Distributor assemblies, especially for separation units in modular process equipment.

By designing modular dispenser components and using standardized interfaces and fastening elements, the problems of large space occupation and complex fluid connections in traditional process equipment have been solved, achieving stable and simplified fluid connections and efficient biopharmaceutical production.

CN116324254BActive Publication Date: 2026-05-26SARTORIUS STEDIM BIOTECH GMBH
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SARTORIUS STEDIM BIOTECH GMBH
Filing Date
2021-09-27
Publication Date
2026-05-26

AI Technical Summary

Technical Problem

Traditional process equipment requires a lot of space, carries the risk of backmixing, and fluid connections are not easy to change or adjust, leading to complex operation and increased costs, especially affecting yield and quality in the preparation of biopharmaceutical active substances.

Method used

A distributor assembly comprising a fluid interface, fastening elements, and mounting slots is designed to selectively establish and disconnect fluid connections. It employs standardized interfaces and fastening elements to achieve a modular construction, and ensures stable and secure flow connections through the matching design of the interface elements and fastening elements.

Benefits of technology

It achieves a compact and stable connection of process equipment and devices, simplifies the fluid connection process, reduces operational complexity and costs, and improves production efficiency and product quality.

✦ Generated by Eureka AI based on patent content.

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Abstract

A distributor assembly (14), particularly designed for a separation unit (12) of a modular process equipment unit (10), includes a fluid distribution device with a plurality of fluid interfaces (28, 30), wherein the fluid distribution device is capable of selectively establishing and blocking flow connections between the fluid interfaces (28, 30). The distributor assembly also includes an interface element (42) and a fastening element (58). The interface element (42) is mountable on one of the fluid interfaces (30), and the distributor assembly (14) has an associated mounting groove (60) at the fluid interface (30). The mounting groove (60) is adapted to the shape of the fastening element (58) such that the fastening element (58) can be introduced into the mounting groove (60) up to a defined fastening position in which the fastening element (58) engages with and secures the interface element (42).
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Description

Technical Field

[0001] The present invention relates to a dispenser assembly, particularly for a separation unit of a modular process equipment, the dispenser assembly being provided for performing one or more basic operations in a biotechnology process. Background Technology

[0002] Separation units, such as filter capsules, chromatography columns, or membrane adsorbers, are used in the purification (downstream processes). Currently, these separation units, along with other functional units (sensors, pumps, mixers, etc.) where necessary, are robustly interconnected by means of hoses and / or pipes to enable the execution of specific process steps.

[0003] This conventional process apparatus requires a large amount of space and is very inconvenient to use, partly because many components of the apparatus must be fixed in place. Furthermore, such apparatus has large dead spaces, which on the one hand introduces the risk of unwanted backmixing, and on the other hand conflicts with the desired maximum product yield. This is particularly important when preparing high-quality biopharmaceutical active ingredients. Another drawback of conventional process apparatuses is that the media to be purified must always be cumbersomely stored, for example, in separate tanks or bags, before performing additional separation steps in downstream processes, due to the current lack of compatibility with the interfaces of these intermediate steps (susceptibility to pressure, lack of sterility barriers, lack of suitable interfaces, etc.).

[0004] Many of these drawbacks arise from the outward-extending and inflexible fluid connections of the separation unit, meaning they are not easily altered or adjusted. Furthermore, special measures are typically required to ensure these fluid connections, which further exacerbates the costs associated with constructing and operating the process equipment.

[0005] Specific coupling devices for establishing and separating fluid connections are known, employing fastening elements, such as those described in EP 462 971 B1, EP 1 644 656 B1, EP 1 651 901 B1, WO 2016 / 057794 A1, and US 6 231089 B1. US 7 981 289 B2 shows a fluid handling device with a modular construction of individual modules, its head section having fluid lines and associated fluid interfaces (ports). The fluid interfaces of adjacent modules can be interconnected via connectors. Summary of the Invention

[0006] The purpose of this invention is to improve and simplify the fluid connections between separation units and other functional units in process equipment.

[0007] The objective is achieved by a dispenser assembly according to the invention. Advantageous and objective-oriented designs of the dispenser assembly according to the invention are provided herein.

