Bioprocess system for bioprocess operations, having a display arrangement for displaying system information relating to the bioprocess system

Abstract

The invention relates to a bioprocess system for bioprocess operations, having a display arrangement (21) for displaying system information about the bioprocess system (1), the bioprocess system (1) comprising a system component (6), the system component (6) comprising at least one monitored system component (22), wherein the system components (6) can be assembled into an assembled state in which the bioprocess system (1) is operable for the bioprocess operation, and the system components (6) can be disassembled into a disassembled state in which the bioprocess system (1) is not operable for the bioprocess operation, wherein the biological process system (1) comprises a control arrangement (24) and the display arrangement (21) comprises at least one display component (25), and wherein during a biological process operation, in the assembled state of the biological process system (1), the control arrangement (24) displays process information via the display arrangement (21), and / or wherein the control arrangement (24) displays assembly information via the display arrangement (21) during the assembly of the bioprocess system (1) wherein the process information and / or the assembly information relates at least to the monitored system component (22), and wherein the display arrangement (21) comprises at least one display component (25). According to the invention, the display component (25) comprises a light-emitting element (27), which is arranged separately from the monitored system component (22) and is arranged next to or on the monitored system component (22), and the control arrangement (24) is configured to display the process information and / or the assembly information relating to the monitored system component (22) via the light emitting element (27).

Description

[0001] The present invention relates to a bioprocess system for bioprocess operations according to the preamble of claim 1, which has a display arrangement for displaying system information about the bioprocess system, to a bioprocess system component according to claim 14, to the use of a bioprocess system component according to claim 15, to the use of a display component according to claim 16, to a control arrangement according to claim 17, and to a method according to claim 19.

[0002] Bioprocess systems, such as bioreactors, clarifiers, chromatography units, filtration units, and particularly combinations thereof, often include multiple system components, such as sensors, tubes, containers, and the like. These system components can be divided into disposable components and reusable components. Building such a bioprocess system for bioprocess operations can include the following several work steps: assembling different components by connecting tubes, fixtures, inlets / outlets, placing and calibrating sensors, and the like. These work steps are prone to errors. It is possible to detect such assembly errors electronically, for example, by detecting improperly connected sensors. However, it is also time-consuming to spend time checking, for example, the user interface of an electronic process control to find errors. In addition, less experienced users may have to check the manual or user interface several times to correctly place and connect all components.

[0003] Currently, a bioprocess can be any type of process that uses biological material, in particular cells or their components (such as bacteria, enzymes, chloroplasts, etc.) to produce a product.

[0004] During the use of a bioprocess system for bioprocess operations, numerous warnings and errors may occur. Typically, these warnings and errors are displayed on a user interface. Depending on the size of the bioprocess system, locating the corresponding 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 interactions between the bioprocess system and the electronic process control unit with the user interface. Furthermore, emergency situations may arise that require rapid understanding and a quick response.

[0005] Changing system components of a bioprocess system (particularly single-use system components) may include disassembling and reassembling parts of the bioprocess system. The process may also include consulting the user interface and / or manual several times.

[0006] Visual feedback regarding actions taken and / or the status of a bioprocess system is often limited to the user interface of the electronic process control, which may be located some distance from the respective system component to which the feedback relates.

[0007] According to WO 2016 / 090113 A2, it is known to use a projector to display images of system components during assembly of a bioprocess system and to check their correct placement. Projectors are expensive and complex, require a camera for feedback, and lack flexibility.

[0008] It is also known to check whether a disposable component has been correctly connected and provide feedback via LED elements of a smart clamp (GB 2549190 A). However, the use case of this concept is limited to systems with smart clamps and checking the assembly of these clamps.

[0009] It is a challenge to improve upon known prior art techniques in a manner that enables easier control of the assembly and / or process states of a bioprocessing system.

[0010] The present invention is based on the problem of improving known bioprocess systems such that further optimization with respect to the challenges described is achieved.

[0011] This object is achieved by the characterizing features of claim 1 .

[0012] Main implementation of the present invention is, by placing light emitting element next to system components, a very flexible and cheap mode is proposed and directly on bioprocessing system or next to bioprocessing system a graphical user interface is provided.Preferably, the light emitting element of repeated use can be placed next to disposable system components, and illustrates assembling and / or process information about disposable components.It can also be used for repeated use components, can be used for the different components in different use cases, or even can be flexibly repositioned to adapt different bioprocessing systems or bioprocessing operations.In this way, bioprocessing system itself becomes graphical user interface, thereby significantly reduces time and / or cost expense for locating warning or error source, and also increases the ease of use of system during assembly.Identical light emitting element can be used for the correct or incorrect assembling and process state (unexpected overpressure during the bioprocessing operation) of system components being visualized.

[0013] In detail, it is proposed that: the display component includes a light-emitting element, which is arranged separately from the monitored system component and is arranged close to the monitored system component or is arranged on the monitored system component, and the control arrangement is configured to display process information and / or assembly information related to the monitored system component via the light-emitting element.

[0014] A very preferred embodiment according to claim 2 relates to LEDs as light-emitting elements and / or LED strips with light-emitting elements. LEDs are cheap and simple light-emitting elements that have quite good possibilities for encoding information in color, brightness, flashing frequency and / or spatial movement (e.g. of color along an LED strip). They can be easily connected by non-professionals or embedded by the manufacturer into a system component. The resulting flexibility makes it easy for the manufacturer and / or the user to configure the display arrangement as required. The display arrangement further allows a cost-effective way to display a reasonable amount of information on or in the immediate vicinity of a system component. All explanations given for LEDs apply to other types of light-emitting elements. In particular, the LEDs can be OLEDs.

[0015] According to claim 3, a plurality of display components and / or lighting elements may be paired with a plurality of system components, thereby allowing process and / or assembly information for a plurality of components to be displayed using the display arrangement.

