Control system of nuclear medicine synthesizer

Abstract

The invention discloses a control system of a nuclear medicine synthesizer, which comprises a power supply module, a main control module, a data interaction and remote monitoring module, a sensing and safety triggering module, an execution module and a man-machine interaction and data storage module, and all the modules form a sensing-control-execution circulation system through signal interaction. The whole-process control and radiation safety protection of nuclear drug synthesis are realized; the power supply module outputs alternating-current 220V and direct-current 24V voltages and provides adaptive power supply for the other modules; the main control module is a system control core, is internally provided with safety interlocking logic, and is in signal connection with the data interaction and remote monitoring module, the sensing and safety triggering module, the execution module and the man-machine interaction and data storage module. And a closed-loop protection system of real-time monitoring, threshold value judgment and quick response is formed in combination with built-in safety interlocking logic of the main control module.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of electrical automation, and particularly relates to a control system of a nuclear medicine synthesizer. BACKGROUND

[0002] The existing nuclear medicine synthesizer control system is mostly designed in a modular manner, integrates core components such as a power supply unit, a control unit, a sensing unit, an execution unit and a human-computer interaction unit, and can realize basic process functions such as liquid transfer, heating, cooling and reaction regulation. The control unit takes PLC as the core, realizes data interaction with each module through a switch, and some systems are configured with a remote communication module to support local operation and basic remote monitoring. The human-computer interaction unit mostly uses an industrial computer to complete process parameter setting, device state display and basic operation log recording. Such systems are widely used in the synthesis and production of nuclear medicines such as PET and SPECT, covering scenes such as research laboratories and small and medium-sized production enterprises, and meet the basic process needs of different production scales through full manual, semi-automatic or full-automatic control modes, providing technical support for the automation of nuclear medicine synthesis.

[0003] However, the existing nuclear medicine synthesizer control system still has many problems to be improved in actual application: lacking of special safety protection design for the high radioactivity characteristics of nuclear medicine synthesis, not forming a closed loop of real-time monitoring and linkage protection of radiation dose, and being difficult to quickly respond to the risk of radioactive leakage; the compatibility and expansibility of the modular architecture are insufficient, and when new functional components are added, the original system needs to be greatly modified, and the flexibility of adapting to different radiation risk levels and production scales is limited; the linkage logic of the control mode and safety protection is imperfect, and the safety interlocking action priority is lower than the conventional process operation in some scenes, which has safety hazards; the data monitoring and traceability capability is insufficient, the radiation dose data is not included in the whole process record, and the export format and retention period are difficult to meet the strict requirements of GMP on compliance; the regulation accuracy and batch repeatability of process parameters are poor, and the key parameters such as temperature and pressure fluctuate greatly, which affects the efficiency and purity of nuclear medicine synthesis. SUMMARY

[0004] In order to overcome the above-mentioned defects of the prior art, the application provides a control system of a nuclear medicine synthesizer, which solves the problems of lack of radiation protection, poor module adaptation, insufficient safety linkage, poor compliance traceability and parameter accuracy in the prior art.

[0005] To achieve the above-mentioned purpose, the application provides the following technical solutions: A control system of a nuclear medicine synthesizer, comprising a power supply module, a main control module, a data interaction and remote monitoring module, a sensing and safety triggering module, an execution module and a human-computer interaction and data storage module, each module forms a sensing-control-execution cycle system through signal interaction to realize the whole process control of nuclear medicine synthesis and radiation safety protection. The power supply module outputs alternating current 220V and direct current 24V voltage to provide adaptive power supply for the remaining modules; The main control module is the core of system control, and is internally provided with safety interlocking logic, and is signal connected with the data interaction and remote monitoring module, the sensing and safety triggering module, the execution module and the man-machine interaction and data storage module, receives the reaction area radiation dose, temperature, pressure, flow and other parameters and safety triggering signals collected by the sensing and safety triggering module, sends control instructions to the execution module, and realizes data transmission and remote monitoring through the data interaction and remote monitoring module; The sensing and safety triggering module is used for collecting safety triggering signals and reaction area radiation dose, temperature, pressure, flow and other parameters in the nuclear medicine synthesis process; The execution module receives the instructions of the main control module, and executes liquid transfer, heating, pipeline on-off and ventilation protection actions; The man-machine interaction and data storage module is used for realizing parameter setting, equipment monitoring and data storage and export; When the radiation dose collected by the sensing and safety triggering module exceeds the preset threshold value, the main control module triggers the safety interlocking action, controls the devices involving liquid transfer and heating in the execution module to suspend operation, controls the pipeline on-off component to be closed to form a closed loop, and starts the ventilation protection component.

