Biological preparation freeze-drying pre-treatment apparatus and method

CN122943565APending Publication Date: 2026-10-20SHANDONG ZHONGRUIYUAN BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202611295517.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-08-25
Publication Date
2026-10-20

AI Technical Summary

Technical Problem

[0002]生物制剂在冷冻干燥保存前,需先完成预冻处理,以保障后续冻干过程能够形成符合要求的冰晶结构,维持生物制剂的活性,目前常用的冻干预处理装置多采用直接放入冻干机搁板或普通低温冰箱降温,容易因搁板上下温差大、溶液内外温场不均问题,形成大粒径冰晶,刺破蛋白分子空间结构、破坏细胞完整性,导致生物制剂活性大幅下降;此外,现有技术在预处理过程中通常为整体温度控温,由于金属搁板导热存在固有热阻,搁板中心与边缘、加热/冷却源附近与远端之间不可避免地会产生显著的温度梯度,容易出现批次间一致性差的问题

Benefits of technology

[0015]相较于现有技术,本发明通过隔温板围出容纳腔填充导热介质,并配合导热隔板内的循环流道形成强制循环,使得导热介质能够均匀流经导热隔板各个区域,结合温度调节组件对导热介质温度的调控,能够让搁板整体温度均匀一致,避免搁板出现梯度温度差,保证放置在搁板上的多份生物制剂能够获得一致的预处理温度条件,避免因温度不均导致部分生物制剂活性受损或预处理效果不达标,有效提升了生物制剂冻干预处理的稳定性和产品合格率。

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Abstract

This invention discloses a device and method for cryo-intervention of biological agents, relating to the field of biochemistry. It includes a pretreatment chamber and shelves within the chamber. The pretreatment chamber contains a pretreatment mechanism, which includes a heat-conducting partition, an insulation plate, a receiving cavity, and a circulation channel. This invention uses the insulation plate to enclose the receiving cavity, which is filled with a heat-conducting medium. Combined with the circulation channel within the heat-conducting partition, forced circulation is formed, allowing the heat-conducting medium to flow evenly through all areas of the partition. Combined with a temperature control component to regulate the temperature of the heat-conducting medium, the overall temperature of the shelf is made uniform, avoiding temperature gradients and ensuring that multiple portions of biological agents placed on the shelf receive consistent pretreatment temperature conditions. This prevents the activity of some biological agents from being damaged or the pretreatment effect from failing due to uneven temperature, effectively improving the stability and product qualification rate of cryo-intervention of biological agents.
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Description

Technical Field

[0001] This invention relates to the field of biochemistry, and in particular to a device and method for cryotreatment of biological agents. Background Technology

[0002] Before freeze-drying, biological agents need to undergo pre-freezing to ensure that the subsequent freeze-drying process can form the required ice crystal structure and maintain the activity of the biological agents. Currently, commonly used freeze-drying devices often involve directly placing the agent into the freeze dryer shelves or a regular low-temperature freezer for cooling. This can easily lead to the formation of large-diameter ice crystals due to large temperature differences between the upper and lower parts of the shelf and uneven temperature fields inside and outside the solution. These large ice crystals can pierce the spatial structure of protein molecules and damage cell integrity, resulting in a significant decrease in the activity of the biological agents. In addition, existing technologies usually use overall temperature control during pre-treatment. Due to the inherent thermal resistance of the metal shelves, significant temperature gradients inevitably occur between the center and the edge of the shelf, and between the near and far ends of the heating / cooling source, which can easily lead to poor batch-to-batch consistency.

[0003] Therefore, based on the above-mentioned viewpoints, there is still room for optimization in the existing techniques for cryo-intervention of biological agents. Summary of the Invention

[0004] To address the aforementioned problems, this invention provides a biological agent cryopreservation treatment device, comprising a pretreatment chamber and a shelf disposed within the pretreatment chamber. A pretreatment mechanism is defined within the pretreatment chamber, comprising: a thermally conductive partition located below and in contact with the shelf; a heat-insulating plate fitted onto the outer periphery of the shelf and the thermally conductive partition and sealed against the inner wall of the pretreatment chamber, the heat-insulating plate having a downward-curving central portion forming a receiving cavity; the shelf and the thermally conductive partition being sequentially stacked on the upper side of the receiving cavity to close the cavity opening, forming a sealed medium chamber filled with a thermally conductive medium; a temperature regulating component for adjusting the temperature of the thermally conductive medium is disposed within the pretreatment chamber corresponding to the receiving cavity; and a circulation channel extending from the receiving cavity into the interior of the thermally conductive partition and connected to a circulation drive component to guide the thermally conductive medium to form a forced circulation loop between the receiving cavity, the circulation channel, and the thermally conductive partition, flowing evenly through various areas of the thermally conductive partition.

