical storage device, a magnetic storage device, etc.

[0052] In an embodiment, the processor (71) communicates operably with a data storage device (73) comprising at least one database containing fluid filtration data. In an embodiment, the fluid filtration program may be configured to store fluid filtration data generated during the operation of the system in the data storage device (73). In an embodiment, the fluid filtration data may be logically combined with time data in the data storage device so that various data can be retrieved during a given time period.

[0053] The display device (50) is operably arranged with the processor (71). In an embodiment, the integrity test program is configured to perform the following steps as part of a test task when executed by the processor (71): determining whether each disposable filter (25) has satisfied the test task; generating a graphic display including a graphic indication of whether the disposable filter (25) has satisfied the test task; and displaying the graphic display on the display device (50) (see, for example, FIG. 7).

[0054] In an embodiment, the processor (71) is configured to display fluid filtration data received from an integrity testing device (30) and from at least one sensor that communicates electrically with the control unit (71) on a display device (50). The fluid filtration data may also be stored in a data storage device (73) operably arranged with the processor (71).

[0055] FIG. 5 is a schematic diagram of one embodiment of a fluid filtration system (20) configured according to the principles of the present disclosure, illustrating a filter integrity test operation. The illustrated arrangement includes one disposable filter (25). It should be understood that the description of this arrangement (as well as that shown in FIG. 6 and 8 through 12) is applicable to each disposable filter (25) included in a specific embodiment of a fluid filtration system configured according to the principles of the present disclosure.

[0056] The fluid supply conduit (37) includes a fluid supply valve (81) and a test joint (82). The test conduit (40) is fluidly connected to a disposable filter (25) through the test joint (82) of the fluid supply conduit (37).

[0057] The test conduit (40) includes an air filter (85), a test conduit valve (86), and a liquid sensor (87). The air filter (85) is configured to filter particulates from the fluid passing through the air filter (85). The air filter (85) is positioned between the integrity test device (30) and the disposable filter (25) so that pressurized gas delivered from the integrity test device (30) to the disposable filter (25) is filtered through the air filter (85). The test conduit (40) includes a liquid sensor (87) and a test conduit valve (86) to protect the air filter (85) from exposure to liquid.

[0058] A liquid sensor (87) is configured to generate a liquid detection signal in response to detecting liquid in the test conduit (40). A control unit (45) communicates electrically with the liquid sensor (87) to receive the liquid detection signal therefrom. A test conduit valve (86) is arranged with the test conduit (40) to selectively block the test conduit (40).

[0059] A liquid sensor (87) is placed between the integrity test device (30) and the test junction (82), specifically between the air filter (85) and the test junction (82). A test conduit valve (86) is placed between the air filter (85) and the liquid sensor (87).

[0060] The test conduit valve (86) is operably arranged with the control unit (45) so that the control unit (45) can operate the test conduit valve (86) in response to the control unit (45) receiving a liquid detection signal. In an embodiment, the control unit (45) is configured to stop the operation of the pump(s) (34) and / or close the test conduit valve (86) in response to the liquid detection signal to prevent the air filter (85) from being wetted with fluid.

[0061] In an embodiment, the fluid filtration system (20) may include means for removing gas trapped within the conduit to improve the accuracy and consistency of the fluid filtration process. In an illustrated embodiment, the test conduit (40) also includes an exhaust joint (88) for fluid communication with the exhaust conduit (90). The exhaust conduit (90) fluidly communicates with the test conduit (40) through the exhaust joint (88).

[0062] The exhaust conduit (90) includes an exhaust valve (91). The exhaust valve (91) is arranged to be operable with the control unit (45) so that the control unit (45) can selectively operate the exhaust valve (91).

[0063] In an embodiment, the integrity test program 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 conduit (37); opening the test conduit valve (86) to open the test conduit (40); opening the second outlet valve (64) to allow air flow through the disposable filter (25); and operating the integrity test device (30) to induce the flow of pressurized gas through the test conduit (40) and the disposable filter (25). In an embodiment, the test operation includes one of a forward flow test, a submersion test, a bubble point test, a leak test, and a pressure reduction test. In an embodiment, the integrity test program is configured to perform the following steps as part of a test operation when executed by the processor: closing the exhaust valve (91) to block the exhaust conduit (90).

