Tangential Flow Filtration Manifold Assembly

Abstract

The manifold assembly for tangential flow filtration includes a center manifold, at least one end cap, and at least one gasket disposed between the center manifold and the at least one end cap. The center manifold and the at least one end cap may be injection molded, and the at least one end cap may be removably coupled to the center manifold. The at least one compression limiter may be at least partially captured within the center manifold, and the at least one compression pin may be at least partially captured within the end cap. The combination of the at least one compression limiter and the at least one compression pin allows the manifold assembly to be secured in a fixed arrangement. The center manifold may further include a feed port, a drain port, a retentate port, and a filtrate port disposed on the same side of the center manifold.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to European Patent Application No. 22290076.3, filed December 16, 2022, entitled "Tangential Flow Filtration Manifold Assembly," the disclosure of which is incorporated herein by reference in its entirety for all purposes.

[0002] SUMMARY OF THE DISCLOSURE The present disclosure is directed generally to tangential flow filtration arrangements, and more particularly to manifold assemblies that can facilitate tangential flow filtration operations. [Background technology]

[0003] The present invention relates to a manifold assembly that can be utilized by bioprocessing systems for the treatment of biological fluids, particularly, but not exclusively, for purifying biopharmaceutical fluids to obtain products such as monoclonal antibodies, vaccines, and / or recombinant proteins.

[0004] It is known that biopharmaceutical liquids are generally obtained by cultivation in bioreactors and must then be processed to achieve the required characteristics such as purity, concentration, absence of viruses, etc.

[0005] Purification is carried out by a series of processes, including clarification to remove debris from the bioreactor culture and passing the virus filtrate through a filtration arrangement, sometimes followed by concentration by diafiltration and tangential flow filtration. Other operations for purification exist, such as chromatography.

[0006] Tangential flow filtration (TFF) is a separation process that uses membranes to separate components in a liquid solution or suspension based on size or molecular weight. Applications include concentration, clarification, and desalting of proteins and other biomolecules (e.g., nucleotides, antigens, and monoclonal antibodies); buffer exchange; process development; membrane selectivity studies; pre-chromatographic purification to remove colloidal particles; depyrogenation of small molecules such as dextrose and antibiotics; harvesting, washing, or clarification of cell cultures, lysates, colloidal suspensions, and viral cultures; and sample preparation.

[0007] Conventional TFF devices that can be utilized by bioprocessing systems for processing biological fluids can be constructed with laminated sheets of filtration membranes and woven screens, and can also be contained in a cassette format. Conventionally, separate sealing gaskets can be placed on both sides of the cassette or attached to the filtration arrangement (e.g., a compression plate) between the manifold and the holder. The manifold serves to distribute the flow of filtrate to multiple channels within the TFF device. The TFF device and gasket are secured between the manifold and the holder, which work together to provide a securing force to achieve the desired fluid seal. In some other conventional TFF devices, the gasket can be embedded in the TFF device.

[0008] Conventional manifolds in typical filtration configurations can be machined from stainless steel. This results in stainless steel manifolds that are expensive to manufacture and cannot be gamma irradiated. Therefore, stainless steel manifolds are more difficult and expensive to sterilize. Additionally, stainless steel manifolds are not ergonomic due to their weight and the fluid ports located on different sides of each stainless steel manifold. Due to the way stainless steel manifolds must be manufactured, they do not contain fluid ports that are all located on the same side. Therefore, the non-ergonomic nature of stainless steel manifolds makes them difficult to handle and difficult to incorporate into filtration configurations of bioprocessing systems. Summary of the Invention

[0009] The present disclosure is directed to a manifold assembly for a tangential flow filtration assembly / arrangement, including a center manifold, two end caps removably connectable to the center manifold (via a snap-fit ​​arrangement or other known removably connectable method), and a gasket disposed between the center manifold and the end caps. The manifold assembly may be a disposable injection-molded manifold assembly. More specifically, the center manifold and end caps may be injection molded. In other embodiments, the center manifold and end caps may be constructed via additive manufacturing techniques, including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), and digital light synthesis (DLS). The center manifold may be formed or molded around one or more compression limiters such that the one or more compression limiters are at least partially captured within the center manifold. The end caps may be injection molded around one or more compression pins such that the one or more compression pins are at least partially captured within the end caps. In some additional embodiments, one or more compression limiters and one or more compression pins may be coupled to the center manifold and end caps, respectively, via post-molding operations, including, but not limited to, ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods. Configuring the center manifold and end caps in this manner allows the manifold assemblies disclosed herein to be lighter than conventional stainless steel manifolds while still being able to withstand the compressive forces (i.e., from the compression limiters and compression pins) applied to the manifold assembly by the compression mechanism of the filtration arrangement.Additionally, configuring the center manifold and end caps in this manner can further enable the manifold assembly to be sterilized by known sterilization methods, including, but not limited to, gamma irradiation, autoclaving, and other gas or steam-based sterilization methods (including, but not limited to, ethylene oxide, chlorine dioxide, ozone, supercritical carbon dioxide, vaporized hydrogen peroxide, etc.). Configuring the center manifold and end caps in this manner also allows the various ports of the center manifold (e.g., feed port, drain port, retentate port, filtrate port, etc.) to all be located on the same side of the manifold assembly. This provides the operator with a more ergonomic manifold assembly to use and assemble (i.e., connect tubing, etc.) in the securing mechanism of the filtration arrangement. This further reduces the minimum labor volume (MWV), which is important for TFF applications. Moreover, configuring the manifold assembly from various components that are removably coupled to each other allows individual components of the manifold assembly (e.g., center manifold, end caps, gaskets, etc.) to be replaced in the event of damage, rather than the entire manifold assembly.

[0010] In one embodiment, a manifold assembly for a tangential flow filtration assembly includes a manifold, a feed port, a retentate port, and a filtrate port. The manifold may have a first surface, a second surface opposite the first surface, a first end spanning between the first and second surfaces, and a second end spanning between the first and second surfaces, where the second end is opposite the first end. The feed port, retentate port, and filtrate port may all be located on the first end of the manifold.

[0011] In some cases, the manifold assembly further includes an end cap. The end cap may be removably coupled to either the first surface or the second surface of the manifold. In some further examples, the manifold further includes a first series of openings, a second series of openings, and a third series of openings. The first series of openings may be in fluid communication with the feed port. The second series of openings may be in fluid communication with the retentate port. The third series of openings may be in fluid communication with the filtrate port. In some still further cases, the end cap may include a fourth series of openings, a fifth series of openings, and a sixth series of openings. Each of the series of openings in the end cap may extend through the end cap. When the end cap is removably coupled to the manifold, the fourth series of openings in the end cap can be aligned with the first series of openings in the manifold, the fifth series of openings in the end cap can be aligned with the second series of openings in the manifold, and the sixth series of openings in the end cap can be aligned with the third series of openings in the manifold.

[0012] In another embodiment, a manifold assembly for a tangential flow filtration assembly includes a manifold, a compression limiter, and an end cap. The manifold may have a first surface and a second surface opposite the first surface. The compression limiter may be at least partially captured within the manifold such that the compression limiter extends from the first surface to the second surface of the manifold. The end cap may be coupled to the first surface of the manifold.

[0013] In some cases, the manifold may be injection molded or additively manufactured around the compression limiter. In some additional cases, the end cap may include an exterior surface and an opposing interior surface. In some further cases, the manifold assembly may further include a compression pin at least partially captured within the end cap such that a portion of the compression pin extends from the interior surface of the end cap. In some still further cases, the compression pin may be aligned with the compression limiter when the end cap couples to the manifold.

[0014] In some additional cases, the compression limiter may be a cylinder having a conduit. Additionally, when the end cap is coupled to the manifold, a compression pin may abut an end of the compression limiter, and a portion of the compression pin may be disposed within the conduit of the compression limiter. The end cap and the manifold may have a first durometer value, and the compression limiter and compression pin may have a second durometer value greater than the first durometer value.

