Method for cleaning a radioactive drug solution synthesis apparatus and its replacement modules.

Abstract

The present invention provides a radioactive drug solution synthesis apparatus and a method for cleaning replacement modules that can suppress the retention of residual substances in the line. [Solution] The radioactive drug solution synthesis apparatus 10 introduces cleaning solution into one container and overflows the cleaning solution from the other container to introduce it into the suction line. This allows the suction line to be cleaned with the cleaning solution. Here, target water does not actually pass through the vacuum lines L2 and L9, but rather volatile vapor adheres to them. There was a need to easily clean such residues. In response to this, the vacuum lines L2 and L9 can be cleaned with a simple operation of overflowing cleaning solution from one container, without adding any mechanisms.

Description

[Technical Field]

[0001] The present invention relates to a radioactive drug solution synthesis apparatus and a method for cleaning replacement modules. [Background technology]

[0002] Nuclear medicine diagnostic methods have been developed that involve administering a radioactive solution containing a compound labeled with a radionuclide (RI) into the body and then using a specialized device to image the accumulation of this labeled compound in specific locations within the body to diagnose diseases and other conditions. In this diagnostic method, relatively short-lived radionuclides (for example, positron-emitting nuclides) are used. 18 F is labeled with (which has a half-life of 110 minutes), 18 F-FDG (fluorodeoxyglucose) and similar substances are used as radioactive drug solutions.

[0003] An apparatus for synthesizing such radioactive liquids is disclosed, for example, in Patent Document 1. This synthesis apparatus comprises a fixed module and a disposable module. In this synthesis apparatus, after one synthesis is completed, the disposable module is replaced with a new one to prepare for the next synthesis. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] Special Publication No. 2004-515330 [Overview of the project] [Problems that the invention aims to solve]

[0005] In the radioactive drug synthesis apparatus described above, radioactivity may remain in some lines even after cleaning, or reagents may remain in the lines even after synthesizing the radioactive drug. Therefore, it was necessary to suppress the retention of residues in the lines.

[0006] This invention has been made in view of the above circumstances, and aims to provide a radioactive drug solution synthesis apparatus and a method for cleaning replacement modules that can suppress the remaining residue in the line. [Means for solving the problem]

[0007] The radioactive drug solution synthesis apparatus according to the present invention comprises a target liquid container for containing a target liquid containing a radioactive isotope, a reaction vessel for synthesizing a radioactive drug solution using the target liquid, an exchange module having a pipeline unit with a first pipeline connecting the target liquid container and the reaction vessel attached to a substrate, and a fixed module on which the exchange module is detachably installed, wherein at least one of the containers, the target liquid container and the reaction vessel, is provided with a suction line for suction, and a cleaning solution is introduced into one of the containers and the cleaning solution is overflowed from the other container to introduce the cleaning solution into the suction line.

[0008] In a radioactive drug solution synthesis apparatus, a suction line is provided in at least one of the containers, the target liquid container and the reaction vessel. In contrast, the radioactive drug solution synthesis apparatus introduces a cleaning solution into one of the containers and allows the cleaning solution to overflow from the other container, thereby introducing the cleaning solution into the suction line. This allows the suction line to be cleaned with the cleaning solution. Furthermore, the suction line can be cleaned with a simple operation of overflowing the cleaning solution from one of the containers, without the need for additional mechanisms. As a result, the retention of residue in the line can be suppressed.

[0009] A first suction line is provided in the target liquid container. The cleaning solution may be introduced into the first suction line by introducing the cleaning solution into the target liquid container and allowing it to overflow from the target liquid container. In this case, the first suction line can be easily cleaned simply by allowing the cleaning solution to overflow from the target liquid container.

[0010] The reaction vessel may be provided with a second suction line. A cleaning solution may be introduced into the reaction vessel and allowed to overflow from the reaction vessel, thereby introducing the cleaning solution into the second suction line. In this case, the second suction line can be easily cleaned simply by allowing the cleaning solution to overflow from the reaction vessel.

[0011] When multiple cleaning steps are performed to introduce a cleaning solution into a single container, the cleaning solution may be introduced into the suction line during one of the predetermined number of cleaning steps, or during the final cleaning step of the multiple cleaning steps. Since the suction line is not a point where the target liquid directly adheres, it is less contaminated than the area that should be cleaned with each cleaning. Therefore, the frequency of introducing the cleaning solution into the suction line can be adjusted to be appropriate.

[0012] The method for replacing a replacement module according to the present invention is a cleaning method for a replacement module having a target liquid container for containing a target liquid containing a radioactive isotope, a reaction vessel for synthesizing a radioactive drug solution using the target liquid, and a pipeline unit in which a first pipeline connecting the target liquid container and the reaction vessel is attached to a substrate, wherein at least one of the containers, the target liquid container and the reaction vessel, is provided with a suction line for suction, and the cleaning liquid is introduced into the suction line by introducing a cleaning liquid into one of the containers and causing the cleaning liquid to overflow from the other container.

