Provides a method for automatically configuring a test and a bioprocess system

Abstract

The present invention relates to a method for automatic configuration in a biological process system (10) and for verifying a process defined by a flow path representation. The method includes the following steps: - capturing an image of the biological process system (10), the biological process system (10) including conduits (50) for fluid communication between units of the biological process system (10); - analyzing the captured image to identify the conduits (50) connecting the units of the biological process system (10); - generating a processed representation from the captured image, wherein at least a portion of the conduits (50) is identified; and - comparing the processed representation with a flow path representation to verify their functional consistency.

Description

Technical Field

[0001] The present invention relates to bioprocess systems and, in particular, to systems and methods for testing and validating system configurations. Background Art

[0002] Modern bioprocess systems (such as chromatography systems) are usually provided to end users as modular and highly flexible systems. Modern bioprocess systems usually include a frame or rack, in which multiple valves, pumps, detectors, fraction collectors, etc. in the form of individual modules can be installed. The module usually has a connection for electrical power and electronic communication on the back side of the inner back side facing the mounting frame. CPU and bus systems, etc. provide electronic communication capabilities, and connect the bioprocess system to a PC, a tablet or a dedicated computer, etc., for controlling processes, presenting information and results, storing information and external communications. Fluid communication between modules is usually provided by flexible pipes (tubing) on ​​the front side of the module. Different functionalities are provided by different configurations, wherein one configuration utilizes a subset of modules, and another configuration utilizes different subsets. Configuration is usually linked to a flow path, which represents the modules involved, their fluid connections and functionality. Flow path is a tool for establishing different functions (such as detection using a connected chromatogram) and for monitoring both processes. Flow path is usually presented graphically on a PC as part of a GUI.

[0003] Bioprocess systems are usually delivered with multiple predefined configurations including related modules, which include pipes that provide fluid communication between modules. Alternatively, the bioprocess system is provided "non-preconfigured", and the mounting frame and modules and pipes are purchased separately and built by the end user. In either case, the end user can configure his own system by modifying the existing configuration or building a new configuration from scratch. Similarly, the modification of the existing bioprocess system can be carried out from replacing worn or contaminated pipes to testing and realizing a completely new configuration. Through the built-in electronic communication system and the electronic identification of the individual modules, the representation of the flow path and the link between the modules are automatically provided by the bioprocess system. Similar automatic functionality does not exist for fluid communication. The front of the bioprocess framework is usually visually inspected by the user. The graphical representation of the flow path can include annotations or graphics indicating the actual connection between the modules as an auxiliary tool. In addition, users usually use annotations, sketches or images to record (document) the establishment. However, because modern bioprocess systems are able to simultaneously provide a large number of different functions, flow paths, and because the flexibility in the choice of modules and their positions in the framework is so great, the complexity can be high. In addition, the sheer number of pipeline segments, their loops and possible entanglements make it difficult to link flow paths to the correct set of pipelines. This problem is most evident in modular bioprocess systems, but also exists to a large extent in non-modular bioprocess systems, because pipelines can be equally complex and errors can be made when, for example, replacing pipelines or components of pipelines.

[0004] US8821718 describes a bioprocess system which would advantageously benefit from the methods and systems according to the present invention and is hereby incorporated by reference in its entirety.

[0005] US 9304518 discloses systems and methods for assisting in identifying and coordinating fluid connections between modules in a modular bioprocess system, and is hereby incorporated by reference in its entirety. The system disclosed in US 9304518 requires both new hardware and software in order to make the described advantages available to users, and therefore may not be fully usable with existing systems. Summary of the invention

[0006] The object of the present invention is to provide a method of verifying or validating that the physical configuration of a bioprocess system is in correspondence with the flow paths defined in the system software. This is particularly relevant in modular bioprocess systems where units and piping may have been rearranged.

[0007] This is achieved by the method for a bioprocess system according to the independent claim.

[0008] A method for automatically configuring a test in a bioprocess system according to the present invention, wherein the process is defined by a flow path representation, comprises the following steps:

[0009] - capturing at least one image of a bioprocess system comprising conduits for fluid communication between units of the bioprocess system.

[0010] - Analyzing at least one of the captured images in an analysis routine to identify at least a portion of a pipe connecting the units of the bioprocess system.

