JP2021130925A - Administration facility unit - Google Patents

Abstract

To provide an easily installable and removable radiation controlled area.SOLUTION: One embodiment of the present invention is an administration facility unit 101 of a substance containing radioactive nuclides. The substance contains (a) only an α ray emitting radioactive nuclide, or (b) only the α ray emitting radioactive nuclide and a decay product thereof. The administration facility unit 101 is transportable, and has a radiation controlled area 400 and a sickbed 201 set inside the radiation controlled area.SELECTED DRAWING: Figure 1

Description

The present invention relates to a dosing facility unit for administering a substance containing a radionuclide to a human.

Brachytherapy, which is one of the radiation therapies for cancer, includes brachytherapy (place the radiation source in the lesion (near)) and unsealed brachytherapy. The effectiveness of brachytherapy is similar to external irradiation. Unsealed brachytherapy (TRT: Targeted radionuclide therapy, also called targeted isotope therapy, nuclear medicine therapy and internal therapy) uses the source in the body according to the specific distribution in the body indicated by the drug containing the source. It is a method of collecting in a specific part of. Therefore, the above-mentioned medicine is orally or parenterally administered to a patient.

The above drugs mainly emit β-rays or γ-rays, except for Zofigo®. Zofigo® was approved by the FDA in May 2013 as the world's first drug containing alpha-emitting radionuclides, and was also approved by the Ministry of Health, Labor and Welfare in March 2016. Zofigo® is currently the only drug in Japan that contains alpha-emitting radionuclides.

Nuclear Medicine Vol. 48, No. 2 (2011), pp. 121-137

In recent years, drugs containing α-ray emitting radionuclides are expected to be the core drugs of TRT due to their high therapeutic effect and low side effects on surrounding tissues (3rd Cancer Control Promotion Basics). It also applies to part of the plan).

However, in reality, there is no place to conduct various tests (not therapeutic administration) for the Ministry of Health, Labor and Welfare to approve drug candidates containing α-ray emitting radionuclides. This is because the use of the above drug candidates is only permitted within the radiation controlled area.

There are few beds in the radiation controlled area (about 150 beds nationwide). In the radiation controlled area, the permitted amount of radiation nuclides is determined at regular intervals (for example, one year) according to the scale of the equipment mainly installed. Therefore, the room cannot be additionally used to test the drug candidate (including administration to humans) unless the practice of existing treatments and tests is reduced from the previous year. Furthermore, it is unlikely that a facility as a building equipped with the hospital room will be newly constructed or expanded.

The construction (initial cost) of the above facility is expected to require a large amount of cost (about 400 to 500 million yen). In addition to the usual construction costs (required to secure land and the robustness of the building), the radiation controlled area requires the following equipment costs. The following equipment is also required for the expansion of the above facilities.
Shield (Keep the dose emitted outside the radiation controlled area below the legal regulation)
Intake and exhaust equipment (Keep the boundary dose in the radiation controlled area below the legal regulation)
Underground or above-ground storage tanks (collects wastewater containing radioactive substances and shields radiation).

The temporary internal exposure patient treatment facility disclosed in Non-Patent Document 1 requires a concrete enclosure (corresponding to the above shield) and a disposal facility unit (including the above storage tank) separately from the treatment room unit. ..

Therefore, it is an object of the present invention to provide a radioactive controlled area that is easy to install and remove.

In order to solve the above problems, the administration facility unit according to one aspect of the present invention is an administration facility unit of a substance containing a radionuclide, and the substance is (a) α-ray emitting radioactivity as a radionuclide. Containing only the nuclide, or (b) the α-ray emitting radionuclide and the decay product of the α-ray emitting radionuclide, the administration facility unit is portable and contains a radiation controlled area and the radiation controlled area. It is equipped with a bed installed inside the.

According to one aspect of the invention, it is possible to provide a radioactive controlled area that is easy to install and remove.

It is a figure which shows the outline of the administration facility unit (including the vehicle which carries) which concerns on one Embodiment. It is a figure which shows the arrangement of the equipment provided in the administration facility unit of FIG. 1 in detail.