[0005] Preferably, the circulating channel is configured as a vortex tube, which extends spirally from the center region to the edge region or from the edge region to the center region of the heat-conducting partition.

[0006] Preferably, at least two vortex tubes are provided, and the two vortex tubes are symmetrically embedded on the heat-conducting partition, and the flow direction of the heat-conducting medium in the two vortex tubes is opposite.

[0007] Preferably, the circulating flow channel is at least two symmetrically arranged serpentine tubes, with the liquid inlets of each serpentine tube symmetrically distributed on both sides or diagonally opposite the heat-conducting partition, and the liquid outlets of each serpentine tube converging in the middle region of the heat-conducting partition and communicating with the receiving cavity.

[0008] Preferably, the circulating channel is a double vortex or double serpentine guide groove that is integrally formed inside the heat-conducting partition by machining or casting.

[0009] Preferably, the shelf is connected to a plurality of limiting parts, each of which is adapted to the bottom outer contour of the container holding the biological agent, so as to precisely limit the container in a preset position.

[0010] Preferably, the limiting part includes a plurality of limiting bosses evenly distributed circumferentially around the container axis, and a gap for gas flow is reserved between adjacent limiting bosses.

[0011] Preferably, several of the limiting bosses extend downward through the shelf and the heat-conducting partition to directly contact the wall of the circulation channel.

[0012] Furthermore, the present invention also provides a method for cryo-intervention treatment of biological agents, comprising the following steps: S1: Place the container holding the biological agent on the shelf inside the pretreatment chamber. Use the temperature control component to heat or cool the heat-conducting medium in the chamber so that the entire heat-conducting medium reaches the preset pretreatment temperature.

[0013] S2: The heat transfer medium is guided by the circulation drive component and circulation channel to form a closed forced circulation loop between the containment cavity and the circulation channel embedded in the heat transfer partition, so that the heat transfer medium with uniform temperature continues to flow through each area of ​​the heat transfer partition and eliminates the temperature gradient of the heat transfer partition.

[0014] S3: Through the heat-conducting partition that is tightly and thermally bonded to the shelf, the temperature of the heat-conducting medium is evenly transferred to the entire shelf surface, so as to perform synchronous and uniform freezing treatment on the biological agents in all containers on the shelf.

[0015] Compared to existing technologies, this invention uses an insulating plate to enclose a cavity filled with a heat-conducting medium, and in conjunction with the circulating channels within the heat-conducting baffle to form forced circulation. This allows the heat-conducting medium to flow evenly through all areas of the heat-conducting baffle. Combined with the temperature control component to regulate the temperature of the heat-conducting medium, the overall temperature of the shelf is made uniform, avoiding temperature gradients on the shelf. This ensures that multiple biological agents placed on the shelf receive consistent pretreatment temperature conditions, preventing damage to the activity of some biological agents or substandard pretreatment results due to uneven temperature. This effectively improves the stability and product qualification rate of the frozen biological agent treatment. Attached Figure Description

[0016] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0017] Figure 1 This is a schematic diagram of the structure of the present invention.

[0018] Figure 2 This is a schematic diagram of the structure inside the pretreatment box of the present invention.

[0019] Figure 3 This is a schematic diagram of the structure of the receiving cavity of the present invention.

[0020] Figure 4 This is a schematic diagram of the limiting boss of the present invention.

[0021] Figure 5 This is a schematic diagram of the structure of the heat-conducting partition of the present invention.

[0022] Figure 6 This is a schematic diagram of the vortex tube structure of the present invention.

[0023] Figure 7 This is a schematic diagram of the serpentine tube structure of the present invention.

[0024] Figure 8 This is a schematic diagram of the structure of the drive gear of the present invention.

[0025] Figure 9 This is the present invention. Figure 8 Enlarged view of point A in the middle.