[0011] - generating a processed representation from at least one captured image in which at least a portion of a pipeline is identified.

[0012] According to one aspect of the invention, the verification is performed by a step of comparing the processed representation with the flow path representation to verify their functional consistency. The comparison step may be an automatic step. Alternatively, the comparison is performed by a user of the bioprocess system using, for example, the processed representation in the form of a processed image and the flow path representation in the form of a flow path diagram.

[0013] According to one aspect of the invention, the processed representation comprises the processed image and optionally also a list describing the conduits and how the conduits interconnect the modules / units of the bioprocessing system.

[0014] The method according to the invention can utilize at least two captured images to generate a processed representation. The image analysis routine can determine that more images are required or at least may be advantageously used in the identification of the pipe and / or unit, and generate and forward instructions to the operator to capture one more image. The analysis routine can also, for example, identify that an active action is required in order to be able to identify individual features in the image, and instruct the operator to perform (perfume) the active action, such as to move a portion of the pipe, unfold the tube bundle, change the position of the camera, or change the lighting.

[0015] According to one aspect of the invention, the image analysis routine communicates to the user instructions to capture additional images, or alternatively a notification to stop capturing images. The instructions may be supplemented with instructions to perform an effective action.

[0016] Image analysis can utilize prior information related to the bioprocess system. Examples of prior information include, but are not limited to, knowledge of the types of units present in the bioprocess system, the coloring of portions of the pipeline, identification labels, and the like.

[0017] According to one aspect of the present invention, a user captures a plurality of images using a camera, and in the analyzing step, the user receives a notification to capture additional images, or alternatively, the user receives a notification to stop capturing images.

[0018] The method according to the invention may comprise the step of generating an enhanced live view image of the bioprocess system using the processed representation in the form of a processed image, wherein portions of the conduit are distinguishably marked in the enhanced live view image.

[0019] A method according to the present invention may include the step of generating an enhanced live view image of a bioprocess system using a processed representation comprising at least a processed image so as to visually mark portions and units of pipelines involved in specific process steps in the enhanced live view image, wherein the enhanced live view image illustrates at least one step in the process represented by the flow path representation.

[0020] The method according to the present invention can be used to facilitate the establishment and modification of a bioprocess system. An enhanced live view image of the bioprocess system can be generated to indicate to a user where at least one individual pipe connection should be connected. In the flow path representation, at least one individual pipe connection corresponding to a portion of the flow path is identified, and a unit to be used in the portion of the flow path is identified, and the identified unit is marked in the enhanced live view image. The processed image can be used as a component in the enhanced live view image at least in part as an overlay to the live view image.

[0021] According to one aspect of the invention, the processed representation is compared to a representation of the flow path to identify faulty connections and / or missing portions of tubing.

[0022] Thanks to the method and system according to the invention, automatic configuration detection of a bioprocess system can be provided. This is particularly important for modular and / or complex setups, where it may be difficult to pick out the configuration by optical inspection alone.

[0023] One advantage of the present invention is that automatic detection can be used to link a processed representation (e.g., an image and / or a list) to a flow path representation. The established link can be used to validate the system, but also for troubleshooting, facilitating the creation or modification and collecting user information. This represents a major improvement over currently available manual procedures. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1a Schematic illustration of a bioprocess system in which the method according to the invention can be utilized, wherein a) illustrates a mounting frame in a perspective view, b) illustrates the mounting frame with a plurality of modules in an exploded perspective view, and c) is a complete bioprocess system in an elevation view;

[0025] FIG2 is a schematic representation of a flow path typically used in a bioprocess system in which methods according to the present invention may be utilized;

[0026] Figure 3 is a schematic diagram of a processed image produced by the method according to the present invention;

[0027] Figure 4a -d is a schematic diagram of an enhanced image and an enhanced live view produced by the method according to the present invention;

[0028] Figure 5 is a flow chart of a method according to one embodiment of the present invention. DETAILED DESCRIPTION

