A temperature monitoring system for a freeze dryer

Abstract

This utility model belongs to the technical field of freeze-drying equipment and discloses a temperature monitoring system for a freeze dryer. The temperature monitoring system includes a housing, a data acquisition module, a temperature measurement module, a power supply module, and a reading module. The housing forms an adjustable temperature space; the data acquisition module is located within the housing; the temperature measurement module is at least partially inserted into the reagent bottle containing the test reagent and in contact with the test reagent, and the temperature measurement module and the data acquisition module are wirelessly connected; the temperature measurement module transmits the temperature information of the test reagent to the data acquisition module via electromagnetic waves; the power supply module is located inside the housing and supplies power to the temperature measurement module via electromagnetic waves; the reading module is located outside the housing and is signal-connected to the data acquisition module to read the temperature information acquired by the data acquisition module. This utility model achieves power supply and signal transmission wirelessly, reducing the complexity of the spatial layout, ensuring stable signal transmission, and is applicable to equipment of different sizes.

Description

Technical Field

[0001] This utility model relates to the field of freeze-drying equipment technology, and in particular to a temperature monitoring system for a freeze dryer. Background Technology

[0002] Antibody-drug conjugates (ADCs), as a representative therapy in the field of precision medicine, have extremely high requirements for stability and safety in their production process. Freeze-drying technology (i.e., vacuum freeze-drying) is currently a key technology in ADC drug production. The freeze-drying process involves freezing the aqueous ADC solution at low temperatures, and then sublimating the ice directly into water vapor under vacuum conditions, thereby removing moisture and obtaining a solid, dried product. This process maximizes the preservation of the drug's biological activity, extends its shelf life, and facilitates transportation and storage.

[0003] In current freeze-drying production of ADC drugs, temperature monitoring mainly relies on traditional contact temperature sensors, such as thermocouples (PT100 temperature probes). These sensors are directly inserted into or placed in the drug container, transmitting temperature data via electrical signals. The plate temperature control of the freeze dryer typically depends on the signals fed back from these sensors, and is regulated by a PLC system to maintain the desired temperature profile.

[0004] However, this monitoring method has several limitations. First, it requires complex wiring connections between sensors and the data acquisition system. Temperature probes, vacuum pressure sensors, and solenoid valves all need to be connected to the control system via cables. These wiring connections are complex within the limited space of the freeze dryer, especially in medium to large-scale freeze dryers where the wiring is numerous and the layout is even more complex. Simultaneously, the freeze-drying process environment is quite unique, including low temperatures and vacuum conditions, which places higher demands on the stability of signal transmission. Furthermore, existing monitoring systems are difficult to adapt to freeze-drying equipment of different scales (experimental, pilot-scale, and production). Utility Model Content

[0005] The purpose of this invention is to provide a temperature monitoring system for a freeze dryer, which achieves power supply and signal transmission through wireless transmission, reducing the complexity of spatial layout, ensuring stable signal transmission, and being applicable to equipment of different sizes.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] A temperature monitoring system for a freeze dryer, comprising:

[0008] The enclosure, the interior of which forms a temperature-adjustable space;

[0009] The data acquisition module is located within the housing.

[0010] A temperature measuring module is at least partially inserted into and in contact with a reagent bottle containing a test reagent. The temperature measuring module is wirelessly connected to the acquisition module. The temperature measuring module is used to transmit the temperature information of the test reagent to the acquisition module via electromagnetic waves.

[0011] A power supply module is located inside the enclosure, and the power supply module supplies power to the temperature measuring module via electromagnetic waves.

[0012] A reading module, located outside the enclosure and connected to the acquisition module via a signal, is used to read the temperature information acquired by the acquisition module.

[0013] As an optional solution for the temperature monitoring system of a freeze dryer, the acquisition module is provided on both of the two opposite inner walls of the chamber.

[0014] As an optional temperature monitoring system for a freeze dryer, the acquisition module is detachably connected to the housing.

[0015] As an optional solution for the temperature monitoring system of a freeze dryer, the chamber is provided with multiple plates for placing the reagent bottles, and each plate has at least one reagent bottle with the temperature measuring module inside.

[0016] As an optional solution for the temperature monitoring system of a freeze dryer, the temperature measurement module includes a heat conductor and a temperature sensor. The temperature sensor is used to measure the temperature of the heat conductor, and the heat conductor is at least partially in contact with the test reagent.