[0006] Preferably, the main control module comprises a PLC and an extended digital output module; the working voltage of the PLC is DC 24V, which has 14-point digital input ports, 10-point relay type digital output ports, also has 2-way 0-10V analog input ports and 2-way 0-20mA analog output ports; the extended digital output module is a 16-point relay type, which is used to extend the driving capacity of the main control module to the execution module.

[0007] Preferably, the data interaction and remote monitoring module comprises a switch and a 4G module; the working voltage of the switch is DC 12-58V, which is provided with 5 network ports, and the packet forwarding rate is 10.416Mpps, which is used for network connection of the main control module, the central control room, the programming equipment and the 4G module; the working voltage of the 4G module is DC 24V, which is provided with 1-way RS232 interface, 1-way RS485 interface and 2 network ports, and realizes mobile phone monitoring and remote monitoring of the main control module through 4G network.

[0008] Preferably, the power supply module comprises a mains access unit and a switching power supply; the AC 220V voltage output by the mains access unit is used to power the human-computer interaction and data storage module, the module box temperature controller, and the third path through the normally open point of the intermediate relay as the controllable power supply for the heating components in the execution module; the switching power supply converts AC 220V to DC 24V to power the main control module, the data interaction and remote monitoring module, the sensing and safety triggering module, the execution module, and the fan in the module box.

[0009] Preferably, the sensing and safety triggering module comprises a reaction parameter sensor, an emergency stop component, and a miniature radiation dose sensor; the reaction parameter sensor collects reaction bottle pressure, temperature, flow rate, and inlet pressure data; the miniature radiation dose sensor is arranged in the nuclear medicine synthesis core radiation risk area, specifically including the side of the reaction bottle support and the key interfaces of the liquid transfer pipeline, with a measurement accuracy of ±5%, a measurement range of 0.1-10 μSv / h, a response time of ≤1 s, a protection level of IP65, and an output of 0-10V analog signal and digital alarm signal to the main control module; the preset threshold value is 1 μSv / h, and the threshold value can be adjusted through the human-computer interaction and data storage module.

[0010] Preferably, the execution module comprises a liquid transfer component, a heating component, a pipeline on-off component, a state indication component, and a dedicated ventilation component; the liquid transfer component is a vacuum pump, the heating component is a heater, the pipeline on-off component is a plurality of valves, the state indication component is an indicator light, and the dedicated ventilation component has a working voltage of DC 24V, an air volume of 100 m³ / h, and a start-stop response time of ≤1 s; when the main control module triggers the safety interlock, the vacuum pump and the heater are controlled to pause, the corresponding valves are controlled to close, and the dedicated ventilation component is started.

[0011] Preferably, the human-computer interaction and data storage module is an operation computer connected to the main control module through a network cable, supports picture setting and point operation, has a picture development resolution of 1920×1080, and can store and export radiation dose data, equipment operation logs, and process parameter records.

[0012] Preferably, the PLC digital quantity input port I0.0 of the main control module is connected to the emergency stop component, the digital quantity output ports Q0.0-Q0.7 are respectively connected to the vacuum pump, the heater, the indicator light, and valves 17-20, the PLC analog quantity input port is connected to the reaction bottle pressure sensor in a three-wire system, and the analog quantity output port is connected to the proportional valve opening degree setting in a three-wire system; the signals Q2.0-Q3.7 of the extended digital quantity output module are respectively connected to valves 1-16.

[0013] Preferably, the main control module communicates with the syringe, flow meter, and activity meter via serial ports through a 485 expansion board and a 485 expansion module, respectively, to collect syringe action feedback and measurement data from the flow meter and activity meter.

