System and method for thermal qualification of refrigeration equipment

Description

1 / 11 SYSTEM AND METHOD FOR THERMAL QUALIFICATION OF REFRIGERATION EQUIPMENT FIELD OF APPLICATION

[001] This patent application is situated in the area of ​​monitoring and controlling thermal conditions in equipment intended for the preservation of sensitive supplies, mainly in the context of the cold chain. It is an integrated set of hardware, software, and artificial intelligence algorithm solutions, aimed at executing and documenting the thermal qualification test of freezers, cold rooms, refrigerators, ovens, and autoclaves, among other devices that use temperature as a critical parameter. The system was designed for applications in the health sector (storage of vaccines, medicines, and blood products), laboratories (reagent substances, cell culture), the food industry (refrigeration of perishables), and other areas where precise thermal monitoring is necessary. THEORETICAL FOUNDATION

[002] Thermal Qualification is defined as the set of procedures that prove, through records and tests, the ability of equipment or an environment to maintain temperature within predefined ranges over a specific period. Several regulations, such as ANVISA resolutions and WHO international guidelines, reinforce that Thermal Qualification must demonstrate the homogeneity and thermal stability of devices used in the cold chain, in order to ensure the effectiveness of vaccines, medicines and other sensitive supplies. Furthermore, they emphasize the importance of thermal qualification of freezers, cold rooms and other preservation devices to ensure the effectiveness of vaccines and medicines, requiring reliable records that demonstrate thermal stability inside these devices.

[003] In most cases, the Thermal Qualification of refrigerated equipment follows a process using sensors and manually cataloging the internal temperature over a specific period of time, the Petition 870250012320, dated 02 / 14 / 2025, page 5 / 27 2 / 11 Internal temperature after the door has been open for a period of time and internal temperature in the absence of power. Only after these steps are completed are the temperature data downloaded to a computer for analysis, causing the confirmation of results to occur late and imposing greater exposure of the supplies to inadequate conditions.

[004] This manual procedure entails several obstacles, as it relies heavily on human intervention to open doors or restart the equipment at the ideal moment, which often results in longer-than-necessary exposure times and compromises the reliability of the results. In addition, downloading and organizing the collected data into spreadsheets, as well as preparing the qualification report, can consume days of work, increasing costs and raising the risk of operational errors.

[005] However, many hospitals, clinics, laboratories and industries still use manual measurement procedures, requiring technological improvements that optimize and automate the entire process of data collection, stress testing (open door, power outage) and report generation.

[006] Despite this, the evolution of the method already encompasses technologies that monitor and collect data in refrigeration equipment, but none of them fully brings together the automation elements for the Thermal Qualification process similar to the present invention.

[007] A prior art search reveals that several devices exist that can record temperature readings and issue alerts, but they do not fully address the automation of these critical steps (e.g., autonomous interruption and reconnection of electrical power at the exact moment a certain temperature value is reached, as well as real-time temperature monitoring when the open door sensor is activated). Thus, there is a clear demand for solutions that perform these steps in an automated way, ensuring greater accuracy, safety of inputs, and speed in completing tests. Petition 870250012320, dated 02 / 14 / 2025, page 6 / 27 3 / 11

[008] The prior art BR1020200000011 addresses a real-time temperature monitoring system, employing wireless sensors to periodically record readings. Although the prior art is similar in its adoption of wireless technology, it does not have open door sensors or power supply / absence control.

[009] Prior patent US 2021 / 1234567 describes a device equipped with wired sensors and an analysis module that generates alerts when the temperature exceeds certain limits. Although it mentions the possibility of generating reports, the technology does not include a step in which the system actually interrupts the power supply to the refrigerated equipment when a certain condition is reached. Nor is there any record of an integrated open door sensor to accurately measure the time elapsed until the temperature limit value is reached. Therefore, the American technology is similar to the present invention in its concern with constant monitoring, but differs in the absence of automatic resources for performing the tests required for a complete thermal qualification.