[0064] In an embodiment, the integrity test program may be configured to perform the following steps as part of the test operation when executed by a 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 an embodiment, the integrity test program may omit the performance of the above steps, but these help to avoid unwanted fluid (which may cause unnecessary / unwanted dilution) at the product outlet. In another embodiment, the integrity test program may be configured to perform the reverse of the above steps as part of the test operation when executed by a processor, namely, 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).

[0065] The discharge conduit (38) includes a pressure sensor (93). The pressure sensor (93) is configured to generate a pressure signal indicating the pressure measured in the discharge conduit (38). A control unit (45) communicates electrically with the pressure sensor (93) to receive the pressure signal from the pressure sensor (93). In an embodiment, the pressure sensor (93) may be used to confirm that the discharge conduit (38) is not pressurized.

[0066] In an embodiment, the FIT device (30) includes an internal pressure sensor that can be operated independently to detect pressure in the test conduit (40). In an embodiment, the integrity test program is configured to determine whether the test conditions of the test operation are satisfied based on the pressure measured by the pressure sensor of the FIT device (30) in the upstream portion of the disposable filter (25) in the area of ​​the test junction (82).

[0067] In an embodiment, the fluid filtration system (20) may include means for recovering fluid from a disposable filter, which would otherwise be retained inside or not discharged during the filtration operation. FIG. 6 is a schematic diagram of the fluid filtration system (20) illustrating the fluid recovery operation. The used fluid filtration system (20) may be operated to recover fluid from the disposable filter (25) by inducing a pressurized gas through the filter (25). The fluid supply valve (81) may be closed to prevent fluid from flowing from the fluid supply conduit (37) to the upstream end (52) of the disposable filter (25). The fluid supply valve (81) may be closed to ensure that the pressure (air) provided by the FIT device (30) is used to recover the product from the disposable filter (25) (and is not flowed / discharged through the fluid supply conduit (37)). The pressurized gas may be delivered through the disposable filter (25) by the integrity test device (30). The product outlet of the discharge conduit (38) may be opened so that fluid propelled from the disposable filter (25) is transported from the downstream end (54) of the filter (25) through the discharge conduit (38) and out of the product outlet (61). In another embodiment, a separate source of pressurized gas may be provided to perform the fluid recovery operation.

[0068] FIG. 7 is a view of one embodiment of a graphical user interface (95) suitable for use with an integrity test program configured according to the principles of the present disclosure. In the embodiment, the integrity test program is configured to determine whether a disposable filter (25) has satisfied a test task, generate a graphical display including a graphic indication of whether the disposable filter (25) has satisfied a test task, and display the graphical display on a display device (50). The graphical user interface (95) is an example of such a graphical display.

[0069] In another embodiment, the fluid filtration system may include different additional equipment configured to maintain a supply of fluid for delivery to a disposable filter. For example, in another embodiment, the fluid filtration system configured according to the principles of the present disclosure may include at least one tower configured to maintain one or more totes filled with fluid for use with the fluid filtration system. In another embodiment, the fluid filtration system configured according to the principles of the present disclosure may include one or more tanks filled with fluid for use in the system.

[0070] In other embodiments of a fluid filtration system constructed according to the principles of the present disclosure, the fluid filtration system configuration may take an alternative form. For example, in an embodiment, the fluid filtration system may be expanded for a larger volume or reduced for laboratory use. In an embodiment, the fluid filtration system constructed according to the principles of the present disclosure may be used to process various liquids to meet the requirements of the intended application.

[0071] In an embodiment of a method for using a fluid filtration system according to the principles of the present disclosure, any suitable embodiment of a fluid filtration system according to the principles discussed herein may be used. In an embodiment, the method for using a fluid filtration system according to the principles of the present disclosure comprises the step of using a filtration skid having a FIT device integrated therein according to the principles of the present disclosure. In an embodiment, the method for using a fluid filtration system according to the principles of the present disclosure comprises the step of testing the integrity of a disposable filter in the field.