[0026] In the diagram, 1 is the pretreatment box; 10 is the shelf; 2 is the pretreatment mechanism; 20 is the heat-conducting partition; 21 is the insulation plate; 210 is the receiving cavity; 22 is the circulation channel; 220 is the circulation pipe; 2200 is the vortex tube; 2201 is the serpentine tube; 23 is the limiting part; 230 is the limiting boss; 24 is the mounting plate; 240 is the sealing plate; 241 is the exhaust fan blade; 242 is the air duct; 243 is the air duct pipe; 244 is the driven shaft; 245 is the driven gear; 246 is the drive gear ring; 247 is the drive gear; 25 is the exhaust pipe; and 26 is the connecting frame. Detailed Implementation

[0027] The following is in conjunction with the appendix Figure 1 To be continued Figure 9 The embodiments of the present invention will be described in detail below.

[0028] This application discloses a biological agent cryotreatment apparatus and method to solve the problem that the existing technology, which usually uses overall temperature control, is prone to causing significant temperature gradients due to uneven temperature fields within the equipment, affecting the consistency of pretreatment between batches of biological agents.

[0029] Example 1: Refer to Figures 1 to 3As shown, the biological agent cryotreatment device includes a pretreatment box 1 and a shelf 10 disposed inside the pretreatment box 1. The pretreatment box 1 has an upper opening, and a cover plate is detachably fitted to the opening to ensure overall sealing during use. A pretreatment mechanism 2 is limited inside the pretreatment box 1. The pretreatment mechanism 2 includes a heat-conducting partition 20 located below and in contact with the shelf 10. The outer circumferential surfaces of the shelf 10 and the heat-conducting partition 20 are fitted with a heat-insulating plate 21 that is in contact with and sealed to the inner wall of the pretreatment box 1. The middle part of the heat-insulating plate 21 is recessed downward to form a receiving cavity 210. The shelf 10 and the heat-conducting partition 20 are stacked sequentially on the upper side of the receiving cavity 210 to close the opening of the receiving cavity 210, forming a sealed medium chamber. The heat-conducting medium (such as silicone oil) is filled into the shelf 10. Temperature regulating components are respectively provided on both sides of the heat insulation plate 21 corresponding to the receiving cavity 210. At least part of the circulation channel 22 is provided inside the heat-conducting partition 20. The circulation channel 22 is connected to the circulation drive component fixed in the receiving cavity 210 so as to guide the heat-conducting medium to form a forced circulation loop between the receiving cavity 210, the circulation channel 22 and the heat-conducting partition 20, and flow evenly through each area of ​​the heat-conducting partition 20. The temperature regulating component performs temperature rise / fall treatment on the heat-conducting medium, and the temperature is evenly transferred to the heat-conducting partition 20 and the shelf 10 through the heat-conducting medium, reducing the temperature gradient and making the temperature of the biological agent placed on the shelf 10 consistent, thus improving the uniformity of the cryo-intervention treatment.

[0030] Optionally, the temperature control component uses a heat transfer oil circulation heater and a refrigeration compressor fixed at the bottom of the pretreatment tank 1 as the heat source and cold source for regulating the heat transfer medium in the containment cavity 210, respectively. The heat transfer oil circulation heater and the refrigeration compressor are respectively connected to heat transfer pipes that extend into the containment cavity 210. By adjusting the flow rate of the heated or cooled heat transfer oil in the heat transfer pipes, the overall temperature of the heat transfer medium in the containment cavity 210 can be stably controlled. This is conventional prior art and will not be described in detail.

[0031] Furthermore, the circulation drive component adopts a conventional circulation pump (not shown in the figure), the circulation channel 22 adopts a circulation pipe 220, the circulation pump is fixed on the heat insulation plate 21 and immersed in the heat-conducting medium in the receiving cavity 210, the liquid inlet of the circulation pump is directly connected to the receiving cavity 210, and the liquid outlet is connected to the liquid inlet of the circulation pipe 220. The heat-conducting medium in the containment cavity 210 is introduced from the inlet of the circulation pipe 220 through the outlet of the circulation pump and flows along the circulation pipe 220. Finally, it is discharged into the containment cavity 210 through the outlet of the circulation pipe 220. This guides the heat-conducting medium to circulate between the containment cavity 210 and the heat-conducting partition 20, promoting the uniform mixing of the heat-conducting medium in the containment cavity 210 and the heat-conducting partition 20. This avoids temperature differences in different areas of the heat-conducting medium and further improves the uniformity of temperature transfer. At the same time, it transfers the heat of the heat-conducting medium in the containment cavity 210 to the heat-conducting partition 20, accelerating the response speed of temperature rise and fall of various biological agents on the shelf 10. This allows the shelf 10 to be adjusted to the target treatment temperature more quickly, shortening the pretreatment waiting time.