[0014] Preferably, the main control module supports three process control modes: fully manual, semi-automatic, and fully automatic. In fully manual mode, all pumps and valves in the execution module operate independently. In semi-automatic mode, the system runs according to preset steps, and the current step is maintained unless manually switched. In fully automatic mode, the system is started by a start button, and the system runs according to the set logic based on the feedback data from the sensing and safety triggering module. In all three modes, the safety interlock action when the radiation dose exceeds the threshold has a higher priority than the conventional process operation. In the alarm state, the system needs to be reset by the administrator's authorized password of the human-machine interaction and data storage module. Before resetting, it must be confirmed that the radiation dose has dropped below 0.5 μSv / h.

[0015] The technical effects and advantages of the control system for a radiopharmaceutical synthesizer of the present invention are as follows: 1. This invention, by adding a miniature radiation dose sensor and a dedicated ventilation module, combined with the safety interlock logic built into the main control module, forms a closed-loop protection system of "real-time monitoring - threshold judgment - rapid response". When the radiation dose exceeds the threshold, the system can immediately suspend high-risk operations such as liquid transfer and heating, close the valve to form a closed loop, and activate ventilation protection, effectively preventing the spread of radioactive leakage. This solves the pain point of traditional systems lacking dedicated radiation protection, ensuring the safety of personnel and the environment.

[0016] 2. The various modules of this invention interact through standardized interface signals, and all newly added components are compatible with the existing power supply and control logic, eliminating the need for large-scale modifications to existing equipment and reducing upgrade costs. Furthermore, the sensor layout, threshold settings, and functional module configurations can be flexibly adjusted according to the type of radiopharmaceutical, production scale, and risk level, adapting to different scenarios such as conventional and high-level radiopharmaceutical synthesis, research, and large-scale production.

[0017] 3. This invention supports three process control modes: fully manual, semi-automatic, and fully automatic. The radiation safety interlock action has a higher priority than conventional process operations, ensuring safety at all operating levels. The tiered threshold settings and flexible reset mechanism balance production continuity with safety protection requirements, avoiding frequent downtime caused by minor radiation fluctuations and improving production efficiency.

[0018] 4. This invention achieves dual local and remote monitoring through a data interaction and remote monitoring module. Administrators can monitor equipment operating status and radiation dose data in real time, receive alarm prompts, and authorize operations. The human-machine interaction and data storage module can completely store radiation dose data, equipment operation logs, and process parameter records, supporting multi-format export and long-term retention, fully complying with GMP requirements for safety monitoring and traceability in radiopharmaceutical production, and providing strong support for production compliance.

[0019] 5. The main control module of this invention receives reaction parameter sensor data in real time and dynamically adjusts the actions of the execution module to ensure the stability of process parameters such as temperature and pressure, improve the efficiency of radiopharmaceutical synthesis and product purity, solve the problem of poor parameter repeatability between batches in traditional systems, and help to achieve standardized production. Attached Figure Description

[0020] Fig. 1 This is a system flowchart of the control system for a radiopharmaceutical synthesizer proposed in this invention; Fig. 2 This is a flowchart of the implementation steps of the control system for a radiopharmaceutical synthesizer proposed in this invention; Fig. 3 This is a connection diagram of the control system of a radiopharmaceutical synthesizer proposed in this invention. Detailed Implementation

[0021] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0022] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include," "contain," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "includes..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0023] Example 1 refer to Figs. 1-3This embodiment provides a control system for a radiopharmaceutical synthesizer, for basic and complete implementation, and the specific implementation content includes: Implementation scenario: It is suitable for the synthesis and production of conventional PET-based radiopharmaceuticals (such as fluorodeoxyglucose), and must meet the requirements of fully automated control and basic radiation safety protection. The production environment is a standard radiopharmaceutical laboratory (room temperature 20-25℃, humidity 40%-60%).

[0024] Module configuration and connection: Power supply module: The mains power input unit uses a three-phase four-wire AC220V / 50Hz input, and the switching power supply model is NDR-240-24 (output DC24V / 10A); AC220V supplies power to the operating computer (human-machine interaction and data storage module) and the module box temperature controller, and also provides controllable power to the heater through the normally open contact of the intermediate relay (model HH52P); DC24V supplies power to the PLC, switch, 4G module, miniature radiation dose sensor, dedicated ventilation module and fan inside the module box.

