Radiation shielding system for manufacturing radiopharmaceutical

Abstract

Disclosed is a radiation shielding system for manufacturing a radiopharmaceutical. The radiation shielding system for manufacturing a radiopharmaceutical according to an aspect of the present invention comprises: a synthesis unit having a synthesis module device for synthesizing a radiopharmaceutical therein; a distribution unit that is disposed adjacent to one side of the synthesis unit and distributes the radiopharmaceutical synthesized in the synthesis unit; and an auxiliary storage unit disposed on the other side of the synthesis unit and including a power supply device and a control device for controlling an automatic synthesis device.

Description

Radiation shielding systems for radiopharmaceutical manufacturing

[0001] The present invention relates to a radiation shielding system for the manufacture of radiopharmaceuticals, and more particularly, to a radiation shielding system for the synthesis and distribution of Ga-68 PSMA-11 radiopharmaceuticals.

[0002] Radiopharmaceuticals utilize radiation emitted as a result of nuclear decay to investigate and diagnose physiological and pathological processes within the body. These radiopharmaceuticals come in various forms and applications and can be divided into diagnostic and therapeutic uses. Diagnostic radiopharmaceuticals are administered internally and absorbed by specific organs. The radiation emitted from these organs is detected to form images, allowing the diagnosis of disease.

[0003] Diagnostic radiopharmaceuticals primarily utilize gamma rays and positron rays, as they emit highly penetrating radiation when administered to the human body. A representative imaging test utilizing gamma rays is PET-CT. However, due to the nature of the radiopharmaceuticals used in PET-CT, their half-life is only about 120 minutes. Therefore, operating the equipment is impossible without a nearby production facility for producing and dispensing the radiopharmaceuticals.

[0004] Among them, Ga-68 PSMA-11 radiopharmaceuticals are a new medical technology being implemented to diagnose and stage recurrence in prostate cancer patients, and to assist in the diagnosis of whether to perform a tissue biopsy and confirm the location of the tissue in patients suspected of having prostate cancer. Due to the recent increase in the number of prostate cancer patients, the need for Ga-68-11 PSMA radiopharmaceuticals is emerging. Seoul National University Hospital and Ewha Womans University Seoul Hospital recently synthesized and prepared Ga-68 PSMA-11 radiopharmaceuticals in November 2023, and they are being used for diagnostic testing of prostate cancer patients.

[0005] Meanwhile, Ga-68 PSMA-11 radiopharmaceuticals are exempt from the GMP standards stipulated by the Ministry of Food and Drug Safety, and thus do not require clean rooms or expensive hot-cell equipment like production facilities that have received production permits to synthesize and prepare them. However, only a few medical institutions with expensive production facilities that comply with GMP standards currently prepare Ga-68 PSMA-11 radiopharmaceuticals, and many medical institutions are unable to synthesize Ga-68 PSMA-11 radiopharmaceuticals due to the burden of hot-cell purchase costs.

[0006] Furthermore, the typical method of synthesizing and preparing radiopharmaceuticals involves workers manually extracting radioisotopes from a generator, slowly injecting them into a diagnostic kit, and allowing them to stabilize for a set period of time. Once prepared, a portion of the radiopharmaceutical is subjected to quality control inspections. Only when the specific control criteria are met are the drugs used on patients. If this process is performed manually, workers lacking the necessary understanding and skills for radiopharmaceutical synthesis may be exposed to unnecessary radiation exposure during the extraction and synthesis of the radioisotopes.

[0007] The present invention is intended to solve the above problems, and the purpose of the present invention is to provide a radiation shielding system for manufacturing radiopharmaceuticals, which can synthesize and prepare radiopharmaceuticals at low cost without having to equip expensive hot cells in medical institutions that do not have production facilities.

[0008] Another object of the present invention is to provide a radiation shielding system for manufacturing radiopharmaceuticals, which can minimize unnecessary radiation exposure of workers during the synthesis and preparation process of radiopharmaceuticals.

[0009] The tasks of the present invention are not limited to the tasks mentioned above, and other tasks not mentioned will be clearly understood by those skilled in the art to which the present invention pertains from the description below.