[0032] As an optional implementation method, refer to Figures 4 to 6 As shown, when the shelf 10 and heat-conducting baffle 20 in the pretreatment box 1 are circular, the circulation pipe 220 can optionally be configured as a vortex tube 2200. The circulation pipe 220 of the vortex tube 2200 configuration is distributed in a vortex pattern along the surface of the heat-conducting baffle 20, which can cover a larger heat-conducting area, keep the temperature of each area of ​​the heat-conducting baffle 20 consistent, further reduce the temperature difference at different positions of the shelf 10, and improve the pretreatment effect.

[0033] As another alternative implementation method, refer to Figure 7 As shown, when the shelf 10 and heat-conducting baffle 20 in the pretreatment tank 1 are rectangular, the circulation channel 22 can optionally be configured as a serpentine tube 2201, and there are two of them. The liquid inlets of the two serpentine circulation tubes are symmetrically distributed on both sides or diagonally opposite sides of the heat-conducting baffle 20, and the liquid outlets of the two serpentine tubes 2201 are connected in the middle of the heat-conducting baffle 20. In this case, the circulation pump is preferably a three-way pump or two circulation pumps are used. The two liquid outlets of the circulation pump are respectively connected to the liquid inlets of the two serpentine tubes 2201, and the liquid inlet of the circulation pump is connected to the container. The heat-conducting medium in the cavity 210 is simultaneously supplied to the two serpentine tubes 2201. The heat-conducting medium flows through various areas of the heat-conducting baffle 20 along the direction of the serpentine tubes 2201, and finally flows back to the cavity 210 after converging from the middle liquid outlet. This arrangement allows the heat-conducting medium to cover the entire surface of the heat-conducting baffle 20 more evenly, further reducing the temperature difference at different positions of the heat-conducting baffle 20. At the same time, the diagonal or bilateral arrangement of the liquid inlet can offset the temperature gradient caused by liquid inlet on one side, improving the overall temperature uniformity.

[0034] Reference Figure 4 and Figure 5As shown, there are two circulating pipes 220 and two circulating pumps, which are connected to each other. The two vortex-shaped circulating pipes 220 are symmetrically embedded in the heat-conducting baffle 20. The inlet and outlet of the circulating pipe 220 are respectively connected to the outlet and inlet of one of the circulating pumps. The inlets of the two circulating pipes 220 are located at the center and edge of the heat-conducting baffle 20, respectively. After the two circulating pumps are started, the heat-conducting medium enters the two vortex circulating pipes 220 and can slowly spread across the entire surface of the heat-conducting baffle 20 along the vortex trajectory. This allows the heat-conducting medium to flow through every area of ​​the heat-conducting baffle 20, further enhancing the temperature uniformity of the heat-conducting baffle 20. At the same time, the two circulating media flow in opposite directions, which can offset the temperature difference generated by the medium flow and avoid uneven heat distribution between the edge and the center caused by unidirectional flow. This makes the temperature stability of the heat-conducting baffle 20 higher and can meet the pretreatment requirements of biological agents with higher temperature control accuracy.

[0035] Of course, as an optional implementation, the section of circulation pipe 220 passing through the heat-conducting baffle 20 can also be replaced by a vortex-shaped guide groove directly opened in the heat-conducting baffle 20, so that the two guide grooves are connected to the two circulation pipes 220 outside the heat-conducting baffle 20 to form a complete channel for the circulation of heat-conducting medium, thereby reducing the assembly process of additional pipes, reducing the overall assembly complexity of the device, and achieving the same uniform heat conduction effect.