[0008] The dispenser assembly according to the invention is particularly designed for the separation unit of a modular process equipment and includes a fluid dispensing device having multiple fluid interfaces, wherein the fluid dispensing device is capable of selectively establishing and blocking flow connections between the fluid interfaces. The dispenser assembly also includes interface elements and fastening elements. The interface element can be disposed on one of the fluid interfaces, and the dispenser assembly has an associated mounting slot at the fluid interface. The mounting slot is adapted to the shape of the fastening element such that the fastening element can be introduced into the mounting slot up to a defined fastening position in which the fastening element engages with and secures the interface element.

[0009] This invention is based on the understanding that a simple, modular construction of process equipment can be achieved by means of a suitable distributor assembly with the possibility of standardized interfaces. Therefore, in addition to enabling fluid distribution devices that flexibly interconnect separation units and other functional units, the distributor assembly according to the invention also features a special connection technology by which fluid connections and rigid mechanical connections can be established with adjacent distributor assemblies or functional units.

[0010] The dispenser assembly according to the invention is characterized in that the means required for connection, particularly the fastening elements, mounting slots, and corresponding interface elements, with sections that mate with the fastening elements, are easily manufactured. The cost required to install these components to establish a secure and stable connection is minimal.

[0011] In the context of this invention, the term "interface element" includes all components that can be directly connected to one of the fluid interfaces of the dispenser assembly and secured by means of fastening elements that can be introduced into a mounting slot.

[0012] In particular, the interface element can be a connector. This connector has a flow channel defined by its walls, leading to two opposing open ends. With the connector secured, the open ends align with the fluid interface of the dispenser assembly. The connector is fixed to these ends by means of fastening elements. The other end of the connector can be secured to an adjacent dispenser assembly in the same manner, enabling a short, secure flow connection in addition to a rigid mechanical connection. It should be particularly emphasized in this case that the connector walls can be designed to be highly pressure-resistant. Additional measures may be required to achieve safety standards comparable to conventional hose connections.

[0013] In addition to connectors, functional units can also be provided as interface elements, which are flowably connected to the fluid interface in a fixed state. Such functional units should not be construed here as connectors, additional dispenser components, or separation units. Rather, they are other functional units used for different purposes during process execution or control. These functional units can be, for example, venting devices, sampling devices, sensors (especially for measuring pressure, flow rate, viscosity, pH, or conductivity), or spectral measurement devices (UV-VIS, NIR, Raman, etc.). This means that, due to the present invention, such functional units can be directly connected to the fluid interface of the dispenser assembly and thus can be considered as components of the dispenser assembly.

[0014] According to an improved embodiment of the present invention, this functional unit can also be integrated into a blind plug.

[0015] The interface element located on one of the fluid interfaces can also have a diaphragm to provide an inlet for cannulation at a specific point in time. Liquid can be drawn out (e.g., for sampling) or delivered via said inlet, for example, using a syringe. The diaphragm can also be integrated into a blind plug.

[0016] Regardless of other design options for the interface element, the ends that connect to the fluid interface of the dispenser assembly should be generally configured, meaning that the ends should be designed similarly so that each can be secured by a fastening element. According to a preferred design, in the secured state of the interface element, the fastening element engages with a connecting segment in a recess of the interface element. Accordingly, the recess should be substantially identical in all interface elements.

[0017] In some cases, it is desirable, or necessary for proper functioning, to secure the functional unit after installation to prevent twisting. This ensures, for example, that air can escape upwards in the case of an exhaust system.

[0018] According to the first variant, this can be achieved by matching the joint section of the fastening element and the open portion of the interface element, such that the interface element can only be fixed by the fastening element along a single orientation or along a limited number of defined orientations. For example, the basic square shape of the joint section and the open portion ensures that the interface element can only be fixed along one of four possible orientations and cannot be twisted thereafter. The basic triangular shape allows for three orientations, etc.

[0019] According to the second variant, one or more preferred orientations of the interface element can also be achieved by matching the flange of the interface element with the opening associated with the fluid interface, such that the interface element can only be inserted into the opening along a single orientation or a limited number of defined orientations.