[Administration facility unit]
The administration facility unit according to one aspect of the present invention is an administration facility unit of a substance containing a radionuclide. The above-mentioned substances contain only (a) α-ray emitting radionuclides, or (b) α-ray emitting radionuclides and decay products of the α-ray emitting radionuclides as radionuclides. The dosing facility unit is portable and comprises a radiation controlled area and a bed located within the radiation controlled area.

(Explanation of terms)
“Administrative facility unit” refers to a unit structure equipped with the necessary equipment to administer radioactive material to humans. All or part of the administration facility unit is a radiation controlled area (details below). Therefore, the administration facility unit can, for example, carry out clinical trials, clinical trials and treatments using substances containing α-ray emitting radionuclides.

Alpha-emitting radioactive nuclides (also called alpha-ray emitting nuclides or α-ray radioactive nuclides) refer to atoms that contain nuclei that emit alpha rays and decay. Therefore, "a substance containing a radionuclide" refers to a simple substance of the atom and a compound in which the atom is bonded to one or more other atoms.

The state "(a) contains only α-ray emitting radioactive nuclei, or (b) containing only α-ray emitting radioactive nuclei and decay products of the α-ray emitting radioactive nuclei" detects the radiation emitted from the above-mentioned substance. It is determined by the detection method using a possible spectrometer (eg germanium semiconductor detector and silicon semiconductor detector). Germanium semiconductor detectors detect gamma rays. Alpha-ray emission Most of the decay products of alpha-decayed radionuclides emit γ-rays. Gamma rays show an energy distribution that has a unique peak that follows the energy of the decay product. By confirming that the energy distribution has the unique peak and no peak other than the peak, the above state (the presence of a specific α-ray emitting radionuclide or decay product) can be confirmed. It is also possible to directly identify the nuclide and dose by the silicon semiconductor detector.

Alpha-emitting radionuclides are all known alpha-decayed nuclides. Preferred α-ray emitting radionuclides include nuclides corresponding to one or more of (1) to (3). (1) Nuclide having a half-life that is easy to handle as a therapeutic agent, (2) Nuclide whose production method has been established, or (3) Nuclide whose effectiveness on cells or living organisms has been reported. The half-life is, for example, 40 days or less, preferably 30 days or less, more preferably 20 days or less, still more preferably 14 days or less. As (2), nuclides manufactured for animal experiments (for example, Tb-149, Pb-212, Bi-212, Bi-213, At-211, Ra-223, Ra-224 and Ac-225) are used. Preferably, nuclides manufactured for human clinical trials (eg Pb-212, Bi-213, At-211, Ac-225 and Ra-223) are more preferred and commercially available nuclides (eg Ra-223). ) Is the most preferable. Alternatively, as (3), Tb-149, Pb-212, Bi-212, Bi-213, At-211, Ra-223, Ra-224 and Ac, which have been reported to be effective on cells or living organisms. Selected from -225.

"Radiation controlled area" refers to the area specified in the relevant legislation governing the use of radiation for the purpose of safely handling and managing radioactive materials or radiation generators (radiation from). For example, according to the related law in Japan, "Act on Regulation of Radioisotopes, etc.", the dose limit at the boundary of the controlled area is 1.3 mSv / 3 months, and the dose limit at the boundary of the establishment is 250 μSv / 3 months. .. Radiation controlled areas that meet the dose limit at the boundary of business establishments can be placed on land and facilities that do not fall under the business establishments stipulated in the above law without complicated procedures. For example, according to the provisions of the law, the type and thickness of the shield depends on the nuclide and amount used in the radiation controlled area. Therefore, the shield of the radiation controlled area that constitutes at least a part of the administration facility unit is required to shield one or more or all of α-rays, β-rays, and γ-rays depending on the nuclide. For example, assuming clinical use, in I-131, the radiation source is surrounded by lead with a thickness of 7.5 cm, and lead with a thickness of 7.5 cm is required between the radiation source and the operator. On the other hand, Ac-225 requires lead with a thickness of about 0.3 mm or more.

“Transportable” means that the administration facility unit can be transported by means of transportation (vehicles, railroads, ships, aircraft, etc.) or lifted by a hoist (crane, etc.). As described above, the radiation controlled area of the administration facility unit corresponds to the “radioactive controlled area” stipulated in the Act on the Regulation of Radioisotopes, etc. by being surrounded by a thin and light shield.

