Production line and production method of radioactive liquid medicine

Abstract

The embodiment of the invention provides a production line and method for radioactive liquid medicine, the production line comprises a receiving hot chamber, a dilution hot chamber and a split charging hot chamber, and an uncovering mechanism for opening a raw material bottle and a first manipulator for transferring the raw material bottle to a first transfer channel are arranged in the receiving hot chamber; a second manipulator and a dilution assembly are arranged in the dilution hot chamber, and the second manipulator transfers the raw material bottles into the dilution hot chamber; the diluting assembly is used for diluting raw materials in the raw material bottle to obtain a diluent; a split charging station used for split charging of diluent is arranged in the split charging hot chamber, and the split charging station is communicated with the dilution assembly through a capillary pipeline. Corresponding devices are arranged in a plurality of hot chambers with different functions, introduction, dilution, sampling, split charging and discharging of radiopharmaceuticals are achieved, the whole production process is carried out under protection of the high-protection hot chambers, dependence on production personnel is reduced, and therefore consistency of production efficiency and product quality is guaranteed, and personnel burden and risks are reduced.

Description

TECHNICAL FIELD

[0001] Embodiments of the present application relate to the field of production of radiopharmaceuticals, and in particular to a production line and a production method of a radiopharmaceutical production line. BACKGROUND

[0002] Iodine-131 oral solution is a liquid drug containing radioisotope iodine-131, which destroys thyroid tissue or cancer cells by releasing beta rays to achieve the treatment of hyperthyroidism (hyperthyroidism) and thyroid cancer. However, iodine-131 as a volatile radionuclide, its production process is complex, and the production environment needs to realize airtight, clean and anti-radiation function. At present, there is a lack of perfect production process and mature high-automation equipment in the production of iodine-131 in China, and more relies on manual operation through a simple protective hot cell, which not only has low production efficiency, but also brings great labor intensity and radiation risk to the personnel, and may also cause product quality fluctuation due to the poor consistency of manual operation. SUMMARY

[0003] Embodiments of the present application provide a production line and a production method of a radiopharmaceutical production line, aiming to improve the problems of low production efficiency, heavy burden on personnel, high risk and difficult to guarantee the consistency of product quality in manual production of iodine-131 oral solution.

[0004] Specifically, the present application provides a radiopharmaceutical production line, comprising a receiving hot cell, a dilution hot cell and a sub-packaging hot cell, the receiving hot cell and the dilution hot cell are communicated through a first transfer channel;

[0005] The receiving hot cell is used for receiving a raw material bottle containing radioactive raw materials; the receiving hot cell is provided with an uncapping mechanism for opening the raw material bottle and a first mechanical hand for transferring the raw material bottle to the first transfer channel;

[0006] The dilution hot cell is provided with a second mechanical hand and a dilution assembly, the second mechanical hand is used for transferring the raw material bottle to the dilution hot cell; the dilution assembly is used for diluting the raw materials in the raw material bottle to obtain a dilution liquid;

[0007] The sub-packaging hot cell is provided with a sub-packaging station for sub-packaging the dilution liquid, the sub-packaging station is communicated with the dilution assembly through a capillary pipeline.

[0008] Optionally, the radiopharmaceutical production line further comprises a transfer assembly, the transfer assembly is used for transferring the raw material bottle from a warehouse to the receiving hot cell;

[0009] The transfer assembly comprises a cart, the first shielding container is arranged on the cart, and the raw material bottle is placed in the first shielding container.

[0010] Optionally, the bottom of the receiving hot chamber is provided with a raw material inlet; and the receiving hot chamber is further provided with a third mechanical arm for transferring the shielding container into the receiving hot chamber.

[0011] Optionally, the dilution hot chamber is further provided with a detection system for detecting the concentration of radioactive raw material in the raw material bottle and calculating the required amount of dilution solution.

[0012] Optionally, the dilution hot chamber is further provided with a dilution sampling bottle for testing the dilution effect of the dilution solution; and the dilution assembly is further configured to inject dilution solution into the dilution sampling bottle.

