Tangential flow filter manifold assembly

Abstract

A manifold assembly for tangential flow filtration includes a central manifold, at least one end cap, and at least one gasket disposed between the central 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. At least one compression stopper may be captured at least partially within the center manifold, and at least one compression pin may be captured at least partially within the end cap. The combination of the at least one compression stopper and the at least one compression pin enables the manifold assembly to be clamped within the clamping arrangement. The center manifold may further include a feed port, a discharge port, a retentate port, and a filtrate port disposed on a same side of the center manifold.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to European Patent Application No. 22290076.3, filed on Dec. 16, 2022, entitled "TANGENTIAL FLOW FILTRATION MANIFOLD ASSEMBLY", the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure generally relates to tangential flow filtration devices, and in particular, a manifold assembly that can facilitate tangential flow filtration operations. Background Art

[0004] The present invention relates to a manifold assembly that can be utilized by a bioprocessing system for processing biological liquids, and in particular but not exclusively, for purifying biopharmaceutical liquids to obtain products such as monoclonal antibodies, vaccines, and / or recombinant proteins.

[0005] Known biopharmaceutical liquids are typically obtained by culturing in a bioreactor, and they must then be processed to achieve desired characteristics such as purity, concentration, virus-free, etc.

[0006] Purification is carried out through a series of processes, such as clarification, to remove residues from the bioreactor culture, and virus filtration is sometimes followed by diafiltration and concentration by tangential flow filtration via a filtration arrangement (sometimes also referred to as a filtration arrangement structure). There are other operations involved in purification, such as chromatography.

[0007] Tangential flow filtration (TFF) is a separation process that uses a membrane to separate components in a liquid solution or suspension based on size or molecular weight differences. Applications include concentration, clarification, and desalting of proteins and other biomolecules such as nucleotides, antigens, and monoclonal antibodies; buffer exchange; process development; membrane selection studies; pre-chromatography clarification for removal of colloidal particles; de-pyrogenation of small molecules such as glucose and antibiotics; collection, washing, or clarification of cell cultures, lysates, colloidal suspensions, and virus cultures; and sample preparation.

[0008] Conventional TFF devices that can be utilized by a bioprocessing system for processing biological fluids can be constructed by stacking filtration membranes and woven screens and can be included in a cartridge format. Conventionally, separate sealing gaskets can be placed on both sides of the cartridge and can be installed in a filtration arrangement between a manifold and a support (e.g., a compression plate). The manifold is used to distribute the filtered fluid flow across multiple flow paths within the TFF device. The TFF device and the gasket are clamped between the manifold and the support, which cooperate to apply a clamping force to achieve the desired fluid seal. In some other conventional TFF devices, the gasket can be embedded within the TFF device.

[0009] Conventional manifolds of typical filtration arrangements can be machined from stainless steel. This results in stainless steel manifolds that are costly to manufacture and cannot be gamma irradiated. Thus, the stainless steel manifolds are more difficult and expensive to sterilize. Additionally, due to their weight and due to the fluid ports being located on various sides of each stainless steel manifold, the stainless steel manifolds are not ergonomic. Since the stainless steel manifolds must be in the manner in which they are manufactured, the stainless steel manifolds do not include fluid ports all set on the same side. Thus, the non-ergonomic nature of the stainless steel manifolds makes them both difficult to handle and difficult to set up in the filtration arrangement of a bioprocessing system. Summary of the Invention

[0010] The present disclosure relates to a manifold assembly for a tangential flow filtration component / arrangement, which includes a central manifold, two end caps removably coupled to the central manifold (by snap-fit arrangement or other known removable coupling means), and gaskets disposed between the central manifold and the end caps. The manifold assembly can be a single-use injection molded manifold assembly. More specifically, the central manifold and the end caps can be injection molded. In other embodiments, the central manifold and the end caps can be constructed by additive manufacturing techniques, including but not limited to fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), etc. The central manifold can 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 central manifold. The end caps can 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, the one or more compression limiters and the one or more compression pins can be coupled to the central manifold and the end caps respectively by post-forming operations, including but not limited to ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods. Constructing the central manifold and the end caps in this way makes the manifold assembly disclosed herein lighter in weight than conventional stainless steel manifolds, while still being able to withstand the compressive forces applied to the manifold assembly by the compression mechanism of the filtration arrangement (i.e., due to the compression limiters and compression pins). Additionally, constructing the central manifold and the end caps in this way can further enable the manifold assembly to be sterilized by any known sterilization method, including but not limited to gamma irradiation, autoclaving, and other gas- or steam-based sterilization methods, such as but not limited to ethylene oxide, chlorine dioxide, ozone, supercritical carbon dioxide, and vaporized hydrogen peroxide. Constructing the central manifold and the end caps in this way also enables all the ports of the central manifold (e.g., feed port, discharge port, retentate port, filtrate port, etc.) to be disposed on the same side of the manifold assembly. This provides an ergonomic manifold assembly for the operator to use and set up (i.e., connect pipes, etc.) in the clamping mechanism of the filtration arrangement. This further reduces the minimum working volume (MWV), which is crucial for TFF applications. Furthermore, by constructing the manifold assembly from various components that are removably coupled to each other, individual components of the manifold assembly (e.g., the central manifold, the end caps, the gaskets, etc.) can be replaced if damaged, rather than the entire manifold assembly.

[0011] 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 can have a first surface, a second surface opposite the first surface, a first edge spanning between the first surface and the second surface, and a second edge spanning between the first surface and the second surface, where the second edge is opposite the first edge. The feed port, the retentate port, and the filtrate port can all be disposed on the first edge of the manifold.

[0012] In some cases, the manifold assembly further includes an end cap. The end cap can be removably coupled to the first surface or the second surface of the manifold. In some further cases, 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 can be in fluid communication with the feed port. The second series of openings can be in fluid communication with the retentate port. The third series of openings can be in fluid communication with the filtrate port. In some even further cases, the end cap can include a fourth series of openings, a fifth series of openings, and a sixth series of openings. Each series of openings of the end cap can extend through the end cap. When the end cap is removably coupled to the manifold, the fourth series of openings of the end cap can be aligned with the first series of openings of the manifold, the fifth series of openings of the end cap can be aligned with the second series of openings of the manifold, and the sixth series of openings of the end cap can be aligned with the third series of openings of the manifold.

[0013] In another embodiment, a manifold assembly for a tangential flow filtration assembly includes a manifold, a compression limiter, and an end cap. The manifold can have a first surface and a second surface opposite the first surface. The compression limiter can be at least partially captured within the manifold such that the compression limiter extends from the first surface of the manifold to the second surface. The end cap can be coupled to the first surface of the manifold.

[0014] In some cases, the manifold is injection molded or additively manufactured around the compression limiter. In some additional cases, the end cap can include an outer surface and an opposite inner surface. In some further cases, the manifold assembly further includes a compression pin at least partially captured within the end cap such that a portion of the compression pin extends from the inner surface of the end cap. In some even further cases, when the end cap is coupled to the manifold, the compression pin can be aligned with the compression limiter.

[0015] In some additional cases, the compression limiter can be a cylinder having a conduit. Further, when the end cap is coupled to the manifold, the compression pin can abut against one end of the compression limiter, and a portion of the compression pin can be disposed within the conduit of the compression limiter. The end cap and the manifold can have a first durometer value, while the compression limiter and the compression pin can have a second durometer value greater than the first durometer value.

[0016] In yet another embodiment, a manifold assembly for a tangential flow filtration assembly can include a manifold and an end cap. The manifold can have a first surface, a second surface opposite the first surface, and a plurality of ports extending from a first edge of the manifold. The manifold can further have a plurality of first openings extending into the manifold on the first surface, wherein the plurality of first openings can be in fluid communication with the plurality of ports. The end cap can 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 can be aligned with the plurality of first openings.

