Radioactive liquid medicine synthesizing apparatus and detachable module

Abstract

To provide a radioactive chemical synthesis device capable of suppressing permeation of radioactive gas, and a detachable module.SOLUTION: The radioactive drug solution synthesizing apparatus 10 includes a detachable module 12 and a fixed module 14 on which the detachable module 12 is installed. Therefore, the detachable module 12 can be detached from the fixed module 14 and used as a disposable module. Here, among the plurality of tubes 61 of the detachable module 12, at least a part of the first region E1 connected to the containers 60 outside the plate 18 includes the low permeability member 64 having a lower gas permeability than at least a part of the second region E2 supported inside the plate 18. As described above, the first region E1 connected to the vessel 60 outside the plate 18 is a region where the radioactive gas is likely to leak. Since the first area E1 includes the low permeability member 64, the permeation of the radioactive gas can be suppressed by the low permeability member 64.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a radiopharmaceutical solution synthesizer and a removable module. [Background technology]

[0002] A radioactive drug solution containing a compound labeled with a radionuclide (RI) is administered into the body, and the state of the labeled compound gathering at a specific location in the body is imaged using a dedicated device. This diagnostic method uses a relatively short-lived radionuclide (for example, a positron-emitting nuclide, 18 F has a half-life of 110 minutes), 18 F-FDG (fluorodeoxyglucose) and the like are used as radioactive drug solutions.

[0003] An apparatus for synthesizing such a radioactive drug solution is disclosed in, for example, Patent Document 1. This synthesizing apparatus is equipped with a fixed module and a disposable module. In this synthesizing apparatus, when 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 Summary of the Invention [Problem to be solved by the invention]

[0005] In the above-mentioned detachable module, a highly gas-permeable material such as silicone rubber is used for the tube. 18When handling high concentrations of radioactive materials such as [F]HF, it is necessary to more reliably prevent radioactive gas from permeating through the tube connected to the container containing the radioactive liquid and leaking into the fixed module. For example, if the entire device is placed in a container with an activated carbon filter, this reduces workability and, depending on the size of the device, may make it impossible to place it in the container.

[0006] The present invention has been made in view of the above circumstances, and has an object to provide a radioactive chemical solution synthesis device and a detachable module that can suppress the permeation of radioactive gases. [Means for solving the problem]

[0007] A radioactive drug solution synthesis apparatus according to one aspect of the present invention is a radioactive drug solution synthesis apparatus comprising a detachable module and a fixed module on which the detachable module is installed, and synthesizing a radioactive drug solution, wherein the detachable module comprises a container for storing the radioactive liquid, a plurality of tubes, and a plate supporting the plurality of tubes, and at least a part of a first region of the plurality of tubes that is outside the plate and connected to the container includes a low-permeability member having lower gas permeability than at least a part of a second region supported within the plate.

[0008] This radioactive drug solution synthesis apparatus includes a removable module and a fixed module on which the removable module is installed. Therefore, by attaching and detaching the removable module from the fixed module, it can be used as a disposable module. Here, among the multiple tubes of the removable module, at least a portion of a first region connected to a container on the outside of the plate includes a low-permeability member having lower gas permeability than at least a portion of a second region supported within the plate. Thus, the first region connected to the container on the outside of the plate is a region through which radioactive gas is more likely to leak. By including the low-permeability member in such a first region, the permeation of the radioactive gas can be suppressed by the low-permeability member. This makes it possible to suppress the permeation of the radioactive gas in the radioactive drug solution synthesis apparatus.

[0009] The low-permeability member may be a heat-shrinkable tubular member that covers the tube body. In this case, the low-permeability member can be easily attached to the tube body by simply covering the desired portion of the tube body with the tubular member and applying heat.

[0010] The low-permeability member may be a strip-shaped member that is wound around the tube body to cover the tube body. In this case, the low-permeability member can be easily attached to the tube body by winding the strip-shaped member around a desired location on the tube body.

[0011] The low-permeability member may be a tube body made of a material with lower gas permeability than the second region, in which case the need to cover the tube body with another low-permeability member can be eliminated.

[0012] The low-permeability member may include at least one of butyl rubber, nitrile rubber, and fluororubber.

[0013] The container is a reaction container for synthesizing a radioactive drug solution, and the region of a first tube connected to the reaction container that is outside the plate may be the first region including a low-permeability member. Because the reaction container is heated, radioactive gas is likely to leak from the first tube. Therefore, by including a low-permeability member in the first tube, permeation of the radioactive gas can be suppressed.