[0020] To prevent the fastening element, in which the interface element is fixed, from falling out of the mounting slot, a preferred embodiment proposes that the fastening element has a locking element that, in the fastened position, interacts with a mating locking section in or at the mounting slot of the dispenser assembly. Preferably, the locking element and / or locking section is resiliently deflectable. In principle, this principle can also be reversed, meaning that the locking element can be disposed within or on the mounting slot, while the locking section can be disposed on the fastening element.

[0021] This type of fastening can be provided in two functionally different implementation variants. To prevent or make identifiable subsequent operations after the interface element is connected, according to the first implementation variant, the locking element cannot be released from the locking section while the fastening element is in its fastened position. Therefore, the interface element can only be removed by forcibly damaging the housing of the fastening element or the distributor assembly. This non-releasable fastening is recommended for pre-installed and pre-configured structures to eliminate the possibility of user error.

[0022] However, to allow users to remove the installed interface components again, a variation of the second embodiment proposes that the locking element and locking section are matched so that the fastening element can be removed from its fastened position by deflection of the locking element or locking section, if necessary, with the aid of a tool. This releasable fastening is intended for users who, for example, want to implement their own test configuration.

[0023] To prevent errors in the introduction of the fastening element under any circumstances, in a preferred embodiment, the fastening element and the distributor assembly, particularly the mounting slot, have complementary indexing structures that work together to prevent the fastening element from being introduced into the mounting slot in the wrong orientation. This safety measure is then meaningful, for example, when the fastening element has a locking element on one side, which prevents the fastening element from engaging in the fastening position if the fastening element is not correctly oriented in the mounting slot.

[0024] Complementary index structures can have at least one protrusion, such as one or more guides, and at least one recess adapted to the protrusion. This allows for a simple way to provide mechanical encoding based on the Poka-Yoke principle.

[0025] For effective leak protection, the interface element is preferably sealed relative to the fluid interface by at least two sealing rings. Attached Figure Description

[0026] Other features and advantages of the invention will become apparent from the following description and the accompanying drawings. The drawings show:

[0027] Figure 1 This illustrates a process apparatus having multiple separation units and dispenser assemblies for performing one or more basic operations in a biotechnology process;

[0028] Figure 2 Show Figure 1 Another view of the process equipment and apparatus in the middle;

[0029] Figure 3 An exploded view of the dispenser assembly according to the invention without interface elements is shown;

[0030] Figure 4 The diagram shows an interface element with an insertable connector. Figure 3 A partially cut-out view of the allocator component in the image;

[0031] Figure 5 A connector according to the first embodiment is shown;

[0032] Figure 6 The fastening element is shown;

[0033] Figure 7 A dispenser assembly with an insertable fastening element is shown without a connector;

[0034] Figure 8 The mounting slots for the dispenser components are shown;

[0035] Figure 9 A cut-out front view shows a mounting slot with a partially inserted fastening element;

[0036] Figure 10 A cut-out side view shows a mounting slot with a fully inserted fastening element;

[0037] Figure 11a A symbolic diagram showing a fastening element that cannot be loosened;

[0038] Figure 11b A symbolic diagram showing a releasable fastening element;

[0039] Figure 12 Show the hose connector;

[0040] Figure 13 The connector according to the second embodiment is shown;

[0041] Figure 14 The connector according to the fourth embodiment is shown;

[0042] Figure 15 The connector according to the fifth embodiment is shown;

[0043] Figure 16The connector according to the sixth embodiment is shown;

[0044] Figure 17 The blind spot is shown. Detailed Implementation

[0045] exist Figure 1 and 2 The image exemplarily illustrates a process apparatus 10 for performing one or more basic operations in a biotechnology process. The process apparatus 10 includes a plurality of separation units 12, which differ in separation technology (e.g., filter capsules, chromatography columns, membrane adsorbers) and / or filter materials and / or structural types and / or structural dimensions and / or other parameters.

[0046] The separation units 12 are interconnected by means of a specific dispenser assembly 14, which in particular... Figure 1 and Figure 2 In the exemplary application shown, it is also referred to as a dispensing cover. Therefore, the process equipment apparatus 10 includes a plurality of sub-units (modules) 16, each sub-unit being formed by a separation unit 12 and one or two dispenser assemblies 14, the dispenser assemblies being disposed on one or both end sides of the separation unit 12. Each dispenser assembly 14 is robustly connected to at least one adjacent dispenser assembly 14, forming a rigid combination of dispenser assemblies 14.

