MODULAR PROCESSING SYSTEM

Description

[0001] The present invention relates to a modular processing system for biopharmaceutical and / or chemical processes and a method for centrally controlling a modular processing system for biopharmaceutical and / or chemical processes.

[0002] Processes such as cell separation (e.g., by depth filtration), sterile filtration, chromatography steps, virus inactivation, virus filtration, and / or crossflow filtration are familiar from biopharmaceuticals. All of these processes represent unit operations that are regularly interconnected to form different overall processes. Processing systems in which such overall processes are interconnected require comprehensive monitoring of the fluid flow or fluid to ensure that the fluid has the required parameters in the overall process. However, this requires a large number of measuring points in the processing system and complex management of the comprehensive monitoring data.

[0003] For example, WO 2018 / 158273 A1 discloses a modular bioprocessing unit comprising: a housing having one or more internal fluid paths, the housing having at least one inlet and at least one outlet, each in fluid communication with the fluid path or one or more of the fluid paths; one or more sensor elements operatively connected to the or each path; one or more fluid flow-inducing components operatively connected to the or each fluid path; and a plurality of valves for preventing or reducing flow in the or each path.

[0004] The document EP 0 154 845 A2 further discloses a flat filter element for filtering fluids.

[0005] It is therefore the object of the invention to provide a processing system for biopharmaceutical and / or chemical processes that simplifies the monitoring of the fluid in the processing system.

[0006] This task is solved by a modular processing system for biopharmaceutical and / or chemical processes, which includes: at least one processing unit for carrying out a filtration step or a chromatography step in a biopharmaceutical or chemical process; at least one adapter plate which is fluidically connected directly or indirectly to the processing unit, wherein the adapter plate has at least one adapter channel through which at least one fluid stream can flow, flowing to the processing unit, wherein the adapter plate further has at least one deflection element designed as a multi-way valve and / or a pump and / or at least one valve; end brackets, between which the at least one processing unit and the at least one adapter plate are held in a sandwich-like manner; and an external control unit; wherein the adapter plate is designed such that the fluid flow to the processing unit can be at least partially deflected by means of the at least one deflection element designed as a multi-way valve in the adapter channel and / or the fluid flow, preferably its pressure, can be regulated by means of the valve and / or the pump in the adapter channel; wherein at least one sensor is embedded in the processing unit and / or in the adapter plate in order to measure at least one property of the fluid flow in the processing unit orthe adapter plate; wherein the at least one deflection element designed as a multi-way valve and / or the pump and / or the at least one valve are controllable by means of an actuator; and wherein the external control unit is coupled to the at least one sensor (directly or indirectly) in such a way that measurement data from the at least one sensor can be read out and, based on the read-out measurement data, the external control unit controls the actuator in such a way that the fluid flow in the processing unit and / or the adapter plate can be centrally controlled by the external control unit.

[0007] A "processing unit" is understood to mean, in particular, a unit within which a specific process step for the desired method is carried out. In particular, a separation of components of a fluid stream takes place within a processing unit. For example, a processing unit can be a unit for cell separation (e.g., by depth filtration), for sterile filtration, for a chromatography step, for virus inactivation, or for crossflow filtration.

[0008] The adapter plate is connected upstream of the processing unit with respect to the fluid flow, so that the fluid flow flows from the adapter plate to the processing unit.

[0009] The adapter plate, which can be connected upstream of a processing unit in a modular processing system, allows necessary adjustments to the fluid flow to be made. The fluid flow can be at least partially redirected or deflected or its flow direction can be changed and / or the fluid flow can be regulated or controlled with the aid of the adapter plate, preferably or in particular the pressure with which the fluid hits the processing unit. However, both adjustments can also be made simultaneously within one adapter plate. Redirection can preferably be achieved with the aid of at least one deflection element located in or on the adapter channel. Additionally or alternatively, a pump and / or at least one valve can be located in the adapter channel, via which the pressure of the fluid flow in the adapter channel can be regulated or controlled.

[0010] Thus, an adapter plate can be arranged in front of or on a processing unit in a processing system in order to make the necessary adjustments to the fluid flow.

[0011] The installation of an adapter plate upstream of a processing unit in a modular processing system offers the possibility of easily supplying a fluid stream to the downstream processing unit as required for the subsequent process step in the processing system. Due to its design, the adapter plate, in combination with the interconnection of a processing unit, offers a compact design, thus reducing the required floor space and system components. Accordingly, the necessary investment is reduced.

[0012] Furthermore, at least one sensor is embedded in the processing unit and / or adapter plate of the processing system, which can detect at least one property of the fluid flow. This allows measurements to be taken on the fluid flow at preferred positions, thus enabling the fluid flow to be continuously monitored. By embedding the at least one sensor in the processing unit and / or adapter plate, it is particularly unnecessary to connect a separate sensor. This is already incorporated into the adapter plate or processing unit at the factory or provided therein and can advantageously be pre-installed and / or sterilized. This eliminates, in particular, the user's need for calibration or sterilization steps.

[0013] The measurement data from at least one sensor in the processing unit and / or the adapter plate can be read by an external control unit. If the measurement data deviates from predefined optimal values, the external control unit can centrally regulate the fluid flow in the adapter channel and / or the processing unit.

[0014] The modular processing system therefore only requires one external control device to obtain measurement data from the fluid flow and to control the fluid flow in the processing system.

[0015] Preferably, the processing system comprises at least a first and a second processing unit which are fluidically connected to each other, wherein the at least one adapter channel of the adapter plate can be flowed through by at least one fluid stream flowing from the first processing unit to the second processing unit; and wherein the adapter plate is designed such that the fluid flow between the first processing unit and the second processing unit can be at least partially deflected in the adapter channel by means of the at least one deflection element designed as a multi-way valve, and the fluid flow, preferably its pressure, can be regulated by means of the at least one valve and / or the pump in the adapter channel.

[0016] The first and second processing units can be identical or have at least partially different properties. For example, the first and second processing units can vary in size, but can still be easily interconnected or combined with each other using the adapter plate. Preferably, different processing units are interconnected in a processing system, which, for example, use different separation media or are responsible for different processing stages of a process. The same processing units can be used if a capacity expansion is desired.

[0017] The adapter plate is connected between the first processing unit and the second processing unit with respect to the fluid flow and thus fluidically connects the first processing unit and the second processing unit.

[0018] The adapter plate, which can be (at least partially) connected between two processing units in a modular processing system, allows for the necessary adjustments to the fluid flow, enabling processing units (especially standard processing units) to be fluidically connected to one another. The fluid flow can be at least partially redirected or deflected, or its flow direction can be changed, and / or the fluid flow can be regulated or controlled using the adapter plate, preferably or in particular the pressure with which the fluid impinges on the second processing unit. However, both adjustments can also be made simultaneously within one adapter plate.

[0019] Thus, at least one adapter plate can be arranged between two consecutive processing units in a processing system in order to be able to make the necessary adjustments regarding the fluid flow.

[0020] Interconnecting process steps based on a modular processing system with at least one adapter plate between two processing units advantageously enables the combination of any process steps in a single processing system, thus reducing the required floor space and system components. The necessary investment costs are correspondingly lower. Furthermore, a compact and / or flexible interconnection for continuous operation in a processing system, including the monitoring of multiple unit operations, is also enabled.

[0021] Furthermore, it is preferred that at least one sensor is embedded in each of the first and second processing units and in the adapter plate in order to detect at least one property of the fluid flow in the first and second processing units and the adapter plate.

[0022] This ensures continuous monitoring of the fluid flow throughout the processing system. Using the measurement data from the sensors, the control unit can evaluate at least one parameter of the fluid flow at various points in the processing system and immediately initiate measures to correct the corresponding fluid flow parameters should a deviation from the specified limit values ​​occur. This advantageously allows the process result to be influenced via the processing system, and fluid flow parameters that would lead to a negative process result can be influenced in the desired manner. As already described above, the pump and / or the at least one valve and / or the at least one deflection element in the adapter plate can be controlled or regulated accordingly by the control unit.

[0023] Preferably, the external control unit is coupled to the sensors in such a way that measurement data from the sensors can be read out and, based on the read-out measurement data, the fluid flow in the processing units and the adapter plate can be centrally controlled by the external control unit.

[0024] It is preferred that the at least one processing unit and / or the adapter plate each have at least one transponder designed to transmit measurement data from a corresponding sensor to the external control unit; or wherein the sensors of the processing units and / or the adapter plate are coupled to the external control unit via a bus system.

[0025] A "transponder" is understood to be a transmission unit that transmits the sensor's measurement data wirelessly, optically, and / or radio-frequency to the external control unit. Alternatively, the processing system can include a bus system via which the at least one sensor can transmit measurement data to the external control unit.

[0026] The at least one deflection element and / or the pump and / or the at least one valve is / are controllable by means of an actuator.

[0027] An "actuator" is a drive unit that receives control commands from the external control unit and converts the commands into a mechanical movement. This can include adjusting at least one deflection element and / or the pump and / or the valve. The commands are issued by the external control unit.

[0028] This means that not only are measurement data read out centrally, but the fluid flow in the processing system can also be controlled centrally and automatically.

[0029] The sensor can be designed to measure a pressure, a volume flow, a UV value, a pH value, a turbidity and / or a viscosity of the fluid flow.