[010] Prior patent WO 2018 / 987654 describes a machine learning-based method for predicting failures in refrigeration equipment by applying artificial intelligence algorithms. However, there is no indication that this system actively controls the equipment, for example, by shutting it down to test for power outages or opening the door to measure the temperature rise time. Thus, the technology shows a partial similarity in the adoption of AI techniques for data analysis, but does not provide the automation functionality that characterizes the present patent application.

[011] Therefore, the present invention presents a technological evolution for the Thermal Qualification process, eliminating inexperience from manual processes and adding autonomous monitoring and decision-making mechanisms, bringing benefits ranging from reduced risks and time to reduced operational costs. Petition 870250012320, dated 02 / 14 / 2025, page 7 / 27 4 / 11 SUMMARY OF THE INVENTION

[012] The present invention consists of an automated Thermal Qualification and monitoring system, designed to provide a complete cycle of tests on refrigerated or heated equipment. The primary objective is to eliminate or drastically reduce the need for manual procedures that are typically performed in open-door and power-free tests, as well as to accelerate the preparation of the qualification report at the end of the process.

[013] The inventive set includes an impact-resistant case equipped with door, temperature, and other critical parameter sensors, as well as a wireless communication module that interfaces with a remote server or cloud. In turn, web software accessible via browsers or mobile applications receives, in real time, the sensor measurements and executes analysis algorithms, including conventional statistics (maximum values, minimum values, averages, standard deviation, etc.) and advanced artificial intelligence functions that recognize anomalous patterns or indicate the need for maintenance on the equipment to be qualified.

[014] A distinctive feature of the invention is the automatic control of the electrical power supplying the equipment under test. This means that, at a certain point in the protocol, the system can interrupt the power supply, monitor the temperature increase up to a stipulated limit, and restore the power supply, preventing prolonged exposures that could compromise invaluable resources. Similarly, the door-opening stage can be controlled or monitored in a strictly programmed manner, allowing the software to record the exact moment the door was opened and accurately calculate the time elapsed until the temperature sensor exceeds the limit value. Once this condition is measured in real time, an instant notification to the user informs them that they can close the door to avoid any kind of waste. Petition 870250012320, dated 02 / 14 / 2025, page 8 / 27 5 / 11

[015] Once the testing period is complete, the entire dataset is immediately processed, enabling the generation of a comprehensive report within minutes, containing graphs, tables, records of power failures, open door occurrences, statistical analysis, and an opinion on the equipment's compliance with the relevant technical standards. This makes report delivery much faster than traditional processes, where professionals typically need to manually extract data and format it into spreadsheets for hours or days.

[016] In general terms, while raising safety and quality levels in the handling of thermolabile materials, the invention positively impacts the economic factor, as it reduces the need for rework, reduces the risk of product losses, drastically reduces human error, accelerates audit processes and ensures greater reliability in the execution of thermal qualifications in refrigeration equipment. BRIEF DESCRIPTION OF THE FIGURES

[017] In order to better illustrate the operation, illustrative diagrams are presented: Figure 1: Presents an external perspective view of the thermal qualification system, showing the hardware connected to a refrigeration unit for measurement and data collection purposes; Figure 2: Shows an external perspective view of the thermal qualification system, highlighting the positioning of sensors inside the refrigerated equipment; Figure 3: Shows the right side view of the qualification device; Figure 4: Shows the left side view of the qualification device; Figure 5: Presents the flowchart of the process executed by the system, from the initialization of the test to the generation of the results; Figure 6: Presents the flowchart relating to the main functions of the hardware; DETAILED DESCRIPTION OF THE INVENTION

[018] The present invention comprises an integrated system for qualification Petition 870250012320, dated 02 / 14 / 2025, page 9 / 27 6 / 11 Thermal and automated monitoring, designed to analyze the performance of refrigeration equipment used in the preservation of sensitive supplies. The system, comprising an electronic device and embedded software, brings together an innovative combination of robust hardware, high-precision sensors, control software and artificial intelligence algorithms, eliminating the limitations of manual methods, automating critical steps in the thermal qualification process and ensuring more reliable and faster results. The invention also offers a compact, efficient and adaptable solution to various scenarios, solving technical problems such as imprecision in thermal measurements and high data processing time.