[0047] In the illustrated embodiment, all dispenser assemblies 14 have the same basic structure, and each dispenser assembly 14 is associated with and fixedly mounted on the separation unit 12, thereby producing a compact and stable process equipment apparatus 10 with the separation units 12 arranged in a defined manner—especially in a grid.

[0048] exist Figure 3 and 4 The basic structure of the dispenser assembly 14 is derived from this. The dispenser assembly 14 has a housing 18, which is essentially in the form of a right prism, and whose bottom and top surfaces are essentially in the shape of an isoangular polygon, in this case, an octagon. Four main sidewalls 20, oriented at right angles to each other, are interconnected by secondary sidewalls 22 located between them. On one end side, the housing 18 is closed by a cover 24; on the other end side, the housing 18 is open and covered by the bottom or cover section 26 of the associated separating unit 12 (depending on whether the dispenser assembly 14 fits onto the separating unit 12 from below or above its operating position). Figure 3 and 4 Not fully shown in the image.

[0049] Inside the housing 18 is a fluid distribution device having a central working port 28 accessible through the open side of the housing and multiple lateral supply or discharge ports 30. The supply or discharge ports 30 of the fluid distribution device are located in a plane oriented perpendicular to the axial direction of the working port 28. The fluid distribution device shown here has four supply or discharge ports 30, arranged at 90° angles and accessible through corresponding openings 32 in the main sidewall 20 of the housing 18.

[0050] The distributor assembly 14 also includes an interface mechanism by which a flow connection is established between the fluid inlet or outlet 34 of the separation unit 12 and the working interface 28 of the fluid distribution device when the distributor assembly 14 is placed on the bottom or cover section 26 of the separation unit 12. The distributor assembly 14 is secured to the bottom or cover section 26 of the separation unit 12 by means of a mounting mechanism 36 (locking element, etc.). The interface mechanism and mounting mechanism 36 of the bottom or cover section 26 of all separation units 12 are matched with the standardized setting and design of the distributor assembly 14.

[0051] In this embodiment, the fluid distribution device is essentially formed by a multi-way valve, more precisely by a ball valve, which provides the aforementioned fluid interface and is capable of occupying different switching positions. A key component of the valve is a ball 40 with a bore, which is sealed with a sealing ring on each supply or discharge port side and held in position by a support element 38. The ball 40 can be positioned via a spindle 52 (see...). Figure 7 (e.g., rotate to at least two different switching positions.)

[0052] Specific interface elements 42 can be disposed on one or more supply or discharge ports 30 of the fluid distribution device of the distributor assembly 14. Such interface elements 42 can be connectors 44 that establish a flow connection with an adjacent distributor assembly 14 or with other components such as hoses or tubing. However, interface elements 42 can also be specific functional units. Such functional units should not be construed herein as additional distributor assemblies 14 and separation units 12, but rather as specific components that provide or enable additional functions, such as in… Figure 1 and 2 The exhaust device 46 is shown in the figure.

[0053] The following description first describes the connection of two adjacent dispenser assemblies 14 by means of a connector 44, which establishes a fluid connection between the adjacent dispenser assemblies 14 on the one hand and a rigid mechanical connection on the other.

[0054] exist Figure 5A first embodiment of connector 44 is shown separately. Connector 44 is configured here as a double-connection device (double male connector). A continuous flow channel 48 is formed inside connector 44. The walls surrounding flow channel 48 are thick and stable, enabling them to withstand high pressure (4 bar and more if necessary). Inside the housing 18 of distributor assembly 14, connector 44 is sealed by two O-rings 50 respectively.

[0055] In the installed state, the first open end 54 of connector 44 is aligned with one of the supply or discharge ports 30 of the fluid distribution device of dispenser assembly 14. Connector 44 extends from an opening 32 in the associated main sidewall 20 of housing 18 and extends through the opening 32 in the opposite main sidewall 20 of housing 18 of adjacent dispenser assembly 14. The second open end 56 of connector 44 is aligned with the associated supply or discharge port 30 of the fluid distribution device of adjacent dispenser assembly 14.

