Method and apparatus for setting up single-use devices / processes

Abstract

Methods, apparatus, systems, and articles of manufacture are disclosed for setting up single-use devices / processes. An example method disclosed herein includes configuring a control interface via an object-oriented programming interface, the object-oriented programming interface including an object class representing a single-use component in a single-use process. The example method also includes activating the single-use object in the control interface by detecting that all ports associated with the single-use component are connected, and verifying the single-use component.

Description

[0001] This application is a divisional application of the application filed on March 21, 2017, application number 201710170529.1, titled "Method and apparatus for setup of single-use equipment / process". TECHNICAL FIELD

[0002] Generally, the present disclosure relates to process control systems, and more particularly, to a method and apparatus for setup of single-use equipment / process. BACKGROUND

[0003] In industries such as biopharmaceutical, implementation of single-use components in equipment / processes is increasing. For example, single-use equipment / processes are widely adopted in upstream bioreactors, media / solution preparation, etc. Unlike fixed (or permanent) components that do not require revalidation once commissioned, single-use components need to be validated prior to each batch. For example, once a single-use component is used, it is no longer considered to be sterile and must be replaced with a new single-use component for qualified use. Although single-use equipment / processes were initially developed for small scale processes (e.g., preclinical and phase one clinical manufacturing), it is now generally accepted that single-use equipment / processes can also be more economical than traditional stainless steel fixed plants even at commercial scale due to elimination of clean-in-place (CIP) and sterilize-in-place (SIP) processes. The combination of single-use equipment / processes with a manufacturing execution system (MES) can be the fastest method for concept validation of new drugs. Therefore, the use of single-use equipment / processes and MES has been a fast growing trend in industries such as pharmaceutical. SUMMARY

[0004] An example method and apparatus for setup of single-use equipment / processes are described. An example method includes configuring a control interface via an object-oriented programming interface, the object-oriented programming interface including an object class representing a single-use component in the single-use process. The example method also includes activating a single-use object in the control interface by detecting that all ports associated with the single-use component are connected and verifying the single-use component.

[0005] An example apparatus includes a processor system and a memory, the processor communicatively coupled to the processor system, the memory including stored instructions that enable the processor system to configure a control interface via an object-oriented programming interface, the object-oriented programming interface including an object class representing a single-use component in a single-use process. The instructions further enable the processor system to verify the single-use component to activate a single-use (SU) object in the control interface when all ports associated with the single-use component are connected, the SU object being an instance of the object class.

[0006] An example tangible computer-readable storage medium includes instructions that, when executed, cause a machine to at least configure a control interface via an object-oriented programming interface, the object-oriented programming interface including an object class representing a single-use component in a single-use process. The example instructions further cause the machine to activate a single-use (SU) object in the control interface by performing the following: detecting that all ports associated with the single-use component are connected, and verifying the single-use component, the SU object being an instance of the object class.

[0007] An example apparatus includes a bracket, a clamping section, and a clamp manager. The bracket is embedded with a first connection sensor. The clamping section is pivotally coupled to the bracket, the clamping section being embedded with a second connection sensor, the first and second connection sensors for detecting when the apparatus is in a closed position or in an open position. The clamp manager is for transmitting a signal indicative of a change in position. BRIEF DESCRIPTION OF DRAWINGS

[0008] Figure 1 An example process control environment in which the teachings of the present disclosure can be implemented is illustrated.

[0009] Figure 2 is Figure 1 A block diagram of an example implementation of a process automation system (PAS) platform of

[0010] Figure 3 An example single-use (SU) object generated by an example configuration manager of Figure 2 is illustrated.

[0011] Figure 4 An example control interface generated by a PAS platform of Figure 1 and / or Figure 2 is illustrated.

[0012] Figure 5 is an example single-use (SU) object that can be generated by a PAS platform of Figure 1 and / orFigure 2 An exemplary PAS platform of the

[0013] Figure 6 An exemplary PAS platform of the Figure 1 and / or Figure 2 An exemplary PAS platform of the

[0014] Figure 7 An exemplary PAS platform of the Figure 1 and / or Figure 2 An exemplary PAS platform of the

[0015] Figures 8-11 An exemplary control interface generated by a PAS platform of the Figure 1 and / or Figure 2 An exemplary control interface generated by a PAS platform of the

[0016] Figure 12 An exemplary smart fixture that can be used to implement the teachings of the present disclosure is illustrated.

[0017] Figure 13 Another exemplary smart fixture that can be used to implement the teachings of the present disclosure is illustrated.

[0018] Figure 14 A flowchart representing an exemplary method that can be performed to automate single-use device / process verification systems is illustrated.

[0019] Figures 15-18 A flowchart representing an exemplary method that can be performed by an exemplary PAS platform of the Figure 1 and / or Figure 2 An exemplary PAS platform of the

[0020] Figure 19 A flowchart representing an exemplary method that can be performed by an exemplary fixture manager of the Figure 13 An exemplary PAS platform of the

[0021] Figure 20 A block diagram of an exemplary processing platform configured to execute exemplary machine-readable instructions to implement the Figures 14-19 An exemplary PAS platform of the Figure 1 and / or Figure 2 An exemplary PAS platform of the

[0022] Wherever possible, the same reference numbers will be used throughout the drawings and accompanying written description to refer to the same or like parts. DETAILED DESCRIPTION

[0023] Process control environments can be used to implement batch processes in which, for example, a workstation or controller executes a batch execution routine, which is a high-level control routine that directs the operation of one or more of the process control devices in the process control device to execute a series of different steps (often referred to as stages) needed to produce a product such as a particular type of buffer. To implement the different stages, the batch execution routine uses a recipe that specifies the steps to be performed, the quantities and times associated with the steps, and the order of the steps. The steps of a recipe can include, for example, filling a reactor vessel with appropriate materials or ingredients, mixing the materials within the reactor vessel, heating the materials within the reactor vessel to a certain temperature for a certain amount of time, emptying the reactor vessel, and then cleaning the reactor vessel in preparation for the next batch run. Each step defines a stage of the batch run, and the batch execution routine within the controller can execute different control algorithms for the various stages. Of course, for different recipes, the particular materials, quantities of materials, heating temperatures, times, etc. can be different, and thus, these parameters can change from batch run to batch run depending on the product being manufactured or produced and the recipe being used.

[0024] However, before a batch process can be executed, it is important to qualify (e.g., inspect and validate) the equipment and flow path connections involved in the process. Conventionally, process systems that employ fixed set-ups (e.g., stainless steel equipment) perform qualification (e.g., installation qualification, operational qualification, and performance qualification) when the process system is put into service. Once the process system is qualified, the equipment and flow path connections in the process system do not need to be re-qualified unless changes are made to the equipment or connections. Thus, fixed set-up systems can be considered "set it and forget it" systems.

[0025] However, conventional qualification processes (e.g., installation qualification, operational qualification, and performance qualification) cannot be applied to single-use equipment / processes because assembling the single-use equipment / process is an integral part of each batch operation that includes single-use equipment. For example, the equipment and flow path connections in a single-use process must be re-qualified before each batch is executed. Thus, ensuring that single-use components have been properly assembled, connected, and properly documented is critical to single-use equipment / process operation and a major challenge, for example, in regulated industries such as biopharmaceuticals.

[0026] Examples disclosed herein provide single use equipment / process (SUE) verification systems. An example SUE verification system includes an example control interface to facilitate setup of a single use equipment / process. For example, disclosed examples include constructing a graphical control interface using class objects (e.g., SU objects) that represent single use components. In some examples, the graphical control interface is designed using an object-oriented programming protocol.

[0027] An example SUE verification system disclosed herein also includes an example equipment setup table to facilitate verification that the correct single use components are used during setup. For example, the example equipment setup table can provide a list of single use components used in the SUE and characteristics associated with the single use components such as component verification information (e.g., part number, model number, etc.).

[0028] In operation, the graphical control interface provides a blueprint for setting up the single use components. In some disclosed examples, the SUE verification system includes smart clamps for detecting when physical connections are made. For example, when a smart clamp is moved to a closed position, the smart clamp determines whether it is in contact with a single use component and sends a signal identifying which contact position (if any) of the smart clamp is in contact with the single use component. The example SUE verification system can monitor the smart clamp signals to determine when all ports of the single use component are connected.

[0029] In some examples, when it is determined that all ports of the single use component are connected (e.g., based on signals received from one or more smart clamps), the example SUE verification system obtains (e.g., scans) component identification information from the single use component and compares the obtained component identification information to the component verification information stored in the equipment setup table. In some examples, the SUE verification system can prompt a user to scan the single use component. In some examples, the smart clamps can be provided with barcode readers that scan (e.g., automatically scan) the single use component when prompted. In some examples, if the SUE verification system determines that the obtained component identification information and the stored equipment verification information do not match, the SUE verification system disclosed herein can issue an alert and the user can be provided an opportunity to replace the incorrect single use component with the correct single use component.

[0030] As used herein, the term "single use component" refers to an item (or equipment) (e.g., a multi-component setup) used to implement assembly in an equipment system or process and designed or configured to be discarded after completion of a batch process.

[0031] As used herein, the term "single-use device / process" refers to a device or process that includes at least a single-use component in its process flow path.

[0032] As used herein, the term "SU object class" refers to a class definition that represents an object of a single-use component in an object-oriented programming protocol.

[0033] As used herein, the term "SU object" refers to a graphical object in a control interface that is generated as an instance of an SU object class.

[0034] Figure 1 is a block diagram of an example process control environment 100 that includes an example workstation 102 and an example process control system 104. The example workstation 102 can include any computing device, including a personal computer, a laptop computer, a server, a controller, a smart phone, a microcomputer, etc. Additionally, the example workstation 102 can be implemented using any suitable computer system or processing platform (e.g., the example processor platform 2000 illustrated in FIG. 2). For example, the workstation 102 can be implemented using a single-processor personal computer, a single-processor workstation, or a multi-processor workstation, etc. Figure 20

[0035] The example process control system 104 can include any type of manufacturing facility, process facility, automation facility, safety instrumented facility, and / or any other type of process control structure or system. In some examples, the process control system 104 can include multiple facilities located at different sites. Additionally, the example process control environment 100 can include other process control systems (not shown) that can be included in the same facility and / or located at different facilities.

[0036] The example process control environment 100 of Figure 1 is provided to illustrate one type of environment in which the example methods and apparatus described in greater detail below can be advantageously employed. However, other systems of greater or lesser complexity than the example process control environment 100 and / or example process control system 104 shown can be employed if desired, as well as systems for interfacing with process control activities. Figure 1 The example methods and apparatus disclosed herein can be employed in other systems of greater or lesser complexity than the example process control environment 100 and / or example process control system 104 shown, if desired, as well as systems for interfacing with process control activities.

[0037] Figure 1 The example process control system 104 of Figure 1 ​The example process control system 104 also includes process control devices 108 (e.g., input and / or output devices). The process control devices 108 can include any type of process control component capable of receiving input, generating output, and / or controlling a process or control loop. In Figure 1 In the illustrated example, the process control devices 108 represent single-use devices / processes, such as systems comprised of delivery hoses, mixing bags, etc. However, other process control systems 104 can include a combination of single-use devices / processes and fixed setup (e.g., permanent or reusable) devices / processes. The process control devices 108 can include control devices such as valves, pumps, fans, heaters, coolers, and / or mixers to control a process. Additionally, the process control devices 108 can include one or more measurement or monitoring devices, such as pH sensors, temperature sensors, manometers, meters, fluid level meters, flow meters, vapor sensors, etc., to measure portions of the process. Figure 1 The example process control devices 108 can receive instructions from the controller 106 via inputs 110A to execute specified commands and cause changes to a process implemented and / or controlled by the process control devices 108. Further, the measurement or monitoring devices can measure process data, environmental data, input device data, etc., and send the measured data as process data to the controller 106 via outputs 110B. The process data can include values of variables (or parameters) corresponding to the measured output from each process control device 108.

