Modular Processing System
The modular processing system simplifies fluid stream monitoring in biopharmaceutical and chemical processes by integrating adapter plates with sensors and centralized control, enhancing efficiency and reducing complexity.
Patent Information
- Application Number
- JP2022534404
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-12-09
- Filing Date
- 2020-12-09
- Publication Date
- 2025-08-08
- Estimated Expiration
- 2040-12-09
AI Technical Summary
Existing biopharmaceutical and chemical processing systems require complex monitoring of fluid streams across multiple measurement points, necessitating comprehensive data management and multiple system components.
A modular processing system with integrated adapter plates and sensors that allow for centralized control of fluid flow, including deflection and pressure adjustment, and direct integration of sensors for real-time monitoring, reducing the need for separate connections and simplifying data management.
The system enables compact, flexible, and efficient fluid flow management with continuous monitoring, allowing for real-time adjustments and reducing the system's footprint and investment costs.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to a modular processing system for biopharmaceutical and / or chemical processes and to a method for centrally controlling a modular processing system for biopharmaceutical and / or chemical processes. [Background technology]
[0002] Processes such as cell separation (e.g., by depth filtration), sterile filtration, chromatography steps, virus inactivation, virus filtration, and / or cross-flow filtration are known from the biopharmaceutical field. All these processes are basic operations that are commonly employed in various overall processes. Processing systems employing such overall processes require comprehensive monitoring of the fluid stream or fluids to ensure that the fluids have the parameters required for the overall process. However, this requires multiple measurement points in the processing system and careful management of comprehensive monitoring data. Summary of the Invention [Problem to be solved by the invention]
[0003] It is therefore an object of the present invention to provide a processing system for biopharmaceutical and / or chemical processes that simplifies the monitoring of fluids in the processing system. [Means for solving the problem]
[0004] This issue is 1. A modular processing system for biopharmaceutical and / or chemical processes, comprising: at least one processing unit; at least one adapter plate that can be fluidly connected directly or indirectly to a processing unit, the adapter plate having at least one adapter channel through which at least one fluid stream to the processing unit can flow, the adapter plate further comprising at least one deflection member and / or pump and / or at least one valve; an external control device; Equipped with the adapter plate is designed such that the fluid flow to the processing unit can be at least partially deflected by at least one deflection element in the adapter channel and / or the fluid flow, preferably its pressure, can be controlled by at least one valve and / or pump in the adapter channel, at least one sensor is incorporated into the processing unit and / or the adapter plate for detecting at least one property of the fluid flow in the processing unit or the adapter plate; The external control device is solved by a modular processing system that can be coupled (directly or indirectly) to at least one sensor so that it can read out measurement data of the at least one sensor and centrally control the fluid flow in the processing unit and / or adapter plate based on the read-out measurement data.
[0005] A "processing unit" is specifically defined as a unit in which a specific processing step for a desired method is performed. A processing unit specifically separates components of a fluid stream. A processing unit can be, for example, a unit used for cell separation (e.g., by depth filtration), sterile filtration, a chromatography step, viral inactivation, or cross-flow filtration.
[0006] The adapter plate is positioned upstream of the processing unit in terms of fluid flow such that the fluid flows from the adapter plate to the processing unit.
[0007] Adapter plates, which can be arranged upstream of a processing unit in a modular processing system, allow for necessary adjustments to the fluid flow, which may involve at least partially redirecting or deflecting the fluid flow or changing the flow direction of the fluid flow, and / or the pressure of the fluid flow, preferably or especially the fluid, as it reaches the processing unit, may be adjusted or controlled by the adapter plate.
[0008] However, both adjustments can also be performed simultaneously within one adapter plate. Preferably, the deflection can be achieved by at least one deflection member positioned in or on the adapter channel. Additionally or alternatively, a pump and / or at least one valve can be positioned in the adapter channel, which can adjust or control the pressure of the fluid flow in the adapter channel.
[0009] Additionally, adapter plates can be placed in the processing system upstream of or on the processing units to provide necessary adjustments to fluid flow.
[0010] The placement of an adapter plate upstream of a processing unit in a modular processing system provides the ability to easily supply fluid flow to downstream processing units in the manner required for subsequent processing steps in the processing system. Based on this structure, the adapter plate, combined with the configuration of the processing units, results in a compact structure, reducing the required footprint and system components, and therefore the required investment.
[0011] Furthermore, at least one sensor capable of detecting at least one property of the fluid flow is integrated into the processing unit and / or adapter plate in the processing system. As a result, fluid flow measurement can be performed at a preferred location, thereby making it possible to constantly monitor the fluid flow. Integrating at least one sensor into the processing unit and / or adapter plate, in particular, eliminates the need for a separate sensor connection. The sensor can be already integrated or provided in the adapter plate or processing unit at the factory and can advantageously be pre-installed and / or sterilized. As a result, users can skip the work steps of calibration or sterilization.
[0012] The measurement data of the at least one sensor in the processing unit and / or the adapter plate can be read out by an external control device.
[0013] If the measurement data deviates from a predetermined optimum, the external controller can centrally adjust the fluid flow in the adapter channel and / or processing unit.
[0014] Additionally, the modular treatment system only requires an external regulator or controller to obtain measurement data from the fluid flow and regulate the fluid flow in the treatment system.
[0015] Preferably, the processing system comprises at least a first processing unit and a second processing unit that are fluidly connected to each other; at least one fluid stream flowing from the first processing unit to the second processing unit can flow through at least one adapter channel of the adapter plate; The adapter plate is designed such that the fluid flow between the first and second processing units can be at least partially deflected by at least one deflection member in the adapter channel, and the fluid flow, preferably its pressure, can be controlled by at least one valve and / or pump in the adapter channel.
[0016] The first and second processing units may have the same design or at least partially different characteristics. The first and second processing units may, for example, be different in size, but can nevertheless be interconnected or combined with each other in a simple manner by means of an adapter plate. The processing system is preferably configured with various processing units, for example, using different separation media or performing different processing steps of the method. If capacity expansion is desired, equivalent processing units can be used.
[0017] An adapter plate is arranged between the first and second processing units for fluid flow, thus fluidly connecting the first and second processing units.
[0018] An adapter plate, which can be arranged (at least partially) between two processing units in a modular processing system, allows the necessary adjustments to be made to the fluid flow, thereby allowing processing units (especially standard processing units) to be fluidly connected to one another. This involves appropriately and at least partially diverting or deflecting the fluid flow, or changing the flow direction of the fluid flow, and / or the pressure of the fluid flow, preferably or especially the fluid, as it reaches the second processing unit, can be adjusted or controlled by the adapter plate. However, both adjustments can also be made simultaneously within one adapter plate.
[0019] Also, at least one adapter plate can be arranged between two consecutively arranged processing units in the processing system to provide the necessary adjustments for fluid flow.
[0020] Advantageously, configuring a process step based on a modular processing system with at least one adapter plate between two processing units allows any process step in the processing system to be combined, reducing the footprint and the need for system components. Therefore, the required investment is reduced. Additionally, a particularly compact and / or flexible configuration for a continuous operation mode in the processing system, including monitoring of some basic operations, is provided.
[0021] It is further preferred that at least one sensor is integrated into the first and second processing units and / or the adapter plate for detecting 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 during the process of the processing system. Using the measurement data of the sensor, a regulator or controller can analyze at least one parameter of the fluid flow at various locations in the processing system and, if a deviation from a predetermined limit value is identified, can immediately initiate an action to correct the corresponding parameter of the fluid flow. As a result, the process results can be favorably influenced during the process of the processing system, and parameters of the fluid flow that may lead to negative process results can be influenced in a desired manner. As mentioned above, but not limited to, the pump and / or at least one valve and / or at least one deflector in the adapter plate can be correspondingly controlled or adjusted by the controller.
[0023] An external control device is preferably coupled to the sensor so that it can read out the measurement data of the sensor and centrally control the fluid flow in the processing unit and / or adapter plate based on the read-out measurement data.
[0024] Preferably, at least one processing unit and / or adapter plate each comprises at least one transponder designed to transmit measurement data of the corresponding sensor to an external control device, or the sensors of the processing unit and / or adapter plate are coupled to the external control device via a bus system.
[0025] A "transponder" is defined as a transmitting unit that transmits the measurement data of a sensor wirelessly, optically and / or radio-wavely to an external control device. Alternatively, the processing system may comprise a bus system, by means of which at least one sensor can transmit its measurement data to an external control device.
[0026] Preferably, the at least one deflection member and / or the pump and / or the at least one valve are controllable by an actuator.
[0027] An "actuator" is defined as a motion control unit that receives a control command from an external regulator or controller and converts the command into mechanical movement, which may include actuating at least one deflection member and / or pump and / or valve. This command is output by the external controller.
[0028] Thus, not only can the measurement data be read out centrally, but the fluid flow can also be centrally controlled by automated means in the processing system.
[0029] The sensor can be designed to measure the pressure, volumetric flow rate, UV value, pH value, turbidity, and / or viscosity of the fluid stream.
[0030] Thus, at least one parameter of the fluid flow can be monitored, if necessary, and any necessary adjustments can be made to the fluid flow, which can be indicated by an external controller and / or the external controller can generate an output (such as an alarm) to a user, who can then make any 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 biasing member, the pump, and / or the at least one valve each comprise a rechargeable battery.