[0056] Secure the connector 44 in each of the two adjacent distributor assemblies 14 using universal fastening elements 58, which are designed to be inserted into the mounting slots 60, as will be discussed in more detail later. Figure 6 The fastening element 58 is shown separately, and in Figure 7 The fastening elements (without connectors) in the dispenser assembly 14 are shown in the installed state.

[0057] The fastening element 58 is substantially rectangular in shape, with a substantially semi-circular cutout. The edge face of the cutout forms a mating section 62, which matches a recess 64 in the outer contour of the connecting element 42, which is, in this case, a connector 44.

[0058] On the first side, the fastening element 58 has a resiliently deflectable locking element 66 in the form of a tongue or hook. On the opposite second side, two elongated protrusions 68 are formed, which can also be referred to as mounting rails. The protrusions 68 are formed on two adjacent side edges of the engagement section 62 and extend substantially parallel to each other. Furthermore, two recesses 70 are provided on the second side opposite to the end of the engagement section 62.

[0059] exist Figures 8 to 10 The mounting slot 60 is visible in more detail, into which the fastening element 58 can be inserted. The mounting slot 60 is formed in the housing 18 of the dispenser assembly 14 and is freely accessible. The mounting slot 60 is located at the supply or discharge port 30 such that it intersects with an inwardly projecting opening 32 configured for the supply or discharge port 30.

[0060] The shape of the mounting slot 60 is adapted to the shape of the fastening element 58. In particular, the mounting slot 60 has a main channel corresponding to the plate-like shape of the fastening element 58. Furthermore, on the first side, the mounting slot 60 has two recesses 72, which are complementary to the protrusions 68. On the opposite side of the mounting slot 60, there is a locking section 74 in the form of a notch with a locking surface, which matches the locking element 66.

[0061] Because the special configuration of the fastening element 58 with protrusion 68 and the mounting slot 60 with recess 72 forms a complementary index structure, the fastening element 58 can only be introduced into the mounting slot 60 along the orientation in which the protrusion 68 engages with the recess 72.

[0062] To further prevent the fastening element 58 from being introduced along the joint section 62 in an orientation that is not aligned with the opening 32, it can be withdrawn, with the mounting slot 60 below—regarding the introduction direction A (see [reference]). Figure 9 — It becomes slightly narrower towards the center of the opening 32. Correspondingly, the width of the fastening element 58 also decreases towards the end where the engagement section 62 is formed. This prevents the fastening element 58 from being inadvertently introduced into the mounting slot 60 with its wider end first.

[0063] Advantageous in manufacturing is that the fastening element 58 becomes thinner downwards—also with respect to the introduction direction A—meaning that the two segments near the (here, semi-circular) cut converge into a wedge shape. This wedge shape also proves advantageous as it aids in the correct axial positioning of the interface element 42. If, for example, the interface element is not fully introduced into the opening 32, and consequently the recess 64 is not fully aligned with the mounting slot 60, the fastening element 58, due to its wedge shape, can still engage in the recess 64 and automatically pull it into the housing 18 as the interface element 42 is further pushed into the mounting slot 60 until it reaches the correct axial position.

[0064] In the desired, correct orientation, the fastening element 58 can be pushed into the mounting slot 60 until the locking element 66, which deflects laterally to the introduction direction A upon insertion, can retract into the notch and be supported on the locking section 74. This position of the fastening element 58 is referred to below as the fastened position.

[0065] The interaction between the locking element 66 and the locking section 74 can also occur in the opposite manner. Therefore, instead of a deflectable tongue or hook, a non-deflectable protrusion, for example, hemispherical in shape, can be formed on the fastening element 58. In this case, at least the section of the main sidewall 20 providing the locking section 74 is elastically deflectable. When the fastening element 58 is introduced into the mounting slot 60, the locking element 66 presses the section of the main sidewall 20 outward until the section snaps back into the fastened position, and the locking element 66 is able to support itself on the locking section 74.