[0017] In some cases, when the end cap is coupled to the manifold, the inner surface of the end cap is disposed closer to the first surface of the manifold than the outer surface of the end cap. In some even further cases, the manifold assembly can further include at least one gasket disposed between the first surface of the manifold and the inner surface of the end cap.

[0018] In some further cases, the manifold can further have a plurality of first passageways disposed on the first surface, and the end cap can further have a plurality of second passageways disposed on the inner surface. When the end cap is coupled to the manifold, the plurality of first passageways and the plurality of second passageways can together form a channel through at least a portion of the manifold assembly.

[0019] Other systems, devices, apparatuses, methods, features, and advantages will be or will become apparent to those skilled in the art upon examination of the following drawings and detailed description. All such additional systems, devices, arrangements, mechanisms, components, apparatuses, methods, features, and advantages are included within this description and are within the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The devices, systems, components, apparatuses, parts, cartridges, plates, manifolds, end caps, gaskets, limiters, pins, passageways, and channels presented herein can be better understood with reference to the following drawings and description. It should be understood that some of the elements in the drawings may not necessarily be drawn to scale, and emphasis has been placed on illustrating the principles disclosed herein. In the drawings, the same reference numerals designate corresponding parts / steps in different views.

[0021] Figure 1 A perspective / front view of a bioprocessing system including a filtration arrangement using a manifold assembly in accordance with an example embodiment of the present disclosure is shown.

[0022] Figure 2 Shown is Figure 1 A perspective view of the filtration arrangement of the bioprocessing system shown in, the filtration arrangement including a manifold assembly in accordance with an example embodiment of the present disclosure.

[0023] Figure 3Shows a perspective view of a manifold assembly of a filtration arrangement according to an example embodiment of the present disclosure and as shown in Figure 2 In.

[0024] Figure 4 Shows Figure 3 An exploded view of the manifold assembly shown in.

[0025] Figure 5A Shows Figure 3 A perspective view of the manifold of the manifold assembly shown in.

[0026] Figure 5B Shows Figure 5A A side view of the manifold shown in.

[0027] Figure 6A Shows Figure 3 A perspective view of the outer surface of an end cap of the manifold assembly shown in.

[0028] Figure 6B Shows Figure 6A A perspective view of the inner surface of the end cap shown in.

[0029] Figure 6C Shows Figure 6A A cross-sectional view of the end cap shown in, the cross-section being taken along Figure 6A Line 6C-6C of.

[0030] Figure 7 Shows Figure 6A A perspective view of the compression pin of the end cap shown in.

[0031] Figure 8 Shows Figure 5A A perspective view of the compression limiter of the manifold shown in.

[0032] Figure 9A Shows Figure 7 The interaction and compression between two compression pins shown in and Figure 8 The compression limiter shown in.

[0033] Figure 9B Shows Figure 9A A cross-sectional view of the interaction and compression between two compression pins and the compression limiter shown in, the cross-section being taken along Figure 9A Line 9B-9B of.

[0034] Figure 9C Shows Figure 3 A cross-sectional view of the manifold assembly shown in and depicts the compression pins of each end cap of the manifold assembly (as shown in Figure 6A In) facing Figure 5AThe compression limiter of the manifold shown abuts, and this cross-section is along Figure 3 taken along line 9C-9C in

[0035] Figure 10 shows Figure 3 a perspective view of the upper gasket of the manifold assembly shown in

[0036] Figure 11 shows Figure 3 a perspective view of the lower gasket of the manifold assembly shown in

[0037] Figure 12A shows Figure 5A a perspective view of the position and arrangement of the manifold shown in

[0038] Figure 12B shows Figure 6A a perspective view of the position and arrangement of the end cap shown in

[0039] Figure 13 shows Figure 3 a cross-sectional view of the feed port and feed conduit of the manifold assembly shown in Figure 3 taken along line 13-13 in

[0040] Figure 14 shows Figure 3 a cross-sectional view of the discharge port and discharge conduit of the manifold assembly shown in Figure 3 taken along line 14-14 in

[0041] Figure 15 shows Figure 3 a cross-sectional view of the manifold assembly shown in Figure 3 taken along line 15-15 in

[0042] Figure 16 shows Figure 3 a cross-sectional view of the filtrate port and filtrate conduit of the manifold assembly shown in Figure 3 taken along line 16-16 in

[0043] Figure 17 shows Figure 3 a cross-sectional view of the reject port and reject conduit of the manifold assembly shown in Figure 3 taken along line 17-17 in Detailed Description

[0044] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, wherein like reference numerals designate the same or corresponding parts throughout, and in which embodiments are shown by way of illustration. 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. Accordingly, the following detailed description is not to be taken in a limiting sense, and the scope of embodiments is defined by the appended claims and their equivalents.

[0045] Aspects of the present disclosure are disclosed in the description herein. Alternative embodiments and their equivalents of the present disclosure may be designed without departing from the spirit or scope of the present disclosure. It should be noted that any discussion herein of "an embodiment", "one embodiment", "an exemplary embodiment", etc., indicates that the described embodiment may include a particular feature, structure, or characteristic, and that particular feature, structure, or characteristic may not necessarily be included in every embodiment. Moreover, references to the foregoing do not necessarily refer to the same embodiment. Finally, it will be readily understood by those of ordinary skill in the art, whether or not explicitly described, that each particular feature, structure, or characteristic of a given embodiment may be used in connection with or combined with those of any other embodiment discussed herein.

[0046] The various operations may be described serially as a number of discrete actions or operations in a manner that is most helpful in understanding the claimed subject matter. However, the order of description should not be construed as implying 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 an order different from the described embodiments. Various additional operations and / or omissions of the described operations may be performed in additional embodiments.

[0047] For the purposes of the present disclosure, the phrase "A and / or B" means (A), (B), or (A and B). For the purposes of the present 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).

[0048] The terms "comprising", "including", "having", etc., as used with respect to embodiments of the present disclosure, are synonymous.

[0049] Turning to Figure 1, shows a bioprocessing system 10 configured to process biological liquids. The bioprocessing system 10 can be configured to, but is not limited to, purifying biopharmaceutical liquids to obtain products such as monoclonal antibodies, vaccines, or recombinant proteins. The bioprocessing system 10 can include a tank cart 20, a processing cart 30, and a filtration arrangement 40. The tank cart 20 can include a feed tank or a recycle tank 22, at least one feed pump 24, and at least one transfer pump 26. In the illustrated embodiment, the tank cart 20 includes a single feed pump 24 and two transfer pumps 26(1), 26(2). The feed tank 22 can be configured to hold biological liquids to be processed by the bioprocessing system 10 and, in some cases, can include a mixer (not shown). The feed pump 24 can be configured to pump biological liquids from the feed tank 22 to the processing cart 30 and ultimately through the filtration arrangement 40. The transfer pumps 26(1), 26(2) can be configured to pump reagents and solutions to the processing cart 30 to introduce the reagents and solutions into the biological liquids. The feed pump 24 and the transfer pumps 26(1), 26(2) can be any type of pump suitable for the bioprocessing system 10, including but not limited to low-shear diaphragm pumps.

[0050] Continuing to refer to Figure 1 , the processing cart 30 is configured to be set adjacent to or against the tank cart 20 and can be configured to support a processing device 32. The processing device 32 can include a series of valves that can determine the flow path according to the operation to transport the biological fluid from the feed tank 22 to the filtration arrangement 40 and extract the filtrate, retentate, and effluent of the biological fluid from the filtration arrangement 40. The processing device 32 can further determine the flow path to transport the filtrate, retentate, and effluent to their respective destinations (e.g., the feed tank 22, other storage devices, etc.) and introduce / mix the reagents and solutions into the biological liquids. The processing device 32 can include a controller 34 configured to control the valves of the processing device 32.