[0038] In Figure 1 In the illustrated example, the example controller 106 communicates with the process control devices 108 within the process control system 104 via inputs 110A and / or outputs 110B. The example inputs 110 and the example outputs 112 can be implemented by a data bus 110. In some examples, the data bus 110 can be coupled to an intermediate communication component (e.g., field junction box, marshalling cabinet, etc.) within the process control system 104. Further, the communication component can include input / output (I / O) devices (e.g., I / O cards) to receive data from the process control devices 108 and convert (or translate) the data into communications capable of being received and processed by the example controller 106. Additionally, the I / O devices can convert (or translate) data or communications from the controller 106 into a data format capable of being processed by the corresponding process control devices 108. In one example, the data bus 110 can use a fieldbus protocol or other type of wired (e.g., Profibus, DeviceNet, Foundation Fieldbus, etc.) and / or wireless communication protocol (e.g., Wireless HART (Highway Addressable Remote Transducer Highway HART) protocol, etc.).

[0039] In Figure 1In one example, exemplary controller 106 manages one or more process control routines (e.g., process control algorithms, functions, and / or instructions) to control process control devices 108 within process control system 104. Controller 106 can be controlled via, for example, a DeltaV system sold by Emerson Process Management. TM The controller implements this. Exemplary controller 106 control routines calculate process data based on output 110B from process control device 108 for process control applications, including, for example, monitoring applications, alarm management applications, process trend and / or history applications, diagnostic applications, batch processing and / or activity management applications, statistical applications, streaming video applications, advanced control applications, safety instrumented applications, event applications, etc. Controller 106 forwards process data to workstation 102 at periodic intervals and / or while processing or generating process data. Process data sent by controller 106 may include process control values, data values, alarm messages, text, block patterns, component status information, diagnostic information, error messages, parameters, events, and / or device identifiers.

[0040] exist Figure 1 In the example example, workstation 102 executes a process control application. The process control application communicates with exemplary controller 106 to monitor, control, and / or diagnose process control equipment 108. For example, the process control application may include control automation, graphical representation of the process control system 104, user management, process control editing, data collection, data analysis, etc. In some examples, a display connected to workstation 102 displays the process control application via a user interface to present process data in a graphical format, allowing the user of workstation 102 to graphically view (via the application) the process data generated by process control equipment 108.

[0041] exist Figure 1 In the exemplary examples, process control environment 100 includes an exemplary Enterprise Resource Planning (ERP) platform 120, an exemplary Manufacturing Execution System (MES) platform 130, and an exemplary Process Automation System (PAS) platform 140. Exemplary platforms 120, 130, and 140 can be implemented using one or more servers communicating with one or more data storage devices.

[0042] exist Figure 1 In the example example, ERP platform 120 tracks business resources at the enterprise level. For instance, ERP platform 120 can establish basic factory schedules (including production, material usage, delivery, and / or transportation). Figure 1The example ERP platform 120 includes an example project master 122 and an example inventory 124. The example project master 122 defines all information (e.g., characteristics) about materials, components, etc. available to the enterprise. The example inventory 124 indicates the quantity of projects (e.g., materials) available to the enterprise. In the illustrated example, the project master 122 and the inventory 124 are represented as lists. However, other types of data structures (e.g., spreadsheets, data tables, etc.) can additionally or alternatively be used.

[0043] In Figure 1 In the illustrated example, the MES platform 130 manages operational workflows (e.g., processing steps) with manual and process automation systems that perform automation equipment control. Examples of manual workflows include performing material charges, filter changes, etc. Examples of automated processing steps include heating stages, agitation, material transfers, etc. In the illustrated example, the MES platform 130 provides a solution that supports the main production processes in the process control environment 100.

[0044] In the illustrated example, the MES platform 130 tracks and records the conversion of raw materials to finished goods. For example, Figure 1 The MES platform 130 includes an example bill of materials (BOM) 132, an example bill of equipment (BOE) 134, and an example MES recipe 136. The example bill of materials 132 is a list of materials (e.g., raw materials) that can be consumed in manufacturing a product. During execution of a process, as materials are consumed, the quantity of consumed materials is charged to the inventory 124 (e.g., removed from the available quantity) according to the BOM 132. For example, a cleaning solution can be included in the BOM 132. The example bill of equipment 134 is a list of equipment used to manufacture a product. For example, a skid that holds a mixing bag can be included in the BOE 134. In some cases, resources can be included in the BOM 132 and the BOE 134. The example MES recipe 136 can include manual processing steps and automated processing steps to manufacture a product.

[0045] In Figure 1 In the illustrated example, the process control environment 100 includes a PAS platform 140 to facilitate setup of single-use equipment / processes. The example PAS platform 140 provides a graphical control interface for process control of single-use equipment / processes. In some examples, the graphical control interface can be designed as a graphical representation of the single-use equipment / process. The example PAS platform 140 uses an equipment setup table to verify that installed single-use components are the correct single-use components.

[0046] In some examples, the PAS platform 140 facilitates monitoring, supervision, and automated control of single-use equipment / processes. For example, the PAS platform 140 can facilitate batch-level automation in the process control environment 100. The PAS platform 140 can include a plurality of applications stored within and executed by different devices located at different locations having the process control environment. For example, the PAS platform 140 can include an example configuration application (or configuration interface) and an example operation application (or operation interface).

[0047] In Figure 1 In the illustrated example, the workstations 102 are communicatively coupled to the controller 106 and the platforms 120, 130, 140 via an example network 180. Figure 1 The example network 180 of the illustrated example is the Internet. However, the example network 180 can be implemented using any suitable wired and / or wireless network(s), including, for example, one or more data buses, one or more local area networks (LANs), one or more wireless LANs, one or more cellular networks, one or more private networks, one or more public networks, etc. The example network 180 enables the workstations 102 to communicate with the controller 106 and / or the platforms 120, 130, 140. As used herein, the phrase “in communication,” including variants thereof, encompasses direct communication and / or indirect communication through one or more intermediary components and does not require direct physical (e.g., wired) communication and / or constant communication, but includes periodic or aperiodic intervals and single events.

[0048] Figure 2 The PAS platform 140 can facilitate setup of single-use equipment processes Figure 1 A block diagram of an example implementation of the PAS platform 140 of the illustrated example. The PAS platform 140 of the illustrated example includes an example configuration manager 205, an example connection monitor 210, an example component verifier 215, an example setup tester 220, an example SU object class data store 225, an example equipment setup data table 230, an example control interface data store 235, and an example status data store 240. Although the example data stores 225, 230, 235, 240 are illustrated as separate data stores in the illustrated example, one or more of the data stores 225, 230, 235, 240 can be combined into one or more data stores. Additionally, one or more of the data stores 225, 230, 235, 240 can be included in the ERP platform 120 and / or the MES platform 130. Figure 2 A block diagram of an example implementation of the PAS platform 140 of the illustrated example. The PAS platform 140 of the illustrated example includes an example configuration manager 205, an example connection monitor 210, an example component verifier 215, an example setup tester 220, an example SU object class data store 225, an example equipment setup data table 230, an example control interface data store 235, and an example status data store 240. Although the example data stores 225, 230, 235, 240 are illustrated as separate data stores in the illustrated example, one or more of the data stores 225, 230, 235, 240 can be combined into one or more data stores. Additionally, one or more of the data stores 225, 230, 235, 240 can be included in the ERP platform 120 and / or the MES platform 130.

[0049] Figure 2The PAS platform 140 of the illustrated example is provided with an example configuration manager 205 to facilitate configuration of the control interface. In some examples, the example configuration manager 205 provides a user interface (e.g., a configuration interface) via the workstation 102. The example configuration manager 205 provides a graphical module approach for configuring the example control interface 207. For example, the configuration manager 205 facilitates designing the control interface 207 as a graphical representation of the process control system 104.

[0050] In the illustrated example, the control interface 207 can include one or more objects from different object classes, where each object is part of an overall control routine or sub-routine and operates in conjunction with other objects to implement a control strategy. As is known, objects, which can be objects in an object-oriented programming protocol, typically perform one of an input function (e.g., associated with a transmitter, sensor or other process parameter measurement device), a control function (e.g., associated with a control routine that performs PID, fuzzy logic, etc. control) or an output function (which controls the operation of some device, such as a valve, to perform some physical function within the process control system 104). Additionally or alternatively, other techniques such as hybrid and other types of complex function blocks (e.g., model predictive controllers (MPC), optimizers, etc.) can also be used.

[0051] In the illustrated example, the configuration application includes and / or accesses an example SU object class data store 225. As used herein, an object class defines properties (e.g., parameters) and methods (e.g., actions) for an object. Generally, the control interface 207 is composed of function blocks that are objects in an object-oriented programming program that perform functions based on inputs provided thereto and provide outputs to other function blocks within the control interface 207. As used herein, an object represents a process control device 108 and its associated control logic. In conjunction with the Figure 4 An example implementation of the control interface 207 is discussed. The example configuration manager 205 of the illustrated example records the control interface 207 in an example control interface data store 235.

[0052] In the illustrated example, when an object is created in the control interface 207 (e.g., from the SU object class datastore 225), the example configuration manager 205 facilitates generating an object having attributes representative of a corresponding single-use component. For example, a user (e.g., a configuration engineer, an automation engineer, etc.) can drag and drop an object representative of a single-use delivery hose from the SU object class datastore 225 to the control interface 207. Subsequently, the configuration manager 205 specifies a number of ports and / or other inputs / outputs (I / O) associated with the single-use delivery hose and generates a single-use (SU) object representative of the single-use delivery hose from the SU object class datastore 225. In some examples, the configuration manager 205 can prompt the user to specify a number of ports and / or I / O associated with the single-use component, e.g., via a display. In the illustrated example, the SU object can include attributes such as an object identifier, a part number, a lot number, an input / output identifier, etc. The example implementation of an example SU object 300 is discussed in connection with Figure 3 The example implementation of an example SU object 300 is discussed in connection with

[0053] In addition to generating SU objects, the example configuration manager 205 of the illustrated example also creates a device setup table based on the single-use components included in the SUE. The device setup table facilitates verifying that the correct single-use components are used during SUE setup. In some examples, the configuration manager 205 prompts a user (e.g., via a user interface) to populate one or more fields of the device setup table. For example, the configuration manager 205 can request that the user provide a part number, a lot number, a port identifier clamp mapping, etc. The example implementation of an example device setup table 500 is discussed in connection with Figure 5 The example configuration manager 205 of the illustrated example records the device setup table in the example device setup datastore 230.

[0054] In some examples, the configuration manager 205 can obtain a material list entry related to the single-use component. For example, the configuration manager 205 can use a part number associated with the single-use component and / or the SU object to query the material list 132 (e.g., via the MES platform 130) for attributes / characteristics of the single-use component. For example, where a particular lot is required, the configuration manager 205 can query the material list 132 for a lot number associated with the single-use component.