[0017] As an optional solution for the temperature monitoring system of a freeze dryer, the temperature measuring module includes a covering, the heat conductor is at least partially placed inside the covering, and the temperature sensor is located in the covering.

[0018] As an optional solution for the temperature monitoring system of a freeze dryer, the temperature measurement module further includes a first antenna, which is wirelessly connected to the acquisition module and connected to the temperature sensor.

[0019] As an optional solution for the temperature monitoring system of a freeze dryer, the temperature measurement module further includes a connector, with the end of the first antenna away from the temperature sensor connected to the connector, and the connector connected to the reagent bottle.

[0020] As an optional solution for the temperature monitoring system of a freeze dryer, the connector is inserted into the cap of the reagent bottle, and the connector is clamped by the elasticity of the cap.

[0021] As an alternative to the temperature monitoring system for a freeze dryer, the first antenna is spiral-shaped.

[0022] Beneficial effects:

[0023] In this invention, the temperature monitoring system of the freeze dryer adopts a completely wireless design, eliminating the wiring problems of traditional wired temperature monitoring. This makes it particularly suitable for freeze dryer systems with automatic feeding and discharging, facilitating manual installation by the operator and offering high flexibility. The wireless signal transmission method reduces the complexity of the spatial layout, ensures stable signal transmission, and is applicable to equipment of different sizes, thus enhancing adaptability. The temperature measurement module is embedded inside the reagent bottle to directly monitor the reagent temperature, significantly improving the accuracy and completeness of temperature monitoring. Furthermore, the electromagnetic wave wireless power supply enhances the system's maintainability. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the temperature monitoring system of the freeze dryer provided in this embodiment of the utility model;

[0025] Figure 2 This is a schematic diagram of the structure of the temperature measuring module of this utility model inserted into the reagent bottle;

[0026] Figure 3 This is a structural schematic diagram of the temperature measuring module of this utility model.

[0027] In the picture:

[0028] 100. Reagent bottle; 110. Cap;

[0029] 1. Box; 10. Space; 11. Sheet;

[0030] 2. Data Acquisition Module;

[0031] 3. Temperature measurement module; 31. Heat conductor; 32. Temperature sensor; 33. Encasing component; 34. First antenna; 35. Connector;

[0032] 4. Power supply module;

[0033] 5. Reading module;

[0034] 6. Display module. Detailed Implementation

[0035] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, not the entire structure.

[0036] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0037] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0038] In the description of this embodiment, the terms "upper," "lower," "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0039] Please see the appendix Figure 1 This embodiment relates to a temperature monitoring system for a freeze dryer, including a housing 1, a data acquisition module 2, a temperature measurement module 3, a power supply module 4, and a reading module 5. The housing 1 forms an adjustable temperature space 10. The data acquisition module 2 is located within the housing 1. The temperature measurement module 3 is at least partially inserted into a reagent bottle 100 containing the test reagent and in contact with the test reagent; the temperature measurement module 3 and the data acquisition module 2 are wirelessly connected. The temperature measurement module 3 transmits the temperature information of the test reagent to the data acquisition module 2 via electromagnetic waves. The power supply module 4 is located inside the housing 1 and supplies power to the temperature measurement module 3 via electromagnetic waves. The reading module 5 is located outside the housing 1 and is signal-connected to the data acquisition module 2, used to read the temperature information acquired by the data acquisition module 2.

[0040] Specifically, the interior of chamber 1 serves as the working environment for the freeze dryer, forming a temperature-adjustable space 10. The temperature range typically covers -60°C to +60°C to meet the requirements of most freeze-drying processes. The walls of chamber 1 employ a composite insulation structure, consisting of an outer stainless steel protective plate, a middle high-performance vacuum insulation layer, and an inner thermally conductive aluminum plate. This structure effectively reduces the interference of external ambient temperature on the distributed monitoring units inside chamber 1, ensuring a stable low-temperature environment.

[0041] The data acquisition module 2, serving as the system's data aggregation center, employs an advanced dual-band communication design. Specifically, it comprises two independent wireless receiving units: one operating in the 2.4GHz band (2.4000-2.4835GHz) for high-speed data transmission; and the other operating in a lower frequency band (such as 433MHz or 868MHz) to enhance penetration and anti-interference capabilities. This dual-band design enables the system to intelligently switch communication channels based on real-time changes in the freeze dryer's internal environment, ensuring reliable transmission of temperature data in complex metallic environments.