[0030] This allows at least one parameter of the fluid flow to be monitored as needed, and adjustments to the fluid flow can be made if necessary. These adjustments can be made via the external control unit and / or the external control unit can issue an output (e.g., an alarm) to the user. The user can then make further adjustments if necessary, for example, if the pH value of the fluid is too high.

[0031] Preferably, the at least one sensor, the at least one deflection element designed as a multi-way valve, the pump and / or the at least one valve each have a battery.

[0032] With the help of a battery, the sensor receives the necessary energy to take measurements, the deflection element or the valve can be readjusted using the energy if necessary and the pump can deliver the required pumping power if necessary using the energy from the battery.

[0033] In particular, the battery offers the advantage that no external cables are required for connection by the user. The respective component is already supplied with sufficient energy by the battery. In particular, the battery can also be charged inductively.

[0034] Alternatively or additionally, the at least one sensor, the at least one deflection element, the at least one valve and / or the pump can have a wired power supply.

[0035] A wired power supply advantageously provides the required energy for the aforementioned components, particularly in the case of a longer operating time of the processing system.

[0036] Preferably, the processing system has a central power supply for the at least one sensor, the at least one deflection element designed as a multi-way valve, the at least one valve and / or the pump, wherein the at least one processing unit and the at least one adapter plate have partial sections of the power supply which, when joined together, form the central power supply.

[0037] In other words, a section of the wired power supply (cable) is integrated into each of the processing unit and the adapter plate. When the processing system is assembled, the cable sections of the at least one processing unit and the at least one adapter plate are connected to each other. This means that power only needs to be supplied to the processing system at one point. The central power supply, which runs through the processing system, can supply all components in the processing system, such as the sensors, with energy.

[0038] It is preferred that the at least one sensor, the at least one deflection element designed as a multi-way valve, the at least one valve and the pump are designed as one-way elements.

[0039] "Disposable" means that the sensor, deflection element, and pump, along with the processing unit or adapter plate (depending on the element in which they are embedded), can be disposed of after use. This avoids the need for cleaning and reprocessing for subsequent use in a new processing unit or adapter plate.

[0040] Furthermore, the underlying problem is solved by a method for centrally controlling a modular processing system for biopharmaceutical and / or chemical processes. The method comprises the following steps: Providing at least one processing unit for carrying out a filtration step or a chromatography step in a biopharmaceutical or chemical process; providing at least one adapter plate having at least one adapter channel through which at least one fluid stream can flow, wherein the adapter plate further comprises at least one deflection element designed as a multi-way valve and / or at least one valve and / or a pump, wherein the at least one deflection element designed as a multi-way valve and / or the pump and / or the at least one valve is / are controllable by means of an actuator; providing an external control device; directly or indirectly connecting the adapter plate to the processing unit so that the fluid stream can flow from the adapter plate to the processing unit;Providing end brackets and arranging the at least one processing unit and the at least one adapter plate between the end brackets so that the at least one processing unit and the at least one adapter plate are held sandwiched between the end brackets; detecting at least one property of the fluid flow in the processing unit and / or the adapter plate by means of at least one sensor embedded in the processing unit and / or the adapter plate; and coupling the external control unit to the at least one sensor so that measurement data from the at least one sensor can be read out;and coupling the external control unit to the at least one deflection element designed as a multi-way valve and / or the pump and / or the at least one valve in the adapter plate, so that based on the read-out measurement data the external control unit controls the actuator in such a way that the fluid flow in the processing unit and / or the adapter plate can be centrally controlled by the external control unit; ; wherein the fluid flow can be at least partially deflected by means of the at least one deflection element designed as a multi-way valve in the adapter channel, and / or wherein the fluid flow, preferably its pressure, can be regulated by means of the at least one valve and / or the pump in the adapter channel.

[0041] Preferably, the processing system comprises at least a first and a second processing unit; and wherein the first and second processing units are coupled to one another by means of the adapter plate such that the fluid flow can flow from the first processing unit to the second processing unit.

[0042] It is preferred that at least one sensor is embedded in each of the first and second processing units and in the adapter plate; wherein the sensors detect at least one property of the fluid flow in the first and second processing units and the adapter plate; and wherein the sensors are coupled to the external control unit so that measurement data from the sensors can be read out, and based on the read-out measurement data, the fluid flow in the processing units and the adapter plate can be centrally controlled by the external control unit.

[0043] These and other objects, features, and advantages of the present invention will become more apparent upon review of the following detailed description of preferred embodiments and the accompanying drawings. It should also be understood that, although embodiments are described separately, individual features of these embodiments may be combined to form additional embodiments. Fig. 1a)-f) show a basic structure of various processing units; Fig. 2a) shows a processing system with two processing unit groups according to an embodiment, which are connected in parallel using an adapter plate; Fig. 2b) shows the processing system from Fig. 2a ), in which two processing unit groups are connected in series using the adapter plate; Fig. 2c) shows the processing system from Fig. 2b, in which the individual processing units are held together by means of end brackets; Fig. 3a) shows a sectional view through an adapter plate from the Figures 2a) and 2b ) with a multi-way valve; Fig. 3b) shows the multi-way valve from Figure 3a ); Fig. 4a) shows a sectional view of a two-part adapter plate with a sensor according to a further embodiment; Fig. 4b) shows a perspective view of the adapter plate from Fig. 4a ); Fig. 5a) shows a sectional view of an adapter plate according to a further embodiment with an auxiliary branch in which an adapter plate sensor is integrated; Fig. 5b) shows a perspective view of the adapter plate from Fig. 5a ); Fig. 6a) shows a processing system with an adapter plate according to a further embodiment, which has two auxiliary outputs or inputs; Fig. 6b) shows an embodiment of an adapter plate from Fig. 6a), in which an auxiliary access is used for fluid dilution; Fig. 6c) shows an embodiment of an adapter plate made of Fig. 6a ), in which auxiliary accesses are used for virus inactivation; Fig. 7 shows a processing system with an adapter plate according to a further embodiment, in which a pump is integrated; Fig. 8a) shows a sectional view through an adapter plate with a piston pump in a suction position; Fig. 8b) shows a sectional view of the adapter plate from Figure 8a ) in a lifting position; Fig. 9a) shows an exploded view of an adapter plate with a peristaltic pump according to a further embodiment; Fig. 9b) shows a sectional view of the adapter plate from Fig. 9a); Fig. 10a) shows a processing unit according to an embodiment in which a sensor is embedded, the data of which is transmitted wirelessly to an external control unit; and Fig. 10b) shows a processing system according to an embodiment with sensors that are transmitted to the external control unit via a bus system.

[0044] For biopharmaceutical and chemical processes, there are various processing units that can be used within the scope of the present invention. Figures 1a) to 1e ) show a basic structure of various processing units that can be used within the scope of the present invention. This is a selection, but not an exhaustive list.

[0045] Fig. 1a )shows a processing unit 10 that can be used to perform a specific filtration step in a biopharmaceutical or chemical process. For this purpose, the processing unit 10 has a processing housing 12 through which a fluid stream 14 can flow. The fluid stream 14 contains the medium to be filtered. Arranged in the processing housing 12 is at least one filter medium 16 that comprises a porous material that is selected or used depending on which particles or substances are to be filtered out of the fluid stream 14 with the aid of the processing unit 10. For example, the filter medium 16 can be a virus filter, a sterile filter, a depth filter, or a membrane adsorber. The filter medium 16 is preferably designed as a filter mat or membrane or membrane layer(s). In a preferred embodiment, the filter medium 16 can consist of several layers.Typically, the filter medium 16 is arranged essentially in the vertical direction VR in the processing housing 12. In the processing housing 12, the filter medium 16 separates a filtrate side 18 from a retentate side 20. The filter medium 16 is fluidically permeable, whereby filter medium-specific substances cannot pass through the filter medium 16. Since the fluid flow 14 is intended to flow from the retentate side 20 to the filtrate side 18, these filter medium-specific substances remain on the retentate side 20 and / or in the filter medium 16, but essentially do not reach the filtrate side 18 of the processing unit 10. A fluid pressure difference exists between the retentate side 20 and the filtrate side 18, depending on the applied fluid pressure and / or the permeability of the filter medium 16.

[0046] At a preferably upper end 22 of the processing housing 12 there is at least one inlet channel 24. This preferably extends in a substantially horizontal direction HR and feeds the processing unit 10 with the medium to be filtered. As in Figure 1 marked with an arrow, the fluid flow 14 flows through the inlet channel 24 into the processing housing 12. In Figure 1This means that a fluid stream 14 flows from the left into the processing housing 12. At least a portion of the fluid stream 14 then flows from the retentate side 20 through the filter medium 16 to the filtrate side 18. If the processing unit 10 is connected in parallel with another processing unit (not shown here), another portion of the fluid stream 14 flows directly to the further processing unit without penetrating the filter medium 16. This means that this portion of the fluid stream 14 flows into the inlet channel 24 of the further (not shown) processing unit. The fluid stream 14 that has penetrated the filter medium 16 ("filtrate") then flows into an outlet channel 26 at the preferably lower end 28 of the processing housing 12 and from there flows out of the processing housing 12. The outlet channel 26 preferably also extends substantially horizontally HR in the processing housing 12.The filtrate leaving the processing housing 12 can then flow into the outlet channel 26 of another processing unit (not shown here) (parallel connection) and / or flow into the inlet channel 24 of the other processing unit (series connection) for further processing.

[0047] Fig. 1b ) shows the processing unit 10 from Fig. 1a ), which differs from this only in that the filter medium 16 is formed in several layers.

