Bioprocessing system for operating a bioprocess having a display device for displaying system information relating to the bioprocessing system - Patent Application 20070122999

Abstract

The present invention relates to a bioprocessing system for bioprocessing operations, the bioprocessing system having a display device (21) for displaying system information related to the bioprocessing system (1), the bioprocessing system (1) comprising a system component (6) having at least one monitored system component (22), the system component (6) being capable of being assembled into an assembled state in which the bioprocessing system (1) is operable for bioprocessing operations and disassembled into a disassembled state in which the bioprocessing system (1) is not operable for bioprocessing operations, the bioprocessing system (1) comprising a controller (24), the display device (21) comprising at least one display component (25), during bioprocessing operations, in the assembled state of the bioprocessing system (1), the controller (24) displays process information via the display device (21), and / or during assembly of the bioprocessing system (1), the control device (24) displays assembly information via the display device (21), the process information and / or assembly information relating to at least the monitored system component (22), and the display device (21) comprising at least one display component (25). It is proposed that the display component (25) is arranged separately from the monitored system component (22) and comprises a light emitting element (27) arranged next to or on the monitored system component (22), and that the control device (24) is configured to display process information and / or assembly information relating to the monitored system component (22) via the light emitting element (27).

Description

[Technical Field]

[0001] The present invention relates to a bioprocessing system for operating a bioprocess as set forth in the general part of claim 1, wherein the bioprocessing system has a display device for displaying system information related to the bioprocessing system, to a bioprocessing system component as set forth in claim 14, to the use of a bioprocessing system component as set forth in claim 15, to the use of a display component as set forth in claim 16, to a control device as set forth in claim 17, and to a method as set forth in claim 19.

[0002] Bioprocessing systems, such as bioreactors, clarification setups, chromatography setups, filtration setups, and especially combinations thereof, often comprise several system components, such as sensors, tubing, receptacles, etc. These system components can be divided into single-use and multi-use components. Setting up such a bioprocessing system to be used for a bioprocessing operation can involve several work steps of assembling different components by connecting tubing, clamps, inlets / outlets, placing and calibrating sensors, etc. These work steps are prone to errors. Detecting such assembly errors may be possible electronically; for example, an incorrectly connected sensor may be detected. However, the time spent, for example, reviewing the user interface of an electronic process controller to find an error is also time-consuming. Furthermore, an inexperienced user may have to check the manual or user interface several times to correctly place and connect all the components.

[0003] Now, a bioprocess can be any kind of process that uses biological materials, particularly cells or their components such as bacteria, enzymes, chloroplasts, etc., to produce a product.

[0004] During the use of a bioprocessing system for bioprocessing operations, numerous warnings and errors may occur. Often, they are displayed on the user interface. Depending on the size of the bioprocessing system, locating each system component associated with the warning or error, visually inspecting the component, rechecking the user interface, and then possibly taking action can be a tedious process involving multiple trips between the bioprocessing system and the electronic process controller with the user interface. Furthermore, critical situations may arise that require rapid understanding of the situation and rapid reaction.

[0005] Modifying a bioprocessing system, especially a single-use system component, may involve disassembling and reassembling parts of the bioprocessing system, a process that may also involve multiple visits to the user interface and / or manuals, etc.

[0006] Visual feedback regarding actions taken and / or the status of a bioprocessing system is often limited to the user interface of an electronic process controller, which may be located remotely from the respective system component to which the feedback pertains.

[0007] From WO 2016 / 090113 it is known to use projectors to show images of system components during the assembly and detection of correct alignment of a bioprocessing system, which are expensive, complex, require combination with a camera for feedback and lack flexibility.

[0008] It is also known to check whether single use components are connected correctly and provide feedback via LED elements in smart clamps (GB2549190), however the use case for this idea is limited to systems that have smart clamps and check the assembly of these clamps.

[0009] The challenge is to improve the known prior art in a way that allows easier control of the assembly and / or process conditions of the bioprocessing system.

[0010] The present invention is based on the problem of improving known bioprocessing systems to reach further optimization with respect to a specified task.

[0011] The above-mentioned object is solved by the features of the characterizing part of claim 1.

[0012] A key realization of the present invention is that it proposes a highly flexible and inexpensive way to provide a graphical user interface directly on or next to a bioprocessing system by placing light-emitting elements next to the system components. Preferably, multi-use light-emitting elements are placed next to single-use system components and can display assembly and / or process information related to the single-use components. They can also be used for multi-use components, for different components in different use cases, and even flexibly repositioned to suit different bioprocessing systems or bioprocessing operations. In this way, the bioprocessing system itself becomes a graphical user interface, significantly reducing the time and / or cost overhead for locating the source of warnings or errors and also improving the ease of use of the system during assembly. The same light-emitting elements can be used to visualize correct or incorrect assembly of system components and process conditions, such as undesired overpressure during a bioprocessing operation.

[0013] In particular, it is proposed that the display component is arranged separately from the monitored system component and comprises a light-emitting element arranged next to or on the monitored system component, and that the control device is configured to display process information and / or assembly information relating to the monitored system component via the light-emitting element.

[0014] A highly preferred embodiment of claim 2 relates to LEDs as light-emitting elements and / or LED stripes with light-emitting elements. LEDs are inexpensive and simple light-emitting elements with suitable possibilities for encoding information into color, brightness, flashing frequency, and / or spatial movement of color, for example, along the LED stripe. LEDs can be easily connected by a layperson or integrated into system components by manufacturers. The resulting flexibility facilitates the manufacturer and / or user to configure the display device as needed. The display device also enables a cost-effective approach to displaying moderate amounts of information on or next to system components. All descriptions given regarding LEDs are applicable to other types of light-emitting elements. In particular, the LEDs can be OLEDs.

[0015] According to claim 3, multiple display components and / or light emitting elements may be paired with multiple system components, thereby enabling the display of process and / or assembly information for multiple components using the display device.

