US-12623168-B2 - Modular device for fixedly arranging and interconnecting individual separation units and/or function units amongst one another

US12623168B2US 12623168 B2US12623168 B2US 12623168B2US-12623168-B2

Abstract

A modular device for a fixed arrangement and interconnection of individual separation units and/or first functional units for performing one or more unit operations in a biotechnological process. The modular device includes a plurality of distributor caps provided for attachment to the separation units and/or first functional units. The distributor caps each have: a fluid distribution mechanism having a working connection and at least two supply or discharge connections, wherein the fluid distribution mechanism can assume at least two defined switching positions; connection mechanisms for establishing a flow communication between a fluid inlet or outlet of the separation unit or the first functional unit and the working connection of the fluid distribution mechanism; coupling mechanisms for establishing a rigid mechanical coupling and a flow communication with an adjacent distributor cap; and an interface for changing the switching positions of the fluid distribution mechanism.

Inventors

Sebastian Handt
Florian Mieth
Heino Heise
Lukas Becker
Jannik DIPPEL

Assignees

SARTORIUS STEDIM BIOTECH GMBH

Dates

Publication Date: 20260512
Application Date: 20211007
Priority Date: 20201008

Claims (14)

1 . A modular device for a fixed arrangement and interconnection of individual separation units and/or first functional units for performing one or more unit operations in a biotechnological process, wherein the modular device comprises a plurality of distributor caps, of which at least one distributor cap is provided for attachment to a separation unit and one or more further distributor caps are each provided for attachment to a further separation unit or a first functional unit, wherein the distributor caps each have: a fluid distribution means having a working connection and at least two supply or discharge connections, wherein the fluid distribution means can assume at least two defined switching positions, wherein the at least two switching positions of the fluid distribution means enable: a selective opening or blocking of a flow communication between the working connection and at least one supply or discharge connection; and/or a selective opening or blocking of flow communications between the working connection and a plurality of specific or all supply or discharge connections; connection means for establishing a flow communication between a fluid inlet or outlet of the separation unit or the first functional unit and the working connection of the fluid distribution means; coupling means for establishing both a rigid mechanical coupling and a flow communication with an adjacent distributor cap, wherein a rigid connector serving as the coupling means between a first distributor cap an adjacent second distributor cap establishes the rigid mechanical coupling and at a same time the flow communication between a supply or discharge connection of the fluid distribution means of the first distributor cap and a supply or discharge connection of the fluid distribution means of the adjacent second distributor cap; and an interface for manually or automatically changing the switching positions of the fluid distribution means.
2 . The modular device according to claim 1 , characterized in that the distributor caps comprise mounting means for fixedly attaching the distributor cap to an end of a housing of a separation unit or a first functional unit.
3 . The modular device according to claim 1 , characterized in that all or at least a plurality of the distributor caps have a same shape and a same size and the supply or discharge connections, if any, are each arranged at a same location.
4 . The modular device according to claim 1 , characterized in that the supply or discharge connections of the fluid distribution means lie in a plane which is oriented perpendicularly to an axial direction of the working connection.
5 . The modular device according to claim 1 , characterized in that the fluid distribution means comprises four supply or discharge connections arranged at angular intervals of 90°.
6 . The modular device according to claim 1 , characterized in that the distributor caps are in a form of a straight cylinder, a base and a top surface of which are circular, or are an equiangular polygon.
7 . The modular device according to claim 1 , characterized in that in at least one distributor cap, the fluid distribution means comprises at least one valve, including a ball valve and/or a diaphragm valve.
8 . The modular device according to claim 7 , characterized in that the valve is a multi-way valve with a plurality of valve positions, by means of which different flow communications between the working connection and the supply or discharge connections and/or between the supply or discharge connections can be set, wherein the working connection is arranged centrally in the distributor cap with respect to a plane perpendicular to its axial direction.
9 . The modular device according to claim 1 , characterized in that in at least one distributor cap provided for attachment to a separation unit, the working connection is arranged so as to be arranged radially offset with respect to a central fluid outlet of the separation unit, so that when the distributor cap is attached to the separation unit, the working connection is brought into flow communication with a correspondingly offset fluid inlet of the separation unit.
10 . The modular device according to claim 9 , characterized in that in at least one distributor cap, the fluid distribution means comprises at least one valve, characterized in that the valve is a ball valve which can be brought into at least two different valve positions via a centrally arranged spindle and a bevel gear.
11 . The modular device according to claim 1 , characterized in that sterile connectors or hose barbs or blind plugs are attached to the supply or discharge connections, which are each fixed to a securing element which further snaps into a latching means formed on a housing of the distributor cap.
12 . The modular device according to claim 1 , characterized in that at least in one distributor cap, a second functional unit is connected to at least one of the supply or discharge connections.
13 . The modular device according to claim 1 , characterized in that an overpressure protection means, including a burst diaphragm, which releases a corresponding connection when a limit pressure is exceeded is attached to at least one working connection or supply or discharge connection.
14 . A modular device for a fixed arrangement and interconnection of individual separation units and/or first functional units for performing one or more unit operations in a biotechnological process, wherein the modular device comprises a plurality of distributor caps, of which at least one distributor cap is provided for attachment to a separation unit and one or more further distributor caps are each provided for attachment to a further separation unit or a first functional unit, wherein the distributor caps each have: a fluid distribution means having a working connection and at least two supply or discharge connections, wherein the fluid distribution means can assume at least two defined switching positions; connection means for establishing a flow communication between a fluid inlet or outlet of the separation unit or the first functional unit and the working connection of the fluid distribution means; coupling means for establishing a rigid mechanical coupling and a flow communication with an adjacent distributor cap; and an interface for manually or automatically changing the switching positions of the fluid distribution means, wherein, in at least one distributor cap provided for attachment to a separation unit, the working connection is arranged so as to be arranged radially offset with respect to a central fluid outlet of the separation unit, so that when the distributor cap is attached to the separation unit, the working connection is brought into flow communication with a correspondingly offset fluid inlet of the separation unit, and wherein, in at least one distributor cap, the fluid distribution means comprises at least one valve, wherein the valve is a ball valve which can be brought into at least two different valve positions via a centrally arranged spindle and a bevel gear.