[0048] Fig. 1c ) shows a processing unit 10 which is basically similar to the processing unit 10 of Fig. 1a ), but differs in the type of filtration. Therefore, only the parts of the processing unit 10 from Fig. 1c ) which extend from the processing unit 10 Fig. 1a ) differentiate.

[0049] In particular, the processing unit is made of Fig. 1c) for precoat filtration. For this purpose, the filter medium 16 is designed as a precoat filter. The filter medium 16 here comprises a filter carrier 17, which is preferably arranged in the vertical direction VR in the processing housing 12 and which is relatively coarse. The precoat agent is usually mixed with the fluid before being introduced into the filter. This enables the build-up of a filter cake (not shown here). The filter carrier 17 is selected such that at least one filter aid is retained. In order to provide sufficient space for the filter cake in the processing housing 12, an empty space 19 is formed on the retentate side 20.

[0050] Fig. 1d ) shows another processing unit 10. This is similar to the processing unit 10 from Fig. 1a), but has a bulk material 21 instead of a filter medium 16. In particular, the bulk material 21 can be gels or activated carbon, so that the processing unit 10 consists of Fig. 1c ) suitable for chromatography.

[0051] Chromatography can be used to separate mixtures of substances. Bulk material 21 serves as the stationary phase, which is immobilely arranged in the processing unit 10. A mixture of substances is transported to the stationary phase with the aid of a mobile phase (e.g., water). Through interaction between the stationary phase and individual substances in the mobile phase, the flow time of the corresponding substance through the processing unit 10 can be delayed, thus enabling the separation of substances.

[0052] Fig. 1e shows another processing unit 10. This is also similar to the processing unit 10 from Fig. 1a), but differs in that a second outlet channel 27 is provided. This makes this processing unit 10 suitable for tangential flow filtration or crossflow filtration. Here, a suspension to be filtered is pumped at a high speed parallel to the filter medium 16 and the filtrate is drawn off transversely to the flow direction. The filtrate can then be discharged via one of the outlet channels 26. The portion of the fluid stream 14 that does not penetrate the filter medium 16, i.e. the retentate, can be discharged from the processing unit 10 via the second outlet channel 27. Depending on requirements, the filtrate or the retentate from the crossflow filtration can be further processed within the framework of the processing system described later.

[0053] While the filter medium 16 in the Figures 1a) to 1e ) are designed as flat filters, the filter medium 16 can alternatively be a filter candle or filter capsule 40, as shown in Figure 1f )is shown.

[0054] While flat filters are flat and extend in a single plane, a filter cartridge 40 is cylindrical. Preferably, the filter medium 16 comprises a pleated filter material formed in multiple layers to form the cylindrical filter cartridge 40. To ensure the necessary stability of the filter cartridge 40, the filter cartridge 40 preferably comprises a cylindrical support core that supports the filter medium 16 from the inside and a rigid outer cage that surrounds the filter medium 16 from the outside and supports it from the outside. However, both the support core and the outer cage are designed to allow fluid flow through them.

[0055] Figure 1f) schematically shows a fluid flow 14 through the filter candle 40. The fluid flow 14 can be supplied in such a way that the fluid flow 14 flows from an inside of the filter candle 40 to an outside of the filter candle 40 or from the outside of the filter candle 40 to the inside of the filter candle 40. The supply direction is influenced by an end cap, which closes the cylindrical body of the filter candle 40 at one end.

[0056] If the fluid flow through the filter candle 40 is to be from the inside to the outside, the fluid flow 14 is fed to an interior of the filter candle 40 via a first side 42 of the filter candle 40. However, the second, opposite side 44 of the filter candle 40 is closed by the end cap, so that the supplied fluid is forced to flow through the filter medium 16 of the filter candle 40 from the inside to the outside.

[0057] Alternatively, if the filter candle 40 is to be flowed through from the outside to the inside, the filter candle 40 is closed at the first end 42 by an end cap, so that the fluid flows from the outside to the inside. The second end 44 of the filter candle 40, however, is open.

[0058] The filter candle 40 itself is inserted or installed in a flat processing housing 12. The processing housing 12 preferably has walls in its interior that guide the fluid flow 14 accordingly, so that the fluid flow 14 is supplied to the filter candle 40 in the desired manner. If, for example, the fluid flow 14 is to be guided from the inside to the outside of the filter candle 40, walls can be provided that guide a fluid flow 14 into the interior of the filter candle 40. This prevents contact between the medium to be filtered and an outer side of the filter candle 40. At the same time, contact between the filtered medium and the medium to be filtered is prevented.

[0059] If the fluid stream 14 is to flow from the outside to the inside of the filter candle 40, a corresponding wall is preferably also provided adjacent to the second side 44 of the filter candle 40. This wall prevents the filtered medium exiting the second side 44 of the filter candle 40 from coming into contact with the medium to be filtered on the outside of the filter candle 40.

[0060] The filter cartridge 40 can be installed vertically or horizontally in the processing housing 12. The inlet channel 24, through which the medium to be filtered flows into the processing housing 12, is designed accordingly so that the filter cartridge can be oriented vertically or horizontally. The same applies to the outlet channel 26, through which the filtered fluid can flow out of the processing housing 12.

[0061] As in Figure 1f), several filter candles 40 can be arranged in parallel in a processing housing 12. The supply and discharge of the fluid stream 14 from and to the respective filter candle 40 takes place as already described above with regard to a filter candle 40. In addition, however, a partition wall can be provided between the individual filter candles 40 so that the filter candles 40 are separated from one another.

[0062] At least one filter candle valve 46 can be provided in the inlet channel 24 and / or in the outlet channel 26. In the inlet channel 24, the filter candle valve 46 can be designed to enable or prevent further flow into the inlet channel 24. Furthermore, a filter candle valve 46 can be designed to enable or block an inflow or inflow of the fluid stream 14 to or into a filter candle 40. In addition, as in Figure 1f), a filter candle valve 46 may be designed to provide access from the outside into the inlet channel 24 so that additives or another fluid stream 14 can flow into the inlet channel 24.

[0063] In the outlet channel 26, the filter candle valve 46 can be designed to allow or prevent further flow into the outlet channel 26. Furthermore, as in Figure 1f ), a filter candle valve 46 may be designed to provide an additional outlet from the drain channel 26 so that at least a portion of the fluid stream 14 can flow out of the drain channel 26.

[0064] The filter cartridge valves 46 are particularly advantageous for integrity tests. Here, filter cartridges 40 can be subjected to a separate integrity test using the filter cartridge valves 46.

[0065] At least one processing unit sensor 36 can be embedded in the processing housing 12. This sensor is positioned such that a desired parameter of the fluid flow 14 in the processing unit 10 can be monitored or measured. The processing unit sensor 36 will be described in more detail later.

[0066] For the integrity test, the processing unit sensor 36 can be designed in particular to detect the pressure of the fluid stream 14, as shown in Figure 1f ). Advantageously, a processing unit sensor 36 is located before and after a filter candle 40 so that a pressure difference of the fluid stream 14 can be detected.

[0067] Filter candles 40 are particularly suitable for filtration applications in which high pressures act on the filter medium 16.

[0068] Figures 2a) and 2b )each show processing systems 100 with a variety of the Figures 1a) to 1e ) described processing units 10. Processing units 10 that are directly coupled to each other form a processing unit group 11. As in the Figures 2a) and 2b ), the processing systems 100 each comprise a first processing unit group 13 and a second processing unit group 15, which are coupled by means of an adapter plate 200 according to an embodiment of the invention. Figures 2a) and 2b ) directly coupled processing units 10 are shown as parallel connected units, but can also be serially connected. The two processing unit groups 11, which are coupled by means of the adapter plate 200, can be connected in parallel (see Figure 2a )) as well as serially (see Figure 2b)). Optionally, the adapter plate 200 has at least one deflection element, described in more detail later, with which one can switch between these connection modes. This is done in a simple manner and without structural changes to the processing system 100. By simply switching the one or more deflection elements, one can switch between a parallel and serial connection of the processing unit groups 11. Figure 2a ) shows a parallel connection of processing unit groups 11, which are coupled by the adapter plate 200. Figure 2b ) shows a serial connection of the two processing unit groups 11, which are coupled by the adapter plates 200. Although the Figures 2a) and 2b) show processing unit groups 11 which are coupled by the adapter plate 200, the adapter plate 200 can also be used to couple only one processing unit 10 with a processing unit group 11 or two individual processing units 10 with each other.