[0013] Optionally, the radioactive liquid medicine production line further comprises a preparation hot chamber in communication with the dispensing hot chamber through a third transfer channel, for providing product medicine bottles to the dispensing hot chamber.

[0014] Optionally, the radioactive liquid medicine production line further comprises an outfeed system comprising a supply device, a robotic system and a transfer device, the supply device and the transfer device being spaced apart, and the robotic system being disposed between the supply device and the transfer device.

[0015] The bottom of the dispensing hot chamber is provided with an outfeed opening; and an outfeed platform is installed on the side of the dispensing hot chamber close to the robotic system, the outfeed platform being provided with a rotatable rotary guide rail, and the rotary guide rail being provided with a base.

[0016] The supply device is used for carrying a second shielding container, the robotic system is used for transferring the second shielding container to the base, and for transferring the second shielding container with the product medicine bottle on the base to the transfer device; when the base is rotated to a position where the second shielding container is located below the outfeed opening, the product medicine bottle falls into the second shielding container.

[0017] The present application further provides a production method of radioactive liquid medicine, which adopts the radioactive liquid medicine production line according to any one of the above.

[0018] A raw material bottle containing radioactive raw material is sent into the receiving hot chamber, and the raw material bottle is opened by an uncapping mechanism;

[0019] The uncapped raw material bottle is sent into the dilution hot chamber, and the detection system detects the concentration of radioactive raw material in the raw material bottle and calculates the required amount of dilution solution;

[0020] The raw material bottle is transferred to the dilution assembly for dilution to obtain dilution solution; and the dilution solution is sent to the dispensing station for dispensing to obtain a product.

[0021] Optionally, after obtaining the diluent, part of the diluent is injected into a sampling bottle to test the dilution effect; if the test is qualified, the diluent is sent to a dispensing station for dispensing.

[0022] Optionally, after obtaining the product, the product is discharged after being loaded into a second shielding container.

[0023] The beneficial effects of the present application are:

[0024] The production line of radioactive liquid medicine provided by the present application is applied to send a raw material bottle containing radioactive raw materials into a receiving hot chamber, open the raw material bottle by an opening mechanism, and then transfer the opened raw material bottle into the first transfer channel by a first mechanical arm. A second mechanical arm in the dilution hot chamber transfers the raw material bottle from the first transfer channel to the dilution hot chamber for dilution to obtain a diluent. The diluent enters a dispensing station in the dispensing hot chamber through a capillary channel for dispensing to obtain a product. That is, the present application sets multiple hot chambers with different functions and sequentially connected, and sets corresponding devices in the hot chambers to realize the transfer, dilution, sampling, dispensing, and discharging of radioactive medicine. The whole production process is carried out in the protection of high protection hot chamber, reducing the dependence on production personnel, thus ensuring the consistency of production efficiency and product quality, and reducing the burden and risk of personnel. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is a schematic structural diagram of the production line of radioactive liquid medicine provided by an embodiment of the present application;

[0026] Figure 2 is a schematic structural diagram of the transfer assembly in the production line provided by an embodiment of the present application.

[0027] REFERENCE SIGNS:

[0028] 1. Transfer assembly, 101. Trolley, 102. First shielded container, 103. Raw material bottle, 2. Receiving hot chamber, 201. Raw material inlet, 202. Cap opening mechanism, 203. Third robot, 204. Material transfer inlet, 205. First robot, 206. First transfer channel, 207. Dilution sampling bottle, 3. Dilution hot chamber, 301. Dilution assembly, 302. First solid waste collection system, 303. Second robot, 304. Fourth robot, 305. Detection system, 306. Second transfer channel, 307. Capillary tube, 308. Waste liquid collection system, 309. First discharge tube, 4. Sub-packing hot chamber, 401. Sub-packing station, 402. Second solid waste collection system, 403. Detection system, 404. Robot, 405. Fifth robot, 406. Sixth robot, 407. Third transfer channel, 408. Discharge outlet, 409. Discharge platform, 410. Rotary guide rail, 411. Base, 412. Second discharge tube, 5. Preparation hot chamber, 501. Tray, 50101. Product vial, 502. Third solid waste collection system, 6. Discharge system, 601. Supply device, 60101. Second shielded container, 602. Robot system, 603. Transfer device. DETAILED DESCRIPTION

[0029] In order to make the technical problems solved by the present application, the technical solutions and beneficial effects clearer, the present application will be further described in detail below with reference to the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and not used to limit the present application.