[0032] A rechargeable battery provides the sensor with the power it needs to make measurements, and the biasing member or valve can be repositioned with power when needed, allowing the pump to generate the required pump output when needed, using power from the rechargeable battery.
[0033] Rechargeable batteries have the particular advantage that no external cables need to be routed and no connections need to be made by the user. The rechargeable battery already provides sufficient power for the respective components. Rechargeable batteries can also be charged in particular by electromagnetic induction.
[0034] Alternatively or additionally, the at least one sensor, the at least one biasable member, the at least one valve, and / or the pump may comprise an umbilical power source.
[0035] Particularly when the processing system is operated for extended periods of time, the umbilical power supply has the advantage of providing the necessary power to the above-mentioned components.
[0036] Preferably, the processing system comprises a central power supply for at least one sensor, at least one deflection member, at least one valve and / or pump; At least the processing unit and at least one adapter plate have subsections of the power supply which, when assembled, form a central power supply.
[0037] In other words, one subsection of the umbilical power supply (cable) is integrated into each of the processing units and the adapter plate. When the processing system is assembled, the cable sections of at least one processing unit and at least one adapter plate are connected to each other. As a result, the power supply to the processing system is only required at a single point. A central power supply running through the processing system makes it possible to power all components, such as sensors, in the processing system.
[0038] Preferably, the at least one sensor, the at least one biasable member, the at least one valve, and the pump are formed as single-use components.
[0039] In this case, "single use" means that the sensor, deflection element and pump can be disposed of after use together with the processing unit or adapter plate, depending on the elements incorporated, thereby avoiding cleaning and reconditioning for further use in a new processing unit or adapter plate.
[0040] Additionally, the underlying problem is solved by a method for centrally regulating a modular processing system for biopharmaceutical and / or chemical processes, the method comprising: providing at least one processing unit; providing at least one adapter plate that may have at least one adapter channel through which at least one fluid stream may flow, the adapter plate further comprising at least one deflection member and / or at least one valve and / or pump; providing an external controller; directly or indirectly connecting the adapter plate to the processing unit so that fluid flow can flow from the adapter plate to the processing unit; detecting at least one property of the fluid flow in the processing unit and / or adapter plate using at least one sensor integrated in the processing unit and / or adapter plate; coupling an external controller to the at least one sensor such that measurement data can be read from the at least one sensor; coupling an external control device to at least one deflection element and / or pump and / or at least one valve in the adapter plate so that fluid flows in the processing unit and / or adapter plate can be centrally controlled based on the retrieved measurement data; Including, The fluid flow may be at least partially deflected using at least one deflection member in the adapter channel; and / or The fluid flow, and preferably its pressure, can be regulated using at least one valve and / or pump in the adapter channel.
[0041] Preferably, the processing system comprises at least a first processing unit and a second processing unit; The first and second processing units are coupled to each other by an adapter plate so that fluid flow can pass from the first processing unit to the second processing unit.
[0042] Preferably, at least one sensor is integrated into the first and second processing units and into the adapter plate, respectively; the sensor detects at least one property of the fluid flow in the first processing unit, the second processing unit, and the adapter plate; The sensors are coupled to an external control device so that the measurement data of the sensors can be read out and the fluid flow in the processing unit and / or adapter plate can be centrally controlled based on the read out measurement data.
[0043] These objects, features, and advantages of the present invention, as well as other objects, features, and advantages, will become more apparent by considering the following detailed description of the preferred embodiments and the accompanying drawings. It should also be noted that although the embodiments are described separately, it is possible to combine the individual features of these embodiments to form further embodiments.
Brief Description of the Drawings
[0044] [Figure 1a)-f)] It is a diagram showing the basic structure of various processing units. [Figure 2a)] It is a diagram showing a processing system including two groups of processing units configured in parallel using an adapter plate according to an embodiment. [Figure 2b] It is a diagram showing the processing system of FIG. 2a) including two groups of processing units configured in series using an adapter plate. [Figure 2c)] It is a diagram showing the processing system of FIG. 2b) in which individual processing units are held together using end brackets. [Figure 3a)] It is a cross-sectional view passing through the adapter plates of FIGS. 2a) and 2b) including a multi-way valve. [Figure 3b)] It is a diagram showing the multi-way valve of FIG. 3a). [Figure 4a)] It is a cross-sectional view of a two-part adapter plate including a sensor according to a further embodiment. [Figure 4b)] It is a perspective view of the adapter plate of FIG. 4a). [Figure 5a)] It is a cross-sectional view of an adapter plate according to a further embodiment having an auxiliary branch where an adapter plate sensor is integrated. [Figure 5b] It is a perspective view of the adapter plate of FIG. 5a). [Figure 6a)] It is a diagram showing a processing system including an adapter plate according to a further embodiment each having two auxiliary outlets or auxiliary inlets. [Figure 6b] It is a diagram showing an embodiment of the adapter plate of FIG. 6a) where an auxiliary inlet is used for fluid dilution. [Figure 6c] FIG. 6b shows an embodiment of the adapter plate of FIG. 6a) in which the auxiliary inlet is used for viral inactivation. [Figure 7] FIG. 10 shows a processing system with an adapter plate according to a further embodiment in which a pump is integrated. [Figure 8a)] FIG. 1 is a cross-sectional view through the adapter plate with the piston pump in the intake position. [Figure 8b] FIG. 8b is a cross-sectional view of the adapter plate of FIG. 8a) in the stroke position. [Figure 9a)] FIG. 10 is an exploded view of an adapter plate with a peristaltic pump according to a further embodiment. [Figure 9b] FIG. 9b is a cross-sectional view of the adapter plate of FIG. 9a. [Figure 10a)] FIG. 1 illustrates a processing unit according to one embodiment incorporating sensors whose data is transmitted wirelessly to an external control unit. [Figure 10b] FIG. 1 illustrates a processing system according to an embodiment with sensors transmitted to an external controller via a bus system. DETAILED DESCRIPTION OF THE INVENTION
[0045] Various processing units are used in biopharmaceutical and chemical processes. The above processing units can be used in the context of the present invention. Figures 1a) to 1e) show the basic structures of various processing units that can be used in the context of the present invention. These basic structures are a selection and are not an exhaustive list.
[0046] FIG. 1a) illustrates a processing unit 10 that can be used to perform a specific filtration step in a biopharmaceutical or chemical process. To this end, the processing unit 10 includes a processing housing 12 through which a fluid stream 14 can flow. The fluid stream 14 includes a medium to be filtered. At least one filter medium 16 is disposed within the processing housing 12. The filter medium 16 includes a porous material selected or used based on the particles or substances to be filtered from the fluid stream 14 by the processing unit 10. The filter medium 16 can be, for example, a virus filter, a sterilizing filter, a depth filter, or a membrane adsorber. The filter medium 16 is preferably formed as a filter mat or filter membrane or layer(s). In a preferred embodiment, the filter medium 16 can be comprised of multiple layers. Typically, the filter medium 16 is disposed in a substantially vertical direction VR within the processing housing 12. Within the processing housing 12, the filter medium 16 separates a filtrate side 18 from a retentate side 20. The filter media 16 is fluid permeable, and materials other than the filter media cannot pass through the filter media 16. Because the fluid flow 14 is directed from the retentate side 20 to the filtrate side 18 as desired, these materials remain on the retentate side 20 and / or within the filter media 16 and do not substantially reach the filtrate side 18 of the processing unit 10. A fluid pressure differential exists between the retentate side 20 and the filtrate side 18 as a function of the applied fluid pressure and / or the permeability of the filter media 16.
[0047] At least one inlet channel 24 is preferably located at the upper end 22 of the processing housing 12. The inlet channel 24 preferably extends in a substantially horizontal direction HR and supplies the medium to be filtered to the processing unit 10. As shown by the arrows in FIG. 1, the fluid flow 14 flows into the processing housing 12 over the inlet channel 24. In FIG. 1, this means that the fluid flow 14 enters the processing housing 12 from the left. At least a portion of the fluid flow 14 then flows from the retentate side 20 through the filter medium 16 to the filtrate side 18. If the processing unit 10 is configured in parallel with an additional processing unit (not shown here), a further portion of the fluid flow 14 flows directly to the additional processing unit without passing through the filter medium 16. This means that this portion of the fluid flow 14 flows into the inlet channel 24 of the additional processing unit (not shown). The fluid stream 14 ("filtrate") that permeates the filter media 16 then flows into an outlet channel 26 preferably located at a lower end 28 of the processing housing 12 and exits the processing housing 12 at the outlet channel 26.
[0048] The outlet channel 26 likewise preferably extends in a substantially horizontal direction HR within the processing housing 12. The filtrate leaving the processing housing 12 can subsequently flow into the outlet channel 26 of a further processing unit (not shown here) (parallel configuration) and / or into the inlet channel 24 of a further processing unit (series configuration) for further processing.
[0049] Figure 1b) shows a treatment unit 10 which differs from Figure 1a) only in that the filter medium 16 has a multi-layer design.
[0050] Figure 1c) shows a processing unit 10 that is basically formed in the same manner as the processing unit 10 in Figure 1a), but with a different type of filtration. Therefore, hereinafter, only the differences between the processing unit 10 in Figure 1c) and the processing unit 10 in Figure 1a) will be described.