[0072] In one embodiment, a method for performing a field integrity test of a disposable filter includes the step of removingly mounting the disposable filter in a workstation. The workstation includes a cabinet. The upstream end of the disposable filter is fluidly connected to a pump via a fluid supply conduit and to an integrity test device via a test conduit. The pump and the integrity test device are supported by the cabinet. The integrity test device is fluidly connected to a source of pressurized gas, such as pressurized air or nitrogen. The integrity test device is operated to perform a test operation on the disposable filter by inducing a flow of pressurized gas through the test conduit. In an embodiment, the test operation includes one of a forward flow test, a immersion test, a bubble point test, a leak test, and a pressure drop test. In an embodiment, operating the integrity test device to perform the test operation includes the step of determining whether the test conditions of the test operation are satisfied based on the pressure measured in the discharge conduit. In an embodiment, the FIT device (30) is configured to determine the pass or fail of the test based on a selected test method (forward flow, bubble point, pressure drop, etc.) and related test parameters (e.g., pressure, flow, etc.).

[0073] In an embodiment, an integrity test device is operated to perform a test task by using a processor to execute an integrity test program stored on a non-transient computer-readable medium. In an embodiment, the processor executes the integrity test program to determine whether a disposable filter has satisfied the test task. A graphic display is generated that includes a graphic indication of whether the disposable filter has satisfied the test task. The graphic display is displayed on a display device.

[0074] In an embodiment, the fluid supply conduit includes a fluid supply valve and a test joint. The test conduit includes a test conduit valve, and the test conduit is fluidly connected to a disposable filter through the test joint of the fluid supply conduit. In an embodiment, the method further includes the step of closing the fluid supply valve to block the fluid supply conduit during a test operation. The test conduit valve is opened to open the test conduit during a test operation.

[0075] In an embodiment, the test conduit includes an exhaust joint. In an embodiment, the method further includes the step of closing the exhaust conduit by closing the exhaust valve during the test operation. The exhaust conduit is fluidly connected to the test conduit through the exhaust joint. In an embodiment, the method further includes the step of opening the exhaust conduit by opening the exhaust valve after the test operation is completed so that the pressurized gas upstream of the disposable filter is exhausted from the test conduit to the exhaust conduit.

[0076] In an 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 an embodiment, the method further includes the step of closing the first outlet valve to block the first outlet, and the first outlet is fluidly connected to a product container. To open the second outlet, the second outlet valve is opened. The second outlet is fluidly connected to a waste storage container.

[0077] In an embodiment, the method further includes the step of measuring the pressure in the discharge conduit. In an embodiment, operating the FIT device does not include the step of measuring the pressure in the discharge conduit (38) (downstream of the disposable filter (25)). It is understood that the discharge conduit (38) is not pressurized when the waste outlet (62) is not pressurized.

[0078] In an embodiment, the FIT device (30) has an internal flow sensor and an internal pressure that can be operated to determine the pressure in the upstream portion of the test conduit (40) and the disposable filter (25) in the area of ​​the test joint (82). In an embodiment, the method includes the step of measuring the pressure in the upstream portion of the test conduit of the disposable filter. In an embodiment, operating the integrity test device to perform a test operation includes the step of determining whether the test conditions of the test operation are satisfied based on the pressure measured in the test conduit.

[0079] In an 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 an embodiment, the method further includes the step of closing the first outlet by closing the first outlet valve. The first outlet is fluidly connected to a product container for receiving the filtered fluid for final use. To open the second outlet, the second outlet valve is opened. The second outlet is fluidly connected to a waste storage. In another embodiment, the method further includes the step of opening the first outlet by opening the first outlet valve. The first outlet is fluidly connected to a product container. To block the second outlet, the second outlet valve is closed. The second outlet is fluidly connected to a waste storage.

[0080] Referring to FIGS. 8 through 12, a series of filter conditioning sequences is illustrated. FIGS. 8 and 9 are schematic diagrams of a fluid filtration system as in FIG. 5 and illustrate an upstream filter priming operation.