[0030] In the description of the present application, it should be understood that the terms "longitudinal", "radial", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only used to facilitate the description of the present application and simplify the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In the description of the present application, unless otherwise specified, the meaning of "a plurality of" is two or more.

[0031] In the description of the present application, it should be noted that unless otherwise specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication between the two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0032] Figure 1 is a schematic structural diagram of a production line of radioactive liquid medicine provided by an embodiment of the present application. As shown in Figure 1 and with reference to Figure 2 , the production line of radioactive liquid medicine provided by the embodiment of the present application comprises a receiving hot cell 2, a dilution hot cell 3 and a dispensing hot cell 4, the receiving hot cell 2 is communicated with the dilution hot cell 3 through a first transfer channel 206; the receiving hot cell 2 is used for receiving a raw material bottle 103 containing radioactive raw material; the receiving hot cell 2 is provided with an uncapping mechanism 202 used for uncapping the raw material bottle 103 and a first mechanical arm 205 used for transferring the raw material bottle 103 to the first transfer channel 206; the dilution hot cell 3 is provided with a second mechanical arm 303 and a dilution assembly 301, the second mechanical arm 303 is used for transferring the raw material bottle 103 to the dilution hot cell 3; the dilution assembly 301 is used for diluting the raw material in the raw material bottle 103 to obtain a dilution liquid; the dispensing hot cell 4 is provided with a dispensing station 401 used for dispensing the dilution liquid, the dispensing station 401 is communicated with the dilution assembly 301 through a capillary pipe 307.

[0033] It should be noted that the hot cell is a facility specially used for processing radioactive substances, which has the characteristics of shielding, sealing, ventilation and isolation; the receiving hot cell 2, the dilution hot cell 3, the dispensing hot cell 4 and the preparation hot cell 5 in the following text in the embodiment are the hot cells named according to their roles in the production line.

[0034] In the embodiment, by setting a plurality of hot cells with different functions and sequentially communicated, and setting corresponding devices in the hot cells, the entering, dilution, sampling, dispensing and discharging of the radioactive medicine are realized, the whole production process is carried out under the protection of the high protection hot cell, the dependence on the production personnel is reduced, thus the consistency of the production efficiency and the product quality is ensured, and the personnel burden and risk are reduced.

[0035] In application, the raw material bottle 103 containing radioactive raw material is sent into the receiving hot cell 2, the raw material bottle 103 is opened by the uncapping mechanism 202, and then the uncapped raw material bottle 103 is transferred to the first transfer channel 206 by the first mechanical arm 205. The second mechanical arm 303 in the dilution hot cell 3 transfers the raw material bottle 103 from the first transfer channel 206 to the dilution hot cell 3 for dilution, to obtain a dilution liquid. The dilution liquid enters the dispensing station 401 in the dispensing hot cell 4 through the capillary pipe 307 for dispensing, to obtain a product.

[0036] As shown in Figure 2As shown, in an embodiment of the present application, the radioactive liquid medicine production line further comprises a transfer assembly 1 for transferring the raw material bottle from the warehouse to the receiving hot cell 2. The transfer assembly 1 comprises a trolley 101, and a first shielding container 102 is arranged on the trolley 101, and the raw material bottle 103 is placed in the first shielding container 102. Specifically, the trolley 101 is provided with a lifting frame, and the first shielding container 102 is placed on the lifting frame. Further, the bottom of the receiving hot cell 2 is provided with a raw material inlet 201, and the receiving hot cell 2 is further provided with a third mechanical hand 203 for transferring the shielding container 102 into the receiving hot cell 2. Iodine-131 is stored in the raw material bottle 103, and in order to avoid the harm of the beta rays of iodine-131, the raw material bottle 103 needs to be placed in the first shielding container 102.