[0025] Main control module: The PLC selected is Siemens S7-1215C (DC24V power supply), with an expansion of 16-point relay-type digital output module (model SM1222); the PLC has 14 reserved digital input ports I0.0-I1.5, 10 digital output ports Q0.0-Q0.7 and Q1.0-Q1.1, 2 0-10V analog input ports AI0-AI1, and 2 0-20mA analog output ports AO0-AO1.

[0026] Data interaction and remote monitoring module: The switch is an industrial 5-port switch (model KS-205), with a working voltage of DC24V (compatible with DC12-58V) and a packet forwarding rate of 10.416Mpps; the 4G module is an EC20 series (DC24V powered), with 1 RS232 port, 1 RS485 port and 2 network ports, which can access the mobile operator's network through the 4G network.

[0027] Sensing and Safety Trigger Module: The reaction parameter sensors include a pressure sensor (model PT124G-111), a temperature sensor (model PT100), and a flow sensor (model LWGY-15), which respectively collect the reaction bottle pressure, reaction temperature, liquid flow rate, and inlet pressure; the emergency stop component is a mushroom-shaped emergency stop button (model LA38-11ZS), connected to the PLC digital input port I0.0; the miniature radiation dose sensor is model FD-3013 (DC24V powered), installed next to the reaction bottle support (15cm from the center of the reaction bottle) and at two key interfaces (inlet and outlet) of the liquid transfer pipeline, with a measurement accuracy of ±5%, a measurement range of 0.1-10μSv / h, a response time ≤1s, an IP65 protection rating, and outputs a 0-10V analog signal to the PLC analog input port AI0, while the digital alarm signal is connected to the PLC spare input port I1.6.

[0028] The execution module consists of: a vacuum pump (model 2XZ-1) for liquid transfer, connected to PLC digital output port Q0.0; an electric heater (500W power), connected to Q0.1; 20 sets of solenoid valves (model 4V210-08) for pipeline on / off control, with valves 1-16 connected to expansion modules Q2.0-Q3.7, and valves 17-20 connected to PLC body Q0.3-Q0.7; a red-green dual-color indicator light (model AD16-22D), connected to Q0.2; and a small duct fan (model DFBZ-2.5), powered by DC24V, with an air volume of 100m³ / h and a start / stop response time ≤1s, connected to PLC digital output port Q1.2.

[0029] Human-machine interaction and data storage module: The operating computer is an industrial panel PC (screen resolution 1920×1080), connected to the switch via network cable, and WinCC monitoring software is installed. It supports screen settings and jog operation, and can store radiation dose data, equipment operation logs and process parameter records (storage format is CSV, retaining 90 days of data).

[0030] Workflow: The power supply module is started, and each module performs a self-test upon power-on. The PLC establishes communication with the operating computer through the switch, and the operating computer displays that the status of each module is normal.

[0031] By setting the radiation dose preset threshold to 1 μSv / h on the computer, selecting the fully automatic control mode, and clicking the start button, the system starts according to the preset process logic: the vacuum pump starts (Q0.0 is energized), the liquid is transferred to the reaction flask, the heater starts (Q0.1 is energized), the temperature sensor provides real-time temperature data feedback, and the PLC adjusts the heater power to maintain a stable reaction temperature.

[0032] The miniature radiation dose sensor collects the radiation dose in the reaction area in real time. When a sensor detects a dose of 1.2 μSv / h (exceeding the preset threshold), it immediately sends an analog signal and a digital alarm signal to the PLC.

[0033] When the PLC's built-in safety interlock logic is triggered, safety actions are executed first: Q0.0 (vacuum pump) and Q0.1 (heater) stop operating when power is lost; Q0.3-Q0.7 (valve 17-20) and Q2.0-Q2.4 (valve 1-5) close when power is lost, forming a closed loop; Q1.2 (dedicated ventilation module) starts when power is gained, and indicator light Q0.2 flashes red; an alarm pop-up window appears on the operating computer, displaying the over-threshold position and real-time dose value, and the 4G module pushes an alarm SMS to the administrator's mobile phone.

[0034] The administrator checks for potential leaks on-site. Once the radiation dose drops to 0.4 μSv / h (below 0.5 μSv / h), the system is reset by entering the administrator's authorization password on the computer. The system then returns to standby mode and the process can be restarted.