[0036] In the pre-freezing treatment of biological agents, vials are generally used to hold the biological agents to be treated, and several vials are evenly arranged on a shelf 10. However, traditional freeze-drying shelves 10 are generally solid heat-conducting plates, relying solely on the heat conduction of the metal itself to achieve uniform temperature. This makes it difficult to precisely control the temperature deviation throughout the shelf 10, easily leading to differences in the pre-freezing effect of the agents in vials at different locations, affecting the product quality of subsequent freeze-drying. Furthermore, traditional shelves 10 mostly lack positioning and limiting structures for the vials, which can easily cause the vials to shift during pre-freezing, affecting the temperature uniformity of the biological agents in each vial. To address this issue, [the following is a proposed solution]. Figure 4 As shown, several limiting parts 23 are connected to the shelf 10. Each limiting part 23 is adapted to the bottom contour of a vial, which can stably lock and limit the vial in the preset arrangement position, prevent the vial from shaking or shifting due to external force during the pre-freezing process, ensure that all vials have the same thermal contact state with the shelf 10, and reduce the temperature difference between different vials.

[0037] As an optional implementation, in this embodiment, the limiting part 23 is composed of a plurality of limiting protrusions 230 arranged circumferentially around the axis of the vial, forming a limiting structure. A gap is reserved between adjacent limiting protrusions 230, which not only achieves circumferential limiting of the vial, but also does not completely close the contact space between the bottom of the vial and the shelf 10, thus avoiding the limiting structure from blocking the shelf 10 from transferring temperature to the vial and ensuring that the heat conduction efficiency is not affected.

[0038] Furthermore, to improve the heat exchange effect, refer to Figure 4 As shown, several limiting bosses 230 extend downward through the shelf 10 and the heat-conducting partition 20 and directly contact the circulation pipe 220 (or guide groove) inside the heat-conducting partition 20. The limiting bosses 230 themselves are made of heat-conducting metal material. The heat of the heat-conducting medium in the circulation pipe 220 can be directly and quickly transferred to the periphery of the vial through the limiting bosses 230. Combined with the heat exchange between the shelf 10 and the bottom of the vial, the temperature response speed of the biological agent in the vial is further accelerated, while the temperature difference of the biological agent in different positions inside a single vial is reduced, and the uniformity of the pre-freezing treatment is improved.

[0039] It should be noted that when the circulating flow channel 22 adopts pipes such as serpentine tube 2201 / vortex tube 2200, the pipe cross section of serpentine tube 2201 / vortex tube 2200 can be set to a rectangular chamfered tube configuration to increase the heat exchange area between the circulating flow channel 22 and the baffle and limiting boss 230 to improve the heat exchange efficiency.

[0040] Example 2: Based on Example 1, considering that the placement and number of vials containing biological agents on shelf 10 vary depending on the different needs of cryopreservation of biological agents (generally large-scale production needs and small-scale laboratory research needs), the different placement and number of vials will change the air convection state in the upper chamber of the partition inside the pretreatment box 1, thus affecting the temperature uniformity of vials in different positions. To address this issue, refer to... Figure 8 and Figure 9As shown, an airflow adjustment assembly for adjusting the air convection state inside the pretreatment box 1 is provided. Specifically, the airflow adjustment assembly includes a mounting plate 24 with an annular structure on the upper side of the shelf 10. A sealing plate 240 is detachably provided in the middle of the mounting plate 24. Several exhaust fan blades 241 are evenly installed on the mounting plate 24 circumferentially, and corresponding to the several exhaust fan blades 241, an air guide pipe 243 passes through the mounting plate 24 and is connected to the air guide port 242. A driven rotating shaft 244 is fixedly passed through the middle of the exhaust fan blades 241. In use, vials containing biological agents are placed between several adjacent limiting bosses 230, and the sealing plate 240 is sealed and fitted to the middle of the mounting plate 24. When a large number of vials need to be pre-treated, all exhaust fan blades 241 are started to rotate in the forward direction, which will drive the air in the upper chamber of the mounting plate 24 in the pre-treatment box 1 to be blown into the lower chamber of the mounting plate 24, thereby increasing the air convection at the vials on the shelf 10. At the same time, the heat exchange of the shelf 10 is carried out in conjunction with the heat-conducting partition 20 to ensure the temperature uniformity of vials at different positions on the shelf 10.