[0055] Figure 2 The PAS platform 140 of the illustrated example provides an example connection monitor 210 to monitor port connections in the example SUE during setup. In the illustrated example, the example connection monitor 210 monitors the connections between the ports of the SUE and the ports of the single-use components. For example, the connection monitor 210 can monitor the connections between the ports of the SUE and the ports of the single-use delivery hose, the ports of the SUE and the ports of the single-use pump, etc. The example connection monitor 210 can monitor the connections between the ports of the SUE and the ports of the single-use components during setup, e.g., by monitoring the connections between the ports of the SUE and the ports of the single-use components at various times during setup. Figure 2In the example illustrated example, the connection monitor 210 receives signals from one or more clamps in the SUE during setup. For example, when a first single-use assembly is connected via a clamp, the clamp can send a signal identifying the clamp identifier and / or the contact location of the clamp that is engaged with the first single-use assembly. The example connection monitor 210 processes the clamp signal and maps it to a port identifier. For example, the connection monitor 210 can identify the single-use assembly and its ports based on the clamp signal.

[0056] In some examples, the connection monitor 210 updates a state table associated with the SU object based on the detected port connections. For example, the connection monitor 210 can update the SU object state table (e.g., the example SU object state table 700) to identify which port connections are established. The example SU object state table 700 is discussed below in connection with Figure 7 In some examples, the connection monitor 210 updates a state table associated with the SU object based on the detected port connections. For example, the connection monitor 210 can update the SU object state table (e.g., the example SU object state table 700) to identify which port connections are established. The example SU object state table 700 is discussed below in connection with Figure 8 The example control interface with single-use assemblies with verified port connections is discussed below in connection with FIG. 7. The connection monitor 210 can also identify when all ports of a single-use assembly are connected and request a component scan. For example, when the connection monitor 210 determines that all ports of a single-use assembly are connected, the connection monitor 210 can prompt a user (e.g., via a user interface) to scan the single-use assembly. The example control interface including a request to scan a single-use assembly is discussed below in connection with Figure 9 The example control interface including a request to scan a single-use assembly is discussed below in connection with FIG. 7. The connection monitor 210 can store the values of the scan (e.g., component identification information such as part number, lot number, etc.) in the respective fields of the SU object. The example connection monitor 210 can also identify when all SU objects in the control interface 207 are activated.

[0057] Figure 2The PAS platform 140 provides an exemplary component checker 215 to verify that single-use components installed in the SUE are correct. As discussed above, the connectivity monitor 210 stores component identification information in a corresponding field of the SU object. In the illustrated example, the component checker 215 retrieves the component identification information from the SU object and compares it with a stored value (e.g., component inspection information). For example, the component checker 215 may compare the scan part number value retrieved from the SU object with the part number value stored in the device setup table. Alternatively, the component checker 215 may compare the scan batch number value retrieved from the SU object with the batch number value stored in the BOM 132. If the component checker 215 determines that the component identification information (e.g., part number and / or batch number) does not match the component inspection information, the component checker 215 may issue a warning and prevent the user from continuing with the SUE setup. For example, the component checker 215 may present an alarm via a user interface (e.g., an operator interface). In the illustrated example, when component inspector 215 determines that the component identification information matches the component inspection information, component inspector 215 updates the activation state of the SU object. For example, component inspector 215 can change the activation state of the SU object from an "inactive" state to an "active" state. The following section combines... Figure 7 The exemplary implementation of updating the activation state is discussed in the exemplary SU object state table 700. The following section combines... Figure 10 The discussion includes exemplary implementations of the control interface for activated SU objects.

[0058] Figure 2 The PAS platform 140 provides an exemplary setup tester 220 to test connectivity in the SUE. For example, the setup tester 220 can monitor... Figure 7 The SU object status table 700 is used to determine when all SU objects are activated. In the illustrated example, when the tester 220 is set to determine that all SU objects are activated (e.g., via...),... Figure 7 When the SU object status table 700 is accessed, the setup tester 220 checks the electrical connections of the single-use component. In some examples, when the electrical connections of the single-use component are checked, the exemplary setup tester 220 activates the entire control interface. The following section combines... Figure 11 An exemplary implementation of the activation control interface is discussed.

[0059] In some examples, the setup tester 220 performs one or more integrity tests on the SUE. For example, the setup tester 220 can check pressure retention and / or measure the quality of air and / or water required for the filling system (e.g., to a specified pressure). If the setup tester 220 determines that the results of the integrity tests do not satisfy a specified threshold, the example setup tester 220 can issue a warning and can prevent the user from operating the SUE until the integrity tests are satisfied. For example, the setup tester 220 can present an alert indicating that the results of the integrity tests failed to satisfy a specification (e.g., an acceptable threshold). If the setup tester 220 determines that the results do satisfy the specification, the example setup tester 220 can present a message indicating that the SUE is ready to perform a batch.

[0060] In Figure 2 In the illustrated example, the example PAS platform 140 includes an example SU object class data store 225 to store object classes (e.g., SU objects) used to construct and / or design a control interface representing the SUE. The example SU object class data store 225 can be implemented by volatile memory (e.g., synchronous dynamic random access memory (SDRAM), dynamic random access memory (DRAM), RAMBUS dynamic random access memory (RDRAM), etc.) and / or non-volatile memory (e.g., flash memory). The example SU object class data store 225 can additionally or alternatively be implemented by one or more double data rate (DDR) memories such as DDR, DDR2, DDR3, mobile DDR (mDDR), etc. The example SU object class data store 225 can additionally or alternatively be implemented by one or more mass storage devices such as hard disk drives, compact disk drives, digital versatile disk drives, etc. Although the SU object class data store 225 is illustrated as a single database in the illustrated example, the SU object class data store 225 can be implemented by any number and / or type of databases.

[0061] In Figure 2 In the illustrated example, the example PAS platform 140 includes an example device setup data store 230 to store device setup information (e.g., component inspection information). Figure 5The example device settings table 500 of the illustrated example illustrates example single use components and / or characteristics of single use components that can be recorded in the example device settings data store 230. The example device settings data store 230 can be implemented by volatile memory (e.g., SDRAM, DRAM, RDRAM, etc.) and / or non-volatile memory (e.g., flash memory). The example device settings data store 230 can additionally or alternatively be implemented by one or more double data rate (DDR) memories such as DDR, DDR2, DDR3, mobile DDR (mDDR), etc. The example device settings data store 230 can additionally or alternatively be implemented by one or more mass storage devices such as hard disk drives, compact disk drives, digital versatile disk drives, etc. Although in the illustrated example the device settings data store 230 is illustrated as a single database, the device settings data store 230 can be implemented by any number and / or type of databases.

[0062] In Figure 2 In the illustrated example of the present disclosure, the example PAS platform 140 includes an example control interface data store 235 to store control interfaces (e.g., the example control interface 207) that are constructed and / or designed to represent SUEs. The example control interface data store 235 can be implemented by volatile memory (e.g., SDRAM, DRAM, RDRAM, etc.) and / or non-volatile memory (e.g., flash memory). The example control interface data store 235 can additionally or alternatively be implemented by one or more double data rate (DDR) memories such as DDR, DDR2, DDR3, mDDR, etc. The example control interface data store 235 can additionally or alternatively be implemented by one or more mass storage devices such as hard disk drives, compact disk drives, digital versatile disk drives, etc. Although in the illustrated example the control interface data store 235 is illustrated as a single database, the control interface data store 235 can be implemented by any number and / or type of databases.

[0063] In Figure 2 In the illustrated example of the present disclosure, the example PAS platform 140 includes an example state data store 240 to store SU object states associated with SU objects. Figure 7The example SU object status table 700 of the illustrated example illustrates SU object statuses that can be recorded in the example status data store 240. The example status data store 240 can be implemented by volatile memory (e.g., SDRAM, DRAM, RDRAM, etc.) and / or non-volatile memory (e.g., flash memory). The example status data store 240 can additionally or alternatively be implemented by one or more double data rate (DDR) memories such as DDR, DDR2, DDR3, mDDR, etc. The example status data store 240 can additionally or alternatively be implemented by one or more mass storage devices such as hard disk drives, compact disk drives, digital versatile disk drives, etc. Although the status data store 240 is illustrated in the illustrated example as a single database, the status data store 240 can be implemented by any number and / or type of databases.

[0064] Although an example manner of implementing the example PAS platform 140 of Figure 2 is illustrated in Figure 1 , one or more elements, procedures and / or devices illustrated in Figure 2 may be combined, divided, re-arranged, omitted, eliminated and / or implemented in other ways. Further, the example configuration manager 205, the example connection monitor 210, the example component verifier 215, the example setting tester 220, the example SU object class data store 225, the example device setting data store 230, the example control interface data store 235, the example status data store 240, and / or more generally the example PAS platform 140 of Figure 1 may be implemented by hardware, software, firmware and / or any combination of hardware, software and / or firmware. Thus, for example, the example configuration manager 205, the example connection monitor 210, the example component verifier 215, the example setting tester 220, the example SU object class data store 225, the example device setting data store 230, the example control interface data store 235, the example status data store 240, and / or more generally the example PAS platform 140 of Figure 1The exemplary PAS platform 140 can be implemented by one or more analog or digital circuits, logic circuits, programmable processors, application-specific integrated circuits (ASICs), programmable logic devices (PLDs), and / or field-programmable logic devices (FPLDs). When reading any of the device or system claims of this patent to cover pure software and / or firmware implementations, the exemplary configuration manager 205, exemplary connection monitor 210, exemplary component checker 215, exemplary setup tester 220, exemplary SU object class data store 225, exemplary device setup data store 230, exemplary control interface data store 235, exemplary status data store 240, and / or more generally... Figure 1 At least one of the exemplary PAS platforms 140 is hereby explicitly defined as a tangible computer-readable storage device or disk (such as a memory, digital versatile disc (DVD), compact disc (CD), Blu-ray disc, etc.) that includes storage software and / or firmware. Furthermore, Figure 1 The exemplary PAS platform 140 may include, in addition to or alternative to Figure 2 It may include one or more elements, processes and / or devices other than those illustrated herein, and / or may include more than one of any or all of the illustrated elements, processes and and / or devices.

[0065] Figure 3 An exemplary SU object 300 is illustrated, associated with a single-use component represented in the control interface. The illustrated exemplary SU object 300 is associated with a single-use component represented in the graphical control interface associated with the SUE. Figure 3 In the example example, SU object 300 includes SU object property 301 and one or more SU object methods 325. Figure 3 The exemplary SU object 300 includes SU object attributes 301 (such as the exemplary object identifier attribute 305, the exemplary part number attribute 310, the exemplary batch number attribute 315, and the exemplary activation status attribute 320). In the illustrated example, when a single-use component is added to the graphical control interface associated with the SUE, Figure 2 The configuration manager 205 creates SU object 300. Additionally, Figure 2 The exemplary connection monitor 210 can store the values ​​of the corresponding SU objects in object properties 305, 310, 315, and 320.

[0066] In the illustrated example, the object identifier attribute 305 indicates an identifier of the SU object included in the control interface 207. In the illustrated example, the object identifier attribute 305 is an alphanumeric string that uniquely identifies the SU object. For example, the characteristics of a particular SU object can be queried (e.g., retrieved) based on the object identifier value. However, any other method of uniquely identifying the SU object can additionally or alternatively be used.

[0067] In the illustrated example, the part number attribute 310 is an alphanumeric string that identifies a part number (or model number) of the corresponding single-use assembly. For example, the part number can indicate a particular type of delivery hose used (e.g., a ten-foot delivery hose). In the illustrated example, the lot number attribute 315 is an alphanumeric string that indicates a particular lot number to which the corresponding single-use assembly belongs. For example, the lot number can be associated with one or more single-use assemblies that were manufactured at the same time (or nearly the same time).