[0035] Example 2 This embodiment provides a control system for a radiopharmaceutical synthesizer, used for radiation sensor layout optimization. Specific implementation details include: Implementation scenario: It is suitable for the synthesis of highly radioactive nuclides (such as iodine-131 labeled drugs), but the risk of radiation leakage in the reaction area is higher, and the coverage of radiation monitoring needs to be strengthened.

[0036] Core improvements and implementation: Based on Example 1, the layout of the miniature radiation dose sensor in the sensing and safety triggering module is optimized: Two new miniature radiation dose sensors (same model FD-3013) were installed at the tee joint of the liquid transfer pipeline and outside the valve of the reaction bottle outlet (5cm away from the valve), respectively, increasing the sensor coverage density in the core radiation risk area to 2 around the reaction bottle and 4 at key pipeline nodes.

[0037] The 0-10V analog signals from the newly added sensors are connected to the PLC analog input ports AI1 and AI2 (extended by an 8-point analog input module SM1231), and the digital alarm signals are connected to the PLC spare input ports I1.7 and I2.0.

[0038] PLC built-in logic optimization: When any one sensor detects a dose exceeding 1 μSv / h, a safety interlock action is triggered; if two or more sensors exceed the threshold simultaneously, the operating computer will additionally display a high-risk leak indicator, and the 4G module will push leak area location information.

[0039] Example 3 This embodiment provides a control system for a radiopharmaceutical synthesizer, used for graded safety interlocking, and the specific implementation includes: Implementation scenario: It is suitable for small-batch, multi-variety radiopharmaceutical synthesis, but it is necessary to balance production continuity with safety protection and avoid frequent shutdowns caused by slight radiation fluctuations.

[0040] Core improvements and implementation: Based on Example 1, the safety interlocking logic of the main control module is optimized, and tiered thresholds are set: Two threshold levels can be set via computer: a warning threshold of 0.8 μSv / h and an emergency threshold of 1 μSv / h. Both thresholds can be adjusted independently.

[0041] When the radiation dose reaches the warning threshold (0.8-1.0 μSv / h): the PLC triggers the first-level protection action - the dedicated ventilation module starts (Q1.2 is powered on), the operating computer pops up a warning pop-up window, the indicator light Q0.2 switches to flashing yellow, and the 4G module pushes the warning information; at this time, the production process is not stopped, only the change in radiation dose is continuously monitored.

[0042] When the radiation dose reaches the emergency threshold (≥1μSv / h): the PLC triggers the secondary protection action (same as the safety interlock action in Example 1), suspends liquid transfer and heating, and closes the valve to form a closed loop.

[0043] Reset mechanism optimization: In the early warning state, the system can automatically reset when the radiation dose drops below 0.6 μSv / h; in the emergency state, a password authorization from the administrator is required for reset.

[0044] Example 4 This embodiment provides a control system for a radiopharmaceutical synthesizer, used for the coordinated implementation of control modes and radiation protection. Specific implementation details include: Implementation scenario: Suitable for research-oriented radiopharmaceutical synthesis laboratories, which require frequent switching between fully manual, semi-automatic, and fully automatic modes, while ensuring radiation safety under different operating modes.

[0045] Core improvements and implementation: The focus is on verifying the linkage logic between the three control modes and radiation safety mechanisms: Fully manual mode: Switch the computer to the fully manual interface and independently control the operation of each pump and valve by clicking the interface buttons; when the miniature radiation dose sensor detects a dose exceeding 1μSv / h, the PLC forcibly cuts off the control signals of all pumps and valves, and immediately executes the safety interlock action regardless of the manual operation status, and the computer displays a safety interlock forced trigger prompt.

[0046] Semi-automatic mode: The system operates step by step according to preset steps (such as liquid transfer → heating reaction → cooling → discharge). When the current step is heating reaction, the radiation dose exceeds the threshold. The PLC immediately pauses the current step and executes the safety interlock action. After the hidden danger is eliminated and reset, you can choose to continue running from the paused step or restart the process.

[0047] Fully automatic mode: After clicking the start button, the system automatically executes the complete process; when the radiation dose exceeds the threshold, the PLC interrupts the process flow, executes the safety interlock action, and the process status is locked as interrupted. After resetting, the start button must be triggered again to start the process.