(Usefulness of a dosing facility unit primarily specialized for the use of alpha-emitting radiation nuclides)
As can be understood from (Explanation of Terms), the above-mentioned administration facility unit (a structure that is not a building by itself) is a transportable radiocontrolled area (a substance containing) capable of administering α-ray emitting radionuclides (a substance containing). (The bed is installed inside) can be realized. The reasons why the above-mentioned administration facility unit is required to be realized in the future will be described below.

Reason-Part 1
It was around 2006 that the enormous effects of α-ray irradiation in the human body (which could be effective if the irradiation could be controlled) began to be recognized by medical professionals. It was in 2013 that substances containing alpha-emitting radionuclides were first recognized in the world as safe and effective as therapeutic agents for cancer (according to the FDA). In 2016, the Ministry of Health, Labor and Welfare approved Zofigo®, which had already been approved by the FDA, as a treatment for some cancers. The enhancement of radiation therapy in the Third Cancer Control Promotion Basic Plan clearly includes the practical application of the above substances other than Zofigo (registered trademark).

Therefore, the expansion of the newly developed use of the above-mentioned substances (conducting tests for obtaining approval as a therapeutic agent, and administration of the substance as a therapeutic agent) is a matter that will occur in the future. The inventors of the present application anticipate that this expansion will create new demand for radiation-controlled areas (with beds inside) that can handle substantially only alpha-emitting radionuclides. In order to meet this demand, the inventors of the present application have completed the invention of the present application through repeated diligent studies.

Reason-Part 2
Transportable radiation controlled areas with beds inside (with space for humans to live inside) have not been realized so far. Non-Patent Document 1 merely discloses a "transportable hospital room" that can be called a radiation controlled area for the first time by constructing a non-transportable shield (using concrete and / or lead) to the outside. No. With the technique disclosed in Non-Patent Document 1, the radiation emitted in the "transportable hospital room" cannot be specified, and the above-mentioned shield is used for the purpose of shielding all radiation (for example, α-ray, β-ray and γ-ray). is required.

X-ray inspection vehicles fall under the category of transportable radiation controlled areas. The high transparency of X-rays makes the above shielding essential. The area of the inspection (irradiation) room in the X-ray inspection vehicle is about ^{1 m 2.} The weight of the shield surrounding such an area is within the transportable range. On the other hand, in order to administer a substance containing any radioactive nuclei to a human subject or patient and to realize a radiation controlled area in which the space (hospital room including the bed) is shielded by concrete and / or lead. The weight of the shield surrounding the space to be accommodated becomes excessive and cannot be transported. In this way, the construction and expansion of facilities that are not easy to install and remove (equipped with beds in the radiation controlled area) are ideal and realistic, as described in the item "Problems to be Solved by the Invention". not.

By adopting a light and thin shield for the radiation controlled area, (1) the radiation controlled area with a bed can be significantly reduced in weight, and (2) the lightweight radiation controlled area can carry the administration facility unit. (3) The transportable administration facility unit can reduce the construction cost or expansion cost of the facility as a building, and the administration facility unit itself can be easily installed and removed (installation of the administration facility unit at any time and place). ) Is possible.

The reduction of radiation reaching the boundaries of the radiation controlled area allows (4) the adoption of small capacity intake and exhaust equipment.

Adopting a light and thin shield for the storage tank will (5) significantly reduce the weight of the storage tank, (6) make the storage tank installable (that is, transportable) within the radiation controlled area, and (7) bury the storage tank. Eliminates the cost or securing of storage tank installation locations.

Administration facility units that specialize in the use of alpha-emitting radiation nuclides can employ light and thin shields in radiation controlled areas. The dosing facility unit may meet the above demands.

(Use of administration facility unit as a branch of medical facility)
An embodiment of the present invention will be described by exemplifying a case where the administration facility unit is installed in an unused section (parking lot) in an existing facility (hospital). Branches of medical facilities include treatment rooms or clinical trial rooms. In the following, a clinical laboratory will be described as an example.