[0051] Specifically, the processing unit of FIG. 1c is configured for precoat filtration. To this end, the filter medium 16 is configured as a precoat filter. In this case, the filter medium 16 comprises a filter carrier 17, which is preferably arranged in a vertical direction VR within the processing housing 12 and has a relatively coarse design. The precoat medium is typically mixed with the fluid before passing through the filter. This allows for the accumulation of a filter cake (not shown here). The filter carrier 17 is selected to carry at least one filter aid. A void space 19 is formed on the retentate side 20, providing a corresponding space for the filter cake within the processing housing 12.
[0052] Figure 1d) shows a further processing unit 10. The further processing unit 10 has a similar design to the processing unit 10 of Figure 1a), but comprises a bulk material 21 instead of the filter material 16. The bulk material 21 can in particular be a gel or activated carbon, in order to make the processing unit 10 of Figure 1c) suitable for chromatography.
[0053] In the context of chromatography, mixtures of substances can be separated.
[0054] In this case, the bulk material 21 acts as a stationary phase that is immobile in the processing unit 10. A mobile phase (such as water) is used to transport the mixture of substances to the stationary phase. Interactions between the stationary phase and individual substances in the mobile phase may cause delays in the flow time of the corresponding substances through the processing unit 10, allowing the substances to be separated.
[0055] FIG. 1e) shows a further processing unit 10. The further processing unit 10 has a similar design to the processing unit 10 of FIG. 1a), except that it is provided with a second outlet channel 27. As a result, this processing unit 10 is suitable for cross-flow filtration. Cross-flow filtration involves pumping the suspension to be filtered at high speed parallel to the filter medium 16 and extracting the filtrate transverse to the direction of flow. The filtrate can then be extracted via one of the outlet channels 26. The portion of the fluid stream 14 that does not permeate the filter medium 16 (i.e., the retentate) can be extracted from the processing unit 10 via the second outlet channel 27. If necessary, the filtrate or retentate from the cross-flow filtration can then be further processed in the context of the processing system described below.
[0056] Although the filter media 16 in Figures 1a-1e is configured as a flat filter, the filter media 16 may alternatively be a filter cartridge or filter capsule 40 as shown in Figure 1f).
[0057] While flat filters have a flat design and form a plane, filter cartridge 40 has a cylindrical shape. Filter media 16 preferably comprises pleated filter material that is configured in multiple layers to form cylindrical filter cartridge 40. To ensure the required stability of filter cartridge 40, filter cartridge 40 preferably includes a cylindrical support core that supports filter media 16 from the inside and a rigid outer cage that encases and supports filter media 16 from the outside. However, both the support core and the outer cage are designed to allow fluid flow therethrough.
[0058] 1f) shows a general schematic diagram of fluid flow 14 through filter cartridge 40. In this case, fluid flow 14 can be supplied such that fluid flow 14 flows from the inside of filter cartridge 40 to the outside of filter cartridge 40, or from the outside of filter cartridge 40 to the inside of filter cartridge 40. In this case, the supply direction is influenced by end caps that seal the cylindrical body of filter cartridge 40 at the ends.
[0059] When flow is directed from the inside to the outside through the filter cartridge 40, the fluid stream 14 is supplied to the interior of the filter cartridge 40 from a first side 42 of the filter cartridge 40. However, in this case, the supplied fluid is forced to flow from the inside to the outside through the filter media 16 of the filter cartridge 40 because the opposite second side 44 of the filter cartridge 40 is sealed by an end cap.
[0060] Alternatively, if flow is directed from the outside to the inside through the filter cartridge 40, the filter cartridge 40 has a first end 42 sealed by an end cap, allowing fluid to flow from the outside to the inside. In contrast, the second end 44 of the filter cartridge 40 is open in this case.
[0061] The filter cartridge 40 itself is inserted or installed within a flat processing housing 12. The processing housing 12 preferably has walls inside it that appropriately guide the fluid flow 14 so that the fluid flow 14 of the filter cartridge 40 is supplied in a desired manner. For example, if the fluid flow 14 is directed from the inside to the outside of the filter cartridge 40, a wall can be provided to guide the fluid flow 14 into the inside of the filter cartridge 40. This prevents the media to be filtered from contacting the outside of the filter cartridge 40. This also prevents the filtered media from contacting the media to be filtered.
[0062] When fluid stream 14 flows from the exterior to the interior of filter cartridge 40, a corresponding wall is preferably similarly positioned adjacent second side 44 of filter cartridge 40. This wall prevents filtered media exiting second side 44 of filter cartridge 40 from contacting the media to be filtered outside of filter cartridge 40.
[0063] The filter cartridge 40 can be installed in the processing housing 12 in either a vertical or horizontal orientation. In this case, the inlet channel 24, over which the media to be filtered enters the processing housing 12, is appropriately shaped so that flow can properly pass through the filter cartridge with respect to either the vertical or horizontal orientation. The same applies to the outlet channel 26, over which the filtered fluid can exit the processing housing 12.
[0064] As shown in Figure 1f), multiple filter cartridges 40 can be arranged side-by-side within the processing housing 12. Supplying and extracting fluid stream 14 to and from each filter cartridge 40 is accomplished as already described above with respect to the filter cartridges 40. However, additional partition walls can be disposed between the individual filter cartridges 40 so that the filter cartridges 40 are separated from one another.
[0065] At least one filter cartridge valve 46 can be disposed in the inlet channel 24 and / or the outlet channel 26. In the inlet channel 24, the filter cartridge valve 46 can be designed to facilitate or prevent flow from continuing into the inlet channel 24. The filter cartridge valve 46 can further be designed to facilitate or prevent flow of the fluid stream 14 toward or into the filter cartridge 40. As shown in FIG. 1f), the filter cartridge valve 46 can also be designed to allow access into the inlet channel 24 from the outside so that an additive or additional fluid stream 14 can enter the inlet channel 24.
[0066] At the outlet channel 26, the filter cartridge valve 46 can be designed to encourage or prevent flow from continuing into the outlet channel 26. As shown in FIG. 1f), the filter cartridge valve 46 can also be designed to allow further outflow from the outlet channel 26, such that at least a portion of the fluid stream 14 can flow out of the outlet channel 26.
[0067] The filter cartridge valve 46 is particularly advantageous for integrity testing. With the filter cartridge valve 46, the filter cartridges 40 can be independently integrity tested.
[0068] At least one processing unit sensor 36 may be incorporated into the processing housing 12. The at least one processing unit sensor 36 is positioned in the processing unit 10 so as to be able to monitor or measure a desired parameter of the fluid stream 14. The relevant processing unit sensors 36 are described in further detail below.
[0069] For integrity testing, the processing unit sensor 36 may be specifically designed to detect the pressure of the fluid stream 14, as shown in Figure 1f. The processing unit sensor 36 is advantageously positioned upstream and downstream of the filter cartridge 40 so that it can detect the pressure difference of the fluid stream 14.
[0070] The filter cartridge 40 is particularly suitable for filtration applications in which high pressures are exerted on the filter media 16 .
[0071] 2a) and 2b) illustrate a processing system 100 including a plurality of processing units 10, as shown in FIGS. 1a) through 1e). The processing units 10 directly coupled to each other form a processing unit group 11. As shown in FIGS. 2a) and 2b), the processing system 100 includes a first processing unit group 13 and a second processing unit group 15 coupled by an adapter plate 200, respectively, according to one embodiment of the present invention. While the directly coupled processing units 10 in FIGS. 2a) and 2b) are shown as parallel-configured units, they can also be configured in series. The adapter plate 200 allows the two processing unit groups 11 coupled by the adapter plate 200 to be configured either in parallel (see FIG. 2a) or in series (see FIG. 2b). Optionally, the adapter plate 200 includes at least one deflector (described below) for switching between these configurations. This can be easily achieved without any design changes to the processing system 100. By simply switching one or more deflection members, the configuration of the processing unit group 11 can be switched from a parallel configuration to a serial configuration.
[0072] Figure 2a) shows a parallel configuration of processing unit groups 11 coupled by an adapter plate 200. Figure 2b) shows a serial configuration of processing unit groups 11 coupled by an adapter plate 200. Although Figures 2a) and 2b) show processing unit groups 11 coupled by an adapter plate 200, the adapter plate 200 can also be used to couple only one processing unit 10 to a processing unit group 11 or two individual processing units 10 to each other.
[0073] The adapter plate 200 is preferably substantially formed as a plate and can accommodate the fluid flow 14. The adapter plate 200 is preferably formed as a single-use part, and its material properties are preferably selected to allow for sterilization methods such as gamma irradiation, autoclaving, and purging with gases such as ethylene oxide and / or hot steam. The adapter plate can be made, in particular, from plastic. The processing unit 10 located upstream of the adapter plate 200 in the flow direction is referred to as the first processing unit 30, while the processing unit 10 located downstream of the adapter plate 200 in the flow direction is referred to as the second processing unit 32. In other words, as shown in FIGS. 2a and 2b, the first processing unit group 13 consists of the first processing unit 30, and the second processing unit group 15 consists of the second processing unit 32. The adapter plate 200 is positioned between the first processing unit group 13 and the second processing unit group 15 and fluidly connects them. The adapter plate 200 has at least one inlet opening through which the fluid flow 14 can enter the adapter plate 200. As shown in FIG. 2 a), the adapter plate 200 has two inlet openings: a first inlet opening 202 at a lower end 204 of the adapter plate 200, which is preferably coupled to the outlet channel 26 of a first processing unit 30 located directly upstream of the adapter plate 200, and a second inlet opening 206 at an upper end 208 of the adapter plate 200, which is preferably coupled to the inlet channel 24 of this first processing unit 30. In other words, the fluid flow 14 can enter the adapter plate 200 from the aforementioned first processing unit 30 over the first inlet opening 202 and the second inlet opening 206. The adapter plate 200 also has at least one outlet opening through which the fluid flow 14 can exit the adapter plate 200.As shown in FIG. 2a), the adapter plate 200 has two outlet openings: a first outlet opening 210, preferably located at or near the bottom end 204 of the adapter plate 200, which is coupled or can be coupled to the outlet channel 26 of a second processing unit 32 located directly downstream of the adapter plate 200; and a second outlet opening 212, preferably located at or near the top end 208 of the adapter plate 200, which is coupled or can be coupled to the inlet channel 24 of this second processing unit 32. At least one adapter channel 214 extends within the adapter plate 200 and fluidly connects the inlet and outlet openings to one another. Specifically, the adapter channel 214 has a first channel region 216 extending 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 channel region 216 and the second channel region 218 are fluidly connected by a connecting channel region 220 .
