System for processing biotechnology fluids

Abstract

The present application relates to the processing of biotechnology fluids, such as biopharmaceutical liquids, to obtain products such as monoclonal antibodies, vaccines or recombinant proteins, and in particular to a system for processing biotechnology fluids, comprising a bioprocess machine and at least one bioprocess machine helper, configured to be connected to each other and each equipped with a controller, as well as an inter-machine communication tool configured to be connected to a network.

Description

Technical Field

[0004] , ,

[0001] The present invention relates to the processing of biotechnology fluids such as biopharmaceutical liquids for obtaining products such as monoclonal antibodies, vaccines, or recombinant proteins.

Background Art

[0002] Biotechnology fluids such as biopharmaceutical liquids are generally first obtained by processes such as cell or microorganism culture in a bioreactor, and then they need to be further processed to achieve the required properties such as homogeneity, purity, concentration, and absence of viruses. These processes have conventionally been carried out using dedicated equipment such as stainless steel pipes, tanks, and filter housings, and operations are required before and after the actual processing. In particular, the cleaning operation after use has been relatively cumbersome. In the past few years, these processes have alternatively been carried out using equipment in which components in contact with the liquid are disposable components in order to avoid the cleaning operation.

[0003] For example, European Patent Applications EP 2 130 903 and EP 2 208 534 disclose equipment including a disposable element in which most parts are flexible ( "FlexwareTM product") including a processed liquid collection bag and circuit section, and further a filter element, and it is possible to assemble equipment for processing biotechnology fluids by simply equipping the cart with disposable elements since they are permanent or reusable elements ( "hardware") housed in two or more carts. On the other hand, the post-treatment step is essentially the removal and disposal of disposable elements. Other known equipment uses the same approach with reusable elements or specific reusable elements not housed in a cart.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Generally, the main reusable elements of equipment for processing biotechnology fluids are bioprocess machines having biotechnology fluid processors configured to modify at least one physicochemical or biological property of the biotechnology fluid, such as its pH, DO (dissolved oxygen), homogeneity, purity, concentration, and the presence or absence of certain microorganisms, such as viruses and / or other pathogens.

[0005] In addition to the biotechnology fluid processor, the bioprocess machine has a digital controller to control the biotechnology fluid processor. In most cases, the digital controller can control the fluid processor, allowing the machine to automatically perform customized versions of processing, commonly referred to as recipes. [Means for solving the problem]

[0006] This invention aims to further facilitate the setup of equipment for processing biotechnology fluids. Therefore, the present invention provides a system having the following system devices for processing biotechnology fluids: - A bioprocess machine (13) having a biotechnology fluid processor (15) configured to modify at least one physicochemical or biological property of a biotechnology fluid, and a digital controller (16) for controlling the biotechnology fluid processor (15); and - A biotechnology fluid processor helper (21) configured to be physically connected to a biotechnology fluid processor (15), and at least one bioprocess machine helper (14) having a digital controller (22) for controlling the biotechnology fluid processor helper (21); Here: -Each of the digital controller (16) of the bioprocess machine (13) and the digital controller (22) of the machine helper (14) includes a graphical user interface manager (17, 23) (GUI manager), inter-machine communication tools (18, 24) (MtoM communication tools), and detection negotiation pairing managers (19, 25) (DNP manager); -Each MtoM communication tool (18, 24) is configured to connect to the network (12); -The DNP Manager (19) of the bioprocess machine (13) and the DNP Manager (25) of the machine helper (14) are configured to cooperate via the network (12) to establish a pairing state; where: the GUI Manager (17) of the bioprocess machine (13) and the GUI Manager (23) of the machine helper (14) are configured in the pairing state as follows: - The GUI manager (17) of the bioprocess machine (13) has at least one provided capability that it does not have when not in a paired state, the provided capability being an interface function that controls and / or displays the operating parameters of the processor helper (21), or displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21); and - The GUI manager (23) of the machine helper (14) has at least one consumed capability which is modified when it is not in a pairing state, where: if the provided capability is an interface capability that controls and / or displays the operating parameters of the processor helper (21), the consumed capability is an interface capability that controls and / or displays the operating parameters; and if the provided capability is an interface capability that displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21), the consumed capability is an interface capability that displays the physicochemical or biological quantities.

[0007] The physical connection between the machine helper (via the processor helper) and the bioprocess machine (via the fluid processor) is intended to enable the processor helper to assist the fluid processor in modifying at least one physicochemical or biological property of the biotechnology fluid, for example, by pumping liquid, applying another physical action to the liquid, or sensing physicochemical or biological quantities of the liquid such as pH or dissolved oxygen (DO).

[0008] In the system according to the present invention, the machine helper has a digital controller equipped with inter-machine communication tools, and communicates with the bioprocess machine via a network that enables inter-machine communication. Therefore, despite the physical connection between the machine helper and the bioprocess machine, a dedicated communication channel such as a wired serial or parallel link can be enabled relatively easily, and this can be operated simply by plugging in a connector when performing the physical connection.

[0009] The present invention is based on the view that, although pairing must be performed via a network in addition to physical connection, such pairing via a network can be used to automatically reconfigure the bioprocess machine (using its provided capacity) and the machine helper (using its consumed capacity), thereby actually facilitating the setup of equipment for processing biotechnology fluids. Such automated reconfiguration makes the addition of machine helpers extremely convenient and can be performed even during batch processing, thus providing even greater flexibility to the system according to the present invention.

[0010] According to the advantageous features for implementing the system according to the present invention: - The GUI manager (23) of the machine helper (14) is in a standalone operation state when the machine helper (14) is not in a pairing state; - The GUI manager for the bioprocess machine is configured so that the bioprocess machine can be operated standalone when it is not in a paired state; - The GUI manager (17) of the bioprocess machine (13) is configured such that the bioprocess machine (13) can only operate when the bioprocess machine (13) is paired with a predetermined machine helper (14); - The consumed capability is an interface function that controls and / or displays the operating parameters of the processor helper (21); the GUI manager (23) of the machine helper (14) is configured to display at least one control icon (34, 35) of the operating parameters of the consumed capability interface function when not in a pairing state, whereas in the modified form, the consumed capability interface function does not display any icons (34, 35);

[0011] - The digital controller (16) of the bioprocess machine (13) includes a file (20) containing a description of each interface function that may be a provided capability, and the digital controller (22) of the machine helper (14) includes a file (26) containing a description of each interface function that may be a consumed capability; - The DNP manager (19) of the bioprocess machine (13) and the DNP manager (25) of the machine helper (14) are configured to cooperate via the network (12) to establish a pairing state; - The system device includes multiple machine helpers (14), and the DNP manager (19) of the bioprocess machine (13) is configured to establish a pairing state with at least two machine helpers (14) simultaneously;

[0012] - The system device includes a first machine helper (14) and a second machine helper (14); the fluid processor helper (21) of the first machine helper (14) and the fluid processor helper (21) of the second machine helper (14) are configured to be physically connected to each other; the DNP manager (25) of the first machine helper (14) and the DNP manager (25) of the second machine helper (14) are configured to cooperate via a network (12) to establish a pairing state; where the GUI manager (23) of the first machine helper (14) and the GUI manager (23) of the second machine helper (14) are configured in the pairing state as follows:

[0013] - The GUI manager (23) of the first machine helper (14) has at least one provided capability which it does not have when not in a pairing state, the provided capability being an interface function that controls and / or displays the operating parameters of the processor helper (21) of the second machine helper (14), or displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21) of the second machine helper (14); and

[0014] - The GUI manager (23) of the second machine helper (14) has at least one consumed capability which is modified when it is not in a pairing state, where: if the provided capability is an interface function that controls and / or displays the operating parameters of the processor helper (21) of the second machine helper (14), the consumed capability is an interface function that controls and / or displays the operating parameters; and if the provided capability is an interface function that displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21) of the second machine helper (14), the consumed capability is an interface function that displays the physicochemical or biological quantities;

[0015] - - The GUI manager (17) of the bioprocess machine (13), the GUI manager (23) of the first machine helper (14), and the GUI manager (23) of the second machine helper (14) are configured such that, in the pairing state of the bioprocess machine (13) with the first machine helper (14), the first machine helper (14) is paired with the second machine helper (14), and while the bioprocess machine (13) is paired with the second machine helper (14), the GUI manager (17) of the bioprocess machine (13) has the same provided capabilities as the capabilities provided by the first machine helper (14), and the same provided capabilities and consumed capabilities within the second machine helper (14) correspond to the same provided capabilities within the first machine helper (14); -In the paired state between the bioprocess machine and the first machine helper (14), the GUI manager, the GUI manager (17) of the bioprocess machine (13), and the GUI manager (23) of the first machine helper (14) are in a paired state with the second machine helper (14), and the GUI manager (17) of the bioprocess machine (13) has a provided capacity that replicates the capacity provided by the first machine helper (14) corresponding to the capacity consumed by the second machine helper (14);

[0016] - The GUI manager (17) of the bioprocess machine (13) and the GUI manager (23) of the first machine helper (14) are configured such that when the bioprocess machine and the first machine helper (14) are in a paired state, the first machine helper (14) is in a paired state with the second machine helper (14), and the GUI manager (17) of the bioprocess machine (13) has a provided capacity that embeds the capacity provided to the first machine helper (14) corresponding to the capacity consumed by the second machine helper (14);

[0017] - The system device includes a first bioprocess machine (13), a second bioprocess machine (13), and a plurality of machine helpers (14); the DNP manager (25) of at least one machine helper (14) is configured to establish a pairing state with the first bioprocess machine (13) or the second bioprocess machine (13);

[0018] - It has a first machine helper (14), and the consumed capacity is an interface function for controlling and / or displaying the operating parameters of the processor helper (21) of the first machine helper (14); and it has a second machine helper (14), and the consumed capacity is to display the physicochemical or biological quantity of the fluid sensed by the processor helper (21) of the second machine helper (14); here, the first machine helper (14) is a pump, and the consumed capacity is an interface function for controlling and / or displaying the speed of the pump, and the second machine helper (14) is a pH sensor or a flow sensor whose consumed capacity is an interface function for displaying the pH of the fluid or the flow of the fluid; and / or

[0019] - Each of the MtoM communication tools (18, 24) is configured to connect to a network (12) which is a network having an Internet protocol such as Ethernet (registered trademark), Wi-Fi, Bluetooth (registered trademark), or cellular 5G.

Brief Description of the Drawings

[0020] The description of the present invention continues with a detailed description of exemplary embodiments given below as non-limiting examples with reference to the accompanying drawings. In the following drawings:

[0021] [Figure 1] FIG. 1 schematically shows a manufacturing area of a bioprocess manufacturing plant or laboratory where a bioprocess machine forming part of a system for treating biological fluids is arranged. [Figure 2]Figure 2 schematically shows a storage area in a bioprocess manufacturing plant or laboratory where multiple bioprocess machine helpers for a system of processing biological fluids are located, and the bioprocess machine helpers are configured to be associated with the bioprocess machines shown in Figure 1.