[0016] Claim 4 relates to preferred monitored system components where assembly and / or process information can be displayed via light emitting elements. This is particularly important for components that have to be assembled and disassembled, possibly multiple times, for example when changing single-use components, as these work steps are error-prone and time consuming.

[0017] A preferred embodiment as defined in claim 5 is directed to a display component extending along the monitored system component. When a monitored system component, such as a tube, has a longitudinal extension and the display component is located along that extension, the displayed information is particularly well adapted to the monitored system component. For example, an LED stripe may extend along the tube, thereby displaying process information along the tube and making it very easy to identify the cause or location of an alarm or the like. Furthermore, when a tube is changed, the LED stripe may indicate where the new tube should be located, facilitating replacement.

[0018] According to a preferred embodiment as set forth in claim 6, for example when using the bioprocessing system for different consecutive bioprocessing operations, a single-use component can be replaced and the replacement single-use component can be assigned to the same display component, thereby allowing the successive use of the replaced single-use component and the replacement single-use component.

[0019] Claim 7 relates to an embodiment in which the display component is located behind a transparent system component. In this way, the display component does not interfere with handling of the system component.

[0020] When a bioprocessing system combines multiple-use and single-use system components, the single-use system components may have defined positions on the multiple-use system components. These positions may also depend on the respective bioprocessing operations. For example, there may be fixtures for single-use tubes provided on the multiple-use system components, and these tubes may be assembled to the multiple-use system components as needed. According to claim 8, the display component may also have a fixed position on the multiple-use system component, and in particular may be assembled to the multiple-use system component.

[0021] Claim 9 relates to preferred embodiments of the assembly information, which can in particular be based on sensor values. Claim 10 relates to preferred embodiments of the processing information.

[0022] The display component can display different states of monitored system components, such as valves (claim 11). In the valve example, it becomes easy to track which fluid paths in a bioprocessing system are active, simplifying system analysis.

[0023] In another preferred embodiment as defined in claim 12, the display device is user configurable, thereby allowing the display device to be adapted to different assembly variants of the bioprocessing system, to different bioprocessing operations and also to user preferences.

[0024] According to claim 13, the display device is also flexible with regard to the position of the display components, which allows for even greater flexibility.

[0025] Another teaching of equal importance, as set forth in claim 14, relates to a bioprocessing system component.

[0026] All descriptions given regarding the proposed bioprocessing system are fully applicable.

[0027] Another teaching of equal importance, as set forth in claim 15, relates to the use of a bioprocessing system component.

[0028] All descriptions provided regarding the proposed bioprocessing system and the proposed bioprocessing system components are fully applicable.

[0029] Another teaching of equal importance, as set forth in claim 16, relates to the use of a display component within the proposed bioprocessing system.

[0030] All descriptions provided regarding the proposed bioprocessing system, the proposed bioprocessing system components, and the proposed use of the display components are fully applicable.

[0031] Another teaching of equal importance, as set forth in claim 17, relates to a control device for use within the proposed bioprocessing system.

[0032] All descriptions provided regarding the proposed bioprocessing system, the proposed bioprocessing system components, the proposed use of the display components, and the proposed use of the controller are fully applicable.

[0033] In a preferred embodiment as claimed in claim 18, the control device is an electronic process controller for controlling a bioprocessing system. This electronic process controller often already contains assembly and / or process information. In that case, the display device can be used as an extended user interface for the electronic process controller.

[0034] Another teaching of equal importance, as set forth in claim 19, relates to a method of operating the proposed bioprocessing system, wherein the controller displays process and / or assembly information regarding monitored system components via light-emitting elements.

[0035] All descriptions provided regarding the proposed bioprocessing system, the proposed bioprocessing system components, the proposed use of the display components, and the proposed use of the controller, as well as the proposed controller, are fully applicable.

[0036] In the following, embodiments of the invention will be described with reference to the drawings. [Brief explanation of the drawings]

[0037] [Figure 1] 1 is an exemplary diagram illustrating a bioprocessing system in accordance with one embodiment of the present invention. [Figure 2] 1 shows an exemplary diagram of another bioprocessing system in accordance with an embodiment of the present invention. [Figure 3] 1 illustrates exemplary display components of the present invention in different combinations.

[0038] The proposed bioprocessing system 1 can be used to perform a bioprocessing operation. Thus, the term "bioprocessing system" currently refers to one or more functional units used in a bioprocess to perform a bioprocessing operation. A bioprocessing operation can include one or more specific steps of a bioprocess.

[0039] The term "bioprocess" currently refers to any type of biotechnological process, particularly a biopharmaceutical process. Examples of such bioprocesses include the production of bioproducts, preferably monoclonal antibodies, viral vectors, antibody-drug conjugates, small molecules, or vaccines. The proposed solution can also be used for other bioprocesses on plant materials, food, and the like. One focus is on toxic substances, as the proposed solution allows for remote analysis of the bioprocess and the identification of potentially erroneous system components. Such a bioprocess may include a bioreactor 2, in which a bioprocess operation or step "cultivation" may be performed to cultivate bacterial or mammalian cells under given conditions to produce a bioproduct. The exemplary bioprocess may further include a clarification unit, which may be used to perform a bioprocess operation or a step "clarification" used to separate cells from the bioproduct. Together, both may form a bioprocess system 1 for performing a bioprocess operation involving multiple steps. The exemplary bioprocess system 1 may further include a chromatography system 3 for performing a bioprocess operation or step "chromatography" to further purify the bioproduct.

[0040] A bioprocess may be carried out by only one bioprocess system 1, or may be carried out by two or more bioprocess systems 1. When a bioprocess is carried out by two or more bioprocess systems 1, a bioprocess system 1 may be fluidly connected to another bioprocess system 1, for example, by a liquid line 4. In this case, the liquid line 4, which may be, for example, a pipe or tube 5, may be assigned to one or both bioprocess systems 1.