[0074] The above-described configuration of the adapter channel 214 is particularly advantageous when at least one deflection member can be used to switch between a series configuration and a parallel configuration of the two processing units 10. If the adapter plate 200 does not include a deflection member, only a predetermined fluid path can be defined in the adapter plate 200. Alternatively, the adapter channel 214 can be configured as described above, but the section of the adapter channel 214 is permanently sealed, resulting in a predetermined fluid path through the adapter plate 200.
[0075] As shown in FIGS. 2a) and 2b), at least two deflection members are disposed in the adapter channel 214. Specifically, the at least two deflection members are deflection valves 222. In a preferred embodiment, a first deflection valve 224 is disposed in the first channel region 216, and a second deflection valve 226 is disposed in the second channel region 218. In a specific embodiment, the deflection valves 222 can be formed as a multi-way valve 246. FIGS. 2a) and 2b) show a related example of three-way valves as the first valve 224 and the second valve 226. An alternative embodiment of the multi-way valve will be described below with reference to FIGS. 3a) and 3b).
[0076] At least one first processing unit 30 and at least one second processing unit 32 may have the same design or may be different for performing different types of processes. Preferably, the first processing unit 30 of the first processing unit group 13 and the second processing unit 32 of the second processing unit group 15 have the same design. However, it is also conceivable that the first processing unit 30 and the second processing unit 32 are different from each other. For example, at least one first processing unit 30 can be formed as a depth filter, while at least one second processing unit 32 can be formed as a sterilizing filter.
[0077] FIG. 2c) shows the processing system 100 of FIG. 2b), in which the individual processing units 10 and adapter plates 200 are held together by end brackets 34 (the multi-way valve 246 is not shown here). In other words, one end bracket 34 is located at each inlet point where the fluid flow 14 enters the processing system 100 and at each outlet point where the fluid flow 14 leaves the processing system 100. The end brackets 34 can preferably be formed as end plates, with the individual processing units 10 being sandwiched between them. The inlets or outlets can be part of the end brackets 34. Additional end plates with corresponding connections can also be incorporated, particularly between the end brackets 34 and the respective adjacent processing units 10. The fluid flow 14 is preferably pumped into the processing system 100 by an inlet pump 35. FIG. 2c) shows the inlet pump 35 located upstream of the end brackets 34 in the flow direction. The inlet pump 35 can also be advantageously located in an adapter plate 200 located between the end brackets and the adjacent processing units 10. In this way, a space-saving design can be achieved.
[0078] All of the processing systems 100 shown in Figures 2a-2c include an adapter plate 200 located between two processing units 10 to fluidly connect them, but this configuration is not required. The adapter plate 200 can simply be located upstream of at least one processing unit 10 to supply fluid to at least one processing unit 10. The adapter plate 200 can be particularly located between the end bracket 34 and the processing unit 100. This is advantageous, for example, when the downstream processing unit 10 is a unit for membrane chromatography. In the context of chromatography, various media are typically applied sequentially to the filter medium 16. (For example, disinfection, conditioning, rinsing and equilibration steps may be carried out before the actual protein solution to be purified is introduced. Thus, various inlets on the adapter plate 200 can be used to supply individual media to the processing unit 10. The introduction of the media to be purified may be followed by washing and elution steps. Here again, separate inlets and / or outlets on the adapter plate 200 are useful, as described, for example, with reference to Figure 6a). For this purpose, one deflection element each can be arranged at such inlets and / or outlets, which can "switch" their configuration between inlet and outlet.)
[0079] The processing system 100 according to the present invention further comprises at least one sensor integrated into at least one processing unit 10 and / or at least one adapter plate 200. In the embodiment of Figures 2a) to 2c), Figure 2c) shows an example of an adapter plate sensor 228 integrated into the adapter plate 200 and a processing unit sensor 36 integrated into a processing unit 10 arranged downstream of the adapter plate 200 in the flow direction.
[0080] At least one adapter plate sensor 228 is specifically incorporated into the adapter plate 200 such that the adapter plate sensor 228 contacts the fluid flow 14 and at least partially reaches the adapter channel 214 to perform desired measurements on the fluid.
[0081] The adapter plate sensor 228 can be configured to measure, for example, the pressure, volumetric flow rate, UV value, pH value, turbidity, and / or viscosity of the fluid stream 14. The measured values can then be used to control or regulate the filtration process. For this purpose, the measured values are transmitted to the external control device 400. The adapter plate sensor 228 can be configured as a cost-effective, single-use component so that the adapter plate sensor 228 can be disposed of together with the adapter plate 200 after use. The adapter plate sensor 228 can, in particular, already be integrated into the adapter plate 200 at the factory. The adapter plate 200 can then be shipped with the adapter plate sensor 228 already calibrated and sterilized.
[0082] The illustrated adapter plate 200 here couples two processing units 10 in series. However, it is also possible to use the adapter plate sensor 228 in a parallel configuration of two processing units 10. In this case, however, it is advantageous for the adapter plate sensor(s) 228 to be located in or on the first channel region 216 and / or the second channel region 218 to establish contact with the fluid stream 14. When two processing units 10 are configured in series, the adapter plate sensor 228 can also be located in or on the connecting channel region 220.
[0083] At least one adapter plate sensor 228 may also be provided on at least one deflection member of at least one adapter plate 200. This adapter plate sensor 228 is designed to detect the physical setting of the deflection member and transmit this state to the external controller 400.
[0084] 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 previously described with respect to the adapter plate sensor 228. The processing unit sensor 36 is incorporated into the processing unit 10, in particular such that the processing unit sensor 36 is at least partially in contact with the fluid stream 14 to perform the corresponding measurements. The measurements can likewise be transmitted to the external controller 400.
[0085] The processing unit sensor 36 can be positioned anywhere on the processing unit 10 to make the desired measurements. For example, the processing unit sensor 36 can be positioned on the filtrate side 18 of the processing unit 10 to advantageously determine or monitor the filtration results of the processing unit 10. It is also particularly preferred that the processing unit sensor 36 be formed as a cost-effective, single-use component so that the processing unit sensor 36 can be disposed of with the processing unit 10 after use.
[0086] As shown in FIG. 2c), at least one processing unit sensor 36 is preferably located in a processing unit 10 configured downstream of the adapter plate 200. This processing unit sensor 36 may, for example, monitor the pressure that the fluid flow 14 exerts on the filter media 16. However, the processing unit sensor 36 may also be located in any other of the remaining processing units 10 in the processing system 100.
[0087] FIG. 3a) shows a cross-sectional view of the adapter plate 200. As shown in FIG. 3a), the adapter plate 200 is preferably formed in two parts and includes an inlet plate 230 and an outlet plate (not shown here). The plate of the adapter plate 200 provided with at least one inlet opening is referred to as the inlet plate 230. The plate of the adapter plate 200 provided with at least one outlet opening is referred to as the outlet plate. The inlet plate 230 and the outlet plate may have the same shape and / or size. One multi-way valve 246 acting as a deflection member is positioned in each of the first channel region 216 and / or the second channel region 218. The multi-way valve 246 includes a valve tube 248 that extends at least partially into the first channel region 216 and the second channel region 218 and is positioned there so as to be operable (particularly so as to be able to rotate or pivot). The actuation (particularly the rotation) can be achieved by a deflection actuator 257. In this case, the deflection actuators 257 can receive actuation commands from the external controller 400 and convert the actuation commands into mechanical actuation of the multi-way valves 246. The deflection actuators 257 can be particularly located on actuation arms 254 (see FIGS. 3a and 3b) that protrude from the adapter plate 200. As shown in FIGS. 3a and 3b, at least one adapter plate sensor 228 can be located on at least one of the multi-way valves 246 to detect the physical setting of the multi-way valves 246 and transmit this information to the external controller 400. The adapter plate sensor 228 can be particularly located on the actuation arm 254 of the multi-way valve 246.
[0088] At least two valve openings 252 are formed in the covering surface 250 of the valve tube 248. These at least two valve openings 252 are offset from one another in the direction of actuation (particularly the direction of rotation) so as to allow a first fluid flow or a second fluid flow in a first setting of the valve tube 248. This means, for example, that the first fluid flow passes over the first inlet opening 202 of the adapter plate 200 and enters the valve tube 248 through the first valve opening 252, which at least partially overlaps the first inlet opening 202.