Description

FIELD OF THE INVENTION The invention relates to a modular device for a fixed arrangement and interconnection of individual separation units and/or functional units for performing one or more unit operations in a biotechnological process. The invention further relates to a process device arrangement for performing one or more unit operations in a biotechnological process. BACKGROUND In the field of downstream processing, separation units such as filter capsules, chromatography columns or membrane adsorbers are used. Currently, such separation units and possibly further functional units (sensors, pumps, mixers, etc.) are interconnected by means of hoses and/or piping to be able to perform a specific process step. Such a conventional process arrangement requires a lot of space and is very unwieldy, also because many components of the arrangement have to be fixed. In addition, such an arrangement has large dead spaces, which on the one hand involves the risk of undesired back-mixing and on the other hand constitutes an obstacle to a desired maximum product yield. This is particularly important in the production of high-quality biopharmaceutical active substances. A further disadvantage of a conventional process arrangement is that before further separation steps are performed in the downstream process, the medium to be purified must be temporarily stored in a complicated manner, e.g. in a separate tank or in bags, since currently, there is a lack of compatibility of the interfaces of these intermediate steps (pressure-sensitive, no sterile barrier, no suitable connections, etc.). SUMMARY The object of the invention is to make it easier and more flexible to perform one or more unit operations in a biotechnological process, in particular in a downstream process. This object is achieved by a modular device having the features of claim 1. Advantageous and useful embodiments of the modular device according to the invention are specified in the subclaims. The modular device according to the invention serves for a fixed arrangement and interconnection of individual separation units and/or first functional units for performing one or more unit operations in a biotechnological process. The modular device comprises a plurality of distributor caps, of which at least one distributor cap is provided for attachment to a separation unit and one or more further distributor caps are each provided for attachment to a further separation unit or a first functional unit. The distributor caps each have: a fluid distribution means having a working connection and at least two supply or discharge connections, wherein the fluid distribution means can assume at least two defined switching positions;connection means for establishing a flow communication between a fluid inlet or outlet of the separation unit or the first functional unit and the working connection of the fluid distribution means;coupling means for establishing a rigid mechanical coupling and a flow communication with an adjacent distributor cap; andan interface for manually or automatically changing the switching positions of the fluid distribution means. Separation units are here understood to be filter capsules, chromatography columns, membrane adsorbers or similar units typically used in a downstream process for separating biopharmaceutical products. Other functional units, here referred to as first functional units, which serve other purposes in the context of process performance or control are to be distinguished therefrom. Such a first functional unit may be, for example, a pump (head), a sensor (arrangement), a static mixer, a reservoir or intermediate storage tank, a sampling means or a venting means, wherein the first functional unit may also comprise only functionally essential parts of such units. A first functional unit can also simply be an empty pipe used, for example, as a bypass for transporting medium. The distributor caps are primarily intended for attachment to separation units, which in turn are intended for performing the respective unit operation in the biotechnological process. The connection means of the distributor caps establish a flow communication between a fluid inlet or outlet of the separation unit and the working connection of the fluid distribution means. However, the connection means of the distributor caps also allow them to be attached to other (first) functional units. In this case, the connection means of the distributor caps establish a flow communication between a fluid inlet or outlet of the first functional unit and the working connection of the fluid distribution means. This means that for performing the desired unit operation(s), at least one, preferably a plurality of separation units are in any case provided with a distributor cap and, if necessary, further first functional units are also interconnected by means of such distributor caps to form a process device arrangement. Each distributor cap is coupled to at least one further