The administration facility unit is transported and installed in a hospital parking lot by means of transportation. Healthcare workers belonging to the hospital (1) go to the administration facility unit to carry out clinical trials (administration of test substances to subjects, etc.), and (2) manage and monitor the subjects in the administration facility unit. Conduct remotely using equipment. During the study period, subjects will be present in the administration facility unit and will receive additional medical care and treatment as needed.

The administration facility unit does not have to be dedicated to one hospital. After the end of the study period, or when the study is not scheduled to be conducted, the administration facility unit may be transferred to another hospital or the like and used for other than clinical trials (for example, as a treatment room). Since one or more of the above-mentioned administration facility units can be transported, they are shared or temporarily rented by a plurality of hospitals. Therefore, the dosing facility unit can also meet the demand for treatment practices that vary from region to region over a wide range of regions.

The following (a) to (c) are exemplified as preferable requirements required for a radiation controlled area in which a clinical trial is conducted.

(A) Preferred requirements for a medical space (according to the Medical Care Act)
-Space and facility equipment as a bed (sickroom, bed, toilet, hand wash and storage shelves, etc.)
-Simple bed (equipment that allows the patient to lie down in a place other than the bed, such as during administration)
-On-call function (doorbell)
-Lighting equipment-Air conditioning equipment-Facilities for maintaining high quality of life (TV, refrigerator, shower, WiFi (registered trademark), silencer, etc.)
-Installation of an emergency exit on a side different from the normal entrance / exit.

(B) Requirements as a radiation controlled area (according to the Act on Regulation of Radioactive Isotopes, etc.)
-Intake and exhaust equipment and filters (keeping the concentration of radioactive substances below a certain level)
-Drafts and filters (avoid scattering of radiopharmaceuticals treated as unsealed sources)
-Drainage storage facility for radioactive wastewater-Shielder that separates places and spaces where high doses can occur from other spaces-Waste storage with sufficient shielding and fire resistance-Sufficient shielding and fire resistance Radioactive storage-Radiation detector / measuring instrument (contamination inspection at the time of entry / exit, exhaust / drainage monitor)
-A locking function to restrict access to the general public, including inpatients.

(C) Preferred requirements specific to mobiles-Communication equipment for communicating information with maternal facilities such as our hospital-Patient remote monitoring device (CCTV)
-Nursing robot-Power supply equipment (generator, power storage equipment, or equipment that receives power from an external power source)
-Preferably the same volume (for example, about 4000 L), clean water storage tank and drainage storage tank-Towed function required when moving-Unit fixing means (vehicle ring fastening, anchor and outrigger function)
-Impact resistance and robustness (the unit itself does not need earthquake resistance, etc.)
-Connectivity and expandability that allows ancillary equipment and functions such as drainage tanks and generators to be installed in adjacent locations such as other mobile units for the purpose of effective use of space.

(Specific example of administration facility unit)
An example of the administration facility unit satisfying the above requirements (a) to (c) and a combination with the transportation means (vehicle carrying the administration facility unit) are shown in FIGS. 1 and 2. In the following description, the configurations shown together with the member numbers are specific examples for satisfying the requirements (a) to (c) to the minimum.

As shown in FIGS. 1 and 2, the administration facility unit 101 is loaded on the towing vehicle 102. The administration facility unit 101 includes a rest room 200 (radioactive controlled area), an administration room / working room (radioactive controlled area) 400, a toilet room 300 (equipped with a flush toilet 209 and a shower 210), a storage room 600, and a control room 500. And has a duct space. The vehicle 102 is provided with an intake / exhaust means (blower, exhauster or compressor) 418 and a radioactive wastewater storage tank 408 at the traction section.

One of the partitions between the rest room 200 and the administration room / working room 400 is a sliding door, and there is an unlocked door between the administration room / working room 400 and the toilet room 300. Therefore, a person inside the administration facility unit 101 can freely move back and forth between the rest room 200, the administration room / work room 400, and the toilet room 300, and can use the equipment in the three rooms. On the other hand, the door corresponding to the entrance / exit of the administration facility unit 101, the door between the administration room / working room 400 and the storage room 600, and the door between the storage room 600 and the control room 500 are electronic locks 501 (in FIG. 1 in FIG. 1). Five locks are locked by (schematically illustrated by a padlock picture). Therefore, a person who cannot unlock the electronic lock 501 (such as a person who does not have an electronic entry permit) cannot enter the management room 500 and the storage room 600.