[0010] According to one aspect of the present invention, a radiation shielding system for manufacturing a radiopharmaceutical is provided, including: a synthesis unit having an automatic synthesis unit for synthesizing a radiopharmaceutical therein; a distribution unit disposed adjacent to one side of the synthesis unit and for distributing a radiopharmaceutical synthesized in the synthesis unit; and an auxiliary storage unit disposed on the other side of the synthesis unit and having a control unit for controlling the automatic synthesis unit and a power supply unit.

[0011] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided, wherein the synthetic part includes a first shielding door that can be opened and closed at the front, and the first shielding door includes a first shielding glass member at the center so that the synthetic process can be visually observed.

[0012] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided in which the distribution unit and the synthesis unit are formed to have the same height of the bottom surface, and an opening is formed on a surface adjacent to the distribution unit and the synthesis unit so that the bottom surface of the distribution unit and the synthesis unit is connected.

[0013] At this time, a radiation shielding system for manufacturing radioactive pharmaceuticals is provided in the distribution unit, which is equipped with a sliding cover that can open and close the opening.

[0014] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided, wherein the distribution unit includes a shielding block therein, and the shielding block includes a plurality of side walls.

[0015] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided in which one of the two side walls that are arranged to face each other in the longitudinal direction of the shielding block includes a first cut surface, the other of the two side walls includes a second cut surface, and a space is formed in front of each of the first cut surface and the second cut surface.

[0016] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided, wherein the width-wise front side wall of the shielding block includes a third cut surface and a fourth cut surface on both sides in the length direction, a space is formed between the first cut surface and the third cut surface, and a space is formed between the second cut surface and the third cut surface.

[0017] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided, wherein the other side wall among the two side walls further includes a fifth cut surface extending from the lower end of the second cut surface to the floor surface.

[0018] At this time, a radiation shielding system is provided in which the other side wall among the two side walls including the second cut surface and the fifth cut surface is arranged in the direction in which the composite part is located.

[0019] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided, wherein the shielding block is positioned on the upper portion of the widthwise front side wall of the shielding block, and includes an extension wall formed to extend at a predetermined angle toward the widthwise rear.

[0020] At this time, the extension wall is provided with a radiation shielding system for manufacturing radioactive pharmaceuticals, in which a second shielding glass member is provided in the central portion.

[0021] At this time, a radiation shielding system for manufacturing radioactive pharmaceuticals is provided, in which the distribution unit is provided with a second shielding door that can be opened and closed in the height direction at the front upper portion.

[0022] At this time, a radiation shielding system for manufacturing radioactive pharmaceuticals is provided, wherein the second shielding door is made of a transparent material whose inside can be visually confirmed.

[0023] According to another aspect of the present invention, a radiation shielding system for manufacturing a radiopharmaceutical is provided, comprising: a synthesis unit having an automatic synthesis device for automatically synthesizing a radiopharmaceutical therein; a distribution unit disposed adjacent to one side of the synthesis unit and for distributing the radiopharmaceutical synthesized in the synthesis unit; and a waste storage unit disposed below the synthesis unit and for storing used consumables.

[0024] At this time, a radiation shielding system for manufacturing radioactive pharmaceuticals is provided in the waste storage unit, in which rails are provided on both sides of the waste storage box.

[0025] At this time, a radiation shielding system for manufacturing a radioactive pharmaceutical is provided, which further includes a specimen storage unit that is arranged on one side of the distribution unit and can store the manufactured radioactive pharmaceutical.

[0026] According to the above configuration, a radiation shielding system for manufacturing a radiopharmaceutical according to one aspect of the present invention can synthesize and prepare a radiopharmaceutical at a low cost without having to have an expensive hot cell.

[0027] In addition, a radiation shielding system for manufacturing a radiopharmaceutical according to one aspect of the present invention automates the synthesis process of the radiopharmaceutical and has a shielding block and a shielding door in the distribution unit, thereby minimizing unnecessary radiation exposure of workers during the synthesis and preparation process of the radiopharmaceutical.

[0028] In addition, the radiation shielding system for manufacturing a radioactive pharmaceutical according to one aspect of the present invention allows a worker to visually observe the synthesis and distribution process through a shielding door.

[0029] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the detailed description of the present invention or the composition of the invention described in the claims.

[0030] FIG. 1 is a front view illustrating a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0031] FIG. 2 is an enlarged front view of a portion of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0032] FIG. 3 is a perspective view illustrating a synthesis section and a distribution section of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0033] FIG. 4 is a perspective view illustrating a shielding block of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0034] Fig. 5 is a cross-sectional view of part AA of Fig. 1.