[0014] The first tube includes a vacuum line for drawing a vacuum inside the reaction vessel, and the vacuum line does not need to be supported by a plate. When a portion of the vacuum line is supported by a plate, if the supported portion includes a low-permeability member, it becomes difficult to perform installation. On the other hand, when the vacuum line is not supported by a plate, it can include a low-permeability member without considering installation.

[0015] The container is a collection container that collects target water, which is a raw material for radioactive chemical solutions, and the region of a second tube connected to the collection container that is outside the plate may be the first region including a low-permeability member. In the collection container, the presence of target water makes it easier for radioactive gas to leak through the second tube. Therefore, by including a low-permeability member in the second tube, permeation of the radioactive gas can be suppressed.

[0016] The second tube may include at least a collection line for collecting the target water and a discharge line for discharging the collected target water. Since the collection line and the discharge line are lines through which the target water passes, the permeation of radioactive gas can be suppressed by including a low-permeability member in the lines.

[0017] A removable module according to one aspect of the present invention is a removable module that is installed in a fixed module of a radioactive drug solution synthesis device that synthesizes a radioactive drug solution, and includes a container for storing the radioactive liquid, a plurality of tubes, and a plate that supports the plurality of tubes, and a first region of the plurality of tubes that is outside the plate and connected to the container may include a low-permeability member that has lower gas permeability than a second region of the plurality of tubes that is supported within the plate.

[0018] When this detachable module is applied to a radioactive drug solution synthesizer, it is possible to obtain the same functions and effects as those described above. [Effects of the Invention]

[0019] According to the present invention, it is possible to provide a radioactive chemical solution synthesis device and a removable module that can suppress the permeation of radioactive gases. [Brief explanation of the drawings]

[0020] [Figure 1] 1 is a perspective view showing the configuration of a radioactive drug solution synthesis apparatus according to an embodiment of the present invention. [Figure 2] 2 is a front view showing the configuration of a detachable module included in the synthesizing device of FIG. 1. FIG. [Figure 3]FIG. 2 is an enlarged view of the vicinity of the reaction vessel. [Figure 4] FIG. [Figure 5] This is a specific example of a low-permeability member. [Figure 6] FIG. 10 is a diagram showing a detachable module according to a modified example. DETAILED DESCRIPTION OF THE INVENTION

[0021] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the following description, the same elements will be designated by the same reference numerals, and duplicated descriptions will be omitted. 18 The synthesis of F-FDG (fluorodeoxyglucose) will be explained.

[0022] Fig. 1 is a perspective view showing the configuration of a radioactive drug solution synthesizer according to this embodiment. Fig. 2 is a front view showing the configuration of a detachable module included in the synthesizer of Fig. 1. As shown in Figs. 1 and 2, the synthesizer 10 includes a detachable module 12 and a fixed module 14.

[0023] The removal module 12 has a target collection container 15, a reaction container 16, a plurality of lines L1-L15 for flowing fluids, and a plate 18 for positioning and supporting the plurality of lines L1-L15. The plurality of lines L1-L15 are formed from silicone tubes or the like.

[0024] The target collection vessel 15 receives high-energy protons accelerated by a cyclotron (not shown) and converts them into H2 18 Produced by nuclear reaction when irradiated with O 18Target water containing F ions (radioactive fluorine) is collected. This target collection container 15 has a capacity of approximately 7 cc and a V-shaped bottom, making it easy to discharge the collected target water to a subsequent stage. Connected to the target collection container 15 are a collection line L1 for collecting 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 collected target water. The base end of the discharge line L4 extends to the lowest point of the V-shaped bottom.

[0025] The end of this discharge line L4 is connected to the middle of an introduction line L5 that introduces a potassium carbonate (K2CO3) solution and a Kryptofix 222 (K222) solution. 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 trapping F ions. Note that this anion exchange resin cartridge 20 is not included in the detachable module 12 and is therefore indicated by a dashed line.

[0026] The reaction vessel 16 is a vial for synthesizing a radioactive drug solution by reacting raw materials. This reaction vessel 16 has a capacity of approximately 7 cc and a flat bottom for enhanced reactivity. Connected to the reaction vessel 16 are a first multipurpose line L7 for introducing N2 gas as an inert gas, a second multipurpose line L8 branching off from the first multipurpose line L7 and extending to the flat bottom of the reaction vessel 16, and a vacuum line L9 for evacuating the inside of the vial 16.