[0022] [Figure 3] Figure 3 shows a bioprocess machine and one of its bioprocess machine helpers, along with a network in which the bioprocess machine and bioprocess machine helper cooperate to establish a pairing state. [Figure 4] Figure 4 shows the graphical user interface of a bioprocess machine, which is a standalone mixer. [Figure 5] Figure 5 shows the graphical user interface of the mixer when combined with the bioprocess machine helper, which is a pH sensor, at the top, and the graphical user interface of the pH sensor at the bottom. The left side shows the standalone state, and the right side shows the state when combined with the mixer.

[0023] [Figure 6] Figure 6 schematically shows the bioprocess machine helper pump together with the bioprocess machine helper flow sensor at the top. The pump and flow sensor are physically connected, and the pump's graphical user interface is displayed in the center, with the left side showing the standalone state and the right side showing the state combined with the flow sensor. The graphical user interface of the flow sensor is displayed at the bottom, with the left side showing the standalone state and the right side showing the state combined with the pump.

[0024] [Figure 7]Figure 7 shows an exemplary schematic diagram of a GUI adapted when a process machine and machine helper are paired, with the mixer's graphical user interface shown at the top, with the left side showing it paired with a pH sensor, the right side showing it paired with a pH sensor and a pump paired with a flow sensor, the pump's graphical user interface shown in the center, with the left side showing it paired with a flow sensor, the right side showing it paired with a flow sensor and possibly paired with a mixer, and the flow sensor's graphical user interface shown at the bottom, with the left side showing it paired with a pump, and the right side showing it paired with a pump and possibly a mixer.

[0025] [Figure 8] Figure 8 is a schematic diagram of an exemplary GUI adapted when the process machine and machine helper are not paired, showing the mixer's graphical user interface at the top, paired with the pH sensor on the left, the pump paired with the flow sensor on the right, the pump's graphical user interface in the center, shown when paired with the mixer in combination with the flow sensor on the left, and when paired with the flow sensor on the right, and the flow sensor's graphical user interface at the bottom. The left side shows the mixer paired with the pump, and the right side shows the pump paired with the mixer. [Modes for carrying out the invention]

[0026] Figures 1 and 2 show a production area 10 and a storage area 11 of a bioprocess production plant or laboratory where available system devices for processing biotechnology fluids according to the present invention are located.

[0027] System device description: Bioprocess machine and bioprocess machine helper Each system device includes a digital processing unit (microprocessor and / or microcontroller, memory, and network connectivity) and is configured to be connected via wired or wireless connection to a network 12 (Figure 3) that supports the Internet Protocol (IP). For example, wired connections are made via Ethernet®, while wireless connections are made via Wi-Fi, Bluetooth®, or cellular networks such as 5G. This system comprises a bioprocess machine 13 and a plurality of bioprocess machine helpers 14. The bioprocess machine 13 can be set up alone or in association with one or more machine helpers 14 to become equipment for processing biotechnology fluids. As shown in Figure 3, the bioprocess machine 13 includes a biotechnology fluid processor 15 and a digital controller 16.

[0028] The biotechnology fluid processor 15 is configured to modify at least one physicochemical or biological property of the biotechnology fluid, such as its pH, dissolved oxygen (DO), uniformity, purity, concentration, and the presence or absence of certain microorganisms such as viruses. The digital controller 16 is configured to control the biofluid processor 15, as indicated by the bidirectional arrows in Figure 3. Here, the digital controller 16 can control the fluid processor 15 so that the machine 13 can automatically execute a customized version of the process, commonly referred to as a recipe.

[0029] The digital controller 16 includes a graphical user interface (GUI) manager 17, a machine-to-machine (MtoM) communication tool 18, and a discovery-negotiation-pairing (DNP) manager 19. The digital controller 16 also includes a file called a device shape 20, which contains a description of specific interface functions of the GUI that can be displayed by the GUI manager 17. Please note that the term "file" should be interpreted broadly here, encompassing any structured data container, including folders and / or databases. The bioprocess machine helper 14 includes a biotechnology fluid processor helper 21 and a digital controller 22.

[0030] The processor helper 21 is configured to be physically connected to the fluid processor 15, as indicated by the bidirectional arrows in Figure 3. The physical connection allows the processor helper 21 to assist the fluid processor 15 in modifying at least one physicochemical or biological property of the biotechnology fluid, for example, to pump the fluid, exert another physical effect on the fluid, or sense the physicochemical or biological quantities of the fluid, such as pH or DO.

[0031] For example, if the bioprocess machine 13 is a mixer, the biotechnology fluid processor 15 includes a tank and a stirrer; if the machine helper 14 is a pump, the biotechnology fluid processor helper 21 includes fluid drive components such as rollers for a peristaltic pump; and if the machine helper 14 is a pH or flow sensor, the biotechnology fluid processor helper 21 includes a pH probe and a flow probe, respectively.

[0032] The physical connection between the fluid drive component (pump processor helper 21) and the tank + agitator (mixer fluid processor 15) involves pipes and folders to maintain the fluid drive component and the tank + agitator in predetermined relative positions. For example, such folders may be implemented by mounting the pump on the same or similar framework as the mixer, or by a cart to which the pump is mounted, with the cart being maintained in a fixed position relative to the mixer.

[0033] Similarly, pH probes or flow probes need to interact with the fluid and be maintained in place. Generally, physical connections involve interaction between the fluid (see, with or without contact, the rollers of a peristaltic pump that are not in contact with the fluid or the IR probe of a temperature sensor that is not in contact with the fluid) and the folder that maintains the processor helper 21 with respect to the fluid processor 15.

[0034] The digital controller 22 is configured to control the processor helper 21, as indicated by the bidirectional arrows in Figure 3. The digital controller 22 has the same architecture as the digital controller 16: the digital controller 22 includes a GUI manager 23, an MtoM communication tool 24, and a DNP manager 25. The digital controller 22 also includes a file called a device shape 26, which contains a description of specific interface functions of the GUI that can be displayed by the GUI manager 23.

[0035] In each system device 13 or 14, the GUI manager 17 or 23 enables the display of GUIs such as process and instrumentation diagrams (P&IDs) locally on an interactive screen, or remotely on a device with an interactive screen, such as a tablet or smartphone. In each system device 13 or 14, the MtoM communication tool 18 or 24 is configured to connect to the network 12, as indicated by the bidirectional arrows in Figure 3.

[0036] The DNP manager 19 of the bioprocess machine 13 and the DNP manager 25 of the machine helper 14 are configured to cooperate via the network 12 to establish a pairing state. Each system device 13 or 14 can be used as a standalone device or paired with another appropriate system device. The GUI manager 17 or 23 of each system device 13 or 14 is configured to adapt to the pairing state and vice versa in its graphical user interface (GUI).

[0037] For example, if the machine helper 14 is a pump that can be paired with the bioprocess machine 13, in the standalone state of the pump, its GUI allows the user to control the pump, so that the user can use the pump as a standalone unit for tasks such as transferring liquid from one tank to another; on the other hand, when the pump is paired with the bioprocess machine 13, the pump's GUI no longer allows the user to control the pump, and only the GUI of the bioprocess machine 13 allows the pump to be controlled.

[0038] Furthermore, for example, if the machine helper 14 is a sensor that can be paired with the bioprocess machine 13, such a sensor that senses a physicochemical or biological amount of a biotechnology fluid can be used as a standalone unit by the user, as its GUI displays the sensed amount when the sensor is in a standalone state, whereas when the sensor is paired with the bioprocess machine 13, the sensor's GUI only displays a message such as "connected" to indicate that the sensor is in a paired state, and the bioprocess machine 13's GUI displays the amount sensed by the sensor.

[0039] Generally, the GUI manager 17 of the bioprocess machine 13 and the GUI manager 23 of the machine helper 14 are configured as follows in the paired state: - The GUI manager 17 of the bioprocess machine 13 has at least one provided capability which it does not have when not in a pairing state, and the provided capability is an interface function that controls and / or displays the operating parameters of the processor helper 21, or displays the physicochemical or biological quantities of the fluid sensed by the processor helper 21; and

[0040] - The GUI manager 23 of the machine helper 14 has at least one consumed capability which is modified when it is not in a pairing state, where if the provided capability is an interface capability that controls and / or displays the operating parameters of the processor helper 21, the consumed capability is an interface capability that controls and / or displays the operating parameters, and if the provided capability is an interface capability that displays the physicochemical or biological quantities of the fluid sensed by the processor helper 21, the consumed capability is an interface capability that displays the physicochemical or biological quantities.

[0041] ability The interface functions described in the device shape files 20 or 26 of the different system devices 13 and 14 are either of the first type or the second type. The first type of interface function is an interface function that the GUI manager 17 or 23 of system device 13 or 14 does not have when the system device is not paired with another suitable system device, but the GUI manager 17 or 23 is supplemented when system device 17 or 23 is paired with another suitable system device.

[0042] In practice, the first type of interface functionality exists, but it is disabled if system device 13 or 14 is not paired with another appropriate system device, and enabled when system device 13 or 14 is paired with another appropriate system device. When enabled, each such interface function controls and / or displays the operating parameters of the paired system device, or displays a quantity sensed by the paired system device, where the quantity is a physicochemical or biological quantity of the biotechnology fluid being processed.

[0043] For the sake of convenience, such interface functions are referred to as “capabilities” in this specification, and as “provided capabilities” when enabled. The second type of interface function is an interface function that the GUI manager 23 of the system device, which is a machine helper 14, has in its original form when the system device is not paired with another suitable system device, and in a modified form when the system device is paired with another suitable system device.

[0044] In the original form, each such interface function controls and / or displays an operating parameter of a system device, or displays a quantity sensed by a paired system device, where the quantity is a physicochemical or biological quantity of the biotechnology fluid being processed. In the modified form, each such interface function is, for example, the same as in the original form, but with the addition of an indication that the system device is paired with another appropriate system device, or the original form is replaced with one that indicates that the system device is paired with another appropriate system device, where such indication is, for example, an icon, a message, or the absence of a display.

[0045] For linguistic convenience only, such interface functions are referred to as “capabilities” in this specification, and in modified forms as “consumed capabilities.” Note that the device shape file 20 of the bioprocess machine 13 includes a description of the interface function of its GUI manager 17; and the device shape file 26 of the machine helper 14 includes a description of at least one interface function of a second type of GUI manager 23.