[0015] In yet another embodiment, a manifold assembly for a tangential flow filtration assembly may include a manifold and an end cap. The manifold may have a first surface, a second surface opposite the first surface, and a plurality of ports extending from a first end of the manifold. The manifold may further have a plurality of first openings on the first surface extending into the manifold, wherein the plurality of first openings may be in fluid communication with the plurality of ports. The end cap may have an inner surface, an outer surface, and a plurality of second openings extending through the end cap from the inner surface to the outer surface. Additionally, when the end cap is coupled to the first surface of the manifold, the plurality of second openings may be aligned with the plurality of first openings.

[0016] In some cases, when the end cap is coupled to the manifold, the inner surface of the end cap may be disposed closer to the first surface of the manifold than the outer surface of the end cap. In some still further cases, the manifold assembly may also include at least one gasket disposed between the first surface of the manifold and the inner surface of the end cap.

[0017] In some still further cases, the manifold may further have a plurality of first passages disposed on the first surface and the end cap may further have a plurality of second passages disposed on the interior surface. When the end cap is coupled to the manifold, the plurality of first passages and the plurality of second passages can collectively form a passageway through at least a portion of the manifold assembly.

[0018] Other systems, devices, apparatus, methods, features, and advantages will be or become apparent to one with skill in the art upon examination of the following figures and detailed description, and all such additional systems, devices, arrangements, mechanisms, assemblies, apparatus, methods, features, and advantages are encompassed herein and are within the scope of claimed subject matter. [Brief explanation of the drawings]

[0019] The apparatus, systems, assemblies, devices, components, cassettes, plates, manifolds, end caps, gaskets, limiters, pins, pathways, and passages described herein can be better understood with reference to the following figures and descriptions. It should be understood that some elements in the figures are not necessarily to scale, emphasis instead being placed on illustrating the principles disclosed herein. In the figures, corresponding parts / steps are indicated by like reference numerals throughout the various views.

[0020] [Figure 1]FIG. 1 depicts a perspective / front view of a bioprocessing system containing a filtration arrangement utilizing a manifold assembly according to an exemplary embodiment of the present disclosure.

[0021] [Figure 2] FIG. 2 depicts a perspective view of a filtration arrangement of the bioprocessing system depicted in FIG. 1, the filtration arrangement including a manifold assembly according to an exemplary embodiment of the present disclosure.

[0022] [Figure 3] FIG. 3 depicts a perspective view of the manifold assembly depicted in FIG. 2 and of the filtration arrangement according to an exemplary embodiment of the present disclosure.

[0023] [Figure 4] FIG. 4 depicts an exploded view of the manifold assembly depicted in FIG.

[0024] [Figure 5A] FIG. 5A depicts a perspective view of the manifold of the manifold assembly depicted in FIG.

[0025] [Figure 5B] FIG. 5B depicts a side view of the manifold depicted in FIG. 5A.

[0026] [Figure 6A] FIG. 6A depicts a perspective view of the exterior surface of the end cap of the manifold assembly depicted in FIG.

[0027] [Figure 6B] FIG. 6B depicts a perspective view of the interior surface of the end cap depicted in FIG. 6A.

[0028] [Figure 6C] FIG. 6C depicts a cross-sectional view of the end cap depicted in FIG. 6A, the cross-section being taken along line 6C-6C in FIG. 6A.

[0029] [Figure 7] FIG. 7 depicts a perspective view of the compression pin of the end cap depicted in FIG. 6A.

[0030] [Figure 8] FIG. 8 shows a perspective view of the compression limiter of the manifold shown in FIG. 5A.

[0031] [Figure 9A] FIG. 9A depicts a perspective view of the interaction and compression between the two compression pins depicted in FIG. 7 and the compression limiter depicted in FIG.

[0032] [Figure 9B] FIG. 9B depicts a cross-sectional view of the interaction and compression between the two compression pins and compression limiter depicted in FIG. 9A, the cross-section being taken along line 9B-9B in FIG. 9A.

[0033] [Figure 9C] Figure 9C shows a cross-sectional view of the manifold assembly shown in Figure 3, showing the compression pins of each end cap of the manifold assembly, as shown in Figure 6A, abutting the compression limiters of the manifold shown in Figure 5A. The cross-section is taken along line 9C-9C in Figure 3.

[0034] [Figure 10] FIG. 10 depicts a perspective view of the upper gasket of the manifold assembly depicted in FIG.

[0035] [Figure 11] FIG. 11 depicts a perspective view of the lower gasket of the manifold assembly depicted in FIG.

[0036] [Figure 12A] FIG. 12A shows a perspective view of the manifold shown in FIG. 5A and the location and arrangement of the upper and lower gaskets relative to a first side of the manifold.

[0037] [Figure 12B] FIG. 12B shows a perspective view of the end cap shown in FIG. 6A and the location and arrangement of the upper and lower gaskets relative to the interior surface of the end cap.

[0038] [Figure 13] FIG. 13 depicts a cross-sectional view of the feed ports and feed conduits of the manifold assembly depicted in FIG. 3, the cross-section being taken along line 13-13 in FIG.

[0039] [Figure 14] FIG. 14 depicts a cross-sectional view of the drain ports and drain conduits of the manifold assembly depicted in FIG. 3, the cross-section being taken along line 14-14 in FIG.

[0040] [Figure 15] FIG. 15 depicts a cross-sectional view of the manifold assembly depicted in FIG. 3, the cross-section being taken along line 15-15 in FIG.

[0041] [Figure 16] FIG. 16 depicts a cross-sectional view of the filtrate ports and filtrate conduits of the manifold assembly depicted in FIG. 3, the cross-section being taken along line 16-16 in FIG.

[0042] [Figure 17] FIG. 17 depicts a cross-sectional view of the retentate port and retentate conduit of the manifold assembly depicted in FIG. 3, the cross-section being taken along line 17-17 in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0043] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, where like numerals refer to like parts throughout, and in which are shown, by way of illustration, embodiments that may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the embodiments is defined by the appended claims and their equivalents.

[0044] Aspects of the present disclosure are disclosed in the description herein. Alternative embodiments of the present disclosure, and equivalents thereof, may be devised without departing from the spirit or scope of the present disclosure. It should be noted that discussions herein of "one embodiment," "embodiment," "exemplary embodiment," etc., indicate that the described embodiment may include particular features, structures, or characteristics, and that such particular features, structures, or characteristics are not necessarily included in all embodiments. In addition, references to the above do not necessarily include reference to the same embodiment. Finally, whether explicitly described or not, those skilled in the art will readily understand that each particular feature, structure, or characteristic of a given embodiment can be utilized in conjunction with or in combination with any other embodiment described herein.

[0045] Various operations may be described as multiple discrete actions or operations, in a sequence that is most helpful in understanding the claimed subject matter. However, the order of description should not be construed to imply that these operations are necessarily order dependent. In particular, these operations may not be performed in the order presented. The described operations may be performed in a different order than in the described embodiments. Various additional operations may be performed and / or described operations may be omitted in additional embodiments.

[0046] In this disclosure, the phrase "A and / or B" means (A), (B), or (A and B). In this disclosure, the phrase "A, B, and / or C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C).

[0047] As used in connection with aspects of the present disclosure, the terms "including," "including," "having," and the like are synonymous.

[0048] Turning to FIG. 1 , a bioprocessing system 10 configured to process a biological liquid is depicted. The bioprocessing system 10 may be configured to purify a biopharmaceutical liquid to obtain a product such as, but not limited to, a monoclonal antibody, a vaccine, or a recombinant protein. The bioprocessing system 10 may include a tank cart 20, a processing cart 30, and a filtration arrangement 40. The tank cart 20 may include a feed or recycle tank 22, at least one feed pump 24, and at least one transfer pump 26. In the depicted embodiment, the tank cart 20 includes a single feed pump 24 and two transfer pumps 26(1), 26(2). The feed tank 22 may be configured to contain the biological liquid to be processed by the bioprocessing system 10 and, in some cases, may include a mixer (not shown). The feed pump 24 may be configured to pump the biological liquid from the feed tank 22 to the processing cart 30 and ultimately through the filtration arrangement 40. Transfer pumps 26(1), 26(2) may be configured to deliver reagents and solutions to processing cart 30 for introduction of the reagents and solutions into the biological fluid. Feed pump 24 and transfer pumps 26(1), 26(2) may be any type of pump suitable for bioprocessing system 10, including, but not limited to, low-shear diaphragm pumps.

