A synthesis hot chamber system and synthesis method for producing radioactive drugs

Abstract

The present invention designs and develops a synthesis hot chamber system and synthesis method for the production of radioactive drugs. The synthesis hot chamber system includes a shielding box, an exhaust device, a fresh air device, a laminar flow device, a drug loading device, a radioactive drawer device, an activity well device, and a non-drawer device. The synthesis method is completed in the synthesis hot chamber system. The present invention adopts a Class A laminar flow design to ensure a clean environment for the production of radioactive drugs. In order to minimize the risk of personnel contact with radioactive materials, different transfer channels are designed in this patent for the transfer of radioactive and non-radioactive materials, and they are managed in different areas. Non-radioactive materials are transferred at the front of the shielding box to facilitate personnel operation, and radioactive materials are transferred at the back of the shielding box to reduce the risk of co-operators being irradiated.

Description

Technical Field

[0001] The present invention relates to the technical field of preparation of radioactive drugs, and in particular to a synthesis hot chamber system and a synthesis method for producing radioactive drugs. Background Art

[0002] Due to its special nature, the production of radioactive drugs currently faces two major challenges: one is how to effectively ensure the cleanliness of the environment during the drug production process (including synthesis, packaging and other processes), thereby reducing the risk of drug contamination; the other is how to effectively ensure the shielding and sealing inside the hot room to reduce the risk of radiation exposure to synthesis operators.

[0003] The synthesis hot cell used in radiopharmaceutical production provides shielding, sealing, ventilation, and isolation for radiopharmaceutical synthesis, activity testing, and dilution. Currently, hot cells used to shield automated synthesis modules for positron-emitting radiopharmaceuticals generally consist of two components. First, a shielded hot cell for the synthesis module is placed within a Class C clean area. This hot cell is equipped with an air supply and exhaust system to maintain a Class C operating environment. The synthesized product is then transferred via pipelines to a subpackaging hot cell for collection and subpackaging. This subpackaging hot cell is equipped with laminar flow protection and an air supply and exhaust system to maintain a Class A collection and subpackaging environment.

[0004] For example, Chinese invention patent application CN111161899A discloses a hot chamber for radiopharmaceutical synthesis, and Chinese invention patent CN107744468B discloses an automatic packaging system and method for radioisotope liquid capsules.

[0005] As radiopharmaceutical regulations become increasingly stringent, the use of Class A laminar flow in radiopharmaceutical production is an inevitable trend. Therefore, it is urgent to develop a synthetic hot cell system that can minimize the risk of personnel exposure to radioactive materials while meeting Class A environmental requirements. Summary of the Invention

[0006] The present invention aims to provide a synthesis hot chamber system and synthesis method for the production of radioactive drugs. The system adopts a Class A laminar flow design, and different transfer channels are designed for the transfer of radioactive and non-radioactive materials. The system is managed in different zones, thereby reducing the risk of radiation exposure to synthesis operators.

[0007] The technical solution adopted in the present invention is:

[0008] A synthesis hot cell system for producing radiopharmaceuticals, the synthesis hot cell system comprising:

[0009] A shielding box, wherein the interior of the shielding box can be divided into an upper installation area, a synthesis area, and a lower installation area from top to bottom; an inner cavity is provided in the synthesis area, and the inner cavity is a synthesis area of ​​radioactive drugs;

[0010] A fresh air device, the fresh air device is arranged in the upper installation area;

[0011] a laminar flow device, the laminar flow device being disposed in the upper mounting area; the air inlet end of the laminar flow device being in communication with the air outlet end of the fresh air device; and the air outlet end of the laminar flow device being in communication with the top inner area of ​​the inner cavity;

[0012] a non-radioactive drawer device, the non-radioactive drawer device being disposed in the lower mounting area, adjacent to one side of the shielding box; a top surface of the non-radioactive drawer device being communicable with the inner cavity, so as to remove non-radioactive items placed into the non-radioactive drawer device from one side of the shielding box, and the inner cavity being sealed after closing the communicating area between the non-radioactive drawer device and the inner cavity;

[0013] a radioactive drawer device, the radioactive drawer device being disposed in the lower mounting area, adjacent to one side of the shielding box; the radioactive drawer device being configured to hold a lead barrel, and to connect the barrel body of the lead barrel with the inner cavity to form a seal, thereby transferring radioactive materials placed from one side of the shielding box into the inner cavity, or temporarily storing radioactive waste generated during the synthesis process;

[0014] a drug-feeding device, the drug-feeding device being arranged in the lower installation area, adjacent to one side of the shielding box;

[0015] An activity well device is vertically arranged in the lower installation area; a detection inlet end of the activity well device is located near the inner side of the bottom of the inner cavity to perform activity detection on radioactive items;

[0016] An exhaust device, wherein the air inlet end of the exhaust device is connected to the lower part of the inner cavity and the non-drawer device to form a unidirectional airflow from top to bottom in the inner cavity, maintain the pressure difference between the inner cavity and the background environment, and replace the gas in the non-drawer device.

[0017] Furthermore, the non-drawer placement device is arranged in the lower installation area, adjacent to the front face of the shielding box;

[0018] The radioactive drawer device is arranged in the lower mounting area, adjacent to the back side of the shielding box;

[0019] The radioactive drawer device and the non-radioactive drawer device are located on both sides of the shielding box in the length direction;

[0020] The medicine feeding device is arranged in the lower installation area and is located on the same side of the shielding box in the length direction as the non-drawer placement device;

[0021] The activity well device is vertically arranged in the lower installation area and is located between the non-placement drawer device and the radioactive drawer device.

[0022] Furthermore, the front of the inner cavity is provided with a matching openable shielding door; the shielding door is provided with sterile gloves, a lead glass window and a sword-type manipulator;

[0023] and / or, a first inspection door is provided on the back side of the upper installation area;

[0024] And / or, a second detection door is provided on the back side of the synthesis area;

[0025] And / or, a lighting device is provided in the inner cavity.