[0013] By using this replacement module replacement method, it is possible to obtain the same effects and functions as the radioactive drug solution synthesis apparatus described above.

[0014] The radioactive drug solution synthesizing apparatus according to the present invention includes a target solution storage container for storing a target solution containing a radioactive isotope, a reaction container for synthesizing a radioactive drug solution using the target solution, an exchange module having a pipeline unit attached to a substrate and connecting the target solution storage container and the reaction container with a first pipeline, and a fixed module on which the exchange module is removably installed. In the reaction container, a reagent line for introducing a reagent from a reagent container into the reaction container and a gas line for introducing an inert gas into the reaction container are provided. After the synthesis of the radioactive drug solution, by introducing an inert gas into the reaction container, the solution remaining in the reagent line is pushed back into the reagent container.

[0015] In a radioactive drug solution synthesizing apparatus, a reagent line for introducing a reagent from a reagent container into the reaction container and a gas line for introducing an inert gas into the reaction container are provided in the reaction container. In contrast, after the synthesis of the radioactive drug solution, by introducing an inert gas into the reaction container, the solution remaining in the reagent line is pushed back into the reagent container. Thereby, the solution remaining in the reagent line can be removed. Also, with a simple operation of just introducing an inert gas into the reaction container, the reagent line can be cleaned without adding a mechanism. From the above, it is possible to suppress the remaining of residues in the line.

Effect of the Invention

[0016] According to the present invention, it is possible to provide a radioactive drug solution synthesizing apparatus and a cleaning method for an exchange module that can suppress the remaining of residues in the line.

Brief Description of the Drawings

[0017] [Figure 1] It is a perspective view showing the configuration of the radioactive drug solution synthesizing apparatus according to the present embodiment. [Figure 2] It is a front view showing the configuration of the exchange module included in the synthesizing apparatus of FIG. 1. [Figure 3] It is a view showing a line constituting the first pipeline and through which target water passes, and a line constituting the second pipeline and through which the synthesized radioactive drug solution passes, in the exchange module. [Figure 4] This diagram illustrates the cleaning of a vacuum line. [Figure 5] This diagram illustrates the cleaning of a vacuum line. [Figure 6] This diagram illustrates the cleaning of a vacuum line. [Figure 7] This diagram illustrates the cleaning of a vacuum line. [Figure 8] This diagram illustrates the cleaning process for the introduction line. [Figure 9] This diagram illustrates the cleaning process for the introduction line. [Modes for carrying out the invention]

[0018] Embodiments of the present invention will be described below with reference to the drawings. In the following description, the same reference numerals will be used for the same elements, and redundant explanations will be omitted. In this embodiment, the radioactive liquid is 18 This section explains how to synthesize F-FDG (fluorodeoxyglucose).

[0019] Figure 1 is a perspective view showing the configuration of a radioactive drug solution synthesis apparatus according to this embodiment. Figure 2 is a front view showing the configuration of the exchange module included in the synthesis apparatus of Figure 1. As shown in Figures 1 and 2, the synthesis apparatus 10 includes an exchange module 12 and a fixed module 14.

[0020] The replacement module 12 includes a target recovery vial (target liquid container) 15, a reaction vial (reaction vessel) 16, and a conduit unit 19 in which multiple lines L1-L15 are positioned and supported on a plate (substrate) 18 for fluid flow. The multiple lines L1-L15 are formed from silicone tubing or the like.

[0021] Target retrieval vial 15 contains high-energy protons accelerated in a cyclotron (not shown) and H2 18 Irradiated with oxygen, which is produced by nuclear reactions 18Target water containing F ions (radioactive fluorine) is recovered. This target recovery vial 15 has a capacity of, for example, about 7cc and a V-shaped bottom, making it easy to discharge the recovered target water to the next stage. The target recovery vial 15 is connected to a recovery line L1 for recovering the target water, a vacuum line L2 for evacuating the inside of the vial 15, a gas introduction line L3 for introducing N2 gas as an inert gas, and a discharge line L4 for discharging the recovered target water. The base end of the discharge line L4 extends to the lowest point of the V-shaped bottom.

[0022] The end of this discharge line L4 is connected to the middle of the introduction line L5, which introduces potassium carbonate (K2CO3) solution and Cryptofix 222 (K222) solution. The base end of this introduction line L5 is connected to the first reagent vial V1 containing the K2CO3 solution and K222 solution, and the end of the introduction line L5 is 18 It is connected to one end of an anion exchange resin cartridge 20 for capturing F ions. The other end of this anion exchange resin cartridge 20 is connected to 18 A recovery line L6 is connected to recover the target water after F ion capture. Note that this anion exchange resin cartridge 20 is replaced after each synthesis and is not included in the replacement module 12 of this embodiment, so it is shown with a dashed line. However, if it is configured to be reusable by washing with the washing solution described later, the anion exchange resin cartridge 20 may also be included in the replacement module 12.