The rest room (radioactive control area) 200 includes a bed (bed) 201, lighting 213, outlet (100V, 15A) 214, on-call equipment 301, surveillance camera 302, intake / exhaust port 403, dose meter 417 in the control area, desk, and shelf. , Wireless LAN, storage, refrigerator, microwave oven, TV receiver and air conditioning sensor (temperature and humidity). That is, the rest room 200 is provided with equipment that corresponds to a medical space in accordance with the medical law, allows the subject to spend quietly and comfortably, and allows the medical staff to follow up the clinical trial. The above-mentioned unnumbered configuration in the rest room 200 is mainly a configuration that further enhances the habitability of the subject in the rest room 200. The luminaire 213, which is shown as six light bulbs in FIG. 1, is any luminaire. The intake / exhaust port 403 of the rest room 200 sends clean air in a direction in which the airflow does not directly hit the subject in the bed 201. The surveillance camera 302 photographs the inside of the rest room 200 (mainly the bed 201) and conveys the state of the subject to the medical staff via the management room 500.

The administration room / working room (radioactive control area) 400 has an outlet 214, a contamination inspection room 402, an intake / exhaust port 403, a draft for handling an unsealed radiation source, a dose meter 417 in the control area, a cot and a cleaning facility. It has. The unsealed radiation source handling draft 404 handles the unsealed radiation source taken out of the shield inside (for example, dilutes the radiation source to the administration concentration, transfers the diluted source to the administration container, and prepares the test substance. It is a cabinet. The intake / exhaust port 403 of the administration room / working room 400 sends out indoor air to a pipe in the duct space (see FIG. 2). The cot is a bed on which the subject lies and receives the test substance. The subject can sit on a chair and receive the test substance, or lie on bed 201 of the rest room 200 and receive the test substance. The cleaning equipment is used for hand washing and washing of subjects and medical staff.

The pollution inspection room 402 includes a pollution inspection device (survey meter) 405, a controlled area boundary dosimeter 415, and a door. The contamination inspection room 402 is separated by a curtain (represented by a chain double-dashed line and a plurality of v-shapes in FIG. 1). The contamination inspection device 405 is a small device that detects the dose on the surface of the human body leaving the administration facility unit 101. The controlled area boundary dosimeter 415 is an instrument that measures the air dose near the door, and determines the effective dose at the controlled area boundary, which will be described later.

On the outer wall of the administration room / working room 400 (for example, the upper part of the door), there are a surveillance camera 302, a sign 401, and a business boundary dosimeter 413, and a staircase is placed outside the door. The establishment boundary dosimeter 413 is an instrument that measures the air dose outside the unit, and determines the effective dose at the establishment boundary, which will be described later. The person who goes up and down the stairs and the person who opens and closes the door are both photographed and recorded by the surveillance camera 302. A sign 401 indicating that the inside of the administration facility unit 101 is a radiation controlled area is affixed to the door. The sign 401 is also affixed to the emergency exit (for example, the left side outside the control room 500). The staircase does not have to be a part of the administration facility unit 101, and may be an assembly type staircase loaded on the vehicle 102. In FIG. 1, the solid line indicating the opening / closing of the door indicates a normal doorway, and the alternate long and short dash line indicating the opening / closing of the door indicates an emergency exit or a door that is normally closed.

The storage room 600 includes a storage room 406 and a storage room dosimeter 416. The storage 406 stores the unsealed radiation source used in the unsealed radiation source handling draft 404 and the waste to which radioactive substances may be attached. The walls of storage 406 contain substances that block radiation (such as lead). The door of the vault 406 is locked as shown in FIG. The storage room dosimeter 416 is an instrument that measures the air dose in the storage room 600.

The control room 500 includes an intake / exhaust port 403, a computer 502, and a power receiving facility 503. The intake / exhaust port 403 supplies clean air into the control room 500. The power receiving facility 503 is a device for receiving power supply from the outside of the administration facility unit 101. The power receiving facility 503 distributes the power supplied from the outside to all the outlets 214 via EPS.