[0026] Furthermore, the fresh air device includes a pneumatic switch butterfly valve, a manual shutter valve, a fan, a high-efficiency filter and a static pressure box; the gas is filtered by the fresh air device and buffered in the static pressure box;

[0027] And / or, the laminar flow device includes a fan mounting housing, an EC variable frequency fan, an H14-level high-efficiency filter and a pressure differential sensor; the laminar flow device performs secondary filtration on the gas filtered by the fresh air device and stably delivers the gas into the inner cavity, and the pressure differential sensor monitors the pressure difference between the inner cavity and the background environment;

[0028] And / or, the exhaust device includes an EC variable frequency fan, an H14-level BIBO filter, a pneumatic regulating valve, a pressure relief valve, an air duct and an electric shutter regulating valve; the pressure difference between the inner cavity and the background environment is adjusted by the exhaust device.

[0029] Furthermore, the non-drawer placement device includes:

[0030] A non-discharge box body, wherein the side and top surface of the non-discharge box body facing the outside of the shielding box body are open, and the open area of ​​the top surface of the non-discharge box body is connected to the inner cavity; an openable non-discharge first sealing door and a non-discharge second sealing door are respectively provided on the open side and top surface of the non-discharge box body to seal the non-discharge box body and the inner cavity;

[0031] a non-placement drawer assembly, wherein the non-placement drawer assembly is disposed within the non-placement box;

[0032] a non-storage accommodating box, the non-storage accommodating box being suspended and placed on the non-storage drawer assembly; when the non-storage accommodating box is completely placed in the non-storage box, along the height direction of the shielding box, the projection of the non-storage accommodating box is located within the projection area of ​​the open top surface of the non-storage box;

[0033] The non-release air intake component is located below the non-release box body and has a non-release air inlet and a non-release air intake fan; the air outlet end of the non-release air intake component is connected to the non-release box body, and the filtered air replaces the air in the non-release box body, and the replaced air is discharged through the exhaust device

[0034] And / or, the radioactive drawer device comprises:

[0035] A radiation drawer assembly comprising a support base, a radiation sealing door, and a sliding base; the support base is arranged in a direction perpendicular to one side of the shielding box; the sliding base is slidably arranged on the support base and can slide back and forth along the length direction of the support base; the radiation sealing door is vertically arranged near one end of the sliding base facing the outside of the shielding box and moves synchronously with the sliding base;

[0036] A pick-and-place cover assembly is provided on the sliding base and comprises an L-shaped base, a first lifting unit, and a cantilever; the horizontal portion of the L-shaped base is slidably provided on the sliding base; the first lifting unit is provided on the vertical portion of the L-shaped base; the cantilever is connected to the upward movable end of the first lifting unit and is parallel to the length direction of the support base; the other end of the cantilever is used to hang and transfer the barrel cover of the lead barrel;

[0037] A lead bucket lifting assembly is provided near one end of the support base facing the inner side of the lower mounting area, and comprises a lifting fixed base, a second lifting unit, a sliding member, and a movable tray; the lifting fixed base is provided vertically; the sliding member is slidably provided on the lifting fixed base and is driven by the second lifting unit to slide up and down along the surface of the lifting fixed base; the movable tray is provided in a direction parallel to the support base and is connected to the sliding member;

[0038] a transfer door frame, the transfer door frame being arranged below the bottom surface of the inner cavity, and the inner area of ​​the transfer door frame being in communication with the inner cavity; when the movable tray lifts the barrel body of the lead barrel to the transfer door frame, the top end of the barrel body presses against the transfer door frame to form a seal, and the inner area of ​​the barrel body is in communication with the inner cavity;

[0039] A sealing cover lifting assembly is vertically disposed within the inner cavity and located directly above the transfer door frame; the sealing cover lifting assembly comprises a third lifting unit and a magnet; the magnet is located on the downwardly facing movable end of the third lifting unit and magnetically attracts and lifts the sealing cover of the lead barrel;

[0040] And / or, the medicine feeding device includes:

[0041] a medicine upper box body, the medicine upper box body being arranged in the lower installation area;

[0042] A fixed tray is arranged in the medicine supply box.

[0043] Furthermore, the non-drawer placement device further comprises:

[0044] A non-release lifting unit is vertically arranged below the bottom of the non-release box body corresponding to the open area on the top surface of the non-release box body, and its movable end is located inside the non-release box body; the movable end of the non-release lifting unit can cooperate with the bottom surface of the non-release accommodating box to lift the top of the non-release accommodating box to the vicinity of the open area on the top surface of the non-release box body.

[0045] Furthermore, a pneumatic door lock is provided between the non-release first sealed door and the non-release box body; a non-release lifting unit is also provided inside the non-release box body, and the two ends of the non-release lifting unit are respectively hinged to the non-release second sealed door and the inner wall of the non-release box body; the pneumatic door lock and the non-release lifting unit are controlled in linkage.

[0046] Furthermore, the activity well device includes:

[0047] an activity meter, the activity meter being vertically arranged, with a detection inlet end thereof being located near the inner side of the bottom surface of the inner cavity;

[0048] A detection lifting assembly is arranged near the activity meter, and comprises a detection fixing seat, a fourth lifting unit, an inverted L-shaped support arm, a bottle holder and a detection sealing cover; the detection fixing seat is arranged in a direction parallel to the activity meter; the fourth lifting unit is arranged along the length direction of the detection fixing seat, and its movable end is located in the inner cavity; the end of the horizontal part of the inverted L-shaped support arm is connected to the movable end of the fourth lifting unit; the bottle holder is connected to the end of the vertical part of the inverted L-shaped support arm; the detection sealing cover is arranged on the vertical part of the inverted L-shaped support arm; the movable end of the fourth lifting unit can drive the vertical part of the inverted L-shaped support arm and the radioactive items on the bottle holder to sink into the activity meter, and the activity meter is simultaneously closed by the sealing cover.

[0049] Furthermore, the activity well device further comprises:

[0050] A detection deflection assembly is provided near the lower end of the detection fixed seat, and comprises a deflection unit and a deflection member; the upper and lower ends of the fourth lifting unit are movably connected to the detection fixed seat, and the deflection member is connected to the lower end of the fourth lifting unit; the movable end of the deflection unit is hinged to the edge of the deflection member.