[0029] The method according to the present invention relates to the establishment, validation and maintenance of bioprocess systems, in particular modular bioprocess systems (e.g. chromatography systems). Figure 1a -c is schematically depicted, with Figure 1a is the mounting frame in perspective view, with Figure 1b is a mounting frame in an exploded perspective with multiple modules providing different functions in the system, and attached Figure 1c It is a complete bioprocess system in the front view. Bioprocess system 10 includes a mounting frame 15, which has a plurality of compartments 16 in which modules 20 can be accommodated. Compartments 16 can usually accommodate a module each, and can have different sizes, but preferably only in a few standardized sizes. A wide range of modules can be installed in the system, including but not limited to pump modules, valve modules, detector modules, mixing modules and fraction collectors. In the accompanying drawings, module 20 is illustrated by multiple valve modules 20:1, multiple pump modules 20:2 and multiple detection modules 20:3 of different types. Bioprocess system 10 can also be equipped with, for example, one or more chromatographic columns 25, liquid storage containers 26 and containers 27 for accommodating separation fractions. Moreover, other multiple pieces of equipment (not shown) can be provided on or near the mounting frame. Module 20, chromatographic column 25 and other equipment as components of bioprocess system 10 will be referred to as the unit of the bioprocess system and the type of unit.

[0030] The mounting frame 15 is in communication connection with the processing unit 40. The processing unit 40 can be, for example, an integrated CPU in the mounting frame, a stand-alone PC, a laptop PC or a tablet, and generally includes a software suite (suit) for controlling the bioprocess system 10, including algorithms and routines required for performing measurements or production, setting up the system, maintaining the system, storing and analyzing data, etc. The software suite can be, for example, a combination of proprietary software provided by a bioprocess system manufacturer, open software that provides specific analysis, and routines and modifications generated by an end user to adapt the system to specific requirements. The term "system software" will be used hereinafter to represent the software required for setting up, running and maintaining the bioprocess system. Data and system information are generally presented on a graphical unit interface GUI (e.g., a touch screen 41 connected to the processing unit 40).

[0031] The module 20 is provided with electrical contacts on its back side, which are arranged to cooperate with corresponding electrical contacts provided in the compartment 16 of the mounting frame 15. The electrical contacts transmit two signals to and from the module 20 to the mounting frame 15, and provide power to the module for its operation. The module 20 has a separate means for identification (called module ID), which can be read by the processing unit 40 or transmitted to the processing unit 40. The bioprocess systems currently sold on the market generally do not have the ability to provide information about the exact position of the module 20 in the mounting frame 15 to the system software. With modular systems and the possibility of users reconfiguring the system, the system software may not know the location of the module, even if that location is known to be delivered in a preconfigured state. In addition, some bioprocess systems have the possibility of incorporating plug-in modules into the system individually or in a smaller mounting frame including several module positions. In other words, the system software knows which modules are available and their corresponding functions and parameters, but does not know their locations. Future bioprocess systems with knowledge of the exact location of individual modules can be envisioned, for example, by providing RFID tags for the modules 20. This position information can be used in the method according to the invention, which will be exemplified below.

[0032] The bioprocess system 10 is provided with a network of pipes 50, thereby providing fluid communication between different units of the bioprocess system 10 (e.g., modules 20, chromatography columns 25, and storage containers 26). The pipes 50 can extend between the units as separate entities, but can also be joined in a bundle 51. The pipes 50 can be used only for transmission, but can also have functions alone, such as forming a loop 52 or being an integral part of a detection device or passing through a peristaltic pump. The pipes 50 are usually disposable and are replaced regularly due to wear or contamination. The pipes 50 are usually connected to the valves and other units of the module 20 via connectors called hand-tight fittings, which provide tool-free operation. Individual pipe connections are usually pipes of standardized inner dimensions so that a certain length will maintain a predictable volume. The pipe connections can be color-coded so that a specific color represents a specific inner diameter. To some extent, the inner diameter is reflected on the outer diameter of the pipe connection, so that pipe connections of different thicknesses can be distinguished. However, there is no direct or standardized relationship between the inner diameter and the outer diameter of the pipe.

[0033] A camera 60 is provided for acquiring images of the modular bioprocess system 10. The camera 60 may be a dedicated camera, but equally a device with camera facilities (e.g. a smartphone, tablet or laptop). The camera 60 is equipped to transmit the captured images to, for example, the processing unit 40, and preferably wirelessly, e.g. via Bluetooth or WiFi.