[0049] Continuing to show in FIG. 1 , the processing cart 30 is configured to be positioned adjacent to or abutting the tank cart 20 and may be configured to support a processing device 32. The processing device 32 may contain a series of valves that, depending on operation, determine flow paths for delivering the biological liquid from the feed tank 22 to the filtration arrangement 40 and for extracting a filtrate, retentate, and drain of the biological liquid from the filtration arrangement 40. The processing device 32 may further determine flow paths for delivering the filtrate, retentate, and drain to their respective destinations (e.g., the feed tank 22, other storage devices, etc.), as well as for introducing / mixing reagents and solutions with the biological liquid. The processing device 32 may include a controller 34 configured to control the valves of the processing device 32.

[0050] As best shown in FIGS. 1 and 2 , the filtration arrangement 40 includes a filtrate cart 42 that can be positioned adjacent (e.g., proximate) or abutting the tank cart 20 and / or the processing cart 30. The filtration cart 42 may further include a mounting mechanism 44 that can include one or more mounting plates 46 movably disposed on fixed rails 48 and reference rods 49. As further shown in FIG. 2 , the filtration arrangement 40 may further include a manifold assembly 50 that can be disposed on the mounting mechanism 44. As described in more detail below, the manifold assembly 50 can be configured to receive at least one reference rod 49 to facilitate positioning and orientation of the manifold assembly 50 on the mounting mechanism 44. The filtration arrangement 44 may also include any number of filtration cassettes 60 that can be used to filter the biological fluid through the TFF process. As shown in FIG. 2 , the filtration cassettes 60 can be disposed between the manifold assembly 50 and the mounting plate 46 of the mounting mechanism 44. Securing mechanism 44 may be configured to secure one or more filtration cassettes 60 to one side of manifold assembly 50. In some embodiments, as depicted in FIG. 2 , the manifold assembly may be a center manifold assembly 50 with filter cassettes 60 disposed on two sides of manifold assembly 50. In other words, center manifold assembly 50 may be sandwiched between filtration cassettes 60, which may be further sandwiched between securing plates 46 of securing mechanism 44. Once properly positioned, manifold assembly 50 may be configured to deliver biological fluid from processing device 32 to filtration cassettes 60 and from filtration cassettes 60 back to processing device 32.

[0051] Continuing with Figures 1 and 2, tubing 70 can connect the various components of bioprocessing system 10 to one another. Thus, tubing 70 can connect feed tank 22 to feed pump 24, and feed pump 24 can connect processing device 32. Tube 70 can further connect processing device 32 to manifold assembly 50 of filtration arrangement 40. As further shown, tubing 70 can further connect processing device 32 to transfer pumps 26(1), 26(2) and directly to feed tank 22. In addition, tubing 70 can connect transfer pumps 26(1), 26(2) to sources of reagents and solutions, as well as connect processing device 32 to various storage devices for filtrate and drain of biological fluids.

[0052] While FIG. 1 depicts an exemplary embodiment of a bioprocessing system 10 that may be utilized to process a biological fluid, the depicted exemplary embodiment is not intended to be limited to the details shown and described above. It will be apparent that various modifications and structural changes can be made to the bioprocessing system 10 depending on the type of processing performed on the biological fluid. In addition, FIG. 2 depicts an exemplary embodiment of a filtration arrangement 40 that may be utilized by the bioprocessing system 10, the filtration arrangement 40 being configured to utilize a manifold assembly 50, which will be described in further detail below. The depicted exemplary embodiment of the filtration arrangement 40 is not intended to be limited to the details shown and described above. It will be apparent that various modifications and structural changes can be made to the filtration arrangement 44 depending on the type of processing performed on the biological fluid, as long as the filtration arrangement 44 is capable of utilizing the manifold assembly 50 described herein.

[0053] 3 and 4, one embodiment of a disposable manifold assembly 50 utilized in the filtration arrangement 40 of the bioprocessing system 10. The depicted embodiment of the manifold assembly 50 is a center manifold assembly 50, where, as described above, the center manifold assembly 50 allows a filter cassette 60 to be positioned on the opposite side of the manifold assembly 50. As described in further detail below, several components of the manifold assembly 50 depicted in FIGS. 3 and 4 can be injection molded or constructed via additive manufacturing processes, including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), and the like.

[0054] The manifold assembly 50 may include a first side 52, an opposing second side 53, a top end 54 spanning between the first side 52 and the second side 53, and a bottom end 55 opposite the top end 54, which also spans between the first side 52 and the second side 53. The manifold assembly 50 may further include a first longitudinal end 56 spanning between the first side 52, the second side 53, the top end 54, and the bottom end 55, as well as a second longitudinal end 57 opposite the first longitudinal end 56. The second longitudinal end 57 may also span between the first side 52, the second side 53, the top end 54, and the bottom end 55. Thus, the manifold assembly 50 may have a substantially rectangular prismatic shape.

[0055] As best shown in FIG. 4, the manifold assembly 50 may include a center manifold 100, two end caps 200, two upper gaskets 300, and two lower gaskets 400. The center manifold 100 is best shown in FIGS. 4, 5A, and 5B, where the center manifold 100 is depicted insulated from the end caps 200 and gaskets 300, 400 in FIGS. 5A and 5B. The center manifold 100 can be constructed via an injection molding process and may be formed from any number of materials adapted for use in an injection molding process. These materials include, but are not limited to, plastics and thermoplastics such as acrylic, acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polyoxymethylene, polypropylene, thermoplastic elastomers, thermoplastic polyurethanes, silicone, polysulfone, and the like. In some embodiments, the center manifold 100 may be formed from 30% glass fiber reinforced polysulfone. As such, the center manifold 100 can have a durometer hardness value in the range of approximately 80 to 90 on the Rockwell M scale. In some embodiments, the center manifold 100 may be constructed via additive manufacturing techniques, including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), and the like. While FIG. 5B depicts a side view of the first side 102 of the center manifold 100, it should be understood that the second side 104 of the center manifold 100 is a mirror image of, but substantially identical to, that of the first side 102 of the center manifold 100. As such, any depiction and / or description of the first side 102 of the center manifold 100 also applies to the second side 104 of the center manifold 100.

[0056] The center manifold 100 may have a substantially rectangular prismatic shape, like that of the manifold assembly 50, and has a first side 102 and an opposing second side 104. The center manifold 100 further includes a top end 106 spanning between the first side 102 and the second side 104, an opposing bottom end 108 also spanning between the first side 102 and the second side 104, and first and second longitudinal ends 110, 112 facing each other. The first longitudinal end 110 and the second longitudinal end 112 may each span between the first side 102, the second side 104, the top end 106, and the bottom end 108. The first longitudinal end 110 of the center manifold 100 may form at least a portion of the first longitudinal end 56 of the manifold assembly 50, while the second longitudinal end 112 of the center manifold 100 may form at least a portion of the second longitudinal end 57 of the manifold assembly 50. Additionally, the top end 106 of the center manifold 100 may form at least a portion of the top end 54 of the manifold assembly 50, while the bottom end 108 of the center manifold 100 may form at least a portion of the bottom end 55 of the manifold assembly 50.

[0057] The depicted center manifold 100 may include a feed port 120, a drain port 130 (i.e., a lower filtrate port), a filtrate port 140 (i.e., an upper filtrate port), and a retentate port 150, all located at the first longitudinal end 110. Thus, the feed port 120, the drain port 130, the filtrate port 140, and the retentate port 150 are all located on the same side / end of the center manifold 100. With the ports 120, 130, 140, and 150 located on the same side / end of the center manifold 100, then the ports 120, 130, 140, and 150 are located on the same side / end of the manifold assembly 50, as best shown in FIG. 3 . The feed port 120 may, in some embodiments, function as an inlet to the center manifold 100. Feed opening 120 may contain a feed conduit 122 and a series of feed outlets 124 evenly spaced along feed conduit 122 such that feed outlets 124 are oriented toward first side 102 and second side 104 of center manifold 100 (best shown in FIGS. 5B and 13). Drain port 130, filtrate port 140, and retentate port 150 may, in some embodiments, function as outlets to center manifold 100. Drain port 130 may also contain a drain conduit 132 and a series of drain inlets 134 evenly spaced along drain conduit 132 such that drain inlets 134 are oriented toward first side 102 and second side 104 of center manifold 100 (best shown in FIGS. 5B, 14, and 15). Similar to the drain port 130, the filtrate port 140 and the retentate port 150 each contain a conduit 142, 152. The filtrate conduit 142 of the filtrate port 140 may include a series of filtrate inlets 144 spaced along the filtrate conduit 142 such that the filtrate inlets 144 are oriented toward the first and second sides 102, 104 of the center manifold 100 (best seen in FIGS. 5B and 17).Similarly, the retentate conduit 152 of the retentate port 150 may include a series of retentate inlets 154 spaced along the retentate conduit 152 such that the retentate inlets 154 are oriented toward the first and second sides 102, 104 of the center manifold 100 (best shown in Figures 5B and 16).