[0051] As Figure 1 and Figure 2 best shown in Figure 2As further shown in, the filtration arrangement 40 may further include a manifold assembly 50 that may be disposed on the clamping mechanism 44. As will be explained in further detail below, the manifold assembly 50 may be configured to receive at least one of the reference rods 49 to facilitate the position and orientation of the manifold assembly 50 on the clamping mechanism 44. The filtration arrangement 44 may also include any number of filter cartridges 60 that may be used to filter biological liquids through the TFF process. As Figure 2 shown in, the filter cartridge 60 may be disposed between the manifold assembly 50 and the clamping plate 46 of the clamping mechanism 44. The clamping mechanism 44 may be configured to clamp one or more filter cartridges 60 against one side of the manifold assembly 50. In some embodiments, as Figure 2 shown in, the manifold assembly may be a central manifold assembly 50, where the filter cartridges 60 are disposed on both sides of the manifold assembly 50. In other words, the central manifold assembly 50 may be clamped between the filter cartridges 60, which are further clamped between the clamping plates 46 of the clamping mechanism 44. Once properly arranged, the manifold assembly 50 may be configured to convey biological liquid from the processing device 32 to the filter cartridge 60 and back to the processing device 32.

[0052] Continuing to refer to Figure 1 and Figure 2 , the pipes 70 may interconnect the various components of the biological treatment system 10. Thus, the pipes 70 may connect the feed tank 22 to the feed pump 24 and may connect the feed pump 24 to the processing device 32. The pipes 70 may further interconnect the processing device 32 and the manifold assembly 50 of the filtration arrangement 40. As further shown, the pipes 70 may further connect the processing device 32 to the transfer pumps 26(1), 26(2) and directly to the feed tank 22. In addition, the pipes 70 may connect the transfer pumps 26(1), 26(2) to the reagent and solution sources and connect the processing device 32 to the various storage devices for the filtrate and effluent of the biological liquid.

[0053] Figure 1 An example embodiment of a biological treatment system 10 that may be used to process biological liquids is shown, but the example embodiment shown is not intended to be limited to the details shown and described above. It will be apparent that various modifications and structural changes may be made to the biological treatment system 10 depending on the type of treatment to be performed on the biological liquid. In addition, Figure 2 An example embodiment of a filtration arrangement 40 that may be utilized by the biological treatment system 10 is shown and is configured to utilize the manifold assembly 50 described in further detail below. The example embodiment of the filtration arrangement 40 shown is not intended to be limited to the details shown and described above. It will be apparent that various modifications and structural changes may be made to the filtration arrangement 44 depending on the type of treatment to be performed on the biological liquid, provided that the filtration arrangement 44 can utilize the manifold assembly 50 described herein.

[0054] Steering Figure 3 and Figure 4 illustrates an embodiment of a disposable manifold assembly 50 to be utilized in the filtration arrangement 40 of the bioprocessing system 10. The illustrated embodiment of the manifold assembly 50 is a central manifold assembly 50 which, as explained above, enables the filter cartridges 60 to be located on opposite sides of the manifold assembly 50. As explained in more detail below, Figure 3 and Figure 4 several components of the manifold assembly 50 shown in can be injection molded or constructed by additive manufacturing processes including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), etc.

[0055] The manifold assembly 50 can include a first side 52, an opposite 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 and also spanning between the first side 52 and the second side 53. The manifold assembly 50 can further include a first elongated end 56 spanning between the first side 52, the second side 53, the top end 54, and the bottom end 55, and a second elongated end 57 opposite the first elongated end 56. The second elongated end 57 can 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 can have a substantially rectangular prism shape.

[0056] As Figure 4 best shown in, the manifold assembly 50 can 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 Figure 4 , Figure 5A and Figure 5B wherein the center manifold 100 is depicted in isolation from the end caps 200 and gaskets 300, 400 in Figure 5A and Figure 5B . The center manifold 100 can be constructed by an injection molding process and can be formed from any number of materials configured to be utilized in an injection molding process. These materials include plastics and thermoplastics such as, but not limited to, acrylic resin, acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polyoxymethylene, polypropylene, thermoplastic elastomer, thermoplastic polyurethane, silicone, and polysulfone. In some embodiments, the center manifold 100 can be formed from polysulfone reinforced with 30% glass fiber. Thus, 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 can be constructed by additive manufacturing techniques including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), etc. Although Figure 5BA side elevation view of the first side 102 of the central manifold 100 is shown, but it should be understood that the second side 104 of the central manifold 100 may be substantially the same as the first side 102 of the central manifold 100 but in a mirror image. Thus, any depiction and / or description regarding the first side 102 of the central manifold 100 also applies to the second side 104 of the central manifold 100.

[0057] The central manifold 100 may have a shape of a substantially rectangular prism, such as the shape of the manifold assembly 50, and has a first side 102 and an opposite second side 104. The central manifold 100 further includes a top end 106 spanning between the first side 102 and the second side 104, an opposite bottom end 108 also spanning between the first side 102 and the second side 104, and a first elongated end 110 and a second elongated end 112 opposite to each other. The first elongated end 110 and the second elongated 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 elongated end 110 of the central manifold 100 may form at least a part of the first elongated end 56 of the manifold assembly 50, while the second elongated end 112 of the central manifold 100 may form at least a part of the second elongated end 57 of the manifold assembly 50. In addition, the top end 106 of the central manifold 100 may form at least a part of the top end 54 of the manifold assembly 50, while the bottom end 108 of the central manifold 100 may form at least a part of the bottom end 55 of the manifold assembly 50.

[0058] The illustrated central manifold 100 may include a feed port 120, a discharge port 130 (i.e., the lower filtrate port), a filtrate port 140 (i.e., the upper filtrate port), and a retentate port 150, all of which are provided on the first elongated end 110. Thus, the feed port 120, the discharge port 130, the filtrate port 140, and the retentate port 150 are all provided on the same side / end of the central manifold 100. With the ports 120, 130, 140, 150 provided on the same side / end of the central manifold 100, then it follows that, as Figure 3 best shown in, the ports 120, 130, 140, 150 are provided on the same side / end of the manifold assembly 50. In some embodiments, the feed port 120 may serve as an inlet of the central manifold 100. The feed port 120 may include a feed conduit 122 and a series of feed outlets 124 spaced equidistantly along the feed conduit 122 such that the feed outlets 124 are directed onto the first side 102 and the second side 104 of the central manifold 100 (at Figure 5B and Figure 13Best shown in). In some embodiments, the discharge port 130, the filtrate port 140, and the retentate port 150 may serve as outlets to the central manifold 100. The discharge port 130 may further include a discharge conduit 132 and a series of discharge inlets 134 spaced equidistantly along the discharge conduit 132 such that the discharge inlets 134 are oriented on the first side 102 and the second side 104 of the central manifold 100 (in Figure 5B , Figure 14 and Figure 15 Best shown in). Similar to the discharge port 130, the filtrate port 140 and the retentate port 150 each include conduits 142, 152, respectively. 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 on the first side 102 and the second side 104 of the central manifold 100 (in Figure 5B and Figure 17 Best shown in). 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 on the first side 102 and the second side 104 of the central manifold 100 (in Figure 5B and Figure 16 Best shown in).