[0034] The above communication system should be viewed as a functional description. As recognized by the skilled person, communication between different entities in the system can be achieved in many different ways. In addition, communication is a rapidly developing field. Different standards and protocols can be used for communication, and the communication can be wired (wire-bound) (as described above) or wireless or a combination of the two. For example, the signaling between the module 20 and the processing unit 40 can be via a wireless protocol (such as NFC or Bluetooth) and an electrical contact that mainly provides power to the module. Another possibility is that the units in the system (such as the module 20, the mounting frame 15 and the processing unit 40) are individually connected to WiFi, and the communication between the units is indirect via WiFi.

[0035] The specific process utilizing at least one flow path to be performed by the bioprocess system 10 is defined by a script in the system software. A plurality of scripts are typically provided by the system manufacturer, but may also be programmed by the end user or provided by a third party provider. The end user may also choose to modify an existing script to customize the process.

[0036] The script is typically supplemented by a process image or flow diagram given a graphical representation of the process according to the script, and also serves as a graphical interface to the process. In the following, the term "flow representation" is used to describe information stored by the system software that describes a specific configuration in a functional manner. It should be understood that a "flow representation" can be a process image or a flow diagram, and can also contain non-graphic information or consist entirely of non-graphic information. Figure 2a is an example of a flow diagram presented to a user, for example on a GUI 41. The flow diagram in Figure 2a represents a detection process using a chromatographic column 25 and a UV detector in combination with multiple valves and pumps.

[0037] The flow path representation can be used in a variety of ways. During the preconfiguration process, the user uses the flow path representation to visualize and understand the process and, for example, switch valve positions. During operation, the user can monitor the process in real time via the flow path representation corresponding to the process. The flow path representation can also be used to modify an existing process or establish a completely new process in some cases, although most software suites associated with bioprocess systems do not yet allow this type of high-level object programming. From an electronic / electrical communication point of view, the processing unit can be updated all the time (on all time) so that changes automatically indicated in the flow path representation are reflected in how the modules and other units interact. However, for fluid connectivity (i.e., pipelines), no such control and automation is possible for today's systems-the user must manually check that the pipeline matches the flow path.

[0038] The method according to the invention comprises a dedicated image analysis optimized for the automated detection of configurations of bioprocess systems.

[0039] According to one aspect of the invention, the results of the image analysis are used to verify at least one aspect of the functionality of the bioprocess system (10), typically functionality related to a specific process performed or to be performed by the bioprocess system 10 and defined by the flow path representation.

[0040] By image analysis of at least one photographic image of a bioprocess system, a processed representation or other information is generated that identifies characteristic elements in the image. Characteristic elements include, but are not limited to, pipes or portions of pipes. The image analysis includes the following steps:

[0041] A) Capturing at least one image of the bioprocess system 10 (typically the front side of the bioprocess system 10)

[0042] B) analyzing the captured image to identify at least a portion of the pipeline 50. Optionally also identifying other units of the bioprocess system 10. The analysis is preferably performed by an image analysis routine resident in the camera 60 or in the processing unit 40. Alternatively, the analysis routine resides in a remote server or the like with which the camera 60 or the processing unit 40 is able to communicate.

[0043] C) generating a processed representation in which at least a portion of the individual pipe connections are identified. The processed representation may be graphical, for example as a processed image, in which the identified pipe connections are distinguishably marked, for example by individual artificial colors and / or in the form of a list of the identified pipe connections and units to which they are connected. Figure 3 1 shows a processed image as it may be presented to a user on a GUI. All individual pipe connections are identified as objects in the image. Figure 3 In the processed image, it may be more convenient to give color coding or other graphical identification to the identified individual pipe connections. The processed image may be as follows Figure 3 , or alternatively, a photograph of the front of the bioprocess system with the identified pipelines, for example, as an artificial overlay. Moreover, other objects, such as valves and detectors, may be identified as recognizable objects and presented as an artificial overlay. The processed image may be presented to the user together with a list of the identified pipelines and units, or the list may be presented separately, for example, on demand. A number of options regarding how the processed image should be presented may be selectable by the user.