[0081] Referring to FIG. 8, the upstream end (52) of the disposable filter (25) is fluidly connected to the pump (34) through the fluid supply conduit (37). The exhaust conduit (90) is fluidly connected to the joint (82) of the fluid supply conduit (37), so that the upstream end (52) of the disposable filter (25) is fluidly connected to the exhaust conduit (90) through the joint (82) and through a common branch (97) extending between the joint (82) and the upstream end (52) of the disposable filter (25). The exhaust conduit (90) includes an outlet (98), a liquid sensor (87), and an exhaust valve (91). The liquid sensor (87) is positioned between the joint (82) and the outlet (98). The exhaust valve (91) is positioned between the liquid sensor (87) and the outlet (98). The liquid sensor (87) is configured to generate a liquid detection signal in response to detecting liquid in the discharge conduit (90).

[0082] The control unit (45) communicates electrically with the liquid sensor (87) to receive a liquid detection signal from it. In an embodiment, the control unit (45) is programmed with a filter conditioning program that includes a filter priming module. The processor (71) communicates electrically with the pump (34), fluid supply valve (81), exhaust valve (91), and liquid sensor (87) to perform a priming operation for the disposable filter (25) based on instructions from the filter priming module.

[0083] In an embodiment, the filter priming 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 exhaust valve (91) to open the exhaust conduit (90); closing the first outlet valve (63) to block the first outlet (61) of the exhaust conduit (38); opening the second outlet valve (64) to open the second outlet (62) of the exhaust conduit (38); operating the pump (34) to transfer fluid flow to the upstream end (52) of the disposable filter (25) so that air in the fluid supply conduit (37) is displaced into the exhaust conduit (90); stopping the operation of the pump (34) and / or closing the exhaust valve (91) in response to receiving a liquid detection signal.

[0084] Referring to FIG. 9, the liquid rises over the joint (82) and extends toward the liquid sensor (87), thereby indicating that the air upstream of the disposable filter (25) is removed through the exhaust pipe (90).

[0085] FIG. 10 is a schematic diagram of a fluid filtration system as in FIG. 5 and illustrates a downstream filter priming operation. In response to the liquid sensor (87) detecting the presence of liquid, the control unit (45) closes the exhaust valve (91).

[0086] In an embodiment, the filter priming module is configured to perform a downstream filter priming operation, which includes the following steps when executed by the processor (71): closing the exhaust valve (86, 91); opening the fluid supply valve (81) to open the fluid supply conduit (37); 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 transfer the fluid flow to the upstream end (52) of the disposable filter (25) and through the disposable filter (25) and out of the second outlet (62) of the discharge conduit (38); and stopping the operation of the pump (34) after a predetermined amount of time or in response to the pressure in the discharge conduit (38) reaching a predetermined value based on the pressure signal to the pressure sensor (93).

[0087] FIG. 11 is a schematic diagram of a fluid filtration system as in FIG. 5 and illustrates a filter flushing operation. In an embodiment, the control unit (45) is programmed with a filter conditioning program that includes a filter flushing module.

[0088] In an embodiment, the filter flushing module is configured to perform the following steps as part of a flushing operation when executed by the processor (71). The exhaust valve (91) is closed in response to receiving a liquid detection signal from the liquid sensor (87). The first outlet valve (63) is closed to block the first outlet (61) of the discharge conduit (38). The second outlet valve (64) is partially opened to partially open the second outlet (62) of the discharge conduit (38). The fluid supply valve (81) is opened to open the fluid supply conduit (37). The pump (34) is operated to deliver the fluid flow to the disposable filter (25), so that the fluid flow passes through the disposable filter (25) and the discharge conduit (38) and out of the second outlet (62), thereby creating back pressure in the discharge conduit (38). The pressure sensor (93) can be used as a feedback loop to monitor the control unit (45) to generate back pressure defined in the discharge conduit (38) to improve filter membrane wetting.