[0023] The reaction vial 16 is a vial used to synthesize a radioactive drug solution containing a labeled compound by reacting the raw materials. This reaction vial 16 has a capacity of, for example, about 7 cc, a flat bottom, and is designed to enhance reactivity. The reaction vial 16 is connected to a first multipurpose line L7 for introducing N2 gas as an inert gas, a second multipurpose line L8 that branches off from the first multipurpose line L7 and whose terminus extends to the flat bottom of the reaction vial 16, and a vacuum line L9 for evacuating the inside of the vial 16.

[0024] The first multipurpose line L7 and the recovery line L6 are connected by a connecting line L10. An introduction line L11 for introducing acetonitrile is connected to this connecting line L10. The acetonitrile introduced from the second reagent vial V2 through this introduction line L11 is used to flush the solution through the line.

[0025] Furthermore, on the first multipurpose line L7, between the branching point of the second multipurpose line L8 and the connection point of the connection line L10, an introduction line L12 is connected for introducing mannose triflate dissolved in acetonitrile from the third reagent vial V3.

[0026] Furthermore, a drainage line L15 for discharging the synthesized radioactive drug solution branches off from the second multipurpose line L8. A water introduction line L13 is connected to this drainage line L15 to introduce water into the reaction vial 16 to be used to discharge the radioactive drug solution from the reaction vial 16. The base end of the water introduction line L13 is connected to a fourth reagent vial V4 that stores, for example, about 5cc of water. An introduction line L14 is connected to this water introduction line L13 to introduce a sodium hydroxide solution for hydrolysis from a fifth reagent vial V5.

[0027] Furthermore, upstream of the first reagent vial V1, there is a washing solution vial V6 that stores approximately 21cc of water as a washing solution. The first reagent vial V1 and the washing solution vial V6 are connected by a washing solution introduction line L17 which has a control valve.

[0028] The pipe unit plate 18 is formed in a rectangular plate shape from a resin material such as polypropylene, and multiple claw portions 26 position and support the multiple lines L1-L15 described above in predetermined positions. A back plate 13 is provided at a predetermined position on this plate 18 to crush the lines L1-L15 in contact with a piston 28, which will be described later.

[0029] The fixed module 14 is a roughly cubic-shaped member and has a main body 32 and a door 34. The front surface of the main body 32 is provided with a mounting portion 36 for attaching the plate 18 of the replacement module 12. The upper surface of the main body 32 is provided with a housing hole 38 for housing the target recovery vial 15. Furthermore, the upper surface of the stepped portion 32a of the main body 32 is provided with a housing hole 40 for housing the reaction vial 16. A heater (not shown) for heating the reaction vial 16 is provided around this housing hole 40.

[0030] Furthermore, the main body 32 is provided with a storage section (not shown) for removably accommodating the first to fifth reagent vials V1-V5 and the washing solution vial V6.

[0031] The door section 34 is provided so as to be able to open and close by 90 degrees in the direction of arrow A via a hinge provided on the side of the stepped section 32a of the main body section 32. This door section 34 can be opened and closed relative to the main body section 32 by rotating the knob 42 to engage and disengage the hook 44 with the engagement hole 46 of the main body section 32. Multiple pistons 28 are provided at predetermined positions inside this door section 34. These multiple pistons 28 move back and forth by the force of air. Air is supplied to each piston 28 via an air tube 48 extending from the main body section 32. In this way, by moving the pistons 28 back and forth and compressing and releasing the line L1-L15 between them and the substantially circular back plate 13, they can function as on-off valves. For the sake of explanation, the back plate 13 in Figure 2 is labeled 13-1 to 13-13 to distinguish the on-off valves 13-1 to 13-13 that are formed in relation to the pistons 28.

[0032] In this radioactive drug solution synthesis apparatus 10, a purification column 50 for purifying the radioactive drug solution is connected to the drainage line L15. A product supply line L16 extends from this purification column 50 to a product vial (not shown) for supplying the purified drug solution. The purification column 50 is covered with a shielding material to block radiation.

[0033] Here, in the present embodiment, as shown by the shaded lines in FIG. 3, the first pipeline of the present invention is constituted by the discharge line L4, a part of the introduction line L5, a part of the recovery line L6, the connection line L10, and a part of the first multi-purpose line L7. When the anion exchange resin cartridge 20 is also included in the exchange module 12, the first pipeline is constituted including this as well. Further, as shown by the black shading in FIG. 3, the second pipeline of the present invention is constituted by a part of the second multi-purpose line L8 and the drain line L15. Furthermore, the cleaning liquid introduction means is constituted by the cleaning liquid vial V6, the cleaning liquid introduction line L17, the first reagent vial V1, and a part of the introduction line L5.

[0034] Next, the usage method of the above-described radioactive drug synthesis apparatus 10 will be described, including the method for synthesizing radioactive drugs.