[0046] It should be further noted that in device shape files 20 and 26, each capability description has a feature called "role" that identifies whether the capability is of type 1 or type 2. In the first type, the role function is in the "consumer" and refers to the corresponding capability of the paired system device that becomes the "consumed capability" in the paired state. Here, the system device 13 or 14 that has the capability with the role characteristic in the "consumer" is called the capability consumer.

[0047] In the second type, the role feature is in “Provider,” which becomes “Provided Capability” in the paired state, referring to the corresponding capability of the paired system device, and a system device 14 having capability with the role feature in “Provider” is referred to herein as a capability provider. Please note that there is always a correspondence between the abilities provided and the abilities consumed.

[0048] If the provided capability (within capability consumer 13 or 14) is an interface function that controls and / or displays the operating parameters of the capability provider, then the consumed capability (within capability provider 14) is the interface function that controls and / or displays these operating parameters. For example, if the capability provided by the mixer is the start / stop control of a paired pump, then the capacity consumed by the paired pump is the start / stop control of that pump.

[0049] If the capacity provided (in capacity consumer 13 or 14) is an interface function that displays the physicochemical or biological quantities of the biotechnology fluid sensed by capacity provider 14, then the capacity consumed (in capacity provider 14) is the interface function that displays these physicochemical or biological quantities. For example, if the capacity provided by the mixer is a display of the pH of the biotechnology fluid sensed by a paired pH sensor, then the capacity consumed by the paired pH sensor is a display of the sensed pH.

[0050] The corresponding provided and consumed capabilities are referred to herein as “shared capabilities”. Each system device 13 or 14 has a device shape file 20 or 26 that can be deployed at design time and updated at runtime, extending the list of capabilities available to capability consumers or provided by capability providers throughout the lifespan of the system device. This allows the system device to contribute to new platform features without changing (and recertifying) the software packages installed on the system device.

[0051] Here, we describe examples of system devices 13 and 14 and how equipment for processing biotechnology fluids is set up with these system devices. An example of a bioprocess machine 13 is a mixer (capacity consumer). Examples of bioprocess machine helpers 14 are a pH sensor (capacity provider), a flow sensor (capacity provider), and a pump (both capacity consumer and capacity provider).

[0052] Mixer description The mixer includes a tank, an agitator inside the tank, and two inlets to which pipes can be connected to fill the tank. The tank, agitator, and inlet form a biotechnology fluid processor 15. To make it operational, the mixer needs to be connected to at least one pump to flow the biotechnology fluid into one of its inlets. The mixer includes a digital processing unit that includes an industrial programmable logic controller (PLC) and an industrial PC. PLCs are dedicated to the real-time control and monitoring of various equipment modules to which they are connected (e.g., wirelessly or wired), such as agitators and valves that open and close inlets.

[0053] Industrial PCs have software packages installed and a file 20 called "device shape" is saved. The digital processing unit, installed software package, and saved device shape file 20 form the digital controller 16. The installed software package includes: a DNP manager 19; an MtoM communication tool 18 which includes an OPC UA server and an OPC UA client to support data exchange with other system devices; and a GUI manager 17 which enables the display of process and instrumentation diagrams (P&ID) locally on an interactive screen, such as a tablet or smartphone, or remotely on a device with an interactive screen. File 20, called the device shape, contains descriptions of four interface functions that provide capabilities when they become available.

[0054] Description of the capabilities available in the mixer's software package. As mentioned above, such capabilities consist of four interface functions: interface function 1, interface function 2, interface function 3, and interface function 4. Interface Function 1 When enabled, Interface Function 1 supplements the P&ID GUI with process data provided by the paired system device, whatever that paired system device may be. Capability Interface Function 1 has the following description in the mixer's device shape file 20: Domain: "Graphics", Purpose: "Process Value Display", Role: "Consumer", Limitations / Conditions: Optional. The list of properties is: [Table 1]

[0055] This capability description means the following: As a capability consumer with graphics capabilities, the mixer can display process values ​​from multiple paired system devices, and there are no restrictions or conditions on negotiation or pairing, provided that these paired system devices provide at least the process value, the name and unit of the process value, and optionally a valid decimal number using the OPC UA standard. In a modified version, the list of properties would include at least one of the following: [Table 2]

[0056] In such variations, the capability description further means that, if provided by a paired system device, the mixer can use a range of process values ​​to propose an auxiliary type of display (such as a gauge). Interface Function 2 Enabling Capability Interface Function 2 displays whether the P&ID GUI is compatible and whether the required (mandatory) expected pump is paired, and adds a control icon and a display of the paired pump's operating parameters to the P&ID GUI. Interface function 2 has the following description in the mixer's device shapefile 20: Domain: "Control", Purpose: "Pumping", Role: "Consumer", Restrictions / Conditions: Exclusive, Required, Operator Confirmation. The list of properties is: [Table 3]

[0057] This capability description means the following: As a capability consumer with control skills, the mixer must mandatorily pair with the system device, which is the pump, to fulfill the defined role of the pump connected to inlet 1. To pair, the system device must be made available for start / stop commands and provide its current start state. The mixer can control and monitor the pump speed, provided by the paired system device. Operator confirmation is required during the pairing procedure. Once paired, the mixer can exclusively use the system device, which is the pump. In a modified version, the list of properties would include at least one of the following: [Table 4]

[0058] In such modifications, the capability description further implies that the mixer can display the minimum and maximum values ​​of the speed range, provided by the pair of pumps to guide the operator when setting the pump speed. Interface function 3 When interface function 3 is enabled, the P&ID GUI is adjusted to show whether the planned optional pump is paired, and the P&ID GUI is updated to display a control icon and the operating parameters of the paired pump. Capability Interface Function 3 has the following description in the mixer's device shape file 20: Domain: "Control", Purpose: "Pumping", Role: "Consumer", Limitations / Conditions: Exclusive, Optional, Operator Verified. The list of properties is: [Table 5]

[0059] This capability description means that a mixer, as a capability consumer with control skills, can control an optional system device, which is a pump, to achieve a predefined role for the pump connected to inlet 2. For pairing to occur, the system device must be forced to enable start / stop commands and provide its current start state. If provided by the paired system device, the mixer can control and monitor the pump speed. Operator confirmation is required during the pairing procedure. Once paired, the mixer has exclusive use of the system device that is the pump. In a modified version, the list of properties would include at least one of the following: [Table 6]

[0060] In such modifications, the capability description further implies that the mixer can display the minimum and maximum values ​​of the speed range, provided by the pair of pumps to guide the operator when setting the pump speed. Interface Function 4 Enabling interface function 4 allows the P&ID GUI to display other optional paired pumps, and the P&ID GUI is complemented by the display of control icons and operating parameters of the paired pump. Capability Interface Function 4 has the following description in the mixer's device shape file 20: Domain: "Control", Purpose: "Pumping", Role: "Consumer", Restrictions / Conditions: Exclusive, Optional. The list of properties is: [Table 7]

[0061] This capability description means that a mixer, as a capability consumer with control skills, can control any other system device that is a pump. No required properties are assumed. The mixer can start / stop the pump and control and monitor the pump speed, provided it is provided by the paired system device. Operator confirmation is not required during the pairing procedure. Once paired, the mixer has exclusive use of the system device that is a pump.

[0062] It should be noted that not all interface functions of the mixer's GUI manager 17 have been described here. Interface functions related to the instrument modules within the mixer (such as the agitator and inlet valve control) are not described here. Only interface functions that are disabled when the mixer is not paired with the appropriate system device and enabled when the mixer is paired with the appropriate system device are described; other such interface functions may be included in the mixer's GUI manager 17.

[0063] Furthermore, it should be noted that the functions of interface function 2, interface function 3, and interface function 4 represent three levels of functionality that can be provided: predefined mandatory capabilities such as interface function 2, predefined and optional capabilities such as interface function 3, and optional auxiliary capabilities such as interface function 4.

[0064] Description of pH sensor The pH sensor includes a probe for sensing the pH of the biotechnology fluid. The probe forms a biotechnology fluid processor helper 21. The pH sensor includes a digital processing unit that includes a microprocessor and / or microcontroller, memory, and network connectivity. The processing unit is configured to control and monitor flow-sensing probes, which are electrically wired to the probes. The processing unit has a software package installed and a file 26 called the device shape is stored there. The processing unit, installed software package, and saved device shape file 26 form the digital controller 22.

[0065] The installed software package has the same architecture as the software package installed on the mixer, and the software package installed on the pH sensor includes: a DNP manager 25; an MtoM communication tool 24 with an OPC UA server and OPC UA client that supports data exchange with other system devices; and a GUI manager 23 that enables the remote display of a GUI on a device with an interactive screen, such as a tablet or smartphone. File 26, called the device shape, contains a description of one interface function, which is the capability consumed when the format was changed.

[0066] Description of the capabilities available in the pH sensor software package: If a single interface function described in the pH sensor's device shape file is changed, the display of the current value measured by the pH sensor will be retained, a trend curve representing the change in pH over time will be displayed, and it will be indicated that the pH sensor is paired with the appropriate other system device. This capability is described in the pH sensor's device shapefile 26 as follows: Domain: "Graphics", Purpose: "Process Value Display", Role: "Provider", Limitations / Conditions: None. The list of properties is: [Table 8]

[0067] This capability description means that the pH sensor, as a capability provider, can provide a pH (and pH only) process value display dataset to a system device paired using the OPC UA standard. The dataset includes the process value, its name, and its units. Since an OPC UA tag value is specified for each data item, the paired system device can read these values ​​with an OPC UA client. There are no particular restrictions or conditions on negotiation or pairing. In a modified example, the dataset further includes at least one of the minimum or maximum values ​​within the range of values ​​where the pH process value is expected to be found.

[0068] Flow sensor description The flow sensor includes a probe for sensing the flow of biotechnology fluids. The probe forms a biotechnology fluid processor helper 21. The flow sensor includes a digital processing unit that includes a microprocessor and / or microcontroller, memory, and network connectivity. The processing unit is configured to control and monitor flow-sensing probes, which are electrically wired to the probes. The processing unit has a software package installed and a file 26 called the device shape is stored there.

[0069] The processing unit, installed software package, and saved device shape file 26 form the digital controller 22. The installed software package has the same architecture as the software package installed on the mixer. The software package installed on the flow sensor includes: a DNP manager 25; an MtoM communication tool 24 having an OPC UA server and OPC UA client to support data exchange with other system devices; and a GUI manager 23 that enables the GUI to be remotely displayed on a device with an interactive screen, such as a tablet or smartphone. File 26, called the device shape, contains a description of one interface function, which is the capability consumed when the format was changed.