[0041] When only a small batch of vials needs to be pre-processed, the driven shaft 244 and the exhaust fan blade 241 are slowly driven to rotate in opposite directions, so that the lower chamber of the mounting plate 24 is kept in a relatively slightly negative pressure state, which weakens the air convection of vials on the shelf 10 and reduces the interference of gas flow on the temperature stability of vials at different positions. At this time, the temperature uniformity of the small batch of vials can be effectively controlled by the heat-conducting partition 20 with uniform temperature.

[0042] It should be noted that, in order to ensure the maintenance of a slight negative pressure state in the lower chamber of the mounting plate 24, it is best to also have an exhaust pipe 25 connected to the outside on the top cover of the pretreatment box 1. The exhaust pipe 25 has a one-way valve that runs from the inside to the outside, so that the process of maintaining a slight negative pressure in the pretreatment box is in line with the subsequent vacuum-induced nucleation, sublimation and drying treatment of biological agents.

[0043] Furthermore, referring to Figure 8 and Figure 9 As shown, to drive all exhaust fan blades 241 to rotate synchronously, a driven gear 245 is fixedly sleeved on the driven shaft 244. All driven gears 245 mesh with a drive gear ring 246 that is rotatably limited on the mounting plate 24. The drive gear ring 246 also meshes with a drive gear 247 that is rotatably limited on the mounting plate 24. The drive gear 247 is correspondingly assembled and connected to the output shaft of the drive motor (not shown in the figure) that is limited at the pretreatment box 1. The drive motor can be fixed on the mounting plate 24 or fixed on the cover plate of the pretreatment box 1. In use, by driving the drive gear 247 to rotate by the drive motor, the drive gear ring 246 can be rotated as a whole, thereby synchronously driving all exhaust fan blades 241 on the driven shaft 244 to rotate synchronously, which can precisely control the speed and direction of all exhaust fan blades 241.

[0044] Furthermore, referring to Figure 8 and Figure 9 As shown, to improve the performance of the exhaust fan, the air guide pipe 243 is set at an angle, and the rotation limit of the air guide pipe 243 is on the mounting plate 24. The air guide pipe 243 and the driven shaft 244 are fixedly connected by the connecting bracket 26, so that the driven shaft 244 and the exhaust fan blade 241 synchronously drive the air guide pipe 243 to continuously change the blowing / inhaling direction during rotation, guiding the air at different positions in the upper chamber of the shelf 10, thereby reducing the continuous rotation time of the exhaust fan blade 241 and achieving the effect of reducing the energy consumption of the drive motor.

[0045] Implementation 3: Based on Implementation 1 and Implementation 2, before placing vials containing biological agents on shelf 10, it is usually necessary to perform high-temperature steam sterilization inside the pretreatment chamber 1. The biological agents to be processed are then placed in the pretreatment chamber 1 after the temperature inside the pretreatment chamber 1 returns to normal. This usually takes a long time. Therefore, in this implementation, after sterilization in the pretreatment chamber 1, the exhaust fan blades 241 can be turned to guide the high-temperature air or water vapor out. Then, the temperature regulation component can be used to regulate the temperature inside the pretreatment chamber 1. At the same time, the rotation of the exhaust fan blades 241 helps the temperature inside the pretreatment chamber 1 to quickly reach the preset temperature. Compared with the traditional static cooling method, the time for the temperature to return to the normal processing range after sterilization can be significantly shortened, thereby reducing the overall time consumption of the pretreatment process and improving the overall efficiency of the frozen treatment of biological agents.

[0046] Furthermore, the present invention also provides a method for cryo-intervention treatment of biological agents, comprising the following steps: S1: Place the container holding the biological agent on the shelf 10 inside the pretreatment box 1. Use the temperature control component to heat or cool the heat-conducting medium in the containment cavity 210 so that the heat-conducting medium as a whole reaches the preset pretreatment temperature.

[0047] S2: The heat transfer medium is guided by the circulation drive component and the circulation channel 22 to form a closed forced circulation loop between the receiving cavity 210 and the circulation channel 22 embedded in the heat transfer partition 20, so that the heat transfer medium with uniform temperature continuously flows through each area of ​​the heat transfer partition 20, eliminating the temperature gradient of the heat transfer partition 20.

[0048] S3: Through the heat-conducting partition 20 that is tightly and thermally bonded to the shelf 10, the temperature of the heat-conducting medium is uniformly transferred to the entire surface of the shelf 10, so as to perform synchronous and uniform freezing treatment on the biological agents in all containers on the shelf 10.