[0048] Example 5 This embodiment provides a control system for a radiopharmaceutical synthesizer, used for enhanced remote monitoring and data traceability. Specific implementation details include: Implementation scenario: It is suitable for large-scale radiopharmaceutical production enterprises and requires centralized monitoring, remote operation and maintenance, and data compliance traceability of multiple synthesizers (meeting GMP requirements).

[0049] Core improvements and implementation: Based on Example 1, the functions of the data interaction and remote monitoring module and the human-computer interaction and data storage module are enhanced: The 4G module adds VPN dialing functionality, enabling access to the enterprise's internal LAN. Administrators can remotely view real-time radiation dose data and equipment operating status via a mobile app (developed based on the MQTT protocol), receive alarm push notifications, and remotely send reset commands after authorization (remote start-up of processes is not supported).

[0050] The computer now features a data export function, which allows users to export radiation dose curves, equipment start-up and shutdown logs, and process parameter adjustment records by batch and time range. The export format supports both CSV and PDF, and the data includes compliant information such as timestamps, operator IDs, and equipment numbers.

[0051] The switch is connected to the central control room server via a network cable to enable centralized monitoring of 10 synthesizers. The server stores historical data of all devices (retained for 1 year) and supports abnormal data retrieval and statistical analysis.

[0052] Comparative Example 1 This comparative example provides existing system technology, specifically including: Existing technical solutions: The conventional radiopharmaceutical synthesizer control system is used, including a power supply unit, PLC, switch, sensors, pumps and valves, and operating computer. It lacks miniature radiation dose sensors, dedicated ventilation modules, and radiation dose linkage safety interlock logic. Radiation safety relies on manual inspection every 30 minutes, and environmental dose is measured using a portable radiation detector. The equipment operation log only records process parameters and does not store radiation dose data.

[0053] Comparison Tests and Results: Under the same production conditions (synthesis of fluorodeoxyglucose, with simulated slight radioactive leakage during the reaction process), the key indicators of Example 1 of the present invention are compared with those of the prior art: Regarding the response time to radiation leakage, the response time of Embodiment 1 of the present invention is ≤1.2s, covering the entire process of sensor detection and PLC interlocking action; the existing technical solution relies on manual inspection, with a response time ≥30 minutes, resulting in a serious lag in leak detection.

[0054] Regarding the leakage control effect, Embodiment 1 of the present invention can close the valve within 10 seconds to form a closed loop, effectively preventing the spread of radioactive materials; in the prior art, the leakage continued until it was discovered by humans, and the radiation had spread to a local area of ​​the laboratory.

[0055] Regarding data traceability, Embodiment 1 of the present invention can store and export radiation dose data and alarm logs throughout the entire process, achieving complete traceability; existing technical solutions do not record any radiation-related data and cannot trace the leakage process and the scope of impact.

[0056] In terms of compliance, Embodiment 1 of the present invention meets the GMP requirements for safety monitoring and has complete radiation safety data records; the existing technical solutions lack radiation safety monitoring records and do not meet the compliance standards for radiopharmaceutical production.

[0057] Regarding production interruption losses, Embodiment 1 of the present invention only interrupts the production of the current batch, without causing personal injury or environmental risks; existing technical solutions may lead to contamination of multiple batches of products, requiring subsequent comprehensive disinfection of the laboratory, resulting in greater losses.

[0058] Comparison conclusion: Existing technical solutions lack real-time radiation dose monitoring and linkage protection mechanisms, resulting in defects such as delayed detection of radiation leaks, high risk of spread, and insufficient compliance. This invention addresses the core pain points of existing technologies by adding a sensing and safety triggering module and optimizing the safety interlocking logic, thus verifying the inventiveness and practicality of the technical solution.

[0059] Compared with Examples 1-5 and Comparative Example 1, the core differences between Examples 1-5 and the prior art comparative example are in radiation safety protection, control mode adaptation, monitoring and traceability capabilities, scenario coverage and compliance performance. Through multi-dimensional technical optimization, the core pain points of the prior art are comprehensively solved.