[0035] When synthesizing 18 F-FDG, first, a new exchange module 12 is attached to the fixed module 14, and the anion exchange resin cartridge 20 is connected to the introduction line L5 and the recovery line L6. Next, the first to fifth reagent vials V1 - V5 and the cleaning liquid vial V6 are set. Next, high-energy protons accelerated by a cyclotron (not shown) are irradiated onto 18 H2O, and for example, about 2 cc of target water containing 18 F ions (radioactive fluorine) generated by the nuclear reaction is recovered into the target recovery vial 15 through the recovery line L1. At this time, performing vacuum pumping through the vacuum line L2 is preferable because it becomes easier to introduce the target water into the target recovery vial 15 and to confine it.

[0036] Next, N2 gas is introduced into the target recovery vial 15 through the gas introduction line L3, and all of the target water is discharged through the discharge line L4. At this time, by closing the on-off valves 13-1 and 13-4 and opening the on-off valves 13-2 and 13-3, the target water is passed through the anion exchange resin cartridge 20 to 18 capture F ions. Then, the remaining target water is recovered through the recovery line L6.

[0037] Next, the potassium carbonate solution from the first reagent vial V1 is passed through the anion exchange resin cartridge 20 via the introduction line L5. 18 The F ions are eluted and introduced into reaction vial 16. Simultaneously, the Cryptofix solution from the first reagent vial V1 is introduced into reaction vial 16. At this time, valves 13-2, 13-3, 13-5, 13-6, and 13-7 are closed, and valves 13-1, 13-4, and 13-12 are left open. In this state, reaction vial 16 contains approximately 0.9 cc of the raw material.

[0038] Next, the reaction vial 16 is evacuated through the vacuum line L9, and the reaction vial 16 is heated by a heater (not shown), 18 The F ions, potassium carbonate solution, and Cryptofix solution are evaporated to dryness to remove moisture.

[0039] Next, mannose triflate dissolved in acetonitrile is introduced into reaction vial 16 from the third reagent vial V3 through introduction line L12 and the first multipurpose line L7. At this time, valves 13-4, 13-5, and 13-7 are closed, and valve 13-12 is left open. Then, with reaction vial 16 sealed, it is heated at a set temperature of 100°C for 5 minutes using a heater (not shown). This fluorinates the mannose triflate. At this stage, approximately 1.3 cc of raw material is contained in reaction vial 16.

[0040] Next, the reaction vial 16 is evacuated through the vacuum line L9, and the reaction vial 16 is heated by a heater (not shown) to boil the liquid inside, thereby removing acetonitrile, which is harmful to the human body. The set temperature of the heater (not shown) at this time is approximately 80°C.

[0041] Next, approximately 4cc of sodium hydroxide is introduced from the fifth reagent vial V5 into the reaction vial 16 through the introduction line L14. At this time, valves 13-8, 13-10, and 13-11 are closed, and valves 13-9 and 13-13 are left open. Then, the heater (not shown) is set to 100°C, and hydrolysis is carried out by heating in a sealed state. At this time, it is preferable to close valves 13-7, 13-9, 13-10, and 13-11, and open valves 13-8 and 13-13, and introduce N2 gas into the reaction vial 16 through the first multipurpose line L7 and the second multipurpose line L8, and bubble the mixture. In this way, the liquid inside is stirred, and hydrolysis is promoted. 18 Synthesize F-FDG.

[0042] Then, N2 gas is introduced into the reaction vial 16 through the first multi-purpose line L7, and through the second multi-purpose line L8 and the drainage line L15. 18 Discharge F-FDG. At this time, close valves 13-4, 13-5, 13-6, 13-8, 13-9, and 13-10, and open valves 13-7, 13-11, 13-12, and 13-13. Then, remove impurities by passing the solution through the purification column 50 to obtain a pure solution. 18 F-FDG is extracted and supplied to the product vial through product supply line L16.

[0043] Next, approximately 5cc of water from the fourth reagent vial V4 is introduced into the reaction vial 16 through the water introduction line L13. At this time, valves 13-8, 13-9, and 13-11 are closed, and valves 13-10 and 13-13 are left open. Then, N2 gas is introduced into the reaction vial 16 through the first multipurpose line L7, and the remaining gas in the reaction vial 16 is drained through the second multipurpose line L8 and the drain line L15. 18 The water into which F-FDG has been introduced is discharged. At this time, valves 13-4, 13-5, 13-6, 13-8, 13-9, and 13-10 are closed, and valves 13-7, 13-11, 13-12, and 13-13 are left open. Then, impurities are removed by passing the water through the purification column 50 to obtain pure water. 18F-FDG is extracted and supplied to the product vial through product supply line L16.

[0044] According to the radioactive drug solution synthesis apparatus 10 described above 18 The synthesis of F-FDG is performed in a radiation shield (hot cell) not shown in the diagram. After one synthesis cycle is completed, the replacement module 12 is cleaned.