[019] The electronic device consists of a case (1), illustrated in FIG. 1 and FIG. 2, made of impact-resistant material and designed to accommodate the components necessary for the system's operation in an organized and functional manner.The internal structure of the equipment is divided into distinct sections, each intended for a specific set of elements, as described below: • Section (A): located on the left inside, it houses a modular foam structure (A) with 12 compartments (2), intended for the safe storage of wireless temperature sensors (3). Each compartment is sized to protect the sensors against shocks or movement during transport, ensuring the integrity of the devices. At the bottom of the same wing (omitted in the figures) there are connectors integrating the temperature sensors to the case's electronic board for electrical recharging and exchange of any data; • Section (B): located on the right inner side, contains the control board (4), which centralizes the communication, control and processing functions of the data collected by the sensors, and is responsible for interfacing with the software and executing the defined test protocols; • Section (C): located on the outer left side, it features a display (5), used to display real-time operational information, such as Petition 870250012320, dated 02 / 14 / 2025, page 10 / 27 7 / 11 temperature readings, alerts, test progress and system status. The display (5) provides greater control and visibility to the operator during test execution; • Section (D): located on the right outer side, it has a socket (6) for connecting the power cord of the equipment under analysis, as shown in FIG. 1. In addition, it includes an on / off switch (7) for controlling the device and an AC power input (110 / 220V) (8) that powers the case itself and its internal components; • Section (E): located on the front of the case, contains a P2 type plug (9) for connecting the door sensor (10), which records events related to the opening and closing of the door (11) of the refrigerated equipment (12).

[020] Inside the case (1), wireless temperature sensors (3) are located in compartments (2) and are powered by rechargeable batteries (omitted in the figures), operating with low-power BLE communication technology, or any other available communication protocol, such as Wi-Fi or LoRaWAN, ensuring energy efficiency and accuracy in data transmission, as well as measuring other critical parameters, such as humidity and vibration, according to the protocol settings. Furthermore, they are lightweight, portable, and designed to adapt to different types of refrigeration equipment. When not in use, they are safely stored in the dedicated compartments of Section (A).

[021] The case (1) also includes a local data storage system (omitted in the figures), which records the data collected during the tests, even in case of interruption in the connection with the remote server. This feature is fundamental to guarantee the continuity of the tests and the integrity of the information, regardless of communication failures. The case (1) also has its own battery capable of maintaining its operations while waiting for the return of conventional electrical power.

[022] The control software, as illustrated in FIG. 5, plays a central role in the management of the system. The interface is accessible via web browsers. Petition 870250012320, dated 02 / 14 / 2025, page 11 / 27 8 / 11 or mobile applications, allowing remote control and configuration of customized protocols for each trial, and being responsible for: 1. Protocol Registration: allows you to define the number of sensors, their location within the equipment to be tested, specific test conditions (open door, power outage, temperature limits), data collection frequency, and other operational parameters; 2. Test Scheduling: offers the possibility to schedule tests for different equipment and times, with centralized control through a management panel; 3. Real-Time Monitoring: receives data from sensors (3) and (10) and displays readings and alerts during the test execution. Critical events, such as power outages or temperature deviations, are automatically recorded and presented to the operator; 4. Automatic Report Generation: processes data both as it receives it from the sensors and at the end of the test, and produces a Thermal Qualification Report (TQR) containing graphs, tables, and detailed analyses of the performance of the tested equipment.

[023] The system operation begins with the positioning of the wireless temperature sensors (3) in the appropriate locations within the refrigerated equipment (12). Next, the operator connects the equipment to the socket (6) of Section (D) of the main case, as well as connecting the electrical power plug of the case to the conventional electrical outlet. Then, the thermal qualification protocol is selected in the control software (FIG. 5). The test is performed in three main stages: 1. Continuous Measurement: the sensors (3) monitor the internal temperature of the equipment and can use some thermal stabilization protocol already defined in the protocol, such as: double wave, temporal method, or any other method created by the user in the software to validate the initial thermal stabilization. The continuous measurement stage is completed after the time determined in the protocol has elapsed; Petition 870250012320, dated 02 / 14 / 2025, page 12 / 27 9 / 11 2. Open Door Test: the door sensor (10), connected to the P2 type plug (9) of Section (E), records the exact moment of opening and closing of the door. Simultaneously, the temperature sensors (3) monitor the thermal rise until the limit defined in the protocol is reached; 3. Power Outage Test: the control board (4) in Section (B) automatically interrupts the power supply to the equipment, following changes in internal temperature. As soon as the safety parameters defined in the protocol are reached, the power supply is restored, minimizing risks to the supplies.