[0059] The first elongated end 110 further includes an upper slot 160 and a lower slot 162. The upper slot 160 and the lower slot 162 span the first elongated end 110 from the first side 102 to the second side 104 and may be disposed between the feed port 120 and the retentate port 150. As further shown, the upper slot 160 may be spaced from the lower slot 162 such that the upper slot 160 is disposed on the first elongated end 110 closer to the top 106 than the bottom end 108, while the lower slot 162 may be disposed on the first elongated end 110 closer to the bottom end 108 than the top 106. Thus, the upper slot 160 may be disposed above the midpoint of the first elongated end 110, and the lower slot 162 may be disposed below the midpoint of the first elongated end 110. A mating flange 164 may be disposed in each of the upper slot 160 and the lower slot 162. The mating flange 164 may be oriented transverse to the length of the upper slot 160 and the lower slot 162 and may be disposed equidistantly from the first side 102 and the second side 104 of the central manifold 100 within the slots 160, 162. The second elongated end 112 may also include an upper slot 160 and a lower slot 162, each including a mating flange 164 similar to that of the first elongated end 110.

[0060] Continuing to refer to Figure 5A and Figure 5B , and further referring to Figure 8, the central manifold 100 may include a series of compression limiters 170 that are disposed within compression limiter bores 178. Figure 8 An exemplary embodiment of the compression limiter 170 is shown. 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 that extends 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 bores 178 extends through the central manifold 100 from a first side 102 of the central manifold 100 to a second side 104. Next, the compression limiter 170 extends through the compression limiter bore 178 from the first side 102 of the central manifold 100 to the second side 104 of the central manifold 100. Thus, the first end 172 of the compression limiter 170 may be disposed on the first side 102 of the central manifold 100, while the second end 174 of the compression limiter 170 may be disposed on the second side 104 of the central manifold 100 (as Figure 9C best shown in). The compression limiter 170 may be constructed of any metallic material, plastic material, or other material configured to withstand at least about five (5) tons of compressive force. In some embodiments, the compression limiter 170 may be formed of stainless steel, including but not limited to SAE 316L stainless steel. Thus, the compression limiter 170 may have a durometer hardness value in the range of approximately 75 to 95 on the Rockwell B scale. When constructing the central manifold 100, the central 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 bore 178. In some additional embodiments, the compression limiter 170 may be coupled to the central manifold 100 by a post-forming operation, including but not limited to ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods.

[0061] Further reference Figure 5A and Figure 5B, the first side 102 of the central manifold 100 includes a series of feed openings 180 and discharge passages 182, which are disposed closer to the bottom end 108 of the central manifold 100 than to the top end 106 of the central manifold 100. The feed openings 180 may be substantially circular openings, while the discharge passages 182 may be elongated stadium or capsule-shaped openings. The tops of the feed openings 180 and the discharge passages 182 may be horizontally aligned with each other such that the feed openings 180 and the discharge passages 182 span the lower portion of the first side 102 of the central manifold 100 from the first elongated end 110 to the second elongated end 112 in an alternating manner. In other words, a portion (i.e., the top) of each discharge passage 182 may be disposed between two feed openings 180. Additionally, the two outermost discharge passages 182 may be curved, while the two innermost discharge passages 182 may be substantially vertical. Although the outermost discharge passages 182 are curved, all the discharge passages 182 may be elongated in a substantially vertical direction. Further, the two outermost discharge passages 182 may be curved to extend around two reference rod openings 184 disposed below the feed openings 180. The two reference rod openings 184 may be configured to receive the reference rods 49 of the clamping mechanism 44 of the filtration arrangement 40, as Figure 2 shown in. As Figure 5B best shown in, the feed openings 180 may be aligned with the feed outlets 124 of the feed conduits 122 of the feed ports 120. Additionally, the bottom ends of the discharge passages 182 may be aligned with the discharge inlets 134 of the discharge conduits 132 of the discharge ports 130.

[0062] Continuing to refer to Figure 5A and Figure 5B , the first side 102 of the central manifold 100 further includes a series of filtrate passages 186 and retentate openings 188, which are disposed closer to the top end 106 of the central manifold 100 than to the bottom end 108 of the central manifold 100. The filtrate passages 186 may be elongated stadium or capsule-shaped openings, while the retentate openings 188 may be substantially circular openings. The filtrate passages 186 may be elongated in a substantially vertical direction. The bottoms of the retentate openings 188 and the filtrate passages 186 may be horizontally aligned with each other such that the retentate openings 188 and the filtrate passages 186 span the upper portion of the first side 102 of the central manifold 100 from the first elongated end 110 to the second elongated end 112 in an alternating manner. In other words, a portion (i.e., the bottom) of each filtrate passage 186 may be disposed between two retentate openings 188. As Figure 5B best shown in, the retentate openings 188 may be aligned with the retentate inlets 154 of the retentate conduits 152 of the retentate ports 150. Additionally, the tops of the filtrate passages 186 may be aligned with the filtrate inlets 144 of the filtrate conduits 142 of the filtrate ports 140.

[0063] As Figure 5A and Figure 5B further shown in

[0064] , the first side 102 of the central 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 disposed near the filtrate passage 186 and the retentate opening 188, while the lower gasket alignment projection 192 may be disposed near the feed opening 180 and the discharge passage 182. More specifically, the upper gasket alignment projection 190 may include two projections, one disposed near the first elongated end 110 and a second disposed near the second elongated end 112. Additionally, the upper gasket alignment projection 190 may be disposed above the bottom end of the retentate opening 188 and the filtrate passage 186, but below the upper end of the filtrate passage 186. Similar to the upper gasket alignment projection 190, the lower gasket alignment projection 192 may also include two projections, one disposed near the first elongated end 110 and a second disposed near the second elongated end 112. The lower gasket alignment projection 192 may be further disposed below the upper ends of the feed opening 180 and the discharge passage 182, while being disposed above the lower end of the discharge passage 182.

[0064] While Figure 5A and Figure 5B shows the first side 102 of the central manifold 100, it should be understood that the second side 104 of the central manifold 100 may be substantially the same as the first side 102 of the central manifold 100, but in a mirror image. Thus, any depiction and / or description regarding the first side 102 of the central manifold 100 also applies to the second side 104 of the central manifold 100.

[0065] Turning Figures 6A - 6C Figures 6A - 6C , an embodiment of the end cap 200 of the manifold assembly 50 is shown. As previously explained, the manifold assembly 50 may include more than one end cap 200, and each of the end caps 200 of the manifold assembly 50 may be substantially the same as each other. Thus, while Figures 6A - 6CFIG. shows a single end cap 200 of the manifold assembly 50, but it should be understood that any depiction and / or description of the end cap 200 can also apply to other end caps 200 of the manifold assembly 50. Similar to the central manifold 100, the end cap 200 can be constructed by an injection molding process and can be formed of any number of materials configured to be utilized in the injection molding process. These materials include plastics and thermoplastics such as, but not limited to, acrylic resins, acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polyoxymethylene, polypropylene, thermoplastic elastomers, thermoplastic polyurethanes, silicone, and polysulfone. In some embodiments, the end cap 200 can be formed of polysulfone reinforced with 30% glass fiber. Thus, the end cap 200 can have a durometer hardness value in the range of approximately 80 to 90 on the Rockwell M scale. In some embodiments, the central manifold 100 can be constructed by additive manufacturing techniques including, but not limited to, fused deposition modeling (FDM) 3D printing, selective laser sintering (SLS), digital light synthesis (DLS), etc.

[0066] Figures 6A - 6B The end cap 200 shown in FIG. can include an outer surface 202, an inner surface 204 opposite the outer surface 202, a top end 206 spanning between the outer surface 202 and the inner surface 204, and a bottom end 208 opposite the top end 206 and also spanning between the outer surface 202 and the inner surface 204. The end cap 200 can further include a first side end 210 and an opposite second side end 212. The first side end 210 and the second side end 212 can span between the outer surface 202, the inner surface 204, the top end 206, and the bottom end 208. Thus, the end cap 200 can have a substantially rectangular prism shape.