[0045] During the cleaning of the replacement module 12, without opening the radiation shield (not shown), and thus with the replacement module 12 still installed in the fixed module 14, approximately 7cc of cleaning solution is introduced from the cleaning solution vial V6 to the first reagent vial V1 through the cleaning solution introduction line L17. Then, the cleaning solution is introduced from the first reagent vial V1 to the target recovery vial 15 through the introduction line L5 and the discharge line L4. Once a predetermined amount of cleaning solution has been introduced into the target recovery vial 15, the introduction of the cleaning solution is stopped. In this cleaning process, no cleaning solution is introduced into the vacuum line L2. At this time, the on-off valves 13-1 and 13-2 are opened, and the on-off valves 13-3 and 13-4 are closed. In addition to water, acetonitrile, organic solvents, etc., can be used as the cleaning solution.

[0046] Next, N2 gas is introduced into the target recovery vial 15 through the gas introduction line L3, and the entire amount of cleaning solution is discharged through the discharge line L4. At this time, by closing the on-off valves 13-1, 13-3, 13-5, 13-6, and 13-7 and opening the on-off valves 13-2, 13-4, and 13-12, the cleaning water is introduced into the reaction vial 16. Once a predetermined amount of cleaning solution has been introduced into the reaction vial 16, the introduction of the cleaning solution is stopped. In this cleaning process, no cleaning solution is introduced into the vacuum line L9.

[0047] Next, N2 gas is introduced into the reaction vial 16 through the first multipurpose line L7, and the washing solution is bubbling for, for example, about 1 minute. Then, the washing solution is discharged through the second multipurpose line L8 and the drain line L15. At this time, the on-off valves 13-4, 13-5, 13-6, 13-8, 13-9, and 13-10 are closed, and the on-off valves 13-7, 13-11, 13-12, and 13-13 are left open.

[0048] Next, the same process as above is repeated to clean the exchange module 12 a total of three times. In particular, during the third cleaning, the cleaning solution in the reaction vial 16 is heated to 130°C for 10 minutes, boiling the cleaning solution. After the three cleanings are completed, the reaction vial 16 is heated to 80°C, N2 gas is introduced into the reaction vial 16 through the first multipurpose line L7, and the discharge line L4, introduction line L5, recovery line L6, connection line L10, and the first multipurpose line L7, as well as the target recovery vial 15, are nitrogen-purged and dried for about 10 minutes. Furthermore, N2 gas is introduced into the reaction vial 16 through the first multipurpose line L7, and the second multipurpose line L8 and the drain line L15 are nitrogen-purged and dried for about 10 minutes.

[0049] After the above cleaning and drying are complete, open the radiation shield (not shown), replace the anion exchange resin cartridge 20 with a new one, and replace the reagent vials V1-V5 and the washing solution vial V6 with new ones. If the anion exchange resin cartridge 20 can be reused after the above cleaning, it is not necessary to replace the anion exchange resin cartridge 20.

[0050] Next, after the above-mentioned setting for the next synthesis is complete, close the radiation shield (not shown in the diagram). 18 We will resume the synthesis of F-FDG. And, 18 After performing F-FDG synthesis and cleaning of the replacement module 12 a predetermined number of times (for example, about 3 times), the replacement module 12 is replaced.

[0051] In replacing the replacement module 12, the radiation shield (not shown) is opened, the door 34 of the radioactive chemical synthesis apparatus 10 is opened, the used and cleaned replacement module 12 is removed from the main body 32 of the fixed module 14, and replaced with a new one.

[0052] As described in detail above, in the method of using the radioactive drug solution synthesis apparatus 10 according to this embodiment, by introducing a washing solution into the reaction vial 16 through the discharge line L4, introduction line L5, recovery line L6, connection line L10, and first multipurpose line L7, these lines and the reaction vial 16 can be washed. This makes it possible to repeatedly use the replacement module 12, reducing synthesis costs and enabling efficient synthesis of radioactive drugs in terms of cost. In addition, since the inside of the reaction vial 16, which has a particularly high level of residual radioactivity, can be washed, reagent replacement and replacement module 12 replacement can be performed while the level of residual radioactivity is low, thus keeping the exposure of handlers low. Furthermore, since the next synthesis can be started without waiting for the level of residual radioactivity to decrease sufficiently, the radioactive drug solution can be synthesized efficiently in terms of time.

[0053] In particular, since the washing solution is introduced into the target recovery vial 15 after the target water has been discharged, and then introduced into the reaction vial 16 through the discharge line L4, introduction line L5, recovery line L6, connection line L10, and first multipurpose line L7 from the target recovery vial 15, the target recovery vial 15 can also be washed, and the line through which the target water passes from the base end of the discharge line L4 can also be washed. This improves the quality of the radioactive drug solution synthesized by repeatedly using the exchange module 12, and also reduces the amount of radiation exposure when exchanging reagents for the next synthesis or when exchanging the exchange module 12.