[0044] In image analysis, multiple images may be utilized, which represents one aspect of the present invention. One example of using multiple images is to identify individual pipes in a bundle. By using multiple images, for example taken at different angles and / or from different positions, pipes or portions of pipes that are hidden in one view may be visible in another view, and using more than one image may facilitate identification. The camera operator may be instructed by the image analysis program to capture additional images from various positions until the image analysis program is able to identify the object at a certain predefined level of certainty.

[0045] According to one aspect of the invention, the camera operator is instructed by the analysis program to perform effective actions to aid in image analysis. A set of possible effective actions is predetermined and stored in the system along with information about which identification problem the effective action relates to. Typically, problem areas are identified during image analysis, such as areas with complex pipe bundles. Other problems may be general, such as poor lighting, which renders the analysis as problematic overall. Effective actions may include, but are not limited to:

[0046] - Changing the angle and / or distance between the camera 60 and the bioprocess system 10

[0047] - changing lighting conditions,

[0048] - unfold the pipe bundle so that the individual pipe connections are visible,

[0049] - moving a pipe connection so that it can be identified within a set or bundle of pipes. This identification can be simplified if the pipes are provided with some type of marking (e.g. dots or bars at preferably regular intervals),

[0050] - moving parts of the pipeline so that for example a label or other means of fixing identification on the module can be visible,

[0051] - If using such labels, move the labels on the pipe.

[0052] For some of the above mentioned validation actions, it may be advantageous to use video instead of still images, and image analysis should be understood to include video analysis where this is appropriate.

[0053] If multiple images or videos are utilized, steps A and B can be viewed as a loop that runs as long as required to perform recognition.

[0054] According to one aspect of the present invention, image analysis using prior knowledge is utilized. Prior knowledge may be, but is not limited to, information about which type of modules 20 and other units are present in / on the mounting frame 15, the location of the modules 20 in the frame (if such information is available), information about the units and their order in a particular flow path, and the initial configuration associated with the bioprocess system 10 "as delivered". The image analysis routine / program may also utilize markings on the mounting frame 15 or units to scale and / or align the captured image. These markings may be provided for this purpose on the bioprocess system, but may also be existing features, such as logos, model numbers, or other visually distinguishing features (known for their size and color, etc.). Image analysis may further utilize a limited number of known shapes that may be seen in the image. For example, characteristic shapes of elongated pipes, valves, pumps, and columns, and even the color of objects. The color and / or outer diameter of the pipe, while not standardized, can still be used to identify, for example, a specific pipe connection entering and leaving a pipe bundle. Additional knowledge that the pipe passes through the device in certain pumps and detectors can be used to identify that it is the same pipe connection, although hidden from view when inside the device. The prior knowledge is preferably provided in one or more databases accessible by the unit performing the image analysis, such as the processing unit 60. The prior art knowledge database may be a local database or a centralized database accessible via a client-server setup, for example, contained and maintained by the manufacturer. For example, if a new module is introduced or a module is modified in its appearance, the client-server setup will facilitate updating the prior knowledge database. Alternatively, if the prior knowledge database is local, it may be updated regularly and / or on demand from a central database.

[0055] The image analysis routine may include a validation step in which the user verifies that the proposed processed image or portion of the processed image corresponds to the user's perception of the biological process system.

[0056] The image analysis (main step B)) is typically performed in the processing unit 40 and the captured image captured by the camera device 60 is transmitted to the processing unit 40. Alternatively, the processing capacity of the capture device (e.g. a smartphone) is used for at least part of the image processing and the processed representation is passed to the processing unit 40.

[0057] According to one aspect of the invention, the image analysis is based on image data only, ie information generated only from individual pixels in the image, which is referred to as image analysis without a priori knowledge.

[0058] Image analysis may further include multiple operations well known in the field of automatic image analysis. Such operations include, but are not limited to, alignment / straightening, scaling, segmentation, and feature isolation. Image analysis may use artificial intelligence techniques for feature recognition, such as neural networks and deep learning.

[0059] The results of the image analysis represented by the processed representation can be used to verify aspects of the functionality of the system. Verifying aspects of functionality should be given a broad interpretation, including verifying that the pipeline corresponds to the process defined by the flow path representation (e.g., flow path diagram), troubleshooting, optimization, visualization of measurement / separation procedures, setting up or modifying processes, etc. As an example, the processed representation in the form of a processed image and / or list provides a way to verify that the process (e.g., represented by the flow path diagram) is correctly configured for the fluid connections in the bioprocess system 10 (particularly for the pipelines 50 and units).