[0035] FIG. 6 is a right side view illustrating a shielding block of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0036] FIG. 7 is a front view showing a state in which the second shielding door of the distribution unit of the radiation shielding system for manufacturing a radioactive pharmaceutical according to one embodiment of the present invention is lowered.

[0037] FIG. 8 is a perspective view illustrating an auxiliary storage unit of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0038] FIG. 9 is a perspective view illustrating a state in which a waste storage compartment of a radiation shielding system for manufacturing a radioactive pharmaceutical according to one embodiment of the present invention is open.

[0039] Hi, with reference to the attached drawings, embodiments of the present invention are described in detail so that those skilled in the art can easily implement them. The present invention can be implemented in various different forms and is not limited to the embodiments described herein. To clearly explain the present invention, parts irrelevant to the description are omitted from the drawings, and the same reference numerals designate identical or similar components throughout the specification.

[0040] The words and terms used in this specification and claims should not be construed as limited to their ordinary or dictionary meanings, but should be interpreted in a way that is consistent with the technical idea of ​​the present invention, in accordance with the principles by which the inventor can define terms and concepts in order to best explain his or her invention.

[0041] Therefore, the embodiments described in this specification and the configurations illustrated in the drawings correspond to a preferred embodiment of the present invention, and do not represent all of the technical ideas of the present invention, so there may be various equivalents and modified examples that can replace the configuration at the time of filing of the present invention.

[0042] In this specification, terms such as “include” or “have” are intended to describe the presence of a feature, number, step, operation, component, part or combination thereof described in the specification, but should be understood not to exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts or combinations thereof.

[0043] When a component is said to be "in front of," "behind," "above," or "below" another component, this includes not only being placed "in front of," "behind," "above," or "below" the other component in direct contact with it, but also if there is another component intervening therebetween. Furthermore, when a component is said to be "connected" to another component, this includes not only being directly connected to one another, but also being indirectly connected to one another, unless there are special circumstances.

[0044] Hereinafter, a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention will be described with reference to the drawings.

[0045] FIG. 1 is a front view illustrating a radiation shielding system for manufacturing a radiopharmaceutical according to an embodiment of the present invention. FIG. 2 is an enlarged front view of a portion of a radiation shielding system for manufacturing a radiopharmaceutical according to an embodiment of the present invention. FIG. 3 is a perspective view illustrating a synthesis unit and a distribution unit of a radiation shielding system for manufacturing a radiopharmaceutical according to an embodiment of the present invention. Hereinafter, with reference to FIG. 1, the X direction is defined as the length direction, the Y direction as the width direction, and the Z direction as the height direction, and in the width direction, the direction shown in the drawing is defined as the front, and the direction facing the back is defined as the rear.

[0046] Referring to FIG. 1, a radiation shielding system (1) for manufacturing a radioactive pharmaceutical according to one embodiment of the present invention includes a synthesis unit (10), a distribution unit (20), an auxiliary storage unit (40), a waste storage unit (50), and a specimen storage unit (60).

[0047] Referring to Fig. 2, the synthesis unit (10) may be formed of a box-shaped lead shield. The synthesis unit (10) may be equipped with an automatic synthesis device (S) therein to automate the extraction process of the radiopharmaceutical and the synthesis process with the diagnostic kit. Generally, to manufacture a radiopharmaceutical, a radioisotope is extracted, then injected into a diagnostic kit and a predetermined stabilization time is allowed. By automating this process, the radiation exposure dose to the worker during manual work can be reduced. At this time, the generator and diagnostic kit equipped in the automatic synthesis device (S) can be selected and installed by the user according to the manufacturing cost.

[0048] A first shielding door (15) may be provided on the front of the composite part (10). The first shielding door (15) may be made of a shielding material such as lead to shield the inside of the composite part (10). In order to open and close the first shielding door (15) while supporting its weight, a first hinge (11) may be provided on one side of the front surface of the composite part (10), and a second hinge (16) may be provided on one side of the first shielding door (15).

[0049] At this time, as shown in FIG. 5, the first hinge (11) is formed in an 'ㄱ' shape, and the second hinge (16) is formed in an 'l' shape, so that when the first shielding door (15) is closed, the first hinge (11) and the second hinge (16) form a 'U' shape, which can more firmly support the first shielding door (15).