[0058] The first longitudinal end 110 further includes an upper slot 160 and a lower slot 162. The upper slots 160, 162 may span across the first longitudinal end 110 from the first side 102 to the second side 104 and be disposed between the feed port 120 and the retentate port 150. As further shown, the upper slot 160 may be spaced apart from the lower slot 162 such that the upper slot 160 is disposed on the first longitudinal end 110 closer to the top end 106 than to the bottom end 108, while the lower slot 162 may be disposed on the first longitudinal end 110 closer to the bottom end 108 than to the top end 106. Thus, the upper slot 160 may be disposed above the midpoint of the first longitudinal end 110, and the lower slot 162 may be disposed below the midpoint of the first longitudinal end 110. Disposed on each of the upper and lower slots 160, 162 may be an engagement flange 164. The engagement flanges 164 may be oriented transverse to the length of the upper and lower slots 160, 162 and may be disposed within the slots 160, 162 equidistant from the first and second sides 102, 104 of the center manifold 100. The second elongated end 112 may also include upper and lower slots 160, 162 that each contain an engagement flange 164 similar to that of the first elongated end 110.

[0059] Continuing with reference to FIGS. 5A and 5B and further to FIG. 8, the center manifold 100 may include a series of compression limiters 170 disposed within compression limiter openings 178. FIG. 8 depicts an exemplary embodiment of the compression limiter 170. As shown, the compression limiter 170 may be substantially cylindrical in shape and have a first end 172, a second end 174, and a conduit 176 spanning through the compression limiter 170 from the first end 172 to the second end 174. In other embodiments, the compression limiter 170 may have any other shape. Each of the compression limiter openings 178 extends through the center manifold 100 from the first side 102 to the second side 104 of the center manifold 100. The compression limiters 170 then extend through the compression limiter openings 178 from the first side 102 of the center manifold 100 to the second side 104 of the center manifold 100. Thus, the first end 172 of the compression limiter 170 may be located on the first side 102 of the center manifold 100, while the second end 174 of the compression limiter 170 may be located on the second side 104 of the center manifold (as best shown in FIG. 9C ). The compression limiter 170 may be constructed from any metallic, plastic, or other material configured to withstand a compressive force of at least approximately 5 tons. In some embodiments, the compression limiter 170 may be formed from stainless steel, including, but not limited to, SAE 316L stainless steel. Thus, the compression limiter 170 may have a durometer hardness value ranging from approximately 75 to 95 on the Rockwell B scale. When constructing the center manifold 100, the center manifold 100 may be injection molded or additively manufactured around the compression limiter 170 to at least partially capture the compression limiter 170 within the compression limiter opening 178. In some additional embodiments, the compression limiter 170 may be coupled to the center manifold 100 via a post-molding operation, including, but not limited to, ultrasonic bonding, heat bonding, and / or other mechanical insertion methods.

[0060] 5A and 5B, the first side 102 of the center manifold 100 includes a series of feed openings 180 and drain passages 182 positioned closer to the bottom end 108 of the center manifold 100 than to the top end 106 of the center manifold 100. The feed openings 180 may be substantially circular openings, and the drain passages 182 may be elongated stadium- or capsule-shaped openings. The upper ends of the feed openings 180 and drain passages 182 may be horizontally aligned with one another such that the feed openings 180 and drain passages 182 span across the bottom of the first side 102 of the center manifold 100 in alternating directions from the first elongated end 110 to the second elongated end 112. In other words, a portion (i.e., the upper end) of each drain passage 182 may be located between two feed openings 180. Moreover, the two outermost drain paths 182 may be curved, while the two innermost drain paths 182 may be substantially vertical. Despite the outermost drain paths 182 being curved, all of the drain paths 182 may extend in a substantially vertical direction. Moreover, the two outermost drain paths 182 may be curved to extend around two reference rod openings 184 disposed below the feed opening 180. The two reference rod openings 184 may be configured to receive the reference rods 49 of the securing mechanism 44 of the filtration arrangement 40, as shown in FIG. 2. As best shown in FIG. 5B, the feed opening 180 may be aligned with the feed outlet 124 of the feed conduit 122 of the feed port 120. Furthermore, the bottom end of the drain path 182 may be aligned with the drain inlet 134 of the drain conduit 132 of the drain port 130.

[0061] Continuing with Figures 5A and 5B, the first side 102 of the center manifold 100 further includes a series of filtrate pathways 186 and retentate openings 188 positioned closer to the top end 106 of the center manifold 100 than to the bottom end 108 of the center manifold 100. The filtrate pathways 186 may be elongated stadium- or capsule-shaped openings, while the retentate openings 188 may be substantially circular openings. The filtrate pathways 186 may extend in a substantially vertical direction. The bottom ends of the retentate openings 188 and filtrate pathways 186 may be horizontally aligned with each other such that the retentate openings 188 and filtrate pathways 186 alternately traverse the top of the first side 102 of the center manifold 100 from the first elongated end 110 to the second elongated end 112. In other words, a portion (i.e., the bottom end) of each filtrate pathway 186 may be located between two retentate openings 188. 5B, the retentate opening 188 may be aligned with the retentate inlet 154 of the retentate conduit 152 of the retentate port 150. Furthermore, the upper end of the filtrate path 186 may be aligned with the filtrate inlet 144 of the filtrate conduit 142 of the filtrate port 140.

[0062] 5A and 5B, the first side 102 of the center manifold 100 may include an upper gasket alignment projection 190 and a lower gasket alignment projection 192. The upper gasket alignment projection 190 may be positioned proximate the filtrate pathway 186 and the retentate opening 188, while the lower gasket alignment projection 192 may be positioned proximate the feed opening 180 and the drain pathway 182. More specifically, the upper gasket alignment projection 190 may include two projections, one positioned proximate the first longitudinal end 110 and the other positioned proximate the second longitudinal end 112. Additionally, the upper gasket alignment projection 190 may be positioned above the retentate opening 188 and the bottom end of the filtrate pathway 186, but not below the top end of the filtrate pathway 186. Similar to the upper gasket alignment projection 190, the lower gasket alignment projection 192 may include two projections, one positioned proximate the first elongated end 110 and the other positioned proximate the second elongated end 112. The lower gasket alignment projection 192 may further be positioned below the upper end of the feed opening 180 and the drain passage 182, or may be positioned above the lower end of the drain passage 182.

[0063] 5A and 5B depict the first side 102 of the center manifold 100, it should be understood that the second side 104 of the center manifold 100 is a mirror image of, but substantially identical to, that of the first side 102 of the center manifold 100. Thus, any depictions and / or descriptions relating to the first side 102 of the center manifold 100 also apply to the second side 104 of the center manifold 100.