[0069] The adapter plate 200 is preferably substantially plate-shaped and can be flowed through by a fluid stream 14. The adapter plate 200 is preferably designed as a disposable component, wherein the material properties are preferably selected such that a sterilization method such as gamma irradiation, autoclaving, a flow of gas such as ethylene oxide and / or superheated steam can be used. In particular, the adapter plate can be made of plastic. Processing units 10 that are arranged upstream of an adapter plate 200 in the flow direction are referred to as first processing units 30, while processing units 10 that are arranged downstream of an adapter plate 200 in the flow direction are referred to as second processing units 32. In other words, the first processing unit group 13 consists of first processing units 30 and the second processing unit group 15 consists of second processing units 32, as shown in the Figures 2a) and 2b ). The adapter plate 200 is arranged between the first processing unit group 13 and the second processing unit group 15 and fluidically connects them. The adapter plate 200 comprises at least one access opening through which the fluid stream 14 can flow into the adapter plate 200. As shown in Figure 2a), the adapter plate 200 has two access openings, namely a first access opening 202 at the preferably lower end 204 of the adapter plate 200, which is coupled to the outlet channel 26 of the first processing unit 30, which is arranged directly in front of the adapter plate 200, and a second access opening 206 at the preferably upper end 208 of the adapter plate 200, which is coupled to the inlet channel 24 of this first processing unit 30. In other words, a fluid stream 14 can flow from the said first processing unit 30 via the first and second access openings 202 and 206 into the adapter plate 200. Furthermore, the adapter plate 200 has at least one outlet opening, through which the fluid stream 14 can exit the adapter plate 200. As in Figure 2a), the adapter plate 200 has two outlet openings, namely a first outlet opening 210, which is preferably arranged at or near a lower end 204 of the adapter plate 200 and is or can be coupled to the outlet channel 26 of the second processing unit 32, which is arranged directly after the adapter plate 200, and a second outlet opening 212, which is preferably arranged at or near an upper end 208 of the adapter plate 200 and is or can be coupled to the inlet channel 24 of this second processing unit 32. Extending within the adapter plate 200 is at least one adapter channel 214, which fluidically connects the inlet and outlet openings to one another. In particular, the adapter channel 214 has a first channel region 216, which extends between the first inlet opening 202 and the first outlet opening 210.A second channel region 218 extends between the second inlet opening 206 and the second outlet opening 212. The first and second channel regions 216 and 218 are fluidically connected via a connecting channel region 220.

[0070] The above-described structure of the adapter channel 214 is particularly advantageous when the at least one deflection element allows switching between a serial and parallel connection of two processing units 10. If the adapter plate 200 does not have a deflection element, only a predetermined fluid path can be provided in the adapter plate 200. Alternatively, the adapter channel 214 can be constructed as described above, but sections of the adapter channel 214 are firmly closed, creating a predetermined fluid path through the adapter plate 200.

[0071] As in the Figures 2a) and 2b), at least two deflection elements are arranged in the adapter channel 214. In particular, these are deflection valves 222. In a preferred embodiment, a first deflection valve 224 is arranged in the first channel region 216 and a second deflection valve 226 is arranged in the second channel region 218. Specifically, the deflection valves 222 are designed as multi-way valves 246. The Figures 2a) and 2b ) show an example of a 3-way valve as the first valve 224 and second valve 226. An alternative embodiment of a multi-way valve is described below with reference to the Figures 3a) and 3b ) described.

[0072] The at least one first and second processing unit 30 and 32 can be structurally identical or different in order to be able to carry out different types of processes. Preferably, the first processing units 30 in the first processing unit group 13 and the second processing units 32 in the second processing unit group 15 are structurally identical. However, it is also conceivable for the first processing units 30 and the second processing units 32 to differ from one another. For example, the at least one first processing unit 30 can be designed as a depth filter, while the at least one second processing unit 32 can be designed as a sterile filter.

[0073] Fig. 2c ) shows the processing system 100 from Fig. 2b), in which the individual processing units 10 and the adapter plate 200 are held together by means of end supports 34 (multi-way valves 246 not shown here). In other words, a end support 34 is located at the inlet point where the fluid stream 14 enters the processing system 100 and at the outlet point where the fluid stream 14 exits the processing system 100. This can preferably be designed as a end plate, so that the individual processing units 10 are held sandwiched between these end plates. Inlets and outlets can be part of the end support 34. In particular, however, a further end plate with corresponding connections can be introduced between a end support 34 and the respectively adjacent processing unit 10. The fluid stream 14 is preferably pumped into the processing system 100 by means of an inflow pump 35. Figure 2c) shows an inflow pump 35, which is arranged upstream of the end bracket 34 with respect to the flow direction. Advantageously, the inflow pump 35 can also be located in the adapter plate 200, which is located between the end bracket and the adjacent processing unit 10. This allows for a space-saving design.

[0074] Although all processing systems 100, which are in the Figures 2a) to 2c) comprise adapter plates 200 which are arranged between two processing units 10 in order to fluidically connect them, this arrangement is not absolutely necessary. The adapter plate 200 can merely be arranged upstream of at least one processing unit 10 in order to supply a fluid to the at least one processing unit 10. In particular, the adapter plate 200 can be arranged between the end holder 34 and a processing unit 100. This is advantageous, for example, if the downstream processing unit 10 is a unit for membrane chromatography. Typically, different media are added one after the other to the filter medium 16 during chromatography. (The steps of sanitizing / conditioning / rinsing / equilibrating can, for example, be carried out before loading with the protein solution actually to be purified.Therefore, the various inlets on the adapter plate 200 can be used to supply the individual media to the processing unit 10. After loading with the medium to be purified, a washing step and an elution can then follow. Separate inlets and / or outlets on the adapter plate 200 are also helpful here, as is the case, for example, with the . Figure 6a ). A deflection element can be provided at each such input and / or output, with the aid of which the inputs or outputs can be "switched".

[0075] Furthermore, the processing system 100 according to the invention has at least one sensor which is embedded in at least one processing unit 10 and / or at least one adapter plate 200. Figure 2c ) shows the design of the Figures 2a) to 2c) exemplarily an adapter plate sensor 228, which is embedded in the adapter plate 200, and a processing unit sensor 36, which is embedded in the processing unit 10, which is arranged downstream of the adapter plate 200 in the flow direction.

[0076] In particular, the at least one adapter plate sensor 228 is embedded in the adapter plate 200 such that the adapter plate sensor 228 protrudes at least partially into the adapter channel 214 in order to come into contact with the fluid stream 14 and to be able to carry out the desired measurements on the fluid.

[0077] The adapter plate sensor 228 can be configured to measure, for example, the pressure, volume flow, UV value, pH value, turbidity, and / or viscosity of the fluid stream 14. The measured values ​​can be used to control or regulate the filtration process. For this purpose, the measured values ​​are transmitted to the external control unit 400. The adapter plate sensor 228 can be configured as a cost-effective disposable component, so that the adapter plate sensor 228 can be disposed of together with the adapter plate 200 after use. In particular, the adapter plate sensor 228 can be integrated into the adapter plate 200 at the factory. The adapter plate 200 is then delivered with a calibrated and sterilized adapter plate sensor 228.

[0078] The adapter plate 200 shown here connects two processing units 10 in series. However, it is also possible to use adapter plate sensors 228 when connecting two processing units 10 in parallel. In this case, however, it is advantageous for the adapter plate sensor(s) 228 to be arranged in or on the first and / or second channel region 216 and 218 in order to be able to establish contact with the fluid stream 14. If two processing units 10 are connected in series, the adapter plate sensor 228 can also be arranged in or on the connecting channel region 220.

[0079] Furthermore, at least one adapter plate sensor 228 can be provided on at least one deflection element in the at least one adapter plate 200. This sensor is designed to detect the position of the deflection element and transmit this state to the external control unit 400.

[0080] The at least one processing unit sensor 36 can detect at least one parameter of the fluid stream 14 in the corresponding processing unit 10, as already described with respect to the adapter plate sensor 228. In particular, the processing unit sensor 36 is embedded in the processing unit 10 such that it comes into at least partial contact with the fluid stream 14 in order to be able to perform corresponding measurements. The measured values ​​can also be transmitted to the external control unit 400.

[0081] The processing unit sensor 36 can be arranged at any position in the processing unit 10 to perform the desired measurement. For example, the processing unit sensor 36 can be arranged on the filtrate side 18 of the processing unit 10 to advantageously determine or monitor the filtration result of a processing unit 10. In particular, the processing unit sensor 36 is preferably designed as a cost-effective disposable component so that the processing unit sensor 36 can be disposed of together with the processing unit 10 after use.

[0082] As in Figure 2c), at least one processing unit sensor 36 is preferably located in the processing unit 10, which is connected downstream of the adapter plate 200. This sensor can, for example, monitor the pressure with which the fluid stream 14 impinges on the filter medium 16. However, processing unit sensors 36 can also be provided in any of the other processing units 10 of the processing system 100.

[0083] Figure 3a ) shows a sectional view through an adapter plate 200. As in Figure 3a), the adapter plate 200 is preferably designed in two parts and comprises an inlet plate 230 and an outlet plate (not shown here). The inlet plate 230 is the plate of the adapter plate 200 in which the at least one inlet opening is arranged. The outlet plate is the plate of the adapter plate 200 in which the at least one outlet opening is arranged. The shape and / or size of the inlet plate 230 and the outlet plate can be identical. In the first and / or second channel region 216 and 218 there is a multi-way valve 246 which serves as a deflection element. The multi-way valve 246 comprises a valve tube 248 which extends at least partially in the first and second channel region 216 and 218 and is mounted there so that it can be displaced (in particular rotated or rotated). Displacement (in particular rotation) can take place with the aid of a deflection actuator 257.The deflection actuator 257 can receive displacement commands from the external control unit 400 and convert them into a mechanical displacement of the multi-way valve 246. The deflection actuator 257 can, in particular, be arranged on a displacement handle 254 that protrudes from the adapter plate 200 (see ). Figures 3a) and 3b )). As in the Figures 3a) and 3b ), at least one adapter plate sensor 228 may be disposed on at least one of the multi-port valves 246 to detect the position of the multi-port valve 246 and transmit this information to the external control unit 400. In particular, the adapter plate sensor 228 may be disposed on the displacement handle 254 of the multi-port valve 246.