[0016] Claim 4 relates to a preferred monitored system component for which assembly information and / or process information can be displayed via the light-emitting element. Components that must be assembled and disassembled (possibly multiple times) (e.g., when changing single-use components) are of particular interest, since these work steps are error-prone and time-consuming.

[0017] A preferred embodiment according to claim 5 is directed to a display element that extends along the monitored system component. If the monitored system component (e.g., a pipe) has a longitudinal extension and the display element is positioned along this extension, the displayed information can be specifically adapted to the monitored system component. For example, an LED strip can extend along the pipe, thereby displaying process information along the pipe, making it very easy to identify the cause or location of warnings, etc. Furthermore, if a pipe is replaced, the LED strip can indicate where the new pipe will be placed, making replacement easier.

[0018] According to a preferred embodiment of claim 6, for example, when the bioprocess system is used for different continuous bioprocess operations, the disposable parts can be replaced and the replacement disposable parts can be assigned to the same display part, thereby continuously using one display part for the replaced and replacement disposable parts.

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

[0020] When a bioprocess system combines multiple-use and single-use components, the single-use components can have defined positions on the multiple-use components. These positions can also depend on the respective bioprocess operation. For example, a fixture for a disposable tube can be provided on the multiple-use component, and the tube can be assembled onto the multiple-use component as needed. According to claim 8, the display component can also have a fixed position on the multiple-use component and, in particular, can be embedded in the multiple-use 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 process information.

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

[0023] In a further preferred embodiment according to claim 12, the display arrangement is configurable by a user, thereby adapting the display arrangement to different assembly variants of the bioprocess system, different bioprocess operations and user preferences.

[0024] According to claim 13, the display arrangement can also be flexible with respect to the position of the display components, thereby further increasing the flexibility.

[0025] Another teaching of equal importance according to claim 14 relates to components of bioprocess systems.

[0026] All explanations given for the proposed bioprocess system are fully applicable.

[0027] A further teaching of equal importance according to claim 15 relates to the use of components of bioprocess systems.

[0028] All explanations given with respect to the proposed bioprocess system and the proposed bioprocess system components are fully applicable.

[0029] A further teaching of equal importance according to claim 16 relates to the use of the display element in the proposed bioprocess system.

[0030] All explanations given with respect to the proposed bioprocess system, the proposed bioprocess system components and the use of the proposed display components are fully applicable.

[0031] A further teaching of equal importance according to claim 17 relates to a control arrangement for the proposed bioprocess system.

[0032] All explanations given with respect to the proposed bioprocess system, the proposed bioprocess system components, the use of the proposed display components and the use of the proposed control arrangement are fully applicable.

[0033] In a preferred embodiment according to claim 18, the control arrangement is an electronic process control for controlling a bioprocess system. In many cases, the electronic process control already has assembly and / or process information. The display arrangement can then serve as an extended user interface for the electronic process control.

[0034] A further teaching of equal importance according to claim 19 relates to a method for operating the proposed bioprocess system, wherein the control arrangement displays process information and / or assembly information relating to the monitored system components via light-emitting elements.

[0035] All explanations given with respect to the proposed bioprocess system, the proposed bioprocess system components, the use of the proposed display components and the use of the proposed control arrangement, as well as the proposed control arrangement, are fully applicable.

[0036] In the following, embodiments of the present invention are explained with reference to the accompanying drawings. In the following drawings:

[0037] Figure 1 The bioprocess system in an embodiment of the present invention is shown in an exemplary view.

[0038] Figure 2 Another bioprocess system according to an embodiment of the present invention is shown in a schematic diagram.

[0039] Figure 3 Exemplary display components of the present invention are shown in various combinations.

[0040] The proposed bioprocess system 1 may be used when performing a bioprocess operation. Thus, the term "bioprocess system" currently describes one or more functional units used in a bioprocess to perform a bioprocess operation. A bioprocess operation may include one or more different steps of a bioprocess.

[0041] The term "bioprocess" currently refers to any type of biotechnology process, in particular a biopharmaceutical process. An example of such a bioprocess is the production of a bioproduct, preferably a monoclonal antibody or a viral vector or an antibody-drug conjugate or a small molecule or a vaccine. The proposed solution can also be used for other bioprocesses related to plant materials, food, etc. One focus is on toxic substances, because the proposed solution allows remote analysis of the bioprocess and sorting out potential faulty system components. Such a bioprocess can include a bioreactor 2, in which a bioprocess operation or step "cultivation" can be performed to cultivate bacteria or mammalian cells under given conditions to produce a bioproduct. The exemplary bioprocess mentioned can further include a clarification unit, which can be used to perform a bioprocess operation or step "clarification", which is used to separate cells from the bioproduct. Together, the two can also form a bioprocess system 1 for performing a bioprocess operation with multiple steps. The exemplary bioprocess system 1 can further include a chromatography system 3 to perform a bioprocess operation or step "chromatography" to further purify the bioproduct.

[0042] The bioprocess can be performed by only one bioprocess system 1, or it can be performed by more than one bioprocess system 1. When the bioprocess is performed by more than one bioprocess system 1, the bioprocess system 1 can be fluidically connected to another bioprocess system 1, for example, via a liquid line 4. In this case, the liquid line 4 (which can be, for example, a pipe or tube 5) can also be assigned to one or both bioprocess systems 1.

[0043] Figure 1 and Figure 2 Two different bioprocess systems 1 are shown with corresponding system components 6. System components 6 may be the smallest functional units of the bioprocess system 1, such that each system component 6 may be assigned to at least one function and / or may be composed of other system components 6 (then as a complex system component 6). Any explanations given for system components 6 may apply to system components 6 as the smallest functional unit and / or to complex system components 6.