[0068] In the illustrated example, when the assembly identification information (e.g., port number and / or lot number) is retrieved (e.g., scanned) from the corresponding single-use assembly, the connection monitor 210 stores the part number value and / or the lot number value in the custom attributes of the SU object 300. For example, an operator can scan a barcode affixed to the single-use assembly, and the connection monitor 210 can populate the part number field 310 and / or the lot number field 315 with the corresponding values. In some examples, the operator can manually enter the assembly identification information for the corresponding single-use assembly.

[0069] In some examples, the clamp used to implement the physical connection can include a barcode reader to retrieve the assembly identification information from the single-use assembly. In some such instances, the clamp can scan the single-use assembly for the assembly identification information in response to a query by the connection monitor 210. However, other techniques for identifying the single-use assembly and / or retrieving the assembly identification information can additionally or alternatively be used.

[0070] In some examples, the single-use assembly can not be associated with a lot number. In some such instances, the connection monitor 210 stores a value in the lot number field 315 of the SU object 300 that represents an unavailable value (e.g., "N / A," "null," etc.).

[0071] In the illustrated example, the activation status attribute 320 identifies an activation status of the SU object. For example, the status of the SU object 300 can be "active" (e.g., when the connection monitor 210 determines that one or more ports associated with the single-use assembly are connected, and the example component verifier 215 verifies the part number stored in the part number field 310 against component verification information stored in the device settings data store 230, and verifies the batch number value stored in the batch number field 315 against component verification information stored in the bill of materials 132). Additionally, the status of the SU object 300 can be "inactive" (e.g., when the connection monitor 210 determines that one or more ports associated with the single-use assembly are not connected and / or the device verifier 215 does not determine the part number value in the part number field 310 against component verification information stored in the device settings data store 230 and / or does not determine the batch number value stored in the batch number attribute 315 against component verification information stored in the bill of materials 132).

[0072] In some examples, the SU object 300 can include additional or alternative attributes. For example, the SU object 300 can include a port identifier attribute corresponding to one or more ports associated with the single-use assembly. In some examples, the SU object 300 can include a port connection status attribute associated with a corresponding port. The port connection status can indicate whether the corresponding port is "connected" (e.g., a physical connection is detected) or "not connected" (e.g., a physical connection is not detected).

[0073] In some examples, the configuration manager 205 can automatically populate the attributes of the SU object 300. For example, when a delivery hose is added to the graphical control interface, the configuration manager 205 can add two port identifier fields corresponding to the input and output of the delivery hose. In some examples, an operator can manually enter a desired number of port identifiers associated with a corresponding single-use assembly.

[0074] Figure 3 The example SU object 300 includes SU object methods 325 such as the example port (DI) method 330 and the example I / O method 335. In the illustrated example, the example methods 325, 330 define one or more methods associated with the SU object 300. For example, the port method 330 facilitates defining a number of ports available to a single-use assembly represented by a corresponding SU object. The example I / O method 335 facilitates defining additional or alternative inputs / outputs (e.g., analog inputs, analog outputs, digital inputs, digital outputs, etc.) available to a single-use assembly represented by a corresponding SU object.

[0075] Figure 4An example graphical control interface 400 that can be used to set up and verify single-use components in a SUE is illustrated. In Figure 4 the illustrated example, the graphical control interface 400 represents the physical connections of the process control equipment 108 in the SUE. The graphical control interface 400 is designed by a user (e.g., an automation engineer) using, for example, an example configuration manager 205. For example, the user can design the graphical control interface 400 based on a process flow diagram (PFD) and a piping and instrumentation diagram / map (PID) provided for the single-use process control system 104. The PFD represents the flow of materials in the SUE. The PID represents the connections of the instruments in the PFD and focuses on the electrical connections from the instruments and / or equipment in the SUE. In the illustrated example, the configuration manager 205 stores the graphical control interface 400 in an example control interface data store. Figure 2 Figure 2

[0076] As described above, once the graphical control interface 400 is prepared, an operator can utilize the graphical control interface 400 to set up the SUE and perform a corresponding batch. For example, the graphical control interface 400 can guide the operator to identify which single-use components to use and how to connect the single-use components in the SUE. For example, the operator can select a SU object included in the graphical control interface 400 and can be presented with component verification information that identifies the single-use components (e.g., via part number and batch number), a clamp identifier that identifies a clamp used to couple a port of the single-use component, and a contact location for the clamp used to couple the single-use component. In some examples, the graphical control interface 400 can prompt the operator to verify the connections and / or scan the single-use components.

[0077] Figure 4 The example graphical control interface 400 of FIG. 4B represents an inactive graphical interface. In the illustrated example, the inactive graphical interface indicates that no single-use objects are activated and no physical connections are detected. In some examples, the inactive graphical control interface 400 is presented to the user when the user loads the control interface to set up the SUE. In the illustrated example, the SUE includes a mixing bag 402 having four ports MB1Port_A, MB1Port_B, MB1Port_C, MB1Port_D. The example mixing bag 402 is coupled to a first transfer hose 404 having two ports TH1Port_A, TH1Port_B, a second transfer hose 410 having two ports TH2Port_A, TH2Port_B, a third transfer hose 416 having two ports TH3Port_A, TH3Port_B, and a pump 422 having two ports P1Port_A, P1Port_B. The mixing bag 402 also includes an electrical connection 430. Figure 4 In the illustrated example, the SUE includes a mixing bag 402 having four ports MB1Port_A, MB1Port_B, MB1Port_C, MB1Port_D. The example mixing bag 402 is coupled to a first transfer hose 404 having two ports TH1Port_A, TH1Port_B, a second transfer hose 410 having two ports TH2Port_A, TH2Port_B, a third transfer hose 416 having two ports TH3Port_A, TH3Port_B, and a pump 422 having two ports P1Port_A, P1Port_B. The mixing bag 402 also includes an electrical connection 430.​​

[0078] Exemplary mixing bag 402 is coupled to first transfer hose 404 via exemplary clamp 406. In the illustrated example, the left contact position of clamp 406 clamps port TH1Port_B of first transfer hose 404, and the right contact position of clamp 406 clamps mixing bag port MB1Port_A. Port TH1Port_A of first transfer hose 404 is clamped by the right contact position of exemplary clamp 408.

[0079] Exemplary mixing bag 402 is coupled to second transfer hose 410 via exemplary clamp 412. In the illustrated example, the right contact position of clamp 412 clamps port TH2Port_A of second transfer hose 410, and the left contact position of clamp 412 clamps mixing bag port MB1Port_B. Port TH2Port_B of second transfer hose 410 is clamped by the left contact position of exemplary clamp 414.

[0080] Exemplary mixing bag 402 is coupled to third transfer hose 416 via exemplary clamp 418. In the illustrated example, the right contact position of clamp 418 clamps port TH3Port_A of third transfer hose 416, and the left contact position of clamp 418 clamps mixing bag port MB1Port_C. Port TH3Port_B of third transfer hose 416 is clamped by the left contact position of exemplary clamp 420.

[0081] Exemplary mixing bag 402 is coupled to pump 422 via exemplary clamp 424. In the illustrated example, the left contact position of clamp 424 clamps port P1Port_B of pump 422, and the right contact position of clamp 424 clamps mixing bag port MB1Port_D. Port P1Port_A of pump 422 is clamped by the right contact position of exemplary clamp 426.

[0082] Figure 5 is an exemplary device settings table 500 that can be generated and / or configured to store properties associated with single-use components included in a SUE by exemplary configuration manager 205( Figure 2 ) In the illustrated example, device settings table 500 is stored in exemplary device settings data store 230( Figure 2 ) In some examples, device settings table 500 can be stored at exemplary MES platform 130 of Figure 1 . Figure 5The example equipment setup table 500 includes an example object identifier column 505, an example component number column 510, an example port identifier column 515, an example clamp identifier column 520, an example contact location column 525, and an example electrical connection column 530. The example object identifier column 505 indicates identifiers of SU objects recorded by the configuration manager 205. In the illustrated example, the object identifier column 505 is an alphanumeric string that uniquely identifies an SU object. For example, the object identifier value can be used to query (e.g., look up, fetch, etc.) characteristics of a particular SU object. However, any other method of uniquely identifying an SU object can additionally or alternatively be used.

[0083] The example component number column 510 is an alphanumeric string that identifies a component number (or model number) of a single-use assembly. For example, the component number value can indicate a particular type of delivery hose (e.g., a ten-foot delivery hose) used in the SUE.

[0084] The example port identifier column 515 indicates one or more ports associated with the corresponding single-use assembly. For example, a first delivery hose can have an input port (e.g., TH1Port_A) and an output port (e.g., TH1Port_B). The example clamp identifier column 520 indicates a clamp identifier associated with the corresponding port. The example contact location column 525 indicates a contact location of the clamp associated with the corresponding port. The example electrical connection column 530 indicates whether the corresponding single-use assembly includes an electrical connection.

[0085] Figure 5 The example equipment setup table 500 of the illustrated example includes three example rows 550, 555, 560 corresponding to three example single-use assembly entries. The first example row 550 indicates that the type of single-use assembly identified as object “SU TH1” is “T-000201”. The first example row 550 also indicates that the object “SU TH1” has a first port “TH1Port_A” that will be connected to the “right” contact location of “Clamp 408” and a second port “TH1Port_B” that will be connected to the “left” contact location of “Clamp 406”. The first example row 550 further indicates that the object “SU TH1” does not include an electrical connection.

[0086] The second exemplary row 555 indicates that the type of single-use assembly identified as object "SU_MB1" is "B-200499." The second exemplary row 555 also indicates that the object "SU_MB1" has a first port "MB1Port_A" that is to be connected to the "right" contact location of "Jig 406," a second port "MB1Port_B" that is to be connected to the "right" contact location of "Jig 424," a third port "MB1Port_C" that is to be connected to the "left" contact location of "Jig 418," and a fourth port "MB1Port_D" that is to be connected to the "left" contact location of "Jig 412." The second exemplary row 555 also indicates that the object "SU_MB1" includes an electrical connection.

[0087] The third exemplary row 560 indicates that the type of single-use assembly identified as object "SU_P1" is "P-393092." The third exemplary row 560 also indicates that the object "SU_P1" has a first port "P1Port_A" that is to be connected to the "right" contact location of "Jig 426," and a second port "P1Port_B" that is to be connected to the "left" contact location of "Jig 424." The third exemplary row 560 also indicates that the object "SU_P1" includes an electrical connection.

[0088] Although three exemplary single-use assembly entries are represented in the exemplary equipment setup table 500 of Figure 5 more or fewer single-use assemblies can be represented in the exemplary equipment setup table 500, which corresponds to the number of single-use assemblies included in the SUE.

[0089] Figure 6 The exemplary material list table 600, which can be stored by the exemplary MES platform 130 and / or the exemplary ERP platform 120 of Figure 1 The exemplary material list table 600 of the exemplary MES platform 130 and / or the exemplary ERP platform 120 stores information identifying materials (e.g., single-use materials and fixed (e.g., permanent) materials) that are consumed in the production of a product. Figure 6 The exemplary material list table 600 of the exemplary MES platform 130 and / or the exemplary ERP platform 120 stores information identifying materials (e.g., single-use materials and fixed (e.g., permanent) materials) that are consumed in the production of a product.

[0090] Exemplary part number column 605 is an alphanumeric string that identifies a part number (or model number) of a single-use component. For example, the part number can indicate a particular type of delivery hose (e.g., a ten foot delivery hose) that is set up in the SUE. Exemplary pre-allocated lot number column 610 indicates a particular lot number to which the corresponding single-use component belongs. For example, the lot number value can be associated with one or more components that are manufactured at the same time (or nearly the same time). Exemplary quantity identifier column 615 indicates a quantity of the corresponding material that is used (or that is consumed) to produce the corresponding product. Exemplary unit of measure column 620 indicates a unit of measure that is associated with the corresponding single-use component. For example, the single-use component can be measured by “each.”