[0051] A method for synthesizing radiopharmaceuticals, based on the implementation of the aforementioned synthesis hot cell system for producing radiopharmaceuticals, comprises the following steps:

[0052] Step S1, radioactive materials are introduced into the inner cavity through the radioactive drawer device, non-radioactive materials are introduced into the inner cavity through the non-radioactive drawer device, and the remaining synthetic liquid raw materials are placed in the drug application device;

[0053] Step S2, assembling and connecting the synthesizer in the inner cavity, and forming a top-down unidirectional airflow in the inner cavity by cooperating with the fresh air device, the laminar flow device, and the exhaust device;

[0054] In step S3, after the radioactive material is detected by the activity well device, radioactive drugs are synthesized in a synthesizer.

[0055] The beneficial effects of the present invention are:

[0056] The present invention designs and develops a synthesis hot chamber system and synthesis method for the production of radioactive drugs. The synthesis hot chamber system includes a shielded box, an exhaust device, a fresh air device, a laminar flow device, a drug loading device, a radioactive drawer device, an activity well device, and a non-drawer device. The present invention adopts a Class A laminar flow design to ensure a clean environment for the production of radioactive drugs. To minimize the risk of personnel coming into contact with radioactive materials, this patent specifically designs different transfer channels for the transfer of radioactive and non-radioactive materials, and manages them in different zones. For example, non-radioactive materials are transferred at the front of the shielded box to facilitate personnel operation, while radioactive materials are transferred at the back of the shielded box to reduce the risk of radiation exposure to cooperating operators. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0058] Figure 1 Schematic diagram of the three-dimensional structure of the synthetic hot chamber system in the embodiment.

[0059] Figure 2 FIG. 4 is a rear view of a synthesis hot cell system in an embodiment.

[0060] Figure 3 Schematic cross-sectional view of a synthesis hot chamber system in an embodiment.

[0061] Figure 4FIG. 1 is a cross-sectional view of a synthesis area of ​​a synthesis hot cell system in an embodiment.

[0062] Figure 5 3D schematic diagram of a non-drawer device in an embodiment.

[0063] Figure 6 3D schematic diagram of a radioactive drawer in an embodiment, wherein the sealing cover lifting assembly is not shown.

[0064] Figure 7 This is a right side view of the radioactive drawer in the embodiment.

[0065] Figure 8 3D schematic diagram of an activity well device in an embodiment. DETAILED DESCRIPTION

[0066] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like to indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0067] The disclosure below provides many different embodiments or examples to realize different structures of the present invention. In order to simplify the disclosure of the present invention, the parts and settings of specific examples are described below. Of course, they are only examples, and the purpose is not to limit the present invention.

[0068] The embodiments of the invention are described in detail below with reference to the accompanying drawings.

[0069] This embodiment provides a synthesis hot chamber system for the production of radioactive drugs, which includes a shielding box 1, an exhaust device 8, a fresh air device 6, a laminar flow device 7, a drug loading device 4, a radioactive drawer device 3, an activity well device 5 and a non-dose drawer device 2.

[0070] Specifically, as attached Figures 1 to 4 As shown, the shielding box 1 has a rectangular parallelepiped structure. The thickness of the shielding layer (e.g., lead sheet, tungsten alloy, etc.) on the shielding box 1 is calculated based on factors such as the type of radiopharmaceutical and operational flexibility, achieving effective radiation shielding and protecting the safety of synthesis operators. Along the height of the shielding box 1, from top to bottom, the interior area of ​​the shielding box 1 can be divided into an upper installation area 11, a synthesis area 12, and a lower installation area 13.

[0071] The upper installation area 11 is primarily used for installing the exhaust device 8, fresh air device 6, laminar flow device 7, and other components. A first access door 111 is located on the back side of the upper installation area 11 (the side of the shielding box 1 where the operator is located is the front, also known as the front of the upper installation area 11; the other side opposite the front is the back of the shielding box 1, also known as the back of the upper installation area 11). This allows equipment maintenance personnel to open first access door 111 to perform maintenance and inspection on the exhaust device 8, fresh air device 6, laminar flow device 7, and other components within the upper installation area 11.

[0072] Synthesis area 12 primarily serves as the radiopharmaceutical synthesis operation area. Within synthesis area 12, an inner cavity 121 is located near the front of the shielding box 1. Synthesis of radiopharmaceuticals is accomplished within inner cavity 121. The volume of inner cavity 121 is determined by factors such as the size of synthesis area 12, the convenience of synthesis operations, and synthesis requirements. For example, the height of inner cavity 121 is roughly the same as that of synthesis area 12, the length of inner cavity 121 (the length direction, i.e., the length of the front of the shielding box) is roughly the same as that of synthesis area 12, and the width of inner cavity 121 (the width direction, i.e., the width of the shielding box) is approximately three-quarters of the width of the synthesis area. Thus, inner cavity 121 is embedded within synthesis area 12, leaving some space between its back and the back of the shielding box 1 for installation of other components. The top of inner cavity 121 is connected to laminar flow system 7, and the connection between inner cavity 121 and laminar flow system 7 is sealed with an inflatable sealing ring. Thus, the laminar flow system 7 can introduce unidirectional clean gas from top to bottom into the inner cavity 121, effectively controlling the particle count within the inner cavity 121 and ensuring cleanliness during the radiopharmaceutical synthesis process. A cooperating, openable shielding door 122 is located on the front of the inner cavity 121. When closed, the shielding door 122 seals the inner cavity 121. The edges of the shielding door 122 and the front edge of the inner cavity 121 are also sealed with an inflatable sealing ring. Attached to the shielding door 122 are two sterile gloves 123, a lead glass window 124, and a sword-shaped manipulator 125. The sterile gloves 123 are used by synthesis operators for manual operations within the inner cavity 121; the lead glass window 124 is used for observing the interior of the inner cavity 121; and the sword-shaped manipulator 125 is used for radioactive manipulation. A second inspection door 126 is located on the back of the synthesis area 12. This allows equipment maintenance personnel to open the second inspection door 125 to perform maintenance and inspection on components within the synthesis area 12. An air outlet is provided at the lower back of inner chamber 121 to discharge the air within. This outlet, in conjunction with laminar flow device 7, creates a top-down, unidirectional airflow within inner chamber 121, creating a Class A laminar flow environment. A lighting device is also provided within inner chamber 121, comprising a lamp, a mounting base, and radiation-proof lead glass.