[0070] Description of the capabilities available in the flow sensor software package. In the modified format, the single interface function described in the flow sensor's device geometry is replaced by a display of the current value measured by the flow sensor, and the trend curve represents the change in flow over time, indicated by a display of the flow sensor being paired with other appropriate system devices. This capability is described in the flow sensor's device shapefile 26 as follows: Domain: "Graphics", Purpose: "Process Value Display", Role: "Provider", Limitations / Conditions: None. The list of properties is: [Table 9]

[0071] This capability description means that the flow sensor, as a capability provider, can provide a flow (and flow-only) process value display dataset to a system device paired using the OPC UA standard. The dataset includes the process value, its name, and its units. Each data point is assigned an OPC UA tag value, allowing the paired system device to read these values ​​with an OPC UA client. There are no particular restrictions or conditions on negotiation or pairing. In a modified example, the dataset further includes at least one of the minimum or maximum values ​​within the range of values ​​where the flow process value is expected to be found.

[0072] Pump description The pump includes components that act on the fluid to drive it, such as rollers in a peristaltic pump, and a motor that drives such components. The driving motor and driven components that act on the fluid form the biotechnology fluid processor helper 21. The pump includes a digital processing unit that includes a microprocessor and / or microcontroller, memory, and network connectivity. The processing unit is configured to control and monitor electrically wired motors. The processing unit has a software package installed and a file 26 called the device shape is stored there. The processing unit, installed software package, and saved device shape file 26 form the digital controller 22.

[0073] The installed software package has the same architecture as the software package installed on the mixer; the software package installed on the pump includes: a DNP manager 25; an MtoM communication tool 24 with an OPC UA server and OPC UA client that supports data exchange with other system devices; and a GUI manager 23 that can remotely display a GUI on devices with interactive screens such as tablets and smartphones. The file called the device shape contains a description of the interface functionality, which is the capability provided when it was active (interface functionality 1), and a description of the interface functionality, which is the capability consumed in a modified form (interface functionality 2).

[0074] Description of the capabilities available in the pump's software package. As mentioned above, each of these functions has two interfaces: Interface Function 1 and Interface Function 2. Interface Function 1 When interface function 1 is enabled, the GUI is supplemented with data provided by the paired system device, whatever that paired system device may be. Capability Interface Function 1 has the following description in the pump's device shape file 26: Domain: "Graphics", Purpose: "Process Value Display", Role: "Consumer", Limit / Condition: Max=1, Optional. The list of properties is: [Table 10]

[0075] This capability description means the following: As a capability consumer with graphical capabilities, the pump can optionally display at least one flow process value, the name and unit of the process value using the OPC UA standard, provided that the paired system device provides at least one process value. Aside from the maximum number of allowed pairings, no other restrictions or conditions are imposed on negotiation or pairing. In a modified version, the list of properties would include at least one of the following: [Table 11] In such modified versions, the description of capability further implies that the paired system device can optionally provide the minimum and maximum values ​​of the range associated with the flow process value.

[0076] Interface function 2 In the original version, interface function 2 displayed the pump motor speed and had control icons to start / stop the pump motor and to set the pump motor speed. In the modified version, the two control icons are removed from the GUI, and only the pump motor speed display is shown. Capability Interface Function 2 has the following description in the pump's device shape file: Domain: "Control", Purpose: "Pumping", Role: "Provider", Restrictions / Conditions: Exclusive. The list of properties is: [Table 12]

[0077] This capability description means that pump 13, as a capability provider with pumping skills, can provide control and monitoring of its pumping function using the OPC UA standard. A paired system device has exclusive use of the pumping function and can start / stop the pump, set the pump speed, and retrieve the current pumping status and speed. Because OPC UA tag values ​​are specified for control and monitoring, consumers can use the pump with an OPC UA client.

[0078] In a modified version, the list of properties would include at least one of the following: [Table 13] In such modifications, the capability description further implies that the pump 13 can provide minimum and maximum values ​​within the speed range.

[0079] Detection, Negotiation, and Pairing (DNP) Here, we will explain how system devices 13 and 14 can cooperate via the network 12 to establish a pairing state. This is primarily performed by the DNP managers 19 and 25 within system devices 13 and 14 through the discovery, negotiation, and pairing steps described below.

[0080] detection When a system device connects to a network using IP (e.g., Ethernet®, Wi-Fi, Bluetooth®, or cellular such as 5G), it can recognize other connected system devices, including discovery tools. Several architectures already exist that enable discovery across the entire network (for example, the "Bonjour" protocol defined by Apple®, and here, global or local discovery as proposed by the OPC UA standard). Visibility is limited only by potential security policies placed on the network. Using detection tools, system devices can maintain an up-to-date list of visible system devices with which they can exchange information. This list is updated especially when new system devices connect to or disconnect from the network.

[0081] negotiation Based on the capability descriptions provided in the device shapefile, negotiation is initiated between connected system devices: where each system device on the network: refers to the capability descriptions provided by other system devices, identifies matching capabilities based on capability feature domains, purposes, and roles, verifies that it can respect the limitations and conditions associated with the matching capabilities, and checks whether the list of properties provided by the matching capabilities is what is expected. The negotiation process occurs whenever a new system device is discovered on the network, disconnected from the network, or becomes unreachable.

[0082] Pairing Once negotiations are reached, the various contributors will agree on how to adapt to respect the limitations and conditions set out for their respective shared features. The pairing process is complete, and the negotiation between the two system devices is confirmed. Each capability consumer (each provider) remembers the provider's (each consumer's) ID and location (in this case, the OPC UA endpoint) to enable data exchange later.

[0083] Both the capability consumer and the capability provider will apply the limitations and conditions (if any) agreed upon during negotiations. The capability consumer locally issues access to a list of properties in the device shapefile of the consumed capability, allowing the GUI manager installed on the capability consumer to exchange data with the paired capability provider.

[0084] This can be achieved, for example, using a standard publication / subscription approach: when a system device is powered on, the DNP manager creates a specific data queue for each different pair (domain, purpose) described in the device shapefile; the GUI manager subscribes to the (domain, purpose) queue of interest; and each time a pairing occurs, the DNP manager issues access information to the corresponding (domain, purpose) data queue; and GUI manager subscribers to this queue are automatically triggered to access the description and adapt accordingly.

[0085] Certain situations may arise where various system devices on a network can provide specific capabilities that a consumer expects. In such cases, pairing may require a human operator to manually select the capability provider. Even when the conditions are explicitly stated in the ability description, situations may arise where operator approval is still required. Please note that unpairing requires operator intervention to distinguish between intentional disconnection of the system device and a communication failure. If there is no such voluntary action by the user, the disconnection of the system device will be considered abnormal, and appropriate action will be taken, such as generating an alarm. Here, we will explain how to unpair the devices.

[0086] Unpair As mentioned above, unpairing a system device from another paired system device requires a voluntary and explicit action from the user, allowing for distinction between intentional disconnection of the system device and communication failure. This can be done, for example, by providing a dedicated menu accessible to the user on the system device's graphical user interface, which lists each other system device with which the system device is paired, and from such a menu the user can explicitly request to unpair the system device selected in the menu list.

[0087] When the user requests to unpair with another selected system device, (i) a step is performed to remove the effects of the pairing step, (ii) a step is performed to remove any effects of the negotiation step, and (iii) a step is performed to temporarily prevent the system device and the other selected system device from performing the negotiation step.

[0088] To undo the effects of the pairing step, the DNP manager 19 or 25 of the system device locally issues a status change for each capability consumed or provided by the other selected system device and sends a request to proceed with unpairing to the other selected system device via the MtoM communication tool 18 or 24. The DNP manager 19 or 25 of the other selected system device then locally issues a status change for each capability consumed or provided to the system device and sends an acknowledgment of receipt of the request to proceed with unpairing to the system device via the MtoM communication tool 18 or 24.

[0089] For system devices and other selected system devices, the GUI manager 17 or 23 receives warnings about changes in the status of each relevant capability and adapts accordingly. To negate the effects of the negotiation step, any restrictions and conditions (e.g., exclusive) agreed upon by the capability consumer and capability provider during negotiation will be nullified.

[0090] Because previously shared functionality is now available for negotiation again, isolation is implemented by temporarily preventing system devices and other selected system devices from performing the negotiation step, for example using a timeout, which means not accepting the relevant system device in the negotiation step for a predetermined period of time, the length of which is not particularly important, but could be, for example, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, or by using network connectivity, such as ignoring the relevant system device until it is disconnected from and reconnected to the network.

[0091] Here, we will explain in detail the pairing of the mixer with the pH sensor, the pairing of the pump with the flow sensor, the pairing of a previously paired mixer with the pH sensor, the pairing of a previously paired pump with the flow sensor, and the detachment of the paired pump and flow sensor from the mixer while the pH sensor remains paired with the mixer.

[0092] Pairing the mixer with the pH sensor Features of the Mixer GUI When the operator powers on the mixer, they can access the basic P&ID GUI shown in Figure 4 locally via an interactive screen, or remotely using an interactive device such as a tablet or smartphone. The basic P&ID GUI represents the various components required for the mixing process, with icon 27 representing a tank with an agitator, icon 28 representing a mandatory pump communicating with the tank inlet 1, and icon 29 representing an optional pump communicating with the tank inlet 2.

[0093] In the basic P&ID GUI, icon 27 is displayed in a way that indicates a tank with an agitator is present and in operation (e.g., displayed with a persistent solid line), and icon 28 is displayed in a way that indicates a required pump is missing (e.g., displayed with a blinking dashed line). ), Icon 29 is displayed in a way that indicates there are no optional pumps (for example, it is displayed with a persistent dashed line).

[0094] The way the two icons 28 and 29 representing the pump are displayed depends on the pairing status and is automatically updated to indicate that the corresponding pump system device is paired (for example, by displaying the icon with a persistent solid line). The description of the P&ID GUI regarding pairing with the pump will be described later in the section on pairing the mixer and the pump. Next, we will explain the description of the P&ID GUI regarding pairing with the pH sensor.

[0095] When the mixer is powered on, its DNP manager creates a capability data queue ("Graphics," "Process Value Display") on the mixer's digital controller. The pump's GUI manager subscribes to the capability data queue ("Graphics," "Process Value Display") and displays a basic P&ID GUI until a new capability description is issued in this queue.

[0096] Later, when a system device providing the expected properties ("Graphics," "Process Value Display") is paired with the mixer, the mixer's DNP manager issues a description of this capability ("Graphics," "Process Value Display") to the data queue, triggering the GUI manager to access the issued description and adapt the P&ID GUI accordingly by further displaying the current process value (in this case pH) and the process value trend curve 30, as shown at the top of Figure 5.