[0041] 1 and 2 show two different bioprocessing systems 1 with their respective system components 6. A system component 6 may be the smallest functional unit of the bioprocessing system 1, such that each system component 6 can be assigned to at least one function, and / or may be composed of other system components 6 that are also complex system components 6. Any description given of a system component 6 may apply to the system component 6 that is the smallest functional unit and / or to the complex system component 6.

[0042] In FIG. 1 , bioprocessing system 1 includes a bioreactor 2 as a system component 6 that can be used to culture mammalian cells under defined conditions, for example, as described above. In addition to bioreactor 2, bioprocessing system 1 can include other system components 6, such as valves 7, sensors 8, ports, and fluid lines. Preferably, bioreactor 2 includes a single-use bag and a multi-use housing. The housing can be mounted on a platform 9. Bioreactor 2 preferably includes a liquid outlet port 10. Liquid outlet port 10 is connected to a liquid line 4 that can illustratively be used to transfer cell culture medium 11 from bioreactor 2 to a downstream bioprocessing system 1. Liquid line 4 can include a valve 7 for controlling the flow of cell culture medium 11 from bioreactor 2. Liquid flow F in liquid line 4 is indicated schematically by arrows. Liquid line 4 can be, for example, a flexible single-use tubing 5 that is replaced after the transfer is completed, or it can be a rigid pipe that remains fluidly connected to bioreactor 2.

[0043] The bioreactor 2 may also include several sensors 8 that may be used to monitor, and preferably control, the culture conditions within the bioreactor 2. As shown in Figure 1, the bioreactor 2 may include, for example, a pressure sensor 12 connected via a gas line 13 to a gas outlet port 14 of the bioreactor 2 to monitor the pressure within the bioreactor 2. Other sensors, shown only schematically at the bottom of the bioreactor 2 in Figure 1, include a temperature sensor, a dissolved oxygen sensor, a pH sensor, etc.

[0044] Another bioprocessing system 1 is shown in Figure 2. This bioprocessing system 1 can be, for example, a chromatography system 3 including a valve switching cassette 15 for performing simulated moving bed chromatography to purify a biological product in a liquid. The bioprocessing system 1 can include system components 6 such as the valve switching cassette 15 for directing a liquid flow F, a liquid pump 16 for supplying liquid, including the biological product, a wash solution, etc., to the valve switching cassette 15, and sensors 8, such as a liquid flow sensor 17 and an inductive sensor 18, for monitoring the liquid exiting the valve switching cassette 15.

[0045] An electronic process controller 19 is usually used to control each bioprocess operation performed by the bioprocess system 1. For this purpose, the sensor values ​​of each sensor 8 are monitored by the electronic process controller 19. By comparing the collected sensor values ​​with predetermined target values ​​and, inter alia, reacting if necessary, the bioprocess can be controlled. For example, the dissolved oxygen tension in the liquid can be monitored by each dissolved oxygen tension sensor. If the dissolved oxygen tension in the liquid falls below a predetermined threshold, the speed of the agitator 20 of the bioreactor 2 can be increased to increase the dissolved oxygen tension.

[0046] 1, the electronic process controller 19 may be located separately from the rest of the bioprocessing system 1. The electronic process controller 19 may or may not include a display, e.g., a screen, for displaying information regarding the current state of the bioprocessing system 1. However, as proposed, the current state of the bioprocessing system 1 may be displayed to a user by a display device 21, which may be directly connected to the bioprocessing system 1.

[0047] Before using the bioprocessing system 1, and during different stages of the bioprocessing operation, or for continuous bioprocessing operation, some system components 6 need to be changed and some, especially single-use components, need to be replaced. Assembly information, such as the correct placement of sensors 8, tubing 5, etc., can be displayed by the display device 21, as will be described in detail.

[0048] Here, preferably, the electronic process controller 19 is a single device and / or comprises cable-coupled or cableless connections to the fluid lines and / or pumps and / or sensors 8 and / or controls the actuators and / or valves 7 of the bioprocessing system 1 and / or comprises a display, in particular a touch display. The display of the electronic process controller 19 is not part of the proposed display device 21.

[0049] During bioprocess operation, process information such as sensor values, user notifications, and / or a virtual representation of the bioprocess system 1 may also be displayed by the electronic process controller 19.

[0050] A bioprocessing system 1 for operating a bioprocess is proposed, having a display device 21 for displaying system information relating to the bioprocessing system 1.

[0051] As described above, the bioprocessing system 1 includes system components 6 such as tubing 5, valves 7, sensors 8, etc. The system components 6 include at least one monitored system component 22 that is monitored, such as by an electronic process controller 19, preferably by monitoring sensor values ​​associated with the monitored system component 22, and about which information is displayed by the display device 12.

[0052] The system components 6 can be assembled into an assembled state in which the bioprocessing system 1 is operable for bioprocessing operations, and can be disassembled into a disassembled state in which the bioprocessing system 1 is not operable for bioprocessing operations. FIG. 1 illustrates an assembled state of the bioprocessing system 1. FIG. 2 illustrates different assembled states for different system components 6 of the chromatography system 3. The BioSMB system shown is merely an example; other bioprocessing systems 1 and other chromatography systems, such as any resolute flow drive system, can be used. Each of the exemplary assembled states is shown for a different liquid inlet line of the chromatography system 3. The illustrated chromatography system 3 illustratively includes seven liquid inlet lines, three of which are described in more detail below. In the illustrated embodiment, each liquid inlet line includes a liquid pump 16 and a liquid flow sensor 17. For each liquid inlet line, tubing 5, preferably single-use tubing, can be connected to the liquid pump 16 and liquid flow sensor 17 of the respective liquid inlet line. Each tube 5 may be used to guide a particular liquid (e.g., a buffer, a liquid containing a biological product, etc.) to a respective inlet port of the valve switching cassette 15. The direction of liquid flow F in the tubes 5 of the liquid inlet lines is indicated by arrows. In addition to the illustrated liquid inlet lines, the valve switching system 3 may include several liquid outlet lines, two of which are also shown schematically in FIG. 2. Each liquid outlet line may include a tube 5, preferably a single-use tube, that guides liquid exiting the valve switching cassette 15, preferably to a subsequent bioprocessing system 1. As shown in FIG. 2, at least one of the liquid outlet lines may include an inductive sensor 18, and the tube 5 of each liquid outlet line may be connected to the inductive sensor 18.