[0044] exist Figure 1In the figure, the bioprocess system 1 includes a bioreactor 2 as a system component 6, which can, for example and as described above, be used to culture mammalian cells under defined conditions. In addition to the bioreactor 2, the bioprocess system 1 may include system components 6, such as valves 7, sensors 8, ports and fluid lines. Preferably, the bioreactor 2 includes a disposable bag and a multiple-use housing. The housing can be mounted on a platform 9. The bioreactor 2 preferably includes a liquid outlet port 10. The liquid outlet port 10 is connected to a liquid line 4, which can be used, for example, to transfer a cell culture fluid 11 from the bioreactor 2 to a subsequent bioprocess system 1. The liquid line 4 can include a valve 7 to control the flow of the cell culture fluid 11 from the bioreactor 2. The liquid flow F in the liquid line 4 is schematically depicted by arrows. The liquid line 4 can be, for example, a flexible disposable tube 5 that is replaced after the transfer is completed, or it can be a rigid pipe that remains fluidically connected to the bioreactor 2.

[0045] The bioreactor 2 may also include a plurality of sensors 8, which may be used to monitor and preferably also control the culture conditions inside the bioreactor 2. Figure 1 As depicted, the bioreactor 2 may, for example, include a pressure sensor 12 connected to a gas outlet port 14 of the bioreactor 2 via a gas line 13 to monitor the pressure inside the bioreactor 2. Other sensors (which are only Figure 1 The bioreactor 2 in FIG. 1 (schematically indicated in the lower part of FIG. 1 ) includes a temperature sensor, a dissolved oxygen sensor, a pH sensor, etc.

[0046] Figure 2 , another bioprocess system 1 is depicted. This bioprocess system 1 can be a chromatography system 3, which includes, for example, a valve switching cartridge 15 for performing simulated moving bed chromatography to purify a bioproduct in a liquid. The bioprocess system 1 can include system components 6, such as a valve switching cartridge 15 for directing a liquid flow F, a liquid pump 16 for supplying a liquid containing a bioproduct, a wash solution, etc., to the valve switching cartridge 15, and sensors 8 (e.g., a liquid flow sensor 17 and a conductivity sensor 18) for monitoring the liquid exiting the valve switching cartridge 15.

[0047] Typically, electronic process control 19 is used to control the respective bioprocess operations performed by bioprocess system 1. To this end, sensor values ​​of respective sensors 8 are monitored by electronic process control 19. The bioprocess can be controlled by comparing the obtained sensor values ​​with predefined target values ​​and, in particular, reacting as necessary. For example, the dissolved oxygen tension in the liquid can be monitored by a respective dissolved oxygen tension sensor. If the dissolved oxygen tension within the liquid drops below a predefined threshold, the speed of agitator 20 of bioreactor 2 can be increased to increase the dissolved oxygen tension.

[0048] like Figure 1 As depicted, the electronic process controls 19 may be mounted separately from the rest of the bioprocess system 1. The electronic process controls 19 may or may not include a display (e.g., a screen) for displaying information regarding the current status of the bioprocess system 1. However, as proposed, the current status of the bioprocess system 1 may be displayed to a user via a display arrangement 21, which may be directly connected to the bioprocess system 1.

[0049] Before using the bioprocess system 1, and during different stages of bioprocess operation, or for continuous bioprocess operation, some system components 6 need to be changed, and some components (especially single-use components) need to be replaced. As will be explained in detail, assembly information (such as the correct placement of sensors 8, tubes 5, etc.) can be displayed by the display arrangement 21.

[0050] Here, and preferably, the electronic process control 19 is a single device and / or comprises fluid lines and / or pumps and / or a cable harness or cable-free connection to the sensor 8 and / or controls the actuators and / or valves 7 of the bioprocess system 1 and / or comprises a display (in particular a touch display). The display of the electronic process control 19 is not part of the proposed display arrangement 21.

[0051] 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 control 19 .

[0052] Proposed is a bioprocess system 1 for bioprocess operation having a display arrangement 21 for displaying system information about the bioprocess system 1 .

[0053] As explained above, the bioprocess system 1 includes system components 6, such as pipes 5, valves 7, sensors 8, etc. The system components 6 include at least one monitored system component 22, which is a system component 6 that is monitored by the electronic process control 19 or the like (preferably by monitoring sensor values ​​related to the monitored system component 22) and for which information is displayed by the display arrangement 12.

[0054] The system components 6 can be assembled into an assembled state in which the bioprocess system 1 is operable for bioprocess operations, and can be disassembled into a disassembled state in which the bioprocess system 1 is not operable for bioprocess operations. Figure 1 The assembled state of the bioprocess system 1 is shown. Figure 2Different assembled states of the different system components 6 of the chromatography system 3 are shown. The BioSMB system shown is only an example and other bioprocess systems 1 and other chromatography systems can be used, e.g. any Flowdrive system. For the different liquid inlet lines of the chromatography system 3, each of them is depicted in an exemplary assembled state. The depicted chromatography system 3 exemplarily includes seven liquid inlet lines, three of which will be described in more detail below. In the depicted embodiment, each liquid inlet line includes a liquid pump 16 and a liquid flow sensor 17. For each liquid inlet line, a tube 5 (preferably a disposable tube) can be connected to the liquid pump 16 and the liquid flow sensor 17 of the corresponding liquid inlet line. Each tube 5 can be used to guide a certain liquid (e.g., a buffer, a liquid containing a biological product, etc.) into a corresponding inlet port of the valve switching box 15. The direction of the liquid flow F within the tube 5 of the liquid inlet line is depicted by an arrow. In addition to the depicted liquid inlet lines, the valve switching system 3 may include a plurality of liquid outlet lines, two of which are also in Figure 2 Each liquid outlet line may include a tube 5, preferably a disposable tube, which preferably guides the liquid leaving the valve switching box 15 to the subsequent bioprocess system 1. Figure 2 As depicted, at least one of the liquid outlet lines may include a conductivity sensor 18 , and the tube 5 of the respective liquid outlet line may be connected to the conductivity sensor 18 .