[0067] As Figure 6A and Figure 6B best shown in FIG. and FIG., the end cap 200 can include a series of feed openings 220 and a series of discharge openings 230. The feed openings 220 and the discharge openings 230 can span from the outer surface 202, through the end cap 200, to the inner surface 204. Figure 6A FIG. shows that the feed openings 220 and the discharge openings 230 can be substantially circular openings on the outer surface 202 of the end cap 200. As shown, the feed openings 220 can be larger in diameter than the discharge openings 230. In addition, the feed openings 220 and the discharge openings 230 can be horizontally aligned with each other such that the feed openings 220 and the discharge openings 230 span the lower portion of the end cap 200 from the first side end 210 to the second side end 212 in an alternating manner. In other words, each discharge opening 230 can be disposed between two feed openings 220. As Figure 6BAs further shown in, the feed opening 220 may also be formed substantially cylindrically on the inner surface 204 of the end cap 200. Conversely, the discharge opening 230 may have an elongated stadium or capsule shape. Thus, each of the discharge openings 230 may define an elongated inner surface passage 232 along the inner surface 204 of the end cap 200. As shown, the elongated inner surface passage 232 of the discharge opening 230 may extend downward in a substantially vertical direction from the horizontal plane in which the feed opening 220 is provided. Similar to the discharge passages 182 of the central manifold 100, the two outermost elongated inner surface passages 232 may be curved, while the two innermost elongated inner surface passages 232 may be substantially vertical. The two outermost elongated inner surface passages 232 may be curved to extend around two reference rod openings 240 provided below the feed opening 220. The two reference rod openings 240 may be configured to receive the reference rods 49 of the clamping mechanism 44 of the filter arrangement 40, as Figure 2 shown in.

[0068] Continuing to refer to Figure 6A and Figure 6B , the end cap 200 may further include a series of filtrate openings 250 and a series of retentate openings 260. The filtrate openings 250 and the retentate openings 260 may also extend across from the outer surface 202, through the end cap 200, to the inner surface 204. Figure 6A Shown are that the filtrate openings 250 and the retentate openings 260 may be substantially circular openings on the outer surface 202 of the end cap 200. In the illustrated embodiment, the retentate openings 260 may be larger in diameter than the filtrate openings 250. Additionally, the filtrate openings 250 and the retentate openings 260 may be horizontally aligned with each other such that the filtrate openings 250 and the retentate openings 260 span the lower portion of the end cap 200 from the first side end 210 to the second side end 212 in an alternating manner. In other words, each filtrate opening 250 may be disposed between two retentate openings 260. As Figure 6B further shown in, the retentate openings 260 may also be formed substantially cylindrically on the inner surface 204 of the end cap 200. Conversely, the filtrate openings 250 may have an elongated stadium or capsule shape. Thus, each of the filtrate openings 250 may define an elongated inner surface passage 252 along the inner surface 204 of the end cap 200, which extends upward in a substantially vertical direction from the horizontal plane in which the retentate openings 260 are provided.

[0069] Continuing to refer to Figures 6A - 6C, the end cap 200 further includes a series of compression pin housings 270, each of which can be accessed through an external compression pin opening 272 and an internal compression pin opening 274. The external compression pin opening 272 is provided on the outer surface 202 of the end cap 200, while the internal compression pin opening 274 is provided on the inner surface 204 of the end cap 200. Thus, the compression pin housing 270 extends from the outer surface 202 of the end cap 200 to the inner surface 204 of the end cap 200. The compression pin housing 270 can be mainly disposed between the group of the feed opening 220 and the discharge opening 230 and the group of the filtrate opening 250 and the retentate opening 260. In the illustrated embodiment, the compression pin housings 270 can be grouped into a first pair of compression pin housings 270, which are disposed closer to the filtrate opening 250 and the retentate opening 260 than the feed opening 220 and the discharge opening 230, and a second pair of compression pin housings 270, which are disposed closer to the feed opening 220 and the discharge opening 230 than the filtrate opening 250 and the retentate opening 260. As Figure 6C best shown in, each compression pin housing 270 can be configured to receive a compression pin 280.

[0070] Figure 7 A perspective view of the compression pin 280 is shown. The compression pin 280 can 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 can have the same or substantially similar diameters to each other. The flange 284 can have a diameter greater than the diameters of the head 282, the first shank portion 286, and the second shank portion 288. The second shank portion 288 can have a diameter smaller than the diameters of the head 282, the flange 284, and the first shank portion 286. The difference between the diameters of the first shank portion 286 and the second shank portion 288 defines a mating surface 289. The compression pin 280 can be constructed of any metal material, plastic material, or other material configured to withstand at least about five (5) tons of compressive force. Similar to the compression limiter 170, the compression pin 280 can be constructed of stainless steel, including but not limited to SAE 316L stainless steel. Thus, the compression pin 280 can have a durometer hardness value in the range of approximately 75 to 95 on the Rockwell B scale.

[0071] Return Figures 6A - 6C , each compression pin 280 is disposed within the pin housing 270 such that the head 282 of each compression pin 280 is disposed within the associated external compression pin opening 272 on the outer surface 202 of the end cap 200 (as Figure 6A and Figure 6C best shown in), and such that the second shank portion 288 extends out from the internal compression pin opening 274 (as Figure 6C best shown in). Figure 6CThis is best shown because 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 flange 284 has a wider diameter than the outer compression pin opening 272 and the inner compression pin opening 274, such that compression pin 280 is prevented from sliding through compression pin housing 270. More specifically, similar to center manifold 100 around compression limiter 170, end cap 200 can be injection molded or additively manufactured around compression pin 280 to capture compression pin 280 within compression pin housing 270. In some additional embodiments, compression pin 280 can be coupled to end cap 200 via a post - molding operation including, but not limited to, ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods.

[0072] As Figure 6A and Figure 6B Further shown in, end cap 200 also includes engagement arms 290 that extend rearward (i.e., from inner surface 204) from the first side end 210 or the second side end 212 of end cap 200. Each engagement arm 290 can include a proximal or first end 292 coupled to end cap 200 and an opposite distal or second engagement end 294. The second engagement end 294 of each engagement arm 290 can include a protrusion 296. In the illustrated embodiment, end cap 200 can include two engagement arms 290. One engagement arm 290 can extend rearward from the first side end 210 at a position closer to bottom end 208 than top end 206, while the other engagement arm 290 can extend rearward from the second side end 212 at a position closer to top end 206 than bottom end 208. Each engagement arm 290 can be sized to fit within upper slot 160 and / or lower slot 162 of center manifold 100 so as to removably couple end cap 200 to center manifold 100.

[0073] As Figure 3 、 Figure 4 and Figure 9CAs best shown in , when the end caps 200 are removably coupled to the central manifold 100 such that one end cap 200 is coupled to the first side 102 of the central manifold 100 and the other end cap 200 is coupled to the second side 104 of the central manifold 100, the engagement arms 290 can extend into one of the upper slots 160 or the lower slots 162 of the first elongated end 110 and the second elongated end 112 of the central manifold 100. When the engagement arm 290 is disposed within the upper slot 160, the protrusion 296 of the engagement arm 290 can be configured to abut and engage the engagement flange 164 disposed within the upper slot 160. Similarly, when the engagement arm 290 is disposed within the lower slot 162, the protrusion of the engagement arm 290 can be configured to abut and engage the engagement flange 164 disposed within the lower slot 162. For the illustrated embodiment, given the position of the engagement arms 290 on an end cap 200, when the end cap 200 is removably coupled to the first side 102 of the central manifold 100, the engagement arm 290 disposed on the first side end 210 of the end cap 200 is disposed within the lower slot 162 of the first elongated end 110 of the central manifold 100, and the engagement arm 290 disposed on the second side end 212 of the end cap 200 is disposed within the upper slot 160 of the second elongated end 112 of the central manifold 100. Further, when the end cap 200 is removably coupled to the second side 104 of the central manifold 100, the engagement arm 290 disposed on the first side end 210 of the end cap 200 is disposed within the lower slot 162 of the second elongated end 112 of the central manifold 100, and the engagement arm 290 disposed on the second side end 212 of the end cap 200 is disposed within the upper slot 160 of the first elongated end 110 of the central manifold 100. In other embodiments, when coupled to the central manifold 100, the engagement arms 290 of the end cap 200 can be disposed within both upper slots 160 or both lower slots 162 instead of the opposing slots 160, 162. The engagement of the protrusion 296 of the engagement arm 290 of the end cap 200 with the engagement flange 164 of the upper slot 160 and the lower slot 162 removably couples the end cap 200 to the central manifold 100 by snap - fit.