[0042] The communication between acquisition module 2 and reading module 5 adopts an industrial-grade communication protocol, such as the OPC UA (Unified Architecture) protocol. This protocol ensures the security and reliability of the data acquisition process through encrypted transmission and certificate verification. Support for the OPC UA protocol allows this system to be easily integrated into existing freeze dryer control systems, enabling synchronous monitoring and analysis of temperature data and other process parameters (such as vacuum level and cold trap temperature). The physical structure of acquisition module 2 uses a stainless steel shielded shell, which prevents external electromagnetic interference and ensures structural integrity in the high-vacuum environment of the freeze dryer. The installation method of acquisition module 2 takes into account the internal space limitations of the freeze dryer, employing a thin design and magnetic fixing method for easy installation and disassembly without affecting the original temperature uniformity and airflow of the freeze dryer.

[0043] By increasing the number of temperature measurement modules 3, distributing multiple temperature measurement modules 3 in different key areas of the freeze dryer, multi-point temperature monitoring can be achieved, thus ensuring the effectiveness of temperature monitoring. The power supply module 4 is key to achieving complete wireless operation of the temperature measurement modules 3. The power supply module 4 uses electromagnetic wave energy harvesting technology to convert electromagnetic energy of a specific frequency into DC power, remotely powering the temperature measurement modules 3 distributed throughout the freeze dryer. This non-contact power supply method eliminates the maintenance burden of periodically replacing traditional power supplies and avoids the wiring difficulties associated with wired power supply. The power supply module 4 includes a radio frequency (RF) energy transmitter, which comprises an RF signal generator, a power amplifier, and a directional antenna array, thereby directionally transmitting electromagnetic energy to specific areas within the freeze dryer.

[0044] The reading module 5 serves as the main interface between the system and the user. It adopts a multi-functional integrated design, connecting to the display module 6 to achieve data display, storage, analysis, and alarm functions all in one. Meanwhile, the display module 6, equipped with a high-resolution touchscreen, displays temperature data from each measuring point in real time using various formats such as curves and numbers, enhancing visualization.

[0045] In this embodiment, the freeze dryer temperature monitoring system adopts a completely wireless design, eliminating the wiring problems of traditional wired temperature monitoring. This makes it particularly suitable for freeze dryer systems with automatic feeding and discharging, facilitating manual installation by the operator and offering high flexibility. The wireless signal transmission method reduces the complexity of the spatial layout, provides stable signal transmission, and is applicable to equipment of different sizes, making it more adaptable. The temperature measuring module 3 is embedded inside the reagent bottle 100 to directly monitor the reagent temperature, significantly improving the accuracy and completeness of temperature monitoring. Furthermore, the electromagnetic wave wireless power supply enhances the system's maintainability.

[0046] Optionally, a data acquisition module 2 is provided on each of the two opposite inner walls of the housing 1.

[0047] Specifically, a redundant signal receiving network is constructed by symmetrically arranging the acquisition modules 2 on two opposing inner walls (such as the left and right side walls) of the housing 1. Each acquisition module 2 integrates multiple (e.g., 4 or 8) high-performance directional microstrip antenna arrays, which operate using diversity reception technology to process the temperature data sent by the temperature measurement module 3.

[0048] In this embodiment, the symmetrical arrangement of the dual acquisition modules 2 can achieve full signal coverage, eliminate monitoring blind spots, improve detection accuracy, avoid data distortion caused by single-point failures, and ensure data integrity.

[0049] Optionally, the acquisition module 2 can be detachably connected to the housing 1.

[0050] Specifically, the acquisition module 2 includes an antenna and an RF extension cable. The door panel of the housing 1 and the inner wall on one side opposite the door panel are each equipped with an antenna. The RF extension cable enables signal connection between the antenna and the reading module 5. One end of the antenna is located inside the housing 1, and the other end is located outside the housing 1 and is securely connected to the RF extension cable via a threaded connection. Simultaneously, the connector structure of both antennas is attached to the outside of the housing 1. The outside of the housing 1 can be provided with a snap-fit ​​part for attaching the connector structure. The snap-fit ​​part includes two opposing semi-rings, one of which is fixed, while the other can rotate relative to it, thus forming an openable or closable accommodating area between the two semi-rings. The connector structure is circular. When the semi-ring is open, the connector structure is inserted, and then the semi-ring is rotated to close, thereby ensuring the fixation of the connector. Of course, in other embodiments, the connector may also have various detachable installation and fixing methods, such as plug-in or snap-fit, which can be adjusted according to usage requirements.