[0089] In an embodiment, the filter flushing module is configured to create a pulsing effect in the discharge conduit (38) by sequentially opening and closing the second outlet valve (64) to sequentially open and close the second outlet (62). The pulsing effect can be adjusted to help improve the wetting of the filter membrane.

[0090] FIG. 12 is a schematic diagram of a fluid filtration system as in FIG. 5 and illustrates an upstream filter pressurization operation. In an embodiment, the test conduit (40) includes a pressurized air supply conduit for delivering a supply of pressurized air to the upstream end (52) of the disposable filter (25) to pressurize the upstream of the disposable filter (25).

[0091] The upstream end (52) of the disposable filter is in fluid communication with the pressurized air supply conduit (40). The pressurized air supply conduit (40) is connected to a source of pressurized air and is configured to selectively guide the flow of pressurized air through the pressurized air supply conduit (40) to the upstream end (52) of the disposable filter (25).

[0092] In an illustrated embodiment, the pressurized air supply conduit (40) includes an integrity test device (30) connected to a source of pressurized air and adapted to selectively direct the flow of pressurized air through the pressurized air supply conduit (40) to an upstream end (52) of a disposable filter (25). A processor (71) electrically communicates with the integrity test device (30) to selectively operate the integrity test device (30). In another embodiment, the integrity test device (30) may be omitted, and the pressurized air supply conduit (40) may be fluidly connected to another means for delivering pressurized air (e.g., a pressure tank and / or a compressor).

[0093] The joint (82) of the fluid supply conduit (37) includes a first joint, and the pressurized air supply conduit (40) includes a second joint (exhaust joint (88)). The exhaust conduit (90) is fluidly connected to the second joint (88), so that the upstream end (52) of the disposable filter (25) is fluidly connected to the exhaust conduit (40) through the first joint (82) and the second joint (88), and a common branch (99) extends between the second joint (88) and the upstream end (52) of the disposable filter (25).

[0094] The pressurized air supply conduit (40) includes an air supply valve (86) and an air filter (85). The liquid sensor (87), the air supply valve (86), and the air filter (85) are positioned at a common branch (99). The liquid sensor is positioned between the first junction (82) and the air supply valve (86). The air supply valve (86) is positioned between the liquid sensor (87) and the air filter (85).

[0095] In an embodiment, the filter conditioning program includes a filter pressurization module configured to perform the following steps as part of a pressurization operation when executed by a processor (71). A fluid supply valve (81) is closed to block the fluid supply conduit (37). An exhaust valve (91) is closed to block the exhaust conduit (90). First and second outlet valves (63, 64) are closed to block the first and second outlets (61, 62) of the discharge conduit (38), respectively. The flow of pressurized air is directed through the pressurized air supply conduit (40) to the upstream end (52) of the disposable filter (25). In an embodiment, the filter pressurization module may be configured to create a pulsating effect in the pressurized air supply conduit (40) by sequentially opening and closing the air supply valve (86) when executed by the processor (71), thereby sequentially opening and closing the pressurized air supply conduit (40).

[0096] All references, including publications, patent applications, and patents cited herein, are incorporated by reference herein to the same extent as each reference is individually and specifically indicated as being incorporated by reference and its full text is presented herein.

[0097] In the context of describing the invention (particularly in the context of the following claims), the use of singular terms and terms “above” and similar designations shall be interpreted as including both singular and plural forms, unless otherwise specified herein or clearly contradictory in the context. Unless otherwise stated, the terms “comprising,” “having,” “comprising,” and “comprising” shall be interpreted as open-ended terms (i.e., meaning “comprising but not limited thereto).” Unless otherwise specified herein, the ranges of numbers listed herein serve merely as a shorthand method for individually designating each individual number within the said range, and each individual number is included in the specification as if it were individually listed herein. All methods described herein may be performed in any suitable order, unless otherwise specified herein or clearly contradictory in the context. Any and all examples provided herein, or the use of exemplary language (e.g., “e.g., for example”), are merely intended to make the invention easier to understand and, unless otherwise claimed, are not intended to limit the scope of the invention. No language in this specification should be construed as indicating that any unclaimed element is essential to the practice of the invention.