[0053] The disassembled state may be the state prior to adding single-use components, such as tubing 5, to multi-use components, such as liquid pump 16, of chromatography system 3. This disassembled state is exemplarily shown for first liquid inlet line 23 of chromatography system 3 shown in Figure 2. Here, tubing 5, and also the pump head of liquid pump 16, have not yet been installed.

[0054] The bioprocessing system 1 includes a controller 24. The display device 21 includes at least one display component 25. Most likely, the controller 24 will be an electronic process control 19 for controlling the bioprocessing system 1, for example, by actuating the valves 7, controlling the liquid flow F in the valve switching cassette 15, measuring sensor values, etc. The controller may also include or consist of an FPGA or discrete logic component. Preferably, the controller 21 includes a component having control software.

[0055] The controller 24 monitors the monitored system components 22, for example, by reading sensor values ​​associated with the monitored system components 22, and in particular by verifying whether the sensor values ​​are within acceptable ranges.

[0056] 1, the monitored system component 22 may be a bioreactor 2 that is allowed a certain maximum pressure, and the pressure may be measured by a pressure sensor 12 connected to the bioreactor 2. The pressure sensor may be connected to an electronic process controller 19, and the maximum pressure allowed may be defined by the electronic process controller 19.

[0057] In another example, shown for the fourth liquid inlet line 26 in FIG. 2, the monitored system component 22 may be a tube 5 having a certain maximum liquid flow F, which may be measured by a liquid flow F sensor 17 behind a liquid pump 16 that directly or indirectly supplies liquid to the tube 5.

[0058] In an assembled state of the bioprocessing system 1 during bioprocessing operation, the controller 24 displays process information via the display device 21. The process information can be any information related to the bioprocessing operation, such as a flow diagram, sensor values, warnings, errors, alerts, and / or next work steps. Preferably, the process information includes sensor values ​​from the sensors 8 of the bioprocessing system 1 and / or information derived from the sensor values, and may further include information provided to the controller 24 by a user. The process information may also include predictive information, in particular predictive information regarding predicted failures and / or modifications of the bioprocessing system 1. The process information may include information regarding the age of the monitored system components 22. In this way, the user may be instructed when to change the monitored system components 22, such as a filter.

[0059] Additionally or alternatively, during assembly of the bioprocessing system 1, the controller 24 displays assembly information via the display device 21. The assembly information preferably includes information regarding which monitored system components 22 should be connected to which other system components 6 and / or monitored system components 22, and / or where the monitored system components 22 should be located, and / or how and which sensors 8 should be configured and / or calibrated.

[0060] The process information and / or assembly information relates to at least the monitored system component 22 .

[0061] Display device 21 includes at least one display component 25, which is described in more detail below.

[0062] It is essential that the display component 25 is located separately from the monitored system component 22 and comprises a light-emitting element 27 located next to or on the monitored system component 22, and that the control device 24 is configured to display process information and / or assembly information relating to the monitored system component 22 via the light-emitting element 27.

[0063] The term "separate" means that the light emitting element 27 and the display component 25 are not part of the monitored system component 22. The light emitting element 27 being separate from the monitored system component 22 may further mean that the light emitting element 27 and / or the display component 25 have their own energy supply and / or that the light emitting element 27 and / or the display component 25 have their own connection to the controller 24, and / or that the light emitting element 27 and / or the display component 25 are mounted physically separate from the monitored system component 22 or are mounted to the monitored system component 22 but can be handled separately from the monitored system component 22. Preferably, all of these features apply; however, for example, the light emitting element 27 and / or the display component 25 may also be plugged into a socket in the monitored system component 22 for its energy supply and / or connection to the controller 24 while still being separately handleable. In particular, an LED or a display that is part of the (multiple-use) system component 6 should also not be considered to be located separately from the (multiple-use) system component 6. As a result, the display component 25 is also located separately from the monitored system component 22 .

[0064] The light emitting elements 27 and / or the display component 25 are not part of a complex display, in particular an LED screen. Preferably, the display component 25 comprises up to 1000 light emitting elements 27, preferably up to 500, more preferably up to 250 light emitting elements 27. The display component 25 may comprise up to one light emitting element 27 per square mm or per square cm. Preferably, the display component 25 is not adapted to display longer text, images, etc. The minimum distance between at least two, preferably at least three, more preferably at least ten neighboring light emitting elements 27, in particular LEDs 28, may be at least 0.5 mm, preferably at least 1 mm, more preferably at least 2 mm, more preferably at least 5 mm between each of the respective neighboring light emitting elements 27.

[0065] According to one embodiment, it is proposed that the display component 25 is an LED stripe 29 comprising a plurality of LEDs 28 as light emitting elements 27. The one or more light emitting elements 27 can be one or more LEDs 28 respectively.

[0066] To keep display device 21 simple and to convey information to the user in an easily accessible manner, process and / or assembly information is preferably encoded into the color and / or brightness and / or pattern of one or more light emitting elements 27. In particular, there may be cases where process and / or assembly information is encoded into the light of a single light emitting element 27. The information may be replicated by other light emitting elements 27, but preferably be as simple as a single color.

[0067] Figure 1 shows multiple LED stripes 29 attached to and located next to different monitored system components 22. As shown in Figure 3, the LED stripe 29 comprises multiple LEDs 28 at least loosely arranged in a row along a longitudinal extension 30 of the LED stripe 29. Preferably, the LED stripe 29 comprises up to 10 rows of LEDs 28 adjacent to one another, preferably up to 3 rows of LEDs 28, more preferably a single row of LEDs 28.