[0073] The lower installation area 13 is mainly used for the installation of the drug-applying device 4, the radioactive drawer device 3, the activity well device 5 and the non-drawer device 2. Among them, the non-drawer device 2 and the drug-applying device are located on the left hand side of the synthesis operator, and the non-drawer device 2 is adjacent to the front of the lower installation area 13. The radioactive drawer device 3 is located on the right hand of the synthesis operator and is adjacent to the back of the lower installation area 13. That is, the radioactive drawer device 3 and the non-drawer device 2 are located on both sides of the length direction of the shielding box 1. The activity well device 5 is located between the non-drawer device 2 and the radioactive drawer device 3. This setting method is in line with the two-handed operation habits of most synthesis operators, and is conducive to their related synthesis, detection and other operations.

[0074] As attached Figure 4 As shown, the non-radioactive drawer device 2 is located within the lower mounting area 13, to the left of the synthesis operator. It is used to transfer non-radioactive items such as non-radioactive packaging materials and pipelines (such as pipelines, liquid bags, connectors, and other consumables) within the inner cavity 121. Synthesis operators can place and remove non-radioactive packaging materials and pipelines from the front of the shielded box 1, greatly improving convenience. The non-radioactive drawer device 2 includes a non-radioactive box 21, a non-radioactive drawer assembly 22, a non-radioactive receiving box 23, a non-radioactive air intake assembly 24, and a non-radioactive lifting unit 25. Shielding measures for the box 21, non-radioactive drawer assembly 22, non-radioactive box 23, non-radioactive air intake assembly 24, and a non-radioactive lifting unit 25 are implemented as required.

[0075] The non-radioactive box 21 is rectangular in shape, with an open front and top surface. It is equipped with an openable first sealed door 211 and a second sealed door 212, respectively. When the first sealed door 211 is closed, its outer surface is roughly flush with the front of the shielding box 1. The edges of the open area on the front of the non-radioactive box 21 are sealed with an inflatable sealing ring at the corresponding position of the first sealed door 211. Thus, a synthesis operator standing at the front of the shielding box 1, opening the first sealed door 211, and placing non-radioactive packaging materials, pipes, and other non-radioactive items into the non-radioactive box 21. The open top area of ​​the non-radioactive box 21 is connected to the inner cavity 121. The second sealed door 212 is located within the inner cavity 121. When opened, it deflects toward the interior of the inner cavity 121. When closed, its top surface is roughly flush with the inner bottom surface of the inner cavity 121. The edges of the open area on the top surface of the non-container 21 and the corresponding non-container second sealed door 212 are also sealed with an inflatable sealing ring. A pneumatic door lock 213 is also installed between the non-container first sealed door 211 and the non-container 21 to automatically lock the non-container first sealed door 211. A non-container lifting unit 214 is also installed inside the non-container 21. This lifting unit 214 can be a lead screw nut, an electric push rod, a hydraulic cylinder, or an air cylinder. Its ends are hinged to the non-container second sealed door 212 and the inner wall of the non-container 21, thereby enabling the non-container second sealed door 212 to open and close automatically. Furthermore, an interlocking mechanism is provided for the non-container first sealed door 211 and the non-container second sealed door 212, which controls the pneumatic door lock 213 and the non-container lifting unit 214 in a coordinated manner. This prevents the non-container first sealed door 211 and the non-container second sealed door 212 from opening simultaneously, thereby preventing the leakage of radioactive rays from the non-container 21.

[0076] The non-storage drawer assembly 22 is arranged in the non-storage box body 21. The non-storage drawer assembly 22 mainly consists of a plurality of guide roller groups 221, two guide members 222, a bracket 223, a handle 224, etc. The guide roller groups 221 are respectively arranged on the two opposite side walls of the non-storage box body 21. The two guide members 222 respectively pass through the guide roller groups 221 on the same side. The bracket 223 is respectively connected to the two guide members 222. The handle is connected to one end of the two guide members 222 facing the outside of the non-storage box body 21. Thus, the guide roller groups 221, the guide members 222, the bracket 223 and the handle 224 form a drawer structure. By pulling the guide members 222 toward the front opening of the non-storage box body 21, the bracket 223 can be pulled out of the non-storage box body 21.

[0077] The non-radioactive storage box 23 is suspended on the bracket 223 of the non-radioactive drawer assembly 22, and the position of the non-radioactive storage box 23 does not interfere with the position of the non-radioactive lifting unit 214. The non-radioactive storage box 23 is a storage area for non-radioactive items. As the bracket 223 is pulled out of the non-radioactive housing 21, the non-radioactive storage box 23 is also pulled out of the non-radioactive housing 21. After the bracket 223 and the non-radioactive storage box 23 are pushed into the non-radioactive housing 21, the non-radioactive first sealing door 211 is closed and operation can be carried out. When the non-radioactive storage box 23 is completely placed in the non-radioactive housing 21, the projection of the non-radioactive storage box 23 along the height direction of the shielding box 1 is located within the projection area of ​​the open top surface of the non-radioactive housing 21.

[0078] The non-release air intake assembly 24 includes a non-release air inlet 241, a non-release air intake fan 242, and a non-release exhaust duct 243. The non-release air inlet 241 is located at the bottom of the non-release box 21 and is equipped with a high-efficiency filter. The gas passes through the vents on the shielding box 1 and enters the non-release air inlet, and is then filtered. The non-release air intake fan 242 is located at the bottom of the non-release box 21, with its air inlet end connected to the non-release air inlet 241 and its air outlet end connected to the bottom of the non-release box 21. One end of the non-release exhaust duct 243 is connected to the right side wall of the non-release box 21. Thus, clean gas can be introduced into the non-release box 21 through the non-release air intake fan 242 to replace the gas in the non-release drawer device 2, thereby reducing the risk of radioactive gas leakage.