[0060] According to one aspect of the invention, the functional consistency between the flow path representation and the actual conduit is verified by comparing the processed representation resulting from the image analysis with the flow path representation. This may be a manual process, where a user compares, for example, a flow path diagram with the processed image and / or list to verify that the flow path corresponds to the conduit. Alternatively, it is an automated process. The procedure (whether manual or automated) may include user approval of the consistency of the flow path representation and the processed representation.

[0061] According to one aspect of the present invention, image analysis performed on a photographic image of a bioprocess system is used to establish a link between the flow path and the pipes and units. According to one embodiment, the established link between the flow path and the network of pipes and units of the bioprocess system 10 is used to monitor the process running on the bioprocess system 10, verify the process, and / or modify or optimize the process.

[0062] According to one aspect of the present invention, established links between flow circuits and elements of the bioprocess system 10 are established to provide a visual aid in connecting tubing to the various elements to participate in processes associated with the flow circuits.

[0063] The processed representation may be presented to the user on a GUI connected to the processing unit 40. Alternatively, a separate screen or goggles (e.g., virtual reality glasses) may be used for presentation. According to one embodiment of the present invention, the results of the image analysis in which one or more pipes have been identified are presented with the aid of augmented reality AR or virtual reality VR. Using AR or VR, the visual identification of the plastic pipe or collection of pipes is overlaid on the live image of the bioprocess system 10, thereby forming an augmented image of the bioprocess system.

[0064] Testing using the processed representation and the flow path representation according to one aspect of the invention may include one or more of the following steps:

[0065] a) Linking the flow path representation to the processed image and generating an enhanced image in which the pipes and optionally also the modules / units belonging to a specific flow path are given a common identification (e.g. the same color). Thus multiple pipes 50 and optionally modules 20 and other units used in the same process can be grouped and identified in the processed image. Figure 4a The schematic diagram illustrates how multiple individual pipe connections used in the same process are marked as dashed lines in the enhanced image presented to the user on the GUI. Alternatively, a list of the relevant portion(s) of the pipe 50 is generated using the processed representation in list form and links to the flow path representation.

[0066] Live View Along the Flow Path: According to one aspect of the invention, the established link between the flow path diagram and the image of the bioprocess system 10 is used to present an enhanced live view image. As the process proceeds, the conduits 50 and optional modules 20 are marked (e.g., illuminated) in use in the enhanced live view image and also in the flow path diagram. This Figure 4b 2 b. Preferably, as indicated in the figure, the enhanced live view image and the flow path diagram are visible on the same screen. As an alternative, one or more enhanced still images can be presented. According to one embodiment, the simultaneous marking of active modules and pipelines is used by the user to verify that the network of pipelines is correctly connected and corresponds to the flow path defined, such as measurement. Enhanced live view or enhanced still image series can be recorded for later analysis. The flow path diagram and the enhanced live view image can be presented to the user simultaneously, for example, on the same screen showing the flow path diagram and the enhanced live view image of the bioprocess system 10, wherein the pipeline and / or unit under the current operation are indicated in the enhanced live image and on the flow path.

[0067] b) Troubleshooting: According to one aspect of the invention, the established link between the flow path representation and the image of the bioprocess system 10 is used to identify malfunctions of the bioprocess system. Such malfunctions may be, for example, a missing pipe connection or one end of a pipe connection not being coupled to a hand-tight. Some malfunctions may be identified from the processed image alone (e.g., a loose pipe end). Other aspects may be identified through the link to the flow path representation by indicating differences between the representations. Differences (e.g., missing pipe connections) may be indicated on the enhanced live view image, similar to that described above. Figure 4c In the diagram, missing individual pipe connections are shown with dashed lines, while missing connections are shown with dotted lines.