[0027] The first multipurpose line L7 and the recovery line L6 are connected by a connection line L10. An introduction line L11 for introducing acetonitrile is connected to the middle of this connection line L10. The acetonitrile introduced through this introduction line L11 is used to flow the solution in the line.

[0028] In addition, an introduction line L12 for introducing mannose triflate dissolved in acetonitrile is connected 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.

[0029] A drain line L15 for discharging the synthesized radioactive drug solution branches off from the second multipurpose line L8. A water inlet line (water inlet passage) L13 for introducing water used to discharge the radioactive drug solution from the reaction vessel 16 into the reaction vessel 16 is connected to the drain line L15. A water reservoir 22 for storing approximately 5 cc of water to be introduced is connected to the water inlet line L13 near its base end. Furthermore, a cleaning liquid reservoir 24 for storing approximately 5 cc of cleaning liquid for cleaning the reaction vessel 16 is connected to the water inlet line L13 near its base end and upstream of the water reservoir 22. An inlet line L14 for introducing a sodium hydroxide solution for hydrolysis is connected to the water inlet line L13.

[0030] Plate 18 is formed into a rectangle from a resin material such as polypropylene, and positions and supports the above-mentioned multiple lines L1-L15 at predetermined positions using multiple claws 26. A back plate 13 is provided at a predetermined position on plate 18 to compress lines L1-L15 between it and a piston 28, which will be described later.

[0031] The fixed module 14 is a member having a substantially cubic external shape, and includes a main body 32 and a door 34. A mounting portion 36 for mounting the plate 18 of the detachable module 12 is provided on the front surface of the main body 32. A storage hole 38 for storing the target collection container 15 is provided on the upper surface of the main body 32. Furthermore, a storage hole 40 for storing the reaction container 16 is provided on the upper surface of the step portion 32a of the main body 32. A heater (not shown) for heating the reaction container 16 is provided around the storage hole 40.

[0032] The door 34 is configured to open and close 90 degrees in the direction of arrow A via a hinge provided on the side of the step 32a of the main body 32. The door 34 can be opened and closed relative to the main body 32 by rotating a knob 42 to engage and disengage a hook 44 with an engaging hole 46 in the main body 32. A plurality of pistons 28 are provided at predetermined positions inside the door 34. The pistons 28 move back and forth using air. Air is supplied to each piston 28 via an air tube 48 extending from the main body 32. By moving the pistons 28 back and forth in this manner, the pistons 28 can function as on-off valves by compressing and retracting the lines L1-L15 between the pistons 28 and the substantially circular back plate 13. For ease of explanation, the back plate 13 in FIG. 2 is labeled 13-1 to 13-13 to distinguish the on-off valves 13-1 to 13-13 formed between the pistons 28.

[0033] In this radioactive drug synthesis apparatus 10, a purification column 50 for purifying the radioactive drug is connected to the effluent line L15. A product supply line L16 extends from this purification column 50 to a product vial (not shown) to supply the purified drug. The purification column 50 is covered with a shielding material that blocks radiation.

[0034] Next, a maintenance method for the radioactive drug synthesis device 10 will be described, including a method for synthesizing a radioactive drug.

[0035] When synthesizing 18F-FDG as a radioactive drug solution, first, high-energy protons accelerated by a cyclotron (not shown) are injected into H2 18 Produced by nuclear reaction when irradiated with O 18 Approximately 2 cc of target water containing F ions (radioactive fluorine) is collected through collection line L1 into target collection container 15. At this time, it is preferable to draw a vacuum through vacuum line L2, as this makes it easier to introduce and confine the target water into target collection container 15.

[0036] Next, N2 gas is introduced into the target collection container 15 through the gas introduction line L3, and the entire amount of target water is discharged through the discharge line L4. At this time, the on-off valves 13-1 and 13-4 are closed, and the on-off valves 13-2 and 13-3 are opened, so that the target water passes through the anion exchange resin cartridge 20. 18 The F ions are trapped, and the remaining target water is collected through collection line L6.

[0037] Next, the potassium carbonate solution is passed through the introduction line L5 to the anion exchange resin cartridge 20, 18 F ions are eluted and introduced into the reaction vessel 16. At the same time, the Kryptofix solution is introduced into the reaction vessel 16. At this time, the on-off valves 13-2, 13-3, 13-5, 13-6, and 13-7 are closed, and the on-off valves 13-1, 13-4, and 13-12 are opened. In this state, about 0.9 cc of raw material is contained in the reaction vessel 16.