[0079] The non-radioactive lifting unit 25 is vertically mounted below the bottom of the non-radioactive housing 21, corresponding to the open top area of ​​the non-radioactive housing 21. It is a hydraulic or pneumatic cylinder. The movable end of the non-radioactive lifting unit 25 is located within the non-radioactive housing 21. It can lift the non-radioactive container 23 out of the open top area of ​​the non-radioactive housing 21, facilitating access to the non-radioactive contents. To enhance the stability of the lifting process, multiple cooperating cylindrical protrusions and through-holes are provided at the movable end of the non-radioactive lifting unit 25 and at positions corresponding to the non-radioactive container 23.

[0080] As attached Figure 6 and attached Figure 7 As shown, the radioactive material drawer device 3 is located within the lower mounting area 13, to the right of the synthesis operator, and is used for transferring radioactive materials. Because the radioactive material drawer 3 is located in the rear area of ​​the shielding box 1, away from the synthesis operator, it also reduces the wind direction of radiation exposure to the synthesis operator. The radioactive material drawer device 3 includes a radioactive material drawer assembly 31, a retrieval cover assembly 32, a lead drum lifting assembly 33, a transfer door frame 34, and a sealing cover lifting assembly 35.

[0081] The radiation drawer assembly 31 is primarily used for transferring lead barrels. It includes a support base 311, a radiation-sealed door 312, and a sliding base 313. The support base 311 is positioned approximately perpendicular to the back of the shielding box 1. The sliding base 313 is positioned at the top of the support base 311 along its length and can slide along the support base 311. For example, cooperating grooves and sliders are provided between the sliding base 313 and the support base 311. The radiation-sealed door 312 is positioned at the end of the sliding base 313 facing the outside of the shielding box 1. This ensures that the radiation-sealed door 312 and the sliding base 313 move synchronously. As the sliding base 313 moves toward the inside of the shielding box 1, the radiation-sealed door 312 gradually approaches the back of the shielding box 1 until it is approximately flush with the back of the shielding box 1, sealing the shielding box 1. To facilitate the movement of the radiation-sealed door 312, a handle is provided on the outside of the door 312.

[0082] The lift-and-place lid assembly 32 is mounted on the sliding base 313 and moves with it, lifting and adjusting the lead barrel lid 01. The lift-and-place lid assembly 32 comprises an L-shaped base 321, a first lifting unit 322, and a cantilever 323. The horizontal portion of the L-shaped base 321 is parallel to the sliding base 313, while its vertical portion is perpendicular to the sliding base 313, allowing the assembly to slide along the length of the sliding base 313. For example, rails can be provided between the horizontal portion of the L-shaped base 321 and the sliding base 313, along with a drive element such as a cylinder, to enable relative movement between the L-shaped base 321 and the sliding base 313. The first lifting unit 322 is mounted on the vertical portion of the L-shaped base 321, with its movable end facing upward. It can be a hydraulic cylinder or a pneumatic cylinder. The cantilever 323 extends along the length of the support base 311, with one end connected to the movable end of the first lifting unit 322 and the other end supported by the lead barrel lid 01.

[0083] The lead bucket lifting assembly 33 is located near one end of the support base 311, facing inward from the lower mounting area 13. It comprises a lifting base 331, a second lifting unit 332, a sliding member 333, and a movable tray 334. The lifting base 331 is positioned perpendicular to the support base 311. The sliding member 333 is located on one side of the lifting base 331 and can slide along the lifting base 331. The second lifting unit 332 provides power for the movement of the sliding member 333 and can be powered by a pneumatic motor, for example. For example, if the second lifting unit 332 is powered by a pneumatic motor, it is mounted near the lower end of the lifting base 331. The sliding member 333 is mounted on a threaded shaft connected to the pneumatic motor, with a mating guide rail disposed between the sliding member 333 and the lifting base 331. Thus, when the pneumatic motor drives the threaded shaft to rotate, the sliding member 333 is driven to move. The movable tray 334 is positioned parallel to the support base 311 and connected to the sliding member 333. Positioning slots are provided on the movable tray 334. During assembly, the lead barrel is placed on the support plate 334, and the handle of the barrel lid 01 is tilted vertically. The radial sealing door 312 is closed, and the cantilever 323 extends into the handle area of ​​the barrel lid 01. The first lifting unit 322 operates to drive the cantilever upward, lifting the barrel lid 01. Simultaneously, the L-shaped base 321 moves toward the radial sealing door 312, removing the barrel lid 01. The reverse process is followed by the closing of the barrel lid 01.

[0084] The transfer door frame 34 is located at the bottom of the inner cavity 121, corresponding to the position where the lead barrel is placed on the movable tray 334. The interior of the transfer door frame 34 is a circular passageway that fits over the top of the lead barrel. A hole is also formed at the bottom of the inner cavity 121, corresponding to the transfer door frame 34, thereby connecting the transfer door frame 34 and the inner cavity 121. Therefore, when the movable tray 334 lifts the top of the lead barrel's barrel body 02 to the transfer door frame 34 and presses it against the transfer door frame 34, a seal is formed between the barrel body 02 and the transfer door frame 34, allowing radioactive materials to enter the inner cavity 121 through the transfer door frame 34.

[0085] The sealed lid lifting assembly 35 is located within the inner chamber 121, directly above the transfer door frame 34. It comprises a third lifting unit 351 and a magnet 352. The third lifting unit 351 is vertically positioned and primarily used to lift the sealed inner lid 03 of the lead barrel. It can be a hydraulic cylinder or pneumatic cylinder. The magnet 352, located at the movable end of the third lifting unit 351, magnetically attracts the sealed inner lid 03, allowing it to be removed, exposing the radioactive material.