[0089] The second valve opening 252 at least partially overlaps the first outlet opening 210, allowing the first fluid flow to pass beyond the first outlet opening 210 and out of the adapter plate 200. This also applies correspondingly to the second fluid flow, as well as to the second inlet opening 206 and the second outlet opening 212. In each channel region, fluid flow 14 through the connecting channel region 220 is blocked based on the physical setting of the valve opening 252. However, because the first and second fluid flows are allowed to pass through the multi-way valve 246, the first and second processing units 30 and 32, respectively, directly coupled to the adapter plate 200, are configured in parallel with each other.
[0090] 3a) and 3b), each of the valve tubes 248 preferably has at least three valve openings 252. The at least three valve openings 252 are aligned such that, in a first alignment (particularly a rotational physical setting) of the valve tubes 248, at least two of the valve openings 252 enable the first and second fluid flows described above, thereby configuring the first and second processing units 30 and 32, respectively, directly coupled to the adapter plate, in parallel. However, because the valve openings 252 do not at least partially overlap the connecting channel region 220, fluid flow 14 through the connecting channel region 220 is prevented.
[0091] Based on the arrangement of the at least three valve openings 252, in a second alignment (particularly the rotational physical setting) of each valve tube 248, a path to the inlet opening or outlet opening is blocked but access to the connecting channel region 220 is permitted, thereby enabling a serial configuration of the first processing unit 30 and the second processing unit 32.
[0092] In other words, the multi-way valves 246 must be aligned in a serial configuration such that the fluid flow 14 can pass over the first inlet opening 202 of the adapter plate 200, through a valve opening 252 that at least partially overlaps the first inlet opening 202, and into the first valve conduit 248. The fluid flow 14 can pass over the valve opening 252 that at least partially overlaps the connecting channel region 220 and into the connecting channel region 220. The path to the first outlet opening 210 is blocked by the valve conduit 248 because the valve opening 252 does not overlap the first outlet opening 210. The fluid flow 14 can also pass over the valve opening 252 of the second valve conduit 248 that at least partially overlaps the connecting channel region 220 and into the second valve conduit 248. Fluid flow 14 can exit adapter plate 200 over a valve opening 252 in second valve conduit 248 that at least partially overlaps with second outlet opening 212 of adapter plate 200. A path to second inlet opening 206 is blocked by valve conduit 248 because valve opening 252 does not overlap with second inlet opening 206.
[0093] Additionally, switching between series and parallel configurations of two processing units 10 or groups of processing units 11 can be easily performed without design-based reconfiguration. The adapter plate 200 is specifically designed as a compact assembly to reduce the footprint of the processing system 100. The deflection valve 222 can be designed as a cost-effective, single-use component. Potential applications include switching tangential flow filtration from standard to single-pass mode, switching between parallel and series configurations of chromatography units, for example, to combine different chromatography media in series, or to improve performance utilization.
[0094] Figures 3a) and 3b) describe one exemplary embodiment of a rotating deflection member. The physical setting of the deflection member can be actuated by a control signal from an external controller 400. Note, however, that this is also possible for any other type of deflection member (e.g., see the three-way valve described above in Figures 2a)-2c).
[0095] 4a) and 4b) illustrate a preferred embodiment in which at least one adapter plate sensor 228 is integrated with the adapter plate 200. As shown in FIG. 4b), the adapter plate 200 is preferably formed of two or more parts as well. The inlet plate 230 has at least one first inlet opening 202, preferably at the lower end 204 of the adapter plate 200. As shown in FIG. 4a), the inlet plate 230 has two first inlet openings 202. However, the inlet plate 230 does not have the second inlet opening(s) 206. The illustrated adapter plate 200 is intended solely to enable a serial configuration of two processing units 10, so the second inlet opening 206 is not required. For a parallel configuration, at least one second inlet opening 206 can be formed in the inlet plate 230, preferably at the upper end 208 of the adapter plate 200.
[0096] As also shown in Fig. 4b), the outlet plate 232 has at least one second outlet opening 212. In the specific example in Fig. 4b), the outlet plate 232 has two outlet openings 212. If a parallel configuration of two processing units 10 is desired, the outlet plate 232 may further have at least one first outlet opening 210. The inlet plate 230 and the outlet plate 232 may be screwed and / or glued and / or welded and / or clicked together.
[0097] Corresponding channel recesses 234 can be formed in the inlet plate 230 and / or the outlet plate 232. When the inlet plate 230 and the outlet plate 232 are assembled together, an adapter channel 214 is formed, allowing the fluid stream 14 to flow through the adapter plate 200. At least one flow web 236 is preferably formed in the connecting channel region 220 of the adapter channel 214, and this flow web 236 preferably extends substantially in the flow direction of the fluid stream 14 and contributes to guiding the fluid stream 14 in an improved manner. An adapter plate sensor 228 can be integrated into the inlet plate 230 and / or the outlet plate 232 and can protrude into the adapter channel 214 so that a measuring element of the adapter plate sensor 228 can contact the fluid stream 14. The adapter channel 214 preferably at least partially includes a connecting channel 238 for the adapter plate sensor 228. This connecting channel 238 can be an at least partial recess in the adapter channel 214, into which the sensor 228 at least partially protrudes.
[0098] 5a) and 5b) show the adapter plate 200 of FIGS. 4a) and 4b), but in this embodiment, the adapter plate sensor 228 is in or on an auxiliary branch 240. The auxiliary branch 240 forms a branch from the adapter channel 214, into which at least a portion of the fluid flow 14 is diverted. This portion of the fluid flow 14 preferably flows from the adapter channel 214 for at least a certain period of time and is redirected back into the adapter channel 214 at a later time.
[0099] The auxiliary branch 240 can be used to branch off a small amount of the fluid flow 14 for corresponding measurement. The auxiliary branch 240 can be formed by a separate channel member 242 that is at least partially integrated into the adapter plate 200. As shown in FIGS. 5a and 5b, a portion of the auxiliary branch 240 can protrude from the adapter plate 200. As a result, in particular, the adapter plate sensor 228 can also be located outside the adapter plate 200. However, in this arrangement, the adapter plate sensor 228 is still considered to be "integrated" into the adapter plate 200.
[0100] 6a) shows a processing system 100 comprising a first processing unit group 13 and a second processing unit group 15 coupled by an adapter plate 200. In the illustrated embodiment, the coupled processing unit groups 11 are arranged in series by the adapter plate 200. However, the two processing unit groups 11 can equally well be arranged in parallel according to other described embodiments. As mentioned above, the adapter plate 200 can also be formed as only the upstream adapter plate 200.
[0101] According to FIG. 6a), at least one auxiliary outlet and / or auxiliary inlet 244 can be formed in the adapter plate 200. At least a portion of the fluid flow 14 can be extracted or effluent from the adapter channel 214 via the auxiliary outlet. The extracted fluid flow 14 can flow back into the adapter channel 214, or the auxiliary inlet can provide access to the adapter channel 214. For example, at least one auxiliary outlet or auxiliary inlet can be used to facilitate the addition of an external pump and the evacuation of fluid from the first or further upstream processing unit 30 for integrity testing of different processing units 10 of the processing system 100, temporary buffer treatment, or further processing, venting, and / or sampling. In particular, at least one diafiltration medium and / or other reagents can be added via the auxiliary inlet. FIG. 6a) shows the adapter plate 200 with two auxiliary outlets and two auxiliary inlets 244. Tri-clamps or sterile connectors can be possible connections at the auxiliary outlets and inlets 244. An auxiliary pump or an auxiliary valve may be suitably provided at the auxiliary outlet or auxiliary inlet 244 to supply or exhaust fluid at the auxiliary outlet or auxiliary inlet 244 respectively.
[0102] 6b) shows an embodiment of an adapter plate 200 having at least one auxiliary inlet 244 that can be used to add additional fluid to dilute the fluid already present in the adapter plate 200. The additional fluid can be mixed with the fluid already present in the adapter plate 200 by a static mixer 278. An exemplary application where dilution is required would be the requirement to reduce the salt concentration of a fluid during a partial step of an antibody purification method.
[0103] A "static mixer" 278 is defined as a device for mixing fluids where the mixing action is achieved strictly by fluid motion. To achieve the mixing fluid motion, flow-influencing elements are provided within the adapter channel 214. Such elements can be serially arranged screws, fins, or grid-shaped elements. The fluids to be mixed are added to the mixer 278 together in the desired mixing ratio. The elements disrupt the stream of material, twist the stream, and then reunite to achieve the desired mixing.
[0104] In this specific example of adapter plate 200, fluid stream 14 is directed into adapter plate 200. Fluid stream 14 may originate, for example, from upstream processing unit 10. Here, to dilute this fluid stream 14 within adapter plate 200, a further fluid stream 14 may be directed into adapter plate 200 via auxiliary inlet 244. These two fluid streams 14 are then mixed by static mixer 278.
[0105] The adapter plate 200 preferably comprises at least one adapter plate sensor 228 designed to monitor the dilution step. For this purpose, the adapter plate sensor 228 is preferably arranged downstream of the static mixer 278 in the flow direction. The values detected by the adapter plate sensor 228 can then be transmitted to an external control device 400. Based on the received measurement data, the external control device 400 can, for example, adjust the auxiliary pump at the auxiliary inlet 244 and adjust the amount of dilution fluid added.