[0054] Furthermore, since the washing solution from the reaction vial 16 is discharged through the second multi-purpose line L8 and the drainage line L15, these lines can also be cleaned, improving the quality of the radioactive chemical solution synthesized by repeatedly using the replacement module 12, and reducing the complexity of the piping by effectively utilizing the second multi-purpose line L8 and the drainage line L15.

[0055] Furthermore, boiling the washing solution inside the reaction vial 16 enhances the washing effect within the reaction vial 16, and bubbling further enhances the washing effect.

[0056] In the radioactive drug solution synthesis apparatus 10 according to this embodiment, in addition to the above-described cleaning and other processes, the following processes may be performed.

[0057] The radioactive drug solution synthesis apparatus 10 introduces the cleaning solution into at least one of the target recovery vial 15 and the reaction vial 16, and introduces the cleaning solution into the vacuum line (suction line) by overflowing the cleaning solution from the other container.

[0058] As shown in Figure 4, the radioactive drug synthesis apparatus 10 introduces washing solution into the target recovery vial 15 and introduces the washing solution into the vacuum line L2 (first suction line) by causing the washing solution to overflow from the target recovery vial 15. Specifically, the radioactive drug synthesis apparatus 10 introduces washing solution from the washing solution vial V6 to the first reagent vial V1 through the washing solution introduction line L17. Then, the washing solution is introduced from the first reagent vial V1 to the target recovery vial 15 through the introduction line L5 and the discharge line L4. The radioactive drug synthesis apparatus 10 continues to introduce washing solution even if the amount of washing solution introduced into the target recovery vial 15 exceeds its volume. As a result, the overflowed washing solution is introduced into the vacuum line L2. At this time, the on-off valves 13-1 and 13-2 are opened, and the on-off valves 13-3 and 13-4 are closed. In addition, the recovery line L1 and the gas introduction line L3 are kept closed so that the washing solution does not flow through them.

[0059] As shown in Figures 5 to 7, the radioactive drug solution synthesis apparatus 10 introduces the washing solution into the reaction vial 16 and overflows the washing solution from the reaction vial 16, thereby introducing the washing solution into the vacuum line L9 (second suction line).

[0060] Specifically, as shown in Figure 5, the radioactive drug solution synthesis apparatus 10 introduces the washing solution from the washing solution vial V6 to the first reagent vial V1 through the washing solution introduction line L17. Then, the washing solution is introduced from the first reagent vial V1 to the target recovery vial 15 through the introduction line L5 and the discharge line L4. Once a predetermined amount of washing solution has been introduced into the target recovery vial 15, the introduction of the washing solution is stopped. At this time, the on-off valves 13-1 and 13-2 are opened, and the on-off valves 13-3 and 13-4 are closed.

[0061] Next, as shown in Figure 6, the radioactive drug synthesis apparatus 10 introduces N2 gas into the target recovery vial 15 through the gas introduction line L3 and discharges the entire amount of washing solution through the discharge line L4. At this time, by closing the on-off valves 13-1, 13-3, 13-5, 13-6, and 13-7 and opening the on-off valves 13-2, 13-4, and 13-12, washing water is introduced into the reaction vial 16. Once a predetermined amount of washing solution has been introduced into the reaction vial 16, the introduction of washing solution is stopped.

[0062] As shown in Figure 7, the radioactive drug solution synthesis apparatus 10 continues to introduce cleaning solution into the reaction vial 16 even if the amount of cleaning solution exceeds the volume of the reaction vial 16. As a result, the overflowing cleaning solution is introduced into the vacuum line L9. At this time, the on / off valves 13-13 are kept closed to prevent the cleaning solution from flowing into line L8.

[0063] Here, as described above, the washing process of introducing the washing solution into vials 15 and 16 is performed multiple times. The radioactive drug synthesis apparatus 10 may introduce the washing solution into vacuum lines L2 and L9 during one of the predetermined number of washing processes. For example, the radioactive drug synthesis apparatus 10 may introduce the washing solution into vacuum lines L2 and L9 at a frequency of once every n times. Alternatively, the radioactive drug synthesis apparatus 10 may introduce the washing solution into vacuum lines L2 and L9 during the last of the multiple washing processes.

[0064] As shown in Figures 8 and 9, after synthesizing the radioactive drug solution, the radioactive drug solution synthesis apparatus 10 introduces an inert gas into the reaction vial 16, thereby pushing the solution remaining in the introduction line L11 (reagent line) back into the second reagent vial V2 (reagent container).

[0065] Specifically, as shown in Figure 8, after synthesizing the radioactive drug solution, the radioactive drug solution synthesis apparatus 10 introduces N2 gas into the reaction vial 16 via the first multi-purpose line L7. This fills the reaction vial 16 with N2 gas. At this time, the on-off valves 13-7 and 13-12 are kept open. The on-off valves 13-4, 13-5, 13-6, and 13-8 are kept closed.