[0091] Figure 6 Exemplary material list table 600 includes four exemplary rows 650, 655, 660, 665 that correspond to four exemplary material items. First exemplary row 650 indicates that a material item having part number “T-000201” is included in lot number “237925359.” First exemplary row 650 also indicates that the material item having part number “T-000201” is measured by quantity (e.g., “each” or one). First exemplary row 650 also indicates that a total of “3” such material items will be consumed in the setup (e.g., 3 delivery hoses) of the SUE.

[0092] Second exemplary row 655 indicates that a material item having part number “B-200499” is included in lot number “907555555t.” Second exemplary row 655 also indicates that the material item having part number “B-200499” is measured by quantity (e.g., “each” or one). Second exemplary row 655 also indicates that a total of “3” such material items will be consumed in the setup (e.g., 3 mixing bags with pH and conductivity monitoring) of the SUE.

[0093] Third exemplary row 660 indicates that a material item having part number “P-393092” does not need to be in a particular (e.g., pre-allocated) lot. For example, a “pump” of type “P-393092” is not limited to a particular lot number. Exemplary third row 660 also indicates that the material item having part number “P-393092” is measured by quantity (e.g., “each” or one). Third exemplary row 660 also indicates that a total of “4” such material items will be consumed in the setup (e.g., 4 pumps) of the SUE.

[0094] Figure 6The exemplary bill of materials table 600 also includes material items that are not single-use components. The fourth exemplary line 665 indicates that the material item with part number “C-93475” does not need to be in a specific (e.g., pre-assigned) batch. For example, the “cleaning solution” of type “C-93475” is not limited to a specific batch number. The exemplary fourth line 665 also indicates that the material item with part number “C-93475” is measured in “liters”. The fourth line 665 also indicates that the total volume of these material items will be consumed in the SUE setup (e.g., 200 liters of cleaning solution).

[0095] Despite Figure 6 The exemplary bill of materials table 600 shows four exemplary material items, but more or fewer materials may be shown in the exemplary bill of materials table 600, which correspond to the materials that can be used to produce the corresponding products.

[0096] Figure 7 An example is shown that the data can be stored in the exemplary state data storage 240 ( Figure 2 An exemplary SU object status table 700 is used to store information identifying the status of SU objects. Figure 7 The exemplary SU object status table 700 includes an exemplary object identifier column 705, an exemplary inspection component number column 710, an exemplary inspection batch number column 715, an exemplary scan component number column 720, an exemplary scan batch number column 725, an exemplary port identifier column 730, an exemplary port connection status column 735, and an exemplary activation status column 740. The exemplary object identifier column 705 indicates the identifier of the SU object. In the illustrated example, the object identifier column 705 is an alphanumeric string that uniquely identifies the SU object. For example, the object identifier value can be used to query (e.g., find, retrieve, etc.) the characteristics of a specific SU object. However, any other method that uniquely identifies the SU object can be used alternatively or separately.

[0097] The exemplary inspection part number column 710 and the exemplary inspection lot number column 715 identify the component inspection information associated with the corresponding single-use component. The exemplary inspection part number column 710 is an alphanumeric string identifying the part number (or model number) of the single-use component. This can be obtained from... Figure 5 The inspection component number value can be obtained from the exemplary device settings table 500. The exemplary inspection batch number column 715 indicates the specific batch to which the corresponding single-use component belongs. This can be obtained from... Figure 6 Obtain the inspection lot number value from the exemplary bill of materials 600.

[0098] Exemplary scanned part number column 720 and exemplary scanned lot number column 725 identify component identification information acquired (e.g., scanned) from single-use components connected in the SUE. Exemplary scanned part number column 720 is an alphanumeric string that identifies a component (or model) of a single-use device. Exemplary scanned lot number column 725 indicates a particular lot number to which the corresponding single-use device belongs. In the illustrated example, scanned part number values and scanned lot number values are populated based on component identification information acquired (e.g., via scanning) from single-use components in the SUE.

[0099] Exemplary port identifier column 730 indicates one or more ports associated with the corresponding single-use component. For example, a delivery hose can have an input port (e.g., “TH1 Port_A”) and an output port (e.g., “TH1 Port_B”). Exemplary port connection status column 735 indicates a status of the corresponding port. For example, the port connection status can indicate whether the corresponding port is connected (e.g., the connection monitor 210 detects a physical connection) or not connected (e.g., the connection monitor 210 does not detect a physical connection). Exemplary activation status column 740 indicates whether the corresponding SU object is activated. In the illustrated example, the status of the SU object is activated when (1) all ports associated with the corresponding single-use component are connected (e.g., based on values in the port connection status column 735), (2) the scanned part number value in the scanned part number column 720 is verified against the corresponding part number stored in the exemplary inspection part number column 710 and / or Figure 2 the device settings table 500 of the exemplary device settings data store 230 and / or Figure 5 the scanned lot number value stored in the scanned lot number column 725 is verified against the corresponding lot number value stored in the exemplary material list table 600 of the inspection lot number column 715 and / or Figure 6 the scanned lot number column 725.

[0100] Figure 7The exemplary data table 700 of the illustrated example includes three exemplary rows 750, 755, 760 corresponding to three exemplary single-use object entries. The first exemplary row 750 indicates that the SU object identified as object "SU TH1" can be verified by part number "T-000201" and lot number "237925359." The first exemplary row 750 also indicates that the single-use assembly corresponding to the SU object "SU TH1" has a first port "TH1 Port_A" connected to an appropriate clamping location (e.g., detected by the physical connection of the connection monitor 210) and a second port "TH1 Port_B" not connected to an appropriate clamping location. Accordingly, the status of the object "SU TH1" is indicated as "inactive." Additionally, because all ports of the SU object "SU TH1" are not confirmed (e.g., not connected), the connection monitor 210 has not yet acquired component identification information from the single-use assembly in the SUE.

[0101] The second exemplary row 755 indicates that the SU object identified as object "SU MB1" can be verified by part number "B-200499" and lot number "907555555t." The exemplary second row 755 also indicates that the single-use assembly corresponding to the SU object "SU MB1" has four ports (e.g., a first port "MB1 Port_A," a second port "MB1 Port_B," a third port "MB1 Port_C," and a fourth port "MB1 Port_D") each connected to an appropriate clamping location. In the illustrated example, the device verifier 215 (1) verifies the scanned part number "B-200499" of the corresponding object "SU MB1" against the verification part number value "B-200499" and (2) verifies the scanned lot number value "907555555t" of the corresponding object "SU MB1" against the verification lot number value "907555555t." Accordingly, the status of the SU object "SU MB1" in the exemplary SU object status table 700 is indicated as "active."

[0102] The third exemplary line 760 indicates that the SU object identified as object "SU_P1" can be verified by part number "P393092", and the corresponding single-use component does not need to be included in a specific batch. The exemplary third line 760 also indicates that the single-use component corresponding to SU object "SU_P1" has a first port "P1Port_A" connected to (e.g., a physical connection detected by connection monitor 210) a suitable clamping location, and a second port "P1Port_B" also connected to a suitable clamping location. In the exemplary example, device inspector 215 verifies the scanned part number "P-393092" of the corresponding object "SU_P1" against the verification part number value "P-393092". In the exemplary example, the single-use component corresponding to SU object "SU_P1" does not need to be included in a pre-assigned batch. In some examples, if the corresponding single-use component does not need to be included in a specific batch, connection monitor 210 can discard the scanned batch number. In some examples, the connection monitor 210 may store the scan batch number (if available), but this value is ignored when performing the SU object activation test. Therefore, the status of object "SU_P1" in the exemplary SU object status table 700 is indicated as "active".

[0103] Although Figure 7 The exemplary SU object status table 700 shows three exemplary SU object status entries, but more or fewer SU objects may be represented in the exemplary SU object status table 700, which corresponds to the number of SU objects included in the control interface 207.

[0104] Figures 8-11 The graphical control interface at different stages of SUE setup is illustrated. Figure 8 An exemplary graphical control interface 800 is illustrated. Figure 8 An exemplary graphical control interface 800 represents a configuration including verified port connections. Figure 4 The graphical control interface 400. In the illustrated example, clamp 412 is confirmed to be in the closed position and engages two components. For example, the left contact position of clamp 412 engages the mixing bag port MB1Port_B, and the right contact position of clamp 412 engages the delivery hose port TH2Port_A. As described above... Figure 1 and / or Figure 2 As described in the exemplary PAS platform 140, when the exemplary connection monitor 210 detects a port connection, the connection monitor updates... Figure 7 The exemplary SU object status table 700 records the port connection status of the corresponding object. The exemplary connection monitor 210 also updates the graphical control interface displayed to the user to illustrate the verified ports. In the illustrated example, when a port connection is verified, the port is represented by a thick line.

[0105] Figure 9 An example graphical control interface 900 is illustrated. Figure 9 The example graphical control interface 900 of FIG. 1 1 represents a request 905 to scan a single-use component that includes the example mixed bag 402. Figure 4 The graphical control interface 400 of FIG. 1 1. In the illustrated example, the example clamps 406, 412, 418, 424 connected to the ports of the example mixed bag 402 are confirmed to be in a closed position and to engage two components. For example, the right contact position of the first clamp 406 engages the mixed bag port MB1 Port_A and the left contact position of the first clamp 406 engages the transfer hose port TH1 Port_B, the left contact position of the second clamp 412 engages the mixed bag port MB1 Port_B and the right contact position of the second clamp 412 engages the transfer hose port TH2 Port_A, the left contact position of the third clamp 418 engages the mixed bag port MB1 Port_C and the right contact position of the third clamp 418 engages the transfer hose port TH3 Port_A, and the right contact position of the fourth clamp 424 engages the mixed bag port MB1 Port_D and the left contact position of the fourth clamp 424 engages the pump port P1 Port_B. In the illustrated example, the engaged and verified port connections of the clamps 406, 412, 418, 424 are illustrated as thick lines. In response to determining that all ports of the mixed bag 402 are connected (e.g., mixed bag ports MB1 Port_A, MB1 Port_B, MB1 Port_C, MB1 Port_D), the example connection monitor 210 prompts the user to scan a single-use component (e.g., the mixed bag 402).

[0106] Figure 10 An example graphical control interface 1000 is illustrated. Figure 10 The example graphical control interface 1000 of FIG. 12 represents a request 1005 to activate a SU object and identify the SU object that is activated (e.g., the mixed bag 402) that includes the example mixed bag 402. Figure 4 The graphical control interface 400 of FIG. 12. In the illustrated example, the activated SU object is represented by a thick line. As described above, the PAS platform 140 determines to activate a SU object when (1) all ports of a single-use component are connected and (2) the scanned part number matches the verified part number for the single-use component. In some examples, the PAS platform 140 also performs a check to confirm that the scanned lot number from the single-use component matches the verified lot number associated with the single-use component in the example device settings table 700 when the single-use component is associated with a pre-allocated lot number. Figure 7 The example graphical control interface 1000 of FIG. 12 represents a request 1005 to activate a SU object and identify the SU object that is activated (e.g., the mixed bag 402) that includes the example mixed bag 402.