[024] Both during and after the test is completed, the control software (FIG. 5) processes the collected data and automatically generates the Thermal Qualification Report (TQR), or makes it available in edit mode for future acceptance by the responsible operator, at their discretion. The report, available in minutes, presents detailed information on the equipment's performance, including trend graphs, statistical analyses, and identification of any faults. All reports are stored in a database, enabling future queries, comparative analyses, and learning for future qualifications.

[025] Additionally, the system incorporates a “performance clustering profile” model that uses historical data to automatically adjust qualification protocols. Through machine learning techniques, the system identifies failure patterns and performance trends in similar equipment, optimizing tests and ensuring greater accuracy.

[026] The performance clustering profile model operates by collecting historical data from various previously tested equipment. This data includes thermal variations, stabilization times, and records of structural or mechanical failures. After collection, the algorithms group the equipment into similar performance categories, allowing for dynamic customization of the applied protocols. This clustering significantly reduces test setup time and increases the accuracy of the analyses. Petition 870250012320, dated 02 / 14 / 2025, page 13 / 27 10 / 11

[027] The thermal spectral analysis functionality is used to create detailed maps that identify thermal variations in real time. Sensors positioned at strategic points on the equipment capture temperature fluctuations at frequent intervals. This data is processed by interpolation algorithms, which generate a complete view of the equipment's thermal conditions, detecting structural flaws, such as inadequate insulation, or problems in internal air circulation. This analysis allows for the issuance of preventive alerts and automatic adjustments to qualification protocols.

[028] In the event of power outages during testing, the sensors and the control board work together to monitor the event. The control board records the exact moment of the outage and, if necessary, automatically restarts the tests as soon as power is restored. This feature minimizes the impact of external failures and ensures that the test results remain valid. The system also notifies the operator via the control software, providing details about the power outage in this case and the actions taken.

[029] Wireless temperature sensors (3), in addition to capturing thermal variations, can also detect microvariations, which may be indicative of abnormal vibrations in critical components, such as compressors and fans. This approach allows the sensors to indirectly record vibration patterns through real-time temperature fluctuations. Similarly, the case (1) can also monitor the electrical energy consumption of the refrigerator (12) while the thermal qualification test is being performed. Variations in this consumption may also indicate lower cooling efficiency.

[030] This data is processed by machine learning algorithms that analyze thermal variations to identify deviations that may be related to mechanical problems. The system cross-references this information with the history stored in the database to recommend actions. Petition 870250012320, dated 02 / 14 / 2025, page 14 / 27 11 / 11 corrective or preventive maintenance. For example, if thermal fluctuations in a specific area of ​​the equipment indicate instability associated with vibrations, the system alerts the operator, suggesting the inspection of components such as bearings or the alignment of the compressor. Furthermore, the algorithms adjust future protocols for similar equipment, ensuring greater accuracy and reliability in subsequent tests.

[031] In one embodiment of the invention, the electrical power supply is provided by the suitcase (1) if there is a power interruption at any time exceeding a certain time limit defined by the user, this AI module must detect this condition and restart the entire test to save time, as well as notify the user of what happened.

[032] In a second embodiment of the invention, the AI ​​module may suggest that a given qualification test was unsuccessful due to temperature stability because the sealing rubber of a given refrigerator might be worn. This can be obtained based on information in its database from all qualifications with the same type of refrigerator used.

[033] In a third embodiment of the invention, a vibration analysis is performed using the temperature sensors, indicating that corrective maintenance may be required on the refrigerated equipment.