[0086] The drug-feeding device 4 is arranged in the lower installation area 13, near the back of the shielding box 1, and on the left hand side of the synthesizer. It is mainly used for the introduction of other synthetic liquid raw materials (including reagents) during the synthesis of radioactive drugs. The drug-feeding device 4 includes a drug-feeding box 41 and a fixed tray 42. The drug-feeding box 41 is provided with an openable door, which is roughly flush with the back of the shielding box 1 when closed. The fixed tray 42 is arranged in the drug-feeding box 41. Containers storing other raw materials or reagents are placed on the fixed tray 42, and then other raw materials or reagents are delivered to the synthesizer for synthesis through a delivery pump and pipeline connected to the synthesizer.

[0087] As attached Figure 8 As shown, the activity well device 5 is disposed in the lower mounting area 13 and located between the non-drain drawer device 2 and the radioactive drawer device 3 for detecting the activity of radioactive materials. The activity well device 5 includes an activity meter 51, a detection lifting assembly 52, and a detection deflection assembly 53.

[0088] The activity meter 51 is vertically arranged, and its detection inlet end is located near the inner side of the bottom surface of the inner cavity 121.

[0089] The detection lifting assembly 52 is arranged near the activity meter 51. The detection lifting assembly 52 includes a detection fixed seat 521, a fourth lifting unit 522, an inverted L-shaped support arm 523, a bottle holder 524 and a detection sealing cover 525. The detection fixed seat 521 is arranged roughly in a direction parallel to the activity meter 51 and is located in the lower installation area 13. The fourth lifting unit 522 is arranged along the length direction of the detection fixed seat 521, and its two ends are movably connected to the detection fixed seat 521. It can be a cylinder or a hydraulic cylinder. The movable end of the fourth lifting unit 522 is located in the inner cavity 121. One end of the horizontal part of the inverted L-shaped support arm 523 is connected to the movable end of the fourth lifting unit 522. The bottle holder 524 is connected to one end of the vertical part of the inverted L-shaped support arm 523. The detection sealing cover 525 is arranged on the vertical part of the inverted L-shaped support arm 523. When the activity of a radioactive material needs to be measured, the material is first placed on the bottle holder 524. The fourth lifting unit 522 then lowers the material into the activity meter 51 for activity measurement. When the bottle holder 524 is lowered into place, the test seal 525 seals the activity meter 51, and activity testing can then begin. After the activity measurement is complete, the fourth lifting unit 522 lifts the radioactive material out again.

[0090] The detection deflection assembly 53 is disposed within the lower mounting area 13 and connected to the detection lifting assembly 52 to deflect the position of the bottle holder 524. The detection deflection assembly 53 includes a deflection unit 531 and a deflection member 532. The deflection member 532 is connected to the lower end of the fourth lifting unit 522. The deflection unit 531 is primarily used to drive the deflection member 532 and the fourth lifting unit 522 to rotate. It can be a pneumatic cylinder or a hydraulic cylinder. The movable end of the deflection member 532 is hinged to the edge of the deflection member 532. Movement of the movable end of the deflection member 532 drives the deflection member 532 and the fourth lifting unit 522 to rotate, thereby steering the bottle holder 524 and facilitating operation by the operator.

[0091] Fresh air device 6, located within upper mounting area 11, primarily provides fresh air to inner cavity 121, displacing the gas within. Fresh air device 6 includes a pneumatically operated butterfly valve, a manual louver valve, a fan, a high-efficiency filter, and a static pressure box. Fresh air device 6 draws air from the room's air conditioning duct, filters it through the high-efficiency filter, and then delivers it to the static pressure box at the top of upper mounting area 11. Adjusting the manual louver valve and manual louver valve fine-tunes the amount of air entering through the vents in shielding box 1.

[0092] The laminar flow device 7 is arranged in the upper installation area 11, and the gas inlet is connected to the static pressure box of the fresh air device, and the gas outlet is connected to the inner area of ​​the top of the inner cavity 121. The laminar flow device 7 includes a fan installation shell, an EC variable frequency fan, an H14-level high-efficiency filter and a pressure difference sensor. The EC variable frequency fan is arranged in the fan installation shell. The pressure difference sensor is arranged in the inner cavity 121. The EC variable frequency fan extracts the gas from the static pressure box, and performs secondary filtration through the H14-level high-efficiency filter to ensure that the Class A particle standard is met, and then it is sent into the inner cavity 121. The laminar flow device 7 will provide the inner cavity 121 with a stable airflow with a wind speed of 0.45m / s±20%.

[0093] The exhaust device 8 is located within the upper mounting area 11. It is connected to the air outlet of the inner chamber 121 and the exhaust duct 243 of the non-inlet air assembly 24. The exhaust device 8 includes an EC variable frequency blower, an H14-grade BIBO filter, a pneumatic control valve, a pressure relief valve, an air duct, and an electric louver control valve. The EC variable frequency blower is connected to the inner chamber 121 and the exhaust duct 243 via the air duct. The H14-grade BIBO filter, the pneumatic control valve, and the electric louver control valve are positioned sequentially in the direction of the EC variable frequency blower's air outlet, filtering the exhaust gas and regulating the discharge volume. The main function of the exhaust device 8 is to control the pressure differential between the inner chamber 121 and the ambient environment, which can be adjusted by adjusting the opening of the electric louver control valve. The pressure relief pneumatic control valve is used to prevent excessive pressure in the hot chamber during the bio-decontamination process, providing real-time fine-tuning of the pressure relief valve to maintain the pressure within the inner chamber 121.

[0094] It should be noted that the relative positions of the drug-applying device 4, the radioactive drawer device 3, the activity well device 5, and the non-drawer device 2 in the aforementioned embodiment can also be adjusted. For example, the radioactive drawer device 3 and the non-drawer device 2 are located near opposite sides of the shielding box 1, and the drug-applying device 4 is located near the front of the screen box 1. Alternatively, the radioactive drawer device 3 and the non-drawer device 2 are located on a side other than the front and back of the shielding box 1, and the drug-applying device 4 and the activity well device 5 are located near the front of the shielding box 1. Since the drug-applying device 4, the radioactive drawer device 3, the activity well device 5, and the non-drawer device 2 are still located as a whole within the shielding box 1, the safety of the synthesis operator can also be ensured.