[0064] 6B-6C, an embodiment of an end cap 200 of a manifold assembly 50 is depicted. As previously described, the manifold assembly 50 can include multiple end caps 200, and each end cap 200 of the manifold assembly 50 can be substantially identical to one another. Thus, while FIGS. 6A-6C depict a single end cap 200 of the manifold assembly 50, it should be understood that the illustrations and / or descriptions relating to the end cap 200 can also apply to the other end caps 200 of the manifold assembly 50. Similar to the center manifold 100, the end cap 200 can be constructed via an injection molding process and may be formed from any number of materials adapted to be utilized in an injection molding process. These materials include, but are not limited to, plastics and thermoplastics such as acrylic, acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polyoxymethylene, polypropylene, thermoplastic elastomers, thermoplastic polyurethanes, silicone, polysulfone, and the like. In some embodiments, the end cap 200 may be formed from 30% glass fiber reinforced polysulfone. As such, the end cap 200 may have a durometer hardness value in the range of approximately 80-90 on the Rockwell M scale. In some embodiments, the center manifold 100 may be constructed via additive manufacturing techniques, including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), and the like.

[0065] 6A-6B may include an exterior surface 202, an interior surface 204 opposite the exterior surface 202, a top end 206 spanning between the exterior surface 202 and the interior surface 204, and a bottom end 208 opposite the top end 206 and spanning between the exterior surface 202 and the interior surface 204. The end cap 200 may further include a first side end 210 and an opposing second side end 212. The first and second side ends 210, 212 may span between the exterior surface 202, the interior surface 204, the top end 206, and the bottom end 208. Thus, the end cap 200 may have a substantially rectangular prism shape.

[0066] As best shown in FIGS. 6A and 6B , the end cap 200 may include a series of feed openings 220 and a series of drain openings 230. The feed openings 220 and drain openings 230 may span from the exterior surface 202 through the end cap 200 to the interior surface 204. FIG. 6A illustrates that the feed openings 220 and drain openings 230 may be substantially circular openings on the exterior surface 202 of the end cap 200. As shown, the feed openings 220 may be larger in diameter than the drain openings 230. Moreover, the feed openings 220 and drain openings 230 may be horizontally aligned with one another such that the feed openings 222 and drain openings 230 span across the bottom of the end cap 200 in alternating rows from the first side end 210 to the second side end 212. In other words, each drain opening 230 may be located between two feed openings 220. As further shown in FIG. 6B , the feed openings 220 may also be substantially cylindrically shaped on the inner surface 204 of the end cap 200, while the drain openings 230 may conversely have an elongated stadium or capsule shape. Thus, each drain opening 230 may define an elongated interior surface channel 232 along the inner surface 204 of the end cap 200. As shown, the elongated interior surface channels 232 of the drain openings 230 may extend substantially vertically downward from the horizontal plane in which the feed openings 220 are disposed. Similar to the drain channels 182 of the center manifold 100, the two outermost elongated interior surface channels 232 may be curved, while the two innermost elongated interior surface channels 232 may be substantially vertical. The two outermost elongated interior surface channels 232 may be curved to extend around two reference rod openings 240 disposed below the feed openings 220. The two reference rod openings 240 may be configured to receive the reference rods 49 of the securing mechanism 44 of the filtering arrangement 40, as depicted in FIG.

[0067] Continuing with Figures 6A and 6B, end cap 200 may further include a series of filtrate openings 250 and a series of retentate openings 260. Filtrate openings 250 and retentate openings 260 may also span from exterior surface 202 through end cap 200 to interior surface 204. Figure 6A illustrates that filtrate openings 250 and retentate openings 260 may be substantially circular openings on exterior surface 202 of end cap 200. In the illustrated embodiment, retentate openings 260 may be larger in diameter than filtrate openings 250. Moreover, filtrate openings 250 and retentate openings 260 may be horizontally aligned with one another such that filtrate openings 250 and retentate openings 260 alternately span across the bottom of end cap 200 from first side end 210 to second side end 212. In other words, each filtrate opening 250 may be disposed between two retentate openings 260. 6B, the retentate openings 260 may also be substantially cylindrically formed on the interior surface 204 of the end cap 200, while conversely, the filtrate openings 250 may have an elongated stadium or capsule shape. Thus, each of the filtrate openings 250 may define an elongated interior surface channel 252 that extends substantially vertically upward along the interior surface 204 of the end cap 200 from a horizontal plane in which the retentate openings 260 are located.

[0068] 6A-6C, end cap 200 further includes a series of compression pin housings 270 each accessible via an external compression pin opening 272 and an internal compression pin opening 274. External compression pin openings 272 are disposed on the exterior surface 202 of end cap 200, while internal compression pin openings 274 are disposed on the interior surface 204 of end cap 200. Thus, compression pin housings 270 extend from exterior surface 202 of end cap 200 to interior surface 204 of end cap 200. Compression pin housings 270 may be disposed primarily between the group of feed openings 220 and drain openings 230 and the group of filtrate openings 250 and retentate openings 260. In the illustrated embodiment, the compression pin housings 270 can be grouped into a first pair of compression pin housings 270 positioned closer to the filtrate and retentate openings 250, 260 than to the feed and drain openings 220, 230, and a second pair of compression pin housings 270 positioned closer to the feed and drain openings 220, 230 than to the filtrate and retentate openings 250, 260. As best seen in FIG. 6C, each compression pin housing 270 can be configured to house a compression pin 280.

[0069] FIG. 7 depicts a perspective view of a compression pin 280. The compression pin 280 may include a head 282, a flange 284, a first shank portion 286, and a second shank portion 288. The head 282 and the first shank portion 286 may have the same or substantially similar diameters. The flange 284 may have a diameter larger than the diameters of the head 282, the first shank portion 286, and the second shank portion 288. The second shank portion 288 may have a diameter smaller than the diameters of the head 282, the flange 284, and the first shank portion 286. The difference in diameter between the first shank portion 286 and the second shank portion 288 defines an engagement surface 289. The compression pin 280 may be constructed from any metallic material, plastic material, or other material configured to withstand a compressive force of at least approximately 5 tons. Similar to the compression limiter 170, the compression pin 280 may be constructed from stainless steel, including but not limited to SAE 316L stainless steel, and thus may have a durometer hardness value ranging from approximately 75 to 95 on the Rockwell B scale.

[0070] 6B-6C, each compression pin 280 is positioned within the pin housing 270 such that the head 282 of each compression pin 280 is positioned within an associated external compression pin opening 272 on the exterior surface 202 of the end cap 200 (as best seen in FIGS. 6B and 6C) and the second shank portion 288 extends from the internal compression pin opening 274 (as best seen in FIG. 6C). FIG. 6C best illustrates that the flange 284 has a wider diameter than the diameters of the other heads 282, first shank portion 286, and second shank portion 288, and because the flange 284 has a wider diameter than the external and internal compression pin openings 272, 274, the compression pin 280 is prevented from sliding through the compression pin housing 270. More specifically, end cap 200 may be injection molded or additively manufactured, like that of center manifold 100, around compression pin 280, around compression limiter 170, to capture compression pin 280 within compression pin housing 270. In some additional embodiments, compression pin 280 may be coupled to end cap 200 via post-molding operations, including but not limited to ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods.

[0071] 6A and 6B, the end cap 200 also includes engagement arms 290 extending rearward (i.e., from the interior surface 204) from either the first side end 210 or the second side end 212 of the end cap 200. Each engagement arm 290 may include a proximal or first end 292 coupled to the end cap 200 and an opposing distal or second engagement end 294. The second engagement end 294 of each engagement arm 290 may include a protrusion 296. In the illustrated embodiment, the end cap 200 may include two engagement arms 290. One engagement arm 290 may extend rearward from the first side end 210 at a position closer to the bottom end 208 than to the top end 206, while the other engagement arm 290 may extend rearward from the second side end 212 at a position closer to the top end 206 than to the bottom end 208. Each engagement arm 290 can be sized to fit within the upper slot 160 and / or lower slot 162 of the center manifold 100 to removably couple the end cap 200 to the center manifold 100 .