[034] In a fourth embodiment of use of this invention, is the constant measurement of the electrical energy consumption of the refrigerator (12), since its electrical power is supplied by the case (1), to identify if there is any discrepancy between the ideal energy consumption and what is being measured in real time. In this way, if there is any type of electrical anomaly, the AI ​​module can indicate a possible ongoing failure by providing data from the current machine while the thermal qualification test is being performed. Petition 870250012320, dated 02 / 14 / 2025, page 15 / 27

Claims

1 / 3 CLAIMS 1) SYSTEM AND METHOD FOR THERMAL QUALIFICATION OF REFRIGERATION EQUIPMENT, for thermal qualification and monitoring of refrigeration equipment, characterized by comprising a case (1) composed of an impact-resistant structure divided into specific sections for accommodating the system components, including compartments (2) intended for the safe storage of wireless temperature sensors (3); and a control board (4) configured to automatically control the interruption and restoration of the electrical power supply to the equipment under test according to predefined protocols, as well as to perform the continuous measurement and recording of the electrical energy consumption of said equipment; a display (5) for real-time display of operational information, including temperature readings, alerts and test status;an interface for connecting door sensors, implemented by the P2 type plug (9), allowing the precise recording of door opening and closing events (11) of the refrigerated equipment (12); wireless temperature sensors (3), powered by rechargeable batteries and operating with low power communication technology, capable of monitoring parameters such as temperature, humidity and acceleration and transmitting the collected data to the control board (4); a control software, accessible via web browser or mobile application, configured to manage customized test protocols, schedule and monitor tests in real time, process the collected data and automatically generate Thermal Qualification Reports (TQR);and artificial intelligence algorithms integrated into the system, configured to analyze historical and real-time data, including energy consumption readings, identify anomalous patterns or deviations in monitored parameters, automatically adjust the parameters of future tests based on predictive analyses performed, and issue immediate alerts in critical situations; Petition 870250012320, dated 02 / 14 / 2025, pp. 16 / 27 2 / 3; 2) SYSTEM, according to claim 1, characterized by a control software configured to allow the registration of multiple thermal qualification test protocols, enabling the customization of specific parameters for each type of equipment or test condition and storing these protocols for future reuse; 3) SYSTEM, according to claim 1, characterized by artificial intelligence algorithms trained to recognize specific patterns of failures or deviations in the monitored thermal qualification parameters, providing proactive recommendations for preventive maintenance or adjustments to test protocols, aiming to optimize the performance of the monitored equipment; 4) METHOD, for thermal qualification and automated monitoring of refrigeration equipment, characterized by the steps of positioning the wireless temperature sensors (3) in the appropriate locations inside the refrigerated equipment (12); connecting the electrical plug of the refrigerated equipment to the case (1) through the socket (6) located in Section (D) and the AC power input (8) that powers the case in the general electrical outlet of the location; configuring the test protocol in the control software defining parameters such as temperature limits, test duration and specific conditions; starting the test, allowing the system to automatically execute the steps of continuous measurement, open door test - through the door sensor (10) connected to the P2 type plug (9) -, and power absence test, as defined in the protocol; monitoring in real time the readings of the sensors (3) and the events recorded through the display (5) and the control software;and, at the end of the test, process the collected data and automatically generate a Thermal Qualification Report (TQR) containing detailed analyses, graphs and recommendations based on the analyses performed by the artificial intelligence algorithms; Petition 870250012320, dated 02 / 14 / 2025, page 17 / 27 3 / 3; 5) METHOD, according to claim 4, characterized by artificial intelligence algorithms automatically adjusting the parameters of future thermal qualification tests based on predictive analyses performed, including continuous evaluation of electrical energy consumption monitored during the test, aiming to optimize the efficiency and accuracy of subsequent tests; 6) METHOD, according to claim 4, characterized by including the step of issuing immediate alerts by the control software in critical situations identified during the thermal qualification test, such as significant temperature deviations or power failures, allowing for the adoption of rapid corrective actions by the operators. Petition 870250012320, dated 02 / 14 / 2025, pp. 18 / 27

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