[0050] Referring to Fig. 2, a first shielding glass member (18) may be provided in the central portion of the first shielding door (15). At this time, the first shielding glass member (18) may be made of a member with good light transmittance and radiation shielding, such as lead glass, so that a worker can visually check the synthesis process.

[0051] As illustrated in Fig. 3, the radioactive pharmaceutical synthesized in the synthesis unit (10) can be accommodated in a vial shield (2) made of lead to shield the emitted radiation. This vial shield (2) can be moved to a distribution unit (20) to measure its weight and dispense an appropriate amount. To facilitate the operator's transport of the vial shield (2), the vial shield (2) can be equipped with a handle.

[0052] Referring to FIGS. 2 and 3, the distribution unit (20) is made of a box-shaped lead shield and can be placed adjacent to the synthesis unit (10). By placing the distribution unit (20) and the synthesis unit (10) adjacent to each other, the synthesis and distribution of radioactive pharmaceuticals can be performed in one space.

[0053] Referring to Fig. 3, an opening (21) is formed on the adjacent surface of the distribution unit (20) and the composite unit (10), and the vial shield (2) can be moved from the composite unit (10) to the distribution unit (20) through the opening (21). At this time, the height of the bottom surface of the distribution unit (20) and the composite unit (10) can be formed to be the same so that the worker can easily transport the vial shield (2). In addition, the distribution unit (20) and the composite unit (10) can be formed as a single box-shaped shield and separated with a wall in the center.

[0054] The distribution unit (20) may be provided with a sliding cover (22) that can open and close the opening (21). Since the interior of the composite unit (10) must be shielded when the opening is closed, the sliding cover (22) may be made of a shielding material such as lead. To enable a worker to easily open and close the sliding cover (22), a handle may be provided on the sliding cover (22), and a pair of rails may be provided on one side of the distribution unit (20) where the sliding cover (22) is placed.

[0055] Meanwhile, the ceilings of the synthesis unit (10) and the distribution unit (20) are equipped with UV lamps (14, 24) for internal sterilization and disinfection and exhaust holes (13, 23) connected to separate exhaust purification devices, respectively, so that the internal environments of the synthesis unit (10) and the distribution unit (20) can be maintained appropriately. In addition, an operation switch (26) for operating the devices provided in the synthesis unit (10) and the distribution unit (20) can be equipped on one wall of the distribution unit (20).

[0056] FIG. 4 is a perspective view illustrating a shielding block of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention. FIG. 5 is a cross-sectional view of portion AA of FIG. 1. FIG. 6 is a right side view illustrating a shielding block of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention.

[0057] As shown in Fig. 2, a shielding block (30) capable of shielding radiation emitted to the outside from a vial containing a radioactive pharmaceutical during distribution may be provided inside the distribution unit (20).

[0058] Referring to Fig. 4, the shielding block (30) may be formed of a plurality of side walls forming an internal space. According to one embodiment of the present invention, the shielding block (30) may be provided with a first side wall (31) at the front, a second side wall (32) and a fourth side wall (34) that are arranged oppositely in the longitudinal direction (X), a third side wall (33) at the rear, and an extension wall (35) that is formed to extend from the first side wall.

[0059] The second side wall (32) is provided with a first cut surface (32a) cut in the height direction (Z) from one side of the upper surface of the second side wall (32), and a space can be formed forward from the first cut surface (32a) in the width direction (Y). Similarly, the fourth side wall (34) is provided with a second cut surface (34a) cut in the height direction (Z) from one side of the upper surface of the fourth side wall (34), and a space can be formed forward from the second cut surface (34a) in the width direction (Y).

[0060] The first side wall (31) may be provided with a third cutting plane (31a) and a fourth cutting plane (31b) on both sides in the longitudinal direction (X). At this time, the third cutting plane (31a) may be connected to the first cutting plane (32a) at the bottom surface, and a space may be formed between the first cutting plane (32a) and the third cutting plane (31a). In addition, the fourth cutting plane (31b) may be connected to the second cutting plane (34a) at the bottom surface, and a space may be formed between the second cutting plane (34a) and the fourth cutting plane (31b).

[0061] In this way, by forming a space on both sides of the longitudinal direction (X) in front of the shield block (30), it is possible to maintain the shield wall high while making it easy for a worker to put his or her hand inside the shield block (30) and work.