[0072] 3, 4, and 9C , when the end caps 200 are removably coupled to the center manifold 100 such that one end cap 200 is coupled to the first side 102 of the center manifold 100 and the other end cap 200 is coupled to the second side 104 of the center manifold 100, the engagement arm 290 may extend into one of the upper or lower slots 160, 162 of the first and second longitudinal ends 110, 112 of the center manifold 100. When the engagement arm 290 is disposed within the upper slot 160, the protrusion 296 of the engagement arm 290 may be configured to abut and engage with the engagement flange 164 disposed in the upper slot 160. Similarly, when the engagement arm 290 is disposed within the lower slot 162, the protrusion of the engagement arm 290 may be configured to abut and engage with the engagement flange 164 disposed in the lower slot 162. In the illustrated embodiment, considering the position of the engagement arms 290 on the end cap 200, when the end cap 200 is removably coupled to the first side 102 of the center manifold 100, the engagement arms 290 located at the first side end 210 of the end cap 200 are positioned within the lower slots 162 of the first longitudinal end 110 of the center manifold 100, and the engagement arms 290 located at the second side end 212 of the end cap 200 are positioned within the upper slots 160 of the second longitudinal end 112 of the center manifold 100. Additionally, when the end cap 200 is removably coupled to the second side 104 of the center manifold 100, the engagement arms 290 disposed at the first side end 210 of the end cap 200 are positioned within the lower slots 162 of the second longitudinal end 112 of the center manifold 100, and the engagement arms 290 disposed at the second side end 212 of the end cap 200 are positioned within the upper slots 160 of the first longitudinal end 110 of the center manifold 100. In other embodiments, the engagement arms 290 of the end cap 200 may be positioned in both of the upper slots 160 or both of the lower slots 162 when coupled to the center manifold 100, instead of in the opposing slots 160, 162.Engagement of the protrusions 296 of the engagement arms 290 of the end cap 200 with the engagement flanges 164 of the upper and lower slots 160, 162 removably couples the end cap 200 to the center manifold 100 via a snap fit.

[0073] Moreover, when end cap 200 is removably coupled to center manifold 100, feed opening 220 of end cap 200 aligns with feed opening 180 of center manifold 100, regardless of which side 102, 104 of center manifold 100 end cap 200 is coupled to. In addition, drain opening 230, including elongated interior surface passage 232 thereof, aligns with drain passage 182 of center manifold 100. Filtrate opening 250, including elongated interior surface passage 252 of end cap 200, aligns with filtrate passage 186 of center manifold 100, while retentate opening 260 of end cap 200 aligns with retentate opening 188 of center manifold 100. Additionally, when the end cap 200 is coupled to the center manifold 100, the reference rod opening 240 of the end cap 200 is also aligned with the reference rod opening 184 of the center manifold.

[0074] Additionally, when the end caps 200 are removably coupled to the center manifold 100, the compression pins 280 of the end caps are aligned with and at least partially disposed within the compression limiters 170 of the center manifold 100, as best seen in Figures 9A-9C. As shown, each compression limiter 170 can be configured to engage two compression pins 280. More specifically, the second shank portion 288 of one compression pin 280 (e.g., the compression pin 280 of the end cap 200 connected to the first side 102 of the center manifold 100) can be positioned within the conduit 176 of the compression limiter 170 adjacent to the first end 172 of the compression limiter 170, while the second shank portion 288 of the other compression pin 280 (e.g., the compression pin 280 of the end cap 200 connected to the second side 104 of the center manifold 100) can be positioned within the conduit 176 of the compression limiter 170 adjacent to the second end 174 of the compression limiter 170. As further shown, when the end cap 200 is removably coupled to the center manifold 100, the engagement surface 289 of the compression pin 280 of the end cap 200 coupled to the first side 102 of the center manifold 100 is positioned against the first end 172 of the compression limiter 170, while the engagement surface 289 of the compression pin 280 of the end cap 200 coupled to the second side 104 of the center manifold 100 is positioned against the second end 174 of the compression limiter 170.

[0075] The presence of the compression limiter 170 and compression pin 280, in conjunction with the end cap 200 and center manifold 100 being injection molded or manufactured using additive manufacturing techniques, enables the manifold assembly 50 to withstand the clamping force from the clamping mechanism 44 of the filtration arrangement 40. In other words, the compression limiter 170 and compression pin 280 enable the manifold assembly 50 to be subjected to a compressive force of at least about 5 tons.

[0076] 10, 11, 12A, and 12B, upper and lower gaskets 300, 400 are depicted that may be disposed between the center manifold 100 and the end cap 200 when the end cap 200 is removably coupled to the center manifold 100. The manifold assembly 50 may include two upper gaskets 300 and two lower gaskets 400. The upper gaskets 300 are best depicted in FIGS. 10, 12A, and 12B. While only a single upper gasket 300 is depicted in FIGS. 10, 12A, and 12B, it should be understood that each of the upper gaskets 300 of the manifold assembly 50 may be identical to one another. Thus, any depiction and / or description of the upper gasket 300 depicted in FIGS. 10, 12A, and 12B also applies to the other upper gaskets 300 of the manifold assembly 50. Additionally, lower gasket 400 is best seen in Figures 11, 12A, and 12B. While only a single lower gasket 400 is shown in Figures 11, 12A, and 12B, it should be understood that each of the lower gaskets 400 of manifold assembly 50 may be identical to one another. Thus, any depiction and / or description of lower gasket 400 shown in Figures 11, 12A, and 12B also applies to the other lower gaskets 400 of manifold assembly 50.

[0077] 10 , upper gasket 300 includes an exterior surface 302 and an interior surface 304 opposite exterior surface 302. Upper gasket 300 may have a substantially rectangular shape with an upper end 306, a lower end 308 opposite upper end 306, a first side edge 310 spanning from upper end 306 to lower end 308, and a second side edge 312 spanning from upper end 306 to bottom end 308 opposite first side edge 310. Upper gasket 300 may include a series of retentate openings 320, a series of upper filtrate openings 330, and a series of lower filtrate openings 332. The retentate openings 320 and the lower filtrate openings 332 may be disposed within the upper gasket 300 closer to the bottom end 308 than to the top end 306, while the upper filtrate openings 330 may be disposed closer to the top end 306 than to the bottom end 308. The retentate openings 320 and the lower filtrate openings 332 may be substantially horizontally aligned from the first side end 310 to the second side end 312, or may be staggered. Thus, as shown, each lower filtrate opening 332 may be disposed between two retentate openings 320. The upper filtrate openings 330 may be substantially horizontally aligned from the first side end 310 to the second side end 312. Moreover, each upper filtrate opening 330 may be substantially vertically aligned with a corresponding lower filtrate opening 332. In the illustrated embodiment, the lower filtrate openings 332 may be substantially stadium- or capsule-shaped, while the retentate openings 320 and the upper filtrate openings 330 may be substantially circular. In other embodiments, the openings 320, 330, 332 may be any other shape, and the openings 320, 330, 332 may be the same shape or different shapes from one another.

[0078] As further shown, the upper gasket 300 can include two alignment openings 340, one aligned opening 340 positioned closer to the first side end 310 than to the second side end 312, and the other aligned opening 340 positioned closer to the second side end 312 than to the first side end 310. The alignment openings 340 can be sized and shaped to receive the upper gasket alignment protrusions 190 of the center manifold 100.

[0079] 12A , when the upper gasket 300 is positioned against the center manifold 100 (i.e., when the upper gasket 300 is sandwiched between the center manifold 100 and the end cap 200), the upper gasket alignment protrusion 190 may be positioned within the alignment opening 340 of the upper gasket 300. Moreover, the retentate opening 320 of the upper gasket 300 may be positioned within the retentate opening 188. The upper filtrate opening 330 may be aligned with the upper end of the filtrate path 186 of the center manifold 100, while the lower filtrate opening 332 may be aligned with the lower end of the filtrate path 186 of the center manifold 100.

[0080] 12B , when the upper gasket 300 is positioned against the interior surface 204 of the end cap 200 (i.e., when the upper gasket 300 is sandwiched between the center manifold 100 and the end cap 200), the retentate openings 320 of the upper gasket 300 may align with the retentate openings 260 of the end cap 200. Furthermore, the upper filtrate openings 330 of the upper gasket 300 may align with the upper ends of the elongated interior surface channels 252 of the filtrate openings 250 of the end cap 200, while the lower filtrate openings 332 may align with the lower ends of the elongated interior surface channels 252 of the filtrate openings 250 of the end cap 200.

[0081] Top gasket 300 can facilitate a seal between center manifold 100 and end cap 200, as well as around filtrate pathway 186, retentate opening 188, retentate opening 260, and filtrate opening 250. Top gasket 300 can be constructed from any material configured to facilitate a seal between surfaces, including, but not limited to, rubber, silicone, neoprene, cork, thermoplastic elastomer (TPE), and the like.