As shown in FIG. 2, the rest room 200, the administration room / working room 400, and the control room 500 each include an intake / exhaust port 403 and an anti-phase silencer (picture of a microphone in FIG. 2). The intake / exhaust port 403 is connected to the external exhaust port 412 through a pipe in the duct space. The dose contained in the exhaust sent to the external exhaust port 412 through the filter (not shown) is measured by a gas monitor (exhaust dosimeter) 414.

The computer 502 includes an electrically driven mechanical device (the anti-phase silencer, lighting 213, on-call equipment 301, surveillance camera 302, intake / exhaust port 403, dosimeters 414 to 417, intake / exhaust means 418, and electronic lock 501). It is electrically connected. The computer 502 outputs an electric signal for driving the mechanical device according to a preset program, and drives the mechanical device represented by the electric signal (air conditioning, dose rate, entry / exit record, CCTV data, etc.). To record. That is, the computer 502 controls the drive of the mechanical device and monitors the drive. The computer 502 transmits the recorded information to the display device or the wireless communication unit.

The toilet room 300 includes a flush toilet 209 and a shower 210. The flush toilet 209, shower 210 and the above-mentioned washing equipment receive water from an external water supply pipe (not shown). The drainage from the flush toilet 209, the shower 210 and the washing facility is sent to the radioactive wastewater storage tank 408 through the radioactive drainage outlet 410 under the floor. A part of the wastewater in the radioactive wastewater storage tank 408 can be collected from the radioactive wastewater collection port 409 in order to check the dose of the wastewater. Although the example in which the administration facility unit 101 receives water from the outside has been described, the vehicle 102 may further include a water supply tank in the traction portion.

As described above, the administration facility unit 101 is equipped with the equipment (400 series) required for the radiation controlled area. The administration facility unit 101 further includes what is required of a hospital / treatment room where hospitalization / medical treatment is possible, and functions (200 and 300 series) necessary for improving the habitability and quality of life of the resident subject. There is.

The administration facility unit 101 is locked with a set of functions and devices (500 series) for medical staff and related persons to perform work related to the administration facility unit 101 in order to restrict the entry and exit of an unspecified number of people. It is prepared in the space where it is.

As described above, the administration facility unit 101 is transported and installed on the premises (parking lot, etc.) of the existing facility (hospital) by the power of the vehicle 102. The administration facility unit 101 is fixed to the ground by a fixture (such as a ring clasp (via the vehicle 102), an anchor or an outrigger) as needed, and is used as an actual hospitalization facility. By the start of use, the administration facility unit 101 needs to have completed various procedures necessary for radiation control.

The administration facility unit 101 includes power generation equipment, power storage equipment, and / or equipment for receiving power supply. The administration facility unit 101 may perform intake / exhaust via an intake / exhaust facility driven by an external power instead of the intake / exhaust means 418. In order to ensure the safety of the patient, the administration facility unit 101 may provide an emergency exit (see FIG. 1) at a place other than the main doorway (particularly on the diagonal line of the main doorway or in the patient's main living quarters).

FIG. 1 shows an example in which the administration facility unit 101 is mainly divided into three sections (rest room 200, administration room / work room 400, and control room 500). However, the administration facility unit 101 is not limited to the case where it corresponds to a radiation controlled area and has three sections as long as it does not violate the provisions of the Medical Care Act. Four or more compartments (for example, a mode in which the rest room 200 or the administration room / work room 400 is two or more), or two compartments (for example, a mode in which the rest room 200 and the administration room / work room 400 are combined into one compartment). ) Is exemplified. In one example of the administration facility unit 101, for example, a plurality of rest rooms 200 are connected to one administration room / work room 400 in a communicable manner. Also, for example, the rest room 200 may include a plurality of beds 201. Thus, as long as the control room 500 is independent of the rest room 200 and the dosing room / working room 400 by the electronic lock 501, the dosing facility unit 101 can have any combination of compartments.