[0084] At least two valve openings 252 are formed in a lateral surface 250 of the valve tube 248. These are arranged offset from one another with respect to the direction of displacement (in particular the direction of rotation) such that a first fluid flow or a second fluid flow is enabled in a first position of the valve tube 248. This means, for example, that the first fluid flow enters the valve tube 248 via the first inlet opening 202 of the adapter plate 200 through a first valve opening 252 that at least partially overlaps the first inlet opening 202.

[0085] The second valve opening 252 at least partially overlaps the first outlet opening 210, so that the first fluid flow can flow out of the adapter plate 200 via the first outlet opening 210. This applies correspondingly to the second fluid flow and the second inlet and outlet openings 206 and 212. A fluid flow 14 through the connecting channel region 220 is blocked due to the position of the valve openings 252 in the respective channel regions. However, since the first and second fluid flows are permitted by the multi-way valves 246, the first and second processing units 30 and 32, each of which is directly coupled to the adapter plate 200, are connected in parallel.

[0086] Preferably, however, the valve tubes 248 have at least three valve openings 252, as shown in the Figures 3a) and 3b). These are arranged such that, in a first orientation (in particular, rotational position) of the valve tube 248, at least two valve openings 252 are aligned such that the above-described first and second fluid flows are permitted, thus connecting the first and second processing units 30 and 32, each of which is directly coupled to the adapter plate, in parallel. However, a fluid flow 14 through the connecting channel region 220 is prevented because no valve opening 252 at least partially overlaps the connecting channel region 220.

[0087] However, due to the arrangement of the at least three valve openings 252, in a second orientation (in particular rotational position) of the respective valve tube 248, either the passage to an inlet opening or to an outlet opening is blocked, while access to the connecting channel region 220 is permitted. This enables a serial connection of the first and second processing units 30 and 32.

[0088] In other words, in a serial connection, the multi-way valves 246 are to be aligned such that a fluid flow 14 can enter the first valve tube 248 via the first inlet opening 202 of the adapter plate 200 and via a valve opening 252 that at least partially overlaps the first inlet opening 202. The fluid flow 14 can flow into the connecting channel region 220 via a valve opening 252 that at least partially overlaps the connecting channel region 220. The passage to the first outlet opening 210 is blocked by the valve tube 248 because no valve opening 252 overlaps the first outlet opening 210. The fluid flow 14 can then flow into the second valve tube 248 via a valve opening 252 of the second valve tube 248, which at least partially overlaps the connecting channel region 220.The fluid stream 14 can flow out of the adapter plate 200 via a valve opening 252 in the second valve tube 248, which at least partially overlaps with the second outlet opening 212 of the adapter plate 200. The passage to the second access opening 206 is blocked by the valve tube 248, since no valve opening 252 overlaps with the second access opening 206.

[0089] This allows switching between a serial and parallel connection of two processing units 10 or processing unit groups 11 easily and without structural modifications. In particular, the adapter plate 200 is designed as a compact component, so that the processing system 100 requires little space. The diverter valves 222 can be designed as cost-effective disposable components. Possible applications include: switching for tangential flow filtration from standard operation to single-pass operation, switching between parallel and serially connected chromatography units, for example, for the serial combination of different chromatography media or for improving capacity utilization.

[0090] The Figures 3a) and b) describe an exemplary embodiment of a rotatable deflection element. The adjustment of the deflection element can be carried out via control signals from the external control unit 400. It should be noted that this can, however, be carried out for any other type of deflection element (see, for example, the 3-way valve described above in the Figures 2a) to 2c )).

[0091] Figures 4a) and 4b ) show a preferred embodiment of an integration of at least one adapter plate sensor 228 into an adapter plate 200. As in Figure 4b ), the adapter plate 200 is also preferably formed in two or more parts. The inlet plate 230 comprises at least one first access opening 202, preferably at the lower end 204 of the adapter plate 200. As shown in Figure 4a), the inlet plate 230 comprises two first access openings 202. However, it does not have a second access opening(s) 206. Since the adapter plate 200 shown is intended exclusively to enable a serial connection of two processing units 10, these are not absolutely necessary. For a parallel connection, at least one second access opening 206 could be formed in the inlet plate 230, preferably at the upper end 208 of the adapter plate 200.

[0092] As further stated in Figure 4b ), the drain plate 232 comprises at least one second outlet opening 212. In the specific case of Figure 4b), the drain plate 232 has two second outlet openings 212. If a parallel connection of two processing units 10 is desired, the drain plate 232 can additionally have at least one first outlet opening 210. The inlet and outlet plates 230 and 232 can be screwed and / or glued and / or welded and / or clicked together.

[0093] A corresponding channel recess 234 can be formed in the inlet and / or outlet plates 230 and 232. When the inlet and outlet plates 230 and 232 are assembled, an adapter channel 214 is formed, which allows a fluid stream 14 to flow through the adapter plate 200. Preferably, at least one flow web 236 is formed in the connecting channel region 220 of the adapter channel 214, which preferably extends substantially in the flow direction of the fluid stream 14 and contributes to directing the fluid stream 14 in an improved manner. The adapter plate sensor 228 can be integrated into the inlet and / or outlet plates 230 and 232 and protrude into the adapter channel 214, so that a measuring element of the adapter plate sensor 228 can come into contact with the fluid stream 14. Preferably, the adapter channel 214 comprises, at least in some areas, a connecting channel 238 to the adapter plate sensor 228.This connecting channel 238 can be a recess in the adapter channel 214, at least in part, into which the sensor 228 projects at least partially.

[0094] Figures 5a) and 5b ) show the adapter plate 200 from the Figures 4a) and 4b ), however, in this embodiment, the adapter plate sensor 228 is in or on an auxiliary branch 240. The auxiliary branch 240 is a branch from the adapter channel 214, into which at least a portion of the fluid flow 14 is branched. This portion of the fluid flow 14 flows out of the adapter channel 214 at least for a certain time, preferably to be later returned to the adapter channel 214.

[0095] The auxiliary branch 240 can be used to divert small amounts of the fluid flow 14 for corresponding measurements. The auxiliary branch 240 can be formed using a separate channel element 242 that is at least partially integrated into the adapter plate 200. As shown in the Figures 5a) and 5b ), a portion of the auxiliary branch 240 may protrude from the adapter plate 200. In particular, this also allows the adapter plate sensor 228 to be arranged outside the adapter plate 200. However, in this arrangement, the adapter plate sensor 228 is also considered to be "embedded" in the adapter plate 200.

[0096] Figure 6a )shows a processing system 100 with a first and second processing unit group 13 and 15, which are coupled by means of an adapter plate 200. In the embodiment shown, the linked processing unit groups 11 are connected in series via the adapter plate 200; however, it is also possible to connect the two processing unit groups 11 in parallel according to the other described embodiments. As described above, the adapter plate 200 can also be designed as a single upstream adapter plate 200.

[0097] In the adapter plate 200, according to Figure 6a) at least one auxiliary outlet and / or inlet 244 can be formed. At least a portion of the fluid stream 14 can be withdrawn from or flow out of the adapter channel 214 via an auxiliary outlet. The withdrawn fluid stream 14 can flow back into the adapter channel 214 via an auxiliary inlet, or access to the adapter channel 214 can be ensured. The use of at least one auxiliary outlet or inlet enables, for example, the external connection of a pump, an integrity test on different processing units 10 of the processing system 100, the removal of the fluid from the first or further upstream processing units 30 for interim buffering or for further processing, venting, and / or sampling. In particular, at least one diafiltration medium and / or other reagents can be added via an auxiliary inlet. Figure 6a) shows an adapter plate 200 with two auxiliary outlets and inlets 244. Possible connections at an auxiliary outlet and inlet 244 could be Tri-Clamps or sterile connectors. To supply or discharge the fluid at the auxiliary outlet or inlet 244, an auxiliary pump or an auxiliary valve can be provided at the auxiliary outlet or inlet 244.

[0098] Figure 6b ) shows an embodiment of an adapter plate 200 with at least one auxiliary access 244, which can be used to add an additional fluid for dilution to the fluid already contained in the adapter plate 200. Mixing of the additional fluid with the fluid already contained in the adapter plate 200 can be achieved via a static mixer 278. An exemplary application in which dilution is necessary is the need to reduce the salt concentration in the fluid during a sub-step of the antibody polishing process.

[0099] A "static mixer" 278 is understood to be a device for mixing fluids in which the flow movement alone causes mixing. To achieve a mixing flow movement, flow-influencing elements are provided in the adapter channel 214. Such elements can be arranged in a row in the form of helical, lamella, or grids. The fluids to be mixed are fed to the mixer 278 together in the desired mixing ratio. The elements divide the material flow, twist the flows, and recombine them, thus achieving the desired mixing.

[0100] In the specific case of the present adapter plate 200, a fluid stream 14 is supplied to the adapter plate 200. This can originate, for example, from an upstream processing unit 10. In order to dilute this fluid stream 14 in the adapter plate 200, another fluid stream 14 can be supplied to the adapter plate 200 via an auxiliary inlet 244. These two fluid streams 14 are then mixed by means of the static mixer 278.