[0062] Referring to FIG. 4, the fourth side wall (34) may further be provided with a fifth cutting surface (34b) extending from the lower end of the second cutting surface (34a) to the floor surface. In other words, the second cutting surface (34a) and the fifth cutting surface (34b) may form a single surface, thereby allowing one side of the fourth side wall (34) to be opened.

[0063] Referring to Fig. 5, the open side of the fourth side wall (34) and the opening (21) are arranged parallel to each other in the longitudinal direction (X), so that when the sliding cover (22) is opened, the interior of the composite part (10) and the shielding block (30) can be communicated. Accordingly, the worker can easily transport the vial shield (2) from the composite part (10) to the interior of the shielding block (30).

[0064] Referring to Fig. 6, the extension wall (35) can be formed to extend at a predetermined angle (θ) toward the rear from the upper portion of the first side wall (31). With the extension wall (35) provided, radiation directed toward the front of a standing worker during distribution work can be shielded.

[0065] The angle (θ) formed by the extension wall (35) and the first side wall (31) can be a value between 90° and 180°. This angle (θ) can be designed differently depending on the height of the worker and the height of the distribution unit (20), but can preferably be designed to be a value between 130° and 150°.

[0066] As illustrated in Fig. 4, a second shielding glass member (36) may be provided in the central portion of the extension wall (35). At this time, the second shielding glass member (36) may be made of a member with good light transmittance and radiation shielding, such as lead glass, so that the worker can visually check the inside of the shielding block (30).

[0067] Fig. 7 is a front view illustrating a state in which the second shielding door of the distribution unit of the radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention is lowered. Fig. 8 is a perspective view illustrating an auxiliary storage unit of the radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention. Fig. 9 is a perspective view illustrating a state in which the waste storage unit of the radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention is opened.

[0068] Referring to Fig. 7, a second shielding door (25) may be provided on the front of the distribution unit (20). The second shielding door (25) may be provided as a sliding door that can be opened and closed in the height direction for the convenience of distribution work, and may be made of a transparent material.

[0069] When dispensing the synthesized radiopharmaceutical, the second shielding door (25) can be lowered as illustrated in Fig. 7. Accordingly, the worker can perform the dispensing operation by inserting his / her hand between the space formed by the first to fourth cutting surfaces (31a, 31b, 32a, 34a) of the shielding block (30) and the second shielding door (25). By opening only the minimum space required for dispensing, unnecessary radiation exposure to the worker can be reduced.

[0070] Referring to FIGS. 1 and 8, an auxiliary storage unit (40) may be provided on one side of the synthesis unit (10). A power supply unit (P) that supplies power to the automatic synthesis unit (S) and a control unit (C) that can control the automatic synthesis unit (S) may be stored in the auxiliary storage unit (40).

[0071] The auxiliary storage unit (40) is provided with a sliding plate (42) that protrudes outward and a control device (C) mounted thereon, so that the worker can visually check the synthesis process while operating the control device (C).

[0072] At this time, the power supply (P) may be equipped with an uninterruptible power supply that supplies power for a certain period of time even during a power outage.

[0073] Meanwhile, as illustrated in FIG. 5, an air hole (44) is formed between the composite part (10) and the auxiliary storage part (40), so that air inside the composite part (10) can be exhausted through the exhaust hole (13) while low-temperature external air can be supplied into the composite part (10).

[0074] Meanwhile, referring to FIGS. 1 and 9, a waste storage unit (50) may be provided at the bottom of the synthesis unit (10). The waste storage unit (50) may store consumables used in the synthesis of radiopharmaceuticals for a certain period of time during the process of synthesizing radiopharmaceuticals in the synthesis unit (10).

[0075] These consumables contain a small amount of radioactive pharmaceuticals, which may increase the radiation exposure of workers during transport from the synthesis unit (10) to the waste storage unit (50). Therefore, it is preferable that the waste storage unit (50) be located adjacent to the synthesis unit (10).

[0076] The waste storage unit (50) includes a waste storage box (52), and the front of the waste storage box (52) may be shielded with lead. A pair of rails (52a, 52b) may be provided on both sides of the waste storage unit (50) so that a worker can easily take out the waste storage box (52).