The dosing facility unit 101 is a (transportable) container or trailer house. The floor area inside the administration facility unit 101 is 15-40 m ² . When the vehicle 102 is a large towing vehicle capable of traveling on a general road, the administration facility unit 101 can be carried as a ^{container or a trailer house (for example, having a floor area of 15 to 40 m 2).} The weight of a conventional shield (concrete or lead) that can enclose and cover a space with a floor area of 15 m ^{2 or more (eg, a container or trailer house) is well over 10 tons.} As mentioned above, the dosing facility unit 101, which requires only a thin and light shield (eg, a container or trailer house wall can be substituted), can be transported by a vehicle capable of traveling on open roads. The volume inside the administration facility unit 101 is preferably ^{20 to 120 m 3 from the viewpoint of comfort.}

The wall of the dosing facility unit 101 contains a shield. Materials for the shield include those commonly used as shields in radiation controlled areas, such as lead, tungsten, iron and concrete. The thickness of the shield when selected from the materials is a lead equivalent of 0.03 mmPb or more, preferably 0.5 mmPb or more, more preferably 1 mmPb or more from the viewpoint of shielding, and a lead equivalent of 5 cmPb or less from the viewpoint of weight. It is preferably 1 cmPb or less, more preferably 1 mmPb or less. The above lead equivalents and their numerical values shall be in accordance with the provisions of "Notice of Director General of Pharmaceutical Affairs Bureau, Ministry of Health, Labor and Welfare to Prefectural Governor No. 188 of Pharmaceutical Affairs". The exhaust capacity that satisfies the concentration (dose) in the air inside the controlled area is 50 to 500 m ³ / hour, and the exhaust capacity that satisfies the concentration (dose) in the air outside the controlled area is 1 to 1000 m ³ / hour. .. The effective dose limit at the boundary of the radiation controlled area within the legal regulations is 1.3 mSv / 3 months, and the effective dose limit at the boundary of the establishment is 250 μSv / 3 months.

For example, when the wall of the dosing facility unit 101 administering Ac-225 is made of lead with a thickness of 0.3 mm, the exhaust capacity to meet the air limit (dose) in the controlled area is 92 m ³ / hour. The exhaust capacity that meets the concentration limit (dose) in the exhaust to the outside of the controlled area is 231 m ³ / hour. At this time, the effective dose at the boundary of the controlled area is 51 μSv / 3 months, and the effective dose at the boundary of the business establishment is 215 μSv / 3 months, which is lower than the legal and regulatory standards. When the administration facility unit has a width of 3.4 m, a length of 12 m, and a height of 2.8 m, the weight of lead is 0.6 tons, so that it is possible to manufacture a unit capable of traveling on a general road.

For example, when the wall of the administration facility unit 101 to which Ra-223 is administered is made of 5 mm thick lead, the exhaust capacity to meet the air limit (dose) in the controlled area is 214 m ³ / hour and is controlled. The exhaust capacity that meets the concentration limit (dose) in the exhaust to the outside of the area is 693 m ³ / hour. At this time, the effective dose at the boundary of the controlled area is 16 μSv / 3 months, and the effective dose at the boundary of the business establishment is 64 μSv / 3 months, which is lower than the legal and regulatory standards. When the administration facility unit has a width of 3.4 m, a length of 12 m, and a height of 2.8 m, the weight of lead is 9.5 tons, so that it is possible to manufacture a unit capable of traveling on a general road.

For example, when the wall of the dosing facility unit 101 administering Bi-213 is made of lead with a thickness of 0.25 cm, the exhaust capacity to meet the air limit (dose) in the controlled area is 222 m ³ / hour. The exhaust capacity that meets the concentration limit (dose) in the exhaust to the outside of the controlled area is 463 m ³ / hour. At this time, the effective dose at the boundary of the controlled area is 47 μSv / 3 months, and the effective dose at the boundary of the business establishment is 199 μSv / 3 months, which is lower than the legal and regulatory standards. When the administration facility unit has a width of 3.4 m, a length of 12 m, and a height of 2.8 m, the weight of lead is 4.8 tons, so that it is possible to manufacture a unit capable of traveling on a general road.

In the administration room / working room 400, a substance containing an α-ray emitting radionuclide, which is a clinical study drug, an investigational drug, or an approved drug, is administered to a subject or a patient.

Under the following conditions, the thickness of the shield and the exhaust capacity that the controlled area can achieve an effective dose below the legal and regulatory standards as a business boundary were calculated.