[0068] Display component 25 in general, and LED stripe 29 in particular, may preferably be modular components that can be attached to and detached from monitored system component 22. The modules may be manageable as such and may comprise a control unit, e.g., a microprocessor, and / or cables and / or plugs for energy and / or control signals and / or batteries. Display component modules 31 may be connectable to other display component modules 31, preferably by plug-and-socket connections, and energy and / or control signals may be passed from one display component module 31 to the next, allowing for a simple modular design of display device 21 from modules, as shown for example for second liquid inlet line 32 in FIG. 2.

[0069] All LEDs 28 on one LED stripe 29 are connected to one another by at least having a common carrier, such as a plastic stripe on which the LEDs 28 are arranged. The LED stripe 29, together with a power supply and / or control unit, can be part of a display component module 31. The power supply can include a transformer located on the carrier of the LED stripe 29 or external to the LED stripe 29 of the display component module 31. For example, if the system component 6 has a 2.6V output, a transformer or other electronics, including more than a cable-connector, is not required for power supply. In general, the display component module 31 can be treated and used as such, and LED stripes 29 that do not form a display component module 31 may need to be connected to a control unit. The display component module 31 is a plug-and-play component. The display component module 31 can include multiple LED stripes 29, also connected by connectors 33. Thus, it is possible to connect multiple LED stripes 29 to form a single display component module 31 and / or to connect multiple display component modules 31. The same is true for other display components 25.

[0070] When LED stripes 29 are used, the display component module 31 can be easily customized because a single, larger LED stripe 29 can be cut in place (as indicated by the scissors and dashed lines in FIG. 3a). Different types of connectors 33, some of which are illustratively shown in FIGS. 3b-3d, can be used to flexibly connect a single LED stripe 29. In this manner, groups of display components 25 with different shapes can be realized. As illustratively shown in FIGS. 1 and 2, the shape of the monitored system component 22 can be mimicked by the display component 25. This simplifies identification of a particular monitored system component 22, because display component modules 31 for the same type of monitored system component 22 can have the same shape. This is illustratively shown for the monitored liquid pump 16 shown in FIG. 2.

[0071] A display component module 31 may be paired with each monitored system component 22 via controller 24. Additionally or alternatively, other display components 25 may be fixedly incorporated into multi-use system components 6, as shown in Figures 2A-A.

[0072] In particularly easy-to-handle embodiments, display component module 31 and / or display component 25 may include magnets and be attached to metal parts of system component 6 and / or monitored system component 22 via magnets. If system component 6 is not magnetic, counter magnets and / or magnetic materials placed behind respective parts of system component 6 may be used. In the embodiment shown in Figures 2A-A', display component 25 is located on system component 6, in this case chromatography system 3.

[0073] It may be the case that the control device 24 is configured to display process information and / or assembly information relating to at least two, preferably at least three, more preferably at least four different monitored system components 22, in particular different types of monitored system components 22, via at least two, preferably at least three, more preferably at least four light-emitting elements 27 of the at least one display component 25 and / or via at least two, preferably at least three, more preferably at least four display components 25 of the display device 21.

[0074] The display device 21 is preferably configured to display assembly and / or process information for two or more monitored system components 22. To that end, multiple light emitting elements 27 and / or multiple display components 25 may be used. Generally, a single or multiple light emitting elements 27 may display a single piece of information. For example, in FIG. 2, multiple light emitting elements 27 may be positioned along the tubes 5 of the bioprocessing system 1, illuminating green when the tubes 5 are operating as expected, illuminating yellow when the tubes 5 or tube segments have an associated warning, such as abnormal pressure, and illuminating red when the tubes 5 or tube segments have an associated error. This makes it particularly easy for a user to find problems directly in the bioprocessing system 1 without having to move their view back and forth between the tubes 5 and a fixed display positioned away from the tubes 5.

[0075] Here, preferably, each display component 25 and / or each light emitting element 27 is assigned to only one or two monitored system components 22 at a time. In general, reassignment is possible.

[0076] It should be noted that the different display components 25 are materially different from one another, and the LEDs 28 of the LED stripe 29 may be the proposed light emitting elements 27. It is possible for a monitored system component 22 to be paired with two or more light emitting elements 27 of the same or different display components 25, and for a display component 25 to be paired with two or more monitored system components 22. This is exemplarily shown in Figure 1, where a tube 5 representing one of the monitored system components 22 has three parallel display components 25 paired to it, in this case three different LED stripes 29.

[0077] Each monitored system component 22 may have associated therewith at least one or exactly one display component 25. Each display component 25 may be separately connected to the electronic process control 19 and / or separately powered.

[0078] However, additionally or alternatively, as shown for the second liquid inlet line 32 in FIG. 2, several display components 25 may be connected together such that they are connected to the electronic process control 19 together and / or powered together.

[0079] The term "at least one" can always be understood to mean preferably at least two, and more preferably at least three.

[0080] According to one embodiment, it is proposed that the at least one monitored system component 22 comprises at least one single-use component, and / or at least one multi-use component, and / or at least one component that normally contains, preferably conducts, fluid during bioprocess operation, and / or at least one sensor 8. The proposed solution allows for easy reuse of the light emitting element 27 and the display component 25 while discarding the single-use components.

[0081] Preferably, at least one monitored system component 22 comprises at least one tube 5, and / or at least one pipe, and / or at least one filter, and / or at least one bioreactor 2, and / or at least one clamp for connecting the tube 5 and / or pipe to other system components 6.

[0082] The term "normal" means during normal bioprocess operation, including predictable faults, etc. For example, a receptacle behind overpressure valve 7 would normally conduct or contain fluid, but electronic equipment with a water leak in it would not normally conduct or contain fluid.