[0055] The disassembled state may be a state before a disposable component (such as the tube 5) is added to a reusable component (such as the liquid pump 16 of the chromatography system 3). Figure 2 The first liquid inlet line 23 of the chromatography system 3 depicted in FIG, exemplarily shows this disassembled state. Here, the tube 5 and the pump head of the liquid pump 16 are not yet installed.

[0056] The bioprocess system 1 includes a control arrangement 24. The display arrangement 21 includes at least one display component 25. Typically, the control arrangement 24 may be an electronic process control 19 for controlling the bioprocess system 1 (e.g., by actuating valves 7, controlling the flow of liquid F within the valve switching box 15, measuring sensor values, etc.). The control arrangement may also include or be composed of an FPGA or discrete logic components. Preferably, the control arrangement 21 includes components with control software.

[0057] The control arrangement 24 monitors the monitored system component 22 , for example by reading sensor values ​​associated with the monitored system component 22 and in particular by checking whether the sensor values ​​are within an allowed range.

[0058] For example and Figure 1As depicted, the monitored system component 22 may be a bioreactor 2 having a certain allowed maximum pressure, and this pressure may be measured by a pressure sensor 12 connected to the bioreactor 2. The pressure sensor is connected to an electronic process control 19, and the allowed maximum pressure may be defined by the electronic process control 19.

[0059] In another example (which is for Figure 2 In the embodiment depicted by the fourth liquid inlet line 26 in the figure, the monitored system component 22 may be a pipe 5 having a certain maximum liquid flow F, and the liquid flow F may be measured by a liquid flow F sensor 17 after a liquid pump 16 which feeds the pipe 5 with liquid directly or indirectly.

[0060] During bioprocess operation, in the assembled state of the bioprocess system 1, the control arrangement 24 displays process information via the display arrangement 21. The process information can be any information related to the bioprocess operation, such as flow charts, sensor values, warnings, errors, alarms, and / or next work steps. Preferably, the process information includes information (including sensor values ​​from sensors 8 of the bioprocess system 1) and / or information derived from the sensor values, and can additionally include information provided to the control arrangement 24 by a user. It can also be the case that the process information includes predictive information, in particular predictive information about predicted failures and / or changes in the bioprocess system 1. The process information can include information about the lifespan of monitored system components 22. In this way, the user can be informed when to change monitored system components 22, such as filters.

[0061] Additionally or alternatively, during assembly of the bioprocess system 1, the control arrangement 24 displays assembly information via the display arrangement 21. The assembly information preferably comprises information about which monitored system component 22 should be connected to which other system component 6 and / or monitored system component 22, and / or where the monitored system component 22 should be placed, and / or how the sensor 8 or which sensor 8 should be configured and / or calibrated.

[0062] The process information and / or assembly information relates to at least the monitored system component 22 .

[0063] The display arrangement 21 comprises at least one display member 25, which will be explained in further detail below.

[0064] Importantly, the display component 25 includes a light-emitting element 27, which is arranged separately from the monitored system component 22 and is arranged adjacent to or on the monitored system component 22, and the control arrangement 24 is configured to display process information and / or assembly information relating to the monitored system component 22 via the light-emitting element 27.

[0065] The term "separate" means that the light emitting element 27 and the display component 25 are not part of the monitored system component 22. Light emitting element 27 being separate from the monitored system component 22 may also mean that the light emitting element 27 and / or the display component 25 have their own energy supply, and / or the light emitting element 27 and / or the display component 25 have their own connection to the control arrangement 24, and / or the light emitting element 27 and / or the display component 25 are physically mounted away from the monitored system component 22, or are mounted on the monitored system component 22 but can be operated 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 can also be plugged into a socket on the monitored system component 22 for its energy supply and / or connection to the control arrangement 24 while still being separately operable. In particular, an LED or display that is part of the (multi-use) system component 6 should not be considered to be arranged separately from the (multi-use) system component 6. Therefore, the display component 25 is also arranged separately from the monitored system component 22.

[0066] The light-emitting elements 27 and / or the display element 25 are not part of a complex display, in particular not part of an LED screen. Here, and preferably, the display element 25 comprises a maximum of 1,000 light-emitting elements 27, preferably a maximum of 500 light-emitting elements 27, and more preferably a maximum of 250 light-emitting elements 27. The display element 25 may comprise a maximum of one light-emitting element 27 per square millimeter or per square centimeter. Here, and preferably, the display element 25 is not adapted to display long texts, images, etc. The minimum distance between at least two, preferably at least three, and more preferably at least ten adjacent 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, and more preferably at least 5 mm, respectively, between each of the adjacent light-emitting elements 27.

[0067] According to one embodiment, it is proposed that the display component 25 is an LED bar 29 comprising a plurality of LEDs 28 as light emitting elements 27. One or more light emitting elements 27 may be one or more LEDs 28, respectively.

[0068] In order to keep the display arrangement 21 simple and to convey information to the user in an easily accessible manner, it is preferred to encode the process information and / or assembly information into the color and / or brightness and / or pattern of one or more light-emitting elements 27. In particular, it may be the case that the process information and / or assembly information is encoded into the light of a single light-emitting element 27. This information may be replicated by other light-emitting elements 27, but is preferably as simple as a single color.