[0066] In the fastened position, the fastening element 58 interacts with the connector 44 previously inserted into the opening 32. More specifically, the engaging section 62 of the fastening element 58 engages with the recess 64 in the outer contour of the connector 44. Because the recess 64 is bounded on both sides along the axial direction of the connector 44, the connector 44 is secured to the housing 18 of the dispenser assembly 14 in the defined position.

[0067] If it is not expected that the fastening element 58 and connector 44 will be removed later, the locking element 66 and locking section 74 are configured such that the locking element 66 is irreversibly hooked onto the locking section 74. This can be achieved in particular by configuring the locking section 74 as an undercut, the locking section having an inclined locking surface and a locking element 66 that matches the locking surface, as in Figure 11a The symbolic diagram is shown exemplarily. Thus, the fastening element 58 and connector 44 are irreversibly secured and cannot be removed from the housing 18 of the dispenser assembly 14 without damage.

[0068] However, if the fastening element 58 and connector 44 should be allowed to be removed later, then a reversible co-action of the locking element 66 and locking section 74 is provided. This can be achieved, for example, by the configuration of the locking element 66 and locking section 74, as it is in Figure 11b As shown in the symbolic diagram. In this case, it is possible for the locking element 66 to deflect laterally again when pulled out relative to the introduction direction A until it can be guided through the locking section 74. The deflection of the locking element 66 can be achieved by means of a suitable tool that engages in one or both notches 70, allowing the fastening element 58 to be pried out. For this reason, the notches 70 are formed in the area where the fastening element 58 protrudes from the mounting slot 60. Alternatively, the main channel of the mounting slot 60 can be widened at least in sections to allow for tool access.

[0069] Alternatively or additionally, it can be proposed that the fastening element 58 has a reduced wall thickness. More precisely, the wall thickness of the fastening element 58—when correctly oriented relative to the mounting slot 60—decreases along the introduction direction A, meaning that when introduced vertically from top to bottom, the fastening element 58 is thinner at the bottom than at the top. This configuration of the fastening element 58 improves the implementation of the injection molding technology of the mounting slot 60 in the housing 18.

[0070] The second end 56 of connector 44, extending from the opening 32 of the dispenser assembly, is secured to the housing 18 of the adjacent dispenser assembly 14 in the same manner as described above. Thus, the two dispenser assemblies 14 are rigidly connected to each other.

[0071] Different dispenser assemblies 14 can be connected to each of the supply and discharge ports 30 of the dispenser assembly 14. The length of the connector 44 is preferably determined such that the interconnected dispenser assemblies 14 are very close to or in contact with each other. The reduction in the wall thickness of the fastening element 58 described above enables the housing 18 of the interconnected dispenser assemblies 14 to be compressed, pressed, or clamped.

[0072] The geometry of the distributor assembly 14 is predefined with a logical grid of defined locations where the distributor assembly 14 can be configured to connect with adjacent distributor assemblies 14.

[0073] As already mentioned, the supply or discharge port 30 of the dispenser assembly 14 can also be used to connect a specific functional unit. This functional unit, like the previously described connector 44, has a first end 54 that can be introduced into the opening 32 of the dispenser assembly 32. A flow channel 48 formed in this first end 54 establishes a flow connection with the corresponding supply or discharge port 30 of the dispenser assembly 14.

[0074] The functional unit is secured to the housing of the dispenser assembly 14 in the same manner as described above with respect to connector 44. That is, the first end 54 of the functional unit is provided with a recess 64, into which the engagement segment of the fastening element 58 engages when the fastening element is moved to the fastening position.

[0075] Examples of functional units that can be fixed to the housing 18 of the dispenser assembly 14 are exhaust devices 46, sampling devices, sensors (especially for measuring pressure, flow rate, viscosity, pH or conductivity) and spectrum measuring devices (UV-VIS, NIR, Raman, etc.).

[0076] The functional unit can also be connected to the supply or discharge port 30 of the dispenser assembly 14 via a flexible hose, for example by means of a hose connector 76, such as in Figure 12 As shown in the image.

[0077] exist Figures 13 to 16 Another example of the type of connector 44 is shown, which can be secured in the housing 18 of the dispenser assembly 14 by at least one end 54 as described above.

[0078] In a particular embodiment, a mechanical coding section or anti-torsion device is provided, which ensures that the interface element 42 can only be inserted and fixed into the opening 32 of the dispenser assembly 14 along a unique orientation or along a limited number of orientations.