[0098] Preferred embodiments of the present invention are described herein, including the best methods known to the inventors for carrying out the present invention. As one reads the description above, variations of these preferred embodiments may become apparent to a person skilled in the art. The inventors anticipate that a person skilled in the art will appropriately make use of such variations, and the inventors intend that the present invention may be practiced differently from as specifically described herein. Accordingly, the present invention includes all modifications and equivalents of the subject matter of the invention listed in the claims appended herein as permitted by applicable law. Furthermore, any combination of the elements described above in all possible variations of the present invention is included in the present invention, unless otherwise specified herein or otherwise clearly contradicted by the context.

Claims

Claim 1 A fluid filtration system comprising: a workstation comprising a cabinet; a pump supported by the cabinet and adapted to selectively generate fluid flow; a disposable filter and a fluid supply conduit, wherein the disposable filter has an upstream end and a downstream end, the disposable filter is removablely mounted on the workstation, the upstream end of the disposable filter is fluidly connected to the pump through the fluid supply conduit, and the fluid supply conduit includes a test junction; an integrity test device and a test conduit, wherein the integrity test device is supported by the cabinet and is fluidly connected to the upstream end of the disposable filter through the test conduit, the test conduit is fluidly connected to the disposable filter through the test junction of the fluid supply conduit, and the integrity test device is connected to a source of pressurized gas and adapted to selectively direct the flow of pressurized gas through the test conduit and the disposable filter. Conduit; a control unit, wherein the control unit comprises a processor and a non-transitory computer-readable medium having an integrity test program, the processor is arranged with the computer-readable medium to execute the integrity test program, and the processor communicates with the integrity test device to selectively operate the integrity test device to perform a test operation on the disposable filter using a flow of pressurized gas based on instructions from the integrity test program. Claim 2 In claim 1, the fluid supply conduit includes a fluid supply valve, the test conduit includes a test conduit valve, and the integrity test program is configured to perform the following steps as part of the test operation when executed by the processor: the step of closing the fluid supply valve to block the fluid supply conduit; the step of opening the test conduit by opening the test conduit valve; and the step of operating the integrity test device to induce the flow of pressurized gas through the test conduit and the disposable filter. Claim 3 A fluid filtration system according to claim 1 or 2, wherein the test conduit comprises an air filter disposed between the integrity test device and the disposable filter. Claim 4 A fluid filtration system according to claim 1 or 2, wherein the test conduit comprises a liquid sensor disposed between the integrity test device and the test joint. Claim 5 A fluid filtration system according to claim 1, wherein the test conduit comprises an air filter disposed between the integrity test device and the disposable filter, a liquid sensor disposed between the air filter and the test junction, and a test conduit valve disposed between the air filter and the liquid sensor. Claim 6 A fluid filtration system according to claim 1 or 2, wherein the test conduit comprises an exhaust joint, and the fluid filtration system further comprises an exhaust conduit having an exhaust valve that is fluidly connected to the test conduit through the exhaust joint; and the integrity test program is configured to perform a step of closing the exhaust valve to block the exhaust conduit as part of the test operation when executed by the processor. Claim 7 In claim 1 or 2, the fluid filtration system comprises a discharge conduit, wherein the discharge conduit is fluidly connected to the downstream end of the disposable filter, and the discharge conduit comprises 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, wherein the first outlet is adapted for fluid connection to a product container and the second outlet is adapted for fluid connection to a waste repository; the fluid filtration system, wherein the integrity test program is configured to perform the following steps as part of the test operation when executed by the processor: the step of closing the first outlet valve to block the first outlet; the step of opening the second outlet valve to open the second outlet. Claim 8 A fluid filtration system according to claim 7, wherein the discharge conduit comprises a pressure sensor configured to measure pressure within the discharge conduit, the pressure sensor is configured to generate a pressure signal indicating the pressure measured within the discharge conduit, and the processor communicates electrically with the pressure sensor to receive the pressure signal from the pressure sensor. Claim 9 In claim 8, the integrity test device comprises a FIT pressure sensor, the FIT