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

[0039] Next, mannose triflate dissolved in acetonitrile is introduced into the reaction vessel 16 through the introduction line L12 and the first multipurpose line L7. At this time, the on-off valves 13-4, 13-5, and 13-7 are closed, and the on-off valve 13-12 is left open. Then, with the reaction vessel 16 sealed, it is heated at a set temperature of 100°C for 5 minutes using a heater (not shown). This allows the mannose triflate to be fluorinated. In this state, about 1.3 cc of raw material is contained in the reaction vessel 16.

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

[0041] Next, approximately 4 cc of sodium hydroxide is introduced into the reaction vessel 16 through the introduction line L14. At this time, the on-off valves 13-8, 13-10, and 13-11 are closed, and the on-off valves 13-9 and 13-13 are left open. The temperature of a heater (not shown) is set to 100°C, and the mixture is heated in a sealed state to perform hydrolysis. At this time, it is preferable to close the on-off valves 13-7, 13-9, 13-10, and 13-11, open the on-off valves 13-8 and 13-13, and introduce and bubble N2 gas into the reaction vessel 16 through the first multipurpose line L7 and the second multipurpose line L8. This agitates the liquid inside, accelerating hydrolysis. In this way, the reaction vessel 16 is heated to 100°C. 18 F-FDG is synthesized.

[0042] Then, N2 gas was introduced into the reaction vessel 16 through the first multipurpose line L7, and N2 gas was introduced through the second multipurpose line L8 and the drainage line L15. 18 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 opened. Then, impurities are removed through the purification column 50, and pure F-FDG is discharged. 18 F-FDG is extracted and supplied to a product vial through product supply line L16.

[0043] After that, about 5 cc of water is introduced from the water reservoir 22 into the reaction vessel 16 through the water introduction line L13. At this time, the on-off valves 13-8, 13-9, and 13-11 are closed, and the on-off valves 13-10 and 13-13 are opened. Then, N2 gas is introduced into the reaction vessel 16 through the first multipurpose line L7, and N2 gas remaining in the reaction vessel 16 is removed through the second multipurpose line L8 and the drain line L15. 18 The F-FDG is discharged together with the introduced water. 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 opened. Then, impurities are removed through the purification column 50, and the pure F-FDG is obtained. 18F-FDG is extracted and supplied to a product vial through product supply line L16.

[0044] The radioactive drug solution synthesis device 10 18 The synthesis of F-FDG is carried out in a radiation shield (hot cell) not shown. After one synthesis is completed, the detachable module 12 is replaced.

[0045] When replacing the removable module 12, the radiation shield (not shown) is not opened, and therefore, with the removable module 12 remaining installed in the fixed module 14, approximately 5 cc of cleaning liquid is introduced from the cleaning liquid reservoir 24 into the reaction vessel 16 through the water inlet line L13. At this time, the on-off valves 13-8, 13-9, and 13-11 are closed, and the on-off valves 13-10 and 13-13 are opened. As the cleaning liquid, acetonitrile, an organic solvent, etc. can be used in addition to water.

[0046] Next, the on-off valves 13-7, 13-9, 13-10, and 13-11 are closed, and the on-off valves 13-8 and 13-13 are opened, and N2 gas is introduced into the reaction vessel 16 through the first multipurpose line L7 and the second multipurpose line L8, and the cleaning liquid is bubbled. In addition, the reaction vessel 16 is heated by a heater (not shown) to boil the cleaning liquid. This removes the residue adhering to the inside of the reaction vessel 16. 18 F-FDG is dissolved and the inside of the reaction vessel 16 is cleaned, thereby reducing the radioactivity level inside the reaction vessel 16 to 5 mSv / year or less.

[0047] Then, N2 gas is introduced into the reaction vessel 16 through the first multipurpose line L7, and the cleaning liquid is discharged from the reaction vessel 16 through the second multipurpose line L8 and the drain line L15.

[0048] Thereafter, the radiation shield (not shown) is opened, the door 34 of the radioactive drug solution synthesizing apparatus 10 is opened, and the used detachable module 12 is removed from the main body 32 of the fixed module 14 and replaced with a new one.