[0049] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and not restrictive.

[0050] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A biological agent cryotreatment device, comprising a pretreatment chamber (1) and a shelf (10) disposed within the pretreatment chamber (1), characterized in that: The pretreatment box (1) is equipped with a pretreatment mechanism (2), which includes: A heat-conducting partition (20) is located on the underside of the shelf (10) and is attached to it; The insulation plate (21) is fitted on the outer periphery of the shelf (10) and the heat-conducting partition (20) and is sealed to the inner wall of the pretreatment box (1). The middle part of the insulation plate (21) is recessed downward to form a receiving cavity (210). The shelf (10) and the heat-conducting partition (20) are stacked on the upper side of the receiving cavity (210) to close the opening of the receiving cavity (210) and form a sealed medium chamber. The receiving cavity (210) is filled with heat-conducting medium. A temperature regulating component for adjusting the temperature of the heat transfer medium is provided in the corresponding receiving cavity (210) of the pretreatment box (1); The circulation channel (22) extends from the containment cavity (210) into the interior of the heat-conducting baffle (20) and is connected to the circulation drive assembly so as to guide the heat-conducting medium to form a forced circulation loop between the containment cavity (210), the circulation channel (22) and the heat-conducting baffle (20), and to flow evenly through each area of ​​the heat-conducting baffle (20).

2. The biological agent cryo-intervention processing device according to claim 1, characterized in that: The circulating flow channel (22) is configured as a vortex tube (2200), which extends spirally from the center region to the edge region or from the edge region to the center region of the heat-conducting partition (20).

3. The biological agent cryo-intervention processing device according to claim 2, characterized in that: At least two vortex tubes (2200) are provided, and the two vortex tubes (2200) are symmetrically embedded on the heat-conducting partition (20), and the flow direction of the heat-conducting medium in the two vortex tubes (2200) is opposite.

4. The biological agent cryo-intervention processing device according to claim 1, characterized in that: The circulation channel (22) consists of at least two symmetrically arranged serpentine tubes (2201). The liquid inlets of each serpentine tube (2201) are symmetrically distributed on both sides or diagonally opposite the heat-conducting baffle (20). The liquid outlets of each serpentine tube (2201) are connected to the receiving cavity (210) after converging in the middle region of the heat-conducting baffle (20).

5. The biological agent cryo-intervention processing device according to claim 1, characterized in that: The circulating channel (22) is a double vortex or double serpentine guide groove that is integrally formed inside the heat-conducting baffle (20) by machining or casting.

6. The biological agent cryo-intervention processing device according to claim 1, characterized in that: The shelf (10) is connected to a plurality of limiting parts (23), each limiting part (23) being adapted to the bottom outer contour of the container holding the biological agent, so as to precisely limit the container in a preset position.

7. The biological agent cryo-intervention processing device according to claim 6, characterized in that: The limiting part (23) includes a number of limiting bosses (230) evenly distributed around the container axis, with gaps reserved between adjacent limiting bosses (230) for gas flow.

8. The biological agent cryo-intervention processing device according to claim 7, characterized in that: Several of the limiting bosses (230) extend downward through the shelf (10) and the heat-conducting partition (20) and directly contact the wall of the circulation channel (22).

9. A cryo-intervention treatment method using the biological agent cryo-intervention treatment device as described in any one of claims 1-8, characterized in that, The preprocessing method includes the following steps: S1: Place the container containing the biological agent on the shelf (10) in the pretreatment box (1), and heat or cool the heat-conducting medium in the containment cavity (210) through the temperature adjustment component so that the heat-conducting medium as a whole reaches the preset pretreatment temperature. S2: The heat transfer medium is guided by the circulation drive component and circulation channel (22) to form a closed forced circulation loop between the containment cavity (210) and the circulation channel (22) embedded in the heat transfer partition (20), so that the heat transfer medium with uniform temperature continues to flow through each area of ​​the heat transfer partition (20) and eliminates the temperature gradient of the heat transfer partition (20). S3: The temperature of the heat-conducting medium is uniformly transferred to the entire surface of the shelf (10) through the heat-conducting partition (20) that is tightly and thermally bonded to the shelf (10), so as to perform synchronous and uniform freezing treatment on the biological agents in all containers on the shelf (10).