[0101] Preferably, the adapter plate 200 comprises at least one adapter plate sensor 228 designed to monitor the dilution. For this purpose, the adapter plate sensor 228 is preferably arranged downstream of the static mixer 278 in the flow direction. The detected values ​​of the adapter plate sensor 228 can then be transmitted to the external control unit 400. Based on the obtained measurement data, the control unit can, for example, control an auxiliary pump at the auxiliary inlet 244 in order to regulate the amount of dilution fluid to be supplied.

[0102] If the degree of dilution does not meet the required level, the fluid stream 14 could preferably also be discharged via an auxiliary outlet 244. The discharged fluid stream could then be recycled for further dilution or discarded completely. Only a fluid stream 14 with the desired dilution can then be fed to the connected processing unit 10.

[0103] Figure 6c ) shows a further embodiment of an adapter plate 200 with at least one auxiliary exit or access 244. Here, the adapter plate 200 can be used in particular for virus inactivation.

[0104] The structure is basically similar to the Figure 6b ). Instead of a dilution solution, however, a pH-lowering fluid is added via an auxiliary inlet 244. With the aid of the static mixer 278, the pH reducer is mixed with the fluid stream 14 flowing through the adapter plate 200.

[0105] Similar to the Figure 6b), at least one adapter plate sensor 228 can be located downstream of the static mixer 278. This preferably detects the pH value of the fluid stream 14 downstream of the static mixer 278. The measurement data is transmitted to the external control unit 400. If the pH value is too high, the fluid stream 14 can be discharged from the adapter plate 200 via an auxiliary outlet 244. Either the discharged fluid stream 14 is returned to the adapter plate 200 and the pH value is further reduced, or the fluid is discarded. The external control unit 400 can, in particular based on the obtained measurement data, control, for example, an auxiliary pump at the auxiliary inlet 244 in order to regulate the amount of pH reducer to be supplied.

[0106] If the fluid has a suitable pH value, the fluid can continue to flow in the adapter plate 200. To increase the pH value again, a further static mixer 278 is located here. A fluid for increasing the pH value is added via a further auxiliary inlet 244 and mixed with the fluid stream 14 with the aid of the further static mixer 278 in the adapter plate 200. At least one further adapter plate sensor 228 downstream of the further static mixer 278 preferably again monitors the pH value reached by the fluid and transmits the measurement data to the external control unit 400. Here, too, as with the previous static mixer 278, the faulty fluid can be returned or discarded via a further auxiliary outlet 244. The external control unit 400 can, in particular based on the measurement data received, control, for example, an auxiliary pump at the auxiliary inlet 244 in order to regulate the amount of pH increaser to be supplied.

[0107] To achieve complete virus inactivation, the adapter channel 214 between the two static mixers 278 can be configured such that the fluid remains at the reduced pH for a sufficient time. This section is preferably designed in a meandering shape, so that the fluid preferably remains at the reduced pH for 30 minutes.

[0108] It should be noted that the structure of the adapter channel 214 in the Figures 6a) to 6c ) is shown here as an example. The adapter channel 214 can be constructed according to any of the previously described embodiments. In particular, Figures 6a) to 6c) describes a structure in which all steps or all components of virus inactivation are provided in one adapter plate 200. However, several adapter plates 200 can also be connected in series or coupled together, and the individual components can be distributed among these adapter plates 200. This means that virus inactivation has occurred when the fluid stream 14 has flowed through the individual adapter plates 200 with the various components for virus inactivation.

[0109] Auxiliary pumps can be arranged in adapter plate 200 as shown in the Figures 6b ) and 6c ). However, an auxiliary pump can also be arranged externally on the adapter plate 200 or as an external device.

[0110] Furthermore, the section between the two static mixers 278, as with respect to Figure 6c ), also extend at least partially outside the adapter plate 200.

[0111] Figure 7 shows a processing system 100 with a first and second processing unit group 13 and 15. The first and second processing unit groups 13 and 15 are coupled by means of an adapter plate 200. At least one pump 258 is arranged in or on the adapter channel 214 of the adapter plate 200. This can be used in a parallel connection of two processing unit groups 11, but is particularly suitable in a serial connection, as in Figure 7 shown, advantageous because it allows the pressure to be controlled with which the fluid impinges on the processing unit 10 following in the flow direction. In particular, a flow resistance can be overcome in this way, so that a sufficient filtration performance can be achieved in the second processing unit group 15.

[0112] Furthermore, the pump 258 can be designed, in particular, as a positive displacement pump to initiate a negative pressure in the first processing unit group 13 and to build up a desired filtration pressure in the second processing unit group 15. In particular, the pump 258 can be designed as a cost-effective disposable component.

[0113] Pump 258 is coupled to external control unit 400. Pump 258 receives control commands via external control unit 400 that can activate, deactivate, or control or regulate pump 258.

[0114] The control or regulation of the pump 258 is preferably based on measurement data from at least one adapter plate sensor 228 and / or at least one processing unit sensor 36, which has / have recorded at least one parameter of the fluid stream 14 in the processing system 100. For example, measurement data from the at least one sensor can be read out by the external control unit and used to regulate the pump 258 to achieve the desired pressure of the fluid stream 14. For this purpose, limit values ​​can be defined in the external control unit 400. If the pressure of the fluid stream 14 deviates from the defined values, the external control unit 400 can adapt the settings of the pump 258 so that the fluid stream 14 has the desired pressure. Adaptation of the settings on the pump 258 can be performed via a pump actuator that receives the control commands from the external control unit 400.

[0115] Figures 8a) and 8b )show a specific embodiment of an adapter plate 200 with a positive displacement pump, namely a piston pump. The pump 258 is preferably arranged in the connecting channel region 220 and comprises at least one piston 260, which is designed to perform a reciprocating movement, i.e., a linear (translational) movement. For this purpose, the piston 260 is mounted in a cylinder 262. Additionally, the pump 258 has an inlet and an outlet, each of which can be closed by a valve.

[0116] Specifically, a section in the connecting channel region 220 is separated or delimited in the flow direction by an inlet valve 264 and an outlet valve 266. The fluid can flow into this section via the inlet valve 264 and escape via the outlet valve 266. The cylinder 262, in which the piston 260 is mounted and can perform a translational movement therein, is arranged such that the cylinder 262 is arranged at the connecting channel region 220 and is fluidly connected thereto. In particular, the cylinder 262 is arranged between the inlet and outlet valves 264 and 266 at the connecting channel region 220.

[0117] In a first stroke, during suction, the piston 260 performs a backward movement, i.e., a movement away from the connecting channel region 220. The inlet valve 264 opens, and the fluid to be pumped can flow into the connecting channel region 220 or the cylinder 262. In a second stroke, during the delivery movement, the inlet valve 264 closes, and the piston 260 moves toward the connecting channel region 220. The outlet valve 266 opens, and the pumped medium is expelled.

[0118] Preferably, at least one adapter plate sensor 228 is arranged in the adapter channel 214 to monitor the fluid flow 14. For this purpose, the adapter plate sensor 228 can preferably be arranged downstream of the pump 258 in the flow direction, for example, to measure the fluid pressure or the fluid flow. This value can be used to control the pump 258 by means of the external control unit 400.

[0119] Another possibility of a positive displacement pump is shown by the Figures 9a) and 9b ) The pump 258 integrated into the adapter plate 200 is a peristaltic pump. This is preferably arranged in the connecting channel region 220 for the reasons already described above.

[0120] A peristaltic pump, also called a hose pump, is a positive-displacement pump in which the fluid to be pumped is forced through a hose 268 by external mechanical deformation. In this case, the hose 268 thus represents part of the connecting channel region 220 through which the fluid flows in the adapter plate 200. The region in which the hose 268 is arranged is circular, or rather, the connecting channel region 220 widens in an arcuate shape. A rotor 270 is arranged in the circular section of the connecting channel region 220 and is rotatably mounted there.

[0121] The rotor 270 is preferably designed as a circular plate. At least one roller 274 and / or a sliding block is / are arranged on an upper side 272 of the rotor 270. The hose 268 rests at least partially against a lateral surface of the circular section of the connecting channel region 220. By rotating the rotor 270, the hose 268 can be clamped from the inside by the rollers 274 and / or sliding blocks. This causes a clamping point to move along the hose 268 and thereby propel the fluid to be conveyed. The rotor 270 is connected to the pump via a gear mechanism 276, as shown in the Figures 9a) and 9b), rotatable. At least one adapter plate sensor 228 can be arranged in the adapter plate 200, as described with respect to previous embodiments. In particular, the gear mechanism 276 can be controlled by the external control unit 400, preferably via an actuator. The control commands of the external control unit 400 are based at least partially on measured values ​​of the at least one adapter plate sensor 228 and / or the at least one processing unit sensor 36 in the processing system 100.

[0122] Further comments on the previously described embodiments: In various embodiments, the adapter plate 200 is described for linking two processing unit groups 11. However, it should be noted that the descriptions also apply correspondingly to embodiments in which only a first and / or second processing unit 30 and 32 is provided.

[0123] In the described processing systems 100, an adapter plate 200 is shown in each case, which couples two processing unit groups 11. However, it is possible for a processing system 100 to contain a plurality of adapter plates 200. Processing unit groups 11 coupled by an adapter plate 200 are always referred to here as first and second processing unit groups 13 and 15, and the above description applies accordingly to any link between two processing unit groups 11. The same also applies to individual processing units 10 linked by an adapter plate 200 or individual processing units 10 linked to a processing unit group 11.