(conditions)
Administration of substances containing Ac-225 (one of the alpha-emitting radionuclides) will be carried out within the controlled area. The substance of 10 MBq (single dose based on dose) is administered to one patient once a week. Only one patient remains in the controlled area for 5 consecutive days after dosing. The controlled area has ^{a volume of 24 m 3} (2x2x6 m), and the exhaust operating time to exhaust from the controlled area is 2148 hours / 3 months.

(Thickness of shielding and exhaust capacity)
The walls of the controlled area require a thickness of 0.3 mm or more when made of lead. The exhaust capacity that meets the air limit (dose) in the controlled area is 92 m ³ / hour, and the exhaust capacity that meets the concentration limit (dose) in the exhaust outside the controlled area is 231 m ³ / hour. At this time, the effective dose in the controlled area is 51 μSv / 3 months, which is lower than the legal and regulatory standards as the boundary of the business establishment as well as the boundary of the controlled area.

(others)
Lead with a thickness of 10 mm is used for the walls of the waste storage and the radiation source storage where it is necessary to temporarily or medium-term keep the unsealed radiation source inside. The filter installed in the exhaust equipment is confirmed to maintain a transmittance of 0.001 or less by performing a regular DOP test (permeation test of 0.25-0.35 μm dioctylphthalate particles). Handle the above substances (including Ac-225) in the draft to prevent the radiation source from volatilizing or dissipating into the general environment.

The present invention is not limited to the above-described embodiments (including examples), and various modifications can be made within the scope of the claims, and the technical means disclosed in the different embodiments can be appropriately used. The embodiments obtained in combination are also included in the technical scope of the present invention.

(summary)
[1] An administration facility unit for substances containing radionuclides.
The above-mentioned substances contain only (a) α-ray emitting radionuclides, or (b) α-ray emitting radionuclides and decay products of the α-ray emitting radionuclides as radionuclides.
The dosing facility unit is portable and comprises a radiation controlled area and a bed located within the radiation controlled area.
Administration facility unit.

[2] The administration facility unit according to [1], which is a container or a trailer house.

[3] The administration facility unit according to [1] or [2], wherein the floor area inside is 15 to 40 m ^2.

[4] The administration facility unit according to any one of [1] to [3], wherein a sign indicating a radioactive control area is affixed to the outer surface of the administration facility unit.

[5] The administration facility unit according to any one of [1] to [4], wherein the substance is a clinical trial drug, an investigational drug, or an approved drug.

The present invention can be used for the development of a therapeutic agent containing a radionuclide, the implementation of an approval test for the developed therapeutic agent, and the treatment using the approved therapeutic agent.

101 Administration unit 200 Rest room (radioactive control area)
201 beds (beds)
209 Toilet 210 Shower 213 Lighting 214 Outlet 300 Toilet room 301 On-call equipment 302 Surveillance camera 400 Administration room / work room (radioactive control area)
401 Mark 402 Contamination Inspection Room 403 Intake and Exhaust Port 404 Draft for Handling Unsealed Sources 405 Contamination Inspection Equipment 406 Storage 408 Radioactive Drainage Storage Tank 409 Radioactive Drainage Collection Port 410 Radioactive Drainage Discharge Port 413 Office Boundary Dosimeter 414 Gas Monitor 415 Management Area boundary dosimeter 416 Storage room dosimeter 417 Control area dosimeter 418 Intake and exhaust means 500 Control room 501 Electronic lock 502 Computer 503 Power receiving equipment 600 Storage room

Claims (5)

An administration facility unit for substances containing radionuclides,
The above-mentioned substances contain only (a) α-ray emitting radionuclides, or (b) α-ray emitting radionuclides and decay products of the α-ray emitting radionuclides as radionuclides.
The dosing facility unit is portable and comprises a radiation controlled area and a bed located within the radiation controlled area.
Administration facility unit. The dosing facility unit of claim 1, which is a container or trailer house. The administration facility unit according to claim 1 or 2, wherein the floor area inside is 15 to 40 m ^2. The administration facility unit according to any one of claims 1 to 3, wherein a sign indicating a radioactive controlled area is affixed to the outer surface of the administration facility unit. The administration facility unit according to any one of claims 1 to 4, wherein the substance is a clinical trial drug, an investigational drug, or an approved drug.

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