[0037] In application, the first shielding container 102 is taken out by the trolley 101 which can be moved and is placed on the lifting frame. Then the trolley 101 is pushed into the receiving hot cell 2, and the first shielding container 102 is lifted to the raw material inlet 201 through the lifting frame. The first shielding container 102 is transferred into the receiving hot cell 2 by the third mechanical hand 203 and the first mechanical hand 205 controlled by manual or automatic system, and the raw material bottle 103 is taken out from the first shielding container 102. Then the raw material bottle 103 is placed on the uncapping mechanism 202 by the first mechanical hand 205, the cap of the raw material bottle 103 is opened, and the uncapped raw material bottle 103 is placed in the first transfer channel 206 by the first mechanical hand 205.

[0038] In an embodiment of the present application, the dilution hot cell 3 is further provided with a detection system 305 for detecting the concentration of the radioactive raw material (iodine-131) in the raw material bottle 103 and calculating the amount of the required dilution solution. Further, the dilution hot cell 3 is further provided with a dilution sampling bottle 207 for testing the dilution effect of the dilution solution, and the dilution assembly 301 is further configured to inject the dilution solution into the dilution sampling bottle 207. In addition, the bottom of the receiving hot cell 2 is further provided with a material inlet 204 which is a channel for transferring the dilution sampling bottle 207. The dispensing hot cell 4 and the dilution hot cell 3 are communicated through a second transfer channel 306.

[0039] In production, a plurality of dilution sample bottles 207 are manually or mechanically transferred into the receiving hot chamber 2 through the material transfer port 204, then the first mechanical hand 205 picks up the dilution sample bottle 207 and places it in the material transfer channel 206 between the hot chambers, and the second mechanical hand 303 moves it into the dilution hot chamber 3, and the fourth mechanical hand 304 in the dilution hot chamber 3 transfers the raw material bottle 103 to the dilution assembly 301. The dilution assembly 301 injects a certain amount of iodine-131 dilution liquid into the dilution sample bottle 207 for testing dilution effect, and if the test is qualified, the dilution liquid is injected into the dispensing station 401 in the dispensing hot chamber 4 through the capillary pipe 307 for dispensing to obtain the product.

[0040] In an embodiment of the present application, the radioactive liquid medicine production line further comprises a preparation hot chamber 5, which is in communication with the dispensing hot chamber 4 through a third transfer channel 407, for providing product medicine bottles 50101 to the dispensing hot chamber 4. Further, the bottom of the dispensing hot chamber 4 is provided with a discharge port 408; the dispensing hot chamber 4 is provided with a fifth mechanical hand 405, a sixth mechanical hand 406, a robot 404 and an activity detection system 403 for detecting the activity of the product.

[0041] In application, a plurality of empty product medicine bottles 50101 are manually assembled on the tray 501 one by one, and then placed in the third transfer channel 407, and the robot 404 takes the tray 501 from the preparation hot chamber 5 and places it in a fixed position of the dispensing hot chamber 4. Then, the robot 404 picks up the empty product medicine bottle 50101 on the tray 501 and places it on the dispensing station 401, which automatically injects a certain amount of iodine-131 dilution liquid into the product medicine bottle 50101 and completes the medicine sealing action to obtain the product. After dispensing, the robot 404 picks up the sealed product medicine bottle 50101 and transfers it into the activity detection system 403 for iodine-131 product activity detection; after detection, the robot 404 transfers the product medicine bottle 50101 to the discharge port 408 for discharge. The fifth mechanical hand 405 and the sixth mechanical hand 406 assist the robot 404 in picking up and placing the tray 501 and the product medicine bottle 50101.