[0068] c) Assisted establishment: According to one aspect of the present invention, the established link between the flow path representation and the image of the bioprocess system 10 is used to facilitate the establishment of a new process or to modify an existing process. The method comprises the following sub-steps:

[0069] - Identify or construct a flowchart diagram representing a new or modified process

[0070] - Using the established link between the flow path representation and the image of the bioprocess system 10 to produce one or a combination of the following:

[0071] -- An enhanced image of a bioprocess system illustrating how pipes 51 should be connected to the units;

[0072] -- A series of enhanced images that step-by-step illustrate how each pipe connection or selection of pipes should be connected to the unit;

[0073] -- An enhanced live view of the bioprocess system 10 illustrating step-by-step how each pipe connection or selection of pipes should be connected to a unit.

[0074] Figure 4d Illustrated in the diagram is how a live view or still image can indicate where individual pipe connections should be connected, see the dotted circle and arrows at the top of the image indicating in which hand-tight fittings the two ends of the pipe should be connected.

[0075] d) Collecting user information: If permitted by the end user, the image or processed representation may be forwarded to the manufacturer. This can be used for support (e.g. troubleshooting) and also enables the manufacturer to gather information about the use of the device. For example, identifying common configurations and also identifying configurations that do not fully utilize the device capabilities in order to provide the end user with suggested improvements or to provide new or modified pre-configurations can be of high value.

[0076] A non-limiting example of an implementation of the method according to the invention is Figure 5 The flowchart is shown in FIG. 1 and includes the following steps:

[0077] 501 Capturing an image of a bioprocess system 10 provided with a pipeline 10

[0078] 502 Analyze the captured image to identify at least a portion of the pipe 50. Optionally using prior knowledge as described above

[0079] 503 Determine whether the pipe and optionally other features from the captured image are sufficiently identified. For example, a large portion of the pipe may be identified, but in some portion of the captured image, the individual pipe connections appear to overlap, making it impossible for the image analysis routine to resolve the individual pipe connections in that portion. If sufficient, continue to generate a processed representation in step 520. If not, continue to make an assessment of how the image can be improved in step 506

[0080] 506 Determine if more images should be captured. If more images should be captured, proceed to step 508. If it is determined that more images will not improve, even if the feature is not fully recognized, proceed to step 507.

[0081] 507 indicates that not all pipes and / or all other features may be identified, optionally including information on the location and extent of problem areas of the image. The processed representation may still be valuable, and therefore proceed to generate the processed representation (step 520). This step may include and confirmation procedure, where the user approves / disapproves further generation of the processed representation

[0082] 508 One or more problem areas were identified, such as an area with an unrecognized or unresolved pipe

[0083] 509 Select an appropriate valid action, such as moving a pipe. A predetermined set of valid actions is available, and the selection is based on an analysis of the problem area.

[0084] 510 The operator is informed about the selected valid action and how it should be performed and which section of the bioprocess system it involves. Go to capture step 501

[0085] 520 generates a processed representation in which at least a portion of the conduit 50 is identified. Optionally, other features are also identified, such as the module 20 and the chromatography column 25

[0086] 521 Verifying the process running on the bioprocess system 10 by comparing the processed representation to a flow representation (e.g., a flow diagram). Verification may include 512:

[0087] - Produces enhanced images indicating flow paths in use

[0088] - Generates enhanced live view images that follow the process as it develops

[0089] - Troubleshooting, such as finding and indicating missing sections of pipes

[0090] - Assists in the set-up of bioprocess systems by indicating how the pipes should be connected

[0091] - Collect user data.

[0092] As will be clear to the skilled person, the described embodiments can be combined. For example, embodiments using the method according to the invention to assist in the establishment of a bioprocess system can be advantageously combined with using the method according to the invention for troubleshooting. In many cases, synergistic effects can be achieved by using the various embodiments in combination. For example, if the method according to the invention is implemented to collect user data, the results of such collection and the processing of the user data (e.g., suggestions for improving the process) can be presented to the user in an enhanced live view.

Claims

1. A method for automatically configuring detection in a bioprocess system (10), the method comprising the following steps: - capturing a plurality of images of the bioprocess system (10) at different angles and / or from different positions, the bioprocess system (10) comprising a conduit (50) for fluid communication between units of the bioprocess system (10); - analyzing the captured plurality of images in an analysis routine to identify at least a portion of the conduit (50) connecting the units of the bioprocess system (10); - generating a processed representation from the captured plurality of images, wherein at least a portion of the conduit is identified in the captured plurality of images; - verifying a process defined by a representation of a flow path in said bioprocess system, comprising comparing said processed representation with said flow path representation to verify their functional consistency.