[0051] In this embodiment, the acquisition module 2 is connected to the housing 1 via a detachable connection, ensuring quick disassembly and replacement of the acquisition module 2 and improving assembly and disassembly efficiency. It also allows the same acquisition module 2 to adapt to various housing 1 sizes, enhancing its adaptability.

[0052] Please continue to refer to the appendix. Figure 1 The box 1 has multiple shelves 11, which are used to place reagent bottles 100. Each shelf 11 has at least one reagent bottle 100 with a temperature measuring module 3 inside.

[0053] In this embodiment, the space 10 inside the box 1 is divided into multiple layers by multiple plates 11, realizing layered management of reagents and improving the utilization efficiency of the space 10. At the same time, at least one reagent bottle 100 on each plate 11 is equipped with a temperature measuring module 3, that is, there is a measurement and collection point on each plate 11, thereby ensuring the coverage of the collected data.

[0054] Please see the appendix Figure 2 and attached Figure 3 Optionally, the temperature measurement module 3 includes a heat conductor 31 and a temperature sensor 32. The temperature sensor 32 is used to measure the temperature of the heat conductor 31, and the heat conductor 31 is at least partially in contact with the test reagent.

[0055] Specifically, the heat conductor 31 can be made of an iron alloy substrate and electroplated with silver or gold on the outside to improve thermal conductivity and reduce heat loss. One end of the heat conductor 31 directly contacts the test reagent to collect its temperature. The detection end of the temperature sensor 32 contacts the other end of the heat conductor 31. The temperature information can be accurately transmitted to the temperature sensor 32 through the heat conductor 31. The temperature sensor 32 can be a conventional temperature sensing component. The temperature sensor 32 has a temperature sensing core and a circuit board. The temperature sensing core is used to convert the temperature signal into an electrical signal.

[0056] Furthermore, the temperature measuring module 3 includes a cover 33, with the heat conductor 31 at least partially placed inside the cover 33, and the temperature sensor 32 disposed in the cover 33.

[0057] Specifically, the cover 33 is sleeve-shaped and made of insulating material, such as resin or silicone rubber. It is used to isolate the temperature sensor 32, exposing only the heat conductor 31 to the test reagent, thereby protecting the temperature sensor 32.

[0058] Optionally, the temperature measurement module 3 also includes a first antenna 34, which is wirelessly connected to the acquisition module 2 and connected to the temperature sensor 32.

[0059] Specifically, one end of the first antenna 34 is connected to the circuit board of the temperature sensor 32. The temperature sensor 32 converts electrical signals and spreads electromagnetic waves of a specific frequency band through the first antenna 34.

[0060] In this embodiment, the first antenna 34 adopts a spiral structure, which is compact and suitable for miniaturized temperature measurement modules 3. It can achieve uniform radiation within a 360° range and maintain good performance over a wide frequency range without the need for frequent adjustments.

[0061] Optionally, the temperature measuring module 3 also includes a connector 35, with one end of the first antenna 34 away from the temperature sensor 32 connected to the connector 35, and the connector 35 connected to the cap 110 of the reagent bottle 100. The connector 35 is partially inserted into the cap 110 of the reagent bottle 100, and the cap 110 elastically clamps the connector 35.

[0062] Specifically, the temperature measuring module 3 is connected by a suspension method, and the connector 35 is made of non-metallic insulating material, such as a silicone tube. The connector 35 pierces the cover 110, and the elasticity of the cover 110 clamps the connector 35, making installation simple and convenient, allowing users to operate it with gloves inside the isolator. The end of the connector 35 furthest from the cover 110 is connected to the first antenna 34. The connector 35 can be of appropriate length depending on the reagent bottle 100 to ensure that the heat conductor 31 can contact the test reagent inside the reagent bottle 100. It is also important to ensure that the installation height of the temperature measuring module 3 is such that the heat conductor 31 is suspended within the reagent bottle 100, and the actual test reagent cannot be completely higher than the heat conductor 31.