[0042] In an embodiment of the present application, the radioactive liquid medicine production line further comprises a discharging system 6, the discharging system 6 comprises a supply device 601, a robot system 602 and a transfer device 603, the supply device 601 and the transfer device 603 are arranged at intervals, and the robot system 602 is arranged between the supply device 601 and the transfer device 603. A discharging platform 409 is arranged on the side of the dispensing hot cell 4 close to the robot system 602, and a rotatable rotary guide rail 410 is arranged on the discharging platform 409, and a base 411 is arranged on the rotary guide rail 410. The supply device 601 is used to carry a second shielding container 60101, the robot system 602 is used to transfer the second shielding container 60101 to the base 411, and is used to transfer the second shielding container 60101 with the product medicine bottle 50101 on the base 411 to the transfer device 603; when the base 411 rotates to the position where the second shielding container 60101 is located below the discharging port 408, the product medicine bottle 50101 falls into the second shielding container 60101.

[0043] Specifically, the supply device 601 with the second shielding container 60101 is transferred from the warehouse to the predetermined position by manual or automatic equipment (such as a robot, etc.) during production; the robot system 602 automatically grabs an empty second shielding container 60101 and places it on the base 411, the base 411 rotates the second shielding container 60101 to the position directly below the discharging port 408, receives the product medicine bottle 50101, and then transfers the second shielding container 60101 with the product medicine bottle 50101 out, the second shielding container 60101 with the product medicine bottle 50101 is taken away by the robot system 602 and placed on the transfer device 603, and after the second shielding container 60101 is placed on the transfer device 603, it is manually transferred to the product warehouse for storage.

[0044] In addition, the waste liquid collection system 308 is arranged in the dilution hot cell 3, and the dilution assembly 301 is communicated with the waste liquid collection system 308 through the first discharge pipeline 309; the dispensing station 401 is communicated with the waste liquid collection system 308 through the second discharge pipeline 412. After production, the radioactive waste liquid generated by the dilution hot cell 3 and the dispensing hot cell 4 is discharged into the waste liquid collection system 308 through the first discharge pipeline 309 and the second discharge pipeline 412 respectively for treatment. The first solid waste collection system 302, the second solid waste collection system 402 and the third solid waste collection system 502 are arranged in the raw material dilution hot cell 3, the dispensing hot cell 4 and the preparation hot cell 5 respectively; after production, the radioactive solid waste generated in the raw material dilution hot cell 3, the dispensing hot cell 4 and the preparation hot cell 5 is respectively put into the solid waste collection system 302, the solid waste collection system 402 and the solid waste collection system 502 for treatment.

[0045] The embodiment of the present application also provides a production method of radioactive liquid medicine, which adopts the production line of radioactive liquid medicine in any one of the above embodiments to have all the effects; the production method comprises the following steps:

[0046] The raw material bottle 103 containing radioactive raw materials is sent into the receiving hot chamber 2, and the raw material bottle 103 is opened by the opening mechanism 202;

[0047] The opened raw material bottle 103 is sent into the dilution hot chamber 3, the concentration of the radioactive raw materials in the raw material bottle 103 is detected by the detection system 305, and the required amount of dilution solution is calculated;

[0048] The raw material bottle 103 is transferred to the dilution assembly 301 to be diluted to obtain a dilution solution; and the dilution solution is sent to the dispensing station 401 to be dispensed to obtain a product.

[0049] Part of the dilution solution is injected into the sampling bottle 207 to test the dilution effect after the dilution solution is obtained; if the test is qualified, the dilution solution is sent to the dispensing station 401 to be dispensed.

[0050] The product is discharged after being loaded into the second shielding container 60101.

[0051] The above embodiments are only used to illustrate the technical solutions of the present application, but not limit the present application; although the present application is described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions recorded in the above embodiments can be modified, or some technical features can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application, and should be included in the protection scope of the present application.

Claims

1. A production line for a radioactive liquid pharmaceutical, characterized in that, It includes a receiving hot chamber (2), a dilution hot chamber (3) and a dispensing hot chamber (4), wherein the receiving hot chamber (2) and the dilution hot chamber (3) are connected by a first transfer channel (206); The receiving hot chamber (2) is used to receive a raw material bottle (103) containing radioactive raw materials; the receiving hot chamber (2) is provided with an opening mechanism (202) for opening the raw material bottle (103) and a first robotic arm (205) for transferring the raw material bottle (103) to the first transfer channel (206); The dilution chamber (3) is equipped with a second robotic arm (303) and a dilution assembly (301). The second robotic arm (303) is used to transfer the raw material bottle (103) into the dilution chamber (3). The dilution assembly (301) is used to dilute the raw material in the raw material bottle (103) to obtain a diluted solution. The dispensing hot chamber (4) is equipped with a dispensing station (401) for dispensing the diluent, and the dispensing station (401) is connected to the dilution component (301) through a capillary tube (307).