[0083] According to one embodiment, it is proposed that at least one display component 25, in particular at least one LED stripe 29, is arranged with a longitudinal extension 30 so as to extend along at least one, in particular exactly one, monitored system component 22. The fourth liquid inlet line 26 in FIG. 2 exemplarily shows how the LED stripe 29 is integrated into the multiple-use system component 6 and is arranged behind the tube 5, thereby extending along the tube 5. The resulting effect is that the tube 5 itself appears to display process information. For assembly information, the LED 28 may light up yellow when the tube 5 is still missing, green when the tube 5 is correctly positioned, and red when the tube 5 is connected to an incorrect outlet or an incorrect inlet.

[0084] Preferably, the at least one display element 25, in particular the at least one LED stripe 29, is arranged with a longitudinal extension 30 so as to extend at least partially parallel to the at least one, in particular exactly one, monitored system component 22. Preferably, the at least one display element 25 extends parallel to the at least one monitored system component 22 over at least 50%, preferably at least 60%, more preferably at least 70% of its own longitudinal extension 30 insofar as it comprises light-emitting elements 27 and / or of the longitudinal extension 30 of the monitored system component 22.

[0085] The display element 25 may also be used to display the flow path and / or flow direction by lighting the light emitting elements 27 sequentially along the longitudinal extension 30 in the direction of flow.

[0086] Additionally or alternatively, at least one display component 25, in particular at least one LED stripe 29, is arranged to extend at least partially around the monitored system component 22 (see FIG. 2 ), where at least partially means over at least 50% of the perimeter of the monitored system component 22 and / or at least partially along most of the sides of the monitored system component 22, for example at least partially along three of the four sides.

[0087] As a preferred variant, it is further proposed that the bioprocessing system 1 is configured such that at least one monitored single-use component assigned to at least one display component 25 can be replaced with a new single-use component and the new single-use component can be assigned to the at least one display component 25. By assigning a monitored single-use component to a display component 25, the monitored single-use component and the display component 25 are paired with each other. The display component 25 then displays assembly information and / or process information of the monitored single-use component. The same is possible for the at least one light-emitting element 27, whereby the light-emitting element 27 of a single display component 25 can be paired with different monitored system components 22.

[0088] The light emitting elements 27 may also indicate process information not directly accessible by the sensors 8, such as the direction of liquid flow F in the pipe. This information may be provided, for example, to the electronic process control 19. The representation of liquid flow F in the pipe by the light emitting elements 27 is exemplarily shown by the lower inlay shown in FIG. 1 . As shown, three display elements 25, preferably LED stripes 29, are arranged in parallel. The LEDs 28 of each LED stripe 29 may be controlled to represent the direction of liquid flow F, as indicated by the dashed lines depicted in the inlay. It should also be noted here that the pattern of the LEDs 28 is not necessarily static but may be “moving.” In this way, dynamics within the bioprocess system 1, such as liquid flow F, may also be reflected by the display device 21.

[0089] According to another embodiment, it is proposed that at least one display component 25 is arranged behind the transparent monitored system component 22 and assigned to said transparent monitored system component 22. FIG. 2 shows different envisaged embodiments in AA to A-A''', where preferably the transparent monitored system component 22 is a tube 5. "Behind" means with respect to a front view of the system component 6 and / or a front view of the bioprocessing system 1, which can be determined in most cases. In particular, the transparent monitored system component 22 can be arranged on another system component 6, in which case "behind" means that the display component 25 is located between the transparent monitored system component 22 and the other system component 6. In the embodiment shown in FIGS. 2A-A to A-A''', the other system component 6 can be a chromatography system 3 and the transparent monitored system component 22 is a single-use tube 5.

[0090] It is further preferred that the at least one, preferably multi-use system component 6 includes at least one predetermined location for at least one, particularly two or more, monitored, preferably single-use system components 22, particularly tubes 5, and at least one location for a display component 25, particularly LED stripe 29, next to, particularly behind, the location for the monitored system component 22. Placing the display component 25 in the predetermined location makes it easier for the user to assemble the display device 21, or even for the display device 21 to be pre-configured, for example, by a manufacturer of the preferably multi-use system component 6. Thus, the display device 21 can be at least partially pre-configured.

[0091] Preferably, at least one location for display component 25 is recess 34 in which display component 25 is disposed, as shown in Figures 2A-A. Display component 25 may be disposed entirely within recess 34 and / or flush with the surface in which recess 34 is located. In this way, display component 25 does not interfere with handling of system component 6.

[0092] As shown in Figures 2A-A'' and 2A-A''', these locations may also include fastening elements 35 for one or more single-use components, in particular one or more tubes 5 and / or one or more display components 25. Preferably, one or more display elements and / or one or more single-use components may be snapped onto the fastening elements 35.

[0093] According to another embodiment, it is proposed that the assembly information comprises information on whether the monitored system components 22 assigned to the respective display component 25 have been correctly assembled. Alternatively or additionally, the assembly information may comprise information on whether the monitored system components 22, in particular the sensors 8, have been correctly connected and / or calibrated. Alternatively or additionally, the assembly information may also comprise information on whether the calibration of the monitored system components 22 was successful.

[0094] Preferably, the process information includes information based on sensor values ​​of sensors 8 of the bioprocess system 1 used to monitor process parameters of the bioprocess during bioprocess operation. The sensor values ​​are indicative of bioprocess operation for each monitored system component 22, thereby monitoring the monitored system component 6. The one or more sensors 8 may include a liquid flow sensor 17 and / or a pressure sensor 12, which may inherently be indicative of bioprocess operation not only for the monitored system component 22 directly associated with the sensor 8, but also for monitored system components 22 that are, for example, fluidly coupled to the sensor 8.

[0095] Assembly information may be displayed during initial assembly, during assembly when changing bioprocess operations, and / or during changes to some components for disassembly and / or reassembly when entering a new stage of bioprocess operation and / or especially when changing single-use components.

[0096] After assembling the bioprocessing system 1, bioprocessing operation can begin. The proposed display device 21 allows for the use of the same display components 25 during assembly and during bioprocessing operation. Thus, the process information may include information on whether the monitored system components 22 assigned to the respective display components 25 are operating within normal parameter ranges and / or whether a warning has been triggered for the monitored system components 22 and / or whether an error has been triggered for the monitored system components 22.