[0063] The operation process of this system in conjunction with the freeze dryer is as follows.

[0064] 1. Install the acquisition module 2 on the housing 1.

[0065] 2. Open the enclosure 1 and install the temperature measuring module 3. Specifically, select the corresponding temperature measuring point on each layer and place the temperature measuring module 3.

[0066] 3. Start the operating procedure for chamber 1, which includes the CIP (clean in place) procedure and the SIP (sterilize in place) procedure. The CIP procedure typically involves thoroughly rinsing the inner walls and shelves of the freeze-drying chamber with a cleaning solution at a specific temperature (which may be purified water, water for injection, or an aqueous solution containing detergent) through a spray device. During the SIP procedure, sterilization is performed using high-temperature, high-pressure steam.

[0067] 4. Send the required temperature measurement module 3 into the isolator, ready for production.

[0068] 5. Test whether all temperature measurement modules 3 can receive signals normally. If they cannot receive signals normally, they cannot be used in the production process.

[0069] 6. According to the pre-designed layout diagram, place the temperature measuring module 3 into the reagent bottle 100 in sequence.

[0070] After testing, 25 temperature measurement modules 3 were installed at different points on 5 layers 11 inside the enclosure 1, and the data collection coverage reached 99%. 20 temperature measurement modules 3 were installed at different points on 4 layers 11 inside the enclosure 1, and the data collection coverage reached 95%.

[0071] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the present utility model, and are not intended to limit the implementation of the present utility model. Those skilled in the art can make various obvious changes, readjustments, and substitutions without departing from the protection scope of this utility model. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A temperature monitoring system for a lyophilizer, the system comprising: include: The box (1) has an adjustable temperature space (10) inside. Acquisition module (2), wherein the acquisition module (2) is located in the housing (1); The temperature measuring module (3) is at least partially inserted into the reagent bottle (100) containing the test reagent and in contact with the test reagent. The temperature measuring module (3) is wirelessly connected to the acquisition module (2). The temperature measuring module (3) is used to transmit the temperature information of the test reagent to the acquisition module (2) via electromagnetic waves. The power supply module (4) is located inside the housing (1), and the power supply module (4) supplies power to the temperature measuring module (3) via electromagnetic waves; The reading module (5) is located outside the housing (1) and is connected to the acquisition module (2) by signal. It is used to read the temperature information acquired by the acquisition module (2).

2. The temperature monitoring system of a lyophilizer according to claim 1, wherein, The acquisition module (2) is provided on both of the two opposite inner walls of the box (1).

3. The temperature monitoring system for a lyophilizer of claim 1, wherein, The acquisition module (2) is detachably connected to the housing (1).

4. The temperature monitoring system for a lyophilizer of claim 1, wherein, The box (1) is provided with multiple plates (11), which are used to place the reagent bottles (100). Each plate (11) has at least one reagent bottle (100) with the temperature measuring module (3) inside.

5. The temperature monitoring system for a lyophilizer of claim 1, wherein, The temperature measurement module (3) includes a heat conductor (31) and a temperature sensor (32). The temperature sensor (32) is used to measure the temperature of the heat conductor (31). The heat conductor (31) is at least partially used to contact the test reagent.

6. The temperature monitoring system of a lyophilizer according to claim 5, wherein, The temperature measuring module (3) includes a cover (33), the heat conductor (31) is at least partially placed inside the cover (33), and the temperature sensor (32) is located in the cover (33).

7. The temperature monitoring system of a lyophilizer according to claim 5, wherein, The temperature measurement module (3) also includes a first antenna (34), which is wirelessly connected to the acquisition module (2) and connected to the temperature sensor (32).

8. The temperature monitoring system of a lyophilizer according to claim 7, wherein, The temperature measurement module (3) also includes a connector (35), one end of the first antenna (34) away from the temperature sensor (32) is connected to the connector (35), and the connector (35) is connected to the reagent bottle (100).

9. The temperature monitoring system of a lyophilizer according to claim 8, wherein, The connector (35) is partially inserted into the cap (110) of the reagent bottle (100), and the connector (35) is elastically clamped by the cap (110).

10. The temperature monitoring system of a lyophilizer of claim 7, wherein, The first antenna (34) is spiral-shaped.

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