[0069] Figure 1 A plurality of LED strips 29 are shown attached to and positioned proximate to different monitored system components 22. Figure 3 As depicted, LED strip 29 comprises a plurality of LEDs 28 at least loosely positioned in rows along a longitudinal extension 30 of LED strip 29. Preferably, LED strip 29 comprises at most 10 rows of LEDs 28 immediately adjacent to one another, preferably at most 3 rows of LEDs 28, more preferably only a single row of LEDs 28.

[0070] Typically, the display unit 25 (and in particular the LED strip 29) may be a modular unit that can preferably be attached to and removed from the monitored system unit 22. The module itself may be operational and may include: a control unit (e.g. a microprocessor), and / or cables and / or plugs for energy and / or for control signals, and / or a battery. Display unit modules 31 may be connected to other display unit modules 31 (preferably via plugs and sockets), and energy and / or control signals may be passed from one display unit module 31 to the next, thereby enabling the system to be monitored according to (e.g., for) Figure 2 The module (depicted by the second liquid inlet line 32 in FIG) provides a simple and modular design for the display arrangement 21.

[0071] All LEDs 28 on an LED strip 29 are connected to each other at least by a common carrier such as a plastic strip, on which the LEDs 28 are placed. Together with a power supply and / or a control unit, the LED strip 29 can be part of a display component module 31. The power supply can include a transformer placed on the carrier of the LED strip 29 or outside the LED strip 29 of the display component module 31. For example, if the system component 6 has a 2.6V output, a transformer or other electronic device (which includes more than just a cable connector) is not mandatory for powering it. Typically, the display component module 31 itself can be operated and used, while the LED strip 29 that does not form the display component module 31 may need to be connected to the control unit. The display component module 31 is a plug-and-play component. The display component module 31 can include multiple LED strips 29 that are also connected by a connector 33. It is therefore possible to connect multiple LED strips 29 to form a single display component module 31, and / or to connect multiple display component modules 31. The same is true for the other display components 25.

[0072] When using LED strips 29, the display component module 31 can be easily customized because a single larger LED strip 29 can be cut at predefined locations (e.g., by Figure 3 The scissors and dotted lines in a). Different types of connectors 33 (some of which are in Figure 3 b)- Figure 3 d) can be used to flexibly connect individual LED strips 29. In this way, combinations of display components 25 of different shapes can be achieved. Figure 1 and Figure 2 As exemplarily depicted, the shape of the monitored system component 22 can be simulated by the display component 25. This simplifies the identification of a specific monitored system component 22, because the display component modules 31 for the same type of monitored system component 22 can have the same shape. Figure 2 This is exemplarily depicted by the monitored liquid pump 16 shown in FIG.

[0073] The display component modules 31 may be paired with corresponding monitored system components 22 via the control arrangement 24. Additionally or alternatively, as Figure 2 As shown in AA, the other display component 25 can be fixedly embedded in the multiple-use system component 6.

[0074] In a particularly convenient embodiment, the display component module 31 and / or the display component 25 include magnets and can be attached to the metal portion of the system component 6 and / or the monitored system component 22 via the magnets. If the system component 6 is not magnetic, a pair of magnets and / or magnetic material placed behind the corresponding portion of the system component 6 can be used. Figure 2 In the embodiment depicted in AA', the display component 25 is positioned on the system component 6 (in this case the chromatography system 3).

[0075] It may be the case that the control arrangement 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, and 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 component 25 and / or via at least two, preferably at least three, more preferably at least four display components 25 of the display arrangement 21.

[0076] Preferably, the display arrangement 21 is configured to display assembly information and / or process information of more than one monitored system component 22. To this end, multiple light emitting elements 27 and / or multiple display components 25 may be used. Typically, a single or multiple light emitting elements 27 may display a single piece of information. For example, in Figure 2In the embodiment, a plurality of light emitting elements 27 are arranged along the pipe 5 of the bioprocess system 1 and can light up green when the pipe 5 is functioning as expected, can light up yellow when the pipe 5 or the pipe section has an associated warning (e.g., abnormal pressure), and can light up red when the pipe 5 or the pipe section has an associated error. This makes it particularly easy for the user to find a problem directly at the bioprocess system 1 without having to shift their gaze back and forth between a fixed display placed far away from the pipe 5 and the pipe 5.

[0077] Here and preferably, each of the display components 25 and / or each of the lighting elements 27 is assigned at a time to only one or only two monitored system components 22. A reassignment is generally possible.

[0078] It should be noted that different display components 25 are physically different from each other, and that the LEDs 28 of the LED strip 29 may be the proposed light emitting elements 27. A monitored system component 22 may be paired with more than one light emitting element 27 of the same or different display components 25, and a display component 25 may be paired with more than one monitored system component 22. Figure 1 , in which a tube 5 representing one of the monitored system components 22 has three parallel display components 25 paired therewith (in this case three different LED strips 29).

[0079] 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 controls 19 and / or separately powered.

[0080] However, additionally or alternatively, and as for Figure 2 As depicted by the second liquid inlet line 32 in FIG. 1 , several display components 25 may be connected in such a way that they are commonly connected to the electronic process control 19 and / or are commonly powered.

[0081] The term "at least one" is always to be understood as preferably also meaning at least two and more preferably at least three.

[0082] According to one embodiment, it is proposed that 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 regularly contains and preferably conducts a fluid during a bioprocess operation and / or at least one sensor 8. The proposed solution allows for easy reuse of the light element 27 and the display component 25 while discarding the single-use component.

[0083] Preferably, at least one monitored system component 22 comprises: at least one tube 5, and / or at least one pipeline, 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 pipeline to other system components 6.

[0084] The term "regularly" is meant to include expected faults during regular bioprocess operation, etc. For example, a container behind the overpressure valve 7 will regularly conduct or contain fluid, whereas an electronic device into which water has leaked will not regularly conduct or contain fluid.