[0097] This can be seen from FIG. 2, where the display component 25 paired with the liquid pump 16 of the first liquid inlet line 23 may indicate during assembly that a single-use pump head should be installed there. After installing the single-use pump head, during operation of the bioprocess, the display component 25 paired with the liquid pump 16 to which the pump head is connected there may indicate whether the pump is operating within a predetermined range of revolutions per minute. This is shown for the fourth liquid inlet line 26, where the pump head and tubing 5 are already installed. In this case, the light emitting element 27 may emit a green light. As explained further below, if the monitored system component 22 is operating within normal parameter ranges, this may also be indicated by the light emitting element 27 not emitting any light.

[0098] Additionally or alternatively, the process information may include information based on sensor values ​​of sensors 8 of the bioprocess system 1 used to monitor process parameters of the bioprocess during bioprocess operation.

[0099] The possible sequential use of the display device 21 is further embodied in that the assembly information and the process information preferably comprise information based on sensor values ​​of the same sensor 8, displayed by the same display component 25 and / or light emitting element 27, but at different times.

[0100] In the simulation mode, the display device 21 may show a simulation of the use of the bioprocessing system 1. For example, a programmed flow diagram may be shown by a light pattern on the bioprocessing system 1 prior to the actual use of the bioprocessing system 1 according to the flow diagram.

[0101] Preferably, in order to conserve energy, the display component 25 may be disabled when not needed, for example when the respective monitored system component 22 is operating normally.

[0102] This is particularly advantageous when there are several monitored system components 22, as it helps the user more easily identify errors or warnings. It also saves costs, as the light emitting element 27 consumes less power when the paired monitored system components 22 are operating within normal parameter ranges.

[0103] According to one embodiment, it is proposed that the process information comprises the status of the monitored system components 22 assigned to the respective display components 25, preferably the status being an open and / or closed state for the valves 7. The display components 25 together may show a flow diagram, for example by showing all active fluid conducting lines and valves 7 in green.

[0104] In a preferred embodiment, the process and / or assembly information displayed by the display device 21 via the at least one display component 25 may be selected by a user, for example by setting thresholds, allowing the user to adapt the display device 21 to their personal needs.

[0105] For ease of configuration, preferably the user can select between different display modes and / or set the display mode, in particular by defining normal parameter ranges. One display mode can be a flow diagram and / or a process step monitoring mode and / or a process quality monitoring mode.

[0106] In one possible embodiment, the manufacturer defines some thresholds and the user can set other thresholds of process parameters for the display device 21. The thresholds can be used to trigger warnings or alerts.

[0107] According to one embodiment, it is proposed that the at least one display component 25 is fixedly installed, preferably on a multi-use system component 6, and / or that the at least one display component 25 can be flexibly installed by a user, connected to a control device 24 and preferably flexibly assigned to a system component 6.

[0108] The controller 24 may be configured to operate in different process modes, preferably including an installation mode for initial assembly, and / or an operation mode for general operation, and / or a quality control mode for specific operations to verify the quality of a bioprocess operation, and / or a critical process step mode to provide more information during a critical process step. The display device 21 and / or at least one display component 25 may be controlled differently based on the current process mode, thereby providing different information based on the process mode.

[0109] Another teaching of equal importance relates to a bioprocess system component 6, particularly a multi-use bioprocess system component 6, including at least one predetermined location for at least one, particularly two or more, single-use system components 22 to be monitored, particularly tubes 5, and at least one location for a display component 25, particularly an LED stripe 29, next to, particularly behind, the location for the single-use system component 22 to be monitored. Preferably, the at least one location for the display component 25 is a recess 34 in which the display component 25 is disposed. More preferably, the display component 25 is disposed completely inside the recess 34.

[0110] All the explanations given regarding the proposed bioprocessing system 1, in particular any explanations given regarding the multi-use components, are fully applicable.

[0111] Another teaching of equal importance relates to the use of bioprocessing system components 6, particularly multi-use bioprocessing system components 6, within the proposed bioprocessing system 1.

[0112] All descriptions given regarding the proposed bioprocess system 1 and the proposed bioprocess system components 6 are fully applicable.

[0113] Another equally important teaching relates to the use of a display component 25 within the proposed bioprocessing system 1.

[0114] All descriptions provided regarding the proposed bioprocessing system 1, the proposed bioprocessing system components 6, and the proposed use of the display component 25 are fully applicable.

[0115] Another teaching of equal importance relates to a controller 24 for use within the proposed bioprocessing system 1.

[0116] All descriptions provided regarding the proposed bioprocessing system 1, the proposed bioprocessing system components 6, the proposed use of the display components 25, and the proposed use of the controller 24 are fully applicable.

[0117] According to one embodiment, it is proposed that the control device 24 is an electronic process controller 19 for controlling the bioprocess operation, which may be controlling valves 7, sensing sensor values, etc. as explained above.

[0118] Another teaching of equal importance relates to a method of operating the bioprocessing system 1, in which the controller 24 displays process and / or assembly information regarding the monitored system components 22 via light emitting devices 27.

[0119] All descriptions provided regarding the proposed bioprocessing system 1, the proposed bioprocessing system components 6, the proposed use of the display components 25, and the proposed use of the controller 24, as well as the proposed controller 24, are fully applicable.