[0082] 11 , the lower gasket 400, similar to the upper gasket 300, includes an exterior surface 402 and an interior surface 404 opposite the exterior surface 402. The lower gasket 400 may have a substantially rectangular shape with an upper end 406, a lower end 408 opposite the upper end 406, a first side edge 410 spanning from the upper end 406 to the lower end 408, and a second side edge 412 opposite the first side edge 410 that also spans from the upper end 406 to the lower end 408. The lower gasket 400 may include a series of feed openings 420, a series of upper drain openings 430, and a series of lower drain openings 432. The feed openings 420 and the upper drain openings 430 may be located within the lower gasket 400 closer to the top end 406 than to the bottom end 408, and the lower drain openings 432 may be located closer to the bottom end 408 than to the top end 406. The feed openings 420 and the upper drain openings 430 may be substantially horizontally aligned from the first side end 410 to the second side end 412, or may be staggered. Thus, as shown, each drain opening 430 may be located between two feed openings 420. The lower drain openings 432 may be substantially horizontally aligned from the first side end 410 to the second side end 412. Moreover, each upper drain opening 430 may be substantially vertically aligned with a corresponding lower drain opening 432. In the illustrated embodiment, the upper drain openings 430 may be substantially stadium- or capsule-shaped, while the feed openings 420 and the lower drain openings 432 may be substantially circular. In other embodiments, openings 420, 430, 432 may be any other shape, and openings 420, 430, 432 may be the same shape or different shapes from one another.

[0083] As further depicted, the lower gasket 400 can include two alignment openings 440, one aligned opening 440 positioned closer to the first side end 410 than to the second side end 412, and the other aligned opening 440 positioned closer to the second side end 412 than to the first side end 410. The alignment openings 440 may be sized and shaped to receive the lower gasket alignment protrusions 192 of the center manifold 100. The lower gasket 400 may further include a pair of reference rod openings 450 positioned between the horizontally aligned lower drain opening 432, the horizontally aligned feed opening 420, and the upper drain opening 430.

[0084] 12A , when the lower gasket 400 is positioned relative to the center manifold 100 (i.e., when the lower gasket 400 is sandwiched between the center manifold 100 and the end cap 200), the lower gasket alignment projection 192 of the center manifold 100 may be positioned within the alignment opening 440 of the lower gasket 400. Additionally, the feed opening 420 of the lower gasket 400 may be aligned with the feed opening 180. The upper drain opening 430 may be aligned with the upper end of the drain passage 182 of the center manifold 100, and the lower drain opening 432 may be aligned with the lower end of the drain passage 182 of the center manifold 100. Additionally, the datum rod opening 450 of the lower gasket 400 may be aligned with the datum rod opening 184 of the center manifold 100.

[0085] 12B , when the lower gasket 400 is positioned against the interior surface 204 of the end cap 200 (i.e., when the lower gasket 400 is sandwiched between the center manifold 100 and the end cap 200), the feed opening 420 of the lower gasket 400 may align with the feed opening 220 of the end cap 200. Furthermore, the upper drain opening 430 of the upper gasket 400 may align with the upper end of the elongated interior surface passage 232 of the drain opening 230 of the end cap 200, while the lower drain opening 432 may align with the lower end of the elongated interior surface passage 232 of the drain opening 230 of the end cap 200. In addition, the datum rod opening 450 of the lower gasket 400 may align with the datum rod opening 240 of the end cap 200.

[0086] Similar to upper gasket 300, lower gasket 400 can facilitate a seal between center manifold 100 and end cap 200 and can seal around feed opening 180, drain passage 182, feed opening 220, and drain opening 230. Lower gasket 400 can be constructed from any material configured to facilitate a seal between surfaces, including, but not limited to, rubber, silicone, neoprene, cork, thermoplastic elastomer (TPE), and the like.

[0087] 13-17, various cross-sectional views of the manifold assembly 50 are shown depicting various flow paths through the manifold assembly 50, particularly when the manifold assembly 50 is positioned within the securing mechanism 44 of the filtration arrangement 40 and aligned with the filtration cassette 60. The flow path of the feed liquid is best seen in FIG. 13. The feed liquid flows into the manifold assembly 50 through the feed ports 120 and into the feed conduits 122. As previously explained, the feed conduits 122 include a series of feed outlets 124 aligned with the feed openings 180 on the sides 102, 104 of the center manifold 100, the feed openings 420 in the lower gaskets 400 disposed on the sides 102, 104 of the center manifold 100, and the feed openings 220 in the end caps 200 mounted on the sides 102, 104 of the center manifold 100. Thus, as shown, the feed liquid flows through the feed conduit 122 into the feed port 120 and out the feed outlet 124 of the feed conduit 122. The feed liquid then flows through the feed opening 180 in the center manifold 100, the feed opening 420 in the lower gasket 400, the feed opening 220 in the end cap 200, and into the filtration cassettes 60 located on either side 52, 53 of the manifold assembly 50.

[0088] As previously described, as liquid flows through filtration cassette 60, it is filtered into drain liquid, filtrate, and retentate, which return to manifold assembly 50 via filtration cassette 60 for flow back to processing device 32. FIGS. 14 and 15 depict the flow path of the drain liquid from filtration cassette 60 to manifold assembly 50 and from drain port 130. More specifically, the drain liquid enters manifold assembly 50 through drain opening 230 in end cap 200. The drain liquid may then separate into a first separated drain liquid and a second separated drain liquid. The first separated drain liquid may flow downward through a first passage defined by outer surface 402 of lower gasket 400 and elongated inner surface path 232 of drain opening 230 located in inner surface 204 of end cap 200. The first separated drain liquid then flows through the lower drain opening 432 of the lower gasket 400. The second separated drain liquid may flow through the upper drain opening 430 of the lower gasket 400 and then downwardly through a second passage defined by the drain path 182 of the center manifold 100 and the inner surface 404 of the lower gasket 400. The two separated drain liquids may mix or combine with each other at the lower end of the drain path 182 of the center manifold 100 before the drain liquid then flows through the drain inlet 134 of the drain conduit 132. Finally, the drain liquid may then flow through the drain conduit 132 and out the drain port 130.

[0089] 15 and 16 depict the flow path of filtrate from filtration cassette 60 to manifold assembly 50 and from filtrate port 140. More specifically, filtrate enters manifold assembly 50 through filtrate openings 250 in end cap 200. The filtrate may then separate into a first separated filtrate and a second separated filtrate. The first separated filtrate may flow upward through a first passage defined by outer surface 302 of upper gasket 300 and elongated interior surface channels 252 of filtrate openings 250 located in inner surface 204 of end cap 200. The first separated filtrate may then pass through upper filtrate openings 330 in upper gasket 300. The second separated filtrate may flow upward through lower filtrate openings 332 in lower gasket 300 and then through a second passage defined by filtrate channels 186 in center manifold 100 and inner surface 304 of upper gasket 300. The two separated filtrates may be mixed or combined with each other at the upper end of the filtrate path 186 of the center manifold 100 before the filtrate then flows through the filtrate inlet 144 of the filtrate conduit 142. Finally, the filtrate may then flow through the filtrate conduit 142 and out the filtrate port 140.

[0090] 17 depicts the flow path of retentate from filtration cassette 60 to manifold assembly 50 and from retentate port 150. More specifically, retentate enters manifold assembly 50 through retentate opening 260 in end cap 200. Because retentate opening 260 in end cap 200 is aligned with retentate opening 320 in top gasket 300 and retentate opening 188 in center manifold 100, retentate then flows through retentate opening 260 in end cap 200, and then through retentate opening 320 in top gasket 300 and retentate opening 188 in center manifold 100. The retentate then flows through retentate inlet 154 into retentate conduit 152. Finally, the retentate may then flow through retentate conduit 152 and out retentate port 150.