[0097] In fact, as mentioned above, the mixer's device shapefile includes a capability called Interface Function 1, which, when enabled, supplements the P&ID GUI with process data provided by the paired system device, whatever the paired system device may be; this capability has the following description: Capability with Graphics Skills: As a consumer, the mixer can display process values ​​from multiple paired system devices, provided that the multiple paired system devices provide at least the process value, the name and unit of the process value, and optionally a valid decimal number using the OPC UA standard. There are no restrictions or conditions on negotiation or pairing.

[0098] Features of the pH Sensor GUI When the operator powers on the pH sensor, they can remotely access the original GUI shown in Figure 5 (bottom left) using an interactive device such as a tablet or smartphone. The original GUI includes the current value 31 measured by the pH sensor and a trend curve 32 representing the change in pH over time.

[0099] When the pH sensor is powered on, its DNP manager creates a capability data queue ("Graphics," "Process Value Display") on the pH sensor's digital controller. The pH sensor's GUI manager subscribes to the capability data queue ("Graphics," "Process Value Display") and displays the original GUI until a new capability description is issued in this queue.

[0100] Later, when a system device with the expected characteristics ("graphics," "process value display") is paired with the pH sensor, the pH sensor's DNP manager issues a description of this capability ("graphics," "process value display") to the data queue and displays the additional message "connected"33, which triggers the GUI manager, as shown in the lower right of Figure 5, to access the issued description and adapt the GUI accordingly.

[0101] In fact, as described above, the pH sensor's device shapefile encompasses its capabilities, and in the case of a modified format, it holds a display of the current value measured by the pH sensor and a trend curve representing the change in pH over time, and adds a display indicating that the flow sensor is paired with the appropriate other system device, which in this case is the message "Connected"33; this capability has the following description: As a capability provider, the pH sensor can provide a pH (and pH only) process value display dataset to a system device paired using the OPC UA standard. The dataset contains the process value, its name, and its units. Since an OPC UA tag value is specified for each data item, the paired system device can read these values ​​with an OPC UA client. There are no particular restrictions or conditions on negotiation or pairing.

[0102] DNP sequencing The operator connects the mixer and pH sensor to the same network 12. Once the above DNP is executed and complete, the mixer's P&ID GUI and the pH sensor's GUI will automatically update; the mixer's P&ID GUI will further display the current pH value and a pH value trend curve30; and the pH sensor's GUI will further display the message "Connected"33. It goes without saying that in order for the pH sensor to sense the pH of the fluid being processed by the mixer, the pH sensor must be physically connected to the mixer.

[0103] The message "Connected" on the pH sensor's GUI clearly indicates that the pH sensor is in a paired state, not a standalone state. Here, we will describe in detail an example of a DNP sequence. In this example, the pH sensor is initially connected to network 12 using IP, but of course, the reverse is also possible. Since the pH sensor is a capability provider of the capabilities described in the device shape file 26, as long as the pH sensor is connected to the network 12, its MtoM communication tool 24 will provide the sensed pH value in real time and, thanks to the included OPC UA server, will be available on the network 12 at the OPC UA endpoint specified in the capability description of the device shape file 26, i.e., opc.tcp: / / pH / 4:control / 4:.

[0104] To enable DNP, in the pH sensor, the DNP manager 25 provides data to the MtoM communication tool 24, making the capability description in the device shape file 26, which includes the characteristics in the capability description, available; the DNP manager 25 creates a data queue ("graphics", "process value display") for this capability within the digital controller 22 of the pH sensor. The MtoM communication tool 24 then waits for the detection of another system device on the network 12. Next, in preparation for adaptation at the pH sensor, the GUI manager 23 subscribes to the data queue ("Graphics", "Process Value Display") created by the DNP manager 25 and displays the original GUI format.

[0105] Next, the mixer connects to the network and performs a similar procedure according to its device shapefile 20, as detailed below. To enable DNP, in the mixer, the DNP manager 19 provides data to the MtoM communication tool 18 to make available the capability descriptions in the device shape file 20, i.e., interface function 1, interface function 2, interface function 3, and interface function 4, including the properties of each capability description; and the DNP manager 19 then creates data queues ("graphics", "process value display") for capability interface function 1 and ("control", "pumping") for capability interface functions 2, interface function 3, and interface function 4 in the mixer's digital controller 16. The MtoM communication tool 18 then waits for the discovery of another system device on the network.

[0106] Still within the mixer, in preparation for adaptation, GUI Manager 17 subscribes to the ("Graphics", "Process Value Display") and ("Control", "Pumping") data queues created by the DNP Manager and displays the basic P&ID GUI.

[0107] In the pH sensor, when the MtoM communication tool 24 detects that the mixer is connected to the network 12, it notifies the DNP manager 25 of this, which requests the MtoM communication tool 24 to provide a capability description provided by the mixer. Once provided, the capability description is reviewed by the DNP manager 25, which identifies a match between the capability interface function 1 made available by the mixer and the local capability with applicable limitations / conditions. The DNP manager 25 then requests the MtoM communication tool 24 to suggest to the mixer that it apply a pairing between the local capability and the capability interface function 1 within the mixer.

[0108] When the MtoM communication tool 24 receives a pairing acceptance, it provides the pairing acceptance to the DNP manager 25, which issues a description of the mixer's capability interface function 1 in the ("Graphics", "Process Value Display") data queue and requests the MtoM communication tool 24 to confirm the application of the mixer's capability interface function 1. The GUI manager 23 is automatically notified of the publication in the ("Graphics", "Process Value Display") data queue, receives the description of the mixer's capability interface function 1, and displays the modified GUI, i.e., displays the additional message "Connected" 33. The modified GUI is displayed until a pairing is unpaired.

[0109] In the mixer, when the MtoM communication tool 18 detects that the pH sensor is connected to the network 12, it notifies the DNP manager 19, which requests the MtoM communication tool 18 to provide a capability description indicated by the pH sensor. Once provided, the capability description is reviewed by the DNP manager 19, which identifies a match between the capability interface function 1 made available by the pH sensor and the local capability with applicable limitations / conditions.

[0110] When the MtoM communication tool 18 receives confirmation from the pH sensor that the capability interface function 1 has been applied, the confirmation is forwarded to the DNP manager 19, which issues a description of the pH sensor's capability ("graphics", "process value display") to the data queue.

[0111] The GUI manager 17 is automatically notified of publications in the data queue ("Graphics", "Process Value Display") and receives a description of the pH sensor's capabilities, including the OPC UA tag of the flow value opc.tcp: / / pH / 4:control / 4:V. It then adapts the P&ID GUI by further displaying the current pH value and the pH value trend curve 30, and thanks to the OPC UA client in the MtoM communication tool 18, the tag provided for the pH value is used to continuously update the pH value until an unpairing occurs.

[0112] Pairing of pump and flow sensor Pump GUI Features Once the operator powers on the pump, they can remotely access the basic GUI shown in the left center of Figure 6 from a device with an interactive screen, such as a tablet or smartphone. The basic P&ID GUI includes a start / stop button 34 that allows operation of the pump, a variator 35 that allows changing the pump speed, and a display 36 of the current pump speed and a curve display 37 that show the change in pump speed over time.

[0113] When the pump is powered on, its DNP manager 25 creates a capability data queue ("Graphics," "Process Value Display") on the pump's digital controller 22. The pump's GUI manager 23 subscribes to the capability data queue ("Graphics," "Process Value Display") and displays the basic GUI until a new capability description is issued to this queue.

[0114] Later, when a system device providing the expected capabilities ("graphics," "process value display") is paired with the pump, the pump's DNP manager 25 issues this capability description to the ("graphics," "process value display") data queue, triggering the GUI manager 23 to access the issued description and, accordingly, adapt the GUI by further displaying the current flow value and the flow value trend curve 38, as shown in the center right of Figure 6.

[0115] In fact, as mentioned above, the pump's device shape file includes a capability named Interface Feature 1, which, when enabled, complements the GUI with data provided by the paired system device; this capability has the following description: The pump, as a capable consumer with graphical skills, can optionally display only one flow process value using the OPC UA standard, provided that the paired system device provides at least the process value, the name of the process value, and the units. No other restrictions or conditions are imposed on negotiation or pairing, except for the maximum number of allowed pairings.

[0116] Features of the Flow Sensor GUI When the operator powers on the flow sensor, they can remotely access the original GUI shown in Figure 6 (bottom left) using an interactive device such as a tablet or smartphone. The original GUI includes a display of the current value 39 measured by the flow sensor and a display of a trend curve 40 representing the change in flow rate over time.

[0117] When the flow sensor is powered on, its DNP manager 25 creates a capability data queue ("graphics," "process value display") within the flow sensor's digital controller 22. The flow sensor's GUI manager 23 subscribes to the capability data queue ("graphics," "process value display") and displays the original GUI until a new capability description is issued to this queue.

[0118] Later, when a system device that uses the capabilities of the expected properties ("graphics", "process value display") is paired with the flow sensor, the flow sensor's DNP manager 25 issues this capability description to the ("graphics", "process value display") data queue, triggering the GUI manager 23 to access the issued description and adapt the GUI accordingly by simply displaying the message "Connected" 41, as shown in the lower right of Figure 6.

[0119] In fact, as described above, the device shape file 26 of the flow sensor contains the capability, and in the modified format, it replaces the display of a trend curve representing the change in flow over time with a display of the current value measured by the flow sensor and a display indicating that the flow sensor is paired with the appropriate other system device, this display here being the message "Connected" 41; this capability has the description that means: As a capability provider, the flow sensor can provide a flow (and flow only) process value display dataset to a system device paired using the OPC UA standard.

[0120] The dataset contains process values, their names, and their units. Each data entry has an OPC UA tag value, allowing paired system devices to read these values ​​with an OPC UA client. There are no particular restrictions or conditions on negotiation or pairing.

[0121] DNP sequencing The operator connects the pump and flow sensor to the same network 12 (Figure 3). Once the above DNP is executed, the pump GUI and the flow sensor GUI are automatically updated: the pump P&ID GUI further displays the current flow value and the flow value trend curve38; the flow sensor GUI displays only the message "Connected"41. Needless to say, in order for the flow sensor to be able to sense the flow of fluid driven by the pump, the flow sensor must be physically connected in a known way to the pump or the pipe through which the pump-driven fluid flows, as shown at the top of Figure 6 by reference numeral 42.

[0122] Since both the pump and the flow sensor are machine helpers 14, note that the physical connection 42 is between the two processor helpers 21 (and not between the fluid processor 15 and the processor helper 21). Furthermore, it is noteworthy that the pump's DNP manager 25 can act as the bioprocess machine 13's DNP manager 19 in relation to the flow sensor's DNP manager 25, and thanks to the fact that the capability pump interface function 1 has the same role characteristic "consumer" as each capability of the bioprocess machine 13's device shape file 20, they cooperate via the network 12 to establish a pairing state between the pump and the flow sensor.