[0095] When the synthesis hot cell system in this embodiment is used to synthesize radiopharmaceuticals, the general process is as follows:

[0096] 1. First, non-radioactive items such as the synthesizer tubing kit and diluent bag are introduced into the inner cavity 121 through the front non-placement drawer device 2;

[0097] 2. Install the pipelines on the synthesizer through the sterile gloves 123 on the shield door 122 of the synthesis hot chamber system;

[0098] 3. The radioactive material is introduced into the inner cavity 121 through the radioactive drawer device 3 at the back, and the raw material liquid bottle is taken out from the lead barrel using the sterile gloves 123; the remaining synthetic liquid raw materials are placed on the fixed tray 42 inside the drug application device 4;

[0099] 4. Place the radioactive material on the bottle holder 524 and then sink it into the activity meter 51 to measure the activity;

[0100] 5. Use sterile gloves 123 to hang the diluent on the side wall of the inner cavity 121 and connect the pipes between the diluent bag, the item bottle and the synthesizer;

[0101] 6. The synthesizer automatically completes the synthesis of the liquid medicine;

[0102] 7. After the liquid medicine is synthesized, it is transferred out through the subsequent capillary line;

[0103] 8. Throw radioactive waste such as synthesizer pipelines, diluent bags, raw material liquid bottles into the solid waste lead barrel and transfer them out from the back of the shielding box 1 through the radioactive drawer device 3.

[0104] The synthesis hot cell system in this embodiment uses a Class A laminar flow design to ensure a clean environment for radiopharmaceutical production. To minimize the risk of human contact with radioactive materials, the synthesis hot cell system has separate transfer channels designed for radioactive and non-radioactive materials, and these channels are managed separately. Non-radioactive materials are transferred through the front of the shielded enclosure for easy operation, while radioactive materials are transferred through the back of the enclosure, reducing the risk of radiation exposure to cooperating operators.

Claims

1. A synthetic hot cell system for the production of radiopharmaceuticals, characterized in that: The synthesis hot chamber system comprises: A shielding box, wherein the interior of the shielding box can be divided into an upper installation area, a synthesis area, and a lower installation area from top to bottom; an inner cavity is provided in the synthesis area, and the inner cavity is a synthesis area of ​​radioactive drugs; A fresh air device, the fresh air device is arranged in the upper installation area; a laminar flow device, the laminar flow device being disposed in the upper mounting area; the air inlet end of the laminar flow device being in communication with the air outlet end of the fresh air device; and the air outlet end of the laminar flow device being in communication with the top inner area of ​​the inner cavity; a non-radioactive drawer device, the non-radioactive drawer device being disposed in the lower mounting area, adjacent to one side of the shielding box; a top surface of the non-radioactive drawer device being communicable with the inner cavity, so as to remove non-radioactive items placed into the non-radioactive drawer device from one side of the shielding box, and the inner cavity being sealed after closing the communicating area between the non-radioactive drawer device and the inner cavity; a radioactive drawer device, the radioactive drawer device being disposed in the lower mounting area, adjacent to one side of the shielding box; the radioactive drawer device being configured to hold a lead barrel, and to connect the barrel body of the lead barrel with the inner cavity to form a seal, thereby transferring radioactive materials placed from one side of the shielding box into the inner cavity, or temporarily storing radioactive waste generated during the synthesis process; a drug-feeding device, the drug-feeding device being arranged in the lower installation area, adjacent to one side of the shielding box; An activity well device is vertically arranged in the lower installation area; a detection inlet end of the activity well device is located near the inner side of the bottom of the inner cavity to perform activity detection on radioactive items; an exhaust device, wherein an air inlet end of the exhaust device is in communication with the lower portion of the inner cavity and the non-drawer device, so as to form a unidirectional airflow from top to bottom in the inner cavity, maintain a pressure difference between the inner cavity and the background environment, and replace the gas in the non-drawer device; wherein the non-drawer placement device is arranged in the lower installation area, adjacent to the front face of the shielding box; The radioactive drawer device is arranged in the lower mounting area, adjacent to the back side of the shielding box; The radioactive drawer device and the non-radioactive drawer device are located on both sides of the shielding box in the length direction; The medicine feeding device is arranged in the lower installation area and is located on the same side of the shielding box in the length direction as the non-drawer placement device; The activity well device is vertically arranged in the lower installation area and is located between the non-placement drawer device and the radioactive drawer device.

2. The synthetic hot cell system for radiopharmaceutical production according to claim 1, characterized in that: The front of the inner cavity is provided with a matching openable shielding door; the shielding door is provided with sterile gloves, a lead glass window and a sword-type manipulator; and / or, a first inspection door is provided on the back side of the upper installation area; And / or, a second detection door is provided on the back side of the synthesis area; And / or, a lighting device is provided in the inner cavity.

3. The synthetic hot cell system for radiopharmaceutical production according to claim 1, characterized in that: The fresh air device includes a pneumatic switch butterfly valve, a manual shutter valve, a fan, a high-efficiency filter and a static pressure box; the gas is filtered by the fresh air device and buffered in the static pressure box; And / or, the laminar flow device includes a fan mounting housing, an EC variable frequency fan, an H14-level high-efficiency filter and a pressure differential sensor; the laminar flow device performs secondary filtration on the gas filtered by the fresh air device and stably delivers the gas into the inner cavity, and the pressure differential sensor monitors the pressure difference between the inner cavity and the background environment; And / or, the exhaust device includes an EC variable frequency fan, an H14-level BIBO filter, a pneumatic regulating valve, a pressure relief valve, an air duct and an electric shutter regulating valve; the pressure difference between the inner cavity and the background environment is adjusted by the exhaust device.