[0074] Further, when the end cap 200 is removably coupled to the central manifold 100, the feed opening 220 of the end cap 200 is aligned with the feed opening 180 of the central manifold 100, regardless of which side 102, 104 of the central manifold 100 the end cap 200 is coupled to. Further, the discharge opening 230, including the elongated inner surface passage 232 of the discharge opening 230, is aligned with the discharge passage 182 of the central manifold 100. The filtrate opening 250 of the end cap 200, including the elongated inner surface passage 252, is aligned with the filtrate passage 186 of the central manifold 100, while the retentate opening 260 of the end cap 200 is aligned with the retentate opening 188 of the central manifold 100. Further, when the end cap 200 is coupled to the central manifold 100, the reference rod opening 240 of the end cap 200 is also aligned with the reference rod opening 184 of the central manifold 100.

[0075] In addition, when the end cap 200 is removably coupled to the central manifold 100, and as best shown in Figures 9A - 9C , the compression pins 280 of the end cap are aligned with and at least partially disposed within the compression limiters 170 of the central manifold 100. As shown, each compression limiter 170 may 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 coupled to the first side 102 of the central manifold 100) may be disposed within the conduit 176 of the compression limiter 170 near 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 coupled to the second side 104 of the central manifold 100) may be disposed within the conduit 176 of the compression limiter 170 near the second end 174 of the compression limiter 170. As further shown, when the end cap 200 is removably coupled to the central manifold 100, the engagement surface 289 of the compression pin 280 of the end cap 200 coupled to the first side 102 of the central manifold 100 is disposed facing 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 central manifold 100 is disposed facing the second end 174 of the compression limiter 170.

[0076] Due to the end cap 200 and the central manifold 100 being injection molded or manufactured using additive manufacturing techniques, the presence of the compression limiters 170 and the compression pins 280 enables the manifold assembly 50 to withstand the clamping force from the clamping mechanism 44 of the filter arrangement 40. In other words, the compression limiters 170 and the compression pins 280 enable the manifold assembly 50 to withstand a compression force of at least about five (5) tons.

[0077] Turning to Figure 10 , Figure 11 , Figure 12A and Figure 12B , there are shown upper gaskets 300 and lower gaskets 400 that may be disposed between the central manifold 100 and the end cap 200 when the end cap 200 is removably coupled to the central manifold 100. The manifold assembly 50 may include two upper gaskets 300 and two lower gaskets 400. The upper gaskets 300 are best shown in Figure 10 , Figure 12A and Figure 12B . Although Figure 10 , Figure 12A and Figure 12B show only a single upper gasket 300, it should be understood that each of the upper gaskets 300 of the manifold assembly 50 may be the same as each other. Thus, Figure 10 , Figure 12A and Figure 12BAny depiction and / or description of the upper gasket 300 shown in also applies to another upper gasket 300 of the manifold assembly 50. Additionally, the lower gasket 400 is best shown in Figure 11 , Figure 12A and Figure 12B . Although Figure 11 , Figure 12A and Figure 12B show only a single lower gasket 400, it should be understood that each of the lower gaskets 400 of the manifold assembly 50 can be the same as each other. Thus, Figure 11 , Figure 12A and Figure 12B any depiction and / or description of the lower gasket 400 shown in also applies to another lower gasket 400 of the manifold assembly 50.

[0078] As best shown in Figure 10 , the upper gasket 300 includes an outer surface 302 and an inner surface 304 opposite the outer surface 302. The upper gasket 300 can have a generally rectangular shape with a top edge 306, a bottom edge 308 opposite the top edge 306, a first side edge 310 spanning from the top edge 306 to the bottom edge 308, and a second side edge 312 opposite the first side edge 310 and also spanning from the top edge 306 to the bottom edge 308. The upper gasket 300 can include a series of retention openings 320, a series of upper filtrate openings 330, and a series of lower filtrate openings 332. The retention openings 320 and the lower filtrate openings 332 can be disposed in the upper gasket 300 closer to the bottom edge 308 than to the top edge 306, while the upper filtrate openings 330 can be disposed closer to the top edge 306 than to the bottom edge 308. The retention openings 320 and the lower filtrate openings 332 can be substantially horizontally aligned from the first side edge 310 to the second side edge 312 and can be arranged in an alternating manner. Thus, as shown, each lower filtrate opening 332 can be disposed between two retention openings 320. The upper filtrate openings 330 can be substantially horizontally aligned from the first side edge 310 to the second side edge 312. Additionally, each upper filtrate opening 330 can be substantially vertically aligned with a corresponding lower filtrate opening 332. In the illustrated embodiment, the lower filtrate openings 332 can be substantially stadium or capsule-shaped, while the retention openings 320 and the upper filtrate openings 330 can be substantially circularly shaped. In other embodiments, the openings 320, 330, 332 can have any other shape, and the openings 320, 330, 332 can have the same shape or different shapes from each other.

[0079] As further shown, the upper gasket 300 may include two alignment openings 340, where one alignment opening 340 is disposed closer to the first side edge 310 than the second side edge 312, and the other alignment opening 340 is disposed closer to the second side edge 312 than the first side edge 310. The alignment openings 340 are sized and shaped to receive the upper gasket alignment protrusions 190 of the central manifold 100.

[0080] As Figure 12A best shown, when the upper gasket 300 is disposed against the central manifold 100 (i.e., when the upper gasket 300 is sandwiched between the central manifold 100 and the end cap 200), the upper gasket alignment protrusions 190 may be disposed within the alignment openings 340 of the upper gasket 300. Additionally, the entrapment opening 320 of the upper gasket 300 may be disposed within the entrapment opening 188. The upper filtrate opening 330 may be aligned with the upper end of the filtrate passage 186 of the central manifold 100, and the lower filtrate opening 332 may be aligned with the lower end of the filtrate passage 186 of the central manifold 100.

[0081] As Figure 12B best shown, when the upper gasket 300 is disposed against the inner surface 204 of the end cap 200 (i.e., when the upper gasket 300 is sandwiched between the central manifold 100 and the end cap 200), the entrapment opening 320 of the upper gasket 300 may be aligned with the entrapment opening 260 of the end cap 200. Additionally, the upper filtrate opening 330 of the upper gasket 300 may be aligned with the upper end of the elongated inner surface passage 252 of the filtrate opening 250 of the end cap 200, and the lower filtrate opening 332 may be aligned with the lower end of the elongated inner surface passage 252 of the filtrate opening 250 of the end cap 200.

[0082] The upper gasket 300 may facilitate sealing between the central manifold 100 and the end cap 200 and around the filtrate passage 186, the entrapment opening 188, the entrapment opening 260, and the filtrate opening 250. The upper gasket 300 may be constructed of any material configured to facilitate sealing between surfaces, including but not limited to rubber, silicone, neoprene, cork, thermoplastic elastomer (TPE), etc.