[0079] According to the first alternative, for this purpose, the edge of the opening 32 is not rounded, and the connector 44, or generally the interface element 42, has a flange 78 with a correspondingly fitted outer circumference. For example, as in Figures 14 to 16 As shown, the flange 78 can have a polygonal shape, wherein the corners can be rounded. In order for this interface element 42 to be secured to the supply or discharge port 30 of the dispenser assembly 14, the associated opening 32 must have a shape corresponding to the polygon. For example, in Figure 7 The opening 32 shown has a basic square shape. Figure 15 The flange 78 of the connector 44 shown in the figure matches the basic shape of the square.

[0080] Depending on the specific shape of the opening 32 and the flange 78, the interface element 42 can be inserted and fixed along only one or more defined (non-arbitrary) orientations.

[0081] According to the second alternative, it is also feasible in principle that the recess 64 of the interface element 42 is shaped such that the fastening element 58 can only be moved into the fastening position when the interface element 42 occupies a very specific or limited number of defined orientations. This can be achieved, for example, by the basic elliptical shape of the bottom of the recess 64, which allows for a first orientation and a 180° rotation around the longitudinal axis. Furthermore, many other mutually matching configurations of the recess 64 of the interface element 42 and the engagement segment 62 of the fastening element 58 are also feasible, allowing only one or only a limited number of defined orientations of the interface element 42. For example, in the case of a basic square shape at the bottom of the recess 64 and a corresponding shape at the engagement segment 62 of the fastening element 58, four orientations of the interface element 42 with a rotational angular distance of 90° are feasible.

[0082] If a functional unit, such as the exhaust device 46, is required to have a specific orientation in operation, then such a coding section or anti-torsion device is meaningful.

[0083] Unused supply or discharge ports 30 can be sealed by means of blind plugs 80, as they are located in... Figure 17As shown in the diagram. Like each of the other interface elements 42, the blind plug 80 is also sealed about the housing 18 by two O-rings 50 and secured by fastening elements 58, wherein the blind plug is disposed within the housing. In principle, it is also possible to integrate the functional unit into the blind plug 80.

[0084] A diaphragm can also be provided as an interface element 42, which closes a corresponding, otherwise unused, supply or discharge port 30. This creates the possibility of providing an inlet for a cannula at this location, allowing liquid to be extracted or supplied, for example, using a syringe. The diaphragm can also be integrated into a blind plug 80.

[0085] Regardless of the final configuration of the process equipment unit 10 constructed by means of the distributor assemblies 14, all distributor assemblies 14 and at least all separation units 12 directly mounted on the distributor assemblies 14, as well as the remaining components (functional units, hoses, etc.), are configured as single-use components, meaning they are intended for single use and are accordingly formed of suitable plastic materials. As long as the individual components allow this, the entire process equipment unit 10, or at least a large portion thereof, can be pre-sterilized before being put into operation, enabling it to be put into immediate use.

[0086] As described above with the aid of several examples, dispenser component 14 can be used in the biopharmaceutical industry, particularly for performing one or more process steps in downstream processes. However, the invention is not limited to this application. Furthermore, applications in binding / eluting and flow-through processes are feasible within the scope of membrane chromatography and column chromatography applications.