Claims

1. A bioprocessing system for a bioprocessing operation, the bioprocessing system having a display device for displaying system information related to the bioprocessing system, the bioprocessing system having a system component having at least one monitored system component, the system component being capable of being assembled into an assembled state in which the bioprocessing system is operable for the bioprocessing operation, and being disassembled into a disassembled state in which the bioprocessing system is not operable for the bioprocessing operation; The bioprocessing system (1) comprises a control device (24), the display device (21) comprises at least one display component (25), In an assembled state of the bioprocessing system (1) during bioprocessing operation, the control device (24) displays process information via the display device (21), and / or, during assembly of the bioprocessing system (1), the control device (24) displays assembly information via the display device (21); the process information and / or the assembly information relates to at least the monitored system component (22), and the display device (21) comprises at least one display component (25); The display component (25) is arranged separately from the monitored system component (22) and includes a light-emitting element (27) arranged next to or above the monitored system component (22), and the control device (24) is configured to display the process information and / or the assembly information related to the monitored system component (22) via the light-emitting element (27). A bioprocess system comprising:

2. 2. The bioprocess system of claim 1, wherein the display component (25) is an LED stripe (29) comprising a plurality of LEDs (28) as light-emitting elements (27), and / or the light-emitting elements (27) are LEDs (28), and / or the process information and / or the assembly information are encoded in the color and / or brightness and / or pattern of one or more of the light-emitting elements (27).

3. 3. The bioprocess system according to claim 1, wherein the control device (24) is configured to display process and / or assembly information relating to at least two, preferably at least three, more preferably at least four different monitored system components (22), in particular different types of monitored system components (22), via at least two, preferably at least three, more preferably at least four light-emitting elements (27) of at least one display element (25) and / or via at least two, preferably at least three, more preferably at least four display elements (25) of the display device (21), preferably wherein each of the display elements (25) and / or each of the light-emitting elements (27) is assigned to only one or only two monitored system components (22) at a time.

4. 4. The bioprocessing system according to claim 1, wherein the at least one monitored system component (22) comprises at least one single-use component, and / or at least one multiple-use component, and / or at least one component that normally contains, preferably conducts, a fluid during the bioprocessing operation, and / or at least one sensor (8); preferably, the at least one monitored system component (22) comprises at least one tube (5), and / or at least one pipe, and / or at least one filter, and / or at least one bioreactor (2), and / or at least one clamp for connecting the tube (5) and / or pipe to other system components (6).

5. At least one display component (25), in particular at least one LED stripe (29), is arranged with a longitudinal extension (30) so as to extend along at least one, in particular exactly one, monitored system component (22), preferably 5. The bioprocessing system according to claim 1, wherein at least one display component (25), in particular at least one LED stripe (29), is arranged with a longitudinal extension (30) so as to extend at least partially parallel to at least one, in particular exactly one, system component (22) to be monitored.

6. 6. The bioprocessing system according to claim 1, wherein the bioprocessing system is configured such that at least one monitored single-use component assigned to at least one display component can be replaced with a new single-use component, and the new single-use component can be assigned to the at least one display component.

7. 7. The bioprocessing system according to claim 1, wherein at least one display component (25) is arranged behind a transparent monitored system component (22) and assigned to said transparent monitored system component (22), preferably said transparent monitored system component (22) being a tube (5).

8. 8. The bioprocessing system according to claim 1, wherein the at least one multiple-use system component (6) comprises at least one predetermined position for at least one, in particular two or more, single-use components to be monitored, in particular tubes (5), and at least one position for a display component (25), in particular an LED stripe (29), next to, in particular behind, the position for the single-use components to be monitored; preferably, the at least one position for the display component (25) is a recess (34) in which the display component (25) is arranged; more preferably, the display component (25) is arranged completely inside the recess (34).

9. 9. The bioprocess system according to claim 1, wherein the assembly information includes information on whether the monitored system components (22) assigned to the respective display components (25) have been correctly assembled and / or calibrated, preferably the assembly information includes information based on sensor values ​​of sensors (8) of the bioprocess system (1) used to monitor process parameters of the bioprocess during the bioprocess operation.

10. 10. The bioprocess system according to claim 1, wherein the process information comprises information on whether the monitored system components (22) assigned to the respective display components (25) are operating within normal parameter ranges and / or whether a warning has been triggered for the monitored system components (22) and / or whether an error has been triggered for the monitored system components (22); and / or the process information comprises information based on sensor values ​​of sensors (8) of the bioprocess system (1) used to monitor process parameters of the bioprocess during the bioprocess operation, preferably wherein the assembly information and the process information comprise information based on the sensor values ​​of the same sensors (8), preferably displayed by the same display components (25) and / or the light-emitting elements (27).

11. 11. The bioprocessing system according to claim 1, wherein the process information comprises a status of the monitored system component (22) assigned to each display component (25), preferably the status being an open and / or closed state for a valve (7).

12. 12. The bioprocess system according to claim 1, wherein the process information and / or the assembly information displayed by the display device (21) via the at least one display component (25) can be selected by a user, preferably by the user being able to select between different display modes and / or to configure the display mode, in particular by defining normal parameter ranges.

13. 13. The bioprocessing system according to any one of claims 1 to 12, characterized in that at least one display component (25) is fixedly installed on the multi-use system component (6) and / or at least one display component (25) can be flexibly installed by a user and connected to the control device (24), preferably flexibly assigned to a system component (6).

14. 1. A bioprocessing system component, in particular a multi-use bioprocessing system component (6), comprising at least one predetermined position for at least one, in particular two or more, single-use components (22) to be monitored, in particular tubes (5), and at least one position for a display component (25), in particular an LED stripe (29), next to, in particular behind, said position for said single-use components to be monitored, wherein preferably said at least one position for said display component (25) is a recess (34) in which said display component (25) is arranged, more preferably said display component (25) is arranged completely inside said recess (34).

15. Use of a bioprocessing system component, in particular a multiple use bioprocessing system (1) component, in a bioprocessing system (1) according to any one of claims 1 to 13.

16. Use of a display component (25) in a bioprocessing system (1) according to any one of claims 1 to 13.

17. A control device for use in a bioprocessing system (1) according to any one of claims 1 to 13.

18. 18. The control device according to claim 17, characterized in that the control device (24) is an electronic process controller (19) for controlling the operation of a bioprocess.

19. 14. The method of operating a bioprocessing system (1) according to any one of claims 1 to 13, wherein the control device (24) displays the process information and / or the assembly information relating to the monitored system component (22) via the light emitting device (27).

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