[0083] Return Figure 11, the lower gasket 400, like the upper gasket 300, includes an outer surface 402 and an inner surface 404 opposite the outer surface 402. The lower gasket 400 may have a substantially rectangular shape with a top edge 406, a bottom edge 408 opposite the top edge 406, a first side edge 410 extending from the top edge 406 to the bottom edge 408, and a second side edge 412 opposite the first side edge 410 and also extending from the top edge 406 to the bottom edge 408. The lower gasket 400 may include a series of feed openings 420, a series of upper discharge openings 430, and a series of lower discharge openings 432. The feed openings 420 and the upper discharge openings 430 may be disposed in the lower gasket 400 closer to the top edge 406 than to the bottom edge 408, while the lower discharge openings 432 may be disposed closer to the bottom edge 408 than to the top edge 406. The feed openings 420 and the upper discharge openings 430 may be substantially horizontally aligned from the first side edge 410 to the second side edge 412 and may be arranged in an alternating manner. Thus, as shown, each upper discharge opening 430 may be disposed between two feed openings 420. The lower discharge openings 432 may be substantially horizontally aligned from the first side edge 410 to the second side edge 412. Additionally, each upper discharge opening 430 may be substantially vertically aligned with a corresponding lower discharge opening 432. In the illustrated embodiment, the upper discharge openings 430 may be substantially stadium or capsule-shaped, while the feed openings 420 and the lower discharge openings 432 may be substantially circularly shaped. In other embodiments, the openings 420, 430, 432 may have any other shape, and the openings 420, 430, 432 may have the same shape or different shapes from each other.

[0084] As further shown, the lower gasket 400 may include two alignment openings 440, one alignment opening 440 being disposed closer to the first side edge 410 than to the second side edge 412 and the other alignment opening 440 being disposed closer to the second side edge 412 than to the first side edge 410. The alignment openings 440 may be sized and shaped to receive the lower gasket alignment projections 192 of the central manifold 100. The lower gasket 400 may further include a pair of reference rod openings 450, which are disposed between the horizontally aligned lower discharge openings 432 and the horizontally aligned feed openings 420 and upper discharge openings 430.

[0085] As Figure 12AAs best shown, when the lower gasket 400 is disposed against the central manifold 100 (i.e., when the lower gasket 400 is sandwiched between the central manifold 100 and the end cap 200), the lower gasket alignment protrusion 192 of the central manifold 100 can be disposed within the alignment opening 440 of the lower gasket 400. In addition, the feed opening 420 of the lower gasket 400 can be aligned with the feed opening 180. The upper discharge opening 430 can be aligned with the upper end of the discharge passage 182 of the central manifold 100, and the lower discharge opening 432 can be aligned with the lower end of the discharge passage 182 of the central manifold 100. In addition, the reference rod opening 450 of the lower gasket 400 can be aligned with the reference rod opening 184 of the central manifold 100.

[0086] As Figure 12B As best shown, when the lower gasket 400 is disposed against the inner surface 204 of the end cap 200 (i.e., when the lower gasket 400 is sandwiched between the central manifold 100 and the end cap 200), the feed opening 420 of the lower gasket 400 can be aligned with the feed opening 220 of the end cap 200. In addition, the upper discharge opening 430 of the lower gasket 400 can be aligned with the upper end of the elongated inner surface passage 232 of the discharge opening 230 of the end cap 200, and the lower discharge opening 432 can be aligned with the lower end of the elongated inner surface passage 232 of the discharge opening 230 of the end cap 200. Additionally, the reference rod opening 450 of the lower gasket 400 can be aligned with the reference rod opening 240 of the end cap 200.

[0087] Similar to the upper gasket 300, the lower gasket 400 can facilitate sealing between the central manifold 100 and the end cap 200 and can seal around the feed opening 180, the discharge passage 182, the feed opening 220, and the discharge opening 230. The lower gasket 400 can be constructed of any material configured to facilitate sealing between surfaces, including but not limited to rubber, silicone, neoprene, cork, thermoplastic elastomer (TPE), etc.

[0088] Turning Figures 13 - 17 , various cross-sectional views of the manifold assembly 50 are shown, which depict various flow passages through the manifold assembly 50, particularly when the manifold assembly 50 is disposed within the clamping mechanism 44 of the filtration arrangement 40 and aligned with the filter cartridge 60. The flow passage of the feed liquid is in Figure 13Best shown in. The feed liquid flows through the feed port 120 into the manifold assembly 50 and into the feed conduit 122. As previously explained, the feed conduit 122 includes a series of feed outlets 124 that are aligned with the feed openings 180 on the two sides 102, 104 of the central manifold 100, the feed openings 420 of the lower gasket 400 disposed on the two sides 102, 104 of the central manifold 100, and the feed openings 220 of the end caps 200 attached to the two sides 102, 104 of the central manifold 100. Thus, as shown, the feed liquid flows into the feed port 120, through the feed conduit 122, and out of the feed outlets 124 of the feed conduit 122. Then, the feed liquid passes through the feed openings 180 of the central manifold 100, the feed openings 420 of the lower gasket 400, the feed openings 220 of the end caps 200, and enters the filter cartridges 60 disposed on either side 52, 53 of the manifold assembly 50.

[0089] As previously explained, when the liquid flows through the filter cartridge 60, the liquid is filtered into a discharge liquid, a filtrate liquid, and a retained liquid, which return to the manifold assembly 50 via the filter cartridge 60 for flowing back to the processing device 32. Figure 14 and Figure 15 The flow path of the discharge liquid entering the manifold assembly 50 from the filter cartridge 60 and leaving from the discharge port 130 is shown. More specifically, the discharge liquid flows into the manifold assembly 50 via the discharge opening 230 of the end cap 200. Then, the discharge liquid can be separated into a first separated discharge liquid and a second separated discharge liquid. The first separated discharge liquid can flow downward through a first channel defined by the outer surface 402 of the lower gasket 400 and the elongated inner surface passage 232 of the discharge opening 230 provided on the inner surface 204 of the end cap 200. Then, the first separated discharge liquid flows through the lower discharge opening 432 of the lower gasket 400. The second separated discharge liquid can flow through the upper discharge opening 430 of the lower gasket 400 and then flow downward through a second channel defined by the discharge passage 182 of the central manifold 100 and the inner surface 404 of the lower gasket 400. Before the discharge liquid then flows through the inlet 134 of the discharge conduit 132, the two separated discharge liquids can be mixed or combined with each other at the lower end of the discharge passage 182 of the central manifold 100. Finally, the discharge liquid can then flow through the discharge conduit 132 and leave from the discharge port 130.

[0090] Figure 15 and Figure 16Shows the flow path of the filtrate liquid entering the manifold assembly 50 from the filter cartridge 60 and leaving through the filtrate port 140. More specifically, the filtrate liquid flows into the manifold assembly 50 via the filtrate opening 250 of the end cap 200. Then, the filtrate liquid can be separated into a first separated filtrate liquid and a second separated filtrate liquid. The first separated filtrate liquid can flow upward through a first channel defined by the outer surface 302 of the upper gasket 300 and the elongated inner surface passage 252 of the filtrate opening 250 provided on the inner surface 204 of the end cap 200. Then, the first separated filtrate liquid can pass through the upper filtrate opening 330 of the upper gasket 300. The second separated filtrate liquid can flow through the lower filtrate opening 332 of the upper gasket 300 and then flow upward through a second channel defined by the filtrate passage 186 of the central manifold 100 and the inner surface 304 of the upper gasket 300. Before the filtrate liquid then flows through the filtrate inlet 144 of the filtrate conduit 142, the two separated filtrate liquids can be mixed or combined with each other at the upper end of the filtrate passage 186 of the central manifold 100. Finally, the filtrate liquid can then flow through the filtrate conduit 142 and leave through the filtrate port 140.