[0077] Referring to Fig. 1, a specimen storage unit (60) may be provided on one side of a distribution unit (20). Radiopharmaceuticals prepared in the synthesis unit (10) and distribution unit (20) undergo pre-inspection and post-inspection for quality control to determine whether they are suitable as pharmaceuticals and determine whether or not they can be used. At this time, the initially produced radiopharmaceuticals may be stored in the specimen storage unit (60) for post-inspection. In addition, the specimen storage unit (60) may be formed of a shielding material, such as lead, to shield radiation emitted from the radiopharmaceutical.

[0078] The stability of a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention is evaluated as follows.

[0079] For the production of Ga-68 PSMA-11 radiopharmaceuticals, it is assumed that the radiation shielding system is designed with an inner wall made of 30 tons of lead, and the first shielding glass member (18) and the second shielding glass member (36) are designed with a thickness of 150 tons of lead glass. In addition, it is assumed that the Ge-68 / Ga-68 generator provided inside the composite part (10) is shielded with 80 mm of lead, and a radiation shielding tool made of tungsten is used.

[0080] The gamma constant of Ge-68 / Ga-68 radioisotopes was based on the radionuclide information in 'The Health Physics and Radiological Health Handbook (Revised Edition)', and the linear attenuation coefficient for lead was calculated by interpolating the linear attenuation coefficient for each material by applying the highest ratio of the specific energy of each radioisotope. The Ge / Ga-68 generator is assumed to store one with a maximum activity of 1,850 MBq, and the daughter nuclide Ga-68 was evaluated as a single release amount. For a conservative evaluation, the gamma constant of Ge-68 / Ga-68 radioisotopes and the linear attenuation coefficient for lead were evaluated using Ga-68. The internal dimensions of the storage box where the Ga-68 radioisotope and the PSMA-11 diagnostic kit are synthesized are 700 mm x 700 mm x 600 mm in length, width, and height, respectively, and it is shielded with lead (Pb30 mm). The dimensions of the front lead glass of the storage box are 400 mm Х 280 mm in width, length, and thickness, respectively, and the lead glass is T150 mm, and the equivalent lead weight is Pb30 mm. In addition, the minimum distance between the storage box and the surrounding boundary wall was assumed to be 1.5 m (γ=1.5 m).

[0081]

[0082] After shielding with a minimum thickness of Pb80mm for the Ge-68 / Ga-68 generator container and lead Pb30mm for the storage box, the dose rate is as follows.

[0083]

[0084] Assuming that the worker's working hours in the Ga-68 PSMA-11 dedicated radiation shielding system are 40 hours per week and 50 weeks per year, the calculation is as follows.

[0085]

[0086] The single dose of radioactivity prepared after synthesis of Ga-68, a progeny nuclide extracted from the Ge-68 / Ga-68 generator, and the PSMA-11 diagnostic kit was conservatively estimated at the maximum dose of 1,850 MBq (50 mCi). The minimum distance between the radiation shielding system and the surrounding boundary wall was assumed to be 1.5 m (γ=1.5 m).

[0087]

[0088] The minimum thickness of the lead shield containing the Ga-68 PSMA-11 radiopharmaceutical is Pb10mm, and the dose rate after shielding with the lead shielding thickness of the radiation shielding system is Pb30mm is as follows.

[0089]

[0090] If the worker's working hours in the Ga-68 PSMA-11 dedicated radiation shielding system are calculated as 40 hours per week and 50 weeks per year, the following is true.

[0091]

[0092] As shown in the above evaluation, when a radiopharmaceutical is synthesized and prepared using a radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention, the annual radiation dose of the worker does not exceed 20 mSv per year. Therefore, it can be seen that the radiation shielding system for manufacturing a radiopharmaceutical according to one embodiment of the present invention satisfies the design criteria for shielding materials according to Radiation Regulation No. 13.

[0093] By using a radiation shielding system for manufacturing a radiopharmaceutical according to one aspect of the present invention, a radiopharmaceutical can be synthesized and prepared at low cost without having to have an expensive hot cell.

[0094] In addition, by using a radiation shielding system for manufacturing a radiopharmaceutical according to one aspect of the present invention, unnecessary radiation exposure of workers can be minimized during the synthesis and preparation process of a radiopharmaceutical, and workers can visually check the synthesis and distribution process.