4. The synthetic hot cell system for radiopharmaceutical production according to claim 1, characterized in that: The non-drawer placement device comprises: A non-discharge box body, wherein the side and top surface of the non-discharge box body facing the outside of the shielding box body are open, and the open area of ​​the top surface of the non-discharge box body is connected to the inner cavity; an openable non-discharge first sealing door and a non-discharge second sealing door are respectively provided on the open side and top surface of the non-discharge box body to seal the non-discharge box body and the inner cavity; a non-placement drawer assembly, wherein the non-placement drawer assembly is disposed within the non-placement box; a non-storage accommodating box, the non-storage accommodating box being suspended and placed on the non-storage drawer assembly; when the non-storage accommodating box is completely placed in the non-storage box, along the height direction of the shielding box, the projection of the non-storage accommodating box is located within the projection area of ​​the open top surface of the non-storage box; The non-release air intake component is located below the non-release box body and has a non-release air inlet and a non-release air intake fan; the air outlet end of the non-release air intake component is connected to the non-release box body, and the filtered air replaces the air in the non-release box body, and the replaced air is discharged through the exhaust device And / or, the radioactive drawer device comprises: A radiation drawer assembly comprising a support base, a radiation sealing door, and a sliding base; the support base is arranged perpendicular to the back surface of the shielding box; the sliding base is slidably arranged on the support base and can slide back and forth along the length direction of the support base; the radiation sealing door is vertically arranged near one end of the sliding base facing the outside of the shielding box and moves synchronously with the sliding base; A pick-and-place cover assembly is provided on the sliding base and comprises an L-shaped base, a first lifting unit, and a cantilever; the horizontal portion of the L-shaped base is slidably provided on the sliding base; the first lifting unit is provided on the vertical portion of the L-shaped base; the cantilever is connected to the upward movable end of the first lifting unit and is parallel to the length direction of the support base; the other end of the cantilever is used to hang and transfer the barrel cover of the lead barrel; A lead bucket lifting assembly is provided near one end of the support base facing the inner side of the lower mounting area, and comprises a lifting fixed base, a second lifting unit, a sliding member, and a movable tray; the lifting fixed base is provided vertically; the sliding member is slidably provided on the lifting fixed base and is driven by the second lifting unit to slide up and down along the surface of the lifting fixed base; the movable tray is provided in a direction parallel to the support base and is connected to the sliding member; a transfer door frame, the transfer door frame being arranged below the bottom surface of the inner cavity, and the inner area of ​​the transfer door frame being in communication with the inner cavity; when the movable tray lifts the barrel body of the lead barrel to the transfer door frame, the top end of the barrel body presses against the transfer door frame to form a seal, and the inner area of ​​the barrel body is in communication with the inner cavity; A sealing cover lifting assembly is vertically disposed within the inner cavity and located directly above the transfer door frame; the sealing cover lifting assembly comprises a third lifting unit and a magnet; the magnet is located on the downwardly facing movable end of the third lifting unit and magnetically attracts and lifts the sealing cover of the lead barrel; And / or, the medicine feeding device includes: a medicine upper box body, the medicine upper box body being arranged in the lower installation area; A fixed tray is arranged in the medicine supply box.

5. The synthetic hot cell system for radiopharmaceutical production according to claim 4, characterized in that: The non-drawer device further comprises: A non-release lifting unit is vertically arranged below the bottom of the non-release box body corresponding to the open area on the top surface of the non-release box body, and its movable end is located inside the non-release box body; the movable end of the non-release lifting unit can cooperate with the bottom surface of the non-release accommodating box to lift the top of the non-release accommodating box to the vicinity of the open area on the top surface of the non-release box body.

6. The synthetic hot cell system for radiopharmaceutical production according to claim 4 or 5, characterized in that: A pneumatic door lock is provided between the non-release first sealed door and the non-release box body; a non-release lifting unit is also provided inside the non-release box body, and the two ends of the non-release lifting unit are respectively hinged to the non-release second sealed door and the inner wall of the non-release box body; the pneumatic door lock and the non-release lifting unit are controlled in linkage.

7. The synthetic hot cell system for radiopharmaceutical production according to claim 1, characterized in that: The activity well device comprises: an activity meter, the activity meter being vertically arranged, with a detection inlet end thereof being located near the inner side of the bottom surface of the inner cavity; A detection lifting assembly is arranged near the activity meter, and comprises a detection fixing seat, a fourth lifting unit, an inverted L-shaped support arm, a bottle holder and a detection sealing cover; the detection fixing seat is arranged in a direction parallel to the activity meter; the fourth lifting unit is arranged along the length direction of the detection fixing seat, and its movable end is located in the inner cavity; the end of the horizontal part of the inverted L-shaped support arm is connected to the movable end of the fourth lifting unit; the bottle holder is connected to the end of the vertical part of the inverted L-shaped support arm; the detection sealing cover is arranged on the vertical part of the inverted L-shaped support arm; the movable end of the fourth lifting unit can drive the vertical part of the inverted L-shaped support arm and the radioactive items on the bottle holder to sink into the activity meter, and the activity meter is simultaneously closed by the sealing cover.

8. The synthetic hot cell system for radiopharmaceutical production according to claim 7, characterized in that: The activity well device also includes: A detection deflection assembly is provided near the lower end of the detection fixed seat, and comprises a deflection unit and a deflection member; the upper and lower ends of the fourth lifting unit are movably connected to the detection fixed seat, and the deflection member is connected to the lower end of the fourth lifting unit; the movable end of the deflection unit is hinged to the edge of the deflection member.

9. A method for synthesizing a radiopharmaceutical, characterized in that: The synthesis method is based on the implementation of the synthesis hot cell system for producing radiopharmaceuticals according to any one of claims 1 to 8, comprising the following steps: Step S1, radioactive materials are introduced into the inner cavity through the radioactive drawer device, non-radioactive materials are introduced into the inner cavity through the non-radioactive drawer device, and the remaining synthetic liquid raw materials are placed in the drug application device; Step S2, assembling and connecting the synthesizer in the inner cavity, and forming a top-down unidirectional airflow in the inner cavity by cooperating with the fresh air device, the laminar flow device, and the exhaust device; In step S3, after the radioactive material is detected by the activity well device, radioactive drugs are synthesized in a synthesizer.

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