[0085] According to one embodiment, it is provided that at least one display element 25 , in particular at least one LED strip 29 , is arranged to extend with a longitudinal extension 30 along at least one, in particular precisely one, monitored system component 22 . Figure 2 The fourth liquid inlet line 26 in FIG. 1 illustrates how an LED strip 29 can be embedded in a multi-use system component 6 and positioned behind the tube 5, thereby extending along the tube 5. The resulting effect makes the tube 5 itself appear to be displaying process information. For assembly information, the LED 28 can light up yellow when the tube 5 is still missing, turn green when the tube 5 is correctly positioned, and turn red when the tube 5 is connected to the wrong outlet or inlet.

[0086] Preferably, the at least one display element 25, in particular the at least one LED strip 29, is arranged to extend with a longitudinal extension 30 at least partially parallel to at least one, in particular precisely one, monitored system component 22. Preferably, the portion of the at least one display element 25 extending parallel to the at least one monitored system component 22 accounts for at least 50%, preferably at least 60%, more preferably at least 70% of its own longitudinal extension 30 (as long as this extension includes the light-emitting elements 27) and / or of the longitudinal extension 30 of the monitored system component 22.

[0087] The display component 25 can also be used to display the flow path and / or flow direction by successively lighting up the light-emitting elements 27 along the longitudinal extension 30 in the flow direction.

[0088] Additionally or alternatively, at least one display component 25, in particular at least one LED strip 29, is arranged to extend at least partially around the monitored system component 22 (see Figure 2 Here, “at least partially” means at least 50% of the circumference of the monitored system component 22 and / or at least partially along most sides of the monitored system component 22, such as at least partially along three of the four sides.

[0089] As a preferred embodiment, the bioprocess system 1 is further configured such that at least one monitored single-use component assigned to at least one display element 25 can be exchanged for a new single-use component, and the new single-use component can be assigned to at least one display element 25. By assigning the monitored single-use component to the display element 25, the monitored single-use component and the display element 25 are paired with each other. The display element 25 then displays assembly information and / or process information for the monitored single-use component. The same is possible for the at least one light-emitting element 27, thereby pairing the light-emitting element 27 of a single display element 25 with different monitored system components 22.

[0090] The light emitting element 27 can also depict process information that cannot be directly obtained by the sensor 8, such as the direction of the liquid flow F in the pipe. This information can be provided to the electronic process control 19, for example. Figure 1 The lower inlay shown in FIG 1 exemplarily depicts the representation of the flow of liquid F within the pipeline by light-emitting elements 27. As depicted, three display components 25, preferably LED strips 29, are arranged in parallel. The LEDs 28 of each LED strip 29 can be controlled so that they represent the direction of the liquid flow F, which is indicated by the dotted line depicted in the inlay. It should also be noted that the pattern of LEDs 28 is not necessarily static, but can "move." In this way, dynamics within the bioprocessing system 1 (e.g., the flow of liquid F) can also be reflected by the display arrangement 21.

[0091] According to a further embodiment, it is provided that at least one display component 25 is arranged behind the transparent monitored system component 22 and is assigned to the transparent monitored system component 22 . Figure 2 Different envisaged embodiments are shown in AA to AA''. Here and preferably, the transparent monitored system component 22 is a tube 5. "Behind" means a front view relative to the system component 6 and / or a front view of the bioprocess system 1, which can generally be determined. In particular, the transparent monitored system component 22 can be placed on another system component 6, and "behind" then means that the display component 25 is positioned between the transparent monitored system component 22 and the other system component 6. Figure 2 In the embodiment depicted in AA to AA'', the further system component 6 would be the chromatography system 3 and the transparent monitored system component 22 would be the single-use tubing 5 .

[0092] It is further preferred that at least one (preferably multiple-use) system component 6 comprises at least one predefined position for at least one, in particular more than one, monitored (preferably single-use) system component 22 (in particular tube 5), and at least one position for a display component 25 (in particular an LED strip 29), the display component 25 being immediately adjacent to, in particular behind, the position of the monitored system component 22. Placing the display component 25 in the predefined position makes it easy for a user to assemble the display arrangement 21, or even for the manufacturer of the (preferably multiple-use) system component 6 to preconfigure the display arrangement 21. Thus, the display arrangement 21 can be at least partially preconfigured.

[0093] Preferably, if Figure 2 As shown in FIG. AA, at least one location for the display component 25 is a recess 34 in which the display component 25 is placed. The display component 25 can be placed completely inside the recess 34 and / or arranged flush with the surface where the recess 34 is located. In this way, the display component 25 does not get in the way when the system component 6 is operated.

[0094] like Figure 2 AA" and AA"', these locations can also include fastening elements 35 for one or more disposable components (in particular one or more tubes 5) and / or for one or more display components 25. Preferably, one or more display elements and / or one or more disposable components can be snapped into the fastening elements 35.

[0095] According to another embodiment, it is proposed that the assembly information includes information on whether the monitored system component 22 assigned to the corresponding display component 25 has been correctly assembled. Alternatively or additionally, the assembly information may include information on whether the monitored system component 22 (particularly the sensor 8) has been correctly connected and / or calibrated. Alternatively or additionally, the assembly information may also include information on whether the calibration of the monitored system component 22 was successful.

[0096] Preferably, the process information includes information based on sensor values ​​of sensors 8 of the bioprocess system 1, which are used to monitor process parameters of the bioprocess during bioprocess operation. The sensor values ​​describe the bioprocess operation with respect to the corresponding monitored system component 22, thereby monitoring the monitored system component 6. One or more sensors 8 may include a liquid flow sensor 17 and / or a pressure sensor 12, which inherently can describe the bioprocess operation not only with respect to the monitored system component 22 directly associated with the sensor 8, but also, for example, with respect to fluidically coupled monitored system components 22.