[0106] Preferably, if the degree of dilution is not as required, the fluid stream 14 can also be diverted via the auxiliary outlet 244. The diverted fluid stream can then be returned to its original direction for further dilution or for complete disposal. Only the desired diluted fluid stream 14 can then be directed to the connected processing unit 10.
[0107] Figure 6c) shows a further embodiment of the adapter plate 200 with at least one auxiliary outlet or inlet 244. In this case, the adapter plate 200 can be used in particular for virus inactivation.
[0108] This configuration is essentially similar to that in Figure 6b), except that instead of a dilute solution, a pH-lowering fluid is added through auxiliary inlet 244. Using static mixer 278, the pH-lowering agent is mixed with fluid stream 14 flowing through adapter plate 200.
[0109] Similar to FIG. 6b), at least one adapter plate sensor 228 can be positioned downstream of static mixer 278. In this case, adapter plate sensor 228 preferably detects the pH value of fluid stream 14 downstream of static mixer 278. The measured value is then transmitted to external controller 400. If the pH value is too high, fluid stream 14 can be diverted out of adapter plate 200 via auxiliary outlet 244. The diverted fluid stream 14 can be redirected back into adapter plate 200 to further reduce the pH value or to discard the fluid. Based on the received measurement data, external controller 400 can, for example, adjust the auxiliary pump at auxiliary inlet 244 to adjust the amount of pH-lowering agent added.
[0110] If the fluid has a suitable pH, it can continue to flow through the adapter plate 200. Subsequently, a further static mixer 278 is positioned within the adapter plate 200 to raise the pH again. The fluid for raising the pH is added via the further auxiliary inlet 244 and mixed with the fluid flow 14 within the adapter plate 200 using the further static mixer 278. Preferably, at least one further adapter plate sensor 228 positioned downstream of the further static mixer 278 monitors the achieved pH of the fluid and transmits the measurement data to the external controller 400. Again, similar to the static mixer 278 described above, defective fluid can be diverted or discarded via the further auxiliary outlet 244. Based on the received measurement data, the external controller 400 can, for example, adjust the auxiliary pump at the auxiliary inlet 244 to adjust the amount of pH-raising agent added.
[0111] An adapter channel 214 can be formed between two static mixers 278 so that the fluid maintains a reduced pH value for a sufficient period of time to achieve complete viral inactivation. This partial path is preferably serpentine in shape so that the fluid maintains a reduced pH value, preferably for 30 minutes.
[0112] It should be noted that the configuration of the adapter channel 214 shown in Figures 6a)-6c) is an exemplary representation. The adapter channel 214 can be configured according to any of the embodiments described above. Figures 6a)-6c) particularly describe a configuration in which all steps or all components of viral inactivation are provided in one adapter plate 200. Several adapter plates 200 can be arranged in series or coupled to each other, and individual components can be distributed among these adapter plates 200. This means that viral inactivation is achieved as the fluid stream 14 travels through individual adapter plates 200 that have various components for viral inactivation.
[0113] As shown in Figures 6b) and 6c), the auxiliary pump can be located within the adapter plate 200. However, the auxiliary pump can also be located outside the adapter plate 200 or as an external device.
[0114] As depicted in FIG. 6 c ), a partial path may extend between two static mixers 278 and may extend at least partially outside the adapter plate 200 .
[0115] 7 shows a processing system 100 having a first processing unit group 13 and a second processing unit group 15. The first processing unit group 13 and the second processing unit group 15 are connected by an adapter plate 200. At least one pump 258 is arranged in or on the adapter channel 214 of the adapter plate 200. Although the at least one pump 258 may be used when two processing unit groups 11 are arranged in parallel, as shown in FIG. 7, it is particularly advantageous in a serial configuration, since it allows the pressure exerted by the fluid on the processing unit 10 located downstream in the flow direction to be controlled. In particular, these measures can overcome flow resistance, thereby achieving sufficient filtration performance in the second processing unit group 15.
[0116] The pump 258 may be formed as a positive displacement pump, in particular for generating a vacuum in the first group of processing units 13 and building up a desired filtration pressure in the second group of processing units 15. The pump 258 may be formed as a cost-effective single-use component, in particular.
[0117] The pump 258 is coupled to an external controller 400. From the external controller 400, the pump 258 receives control commands that can start, stop, or otherwise control or regulate the pump 258.
[0118] The pump 258 is preferably controlled or regulated based on measurement data from at least one adapter plate sensor 228 and / or at least one processing unit sensor 36, which record at least one parameter of the fluid stream 14 in the processing system 100. The measurement data from the at least one sensor can be read, for example, by an external controller and used to regulate the pump 258 to achieve a desired pressure in the fluid stream 14. For this purpose, limit values can be defined in the external controller 400. If the pressure of the fluid stream 14 deviates from the defined value, the external controller 400 can adjust the settings of the pump 258 so that the fluid stream 14 has the desired pressure. The settings of the pump 258 can be adjusted by a pump actuator that receives a control command from the external controller 400.
[0119] 8a) and 8b) show a particular embodiment of the adapter plate 200 with a positive displacement pump, in particular a piston pump. The pump 258 is preferably arranged in the connecting channel area 220 and comprises at least one piston 260 designed to perform a stroke movement, i.e. a linear (translational) movement. The piston 260 is for this purpose arranged in a cylinder 262. The pump 258 further has an inlet and an outlet, each of which can be sealed by a valve.
[0120] Specifically, a compartment in the connecting channel region 220 is separated or isolated in the flow direction by an inlet valve 264 and an outlet valve 266. Fluid can flow into the compartment using the inlet valve 264 and out of the compartment using the outlet valve 266. A cylinder 262 that houses a piston 260 and within which the piston 260 can translate is configured such that the cylinder 262 is disposed on the connecting channel region 220 and fluidly connected to the connecting channel region 220. The cylinder 262 is particularly disposed between the inlet valve 264 and the outlet valve 266 in the connecting channel region 220.
[0121] During the first stroke, i.e., intake, the piston 260 performs the opposite movement, i.e., movement away from the connecting channel region 220. When the inlet valve 264 opens, the fluid to be conveyed can enter the connecting channel region 220 or the cylinder 262. During the second stroke, i.e., the conveying movement, the inlet valve 264 closes and the piston 260 moves in a direction towards the connecting channel region 220. When the outlet valve 266 opens, the medium to be conveyed is forced out.
[0122] At least one adapter plate sensor 228 is preferably disposed within the adapter channel 214 to monitor the fluid flow 14. To this end, the adapter plate sensor 228 may be preferably disposed downstream of the pump 258 in the flow direction to measure, for example, fluid pressure or fluid flow rate, which value can be used to regulate the pump 258 using the external controller 400.
[0123] A further option for a positive displacement pump is shown on the basis of Figures 9a) and 9b). The pump 258 integrated into the adapter plate 200 is a peristaltic pump. The peristaltic pump is preferably arranged in the connecting channel region 220 for the reasons already mentioned above.
[0124] A peristaltic pump (also called a hose pump) is a positive displacement pump in which the fluid to be transported is forced through the hose 268 by mechanical deformation external to the hose 268. In this example, the hose 268 therefore forms part of the connecting channel region 220 through which the fluid enters the adapter plate 200. The region in which the hose 268 is arranged is circular, i.e., the connecting channel region 220 extends in an arc shape. A rotor 270 is arranged in the circular section of the connecting channel region 220 and is rotatably arranged in the circular section.
[0125] The rotor 270 is preferably formed as a round, circular plate. At least one roller 274 and / or one sliding block are arranged on the upper surface 272 of the rotor 270. The hose 268 is at least partially positioned on the covering surface of the circular section of the connecting channel region 220. The hose 268 can be clamped from the inside by the roller 274 and / or sliding block upon rotation of the rotor 270. This causes the clamped location to move along the hose 268, thus having the effect of moving the conveyed fluid forward. As shown in FIGS. 9a and 9b, the rotor 270 can be rotated by a gear mechanism 276. As described in the above embodiment, at least one adapter plate sensor 228 can be arranged on the adapter plate 200. The gear mechanism 276 can be controlled, in particular, by an external control device 400, preferably using an actuator. In this case, control commands from the external controller 400 are based at least in part on measurements of at least one adapter plate sensor 228 and / or at least one processing unit sensor 36 in the processing system 100 .
[0126] Further notes regarding the above-described embodiment are as follows.
[0127] An adapter plate 200 for coupling to a processing unit group 11 is described in various embodiments. However, it is noted that the description applies equally to embodiments in which only a first processing unit 30 and / or a second processing unit 32 are provided.
[0128] The illustrated processing system 100 shows one adapter plate 200 for each of the processing unit groups 11. However, the processing system 100 can include multiple adapter plates 200. The processing unit groups 11 connected by the adapter plates 200 are always shown here as a first processing unit group 13 and a second processing unit group 15, but the above description applies correspondingly to any connection between two processing unit groups 11. The same applies to the processing units 10 connected by the adapter plates 200 or to individual processing units 10 connected to the processing unit groups 11.
[0129] The above-described embodiment describes the pump 258 in the adapter plate 200 as a means for adjusting the pressure of the fluid stream 14. Instead of or in addition to the pump 258, at least one valve can be disposed in the adapter channel 214. The valve is designed to throttle or change the cross-sectional size of the adapter channel 214 to adjust the pressure of the fluid stream 14. The valve can be controlled by an external controller 400. The control signal is based, inter alia, on measured pressure parameters measured by at least one adapter plate sensor 228 and / or processing unit sensor 36.