[0123] The message "Connected" 41 on the flow sensor's GUI clearly indicates that the flow sensor is in a paired state and not a standalone state. Here, we will describe in detail an example of a DNP sequence. In this example, the flow sensor is initially connected to network 12 using IP, but of course, the reverse is also possible.

[0124] Since the flow sensor is a capability provider of the capabilities described in the device shape file 26, as long as the flow sensor is connected to the network 12, its MtoM communication tool 24 will provide the sensed flow values ​​in real time and make them available on the network 12 thanks to the OPC UA server that contains them at the OPC UA endpoint specified in the capability description of the device shape file 26, i.e., opc.tcp: / / flow / 4:control / 4:.

[0125] To enable DNP, in the flow sensor, the DNP manager 25 provides data to the MtoM communication tool 24 to make the capability description in the device shape file 26, which includes the capability description properties, available; the DNP manager 25 creates data queues ("graphics", "process value display") for this capability within the digital controller 22 of the flow sensor. The MtoM communication tool 24 then waits for the detection of another system device on the network 12.

[0126] Still in the flow sensor, in preparation for adaptation, the GUI manager 23 subscribes to the data queue ("graphics", "process value display") created by the DNP manager 25 and displays the original form of the GUI.

[0127] Next, the pump is connected to the network and a similar procedure is performed according to its device shape file 26, as detailed below. Regarding capability interface function 2 (where the pump is the capability provider), as long as the pump is connected to network 12, its MtoM communication tool 24 provides the pump's operating parameters (start / stop, stop control, start status, speed setting and value) in real time, which become available on network 12 thanks to the OPC UA servers that include opc.tcp: / / start, opc.tcp: / / started, and opc.tcp: / / speed / 4, respectively, at the OPC UA endpoints specified in the capability description of the device shape file 26.

[0128] To enable DNP, in the pump, the DNP manager 25 provides data to the MtoM communication tool 24 to make available the capability descriptions in the device shape file 26, i.e., interface function 1 and interface function 2, which include properties for each capability description; the DNP manager 25 creates data queues ("graphics", "process value display") for capability interface function 1 and ("control", "pumping") for capability interface function 2 within the pump's digital controller 22. The MtoM communication tool 24 then waits for the discovery of another system device on the network 12.

[0129] While still inside the pump and preparing for adaptation, the GUI manager 23 subscribes to the data queues created by the DNP manager 25 ("Graphics", "Process Value Display") and ("Control", "Pumping") and displays a basic GUI.

[0130] When the flow sensor detects that the pump is connected to network 12, the MtoM communication tool 24 notifies the DNP manager 25 of this, which requests the MtoM communication tool 24 to provide a capability description indicated by the pump. Once provided, the capability description is reviewed by the DNP manager 25, which identifies a match between the capability interface function 1 indicated by the pump and the local capability with applicable limitations / conditions. The DNP manager 25 then requests the MtoM communication tool 24 to suggest to the pump that a pairing be applied between the local capability and the capability interface function 1 within the pump.

[0131] When the MtoM communication tool 24 receives a pairing acceptance, it provides the pairing acceptance to the DNP manager 25, which issues a description of the pump's capability interface function 1 in the data queue ("Graphics", "Process Value Display") and requests the MtoM communication tool 24 to confirm the application of the pump's capability interface function 1. The GUI manager 23 is automatically notified of the publication in the data queue ("Graphics", "Process Value Display") and receives the description of the pump's capability interface function 1, i.e., displays the modified GUI, i.e., displays only the message "Connected" 41. The modified form of the GUI is displayed until a pairing unpair occurs.

[0132] In the pump, when the MtoM communication tool 24 detects that the flow sensor is connected to the network 12, it notifies the DNP manager 25 of this, which requests the MtoM communication tool 24 to provide a capability description indicated by the flow sensor. Once the capability description is provided, it is reviewed by the DNP Manager 25, which identifies a match between the capability interface function 1 made available by the flow sensor and the local capability with applicable limitations / conditions.

[0133] When the MtoM communication tool 24 receives confirmation from the flow sensor that the capability interface function 1 has been applied, the confirmation is forwarded to the DNP manager 25, which issues a description of the flow sensor's capability in the data queue ("Graphics", "Process Value Display").

[0134] The GUI manager 23 automatically receives notification of publications in the data queue ("Graphics", "Process Value Display") and receives a description of the flow sensor's capabilities, including the OPC UA tag of the flow value opc.tcp: / / flow / 4:control / 4:V, and further displays the current flow value and the flow value trend curve 38, thereby adapting the GUI as shown in the center right of Figure 6. Thanks to the OPC UA client in the MtoM communication tool 24, the tags provided to the flow value are used to continuously update the flow value until an unpairing occurs.

[0135] It should be noted that the pump device shape file 26 has the additional capability to allow the pump to provide the flow values ​​sensed by the flow sensor, as if the flow sensor were part of the pump. This will be discussed later. Note that, as shown at the top of Figures 7 and 8, this allows the flow trend curve to be included in the control panel 44 of the mixer's P&ID GUI.

[0136] Pairing of previously paired mixer and pH sensor with previously paired pump and flow sensor. Further features of the mixer GUI As described above, when paired with the pH sensor, the mixer's P&ID GUI will, with respect to the basic P&ID, as shown in Figure 5 above, This is supplemented by the display of the pH value and the pH trend curve.

[0137] As mentioned above, the basic P&ID GUI shown in Figure 4 has an icon 27 representing a tank with a stirrer, an icon 28 representing a required pump that has fluid communication with tank inlet 1, an icon 29 representing an optional pump that has fluid communication with tank inlet 2, an icon 27 that is displayed in a way that indicates that a tank with a stirrer exists and is in operation (e.g., displayed with a persistent solid line), an icon 28 that is displayed in a way that indicates that a required pump is missing (e.g., displayed with a blinking dashed line), and an icon 29 that is displayed in a way that indicates that there is no optional pump (e.g., displayed with a persistent dashed line).

[0138] The way the two icons 28 and 29 representing the pump are displayed depends on the pairing status and is automatically updated to indicate that the corresponding pump system device is paired (for example, by displaying the icon with a persistent solid line).

[0139] Further details regarding pairing with pH sensors are provided elsewhere in this specification. We will explain the pairing with the pump in more detail later.

[0140] When the mixer is powered on, its DNP manager 19 creates a ("control", "pumping") capability data queue within the mixer's digital controller 16. The mixer's GUI manager 17 subscribes to the ("control", "pumping") capability data queue. Icon 28 is displayed in a way that indicates there are no required pumps until a new capability description with a Control_Local_Name equal to "Pump_on_inlet1" is issued in this queue (for example, displayed as a blinking dashed line). Icon 29 is displayed in a way that indicates there are no optional pumps until a new capability description with a Control_Local_Name equal to "Pump_on_inlet2" is issued in this queue (for example, displayed as a persistent dashed line).

[0141] Later, when a system device providing the ("control", "pumping") capability is paired with the mixer, the mixer's DNP manager 19 issues a description of this capability completed with Control_Local_Name equal to "Pump_on_inlet1" in the ("control", "pumping") capability data queue, triggering the GUI manager 17 to access the issued description and, accordingly, adapt the P&ID GUI by displaying an icon 28 in a way that indicates the required pump is paired (e.g., displayed with a persistent solid line), as shown in the upper right of Figure 7.

[0142] In fact, as described above, the mixer's device shape file 20 includes a capability called Interface Function 2, which, when enabled, adapts the P&ID GUI to display whether the required expected pump is paired, supplementing the P&ID GUI with a display of control icons and the operating parameters of the paired pump, and this capability has the following description: The mixer, as a capability consumer with control skills, is required to force the system device, which is the pump, to pair and perform the defined role of the pump connected to inlet 1.

[0143] For pairing to occur, the system device must be forced to enable start / stop commands and provide its current start state. If provided by the paired system device, the mixer can control and monitor the pump speed. Operator confirmation is required during the pairing procedure. Once paired, the mixer can exclusively use the system device, which is the pump.

[0144] Similarly, when a system device that later provides ("control", "pumping") capability is paired with the mixer, the mixer's DNP manager 19 issues a description of this capability completed with Control_Local_Name equal to "Pump_on_inlet2" in the ("control", "pumping") capability data queue, triggering the GUI manager 17 to access the issued description and, accordingly, adapt the P&ID GUI by displaying an icon 29 in a way that indicates an optional pump is paired (e.g., displayed with a persistent solid line).

[0145] In fact, as described above, the mixer's device shape file 20 includes a capability named interface function 3, which, when enabled, adapts the P&ID GUI to indicate whether a planned optional pump is paired, supplementing the P&ID GUI with a control icon and a display of the paired pump's operating parameters; this capability has the following description: The mixer, as a capability consumer with control skills, can control an optional system device which is a pump to achieve a predefined role for the pump connected to inlet 2.

[0146] For pairing to occur, the system device must be forced to enable start / stop commands and provide its current start state. If provided by the paired system device, the mixer can control and monitor the pump speed. Operator confirmation is required during the pairing procedure. Once paired, the mixer can exclusively use the system device, which is the pump.

[0147] Further features of the pump GUI The operator connects the pump to the same network 12. When the mixer detects a pump, the mixer's P&ID GUI alerts the operator (for example, on a display not shown in a pop-up window) to ensure that a pump that meets the expected requirements for the pump is available and usable, and prompts them to select one of the available pumps.

[0148] Once the operator has physically connected the pump to mixer inlet 1, select inlet 1 can be selected. The flow sensor GUI remains unchanged; in other words, message 41 is displayed, as shown at the bottom of Figure 7. The mixer's P&ID GUI and the pump's GUI will be automatically updated.

[0149] In the mixer's P&ID GUI, as shown in Figure 7 above, an icon 28 is displayed to indicate that a required pump is present and operating at inlet 1 (for example, displayed with a persistent solid line), and the control panel 44 is displayed in the mixer's P&ID GUI, allowing the operator to control and monitor the pump at inlet 1. The control panel 44 includes start / stop buttons to operate the pump, a variator to change the pump speed, and a display of a trend curve representing the flow rate fluctuations measured by a flow meter paired with the pump.

[0150] In the pump's GUI, as shown in the center of Figure 7, the start / stop button 34 for operating the pump and the variator 35 for changing the pump speed are disabled. Only the flow rate and speed are displayed. When the pump is powered on, its DNP manager 25 creates a ("control", "pumping") capability data queue within the pump's digital controller 22. The pump's GUI manager 23 subscribes to the ("control", "pumping") capability data queue and displays the basic GUI until a new capability description is issued to this queue.