[0097] Assembly information can be displayed during initial assembly, during assembly when modifying a bioprocessing operation, and / or during changes of some components when entering a new phase of a bioprocessing operation, and / or for disassembly and / or reassembly (particularly when changing single-use components).

[0098] After assembling the bioprocess system 1, bioprocess operation can begin. The proposed display arrangement 21 allows the use of the same display component 25 during assembly and during bioprocess operation. Thus, it may be the case that the process information includes information such as whether the monitored system component 22 assigned to the corresponding display component 25 is operating within normal parameters, and / or whether a warning has been triggered with respect to the monitored system component 22, and / or whether an error has been triggered with respect to the monitored system component 22.

[0099] Can be based on Figure 2 To understand this, the display component 25 paired with the liquid pump 16 of the first liquid inlet line 23 can indicate during assembly that a disposable pump head is now to be installed. After the disposable pump head is installed and during operation of the bioprocess, the display component 25 paired with the liquid pump 16 now connected to the pump head can indicate whether the pump is operating within a predetermined range of revolutions per minute. This is indicated in the fourth liquid inlet line 26, to which the pump head and tubing 5 are already installed. In this case, the light-emitting element 27 can emit a green light. As will be explained further below, if the monitored system component 22 is operating within normal parameters, this can also be indicated by the light-emitting element 27 not emitting any light.

[0100] Additionally or alternatively, the process information may include information based on sensor values ​​of sensors 8 of the bioprocess system 1 , the sensors 8 being used to monitor process parameters of the bioprocess during operation of the bioprocess.

[0101] The possible continuous use of the display arrangement 21 is further specified in that the assembly information and the process information preferably comprise information based on sensor values ​​of the same sensor 8, which information is preferably displayed by the same display means 25 and / or lighting element 27 (albeit at different times).

[0102] In simulation mode, the display arrangement 21 may show a simulation of the use of the bioprocess system 1. For example, a programmed flow chart may be shown by light patterns on the bioprocess system 1 before the bioprocess system 1 is actually used according to the flow chart.

[0103] Here, and preferably, in order to save energy, the display component 25 may be disabled when not needed, for example when the corresponding monitored system component 22 is operating under normal conditions.

[0104] This is particularly advantageous when there are several monitored system components 22, as it will help the user more easily identify errors or warnings. This will also save costs, as the light emitting element 27 will consume less power when the paired monitored system components 22 are operating within normal parameter ranges.

[0105] According to one embodiment, it is provided that the process information includes the status of the monitored system component 22 assigned to the corresponding display element 25, preferably the open and / or closed state of the valve 7. The display element 25 can also show the process diagram, for example by showing all active fluid-conducting lines and valves 7 in green.

[0106] In a preferred embodiment, the process information and / or assembly information displayed by the display arrangement 21 via the at least one display member 25 is user selectable. By configuring, for example, threshold values, the user can adapt the display arrangement 21 to his personal needs.

[0107] For ease of configuration, preferably the user can select between different display modes and / or configure the display mode, in particular by defining normal parameter ranges. A display mode can be a flow chart and / or a process step monitoring mode and / or a process quality monitoring mode.

[0108] In one possible embodiment, the manufacturer defines some thresholds and the user may configure other thresholds for process parameters of the display arrangement 21. The thresholds may be used to trigger warnings or alarms.

[0109] According to one embodiment, it is proposed that: at least one display component 25 is fixedly mounted on the (preferably multi-use) system component 6, and / or at least one display component 25 can be flexibly mounted by the user and can be connected to the control arrangement 24 and preferably can be flexibly assigned to the system component 6.

[0110] The control arrangement 24 can be configured to operate in different process modes, preferably including: a setup mode for initial assembly, and / or an operation mode for general operation, and / or a quality control mode for specific operations to check the quality of a bioprocess operation, and / or a key process step mode for providing more information during key process steps. The display arrangement 21 and / or at least one display component 25 can be controlled differently based on the current process mode, thereby providing different information based on the process mode.

[0111] Another teaching of equal importance relates to a bioprocess system component 6, in particular a multiple-use bioprocess system component 6, comprising at least one predefined location for at least one, in particular more than one, monitored single-use system component 22 (in particular a tube 5), and at least one location for a display component 25 (in particular an LED strip 29), the display component 25 being located immediately adjacent to, in particular behind, the location of the monitored single-use system component 22. Preferably, the at least one location for the display component 25 is a recess 34, in which the display component 25 is placed. More preferably, the display component 25 is placed completely inside the recess 34.

[0112] All explanations given with respect to the proposed bioprocess system 1 , in particular any explanations given with respect to the multiple-use components, are fully applicable.

[0113] Another teaching of equal importance relates to the use of bioprocess system components 6 , in particular multi-use bioprocess system components 6 , in the proposed bioprocess system 1 .

[0114] All explanations given for the proposed bioprocess system 1 and the proposed bioprocess system component 6 are fully applicable.

[0115] Another teaching of equal importance relates to the use of the display element 25 in the proposed bioprocess system 1 .

[0116] All explanations given with respect to the proposed bioprocess system 1 , the proposed bioprocess system component 6 and the use of the proposed display component 25 are fully applicable.

[0117] Another teaching of equal importance relates to the control arrangement 24 for the proposed bioprocess system 1 .

[0118] All explanations given with respect to the proposed bioprocess system 1 , the proposed bioprocess system component 6 , the use of the proposed display component 25 and the use of the proposed control arrangement 24 are fully applicable.

[0119] According to one embodiment, it is proposed that the control arrangement 24 is an electronic process control 19 for controlling bioprocess operations. As described above, the electronic process control 19 may control valves 7, sense sensor values ​​and the like.