[0107] Figure 11 An example graphical control interface 1100 is illustrated. Figure 11The exemplary graphical control interface 1100 represents the active graphical control interface. Graphical control interface 1100 is activated when all SU objects in control interface 207 are activated and electrical connections are confirmed. In the illustrated example, confirmed electrical connections are indicated via bold boxes 1105 and 1110. For example, electrical connection 430 of mixing bag 402 is identified by the first bold box 1105, and electrical connection of port 422 is identified by the second bold box 1110. For clarity, port identifiers are not shown in graphical control interface 1100.

[0108] Figure 12 An exemplary smart gripper 1200 described herein is illustrated. Figure 12 The exemplary smart gripper 1200 is a tri-clamp system. Although Figure 12 The exemplary smart clamp 1200 is a three-clamp clamp, but other types of clamps may be used alternatively or in lieu of them. Figure 12 The smart clamp 1200 includes an exemplary base bracket 1202 pivotally coupled to an exemplary C-shaped clamping portion 1204. The exemplary base bracket 1202 is also coupled to an exemplary bolt 1206. In the illustrated example, the bolt 1206 is threadedly coupled to a wing nut 1208 that can be used to tighten or loosen the smart clamp 1200. Additionally, although... Figure 12 The exemplary bolt 1206 is coupled to the exemplary wing nut 1208, but other types of fasteners may be used alternatively to fasten the smart clamp 1200.

[0109] The exemplary smart clamp 1200 also includes exemplary connection sensors 1210-1213 (e.g., proximity sensors) embedded in the exemplary base bracket 1202 and the exemplary C-shaped clamping portion 1204. In the illustrated example, the base bracket 1202 is embedded with exemplary connection sensors 1210, 1212. The exemplary C-shaped clamping portion 1204 is embedded with exemplary connection sensors 1211, 1213.

[0110] exist Figure 12 In the exemplary example, exemplary connection sensor 1211 is embedded in the first clamping lip 1214 of the C-shaped clamping portion 1204, and exemplary connection sensor 1213 is embedded in the second clamping lip 1215 of the C-shaped clamping portion 1204. As described above, Figure 2 An exemplary connection monitor 210 can use values ​​from connection sensors 1210-1213 to detect when the smart gripper 1200 is in the open position (e.g., ...). Figure 12The connection monitor 210 can process the output provided by the connection sensors 1210-1213 and determine that the smart clamp 1200 is in the closed position when the connection sensors 1210, 1212 of the base bracket 1202 are in contact (or nearly in contact (e.g., in proximity) with the connection sensors 1211, 1213 of the c-shaped clamping portion 1204. Alternatively, the connection monitor 210 can process the output provided by the connection sensors 1210-1213 and determine that the smart clamp 1200 is in the open position when the connection sensors 1210, 1212 of the base bracket 1202 are not in contact with and / or are not in proximity to the connection sensors 1211, 1213 of the c-shaped clamping portion 1204.

[0111] Additionally, based on the output provided by the connection sensors 1210-1213, the example connection monitor 210 can determine that the smart clamp 1200 is in a non-engaged state (e.g., the output from all four connection sensors 1210-1213 indicates that they are not in contact with and / or are not in proximity to the assembly) or that the smart clamp 1200 is in a fully engaged state (e.g., the output from all four connection sensors 1210-1213 indicates that they are in contact with and / or are in proximity to the assembly). Thus, the output from the smart clamp 1200 can be used to determine whether both contact positions of the smart clamp 1200 are connected or whether both contact positions of the smart clamp 1200 are not connected.

[0112] In some examples, when the connection sensors 1210-1213 are engaged, the sensors 1210-1213 automatically gather information about the assembly to which they are coupled. For example, the connection sensors 1210-1213 can determine single-use assembly identification information (e.g., part number, lot number, model number, etc.) and / or gather assembly identification information. In some examples, the connection sensors 1210-1213 gather the assembly identification information described above via a radio frequency identification (RFID) device (e.g., tag) attached to the single-use assembly. In other examples, the connection sensors 1210-1213 can gather the assembly identification information via a bar code reading device or via Bluetooth. The connection sensors 1210-1213 can transmit the assembly identification information from the smart clamp 1200 to the example connection monitor 210 via the example data bus 110 and / or a wireless connection. Figure 1 Additionally or alternatively, in some cases, a user (e.g., an operator) can input the assembly identification information directly into the connection monitor 210 via, for example, an input interface (e.g., a keyboard, a handheld device, etc.) associated with the example workstation 102. Figure 1 Additionally or alternatively, in some cases, a user (e.g., an operator) can input the assembly identification information directly into the connection monitor 210 via, for example, an input interface (e.g., a keyboard, a handheld device, etc.) associated with the example workstation 102.

[0113] While the example smart clamp 1200 is shown as having two contact positions, it is contemplated that the smart clamp 1200 can have more than two contact positions. For example, the smart clamp 1200 can have three contact positions, four contact positions, or more. Figure 12The example smart clamp 1200 includes two connection sensors 1210, 1212 embedded in the base bracket 1202 and two connection sensors 1211, 1213 embedded in the c-shaped clamp portion 1204, although any other number of sensors can additionally or alternatively be used. For example, the smart clamp 1200 can include zero, one, two, etc. connection sensors embedded in the base bracket 1202 and / or can include zero, one, two, etc. connection sensors embedded in the c-shaped clamp portion 1204.

[0114] In the illustrated example, the connection sensors 1210-1213 provide proximity detection, engagement detection, information collection, and network connectivity. However, these features can be divided among any number of sensors. For example, the first and second connection sensors 1210, 1212 can be contact sensors (e.g., magnetic sensors) that detect when the smart clamp 1200 is in a closed position or an open position. The example third and fourth sensors 1211, 1213 can detect when the smart clamp 1200 is in an unengaged state (e.g., neither the second nor the third sensor is engaged), a partially engaged state (e.g., either the second or the third sensor is engaged), or a fully engaged state (e.g., both the second and the third sensor are engaged). One or more of the connection sensors 1210-1213 can read component identification information from a component that is secured by the smart clamp 1200. Additionally, network connectivity can be achieved by a communication device that is coupled to the smart clamp 1200.

[0115] Although Figure 12 The example smart clamp 1200 facilitates securing two interchangeable components, although in some cases one of the components can be attached (e.g., permanently attached) to the smart clamp 1200. For example, an input / output port of a stainless steel drum can be permanently attached to one of the contact positions of the smart clamp 1200 (e.g., the right contact position of the smart clamp 1200 is connected). In some such cases, the example connection sensors 1212, 1213 can continuously indicate an engaged state, while the state of the connection sensors 1210, 1211 can vary based on the presence of the second component. In other cases, the smart clamp 1200 can not include the connection sensors 1212, 1213 and include the connection sensors 1210, 1211. In some such cases, rather than identifying the smart clamp 1200 as one of three possible engagement states (e.g., an unengaged state, a partially engaged state, and a fully engaged state), the example connection monitor 210 can identify the smart clamp 1200 as one of two possible engagement states (e.g., a partially engaged state or a fully engaged state) based on signals received from the smart clamp 1200.

[0116] Figure 13 A cross-sectional view of another example smart clamp 1300 is illustrated. Figure 13 The example smart clamp 1300 is illustrated in a closed position and clamping a first port 1330 of a first single-use component Component_A and a second port 1332 of a second single-use component Component_B. The example smart clamp 1300 includes an example base bracket 1302 pivotally coupled to an example C-shaped clamping portion 1304. In the illustrated example, the example connection sensors 1306, 1308 are embedded in the base bracket 1302 and the example connection sensors 1307, 1309 are embedded in the C-shaped clamping portion 1304. One or more of the connection sensors 1306-1309 detect when the smart clamp 1300 is in a closed position or in an open position. Figure 13 Figure 13 The example connection sensors 1306-1309 also detect when the smart clamp 1300 is in a fully engaged state (e.g., both contact positions 1312, 1314 are in a closed position and clamping a respective port) or in a non-engaged state (e.g., either contact position 1312, 1314 is in an open position or not clamping a port).

[0117] In the illustrated example, the smart clamp 1300 includes an example clamp manager 1310. The example clamp manager 1310 monitors the output from the connection sensors 1306-1309 and determines when the contact positions are engaged. In the illustrated example, when the engagement positions are engaged, the clamp manager 1310 sends a signal to the connection monitor 210. In some examples, the clamp manager 1310 can include clamp identification information in the signal. For example, the clamp manager 1310 can include a clamp identifier that identifies the smart clamp 1300 and a value that indicates which contact position of the smart clamp 1300 (e.g., left contact position 1312 and / or right contact position 1314) is engaged. As described above, the connection monitor 210 can use the clamp identification information and the device settings table 500 to determine whether the correct clamp is connected to the correct port and / or when the corresponding single-use component’s port is connected. Figure 13 Figure 2 Figure 5

[0118] ​​​​In some examples, fixture manager 1310 may cause one or more of the connection sensors 1306-1309 to read component identification information (e.g., part number, batch number, model number, etc.). For example, fixture manager 1310 may receive a request from connection monitor 210 to obtain component identification information. In some such cases, fixture manager 1310 may cause the appropriate connection sensor to perform a scan of the connection port to obtain component identification information. For example, if connection monitor 210 sends a request for component identification information associated with single-use component Component_A (e.g., connection monitor 210 can determine that the ports of single-use component Component_A are connected), fixture manager 1310 may cause connection sensors 1306, 1307 to scan port 1330 to obtain component identification information.

[0119] exist Figure 14 In the illustrated example, the exemplary smart gripper 1300 includes an exemplary status indicator 1311 (e.g., a light-emitting diode (LED)). The status indicator 1311 indicates the status of the smart gripper 1300. For example, the smart indicator 1311 may output red when the smart gripper 1300 is in the open position and yellow when the smart gripper 1300 is in the closed position. When the smart gripper 1300 is in the closed position and fully engaged, the smart indicator 1311 may output green. For example, the gripper manager 1310 may cause the smart indicator 1311 to output green in response to a signal from the PAS system 140 indicating that the control interface is fully activated. Alternatively, in response to a request for component identification information, the gripper manager 1310 may prompt the user to scan a single-use component, Component_A. For example, when a request to scan component identification information is received, the gripper manager 1310 may cause the status indicator 1311 to flash. In some examples, the smart gripper 1300 may provide LEDs for each contact position 1312, 1313 to identify which single-use component is to be scanned.

[0120] exist Figures 15-18 The diagram shows a flowchart illustrating an exemplary method for automating a SUE (Statistical Uncertainty) testing system. Figure 1 The diagram shows the representation used for implementation. Figure 2 and / or Figure 19 A flowchart of an exemplary method of the PAS platform 140. Figure 13 The diagram shows the method for implementation. Figures 14-19 A flowchart of an exemplary method for a fixture manager 1310. In these examples, a processor (such as those described below) can be used. Figures 14-19The method is implemented by machine-readable instructions of a program executed by the processor 2012 shown in the exemplary processor platform 2000 discussed. The program may be embodied in software stored on a tangible computer-readable storage medium (such as a CD-ROM, floppy disk, hard disk drive, digital versatile disc (DVD), Blu-ray disc, or memory associated with the processor 2012), but the entire program and / or portions thereof may alternatively be executed by a device other than the processor 2012 and / or embodied in firmware or dedicated hardware. Furthermore, although references... Figures 14-19 The flowcharts illustrated herein describe exemplary procedures, but many other methods can be used instead to automate the SUE inspection system, implement the exemplary PAS platform 140, and / or implement the exemplary fixture manager 1310. For example, the execution order of the boxes can be changed, and / or some of the boxes described can be changed, eliminated, or combined.