[0151] Later, when a system device providing the ("control", "pumping") capability with the expected characteristics is paired with the pump, the pump's DNP manager 25 issues a description of this capability in the ("control", "pumping") capability data queue, triggering the GUI manager 23 to access the issued description and adapt the GUI accordingly by releasing start / stop buttons 34 that allow the pump to be operated and a variator 35 that allows the pump speed to be changed.

[0152] In fact, as mentioned above, the pump device shape file 26 includes a capability named interface function 2, which in its original form has a control icon (button 34) that displays the pump motor speed and allows the pump motor to be started / stopped, and a control icon (variator 35) that allows the pump motor speed to be set.

[0153] In the modified format, the two control icons are removed from the GUI, and only the pump motor speed display is shown; this capability has the following description: The pump, as a capability provider with pumping skills, can provide control and monitoring of pumping functionality using the OPC UA standard. The paired system device has exclusive use of the pumping functionality and can start / stop the pump, set the pump speed, and retrieve the current start state and speed. Because separate OPC UA tag values ​​are specified for control and monitoring, the consumer can use the pump with an OPC UA client.

[0154] DNP sequencing The mixer (previously paired with a pH sensor) and the pump (previously paired with a flow sensor) are deployed on the same network 12, allowing them to recognize each other and initiate a negotiation step. The pump will be made available for use with capability interface function 2.

[0155] The mixer enables the use of three capabilities ("control", "pumping") that share the same domain and purpose: capability interface function 2, which requires the pumping system to be forcibly paired to achieve a defined role for the pump connected to inlet 1; capability interface function 3, which allows the mixer to control and monitor an optional pump system to achieve a defined role for the pump connected to inlet 2; and capability interface function 4, which allows the mixer to control and monitor other optional pump systems.

[0156] All three abilities are consistent with the abilities that Pump exhibits. If negotiation is successful, the pairing procedure can be initiated. The capability displayed by the pump has one defined limitation / condition: "Only one system can be paired with the pump to use this capability." Since there is no system yet paired with a pump that uses this capability, this condition is confirmed and pairing becomes possible. Two of the three capabilities of the mixer have a single restriction / condition defined: "Operator confirmation is required during pairing." Pairing is only achieved if confirmed by the operator.

[0157] Next, a warning message is displayed by the mixer's P&ID GUI (not shown; for example, it appears in a pop-up window) prompting the operator to assign the pump to one of three possible uses. Once the operator assigns the pump to inlet 1, the pairing procedure continues. Both the mixer and pump remember the identification and location (OPC UA endpoint) of the paired system for this function. In the illustrated example, only the mixer uses this information to later control and monitor the pump. Once paired, the pump is also prevented from pairing with another system that has this capability.

[0158] On both the mixer and the pump, the DNP manager 19 or 25 issues capability descriptions to the capability data queues ("Control" and "Pumping"). To match the operator's selection, on the mixer side, this function is issued with the "Control Application" value set to "Pump_on_inlet1". As mentioned above, for both the mixer and the pump, GUI manager 17 or 23 subscribes to its capacity data queue and updates it automatically.

[0159] In a modified version not shown, instead of disconnecting the pump from the GUI, when pairing the pump with another appropriate system device such as a mixer, the start / stop button 34 and variator 35 are disconnected, and only the variator 35 is disconnected from the pump's GUI, while the start / stop button 34 remains active.

[0160] The pH sensor remains paired with the mixer, and the paired pump and flow sensor are removed from the mixer. As mentioned above, unpairing a system device from another paired system device requires a voluntary and explicit action from the user, which allows for the distinction between intentional disconnection of the system device and communication failure. This is accomplished by providing a dedicated menu (not shown in the diagram) that the user can access through the GUI of each system device. In this example, the mixer's P&ID GUI, the pH sensor's GUI, the pump's GUI, and the flow sensor's GUI each have such a dedicated menu.

[0161] This dedicated menu lists each other system device to which the system device is paired, and from such a menu, the user can explicitly request to unpair the system device selected in the menu list. When the user requests to unpair with another selected system device, (i) a step is performed to cancel the effects of the pairing step, (ii) a step is performed to cancel the effects of the negotiation step, if any, and (iii) a step is performed to temporarily prevent the system device and the other selected system device from performing the negotiation step, if any.

[0162] To undo the effects of the pairing step, the DNP manager 19 or 25 of the system device locally issues a status change for each capability consumed or provided by the other selected system device and sends a request to proceed with unpairing to the other selected system device via the MtoM communication tool 18 or 24.

[0163] Next, the DNP manager 19 or 25 of the other selected system device locally issues status changes for each capability consumed by or provided to the system device, and sends an acknowledgment of receipt of the request to proceed with unpairing via the MtoM communication tool 18 or 24 to the system device.

[0164] For system devices and other selected system devices, the GUI manager 17 or 23 receives warnings about changes in the status of each relevant capability and adapts accordingly. Figure 8 shows the changes in the mixer's P&ID GUI, pump GUI, and flow sensor GUI, in addition to user selection. The pump paired with the flow sensor can be unpaired from the mixer via the mixer's dedicated menu.

[0165] Within the mixer, the DNP manager 19 issues a state change for the corresponding capability, i.e., interface function 2, to the appropriate queue, i.e., the ("control", "pumping") queue, which triggers the GUI manager 17 to adapt accordingly by disabling capability interface function 2, as shown at the top of Figure 8, and the control panel 44 is released from the mixer's P&ID GUI. Within the mixer, the DNP manager 19 then requests the MtoM communication tool 18 to send a request to the pump to proceed with unpairing.

[0166] This request is sent via network 12, received by the pump's MtoM communication tool 24, forwarded to the pump's DNP manager 23, which then issues it to the appropriate queue, i.e., the ("control", "pumping") queue, issuing a status change for the corresponding capability, i.e., interface function 2, which triggers the GUI manager 23 to adapt accordingly by returning the capability interface function 2 to its original form, so that the variator 35 and start / stop button 34 are present on the pump's GUI, as shown in the center of Figure 8.

[0167] Since the flow sensor is not involved in the unpairing process (it remains paired with the pump), no action is taken, and therefore its GUI remains unchanged, as shown at the bottom of Figure 8. The same applies to the pH sensor, which is not involved in the unpairing process (it remains paired with the mixer). The pump's DNP manager 25 sends an acknowledgment of receipt of the request to proceed with unpairing via the MtoM communication tool 24 to the mixer.

[0168] As mentioned above, the (exclusive) negotiation step between the mixer and pump is disabled; and since the previously shared capabilities can now be used for negotiation again, the aforementioned isolation is implemented to temporarily prevent the mixer and pump from performing the negotiation step. Other unpairings (mixer and pH sensor, pump and flow sensor) are performed in the same way.

[0169] Ability transmission As mentioned above, the pump has the additional capability to provide the flow values ​​sensed by the flow sensor, as if the flow sensor were part of the pump itself. This additional capability, named Interface Function 3, is described in the pump's device shape file 26. The description of capability interface function 3 includes an identifier (capabilityUniqueID) which also references the identifier of another capability (refToCapabilityUniqueID), i.e., the associated capability of the flow sensor paired with the pump, if any. In this regard, to simplify the disclosure above, it has not been mentioned that each capability description includes a capability-specific identifier (capabilityUniqueID), which in this example is a four-digit value.

[0170] Interface function 3 If available, interface function 3 is similar to the interface function of the pH sensor disclosed above: in the modified form, interface function 3 of the pump holds a display of the current value measured by the flow sensor, and the trend curve represents the change in flow over time while the display is changed to indicate that the pump is paired with the appropriate other system device, which is here done by interface function 2 when paired with the appropriate other system device such as a mixer, by releasing two control icons 34 and 35 from the pump's GUI.

[0171] Capability Interface Function 3 has the following description in the pump's device shape file 26: Domain: "Graphics", Purpose: "Process Value Display", Role: "Provider", Limitations / Conditions: NotAvailable. The list of properties is: [Table 14]

[0172] In these cases, the `capabilityUniqueID` property is a unique identifier for the pump's interface function 3; a tag attribute "tag=undefined, source=refToCapabilityUniqueID" is provided, which is updated when paired with the flow sensor and uses the corresponding attribute in the description of the flow sensor's capability issued to the queue ("Graphics", "Process Value Display") within the pump. The limit / condition features are also updated to be the same as the flow sensor's capability; such updates indicate that capability interface function 3 is available.

[0173] The description of pump capability interface function 3 means that the pump, as a capability provider, can provide a flow (and flow only) process value display dataset to a system device paired using the OPC UA standard. This capability is negotiable only if enabled by the pump. The dataset includes the process value, its name, and its units.

[0174] Generally, capabilities such as interface function 3 operate when activated in the same way as the capabilities of other paired system devices, and can be provided to system devices other than the pump, as if they were coming from the system device itself.

[0175] For convenience, a mechanism involving capabilities such as the pump's interface function 3 can be called capability propagation, and a source capability (such as the flow sensor's capability) can activate a capability that replicates the source capability (such as interface function 3), referring to the fact that the source capability (such as the flow sensor's capability) becomes available in the same material through a system device such as a pump; capabilities such as interface function 3 can be called capability transfer functions (propagators).

[0176] Needless to say, such capabilities (interface function 3, etc.) replicate the source capabilities, so the capabilities provided by the bioprocess machine 13 (mixer in this case) replicate the capabilities provided by the machine helper 14 (pump in this case).

[0177] Multiple shared capabilities In a modified example not shown, the pump does not have the capability as interface function 3: the flow sensor is paired with the pump and mixer together, instead of being paired with the pump alone, so the mixer obtains the flow value directly from the flow sensor (and not from the pump, which obtains the flow value from the flow sensor).

[0178] In fact, the flow sensor's capabilities do not impose any limitations on the number of other system devices that can be paired, but the mixer's capability interface function 1 can display process values ​​from multiple paired system devices, such as the flow sensor, in addition to the pH sensor. For convenience, the fact that a capacity (such as the capacity of a flow sensor) is consumed by multiple other system devices can be referred to as the sharing of capacity among multiple devices.

[0179] ability stratification In another variation not shown, capability interface function 3 not only replicates the source capability (the capability of the flow sensor) but also enables the pump to provide additional functionality that it cannot provide without the flow sensor, namely flow regulation.

[0180] Interface function 3 If interface function 3 is available, the pump speed can be controlled and monitored to adjust the flow rate through the pump using the OPC UA standard. Capability Interface Function 3 has the following description in the pump's device shape file: Domain: "Control", Purpose: "PV Regulation", Role: "Provider", Restrictions / Conditions: Exclusive, NotAvailable. The list of properties is: [Table 15]

[0181] In these cases, the capabilityUniqueID property is a unique identifier for the pump's interface function 3; a tag attribute "tag=undefined, source=refToCapabilityUniqueID" is provided and updated upon pairing with the flow sensor, along with the corresponding attribute in the description of the flow sensor's capability issued to the queue ("Graphics", "Process Value Display") within the pump. Limitation / conditional features are also updated to indicate that capability interface function 3 is available.