[0130] The above-described embodiment of the pump 258 in the adapter plate 200 may alternatively be configured as a compressed air pump, preferably with at least one membrane that moves up and down to move the fluid in the flow direction.
[0131] The valves described above can essentially be electrically, mechanically, pneumatically or hydraulically actuated.
[0132] It is also noted that although the adapter plate 200 is shown formed in two pieces, it is envisioned that it could also be formed as a single piece.
[0133] The above description describes the use of the processing system 100 or adapter plate 200 with biopharmaceuticals, however, the principles illustrated can also be applied to other processes such as food processing, chemical manufacturing processes, beverage filtration, particle fractionation, wastewater treatment, etc.
[0134] It is particularly noted that in the described embodiment, the adapter plates 200 are directly coupled to the respective second processing units 32, i.e., no further elements are arranged in between. However, it is possible to connect the adapter plates 200 to the second processing units 32 using compatible connectors. The compatible connectors are preferably made sterile and / or leak-proof. A tank or other component may also be arranged in between.
[0135] The adapter plate 200 can also be arranged upstream and / or downstream of the last processing unit 10 of the processing system 100. In particular, the filter cassettes "Sartoclear™ Depth Filter Cassettes" and / or filter cassettes "Sartoclear™ DL Series" and / or filter cassettes "Sartoclear™ S Series" by Sartorius Stedim Biotech GmbH can be used as one or more processing units 10.
[0136] The various embodiments of the processing system 100 or adapter plate 200 have been described separately based on the individual figures. However, it should be noted that the individual embodiments or parts of the individual embodiments can be combined with each other. To avoid repetition, elements already described with respect to the individual embodiments will not be described again.
[0137] Signal transmission in processing system 100 will now be described.
[0138] As already discussed in detail above, the at least one adapter plate 200 and / or the at least one processing unit 10 each include at least one sensor that 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 controller 400 by a cable or wirelessly so that measurements of the at least one sensor can be transmitted to the external controller 400.
[0139] FIG. 10a) shows a processing unit 10 in which a processing unit sensor 36 is provided or incorporated.
[0140] The processing unit sensor 36, for example, measures the pressure of the fluid stream 14 before the fluid contacts the filter media 16. As a result, it is possible to monitor whether the fluid stream 14 has sufficient pressure so that satisfactory filtration performance can be achieved.
[0141] The processing unit 10 comprises at least one processing unit transponder 38 arranged in or on the processing unit 10. FIG. 10a) shows an example of a processing unit transponder 38 arranged on the processing unit 10. The processing unit transponder 38 is coupled to the processing unit sensor 36 by cable, wirelessly, or optically and receives measurement data from the processing unit sensor 36. The measurement data is transmitted, inter alia, with the unique address of the processing unit sensor 36, thereby allowing the measurement data to be unambiguously assigned to the sensor. These data are transmitted wirelessly from the processing unit transponder 38 to an external control device 400. The transmission is preferably automatic.
[0142] The processing unit transponder 36 may be configured as a passive transponder, preferably a "Radio Frequency Identification Device" (RFID), or as an active transponder with its own power source. To this end, the processing unit transponder 36 is equipped with a rechargeable battery or is connected to an external power source. The processing unit transponder 36 may in particular use the "Near Field Communication" (NFC) data transmission standard.
[0143] Preferably, the data can be transmitted via WiFi, Bluetooth and / or mobile radio standards (LTE, 5G, GSM, etc.).
[0144] If the processing unit 10 comprises multiple processing unit sensors 36, all or at least some of the processing unit sensors 36 may use one processing unit transponder 38 to transmit measurement data to the external control device 400. Alternatively, the processing unit sensors 36 may be equipped with integrated transponders such that each processing unit sensor 36 has its own transponder.
[0145] The use of a transponder for wireless data transmission of sensor data to an external control device 400 has been discussed with respect to a processing unit 10 for illustrative purposes. If the processing system 100 includes multiple processing units 10, each including at least one processing unit sensor 36, then the multiple processing units 10, or at least some of them, may jointly use a single processing unit transponder 38 for data transmission. The jointly used processing unit transponder 38 may be located within or on one of the multiple processing units 10, or may be formed as an external unit.
[0146] It should be noted that the use of at least one transponder for wireless data transmission is described herein with respect to at least one processing unit for illustrative purposes. However, the at least one transponder may also be used in conjunction with at least one adapter plate sensor 228 in at least one adapter plate 200. Alternatively, at least one processing unit sensor 36 and at least one adapter plate sensor 228 may share a single transponder. The transponder may be located in or on the processing unit 10, on the adapter plate 200, or as an external device.
[0147] FIG. 10 b) shows an embodiment of the processing system 100 with data transmission from at least one sensor to an external controller 400 using a cable.
[0148] 10b) particularly illustrates a processing system 100 comprising two processing unit groups 11 coupled by an adapter plate 200. For illustrative purposes, two of the processing units 10 are equipped with processing unit sensors 36, and the adapter plate 200 is equipped with an adapter plate sensor 228. However, as already mentioned above, the number of processing units 10 and the number of adapter plates 200 are both variable. Furthermore, the number and location of sensors in the processing system 100 are variable based on the above description of other embodiments.
[0149] In this case, the individual sensors 228, 36 are coupled to an external control device 400 by means of a bus system 300. The bus system 300 preferably comprises at least one bus conductor that runs along at least one processing unit 10 and at least one adapter plate 200. The individual sensors 228, 36 of the processing system 100 are coupled to at least one bus conductor by means of cables 302. For this purpose, all sensors 228, 36 can be coupled to separate bus conductors, or several sensors 228, 36 can use the same bus conductor. In particular, the cables 302 of several sensors 228, 36 integrated into a processing unit 10 or adapter plate 200 can be initially combined in the processing unit 10 or adapter plate 200, with only one cable 302 leading out from the processing unit 10 or adapter plate 200 and then coupled to the bus conductor. Measurement data of the sensors 228, 36 are transmitted according to wireless data transmission as described with reference to FIG. 10a) and analyzed by the external control device 400.
[0150] The bus conductors may preferably be arranged in at least one rail that is led along the at least one processing unit 10 and the at least one adapter plate 200 .
[0151] The sensors 228, 36 can be equipped with rechargeable batteries that provide the sensors 228, 36 with the power they require during operation. Alternatively, each individual sensor 228, 36 can be powered by an external power source. For this purpose, at least one cable required to power the sensors 228, 36 can be routed within the rails described above and then coupled to the individual sensors 228, 36. When multiple sensors 228, 36 are positioned in the processing unit 10 or the adapter plate 200, it is preferable that one mains power cable protrudes from each of the processing unit 10 and the adapter plate 200 and then be coupled to a mains cable routed within the rails of the bus system 300, for example. The mains power cable is connected to the individual sensors 228, 36 in the processing unit 10 or the adapter plate 200. Thus, the user can power the sensors 228, 36 in just a few steps.
[0152] Alternatively, at least one processing unit 10 and at least one adapter plate 200 have an integrated power supply. For this purpose, at least one processing unit 10 and at least one adapter plate 200 are each integrated with at least a subsection of a power supply conductor. The subsections of the power supply conductor can be connected to each other as soon as the individual components (processing unit, adapter plate) are joined. The power supply conductor is powered at a single point by an external power source. The individual sensors 228, 38 are connected to the power supply conductor. One of the termination brackets 34 that holds the processing unit 10 and the adapter plate 200 in a sandwich-like manner preferably also includes a subsection of the power supply conductor, and the external power source is connected to the subsection of the power supply conductor within the termination bracket 34.
[0153] The power supply has been described above with respect to the sensors 228, 36 of the processing system 100 strictly for purposes of illustration. However, it is noted that all other elements of the processing system 100 that require power may also have rechargeable batteries or be powered using any of the cabled power options described above. To this end, reference is made, for example, to the actuator of the deflection member, the pump 258, or at least one valve controlling the pressure within the adapter plate 200.
[0154] For this purpose, the bus system 300 can also be used to transmit control commands from an external control device 400 to individual components in the adapter plate 200, such as actuators or deflection members, at least one valve for pressure control, or the pump 258. For this purpose, at least one control bus conductor is provided in the bus system 300, allowing data to be transmitted from the external control device 400 to the controlled elements. For this purpose, any of the controlled elements can be directly coupled to a separate or common control bus conductor. Alternatively, main data conductors can be led into the adapter plate 200, for example from corresponding control bus conductors, where they split off and connect to the individual components to be controlled.
[0155] As an alternative to transmitting data using cables, control signals can be transmitted wirelessly, as previously described with respect to data transmission between sensors 228, 36 and in external controller 400. To this end, external controller 400 can have its own transponder that transmits control commands to corresponding components in processing system 100 that facilitate regulating fluid flow 14.
[0156] Thus, the treatment system 100 of the present invention provides several advantages. First, at least one sensor 228, 36 is integrated into the treatment system 100, eliminating the need for careful connection, calibration, and sterilization of the sensor 228, 36. Furthermore, the treatment system 100 includes only one external controller 400, which simultaneously collects measurement data from the sensors 228, 36 and uses the measurement data to regulate the fluid flow 14. This means that the user has only one point of contact to simultaneously monitor and regulate the treatment system 100.