[0124] In the embodiments described above, a pump 258 in the adapter plate 200 was described as a means for regulating the pressure of the fluid flow 14. Alternatively or in addition to the pump 258, at least one valve can be provided in the adapter channel 214. The valve is designed to narrow the adapter channel 214 or to vary the size of the cross-section of the adapter channel 214 and thus regulate the pressure of the fluid flow 14. The valve can be controlled by the external control unit 400. In particular, the control signals are based on measured pressure parameters measured by at least one adapter plate sensor 228 and / or processing unit sensor 36.

[0125] The above-described embodiments of pumps 258 in an adapter plate 200 may alternatively be designed as a compressed air pump, in which preferably at least one membrane is moved up and down so that the fluid is moved in the direction of flow.

[0126] The valves described above can generally be actuated electrically, mechanically, pneumatically or hydraulically.

[0127] Furthermore, it is pointed out that although the adapter plates 200 shown are designed in two parts, it is also conceivable to design them in one part.

[0128] The above description focuses on the biopharmaceutical use of the processing systems 100 and the adapter plates 200. However, the principle shown can also be applied to other processes, such as food production, chemical production processes, beverage filtration, particle fractionation, wastewater treatment, and the like.

[0129] In particular, it should be noted that in the described embodiments, the adapter plate 200 is coupled to a second processing unit 32 directly or without the interposition of additional elements. However, it is possible to connect the adapter plate 200 to the second processing unit 32 via a compatible connector. This is preferably sterile and / or drip-free. Tanks or other components can also be interposed.

[0130] The adapter plate 200 can also be arranged before and / or after the last processing unit 10 of a processing system 100. One or more processing units 10 can be, in particular, a "Sartoclear®< Depth Filter Cassette" filter cassette and / or a "Sartoclear®< DL Series" filter cassette and / or a "Sartoclear®< S Series" filter cassette from Sartorius Stedim Biotech GmbH.

[0131] The various embodiments of the processing systems 100 and the adapter plates 200 have been described separately with reference to the individual figures. However, it should be noted that the individual embodiments or parts of the individual embodiments can be combined with one another. To avoid repetition, elements already described with respect to the individual embodiments have not been described again.

[0132] The signal transmission in the processing system 100 is described below: As already explained in detail above, the at least one adapter plate 200 and / or the at least one processing unit 10 each has at least one sensor. This sensor measures at least one parameter of the fluid flow 14 in the processing system 100. The at least one sensor is coupled to the external control unit 400 either by cable or wirelessly, so that measured values ​​from the at least one sensor can be transmitted to the external control unit 400.

[0133] Figure 10a ) shows a processing unit 10 in which a processing unit sensor 36 is provided or embedded. This sensor measures, for example, the pressure of the fluid stream 14 before the fluid hits the filter medium 16. This allows monitoring of whether the fluid stream 14 has sufficient pressure to achieve satisfactory filter performance.

[0134] The processing unit 10 has at least one processing unit transponder 38 which is arranged in or on the processing unit 10. Figure 10a ) shows, by way of example, a processing unit transponder 38 arranged on the processing unit 10. The processing unit transponder 38 is coupled to the processing unit sensor 36 either by cable, wirelessly, or optically and receives measurement data from the processing unit sensor 36. In particular, the measurement data is transmitted together with a unique address of the processing unit sensor 36, so that the measurement data can be clearly assigned to a sensor. This data is transmitted from the processing unit transponder 38 via radio to the external control unit 400. The transmission preferably takes place automatically.

[0135] The processing unit transponder 36 can be designed as a passive transponder, preferably as a radio frequency identification device (RFID), or as an active transponder with its own power supply. For this purpose, the processing unit transponder 36 has a rechargeable battery or is connected to an external power supply. In particular, the processing unit transponder 36 can use the "Near Field Communication" (NFC) data transmission standard.

[0136] Data transmission can preferably be carried out via WLAN, Bluetooth and / or mobile communications standards (e.g. LTE, 5G, GSM).

[0137] If the processing unit 10 has multiple processing unit sensors 36, all or at least several processing unit sensors 36 can transmit their measurement data to the external control unit 400 via a processing unit transponder 38. Alternatively, the processing unit sensor 36 can be configured with an integrated transponder, so that each processing unit sensor 36 has its own transponder.

[0138] The use of transponders for wirelessly transmitting sensor data to the external control unit 400 was explained using a processing unit 10 as an example. If the processing system 100 has multiple processing units 10, each of which has at least one processing unit sensor 36, these or at least parts thereof can jointly use a processing unit transponder 38 for data transmission. The jointly used processing unit transponder 38 can be arranged in or on one of the processing units 10 or can be designed as an external unit.

[0139] It should be noted that the use of at least one transponder for wireless data transmission has been described here as an example for at least one processing unit. However, the use of at least one transponder can also be carried out correspondingly for at least one adapter plate sensor 228 in at least one adapter plate 200. Alternatively, it is also possible for at least one processing unit sensor 36 and at least one adapter plate sensor 228 to jointly use a transponder. This can be arranged in or on a processing unit 10, an adapter plate 200, or as an external device.

[0140] Figure 10b ) shows an embodiment of a processing system 100 with a wired data transmission from the at least one sensor to the external control unit 400.

[0141] In particular, Figure 10b) a processing system 100 with two processing unit groups 11, which are coupled by an adapter plate 200. By way of example, two of the processing units 10 have a processing unit sensor 36, and the adapter plate 200 has an adapter plate sensor 228. As already described above, the number of processing units 10 and the number of adapter plates 200 are variable. Furthermore, the number and location of the sensors in the processing system 100 are variable according to the previous descriptions of other embodiments.

[0142] The individual sensors 228, 36 are coupled to the external control unit 400 via a bus system 300. The bus system 300 comprises at least one bus line, which preferably runs along the at least one processing unit 10 and the at least one adapter plate 200. The individual sensors 228, 36 of the processing system 100 are coupled to the at least one bus line via cable 302. Each sensor 228, 36 can be coupled to a separate bus line, or multiple sensors 228, 36 can use the same bus line. In particular, the cables 302 of several sensors 228, 36, which are embedded in a processing unit 10 or an adapter plate 200, can first be brought together in the processing unit 10 or in the adapter plate 200, so that only one cable 302 is led out of the processing unit 10 or the adapter plate 200 and is to be coupled to a bus line.The measurement data of the sensors 228, 36 are transmitted according to the wireless data transmission, as described with respect to the . Figure 10a ), transmitted and evaluated by the external control unit 400.

[0143] The bus lines can preferably be arranged in at least one rail that runs along the at least one processing unit 10 and the at least one adapter plate 200.

[0144] The sensors 228, 36 can be equipped with a rechargeable battery that supplies the sensors 228, 36 with the required energy during their operating time. Alternatively, the individual sensors 228, 36 can be powered via an external power source. The at least one cable required to supply energy to the sensors 228, 36 can also run in the rail described above and then be coupled to the individual sensors 228, 36. If multiple sensors 228, 36 are located in a processing unit 10 or adapter plate 200, it is preferred that a main power supply cable protrudes from the processing unit 10 and the adapter plate 200, which can then be coupled to a main cable that runs, for example, in the rail of the bus system 300. The main power supply cable is connected to the individual sensors 228, 36 in the processing unit 10 or the adapter plate 200.This allows the user to supply the sensors 228, 36 with energy in just a few steps.

[0145] Alternatively, the at least one processing unit 10 and the at least one adapter plate 200 have an integrated power supply. For this purpose, at least a partial section of a power supply line is integrated into the at least one processing unit 10 and the at least one adapter plate 200. The partial sections of the power supply line can be connected to one another once the individual components (processing units, adapter plates) are joined together. The power supply line is fed at one point by an external energy source. The individual sensors 228, 38 are connected to the power supply line. Preferably, one of the end brackets 34, which sandwich the processing units 10 and adapter plates 200, also comprises a partial section of the power supply line, and the external energy source is connected to the partial section of the power supply line in the end bracket 34.

[0146] The power supply was described above only for sensors 228, 36 of the processing system 100 by way of example. However, it should be noted that all other elements of the processing system 100 that require power can also be supplied either by a battery or by one of the wired power supply options described above. Examples of this include the actuators of the deflection elements, the pump 258, or the at least one pressure control valve in the adapter plate 200.

[0147] In order to transmit control commands from the external control unit 400 to the individual components, such as the actuators of the deflection elements, the at least one valve for pressure control or the pump 258 in the adapter plate 200, the bus system 300 can also be used for this purpose. For this purpose, at least one control bus line is provided in the bus system 300, which enables the transmission of data from the external control unit 400 to the element to be controlled. Each of the elements to be controlled can be directly linked to a separate or shared control bus line. Alternatively, a main data line can be routed from the corresponding control bus line, for example, into the adapter plate 200, wherein the main data line is split in the adapter plate 200 in order to connect the individual components to be controlled.

[0148] As an alternative to wired data transmission, the control signals can also be transmitted wirelessly, as described with regard to the data transmission between the sensors 228, 36 and the external control unit 400. For this purpose, the external control unit 400 itself can have a transponder that ensures the transmission of control commands to corresponding components in the processing system 100 that enable control of the fluid flow 14.

[0149] The processing system 100 according to the invention thus offers a multitude of advantages. Firstly, at least one sensor 228, 36 is embedded in the processing system 100, eliminating the need for complex connection, calibration, and sterilization of the sensors 228, 36. Furthermore, the processing system 100 comprises only one external control unit 400, via which the measurement data from the sensors 228, 36 are collected and simultaneously used to control the fluid flow 14. Thus, the user has a single point of contact through which they can simultaneously monitor and control the processing system 100.