[0182] The description of pump capability interface function 3 means the following: The pump, as a capability provider with process value adjustment skills, can provide control and monitoring of the pump speed to adjust the flow through the pump using the OPC UA standard. This capability is negotiable only when enabled by the pump. Paired system devices, such as mixers, have exclusive control and can start / stop adjustments, set adjustment parameters, and retrieve data from process values.

[0183] Generally, the capabilities provided by activating additional functions such as interface function 3 can be offered to paired system devices other than flow sensors, and to system devices other than pumps. For convenience, a mechanism including capabilities such as the pump's interface function 3 can be called a functional hierarchy, referring to the fact that source capabilities (such as the flow sensor's capabilities) are embedded in more complex capabilities; and capabilities such as interface function 3 can be called a hierarchical capability.

[0184] Such capabilities (such as interface function 3) may include source capabilities, but the capabilities provided by the bioprocess machine 13 (mixer in this case) must embed the capabilities provided by the relevant machine helper 14 (pump in this case). As used herein, the term “hierarchical capability” is generally used to indicate that source capabilities are required for a machine helper to issue / display a hierarchical capability. For example, “volume calculation” as a hierarchical capability requires “length,” “height,” and “depth” as source capabilities, depending on the shape of the volume to be determined.

[0185] Further variations A variation of the example disclosed above is: - Bioprocess machines are different from mixers. Examples include bioreactors, chromatographs, virus inactivation machines, and tangential flow filters.

[0186] - Unlike pumps, flow sensors, and pH sensors; for example, other active components such as valves and mass flow controllers; other sensors such as mechanical, electronic, optoelectronic, infrared, ultraviolet, pressure sensors, temperature sensors, OD (optical density) sensors, DO (dissolved oxygen) sensors, gas (CO2, ...) sensors, weight sensors, speed (RPM, ...) sensors, flow (gas / air) sensors, humidity sensors, etc., humidity sensors, light / illuminance sensors, position (valve, actuator, switch, ...) sensors, power (watt, ...) sensors, galvanometers, molar sensors Sensors such as pressure sensors, vacuum sensors, title sensors, viability sensors, resistivity sensors, proximity / distance sensors, volume sensors, UV sensors, IR sensors, frequency sensors, molar concentration sensors, duration / time sensors, radiation sensors, colorimeters, glucometers, opacity meters, osmometers, photometers, spectrometers, sound pressure sensors, sonometers, video sensors, photosensors, charge sensors, particle counters, viscosity sensors or lactate sensors; other types of instrumentation; and / or auxiliary devices such as cell retention devices or mixers (different from the mixers in the examples above) that are capability providers.

[0187] - Unlike the mixer in the above example which must be combined with a pump connected to inlet 1 to be operable, the bioprocess machine is operable in a stand-alone state, that is, it does not need to be paired with a bioprocess machine helper to be operable. - The system equipment is originally in a location separate from the production area and the storage area. For example, all system devices are initially in the storage area and are all brought into the production area for installation setup.

[0188] - The interactive screen is replaced or complemented by another user interface such as a passive display and physical buttons, or a passive screen and a keyboard; - The network is different from a network using IP; - The communication standard between machines is different from OPC UA; and / or

[0189] - The system has only one bioprocess machine and one bioprocess machine helper; or there are multiple bioprocess machines and multiple bioprocess machine helpers having at least specific machine helpers that can be combined with different bioprocess machines. Many other variations are possible, and in this regard, it is recalled that the present invention is not limited to the disclosed and illustrated examples.

Claims

1. A system having the following system devices for processing fluids within a bioreactor: - A bioprocess machine (13) having a fluid processor (15) configured to modify at least one physicochemical or biological property of a fluid, and a digital controller (16) for controlling the fluid processor (15); and - A bioprocess machine helper (14) having a fluid processor helper (21) configured to be physically connected to a fluid processor (15), and a digital controller (22) for controlling the fluid processor helper (21); Here: - Each of the digital controllers (16) of the bioprocess machine (13) and the digital controller (22) of the machine helper (14) includes a GUI manager (17, 23), an MtoM communication tool (18, 24), and a DNP manager (19, 25); Each MtoM communication tool (18, 24) is configured to connect to the network (12); - The DNP manager (19) of the bioprocess machine (13) and the DNP manager (25) of the machine helper (14) are configured to cooperate via the network (12) to establish a pairing state; where: the GUI manager (17) of the bioprocess machine (13) and the GUI manager (23) of the machine helper (14) are configured in the pairing state as follows: - The GUI manager (17) of the bioprocess machine (13) has at least one provided capability that it does not have when not in a paired state, the provided capability being an interface function that controls and / or displays the operating parameters of the processor helper (21), or displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21); and - The GUI manager (23) of the machine helper (14) has at least one consumed capability which is modified when it is not in a paired state, where: if the provided capability is an interface function that controls and / or displays the operating parameters of the processor helper (21), the consumed capability is an interface function that controls and / or displays the operating parameters; and if the provided capability is an interface function that displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21), the consumed capability is an interface function that displays the physicochemical or biological quantities. The aforementioned system.

2. The system according to claim 1, wherein the GUI manager (23) of the machine helper (14) is configured to be operable in a standalone manner when it is not paired with the machine helper (14).

3. The system according to claim 1 or 2, wherein the GUI manager of the bioprocess machine is configured so that the bioprocess machine can be operated standalone when it is not in a paired state.

4. The system according to claim 1 or 2, wherein the GUI manager (17) of the bioprocess machine (13) is configured such that the bioprocess machine (13) can operate only when the bioprocess machine (13) is paired with a predetermined machine helper (14).

5. The consumed capacity is an interface function that controls and / or displays the operating parameters of the processor helper (21); The system according to any one of claims 1 to 4, wherein when the GUI manager (23) of the machine helper (14) is not in a pairing state, the interface function of consumed capacity displays at least one control icon (34, 35) of the operation parameter, while in a modified form, the interface function of consumed capacity is configured not to display the control icon (34, 35).

6. The system according to any one of claims 1 to 5, wherein the digital controller (16) of the bioprocess machine (13) includes a file (20) containing a description of each interface function that may be a provided capability, and the digital controller (22) of the machine helper (14) includes a file (26) containing a description of each interface function that may be a consumed capability.

7. The system according to any one of claims 1 to 6, wherein the DNP manager (19) of the bioprocess machine (13) and the DNP manager (25) of the machine helper (14) are configured to cooperate via a network (12) to establish a pairing state.

8. The system according to any one of claims 1 to 7, wherein the system device includes a plurality of machine helpers (14), and the DNP manager (19) of the bioprocess machine (13) is configured to establish a pairing state with at least one machine helper (or more) (14) simultaneously.

9. The system device comprises a first machine helper (14) and a second machine helper (14), the fluid processor helper (21) of the first machine helper (14) and the fluid processor helper (21) of the second machine helper (14) are configured to be physically connected to each other, and the DNP manager (25) of the first machine helper (14) and the DNP manager (25) of the second machine helper (14) are configured to cooperate via a network (12) to establish a pairing state; where: the GUI manager (23) of the first machine helper (14) and the GUI manager (23) of the second machine helper (14) are configured in the pairing state as follows: - The GUI manager (23) of the first machine helper (14) has at least one provided capability that it does not have when not in a pairing state, the provided capability being an interface function that controls and / or displays the operating parameters of the processor helper (21) of the second machine helper (14), or displays the physicochemical or biological quantities of the fluid sensed by the processor helper (21) of the second machine helper (14); - The GUI manager (23) of the second machine helper (14) has at least one consumed capability which is modified when it is not in a paired state, where: if the provided capability is an interface function for controlling and / or displaying the operating parameters of the processor helper (21) of the second machine helper (14), the consumed capability is an interface function for controlling and / or displaying the operating parameters; if the provided capability is an interface function for displaying physicochemical or biological quantities of a fluid sensed by the processor helper (21) of the second machine helper (14), the consumed capability is an interface function for displaying physicochemical or biological quantities. The system according to any one of claims 1 to 8.

10. The system according to claim 9, wherein the GUI manager (17) of the bioprocess machine (13), the GUI manager (23) of the first machine helper (14), and the GUI manager (23) of the second machine helper (14) are configured such that, in the pairing state of the bioprocess machine (13) with the first machine helper (14), the first machine helper (14) is in a pairing state with the second machine helper (14), and while the bioprocess machine (13) is in a pairing state with the second machine helper (14), the GUI manager (17) of the bioprocess machine (13) has the same provided capabilities as the capabilities provided by the first machine helper (14), and the same provided capabilities and consumed capabilities in the second machine helper (14) correspond to the same provided capabilities in the first machine helper (14).

11. The system according to claim 9, wherein the GUI manager (17) of the bioprocess machine (13) and the GUI manager (23) of the first machine helper (14) are in a pairing state between the bioprocess machine and the first machine helper (14), the first machine helper (14) is in a pairing state with the second machine helper (14), and the GUI manager (17) of the bioprocess machine (13) has a provided capacity that replicates the capacity provided by the first machine helper (14) corresponding to the capacity consumed by the second machine helper (14).

12. The system according to claim 9, wherein the GUI manager (17) of the bioprocess machine (13) and the GUI manager (23) of the first machine helper (14) are in a paired state between the bioprocess machine and the first machine helper (14), the first machine helper (14) is in a paired state with the second machine helper (14), and the GUI manager (17) of the bioprocess machine (13) has a provided capability to embed the provided capability into the first machine helper (14) corresponding to the capacity consumed in the second machine helper (14).

13. The system according to any one of claims 1 to 12, wherein the system device comprises a first bioprocess machine (13), a second bioprocess machine (13), and a plurality of machine helpers (14); and the DNP manager (25) of at least one machine helper (14) is configured to establish a pairing state with the first bioprocess machine (13) or the second bioprocess machine (13).

14. A system according to any one of claims 1 to 13, comprising: a first machine helper (14) whose consumed capacity is an interface function that controls and / or displays the operating parameters of a processor helper (21) of a first machine helper (14); and a second machine helper (14) whose consumed capacity is an interface function that displays a physicochemical or biological quantity of a fluid sensed by a processor helper (21) of a second machine helper (14), wherein: the first machine helper (14) is a pump, and the consumed capacity is an interface function that controls and / or displays the speed of the pump; and the second machine helper (14) is a pH sensor or flow sensor, and the consumed capacity is an interface function that displays the pH of the fluid or the flow of the fluid.

15. The system according to any one of claims 1 to 14, wherein each MtoM communication tool (18, 24) is configured to connect to a network (12) which is a network having the Internet Protocol.

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