[0091] Figure 17 Shows the flow path of the retentate liquid entering the manifold assembly 50 from the filter cartridge 60 and leaving through the retentate port 150. More specifically, the retentate liquid flows into the manifold assembly 50 via the retentate opening 260 of the end cap 200. Since the retentate opening 260 of the end cap 200 is aligned with the retentate opening 320 of the upper gasket 300 and the retentate opening 188 of the central manifold 100, after flowing through the retentate opening 260 of the end cap 200, the retentate liquid then flows through the retentate opening 320 of the upper gasket 300 and the retentate opening 188 of the central manifold 100. Then, the retentate liquid flows through the retentate inlet 154 and into the retentate conduit 152. Finally, the retentate liquid can then flow through the retentate conduit 152 and leave through the retentate port 150.

[0092] The manifold assembly 50 disclosed herein provides a single-use manifold assembly that is injection molded or manufactured using an additive manufacturing process and that provides improvements over conventional stainless steel manifolds. As explained above, the manifold assembly 50 includes a central manifold 100, two end caps 200 removably coupled (by snap-fit arrangement or other known removable coupling means) to the central manifold 100, and gaskets 300, 400 disposed between the central manifold 100 and the end caps 200. The central manifold 100 and the end caps 200 may be injection molded to at least partially capture a compression limiter 170 within the central manifold 100 and at least partially capture a compression pin 280 within the end caps 200. In other embodiments, the compression limiter 170 and the compression pin 280 may be coupled to the central manifold 100 and the end caps 200, respectively, by post-molding operations including, but not limited to, ultrasonic bonding, thermal bonding, and / or other mechanical insertion methods. Constructing the central manifold 100 and the end caps 200 in this manner enables the manifold assembly 50 to be sterilized by any known sterilization method, including, but not limited to, gamma irradiation, autoclaving, and other gas- or vapor-based sterilization methods such as, but not limited to, ethylene oxide, chlorine dioxide, ozone, supercritical carbon dioxide, and vaporized hydrogen peroxide. Additionally, constructing the central manifold 100 and the end caps 200 in this manner further enables the ports 120, 130, 140, 150 of the central manifold 100 to all be disposed on the same side of the manifold assembly 50. This makes the manifold assembly 50 more ergonomic for an operator to use and set up in the clamping mechanism 44 of the filtration arrangement 40. Constructing the central manifold 100 and the end caps 200 in this manner also enables the manifold assembly 50 disclosed herein to be lighter in weight than a conventional stainless steel manifold. Additionally, by constructing the manifold assembly 50 from various components that are removably coupled to one another, individual components of the manifold assembly 50 (e.g., the central manifold 100, the end caps 200, the gaskets 300, 400, etc.) may be replaced if damaged, rather than the entire manifold assembly 50.

[0093] Although the devices presented herein have been shown and described in detail and reference has been made to their specific embodiments, they are still not intended to be limited to the details shown, as it will be apparent that various modifications and structural changes may be made therein without departing from the scope of the invention and within the scope of the claims and their equivalents. For example, the flow paths presented herein may be modified to include any number of channels, deviations, cavities, inlets, and outlets, the components of the manifold assemblies presented herein may include any number of ports, openings, and holes, and the manifold assemblies may include any number of components, end caps, compression pins, compression limiters, and gaskets.

[0094] In addition, various features from one of the embodiments can be incorporated into another of the embodiments. That is, it is believed that the foregoing disclosure encompasses a number of different inventions having independent utility. While each of these inventions has been disclosed in a preferred form, the specific embodiments thereof disclosed and shown herein should not be taken in a limiting sense, as many variations are possible. The subject matter of the present invention includes all novel and non-obvious combinations and sub-combinations of the various elements, features, functions, and / or properties disclosed herein. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure set forth in the following claims.

[0095] It should also be understood that terms such as "left", "right", "top", "bottom", "front", "rear", "side", "height", "length", "width", "upper", "lower", "inner", "outer", "inside", "outside", as may be used herein, merely describe reference points and do not limit the present invention to any particular orientation or configuration. Additionally, the term "exemplary" is used herein to describe an example or illustration. Any embodiment described herein as exemplary should not be construed as a preferred or advantageous embodiment, but rather as an example or illustration of a possible embodiment of the present invention. Further, it should be understood that the components of the bioprocessing system described herein, the manifold assemblies described herein, or portions thereof, can be fabricated from any suitable material or combination of materials, such as but not limited to thermoplastics, plastics, or metals (e.g., copper, bronze, aluminum, steel, etc.), as well as derivatives thereof 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.

[0096] Finally, as used herein, the term "comprising" and its derivatives (such as "comprising...") should not be construed in an exclusive sense, that is, these terms should not be interpreted as precluding the possibility that the subject matter described and defined may include further elements, steps, etc. Similarly, in any description reciting "a" or "first" element or the like, the disclosure should be understood to include incorporating one or more such elements, neither requiring nor precluding two or more such elements. Also, as used herein, the term "about" and its family of terms (such as "approximately") should be understood to indicate values very close to those accompanying the foregoing terms. That is, a reasonable deviation from the exact value should be accepted, as those skilled in the art will understand that such deviation from the indicated value is inevitable due to measurement inaccuracies, etc. The same applies to the terms "circa", "about", "substantially", and "essentially".

Claims

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

2. The manifold assembly according to claim 1, further comprising: An end cap removably coupled to the first surface or the second surface of the manifold.

3. The manifold assembly according to claim 2, wherein, The manifold further comprises: 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.

4. The manifold assembly according to claim 3, wherein, The end cap further comprises: 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.

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

6. A manifold assembly for a tangential flow filtration component, the manifold 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 such that the compression limiter extends from the first surface of the manifold to the second surface; And An end cap coupled to the first surface of the manifold.

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

8. The manifold assembly according to claim 7, wherein, The end cap includes an outer surface and an inner surface opposite the outer surface.

9. The manifold assembly according to claim 8, further comprising: A compression pin at least partially captured within the end cap such that a portion of the compression pin extends from the inner surface of the end cap.

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

11. The manifold assembly according to claim 9, wherein, The compression limiter is a cylinder having a conduit.

12. The manifold assembly according to claim 11, wherein, When the end cap is coupled to the manifold, the compression pin abuts against one 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 according to claim 9, wherein, The end cap and the manifold have a first durometer value.

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

15. A manifold assembly for a tangential flow filtration component, the manifold assembly comprising: A manifold having a first surface, a second surface opposite the first surface, and a plurality of ports extending from the first edge of the manifold, the manifold further comprising a plurality of first openings extending into the manifold on the first surface and in fluid communication with the plurality of ports; And A end cap having an inner surface, an outer surface, and a plurality of second openings extending from the inner surface to the outer surface through the end cap, the plurality of second openings being aligned with the plurality of first openings when the end cap is coupled to a first surface of the manifold.

16. The manifold assembly according to claim 15, wherein, When the end cap is coupled to the manifold, the inner surface of the end cap is disposed closer to the first surface of the manifold than the outer surface of the end cap.

17. The manifold assembly according to claim 16, further comprising at least one gasket disposed between the first surface of the manifold and the inner surface of the end cap.

18. The manifold assembly according to claim 16, wherein, The manifold further comprises a plurality of first passages disposed on the first surface.

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

20. The manifold assembly according to claim 19, wherein, When the end cap is coupled to the manifold, the plurality of first passages and the plurality of second passages together form a passage through at least a portion of the manifold assembly.

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