2. The production line for radioactive liquid pharmaceuticals according to claim 1, characterized in that, The radioactive liquid drug production line also includes a transfer assembly (1) for transferring the raw material bottle from the warehouse to the receiving heat chamber (2); The transfer assembly (1) includes a trolley (101) on which a first shielding container (102) is provided, and the raw material bottle (103) is placed inside the first shielding container (102).

3. The production line for radioactive liquid pharmaceuticals according to claim 2, characterized in that, The bottom of the receiving heat chamber (2) is provided with a raw material inlet (201); the receiving heat chamber (2) is also provided with a third robotic arm (203) for transferring the shielding container (102) into the receiving heat chamber (2).

4. The production line for radioactive liquid pharmaceuticals according to claim 1, characterized in that, The dilution chamber (3) is also equipped with a detection system (305), which is used to detect the concentration of radioactive material in the raw material bottle (103) and to calculate the amount of dilution solution required.

5. The production line for radioactive liquid pharmaceuticals according to claim 1, characterized in that, The dilution chamber (3) also contains a dilution sampling bottle (207) for testing the dilution effect of the diluent; the dilution assembly (301) is also configured to inject the diluent into the dilution sampling bottle (207).

6. The production line for radioactive liquid pharmaceuticals according to claim 1, characterized in that, The radioactive liquid drug production line also includes a preparation heat chamber (5), which is connected to the dispensing heat chamber (4) via a third transfer channel (407) and is used to provide product vials (50101) to the dispensing heat chamber (4).

7. The production line for radioactive liquid pharmaceuticals according to claim 6, characterized in that, The radioactive liquid drug production line also includes a discharge system (6), which includes a supply device (601), a robot system (602), and a transfer device (603). The supply device (601) and the transfer device (603) are arranged at intervals, and the robot system (602) is arranged between the supply device (601) and the transfer device (603). The bottom of the dispensing hot chamber (4) is provided with a discharge port (408); a discharge platform (409) is installed on the side of the dispensing hot chamber (4) near the robot system (602), and a rotatable rotating guide rail (410) is provided on the discharge platform (409), and a base (411) is provided on the rotating guide rail (410). The supply device (601) is used to carry the second shielding container (60101), the robot system (602) is used to transfer the second shielding container (60101) to the base (411), and to transfer the second shielding container (60101) containing the product bottle (50101) on the base (411) to the transfer device (603); when the base (411) rotates to the position of the second shielding container (60101) below the discharge port (408), the product bottle (50101) falls into the second shielding container (60101).

8. A method for producing a radioactive liquid drug, characterized in that, The production line for radioactive liquid pharmaceuticals as described in any one of claims 1 to 7 is employed; the production method comprises the following steps: The raw material bottle (103) containing radioactive material is sent into the receiving heat chamber (2), and the raw material bottle (103) is opened by the cap opening mechanism (202); The opened raw material bottle (103) is sent into the dilution hot chamber (3), and the detection system (305) detects the concentration of radioactive raw material in the raw material bottle (103) and calculates the amount of dilution solution required. The raw material bottle (103) is transferred to the dilution assembly (301) for dilution to obtain a diluted solution; the diluted solution is sent to the dispensing station (401) for dispensing to obtain the product.

9. The production method according to claim 8, characterized in that, After obtaining the diluent, a portion of the diluent is injected into a sampling bottle (207) to test the dilution effect; if the test is qualified, the diluent is sent to the dispensing station (401) for dispensing.

10. The production method according to claim 8, characterized in that, After obtaining the product, the product is loaded into the second shielded container (60101) and then discharged.

Images