[0060] Regarding radiation safety protection, the comparative example lacks real-time monitoring and coordinated protection mechanisms, relying on manual inspections every 30 minutes. Radiation leak response times exceed 30 minutes, with leaks continuously spreading to localized areas of the laboratory, and no radiation-related data is recorded. In contrast, Examples 1-5 are equipped with miniature radiation dose sensors and dedicated ventilation modules, forming a monitoring-judgment-execution loop system. Leak response times are ≤1.2s, and valves can be shut off within 10 seconds to form a closed loop. Example 2 further optimizes sensor layout, increasing coverage density in core radiation risk areas, and multi-sensor collaborative monitoring reduces the risk of missed detections. Example 3 sets tiered thresholds to balance production continuity and safety protection, avoiding frequent shutdowns caused by minor fluctuations, significantly improving protection reliability and flexibility.

[0061] Regarding control mode adaptability, the comparative model only supports basic process control, and there is no unified safety protection logic for different operating modes. Example 4 verifies the linkage between fully manual, semi-automatic, and fully automatic modes and radiation protection. Regardless of the operating state, the safety interlock action is executed first when radiation exceeds the threshold. During manual operation, the control signal is forcibly cut off. In semi-automatic mode, the current step can be paused and resumed later. In fully automatic mode, the process state is locked to ensure the safety baseline under various operating scenarios.

[0062] Regarding monitoring and traceability capabilities, the comparative example only records process parameters and lacks remote monitoring functionality, resulting in gaps in data traceability. Examples 1-5 achieve comprehensive monitoring through a 4G module and an operating computer. Example 5 further enhances remote operation and maintenance capabilities, allowing administrators to view data in real time, receive alarms, and remotely authorize resets via a mobile app. It also supports batch export of multi-format data, including timestamps, operator IDs, and other compliant information. The central control room server can centrally store one year's worth of historical data, meeting the traceability needs of large-scale production.

[0063] In terms of scenario coverage, the comparative example is only applicable to the synthesis of low-risk, single-variety radiopharmaceuticals, with limited adaptability. Example 1 is suitable for the production of conventional PET-based radiopharmaceuticals, Example 2 is for enhanced protection of high-level radiopharmaceuticals, Example 3 meets the needs of small-batch, multi-variety production, Example 4 is suitable for multi-mode operation in scientific research laboratories, and Example 5 supports centralized management for large-scale enterprises, forming a full-scenario coverage system that adapts to the needs of different production scales and risk levels.

[0064] In terms of compliance, the comparative example lacked radiation safety monitoring records, failing to meet GMP safety requirements for radiopharmaceutical production. Examples 1-5 all possess complete radiation dose data storage, alarm log recording, and traceability functions, with data retention periods up to one year, fully meeting GMP compliance standards and avoiding the significant losses of multiple batches of product contamination and comprehensive laboratory disinfection required in the comparative example.

[0065] In summary, through module optimization, logic upgrades, and functional expansion, this invention comprehensively surpasses existing technologies in key indicators such as radiation safety protection, scenario adaptation, and compliance traceability, and the creativity and practicality of the technical solution have been fully verified.

[0066] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of protection of the claims.

[0067] In conclusion, the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A control system for a radiopharmaceutical synthesizer, characterized in that, It includes a power supply module, a main control module, a data interaction and remote monitoring module, a sensing and safety triggering module, an execution module, and a human-machine interaction and data storage module. Each module forms a sensing-control-execution loop system through signal interaction to achieve full-process control of radiopharmaceutical synthesis and radiation safety protection. The power supply module outputs AC 220V and DC 24V voltages to provide power to the other modules. The main control module is the core of the system control, with built-in safety interlock logic. It is connected to the data interaction and remote monitoring module, the sensing and safety triggering module, the execution module, and the human-machine interaction and data storage module. It receives radiation dose, temperature, pressure, flow parameters and safety triggering signals of the reaction area collected by the sensing and safety triggering module, sends control commands to the execution module, and realizes data transmission and remote monitoring through the data interaction and remote monitoring module. The sensing and safety triggering module is used to collect safety triggering signals and parameters such as radiation dose, temperature, pressure, and flow rate in the reaction area during the radiopharmaceutical synthesis process. The execution module receives instructions from the main control module and performs liquid transfer, heating, pipeline switching and ventilation protection actions. The human-computer interaction and data storage module is used to realize parameter setting, equipment monitoring and data storage export; When the radiation dose collected by the sensing and safety triggering module exceeds the preset threshold, the main control module triggers a safety interlock action, the equipment involved in liquid transfer and heating in the control execution module stops operating, the control pipeline on / off components are closed to form a closed loop, and the ventilation and protection components are activated.

2. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The main control module includes a PLC and an extended digital output module; the PLC operates at DC24V and has 14 digital input ports, 10 relay-type digital output ports, 2 0-10V analog input ports, and 2 0-20mA analog output ports; the extended digital output module is a 16-point relay type module used to extend the main control module's driving capability for the execution module.

3. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The data interaction and remote monitoring module includes a switch and a 4G module. The switch operates at DC 12-58V, has 5 network ports, and a packet forwarding rate of 10.416Mpps. It is used for network connection between the main control module and the central control room, programming equipment, and the 4G module. The 4G module operates at DC 24V, has one RS232 interface, one RS485 interface, and two network ports. It enables mobile phone monitoring and remote monitoring of the main control module through the 4G network.

4. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The power supply module includes an AC power input unit and a switching power supply. The AC220V output voltage from the AC power input unit powers the human-machine interaction and data storage module, the module box temperature controller, and the third power supply via a normally open intermediate relay as a controllable power supply for the heating components in the execution module. The switching power supply converts AC220V to DC24V to power the main control module, data interaction and remote monitoring module, sensing and safety triggering module, execution module, and the fan inside the module box.

5. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The sensing and safety triggering module includes a reaction parameter sensor, an emergency stop component, and a miniature radiation dose sensor. The reaction parameter sensor collects data on the pressure, temperature, flow rate, and inlet pressure of the reaction vessel. The miniature radiation dose sensor is deployed in the core radiation risk area of ​​the radiopharmaceutical synthesis, specifically next to the reaction vessel support and at key interfaces of the liquid transfer pipeline. It has a measurement accuracy of ±5%, a measurement range of 0.1-10 μSv / h, a response time ≤1s, an IP65 protection rating, and outputs 0-10V analog signals and digital alarm signals to the main control module. The preset threshold is 1 μSv / h, and the threshold can be adjusted through the human-machine interaction and data storage module.

6. The control system of the radiopharmaceutical synthesizer according to claim 1, characterized in that, The execution module includes a liquid transfer component, a heating component, a pipeline on / off component, a status indicator component, and a dedicated ventilation component. The liquid transfer component is a vacuum pump, the heating component is a heater, the pipeline on / off component is multiple sets of valves, the status indicator component is an indicator light, and the dedicated ventilation component operates at DC24V, has an air volume of 100m³ / h, and a start / stop response time of ≤1s. When the main control module triggers the safety interlock, it controls the vacuum pump and heater to pause, controls the corresponding valves to close, and starts the dedicated ventilation component.

7. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The human-computer interaction and data storage module is an operating computer that is connected to the main control module via a network cable. It supports screen settings and jog operation, with a screen resolution of 1920×1080. It can store and export radiation dose data, equipment operation logs, and process parameter records.

8. The control system for a radiopharmaceutical synthesizer as described in claim 2, characterized in that, The PLC digital input port I0.0 of the main control module is connected to the emergency stop component, and the digital output ports Q0.0-Q0.7 are connected to the vacuum pump, heater, indicator light, and valves 17-20, respectively. The PLC analog input port is connected to the reaction bottle pressure sensor using a three-wire connection, and the analog output port is connected to the proportional valve opening setting using a three-wire connection. The signals Q2.0-Q3.7 of the extended digital output module are connected to valves 1-16, respectively.

9. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The main control module communicates with the syringe, flow meter, and activity meter via serial ports through the 485 expansion board and 485 expansion module, respectively, to collect syringe action feedback and measurement data from the flow meter and activity meter.

10. The control system for a radiopharmaceutical synthesizer as described in claim 1, characterized in that, The main control module supports three process control modes: fully manual, semi-automatic, and fully automatic. In fully manual mode, all pumps and valves in the execution module operate independently. In semi-automatic mode, the system runs according to preset steps, and the current step is maintained unless manually switched. In fully automatic mode, the system is started by a start button, and the system runs according to the set logic based on the feedback data from the sensing and safety triggering modules. In all three modes, the safety interlock action when the radiation dose exceeds the threshold has a higher priority than the conventional process operation. In the alarm state, the system needs to be reset by the administrator's authorized password through the human-machine interaction and data storage module. Before resetting, it must be confirmed that the radiation dose has dropped below 0.5 μSv / h.

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