[0157] Furthermore, data transmission is provided in a simple manner for the user. Both wireless and cable-based data transmission between the external controller 400 and the individual components of the processing system 100 that communicate with the external controller 400 can be provided in a simple and fast manner. Complicated cable connections are avoided. As a result, a compact and easy-to-use processing system 100 is provided. [Explanation of symbols]
[0158] 10 Processing Unit 11 Processing Units 12 Processing housing 13 First Processing Unit Group 14 Fluid flow 15 Second Processing Unit Group 16 Filter media 17 Filter Carrier 18 Filtrate side 19 Free Space 20 Retentate side 21 Bulk materials 22 Upper end of processing housing 24 Inlet Channel 26 Exit Channel 27 Second Exit 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 cartridges 42 first side of filter cartridge 44 Second side of filter cartridge 46 Filter cartridge valve 100 Processing Systems 200 Adapter Plate 202 first entrance opening 204 Lower end of adapter plate 206 Second entrance opening 208 Upper end of adapter plate 210 first exit opening 212 Second Exit Opening 214 Adapter Channel 216 First channel region 218 Second channel region 220 Connection Channel Area 222 Deflector valve 224 First deflector valve 226 Second deflector valve 228 Adapter Plate Sensor 230 Entrance Plate 234 Channel recess 236 Flow Web 238 connection channels 240 Auxiliary branch 242 Channel member 244 Auxiliary entrances or exits 246 Multi-way valve 248 Valve Pipe 250 Valve pipe coating surface 252 Valve opening 254 Actuating Arm 257 Deflection Actuator 258 Pump 260 piston 262 cylinders 264 Inlet valve 266 Outlet Valve 268 Hose 270 rotor 272 Top of rotor 274 Roller 276 Gear Mechanism 278 Static Mixer 300 Bus System 302 Cable 400 External control device HR horizontal direction VR vertical direction
Claims
1. A modular processing system (100) for biopharmaceutical and / or chemical processes, comprising: at least one processing unit (10) for carrying out a filtration or chromatography step in a biopharmaceutical or chemical process; at least one adapter plate (200) fluidly connected directly or indirectly to said processing unit (10), said adapter plate having at least one adapter channel (214) through which at least one fluid stream (14) flowing to said processing unit (10) can pass, said at least one adapter plate (200) further comprising at least one deflector and / or pump (258) and / or at least one valve formed as a multi-way valve; end brackets (34) between which the at least one processing unit (10) and the at least one adapter plate (200) are held in a sandwich fashion; An external control device (400); Equipped with the adapter plate (200) is designed such that the fluid flow (14) to the processing unit (10) can be at least partially deflected by the at least one deflection member formed as a multi-way valve in the adapter channel (214) and / or the fluid flow (14) can be controlled by the at least one valve in the adapter channel (214) and / or the pump (258); at least one sensor (36, 228) is incorporated into the processing unit (10) and / or the adapter plate (200) for detecting at least one property of the fluid flow (14) in the processing unit (10) or the adapter plate (200); the at least one deflection member and / or the pump (258) and / or the at least one valve formed as a multi-way valve are controllable by an actuator (257); The external control device (400) is coupled to at least one sensor (36, 228) so as to be able to read out measurement data from the at least one sensor (36, 228), and the external control device (400) controls the actuators (257) so that the fluid flow (14) in the processing unit (10) and / or the adapter plate (200) can be centrally controlled by the external control device (400) based on the read-out measurement data.
2. The adapter plate (200) the fluid flow (14) to the processing unit (10) can be at least partially deflected by the at least one deflection element formed as a multi-way valve in the adapter channel (214) and / or the pressure of the fluid flow (14) is designed to be controllable by the at least one valve in the adapter channel (214) and / or the pump (258). The modular processing system of claim 1 .
3. 3. A modular treatment system (100) according to claim 1 or 2, comprising at least a first treatment unit (30) and a second treatment unit (32) fluidly connected to each other, At least one fluid stream (14) flowing 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); a first processing unit (30) and a second processing unit (32) connected to the adapter plate (200); a first processing unit (30) connected to the adapter plate (200); a second processing unit (32) connected to the adapter plate (200); a second processing unit (32) connected to the adapter plate (200); a second processing unit (32) connected to the adapter plate (200);
4. The adapter plate (200) the fluid flow (14) between the first processing unit (30) and the second processing unit (32) can be at least partially deflected by the at least one deflection member formed as a multi-way valve in the adapter channel (214), and the pressure of the fluid flow (14) is designed to be controllable by the at least one valve in the adapter channel (214) and / or the pump (258). The modular processing system of claim 3 .
5. 5. The modular processing system (100) of claim 1, wherein at least one sensor (36, 228) is incorporated into the first and second processing units (30) and the adapter plate (200) to detect at least one property of the fluid flow (14) in the first and second processing units (30) and the adapter plate (200), respectively.
6. 6. The modular processing system (100) of claim 5, wherein the external control device (400) is coupled to the sensors (36, 228) such that the external control device (400) can read measurement data from the sensors (36, 228) and the fluid flow (14) in the processing unit (30, 32) and the adapter plate (200) can be centrally controlled by the external control device (400) based on the read measurement data.
7. 7. The modular processing system (10) according to any one of claims 1 to 6, wherein the at least one processing unit (10) and / or the adapter plate (200) each comprise at least one transponder (38) designed to transmit measurement data of a corresponding sensor (36, 228) to the external control device (400), or A modular processing system, 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) by means of a bus system (300).
8. 8. The modular treatment system (100) of claim 1, wherein the sensor (36, 228) is configured to measure pressure, volumetric flow rate, UV value, pH value, turbidity, and / or viscosity of the fluid flow (14).
9. 9. The modular treatment system (100) of claim 1, wherein the at least one sensor (36, 228), the at least one deflection member formed as a multi-way valve, the at least one valve, and / or the pump (258) each comprise a rechargeable battery.
10. 10. The modular treatment system (100) of claim 1, wherein the at least one sensor (36, 228), the at least one deflection member formed as a multi-way valve, the at least one valve, and / or the pump (258) are provided with a power supply via a cable.
11. 11. The modular treatment system (100) of claim 10, comprising a central power supply for the at least one sensor (36, 228), the at least one deflection member formed as a multi-way valve, the at least one valve, and / or the pump (258); A modular processing system, wherein the at least one processing unit (10) and the at least one adapter plate (200) comprise subsections of the power supply that, when assembled, form the central power supply.
12. 12. The modular treatment system (100) of claim 1, wherein the at least one sensor (36, 228), the at least one deflection member formed as a multi-way valve, the at least one valve, and the pump (258) are formed as single-use components.
13. 1. A method for centrally controlling a modular processing system (100) for biopharmaceutical and / or chemical processes, comprising: providing at least one processing unit (10) for carrying out a filtration or chromatography step in a biopharmaceutical or chemical process; providing at least one adapter plate (200) that may have at least one adapter channel (214) through which at least one fluid stream (14) can flow, said adapter plate (200) further comprising at least one deflection member and / or pump (258) and / or at least one valve formed as a multi-way valve, said at least one deflection member and / or pump (258) and / or said at least one valve formed as a multi-way valve being controllable by an actuator (257); Providing an external control device (400); connecting the adapter plate (200) directly or indirectly to the processing unit (10) so that the fluid flow (14) can flow from the adapter plate (200) to the processing unit (10); providing end brackets (34) and positioning the at least one processing unit (10) and the at least one adapter plate (200) such that the at least one processing unit (10) and the at least one adapter plate (200) are held between the end brackets (34) in a sandwich manner; detecting at least one property of the fluid flow (14) in the processing unit (10) and / or the adapter plate (200) using at least one sensor (36, 228) integrated into the processing unit (10) and / or the adapter plate (200); coupling the external control device (400) to the at least one sensor (36, 228) so as to be able to read measurement data from the at least one sensor (36, 228); coupling an external control device (400) to the at least one deflector and / or the pump (258) and / or the at least one valve formed as a multi-way valve in the adapter plate (200) so that the external control device (400) can control the actuator (257) so that the fluid flow (14) in the processing unit (10) and / or in the adapter plate (200) can be centrally controlled by the external control device (400) based on the read-out measurement data; Including, the fluid flow (14) is at least partially deflected using the at least one deflection member formed as a multi-way valve in the adapter channel (214); and / or The method, wherein the fluid flow (14) can be regulated using the at least one valve in the adapter channel (214) and / or the pump (258).
14. 14. The method of claim 13, wherein the pressure of the fluid flow (14) can be adjusted using the at least one valve in the adapter channel (214) and / or the pump (258).
15. The processing system (100) comprises at least one first processing unit (30) and a second processing unit (32); 15. The method of claim 13 or 14, wherein the first treatment unit (30) and the second treatment unit (32) are coupled to each other by the adapter plate (200) so that the fluid flow (14) can flow from the first treatment unit (30) to the second treatment unit (32).
16. At least one sensor (36, 228) is respectively incorporated into the first processing unit (30) and the second processing unit (32) and into the adapter plate (200); the sensor (36, 228) detects at least one property of the fluid flow (14) in the first processing unit (30), the second processing unit (32) and the adapter plate (200); 16. The method of claim 15, wherein the sensors are coupled to an external control device such that measurement data of the sensors can be read out and the processing unit and the fluid flow in the adapter plate can be centrally controlled by the external control device based on the read-out measurement data.
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