[0121] As described above, implementation can be achieved using encoded instructions (e.g., computer and / or machine-readable instructions) stored on tangible computer-readable storage media such as hard disk drives, flash memory, read-only memory (ROM), compact discs (CDs), digital versatile discs (DVDs), caches, random access memory (RAM), and / or any other storage device or storage disk. Figure 14 An exemplary method is provided, wherein information is stored in the tangible computer-readable storage medium for any duration (e.g., over an extended period of time, permanently, transiently, for temporary buffering, and / or for caching information). As used herein, the term tangible computer-readable storage medium is explicitly defined to include any type of computer-readable storage device and / or storage disk, excluding propagation signals and transmission media. As used herein, "tangible computer-readable storage medium" and "tangible machine-readable storage medium" are used interchangeably. Additionally or alternatively, coded instructions (e.g., computer and / or machine-readable instructions) stored on non-transitory computer and / or machine-readable media (such as hard disk drives, flash memory, read-only memory, compact disks, digital multifunction disks, caches, random access memory, and / or any other storage device or storage disk) may be used to implement Figure 1example methods, where information is stored in the non-transitory computer and / or machine readable medium for any duration of time (e.g., for an extended period of time, permanently, for a short period of time, for temporary buffering and / or for caching information). As used herein, the term non-transitory computer readable medium is expressly defined to include any type of computer readable storage device and / or storage disk, and excludes propagating signals and transmission media. As used herein, the phrase "at least" when used as a transitional term in the context of a recitation of at least one feature in a claim is open-ended and means at least one, but also including more than one. All other variations of "comprise," "comprises," "comprising" and "comprises" are explicitly to be construed in an open-ended fashion, and all other variations of "include," "includes," "including" and "includes" are also to be construed in an open-ended fashion. Conversely, the term "consisting" and / or other forms of "consisting" are defined to be closed terms, meaning exclusively.

[0122] Figure 2 are representative of example methods that can be performed to implement Figure 14 and / or Figure 2 An example PAS platform 140 is shown in a flowchart of an example method 1400 of setting up a SUE. Figure 4 Method 1400 of setting up a SUE begins at block 1402 when a user (e.g., an automation engineer) uses a PAS platform 140 to configure a graphical control interface. For example, an example configuration manager 205 Figure 5 ) can guide the user by designing an example graphical control interface 400 Figure 15 ) and configuring an example device setup table 500 Figure 2 Example implementations of block 1402 are described below in connection with Figure 4 Example implementations of block 1406 are described below in connection with

[0123] At block 1404, the PAS platform 140 loads the inactive control interface 400 to implement setup of the SUE. For example, the PAS platform 140 can provide an operating interface to the user and retrieve the graphical control interface 400 of the SUE from an example control interface data store 240 Figure 16 ). Figure 17

[0124] At block 1406, the PAS platform 140 facilitates assembly of the single-use device / process. For example, the graphical control interface can direct an operator to physically connect the single-use components and verify that the correct single-use components are connected. Example implementations of block 1406 are described below in connection with Figure 18 Alternatively, other operations that can facilitate assembly of the single-use device / process can be utilized.

[0125] ​At box 1408, the exemplary PAS platform 140 activates the graphical control interface. For example, the PAS platform 140 can determine that all SU objects in the control interface are activated and connections (e.g., electrical connections, flow path connections, etc.) are confirmed. In the illustrated example, using... Figure 14 The operation of box 1408 can be implemented using this method. Alternatively, other operations that enable the activation of the control interface can be utilized.

[0126] At box 1410, the exemplary PAS platform 140 facilitates the execution of the SUE. For example, PAS platform 140 enables an operator to execute batches to produce products. In the illustrated example, operation of box 1410 may involve using... Figure 15 Alternatively, other operations that facilitate the execution of SUE can be utilized. Subsequently, Figure 1 The exemplary method 1400 ends.

[0127] Figure 2 This indicates that it can be executed to achieve [the desired result]. Figure 15 and / or Figure 14 A flowchart of an exemplary method 1500 for setting up a process control system 104 can be used with an exemplary PAS platform 140. Figure 15 Exemplary method 1500 to implement Figure 2 Use box 1402 to configure the control interface. Figure 4 Method 1500 begins at box 1502, where the exemplary configuration manager 205 ( Figure 3 This facilitates the construction of a graphical control interface representing a Single Use Component (SU). For example, Configuration Manager 205 can provide a user-usable configuration interface to construct a graphical control interface based on a Process Flow Diagram (PFD) representing material flow and a Piping and Instrumentation Diagram (PID) representing the connections of instruments within the PFD. Figure 5 An exemplary graphical control interface 400. In some examples, the configuration manager 205 populates SU objects associated with the corresponding SU object class. For example, the configuration manager 205 may instantiate SU object 300 ( Figure 2 And populate the object ID field 305 with a unique object identifier.

[0128] At box 1504, configuration manager 205 configures the device settings table. For example, configuration manager 205 can generate it based on SU objects added to the graphical control interface. Figure 5Exemplary device setup table 500. In some examples, the configuration manager 205 can prompt a user to define characteristics of the single-use components. For example, the configuration manager 205 can request that the user provide a part number and map the port identifier clamp identifier to a contact location of the clamp. In the illustrated example, the device setup table 500 is stored in the exemplary device setup data store 230 Figure 1 ) described above in connection with Figure 6 Exemplary device setup table 500 describes an exemplary implementation of a device setup table.

[0129] At block 1506, the configuration manager 205 configures a bill of materials. For example, the configuration manager 205 can establish a connection with the bill of materials 132 from the MES platform 130 Figure 2 ) described above in connection with Figure 15 Exemplary bill of materials table 600 describes an exemplary implementation of a bill of materials.

[0130] At block 1508, the exemplary PAS platform 140 determines whether to continue building the control interface. If, at block 1508, the PAS platform 140 determines to continue building the control interface (e.g., adding a new module to the process control system, etc.), then control returns to block 1502. If, at block 1508, the exemplary PAS platform 140 determines not to continue building the control interface (e.g., a termination request is received), then, at block 1510, the PAS platform 140 stores the control interface in the exemplary control interface data store 240 Figure 16 ) described above in connection with Figure 1 The exemplary method 1500 of

[0131] Figure 16 is a flowchart of an exemplary PAS platform 140 method 1600 that can be implemented to achieve Figure 14 and / or 2. Figure 16 The exemplary method 1600 of Figure 2 may be used to implement block 1406 of Figure 13 The method 1600 of Figure 7 begins at block 1602 when the PAS platform 140 detects a port connection. For example, the exemplary connection monitor 210 Figure 3 may receive a signal from the clamp manager 1310 of indicating that the corresponding clamp is in a closed position and that the port is connected.

[0132] At block 1604, the example PAS platform 140 determines whether all ports of the single-use assembly are connected. For example, the connection monitor 210 can query the example SU object status table 700 Figure 2 to determine whether all ports of the corresponding single-use assembly are connected. If at block 1604, the example connection monitor 210 determines that not all ports of the single-use assembly are connected, then control returns to block 1602 to detect another port connection.

[0133] If at block 1604, the example connection monitor 210 determines that all ports associated with the single-use assembly are connected, then at block 1606, the example connection monitor 210 obtains assembly identification information from the single-use assembly. For example, the connection monitor 210 can prompt the user to scan a barcode affixed to the single-use assembly. At block 1608, the example connection monitor 210 records the assembly identification information. For example, the connection monitor 210 can update the part number value 310 and the lot number value 315 of the SU object 300 Figure 7 associated with the single-use assembly.

[0134] At block 1610, the example PAS platform 140 inspects the connected single-use assembly. For example, the assembly inspector 215 Figure 10 may compare the scanned part number value recorded in the part number field 310 of the SU object 300 to the inspection part number value stored in the device settings table 500. In some examples, the assembly inspector 215 can use the object identifier value to map the SU object to the correct single-use assembly entry in the device settings table 500. If at block 1612, the assembly inspector 215 determines that the part number 310 recorded in the SU object 300 does not match the inspection part number value stored in the device settings table 500, then control proceeds to block 1626 to issue a warning. For example, the assembly inspector 215 can display an alert identifying the part number mismatch. Control then returns to block 1602 to await detection of another port connection.

[0135] If, at block 1612, the component inspector 215 determines that the scanned component number value 310 matches the inspected component number value stored in the device settings table 500, then, at block 1614, the example component inspector 215 inspects the lot number of the single-use component. For example, the component inspector 215 can compare the scanned lot number value recorded in the lot number field 315 of the SU object 300 to the inspected lot number value stored in the bill of materials table 600. In some examples, the component inspector 215 can use the component number value to map the SU object to the correct single-use component entry in the bill of materials table 600. If, at block 1616, the component inspector 215 determines that the lot number value 315 does not match the inspected lot number value stored in the bill of materials table 600, then control proceeds to block 1626 and a warning is issued. For example, the component inspector 215 can display an alert identifying the lot number mismatch. Control then returns to block 1602 to await another port connection.

[0136] If, at block 1616, the component inspector 215 determines that the lot number value 315 does not match the inspected lot number value stored in the bill of materials table 600, or if the bill of materials table 600 does not require the corresponding single-use component to be included in a pre-allocated lot (e.g., an unusable lot number), then, at block 1618, the example component inspector 215 updates the status of the SU object. For example, the component inspector 215 can update the activation status value 320 of the SU object 300. Additionally or alternatively, the example component inspector 215 can update the status of the corresponding SU object in the example SU object status table 700 Figure 7 ). For example, the component inspector 215 can update the status stored in the activation status column 730 of the corresponding single object from an “inactive” status to an “active” status.

[0137] At block 1620, the example component inspector 215 activates the SU object in the control interface. For example, the component inspector 215 can transition the SU object displayed in the control interface from a first image (e.g., a thin line) representing an inactive status to a second image (e.g., a thick line) representing an active status, as shown in the example control interface 1000 of Figure 11 At block 1622, the example component inspector 215 determines whether all of the SU objects representing the SUE are activated. For example, the component inspector 215 can parse the SI object status table 700 of Figure 16 to determine whether any of the SU objects are identified as “inactive.”

[0138] If, at box 1622, component checker 215 determines that all SU objects in the control interface are not active, control returns to box 1602 to wait for detection of another port connection. Otherwise, if, at box 1622, component checker 215 determines that all SU objects in the control interface are active, then at box 1624, component checker 215 fully activates the control interface (e.g., activates electrical connections, etc.), such as... Figure 17 The exemplary control interface 1100 is shown. Figure 1 Example method 1600 then ends.

[0139] Figure 17 This indicates that it can be executed to achieve [the desired result]. Figure 14 A flowchart of an exemplary method 1700 of an exemplary PAS platform 140 and / or 2. Figure 17 The exemplary method 1700 can be used to implement Figure 2 Box 1408 is used to facilitate the activation of the control interface when all SU objects in the control interface are activated. Figure 10 Method 1700 begins at box 1702, where the exemplary PAS platform 140 checks the electrical connections. For example, the exemplary setup tester 220 ( Figure 11 The system can determine whether a SU object in the control interface includes electrical connections and / or other inputs / outputs. For example, setup tester 220 can check whether a single-use component corresponding to the SU object is connected to a power source. If setup tester 220 cannot confirm an electrical connection at box 1704, control proceeds to box 1714, and setup tester 220 issues a warning. For example, setup tester 220 can present an alarm indicating that all electrical connections have not been confirmed. In some examples, setup tester 220 can identify SU objects that do not meet the electrical connection test. Control then returns to box 1702 to check the electrical connections.