[0091] The manifold assembly 50 disclosed herein is manufactured using injection molding or additive manufacturing processes to provide a disposable manifold assembly that offers an improvement over existing stainless steel manifolds. The manifold assembly 50 includes a center manifold 100, two end caps 200 removably connectable to the center manifold 100 (via a snap-fit ​​arrangement or other known removably connectable methods), and gaskets 300, 400 disposed between the center manifold 100 and the end caps 200, as described above. The center manifold 100 and end caps 200 may be injection molded to at least partially capture a compression limiter 170 within the center manifold 100 and at least partially capture a compression pin 280 within the end caps 200. In other embodiments, the compression limiter 170 and compression pin 280 may be coupled to the center manifold 100 and end caps 200, respectively, via post-molding operations, including, but not limited to, ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods. Configuring the center manifold 100 and end caps 200 in this manner allows the manifold assembly 50 to be sterilized by known sterilization methods, including, but not limited to, gamma irradiation, autoclaving, and other gas or steam-based sterilization methods (including, but not limited to, ethylene oxide, chlorine dioxide, ozone, supercritical carbon dioxide, vaporized hydrogen peroxide, etc.). Additionally, configuring the center manifold 100 and end caps 200 in this manner also allows the ports 120, 130, 140, and 150 of the center manifold 100 to all be located on the same side of the manifold assembly 50. This makes the manifold assembly 50 more ergonomic for the operator for use in and integration with the securing mechanism 44 of the filtration arrangement 40. Configuring the center manifold 100 and end caps 200 in this manner also allows the manifold assembly 50 disclosed herein to be lighter than conventional stainless steel manifolds.Furthermore, by constructing the manifold assembly 50 from various components that are removably connected to one another, individual components of the manifold assembly 50 (e.g., the center manifold 100, the end caps 200, the gaskets 300, 400, etc.) can be replaced rather than the entire manifold assembly 50 if damaged.

[0092] While the devices presented herein have been shown and described in detail with reference to specific embodiments thereof, it is nevertheless not intended to be limited to the details shown, as it will be apparent that various modifications and structural changes may be made within the scope and range of equivalents of the claims without departing from the scope of the invention. For example, the flow paths presented herein can be modified to include any number of channels, deviations, cavities, inlets, and outlets, the components of the manifold assemblies presented herein can include any number of ports, openings, and holes, and the manifold assemblies can include any number of components, end caps, compression pins, compression limiters, and gaskets.

[0093] Additionally, various features from one embodiment can be incorporated into another embodiment. That is, the above disclosure may be considered to encompass multiple separate inventions with independent utility. While each of these inventions is disclosed in a preferred form, the specific embodiments thereof as disclosed and represented herein should not be considered in a limiting sense, as countless variations are possible. The subject matter of the inventions encompasses all novel and non-obvious combinations and subcombinations of the various elements, features, functions, and / or properties disclosed herein. Accordingly, it is appropriate that the appended claims be accorded the broadest interpretation consistent with the scope of the present disclosure, as set forth in the following claims.

[0094] It should also be understood that terms such as "left," "right," "top," "bottom," "front," "rear," "side," "height," "length," "width," "top," "bottom," "inside," "outside," "internal," and "external," as may be used herein, merely describe points of reference and are not intended to limit the present invention to any particular orientation or configuration. Furthermore, the term "exemplary" is used herein to describe an example or illustration. The embodiments described herein as exemplary should not be construed as preferred or advantageous embodiments, but rather as examples or illustrations of possible embodiments of the present invention. Additionally, it should be understood that the components of the bioprocessing systems described herein, the manifold assemblies described herein, or portions thereof, can be fabricated from any suitable material or combination of materials, including, but not limited to, thermoplastics, plastics, or metals (e.g., copper, bronze, aluminum, steel, etc.), as well as derivatives and combinations thereof. Additionally, it should be further understood that the steps of the methods described herein can be performed in any order or in any suitable manner.

[0095] Finally, when used herein, the term "comprises" and its derivatives (e.g., "comprising") should not be understood in an exclusive sense; i.e., these terms should not be interpreted as excluding the possibility that what is described and defined may include additional elements, steps, etc. Similarly, when any description recites "a" or "a first" element, or its equivalent, it should be understood to include the inclusion of one or more such elements, and not to require or exclude two or more such elements. On the other hand, when used herein, the term "approximately" and its variants (e.g., "approximately") should be understood to indicate a value very close to the value associated with said term. That is, deviations from the exact value within reasonable limits should be allowed, since those skilled in the art will understand that such deviations from a stated value are unavoidable due to inaccuracies of measurement, etc. The same applies to the terms "about," "around," "generally," and "substantially."

Claims

1. 1. A manifold assembly for a tangential flow filtration assembly comprising: a manifold having a first surface, a second surface opposite the first surface, a first end spanning between the first and second surfaces, and a second end spanning between the first and second surfaces and opposite the first end; a feed port extending from the first end of the manifold; a retentate port extending from the first end of the manifold; and A filtrate port extending from the first end of the manifold: The manifold assembly.

2. 10. The manifold assembly of claim 1, further comprising an end cap removably coupled to either the first surface or the second surface of the manifold.

3. a first series of openings in fluid communication with the feed port; a second series of openings in fluid communication with the retentate port; and A third series of openings in fluid communication with the filtrate port: The manifold assembly of claim 2 further comprising:

4. End caps: a fourth series of openings extending through the end cap; a fifth series of openings extending through the end cap; and A sixth series of openings extending through the end cap: The manifold assembly of claim 3 further comprising:

5. 5. The manifold assembly of claim 4, wherein when the end cap is removably coupled to the manifold, the fourth series of openings in the end cap are aligned with the first series of openings in the manifold, the fifth series of openings in the end cap are aligned with the second series of openings in the manifold, and the sixth series of openings in the end cap are aligned with the third series of openings in the manifold.

6. 1. A manifold assembly for a tangential flow filtration assembly comprising: a manifold having a first surface and a second surface opposite the first surface; a compression limiter at least partially captured within the manifold so as to extend from a first surface to a second surface of the manifold; and End cap connected to the first surface of the manifold: The manifold assembly.

7. 7. The manifold assembly of claim 6, wherein the manifold is injection molded or additively manufactured around the compression limiter.

8. The manifold assembly of claim 7 , wherein the end cap includes an exterior surface and an interior surface opposite the exterior surface.

9. a compression pin at least partially captured within the end cap such that a portion of the compression pin extends from an interior surface of the end cap; The manifold assembly of claim 8 further comprising:

10. The manifold assembly of claim 9 , wherein the compression pin is aligned with the compression limiter when the end cap is coupled to the manifold.

11. 10. The manifold assembly of claim 9, wherein the compression limiter is a cylinder having a conduit.

12. 12. The manifold assembly of claim 11, wherein when the end cap is coupled to the manifold, the compression pin abuts an end of the compression limiter and a portion of the compression pin is disposed within the conduit of the compression limiter.

13. The manifold assembly of claim 9 , wherein the end cap and the manifold have a first durometer value.

14. 14. The manifold assembly of claim 13, wherein the compression limiter and the compression pin have a second durometer value greater than the first durometer value.

15. 1. A manifold assembly for a tangential flow filtration assembly comprising: a manifold having a first surface, a second surface opposite the first surface, and a plurality of ports extending from a first end of the manifold, the manifold further including a plurality of first openings extending into the manifold on the first surface and in fluid communication with the plurality of ports; and an end cap having an interior surface, an exterior surface, and a plurality of second openings extending therethrough from the interior surface to the exterior surface, wherein the plurality of second openings are aligned with the plurality of first openings when the end cap is coupled to the first surface of the manifold; The manifold assembly.

16. 16. The manifold assembly of claim 15, wherein when the end cap is coupled to the manifold, an inner surface of the end cap is positioned closer to the first surface of the manifold than an outer surface of the end cap.

17. 18. The manifold assembly of claim 17, further comprising at least one gasket disposed between the first surface of the manifold and the inner surface of the end cap.

18. 17. The manifold assembly of claim 16, further comprising a plurality of first passages disposed on the first surface.

19. The manifold assembly of claim 18 , wherein the end cap further comprises a plurality of second passages disposed on the interior surface.

20. 20. The manifold assembly of claim 19, wherein when the end cap is coupled to the manifold, the plurality of first passages and the plurality of second passages collectively form a passageway through at least a portion of the manifold assembly.

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