[0049] Next, the features of the detachable module 12 of the radioactive liquid synthesizing apparatus 10 according to this embodiment will be described in more detail. As described above, as shown in Fig. 2, the radioactive liquid synthesizing apparatus 10 includes a container 60 for storing a radioactive liquid, a plurality of tubes 61, and a plate 18 for supporting the plurality of tubes 61. A region of the plurality of tubes 61 that is outside the plate 18 and connected to the container 60 is referred to as a first region E1. A region of the plurality of tubes 61 that is supported within the plate 18 is referred to as a second region E2.

[0050] The vessel 60 corresponds to the reaction vessel 16 in which a radioactive chemical solution (radioactive liquid) is synthesized. The tube 61 connected to the reaction vessel 16 is referred to as the first tube 61A. In this embodiment, the tubes 61 constituting the lines L7, L8, and L9 correspond to the first tube 61A. The vessel 60 corresponds to the target collection vessel 15 (collection vessel) in which target water (radioactive liquid) that is the raw material for the radioactive chemical solution is collected. The tube 61 connected to the target collection vessel 15 is referred to as the second tube 61B. In this embodiment, the lines L1, L2, L3, and L4 correspond to the second tube 61B.

[0051] 3 is an enlarged view of the reaction vessel 16 and its surroundings. FIG. 4 is an enlarged view of the target collection vessel 15 and its surroundings. In the radiochemical synthesis apparatus 10, [ 18 When handling high concentrations of [F]HF, etc., particularly in the tube 61 connected to the container 60, 18 [F]HF and the like permeate, facilitating leakage. Therefore, as shown in Figures 3 and 4, at least a portion of the first region E1 of the plurality of tubes 61 includes a low-permeability member 64 that has lower gas permeability than at least a portion of the second region E2. In Figures 3 and 4, the portions of the tubes 61 that include the low-permeability member 64 are colored gray. The portions of the tubes 61 that do not include the low-permeability member 64 are not colored gray.

[0052] In this embodiment, when the detachable module 12 is viewed as a whole (see FIG. 2 ), the second region E2 of the multiple tubes 61 supported within the plate 18 does not include the low-permeability member 64. However, even in the second region E2, a portion of the tubes 61 may include the low-permeability member 64. In addition, in this embodiment, the tubes 61 not connected to the container 60 (e.g., lines L5, L6, L11, L12, L13, L14, and L15) do not include the low-permeability member 64 even in a region outside the plate 18. Furthermore, the first multipurpose line L7 is drawn outward from the plate 18 at both end regions, but the one end connected to the container 60 includes the low-permeability member 64, while the other end not connected to the container 60 does not include the low-permeability member 64. However, even in the tubes 61 not connected to the container 60, the region outside the plate 18 may include the low-permeability member 64.

[0053] 3, the region of the first tube 61A connected to the reaction vessel 16 that is located outside the edge 18a of the plate 18 is the first region E1 including the low-permeability member 64. Since the reaction vessel 16 is heated, the low-permeability member 64 is 18[F]HF and the like vaporize and easily permeate. Therefore, it is preferable that all of the lines L7, L8, and L9 include the low-permeability member 64. In the example shown in FIG. 3, the entire area of ​​each of the lines L7, L8, and L9 between the connection 66 with the reaction vessel 16 and the boundary 67 corresponding to the edge 18a of the plate 18 includes the low-permeability member 64. However, the lines L7, L8, and L9 do not need to include the low-permeability member 64 over the entire area between the connection 66 and the boundary 67, but may include the low-permeability member 64 in only a portion of the area. For example, a portion of the area extending from the connection 66 toward the boundary 67 may not include the low-permeability member 64. A portion of the area extending from the boundary 67 toward the connection 66 may not include the low-permeability member 64. The vacuum line L9 may include the low-permeability member 64 over the entire area between the tip 68 and the boundary 69 on the tip 68 side, or in a portion of the area. For example, a portion of the region extending from the tip 68 toward the boundary 69 may not include the low-permeability member 64. A portion of the region extending from the boundary 69 toward the tip 68 may not include the low-permeability member 64. Of the regions between the connecting portion 66 and the boundaries 67, 69, it is preferable to include the low-permeability member 64 near the center position in the longitudinal direction of the first tube 61A. Note that the region including the low-permeability member 64 may be formed continuously along the longitudinal direction of the first tube 61A, or may be formed intermittently at a predetermined pitch.