[0140] If tester 220 is configured to verify the electrical connection at box 1704, then tester 220 is configured to activate the control interface at box 1706. For example, tester 220 can configure the control interface to include one or more active SU objects. Figure 17 The exemplary control interface 1000 is converted to Figure 18example control interface 1100. At block 1708, the example setup tester 220 performs an integrity test. For example, the setup tester 220 can check pressure retention and / or measure the quality of air and / or water required for the filling system (e.g., to a specified pressure). If, at block 1710, the setup tester 220 determines that the results of the integrity test do not satisfy a specified threshold, then control proceeds to block 1714 and the setup tester 220 issues a warning. For example, the setup tester 220 can present an alert indicating that the results of the integrity test failed to meet a specification (e.g., an acceptable threshold). Control then returns to block 1702 to check the electrical connections.

[0141] If, at block 1710, the setup tester 220 determines that the results of the integrity test do satisfy the specification, then, at block 1712, the setup of the SUE is complete. For example, the setup tester 220 can present a message indicating that the SUE is ready to perform a batch. Figure 1 The example procedure 1700 then ends.

[0142] Figure 2 is a flowchart of an example method 1800 of an example PAS platform 140 that can be performed to implement Figure 18 and / or Figure 14 the example PAS platform 140. Figure 18 The example method 1800 of the example PAS platform 140 can be used to support Figure 2 block 1410 of the example PAS platform 140 to perform a single-use device / process. Figure 13 The method 1800 begins at block 1802, when the PAS platform 140 completes assembly of a SUE. At block 1804, the PAS platform 140 monitors port connections of the single-use components. For example, the connection monitor 210 Figure 18 ) can continue to monitor signals received from the gripper manager 1310 Figure 19 ) to determine whether a connection is broken (e.g., whether a verified physical connection is broken).

[0143] At block 1806, the example connection monitor 210 issues a warning. For example, the connection monitor 210 can present an alert indicating that a physical connection is not verified. In some examples, the connection monitor 210 can identify the physical connection that was detected as not verified and / or the single-use component associated with the physical connection that was detected as not verified. In some examples, the connection monitor 210 can disable the control interface in response to detecting an unverified physical connection in the SUE.

[0144] At block 1808, the connection monitor 210 determines whether the batch of executions is complete. If at block 1808, the connection monitor 210 determines that the batch of executions is not complete, then control returns to block 1804 to continue monitoring the port connections in the process control system 104. If at block 1808, the connection monitor 210 determines that the batch of executions is complete, then the exemplary method 1800 ends. Figure 13 The exemplary method 1800 ends.

[0145] Figure 19 is representative of an exemplary method that can be performed to implement Figure 1 The exemplary clamp manager 1310 of the exemplary method 1900 to monitor assembly connections is a flowchart. Figure 2 The method 1900 begins at block 1902 when the exemplary clamp manager 1310 determines whether the smart clamp 1300 is in a closed position or an open position. For example, the clamp manager 1310 can monitor the connection sensors 1306-1309 to determine when the smart clamp 1300 is in the closed position. If at block 1902, the clamp manager 1310 determines that the smart clamp 1300 is in the open position (e.g., the connection sensors 1306, 1308 indicate that they are not proximate to the connection sensors 1307, 1309), then control returns to block 1902 to wait for a determination that the smart clamp 1300 is in the closed position.

[0146] If at block 1902, the exemplary clamp manager 1310 determines that the smart clamp 1300 is in the closed position, then at block 1904, the clamp manager 1310 determines whether the smart clamp 1300 is in an engaged state. For example, the clamp manager 1310 can monitor the connection sensors 1306-1309 for signals indicating that they are in contact with and / or proximate to an assembly. If at block 1904, the clamp manager 1310 determines that the smart clamp 1300 is not in the engaged state, then control returns to block 1902 to detect when the smart clamp 1300 is in the closed position.

[0147] If at block 1904, the exemplary clamp manager 1310 determines that the smart clamp 1300 is in the engaged state, then at block 1906, the clamp manager 1310 facilitates reading assembly identification information from the assembly. For example, the clamp manager 1310 can cause the connection sensors 1306, 1307 to scan the port 1330 for assembly identification information. In some examples, the clamp manager 1310 can prompt a user to scan the assembly for the assembly identification information. At block 1908, the clamp manager 1310 reports the assembly identification information to the PAS system 140 Figure 1 and / or Figure 1 ) via a wireless connection, Figure 19an exemplary data bus 110, etc. to the PAS system 140. In some examples, the clamp manager 1310 transitions the status indicator 1311 to an inactive state (e.g., red), e.g., the status indicator 1311 was in an active state prior to the disconnection event. At block 1916, the clamp manager 1310 determines whether to shut off power to the smart clamp 1300. If, at block 1916, the clamp manager 1310 determines not to shut off power to the smart clamp 1300, then control returns to block 1902 to determine whether the smart clamp 1300 is in the closed position. If, at block 1916, the clamp manager 1310 determines to shut off power to the smart clamp 1300, then the clamp manager 1310 powers down the smart clamp 1300, and

[0148] At block 1912, the clamp manager 1310 determines whether a disconnection event is detected. For example, the clamp manager 1310 can receive an indication (e.g., a signal) from one or more of the connection sensors 1306-1309 that the smart clamp 1300 is not in the closed position. Additionally or alternatively, the clamp manager 1310 can receive an indication (e.g., a signal) that the smart clamp 1300 is not in the engaged state. For example, the component can have moved, the smart clamp 1300 can have been bumped, etc., causing the clamp manager 1310 to determine that the smart clamp 1300 is no longer engaged. If, at block 1912, the clamp manager 1310 does not detect a disconnection event, then control returns to block 1910 to monitor the connection.

[0149] If, at block 1912, the clamp manager 1310 detects a disconnection event, then, at block 1914, the clamp manager 1310 reports the disconnection event to the PAS system 140. For example, the clamp manager 1310 can transmit the disconnection event to the PAS system 140 via a wireless connection, Figure 20 an exemplary data bus 110, etc. to the PAS system 140. In some examples, the clamp manager 1310 transitions the status indicator 1311 to an inactive state (e.g., red), e.g., the status indicator 1311 was in an active state prior to the disconnection event. At block 1916, the clamp manager 1310 determines whether to shut off power to the smart clamp 1300. If, at block 1916, the clamp manager 1310 determines not to shut off power to the smart clamp 1300, then control returns to block 1902 to determine whether the smart clamp 1300 is in the closed position. If, at block 1916, the clamp manager 1310 determines to shut off power to the smart clamp 1300, then the clamp manager 1310 powers down the smart clamp 1300, and Figures 14-19 the exemplary method 1900 ends. For example, the clamp manager 1310 can transition the status indicator 1311 to an inactive state.

[0150] Figure 1 is capable of executing instructions to implement Figure 2 a method and Figure 13 and / or Figures 14-19 a PAS platform 140 and / or ​FIG. 1 illustrates an example processor platform 2000 of a clamp manager 1310. The processor platform 2000 can be, for example, a server, a personal computer, or any other type of computing device.

[0151] The processor platform 2000 of the illustrated example includes a processor 2012. The processor 2012 of the illustrated example is hardware. For example, the processor 2012 can be implemented by one or more integrated circuits, logic circuits, microprocessors, or controllers from any desired family or manufacturer.

[0152] The processor 2012 of the illustrated example includes a local memory 2013 (e.g., a cache). The processor 2012 of the illustrated example executes instructions to implement an example configuration manager 205, an example connection monitor 210, an example component verifier 215, and an example settings tester 220. The processor 2012 of the illustrated example communicates via a bus 2018 with a main memory including a volatile memory 2014 and a non-volatile memory 2016. The volatile memory 2014 can be implemented by synchronous dynamic random access memory (SDRAM), dynamic random access memory (DRAM), RAMBUS dynamic random access memory (RDRAM), and / or any other type of random access memory device. The non-volatile memory 2016 can be implemented by flash memory and / or any other desired type of memory device. Access to the main memory 2014, 2016 is controlled by a memory controller.

[0153] The processor platform 2000 of the illustrated example also includes an interface circuit 2020. The interface circuit 2020 can be implemented by any type of interface standard, such as an Ethernet interface, a universal serial bus (USB), and / or a PCI Express interface.

[0154] In the illustrated example, one or more input devices 2022 are connected to the interface circuit 2020. The input device(s) 2022 permit a user to enter data and commands into the processor 2012. The input device(s) can be implemented by, for example, audio sensors, microphones, cameras (still or video), keyboards, buttons, mice, touch screens, track pads, track balls, isopoint, and / or voice recognition systems.

[0155] One or more output devices 2024 are also connected to the interface circuit 2020 of the illustrated example. The output devices 2024 can be implemented, for example, by display devices (e.g., a light emitting diode (LED), an organic light emitting diode (OLED), a liquid crystal display, a cathode ray tube display (CRT), a touchscreen, a tactile output device, a printer, and / or a speaker). Thus, the interface circuit 2020 of the illustrated example, in one embodiment, includes a graphics driver card, a graphics driver chip, or a graphics driver processor.

[0156] The interface circuit 2020 of the illustrated example also includes a communication device such as a transmitter, a receiver, a transceiver, a modem and / or network interface card to facilitate exchange of data with external machines (e.g., computing devices of any kind) via a network 2026 (e.g., an Ethernet connection, a digital subscriber line, a telephone line, coaxial cable, a cellular telephone system, etc.).

[0157] The processor platform 2000 of the illustrated example also includes one or more mass storage devices 2028 for storing software and / or data. Examples of such mass storage devices 2028 include floppy

[0158] The encoded instructions 2032 for implementing ​ the methods of FIGS. 1-7 can be stored in the mass storage devices 2028, in the volatile memory 2014, in the non-volatile memory 2016, and / or on a removable tangible computer readable storage medium such as a CD or DVD.

[0159] From the foregoing, it will be appreciated that the above-disclosed methods, apparatus and articles of manufacture make it possible to set up single-use equipment / processes in single-use process control systems. For example, the disclosed examples include a graphical control interface representing a process control system and equipment setup table. In some examples, the example graphical control interface can be used to design a graphical representation of a process control system. The disclosed examples utilize the equipment setup table to verify that single-use components used in a SUE are the correct single-use components. In some examples, a smart clamp is used to secure the single-use components.

[0160] While certain example methods, apparatus and articles of manufacture have been disclosed herein, the scope of coverage of this patent is not limited thereto. On the contrary, this patent covers all methods, apparatus and articles of manufacture falling within the scope of the claims.

Claims

1. An apparatus comprising: a cradle embedded with a first connection sensor; a clamp portion pivotally coupled to the cradle, the clamp portion embedded with a second connection sensor; a clamp manager coupled to the first connection sensor and the second connection sensor; a processor system; and a memory communicatively coupled to the processor system, the memory including stored instructions that enable the processor system to: configure a control interface based at least in part on one or more characteristics of a single-use assembly associated with the apparatus, activate, in the control interface, a representation of the single-use assembly associated with the apparatus based on an indication from one or more signals from the first connection sensor or the second connection sensor, in response to the indication, transition a port indicator corresponding to a port from an inactive state to an active state in the control interface, and update a state table to indicate that the port is connected. the clamp manager communicates the one or more signals via a wireless interface.

2. The apparatus of claim 1, wherein, the first connection sensor facilitates acquisition of assembly identification information from a single-use assembly engaged by the cradle in a closed position.

3. The apparatus of claim 1, wherein, the first connection sensor includes a barcode reader to acquire the assembly identification information.

4. The apparatus of claim 3, wherein, the assembly identification information includes at least: a part number, a model number, or a lot number associated with the single-use assembly.

5. The apparatus of claim 3, wherein, ​

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