[0066] Next, as shown in Figure 9, the radioactive drug synthesis apparatus 10 closes valve 13-7 and opens valve 13-5 from the state shown in Figure 8. This releases the pressure of the N2 gas that was filling the reaction vial 16, and the reagent remaining in the reaction vial 16 is pushed out into the second reagent vial V2 via the first multipurpose line L7 and the introduction line L11. Note that there is no particular limitation on which vial the reagent is pushed into; it may be pushed into any of the reagent vials V3 or V5.

[0067] Next, the operation and effects of the cleaning method for the radioactive drug solution synthesis apparatus and the replacement module 12 according to this embodiment will be described.

[0068] In the radioactive drug synthesis apparatus 10, vacuum lines L2 and L9 are provided for suction in at least one of the containers, the target recovery vial 15 and the reaction vial 16. The radioactive drug synthesis apparatus 10 introduces a cleaning solution into one of the containers and allows the cleaning solution to overflow from the other container, thereby introducing the cleaning solution into the suction lines. This allows the suction lines to be cleaned with the cleaning solution. Here, target water does not actually pass through the vacuum lines L2 and L9, but rather volatile vapors adhere to them. There was a need to easily clean such residues. In response to this, the vacuum lines L2 and L9 can be cleaned with a simple operation of overflowing the cleaning solution from one of the containers, without adding any additional mechanisms. As a result, the retention of residues in the lines can be suppressed. Furthermore, the amount of residual radioactivity can be reduced.

[0069] A vacuum line L2 is provided in the target recovery vial 15. The cleaning solution can be introduced into the vacuum line L2 by introducing the cleaning solution into the target recovery vial 15 and allowing it to overflow from the target recovery vial 15. In this case, the vacuum line L2 can be easily cleaned simply by allowing the cleaning solution to overflow from the target recovery vial 15.

[0070] A vacuum line L9 is provided in the reaction vial 16. The cleaning solution can be introduced into the vacuum line L9 by introducing the cleaning solution into the reaction vial 16 and allowing it to overflow from the reaction vial 16. In this case, the vacuum line L9 can be easily cleaned simply by allowing the cleaning solution to overflow from the reaction vial 19.

[0071] When multiple cleaning steps are performed to introduce a cleaning solution into a single container, the cleaning solution may be introduced into vacuum lines L2 and L9 during one of the predetermined number of cleaning steps, or during the final cleaning step of the multiple cleaning steps. Since vacuum lines L2 and L9 are not areas where the target liquid directly adheres, they are less contaminated than areas that should be cleaned with each cleaning. Therefore, the frequency of introducing the cleaning solution into vacuum lines L2 and L9 can be adjusted to be appropriate.

[0072] The method for replacing the replacement module 12 according to this embodiment is a cleaning method for the replacement module 12 which has a target liquid recovery vial 15 for containing a target liquid containing a radioactive isotope, a reaction vial 16 for synthesizing a radioactive drug solution using the target liquid, and a piping unit in which a first piping connecting the target liquid recovery vial 15 and the reaction vial 16 is attached to a substrate, wherein at least one of the containers of the target recovery vial 15 and the reaction vial 16 is provided with a vacuum line for suction, and the cleaning solution is introduced into the vacuum line by introducing the cleaning solution into one of the containers and causing the cleaning solution to overflow from the other container.

[0073] By using this replacement module 12, it is possible to obtain the same effects and functions as those of the radioactive drug solution synthesis apparatus 10 described above.

[0074] The radioactive drug solution synthesis apparatus 10 according to this embodiment comprises a target liquid recovery vial 15 for containing a target liquid containing a radioactive isotope, a reaction vial 16 for synthesizing a radioactive drug solution using the target liquid, a replacement module 12 having a conduit unit with a first conduit connecting the target liquid recovery vial 15 and the reaction vial 16 attached to a substrate, and a fixed module on which the replacement module is detachably installed. The reaction vial 16 is provided with a reagent line for introducing a reagent from a second reagent vial V2 to the reaction vial 16, and a first multipurpose line L7 for introducing an inert gas to the reaction vial 16. After the synthesis of the radioactive drug solution, the inert gas is introduced into the reaction vial 16 to push the solution remaining in the first multipurpose line L7 back into the second reagent vial V2.

[0075] In the radioactive drug solution synthesis apparatus 10, the reaction vial 16 is equipped with a second reagent vial V2 for introducing reagents from the second reagent vial V2 into the reaction vial 16, and a first multi-purpose line L7 for introducing inert gas into the reaction vial 16. After the synthesis of the radioactive drug solution, introducing inert gas into the reaction vial 16 pushes the solution remaining in the first multi-purpose line L7 back into the second reagent vial V2. This removes the solution remaining in the first multi-purpose line L7. Furthermore, the first multi-purpose line L7 can be cleaned with a simple operation of introducing inert gas into the reaction vial 16 without adding any additional mechanisms. As a result, the retention of residue in the line can be suppressed. This ensures that the liquid volume remains constant when the exchange module 12 is reused by replacing the second reagent vial V2 after pushing out the residue, thereby stabilizing the synthesis.