[0095] Although the embodiments of the present invention have been described, the spirit of the present invention is not limited to the embodiments presented in this specification, and those skilled in the art who understand the spirit of the present invention will be able to easily propose other embodiments by adding, changing, deleting, or adding components within the scope of the same spirit, but this will also be considered to fall within the spirit of the present invention.

Claims

1. A synthesis unit equipped with an automatic synthesis device for synthesizing a radioactive pharmaceutical inside; A distribution unit disposed adjacent to one side of the above-mentioned synthesis unit, through which the radioactive pharmaceutical synthesized in the above-mentioned synthesis unit is distributed; and An auxiliary storage unit disposed on the other side of the above-mentioned synthesis unit and equipped with a control unit for controlling the automatic synthesis unit and a power supply unit; A radiation shielding system for the manufacture of radiopharmaceuticals including:

2. In paragraph 1, A radiation shielding system for manufacturing a radioactive pharmaceutical, wherein the above-mentioned synthesis unit includes a first shielding door that can be opened and closed at the front, and the first shielding door includes a first shielding glass member at the center so that the synthesis process can be visually observed.

3. In paragraph 1, A radiation shielding system for manufacturing a radioactive pharmaceutical, wherein the distribution section and the synthesis section are formed with the same height of the bottom surface, and an opening is formed on an adjacent surface of the distribution section and the synthesis section so that the bottom surface of the distribution section and the synthesis section is connected.

4. In paragraph 3, A radiation shielding system for manufacturing radioactive pharmaceuticals, wherein the above distribution unit is provided with a sliding cover capable of opening and closing the above opening.

5. In paragraph 1, A radiation shielding system for manufacturing a radiopharmaceutical, wherein the distribution unit includes a shielding block therein, and the shielding block includes a plurality of side walls.

6. In paragraph 5, A radiation shielding system for manufacturing a radioactive pharmaceutical, wherein one of the two side walls that are arranged to face each other in the longitudinal direction of the shielding block includes a first cut surface, the other of the two side walls includes a second cut surface, and a space is formed in front of each of the first cut surface and the second cut surface.

7. In paragraph 6, A radiation shielding system for manufacturing a radiopharmaceutical, wherein the widthwise front side wall of the shielding block includes a third cut surface and a fourth cut surface on both sides in the lengthwise direction, a space is formed between the first cut surface and the third cut surface, and a space is formed between the second cut surface and the third cut surface.

8. In paragraph 6, A radiation shielding system for manufacturing a radiopharmaceutical, wherein the other side wall among the above two side walls further includes a fifth cut surface extending from the lower end of the second cut surface to the floor surface.

9. In paragraph 8, A radiation shielding system in which the other side wall among the two side walls including the second cut surface and the fifth cut surface is positioned in the direction in which the composite part is located.

10. In paragraph 5, A radiation shielding system for manufacturing a radiopharmaceutical, wherein the shielding block is positioned on the upper portion of the widthwise front side wall of the shielding block and includes an extension wall formed to extend at a predetermined angle toward the widthwise rear.

11. In paragraph 10, The above extension wall is a radiation shielding system for manufacturing radioactive pharmaceuticals, wherein a second shielding glass member is provided in the central portion.

12. In paragraph 1, A radiation shielding system for manufacturing radioactive pharmaceuticals, wherein the above distribution unit is provided with a second shielding door that can be opened in the height direction at the upper front.

13. In paragraph 12, The second shielding door is a radiation shielding system for manufacturing radioactive pharmaceuticals, made of a transparent material whose inside can be visually confirmed.

14. A synthesis unit equipped with an automatic synthesis device that automatically synthesizes radioactive pharmaceuticals inside; A distribution unit disposed adjacent to one side of the above-mentioned synthesis unit, through which the radioactive pharmaceutical synthesized in the above-mentioned synthesis unit is distributed; and A waste storage unit located at the bottom of the above-mentioned composite section and where used consumables are stored; A radiation shielding system for the manufacture of radiopharmaceuticals including:

15. In paragraph 14, A radiation shielding system for manufacturing radioactive pharmaceuticals, wherein the above waste storage compartment is provided with rails on both sides of the waste storage container.

16. In paragraph 1 or paragraph 14, A radiation shielding system for manufacturing a radiopharmaceutical, further comprising a specimen storage unit arranged on one side of the above distribution unit and capable of storing the manufactured radiopharmaceutical.

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