[0054] Furthermore, the lines L7, L8, and L9 may have a low-permeability member 64 in a part of the region inside the plate 18. For example, the lines L7, L8, and L9 may include a low-permeability member 64 in a part of the region toward the inside of the plate 18 beyond the boundary portions 67 and 69. Note that the on-off valve 13 sandwiches the first tube 61A, thereby preventing the flow of [ 18The flow of [F]HF, etc. can be stopped. Therefore, even if the region of the first tube 61A that is inside the plate 18 relative to the on-off valve 13 contains the low-permeability member 64, the effect is low. Therefore, from the viewpoint of cost, it is preferable that the region including the low-permeability member 64 be located outside the plate 18 relative to the on-off valve 13. Furthermore, from the viewpoint of holding the first tube 61A at the locking portion 71, it is preferable from the viewpoint of holding it well that the region including the low-permeability member 64 be located outside the plate 18 relative to the locking portion 71. Note that the vacuum line L9 is supported by the plate 18 between the boundary portion 67 and the boundary portion 69, but the low-permeability member 64 may be included in the entirety or part of the supported region.

[0055] As shown in FIG. 4 , the region of the second tube 61B connected to the target collection container 15 that is located outside the edge 18b of the plate 18 is the first region E1, which includes the low-permeability member 64. Lines L1, L2, L3, and L4 all include the low-permeability member 64. However, among the second tubes 61B connected to the target collection container 15, the collection line L1 for collecting target water and the discharge line L4 for discharging the collected target water are lines through which the target water passes. On the other hand, lines L2 and L3 are lines through which the target water does not directly pass. Therefore, it is preferable that at least lines L1 and L4 include the low-permeability member 64, and the low-permeability member 64 may be omitted from lines L2 and L3. In the example shown in FIG. 4 , the entire region of line L4 between a connection 66 with the target collection container 15 and a boundary 67 corresponding to the edge 18b of the plate 18 includes the low-permeability member 64. However, the line L4 does not have to include the low-permeability member 64 over the entire area between the connecting portion 66 and the boundary portion 67, but may include it in a partial area. The lines L1, L2, and L3 may include the low-permeability member 64 over the entire area between the tip portion 68 and the connecting portion 66, or in a partial area. Note that the range over which the low-permeability member 64 may be included in the second tube 61B is the same as that for the first tube 61A.

[0056] Next, the characteristics of the tube 61 including the low permeability member 64 will be described. The gas permeability of the tube 61 including the low permeability member 64 may be 1 to 5% of the gas permeability of the tube 61 not including the low permeability member 64. For example, if nylon is used as the low permeability member and silicone rubber is used for the tube 61 not including the low permeability member 64, the permeability of nylon is 0.32 to 0.63 and the permeability of silicone rubber is 15.5 to 51.8. Note that the permeability is expressed in terms of "(cm 3 gas) (cm thickness) x 10 -7} / {(sec)(cm 2 )(cmHgΔp)}" Furthermore, it is preferable that the tube 61 including the low-permeability member 64 has flexibility to an extent that can ensure ease of installation of the container 60 at a predetermined position within the radioactive drug solution synthesizing apparatus 10.

[0057] Next, a specific configuration of the low-permeability member 64 will be described with reference to FIG. 5. As shown in FIG. 5(a), the low-permeability member 64 may be a covering member 73 that covers the tube main body 72. In this case, the tube main body 72 may be the same tube as the tube 61 that does not include the low-permeability member 64. As shown in FIG. 5(b), the covering member 73 may be a heat-shrinkable tubular member 74 that covers the tube main body 72. When covering, the tubular member 74 is placed around the tube main body 72 and heat is applied to cause it to shrink, thereby closely adhering the low-permeability member 64 to the tube main body 72 (see FIG. 5(a)). As shown in FIG. 5(c), the covering member 73 may be a strip-shaped member 75 that is wrapped around the tube main body 72 to cover the tube main body 72. The low-permeability member 64 formed by the covering member 73 may contain at least one of butyl rubber, nitrile rubber, and fluororubber. Note that the covering member 73 may be a coating layer formed by fluorine-coating the tube main body 72, for example. 5(d), the low-permeability member 64 may be a tube body 72 formed of a material having lower gas permeability than the tube 61 that does not include the low-permeability member 64 in the second region E2. In this case, the tube body 72 may include at least one of butyl rubber, nitrile rubber, and fluororubber.

[0058] Next, the operation and effect of the radioactive drug solution synthesizing apparatus and the detachable module 12 according to this embodiment will be described.