[0076] It should be noted that the present invention is not limited to the embodiments described above, and various modifications are possible. For example, in the embodiments described above, the washing solution was first introduced into the first reagent vial V1 through the washing solution introduction line L17, and then into the target recovery vial 15. However, the washing solution vial V6 and the target recovery vial 15 may be directly connected, and the washing solution may be directly introduced into the target recovery vial 15 through the washing solution introduction line L17. In this case, the washing solution introduction means of the present invention is constituted by the washing solution introduction line L17.

[0077] Furthermore, if contamination of the target recovery vial 15 and the discharge line L4 and introduction line L5 that constitute the first pipeline is not a concern, a cleaning solution introduction line L17 may be connected in the middle of the discharge line L4 or introduction line L5, and the cleaning solution may be introduced from the cleaning solution vial V6 toward the reaction vial 16. In this case, the cleaning solution introduction line L17 constitutes the cleaning solution introduction means of the present invention. However, it is preferable to connect the cleaning solution introduction line L17 as far upstream of the discharge line L4 as possible.

[0078] Furthermore, in the above embodiment, the replacement module 12 included a target recovery vial 15 and a reaction vial 16. However, the target recovery vial 15 and reaction vial 16 may be omitted from the replacement module and included in the fixed module in a configuration that does not require replacement. In this case, the replacement module 12 consists of a pipeline unit 19 in which a plurality of lines L1-L15 are positioned and supported on a plate 18 for fluid flow.

[0079] Furthermore, in the above embodiment, as the radioactive drug solution 18 The method for synthesizing F-FDG has been described, but other radioactive drug solutions may also be synthesized. [Explanation of symbols]

[0080] 10...Radioactive drug solution synthesis apparatus, 12...Exchange module, 14...Fixed module, 15...Target recovery vial, 16...Reaction vial, 18...Plate, 19...Pipeline unit, L2...Vacuum line (first suction line), L7...First multipurpose line (gas line), L9...Vacuum line (second suction line), L11...Inlet line (gas line), V2...Second reagent vial.

Claims

1. A radioactive drug synthesis apparatus comprising: a target liquid container for containing a target liquid containing a radioactive isotope; a reaction vessel for synthesizing a radioactive drug solution using the target liquid; an exchange module having a conduit unit with a first conduit connecting the target liquid container and the reaction vessel mounted on a substrate; and a fixed module on which the exchange module is detachably installed, A suction line is provided in at least one of the target liquid container and the reaction vessel. A radioactive drug solution synthesis apparatus that introduces a cleaning solution into one of the aforementioned containers and introduces the cleaning solution into the suction line by overflowing the cleaning solution from the one of the aforementioned containers.

2. The target liquid container is provided with a first suction line. The radioactive drug solution synthesis apparatus according to claim 1, wherein the cleaning solution is introduced into the target liquid container and the cleaning solution is overflowed from the target liquid container to introduce the cleaning solution into the first suction line.

3. The reaction vessel is provided with a second suction line. The radioactive drug solution synthesis apparatus according to claim 1, wherein the cleaning solution is introduced into the reaction vessel and the cleaning solution is overflowed from the reaction vessel to introduce the cleaning solution into the second suction line.

4. When performing multiple cleaning steps in which a cleaning solution is introduced into one of the aforementioned containers, In one of the predetermined number of cleaning steps, the cleaning solution is introduced into the suction line. Alternatively, the radioactive drug solution synthesis apparatus according to claim 1, wherein the cleaning solution is introduced into the suction line during the final cleaning step of the multiple cleaning steps.

5. A method for cleaning a replacement module having a target liquid container for containing a target liquid containing a radioactive isotope, a reaction vessel for synthesizing a radioactive drug solution using the target liquid, and a conduit unit in which a first conduit connecting the target liquid container and the reaction vessel is attached to a substrate, A suction line is provided in at least one of the target liquid container and the reaction vessel. A method for cleaning a replacement module, comprising introducing a cleaning solution into one of the containers and allowing the cleaning solution to overflow from the container, thereby introducing the cleaning solution into the suction line.

6. A radioactive drug synthesis apparatus comprising: a target liquid container for containing a target liquid containing a radioactive isotope; a reaction vessel for synthesizing a radioactive drug solution using the target liquid; an exchange module having a conduit unit with a first conduit connecting the target liquid container and the reaction vessel mounted on a substrate; and a fixed module on which the exchange module is detachably installed, The reaction vessel is provided with a reagent line for introducing reagents from a reagent container into the reaction vessel, and a gas line for introducing inert gas into the reaction vessel. A radioactive drug solution synthesis apparatus that, after the synthesis of the radioactive drug solution, introduces the inert gas into the reaction vessel to push back the solution remaining in the reagent line into the reagent container.

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