pressure sensor is configured to generate a pressure signal indicating a pressure measured upstream of the test conduit of the disposable filter, the processor communicates with the FIT pressure sensor to receive the pressure signal from the FIT pressure sensor, and the integrity test program is configured to perform the following steps as part of the test operation when executed by the processor: receiving the pressure signal from the FIT pressure sensor; determining whether the test conditions of the test operation are satisfied based on the pressure signal. Claim 10 In claim 1 or 2, the fluid filtration system further comprises a display device operably arranged with the processor; and the fluid filtration system, wherein the integrity test program is configured to perform the following steps as part of the test operation when executed by the processor: determining whether the disposable filter has satisfied the test operation; generating a graphic display including a graphic indication of whether the disposable filter has satisfied the test operation; and displaying the graphic display on the display device. Claim 11 A method for performing an in-situ integrity test of a disposable filter, comprising the following steps: removingly mounting the disposable filter in a workstation comprising a cabinet; fluidly connecting the upstream end of the disposable filter to a pump through a fluid supply conduit and to an integrity test device through a test conduit, wherein the pump and the integrity test device are supported by the cabinet; fluidly connecting the integrity test device to a source of pressurized gas; and operating the integrity test device to induce a flow of pressurized gas through the test conduit to perform a test operation on the disposable filter. Claim 12 In claim 11, the step of operating the integrity test device to perform the test operation comprises the step of executing an integrity test program stored on a non-transient computer-readable medium using a processor. Claim 13 A method according to claim 12, further comprising the step of using the processor to determine whether the disposable filter satisfies the test task, generating a graphic display including a graphic indication of whether the disposable filter satisfies the test task, and displaying the graphic display on a display device. Claim 14 A method according to any one of claims 11 to 13, wherein the test operation comprises one of a forward test, a water intrusion test, a bubble point test, a leak test, and a pressure reduction test. Claim 15 In any one of claims 11 to 13, the fluid supply conduit comprises a fluid supply valve and a test joint, the test conduit comprises a test conduit valve, and the test conduit is fluidly connected to the disposable filter through the test joint of the fluid supply conduit, and the method further comprises the following steps: closing the fluid supply valve to block the fluid supply conduit during the test operation; and opening the test conduit by opening the test conduit valve during the test operation. Claim 16 In any one of claims 11 to 13, the test conduit comprises an exhaust joint, and the method further comprises the following step: a step of closing an exhaust valve to block the exhaust conduit during the test operation, wherein the exhaust conduit is in fluid communication with the test conduit through the exhaust joint. Claim 17 In claim 16, a method further comprising the following step: after completing the test operation, opening the exhaust valve to open the exhaust conduit, thereby allowing the pressurized gas upstream of the disposable filter to be exhausted from the test conduit into the exhaust conduit. Claim 18 A method according to any one of claims 11 to 13, further comprising the step of measuring the pressure in the test conduit upstream of the disposable filter; and the step of operating the integrity test device to perform the test operation, comprising the step of determining whether the test conditions of the test operation are satisfied based on the pressure measured in the test conduit. Claim 19 In paragraph 18, the discharge conduit is fluidly connected to the downstream end of the disposable filter, and the discharge conduit comprises a first outlet and a second outlet, and a first outlet valve and a second outlet valve each connected to the first outlet and the second outlet, respectively, and the method further comprises the following steps: closing the first outlet valve to block the first outlet, wherein the first outlet is fluidly connected to a product container; and opening the second outlet valve to open the second outlet, wherein the second outlet is fluidly connected to a waste storage container. Claim 20 In paragraph 18, the discharge conduit is fluidly connected to the downstream end of the disposable filter, and the discharge conduit comprises a first outlet and a second outlet, and a first outlet valve and a second outlet valve each connected to the first outlet and the second outlet, respectively, and the method further comprises the following steps: opening the first outlet valve to open the first outlet, wherein the first outlet is fluidly connected to a product container; closing the second outlet valve to block the second outlet, wherein the second outlet is fluidly connected to a waste storage container.

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