[0087] List of reference numerals

[0088] 10. Process equipment and devices

[0089] 12 Separation Units

[0090] 14 Distributor Components

[0091] 16 sub-units

[0092] 18. Shell

[0093] 20 Main sidewalls

[0094] 22 Secondary sidewalls

[0095] 24 lids

[0096] 26. Bottom or cover section

[0097] 28 Working Interface

[0098] 30 Supply or discharge interface

[0099] 32 Opening

[0100] 34. Fluid inlet or outlet

[0101] 36 Installation Mechanism

[0102] 38 Supporting elements

[0103] 40 spheres

[0104] 42 Interface Components

[0105] 44 Connectors

[0106] 46 Exhaust device

[0107] 48 Flow Channel

[0108] 50 O-ring

[0109] 52 spindles

[0110] 54. First end of the interface element

[0111] 56 The second end of the interface element

[0112] 58 Fastening components

[0113] 60 mounting slots

[0114] 62 Joint section

[0115] 64. Empty space

[0116] 66 Locking elements

[0117] 68 protrusions

[0118] 70 notch

[0119] 72 recess

[0120] 74 Locking Section

[0121] 76 Hose Connector

[0122] 78 Flange

[0123] 80 blind blockage

Claims

1. A distributor assembly (14) for a separation unit (12) of a modular process equipment unit (10), the distributor assembly having: - Shell (18) - A fluid distribution device with multiple fluid interfaces (30), including a working interface (28) accessible through an open side of the housing (18), the fluid distribution device having an interface mechanism for establishing a flow connection between the fluid inlet or fluid outlet (34) of the separation unit (12) and the working interface (28) of the fluid distribution device, the fluid distribution device being capable of selectively establishing and blocking flow connections between the fluid interfaces (30) and / or between the fluid interfaces (30) and the working interface (28). - Interface element (42), and - Fastening element (58). The interface element (42) can be mounted on one of the fluid interfaces (30). The dispenser assembly (14) has an associated mounting slot (60) at the fluid interface (30), and The mounting groove (60) is adapted to the shape of the fastening element (58) such that the fastening element (58) can be introduced into the mounting groove (60) up to a defined fastening position in which the fastening element (58) engages with the interface element (42) and secures the interface element.

2. The dispenser assembly (14) according to claim 1, characterized in that, The interface element (42) is a connector (44) having a flow channel (48) defined by a wall, the flow channel leading to two opposing open ends (54, 56), wherein, in the fixed state of the connector (44), the open ends (54, 56) of the connector (44) are aligned with the fluid interface of the dispenser assembly (14).

3. The dispenser assembly (14) according to claim 1, characterized in that, The interface element (42) is a functional unit that is in a fixed state and is in a flow connection with the fluid interface (30).

4. The dispenser assembly (14) according to claim 3, characterized in that, The functional unit is integrated into the blind plug (80).

5. The dispenser assembly (14) according to claim 3 or 4, characterized in that, The interface element (42) has a diaphragm.

6. The dispenser assembly (14) according to any one of claims 1 to 4, characterized in that, With the interface element (42) in a fixed state, the fastening element (58) engages with the empty portion (64) of the interface element (42) by means of its engagement section (62).

7. The dispenser assembly (14) according to claim 6, characterized in that, The joint section (62) and the open section (64) are matched to each other so that the interface element (42) can only be fixed by the fastening element (58) along a unique orientation or along a limited number of defined orientations.

8. The dispenser assembly (14) according to any one of claims 1 to 4, characterized in that, The flange (78) of the interface element (42) and the opening (32) associated with the fluid interface (30) are matched such that the interface element (42) can only be inserted into the opening (32) in a single orientation or in a limited number of defined orientations.

9. The dispenser assembly (14) according to any one of claims 1 to 4, characterized in that, The fastening element (58) has a locking element (66) or a locking section (74) that, in the fastened position of the fastening element (58), works in conjunction with a matching locking section (74) or locking element (66) in or at the mounting slot of the distributor assembly (14).

10. The dispenser assembly (14) according to claim 9, characterized in that, In the fastened position of the fastening element (58), the locking element (66) can no longer be released from the locking section (74).

11. The dispenser assembly (14) according to claim 9, characterized in that, The locking element (66) and the locking section (74) are matched to each other so that the fastening element (58) can be removed from the fastening position by deflection of the locking element (66) or the locking section (74).

12. The dispenser assembly (14) according to claim 11, characterized in that, The fastening element (58) can be removed from the fastening position by means of a tool.

13. The dispenser assembly (14) according to claim 9, characterized in that, The fastening element (58) and the distributor assembly (14) have complementary indexing structures that work together to prevent the fastening element (58) from being introduced into the mounting slot (60) in the wrong orientation.

14. The dispenser assembly (14) according to claim 13, characterized in that, The index structure has at least one protrusion (68) and at least one recess (72) adapted to the protrusion (68).

15. The dispenser assembly (14) according to any one of claims 1 to 4, characterized in that, The interface element (42) is sealed relative to the fluid interface (30) by at least two sealing rings (50).