[0059] The radioactive drug solution synthesis apparatus 10 includes a detachable module 12 and a fixed module 14 on which the detachable module 12 is installed. Therefore, the detachable module 12 can be used as a disposable module by detaching it from the fixed module 14. Among the multiple tubes 61 of the detachable module 12, at least a portion of a first region E1 connected to the container 60 outside the plate 18 includes a low-permeability member 64 having lower gas permeability than at least a portion of a second region E2 supported within the plate 18. Thus, the first region E1 connected to the container 60 outside the plate 18 is a region through which radioactive gas is more likely to leak. By including the low-permeability member 64 in the first region E1, the low-permeability member 64 can suppress permeation of the radioactive gas. This allows the radioactive drug solution synthesis apparatus 10 to suppress permeation of the radioactive gas.

[0060] The low-permeability member 64 may be a heat-shrinkable tubular member 74 that covers the tube body 72. In this case, the low-permeability member 64 can be easily attached to the tube body 72 simply by covering a desired portion of the tube body 72 with the tubular member 74 and applying heat.

[0061] The low-permeability member 64 may be a strip-shaped member 75 that is wound around the tube body 72 to cover the tube body 72. In this case, the low-permeability member 64 can be easily attached to the tube body 72 by winding the strip-shaped member 75 around a desired location on the tube body 72.

[0062] The low-permeability member 64 may be a tube main body 72 made of a material that has lower gas permeability than the second region E2. In this case, the need to cover the tube main body 72 with another low-permeability member 64 can be omitted.

[0063] The low-permeability member 64 may include at least one of butyl rubber, nitrile rubber, and fluororubber.

[0064] The vessel 60 is a reaction vessel 16 in which a radioactive chemical solution is synthesized, and the region of a first tube 61A connected to the reaction vessel 16 that is outside the plate 18 may be a first region E1 that includes a low-permeability member 64. Since the reaction vessel 16 is heated, the radioactive gas is likely to leak from the first tube 61A. Therefore, by including the low-permeability member 64 in the first tube 61A, permeation of the radioactive gas can be suppressed.

[0065] The container 60 is a target collection container 15 that collects target water, which is a raw material for a radioactive chemical solution, and the region of the second tube 61B connected to the target collection container 15 that is outside the plate 18 may be a first region E1 that includes a low-permeability member 64. In the target collection container 15, the presence of target water makes it easier for radioactive gas to leak from the second tube 61B. Therefore, by including the low-permeability member 64 in the second tube 61B, permeation of the radioactive gas can be suppressed.

[0066] The second tube 61B may include at least a collection line L1 for collecting the target water and a discharge line L4 for discharging the collected target water. Since the collection line L1 and the discharge line L4 are lines through which the target water passes, the permeation of radioactive gas can be suppressed by including the low-permeability member 64 in these lines.

[0067] The removable module 12 according to this embodiment is a removable module 12 that is installed in a fixed module 14 of a radioactive drug solution synthesis device 10 that synthesizes a radioactive drug solution, and includes a container 60 for containing the radioactive liquid, a plurality of tubes 61, and a plate 18 that supports the plurality of tubes 61. A first region E1 of the plurality of tubes 61 that is located outside the plate 18 and connected to the container 60 may include a low-permeability member 64 that has lower gas permeability than a second region E2 of the plurality of tubes 61 that is supported within the plate 18.

[0068] When this detachable module 12 is applied to the radioactive drug solution synthesizing apparatus 10, it is possible to obtain the same functions and effects as those described above.

[0069] Furthermore, in the maintenance method for the radioactive chemical synthesis apparatus 10 according to this embodiment, the removable module 12 is replaced after cleaning the reaction vessel 16 and discharging the cleaning solution. This allows the removable module 12 to be replaced while the residual radioactivity level is low, thereby maintaining low radiation exposure for operators. Although some radioactive material remains in the purification column 50, the purification column 50 is shielded by a shielding material, thereby further reducing radiation exposure for operators. Furthermore, the next synthesis can be performed without waiting for the residual radioactivity level to sufficiently decrease, allowing efficient synthesis of radioactive chemicals. According to the inventor's calculations, under conditions of 300 days of synthesis performed twice a day, the annual radiation exposure for operators can be reduced by approximately one-sixth to one-seventh when the reaction vessel 16 is cleaned and the purification column 50 is shielded compared to when the purification column 50 is not cleaned and is not shielded.