[0120] Another teaching of equal importance relates to a method of operating a bioprocess system 1 , wherein a control arrangement 24 displays process information and / or assembly information relating to monitored system components 22 via light-emitting elements 27 .

[0121] All explanations given with respect to the proposed bioprocess system 1 , the proposed bioprocess system component 6 , the use of the proposed display component 25 and the use of the proposed control arrangement 24 , as well as the proposed control arrangement 24 , are fully applicable.

Claims

1. A bioprocess system for a bioprocess operation, the bioprocess system having a display arrangement (21) for displaying system information about the bioprocess system (1), wherein the bioprocess system (1) comprises system components (6), the system components (6) comprising at least one monitored system component (22), wherein the system components (6) can be assembled into an assembled state in which the bioprocess system (1) is operable for the bioprocess operation, and wherein the system components (6) can be disassembled into a disassembled state in which the bioprocess system (1) is not operable for the bioprocess operation, wherein the bioprocess system (1) comprises a control arrangement (24) and the display arrangement (21) comprises at least one display element (25), wherein during operation of the bioprocess, in the assembled state of the bioprocess system (1), the control arrangement (24) displays process information via the display arrangement (21), and / or wherein during assembly of the bioprocess system (1), the control arrangement (24) displays assembly information via the display arrangement (21), wherein the process information and / or the assembly information relates at least to the monitored system component (22), and wherein the display arrangement (21) comprises at least one display element (25), It is characterized by The display component (25) comprises a light emitting element (27) which is arranged separately from the monitored system component (22) and is arranged next to or on the monitored system component (22), and the control arrangement (24) is configured to display the process information and / or the assembly information relating to the monitored system component (22) via the light emitting element (27).

2. The bioprocess system according to claim 1, characterized in that The display component (25) is an LED bar (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 is encoded into the color and / or brightness and / or pattern of one or more of the light-emitting elements (27).

3. The bioprocess system according to claim 1 or 2, characterized in that The control arrangement (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), and 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 part (25), and / or via at least two, preferably at least three, more preferably at least four display parts (25) of the display arrangement (21), preferably, each of the display parts (25) and / or each of the light-emitting elements (27) being assigned to only one or only two monitored system components (22) at a time.

4. The bioprocess system according to claim 1, characterized in 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 regularly contains and preferably conducts fluid during the bioprocess 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. The bioprocess system according to claim 1, characterized in that The at least one display element (25), in particular at least one LED strip (29), is arranged to extend with a longitudinal extension (30) along at least one, in particular exactly one, monitored system component (22), preferably The at least one display component (25), in particular at least one LED strip (29), is arranged to extend with a longitudinal extension (30) at least partially parallel to at least one, in particular exactly one, monitored system component (22).

6. The bioprocess system according to claim 1, characterized in that The bioprocess system (1) is configured such that at least one monitored disposable component assigned to the at least one display component (25) can be exchanged for a new disposable component, and the new disposable component can be assigned to the at least one display component (25).

7. The bioprocess system according to claim 1, characterized in that The at least one display element (25) is arranged behind a transparent monitored system component (22) and is assigned to the transparent monitored system component (22), preferably the transparent monitored system component (22) being a pipe (5).

8. The bioprocess system according to claim 1, characterized in that At least one multiple-use system component (6) comprises: at least one predefined position for at least one, in particular more than one, monitored disposable component, and at least one position for a display component (25), the monitored disposable component being in particular a tube (5), the display component (25), in particular an LED strip (29), the display component (25) being immediately adjacent to, in particular behind, the position of the monitored disposable component, preferably, the at least one position for the display component (25) being a recess (34), the display component (25) being placed in the recess (34), more preferably, the display component (25) being placed completely inside the recess (34).

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

10. The bioprocess system according to claim 1, characterized in that The process information includes the following information: whether the monitored system component (22) assigned to the corresponding display component (25) is operating within a normal parameter range, and / or whether a warning regarding the monitored system component (22) has been triggered, and / or whether an error regarding the monitored system component (22) has been triggered, and / or, the process information includes information based on sensor values ​​of sensors (8) of the bioprocess system (1), the sensors (8) being used to monitor process parameters of the bioprocess during operation of the bioprocess, preferably, the assembly information and the process information include information based on the sensor values ​​of the same sensors (8), and the information is preferably displayed by the same display component (25) and / or light-emitting element (27).

11. The bioprocess system according to claim 1, characterized in that The process information comprises the status of the monitored system component (22) assigned to the corresponding display component (25), preferably the status being the open and / or closed state of a valve (7).

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

13. The bioprocess system according to claim 1, characterized in that The at least one display element (25) is fixedly mounted on the multiple-use system element (6) and / or the at least one display element (25) can be flexibly mounted by the user and can be connected to the control arrangement (24) and preferably can be flexibly assigned to the system element (6).

14. A bioprocess system component, in particular a multi-use bioprocess system component (6), comprising: At least one predefined position for at least one, in particular more than one, monitored disposable component (22), and at least one position for a display component (25), the monitored disposable component (22), in particular a tube (5), the display component (25), in particular an LED strip (29), the display component (25) being immediately adjacent to, in particular behind, the position of the monitored disposable component, preferably, the at least one position for the display component (25) being a recess (34), the display component (25) being placed in the recess (34), more preferably, the display component (25) being placed completely inside the recess (34).

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

16. Use of a display element (25) in a bioprocess system (1) according to one of claims 1 to 13.

17. Control arrangement for a bioprocess system (1) according to one of claims 1 to 13.

18. A control arrangement according to claim 17, characterised in that The control arrangement (24) is an electronic process control (19) for controlling the bioprocess operation.

19. Method for operating a bioprocess system (1) according to one of claims 1 to 13, wherein the control arrangement (24) displays the process information and / or the assembly information relating to the monitored system component (22) via the light-emitting element (27).

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