2. The method of claim 1, wherein: The step of analyzing the captured plurality of images includes utilizing a priori information associated with the bioprocess system (10).

3. The method of claim 2, wherein: The a priori information includes information about the types of units present in the bioprocess system (10).

4. The method of claim 1, wherein: The analyzing step includes the sub-steps of determining whether additional images are useful for extracting information required to generate the processed representation; and issuing a notification to capture additional images if the additional images are determined to be useful.

5. The method of claim 4, wherein: A camera (60) operated by a user is used to capture the plurality of images, and in the analyzing step, the user receives a notification to capture additional images, or the user receives a notification to stop capturing images.

6. The method of claim 4, wherein: An automatic camera (60) is used to capture the plurality of images, and in the analyzing step, the automatic camera receives a notification to capture additional images, or the automatic camera receives a notification to stop capturing images.

7. The method of claim 5, wherein: During the analysis step, a notification of an active action is issued and transmitted to the user, the notification of the active action including instructions for the user to manipulate at least a portion of the pipeline and / or other units of the bioprocess system (10) to facilitate identification of features in the captured image.

8. The method of any one of claims 1 to 7, further comprising the step of generating an enhanced real-time view image of the bioprocess system (10) using the processed representation in the form of a processed image, wherein at least a portion of the pipeline is distinguishably marked in the enhanced real-time view image.

9. The method of any one of claims 1 to 7, further comprising the step of generating an enhanced real-time view image of the bioprocess system (10) using the processed representation so as to visually mark the parts and units of the pipeline involved in a specific process step in the enhanced real-time view image, the enhanced real-time view image showing at least one step in the process represented by the flow path representation.

10. The method according to any one of claims 1 to 7, wherein: The processed representation is compared to the flow path representation to identify faulty connections and / or missing portions of the conduit (50).

11. The method of any one of claims 1 to 7, further comprising providing setup assistance to a user by generating an enhanced real-time view image of the bioprocess system (10) indicating to the user where at least one individual piping connection should be connected, wherein At least one individual pipe connection and a cell corresponding to a portion of the flow path representation are identified in the processed representation by comparison with the flow path representation, and the identified cell is marked in the enhanced real-time view image.

12. The method of claim 1, comprising the steps of: (501) capturing images of biological process systems; (502) analyzing the captured image to identify at least a portion of the pipeline; (503) determining whether the pipeline and optionally other features from the captured image are adequately identified, and if so, proceeding to generate a processed representation (520), and if not, proceeding to evaluate how the image may be improved (506); (506) determining whether more images should be captured, and if so proceeding with identification of problem areas (508), and if it is determined that more images will not improve the processed representation, proceeding with indication (507); (507) indicating that the image may contain unidentified portions and / or features of the conduit, and continuing to generate a processed representation (520); (508) identifying problem areas in the analyzed image and proceeding to select proactive actions (509); (509) selecting an appropriate proactive action from a predefined list of proactive actions based on the analysis of the problem area; (510) Informing an operator of the selected proactive action and how it should be executed and returning to the capturing step (501); (520) Generating a processed representation using at least a portion of the identified pipeline.

13. A system for automatic configuration detection in a bioprocess system, wherein the process is defined by a flow path representation, the system comprising a bioprocess system (10), a CPU (40), a GUI (41) and a camera (60), wherein the camera (60) is adapted to capture a plurality of images of the bioprocess system (10) at different angles and / or from different positions and to transmit the images to the CPU (40), the bioprocess system (10) comprising conduits (50) for fluid communication between units of the bioprocess system (10); The CPU (40) is adapted to receive the captured images from the camera device and to run an analysis routine adapted to analyze the plurality of captured images to identify at least a portion of the conduit (50) connecting units of the bioprocess system (10); adapted to generate a processed representation from the captured plurality of images, wherein at least a portion of the pipeline (50) is identified, and present the processed representation on the GUI (41); and Suitable for verifying a process defined by a representation of a flow path in the bioprocess system, including comparing the processed representation to the flow path representation to verify their functional consistency.

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