[0150] Furthermore, data transmission is provided in a manner that is simple for the user. Both wireless and wired data transmission between the external control unit 400 and the individual components of the processing system 100 that communicate with the external control unit 400 can be provided in a simple and rapid manner. Complex cabling is avoided. Thus, a compact and easy-to-use processing system 100 is provided. List of reference symbols

[0151] 10 Processing unit 11 Processing unit group 12 Processing housing 13 First processing unit group 14 Fluid stream 15 Second processing unit group 16 Filter medium 17 Filter carrier 18 Filtrate side 19 Empty space 20 Retentate side 21 Bulk material 22 Top of the processing housing 24 Inlet channel 26 Outlet channel 27 Second outlet channel 30 First processing unit 32 Second processing unit 34 End bracket 35 Inlet pump 36 Processing unit sensor 38 Processing unit transponder 40 Filter cartridge 42 First side of the filter cartridge 44 Second side of the filter cartridge 46 Filter cartridge valve 100Processing system 200 Adapter plate 202 First inlet opening 204 Lower end of the adapter plate 206 Second inlet opening 208 Upper end of the adapter plate 210 First outlet opening 212 Second outlet opening 214 Adapter channel 216 First channel section 218 Second channel section 220 Connecting channel section 222 Diverter valve 224 First diverter valve 226 Second diverter valve 228 Adapter plate sensor 230 Inlet plate 234 Channel recess 236 Flow web 238 Connecting channel 240 Auxiliary branch 242 Channel element 244 Auxiliary inlet or outlet 246 Multi-way valve 248 Valve tube 250 Valve tube surface 252 Valve opening 254 Displacement handle 257 Diverter actuator 258Pump 260Piston 262Cylinder 264Inlet valve 266Exhaust valve 268Hose 270Rotor 272Top of rotor 274Roller 276Gear mechanism 278Static mixer 300Bus system 302Cable 400External control unit HRHorizontal direction VRVertical direction

Claims

1. Modular processing system (100) for biopharmaceutical and / or chemical processes, comprising: - at least one processing unit (10) for performing a filtration step or a chromatography step in a biopharmaceutical or chemical process; - at least one adapter plate (200) that can be directly or indirectly fluidically connected to the processing unit (10), wherein the adapter plate (200) has at least one adapter channel (214) through which at least one fluid flow (14) can flow, which flows to the processing unit (10), wherein the adapter plate (200) additionally has at least one deflection element, designed as a multiway valve, and / or a pump (258) and / or at least one valve; - termination brackets (34), between which the at least one processing unit (10) and the at least one adapter plate (200) are held in the manner of a sandwich; and - an external control device (400); wherein the adapter plate (200) is designed in such a way that the fluid flow (14) to the processing unit (10) can be at least partially deflected with the aid of the at least one deflection element, designed as a multiway valve, in the adapter channel (214), and / or the fluid flow (14), preferably the pressure thereof, can be regulated with the aid of the at least one valve and / or the pump (258) in the adapter channel (214); wherein in each case at least one sensor (36, 228) is embedded in the processing unit (10) and / or in the adapter plate (200) in order to detect at least one property of the fluid flow (14) in the processing unit (10) and / or the adapter plate (200); wherein the deflection element, designed as a multiway valve, and / or the pump (258) and / or the at least one valve are controllable by means of an actuator (257); and wherein the external control device (400) is coupled to the at least one sensor (36, 228) in such a way that measurement data of the at least one sensor (36, 228) can be read out, and on the basis of the read-out measurement data the external control device (400) controls the actuator (257) in such a way that the fluid flow (14) in the processing unit (10) and / or the adapter plate (200) can be centrally regulated by the external control device (400).

2. Modular processing system (100) according to claim 1, comprising at least a first and a second processing unit (30, 32), which are fluidically connected to each other, wherein at least one fluid flow (14) that flows from the first processing unit (30) to the second processing unit (32) can flow through the at least one adapter channel (214) of the adapter plate (200); and wherein the adapter plate (200) is designed in such a way that the fluid flow (14) between the first processing unit (30) and the second processing unit (32) can be at least partially deflected with the aid of the at least one deflection element, designed as a multiway valve, in the adapter channel (214), and the fluid flow (14), preferably the pressure thereof, can be regulated with the aid of the at least one valve and / or the pump (258) in the adapter channel (214).

3. Modular processing system (100) according to any one of the preceding claims, wherein in each case at least one sensor (36, 228) is embedded in the first and the second processing unit (30, 32) and in the adapter plate (200) in order to detect at least one property of the fluid flow (14) in the first and the second processing unit (30, 32) and in the adapter plate (200) .

4. Modular processing system (100) according to claim 3, wherein the external control device (400) is coupled to the sensors (36, 228) in such a way that measurement data of the sensors (36, 228) can be read out, and on the basis of the read-out measurement data the fluid flow (14) in the processing units (30, 32) and the adapter plate (200) can be centrally regulated by the external control device (400).

5. Modular processing system (10) according to any one of the preceding claims, wherein the at least one processing unit (10) and / or the adapter plate (200) each have at least one transponder (38) which is designed to transmit measurement data of a corresponding sensor (36, 228) to the external control device (400); or wherein the sensors (36, 228) of the at least one processing unit (10) and / or the at least one adapter plate (200) are coupled to the external control device (400) via a bus system (300).

6. Modular processing system (100) according to any one of the preceding claims, wherein the sensor (36, 228) is designed to measure a pressure, a volumetric flow, a UV value, a pH value, a turbidity and / or a viscosity of the fluid flow (14).

7. Modular processing system (100) according to any one of the preceding claims, wherein the at least one sensor (36, 228), the at least one deflection element designed as a multiway valve, the at least one valve and / or the pump (258) each have a rechargeable battery.

8. Modular processing system (100) according to any one of the preceding claims, wherein the at least one sensor (36, 228), the at least one deflection element, designed as a multiway valve, the at least one valve and / or the pump (258) have a cable-based power supply.

9. Modular processing system (100) according to claim 8, wherein the processing system (100) has a central power supply for the at least one sensor (36, 228), the at least one deflection element, designed as a multiway valve, the at least one valve and / or the pump (258), wherein the at least one processing unit (10) and the at least one adapter plate (200) have sub-sections of the power supply, which form the central power supply when assembled.

10. Modular processing system (100) according to any one of the preceding claims, wherein the at least one sensor (36, 228), the at least one deflection element, designed as a multiway valve, the at least one valve and the pump (258) are designed as single-use elements.

11. Method for centrally regulating a modular processing system (100) for biopharmaceutical and / or chemical processes, comprising the steps: - providing at least one processing unit (10) for performing a filtration step or a chromatography step in a biopharmaceutical or chemical process; - providing at least one adapter plate (200) which has at least one adapter channel (214) through which at least one fluid flow (14) can flow, wherein the adapter plate (200) additionally has at least one deflection element, designed as a multiway valve, and / or a pump (258) and / or at least one valve, wherein the at least one deflection element, designed as a multiway valve, and / or the pump (258) and / or the at least one valve are controllable by means of an actuator (257); - providing an external control device (400); - directly or indirectly connecting the adapter plate (200) to the processing unit (10) such that the fluid flow (14) can flow from the adapter plate (200) to the processing unit (10); - providing termination brackets (34) and arranging the at least one processing unit (10) and the at least one adapter plate (200) between the termination brackets (34) such that the at least one processing unit (10) and the at least one adapter plate (200) are held between the termination brackets (34) in the manner of a sandwich; - detecting at least one property of the fluid flow (14) in the processing unit (10) and / or the adapter plate (200) by means of at least one sensor (36, 228) which is embedded in the processing unit (10) and / or the adapter plate (200); and - coupling the external control device (400) to the at least one sensor (36, 228) such that measurement data of the at least one sensor (36, 228) can be read out; and - coupling the external control device (400) to the at least one deflection element, designed as a multiway valve, and / or the pump (258) and / or the at least one valve in the adapter plate (200) such that on the basis of the read-out measurement data the external control device (400) controls the actuator in such a way that the fluid flow (14) in the processing unit (10) and / or the adapter plate (200) can be centrally regulated by the external control device (400), wherein the fluid flow (14) can be at least partially deflected with the aid of the at least one deflection element, designed as a multiway valve, in the adapter channel (214), and / or wherein the fluid flow (14), preferably the pressure thereof, can be regulated with the aid of the at least one valve and / or the pump (258) in the adapter channel (214).

12. Method according to claim 11, wherein the processing system (100) comprises at least a first and a second processing unit (30, 32); and wherein the first and the second processing unit (30, 32) are coupled to each other by means of the adapter plate (200) such that the fluid flow (14) can flow from the first processing unit (30) to the second processing unit (32).

13. Method according to claim 12, wherein in each case at least one sensor (36, 228) is embedded in the first and the second processing unit (30, 32) and in the adapter plate (200); wherein the sensors (36, 228) detect at least one property of the fluid flow (14) in the first and the second processing unit (30, 32) and in the adapter plate (200); and wherein the sensors (36, 228) are coupled to the external control device (400) such that measurement data of the sensors (36, 228) can be read out, and on the basis of the read-out measurement data the fluid flow (14) in the processing units (30, 32) and in the adapter plate (200) can be centrally regulated by the external control device (400).