[0070] Furthermore, when the inside of the reaction vessel 16 is cleaned with the cleaning liquid, the cleaning liquid is bubbled with N2 gas, so that the cleaning effect of the radioactive chemical liquid remaining in the reaction vessel 16 can be improved.

[0071] Furthermore, when the inside of the reaction vessel 16 is cleaned with the cleaning liquid, the cleaning liquid is boiled, so that the cleaning effect of the radioactive drug liquid remaining in the reaction vessel 16 can be further improved.

[0072] Furthermore, by introducing a cleaning solution into the reaction vessel 16 through the water introduction line L13, the water introduction line L13 can be used for both introducing water and introducing a cleaning solution, thereby avoiding the configuration of the radioactive drug solution synthesis apparatus 10 from becoming complicated.

[0073] The present invention is not limited to the above-described embodiment, and various modifications are possible. For example, although sodium hydroxide is introduced into the reaction vessel 16 for hydrolysis in the above-described embodiment, hydrochloric acid may be introduced instead.

[0074] In the above embodiment, the radioactive drug solution 18Although the synthesis of F-FDG has been described, other radioactive drug solutions may also be synthesized.

[0075] A detachable module 12 as shown in Fig. 6 may be employed. As shown in Fig. 6, the first tube 61A includes a vacuum line L9 that draws a vacuum inside the reaction vessel 16, and the vacuum line L9 does not need to be supported by the plate 18. When a portion of the vacuum line L9 is supported by the plate 18, if the supported portion includes a low-permeability member 64, it becomes difficult to perform installation. On the other hand, when the vacuum line L9 is not supported by the plate 18, the low-permeability member 64 can be included without considering installation ease. [Explanation of symbols]

[0076] 10...Radioactive drug solution synthesis device, 12...Removable module, 14...Fixed module, 15...Target collection container (collection container), 16...Reaction container, 18...Plate, 60...Container, 61...Tube, 61A...First tube, 61B...Second tube, 64...Low-permeability member, 72...Tube main body, 74...Tubular member, 75...Strip-shaped member.

Claims

1. A radioactive drug solution synthesis apparatus comprising: a removable module; and a fixed module on which the removable module is installed, the radioactive drug solution synthesis apparatus comprising: The detachment module includes: a container containing a radioactive liquid; A plurality of tubes; a plate supporting the plurality of tubes; A radioactive drug solution synthesis device, wherein at least a portion of a first region of the plurality of tubes that is outside the plate and connected to the container includes a low-permeability material that has lower gas permeability than at least a portion of a second region supported within the plate.

2. 2. The radioactive drug solution synthesizing apparatus according to claim 1, wherein the low-permeability member is a heat-shrinkable tubular member that covers a tube body.

3. 2. The radioactive drug solution synthesizing apparatus according to claim 1, wherein the low-permeability member is a strip-shaped member that is wound around the tube body to cover the tube body.

4. 2. The radioactive drug solution synthesizing apparatus according to claim 1, wherein the low-permeability member is a tube body formed of a material having a lower gas permeability than the second region.

5. 2. The radioactive drug solution synthesizing apparatus according to claim 1, wherein the low-permeability member includes at least one of butyl rubber, nitrile rubber, and fluororubber.

6. the vessel is a reaction vessel for synthesizing the radioactive drug solution, 2. The radioactive drug solution synthesizing apparatus according to claim 1, wherein a region of a first tube connected to the reaction vessel that is outside the plate is the first region that includes the low-permeability member.

7. The first tube has a vacuum line for evacuating the inside of the reaction vessel, The radiopharmaceutical solution synthesis apparatus of claim 6 , wherein the vacuum line is not supported by the plate.

8. the container is a collection container for collecting target water that is a raw material for the radioactive chemical solution, 2. The radioactive drug solution synthesizing apparatus according to claim 1, wherein a region of a second tube connected to the collection container that is outside the plate is the first region including the low-permeability member.

9. 9. The radiochemical solution synthesizing apparatus according to claim 8, wherein the second tubes include at least a recovery line for recovering the target water and a discharge line for discharging the recovered target water.

10. A removable module that is installed in a fixed module of a radioactive drug solution synthesis apparatus that synthesizes a radioactive drug solution, a container containing a radioactive liquid; A plurality of tubes; a plate supporting the plurality of tubes; A detachable module, wherein a first region of the plurality of tubes that is outside the plate and connected to the container includes a low-permeability member that has lower gas permeability than a second region of the plurality of tubes that is supported within the plate.

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