JP2003022115A - Overall control system for short-lived radiopharmaceutical production and time reduction method for short-lived radiopharmaceutical production - Google Patents

Abstract

PROBLEM TO BE SOLVED: To control the entire system from the beginning to the end of drug production of a drug having an extremely short half-life, control the drug production sequence, and reduce the production time. The purpose is to quickly provide a half-life drug required by a user. SOLUTION: The overall control system for producing short-lived radiopharmaceuticals and the method for shortening time for producing short-lived radiopharmaceuticals according to the present invention include irradiation of a cyclotron device (25), drug synthesis, drug transport / movement, drug delivery. Quality control, dispensing / dispensing of drugs into syringes, and providing syringes to users continuously, and recording them at the same time, as well as automatically controlling the half-life drugs required by users with high efficiency and manufacturing How to

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to an overall control system for producing a short-lived radiopharmaceutical and a method for shortening the time for producing a short-lived radiopharmaceutical, and more particularly to an extremely short half-life (eg, 2 minutes, 10 minutes). Min, 20 min, 110 min, etc.) The entire system from the beginning to the end of drug production, where a drug is produced using a radioisotope consisting of a positron nuclide, and the sequence of drug production is controlled to control the drug production time. Regarding a new improvement for measuring the shortening.

[0002]

2. Description of the Related Art As a conventional method of this kind, a first conventional example is a control method only for automation of control of a cyclotron (target gas injection, irradiation, and extraction), and a second conventional example is a cyclotron. And a method for controlling a drug synthesizing device, as a third conventional example, a method for controlling and recording a cyclotron, a synthesizing device, and a quality inspection device only for a specific drug, and a fourth conventional technique, Japanese Patent Laid-Open No. 2000-356642. There is a method of transferring from an automatic synthesizing device to a quality inspection device and controlling / recording the quality inspection device, which is disclosed in the publication. That is,
In the case of the first conventional example, only the control and recording of a cyclotron as a device for producing a raw material of a radiopharmaceutical are automated. In addition, ancillary devices for operating the cyclotron (for example, a foil cooling device, a target injection / extraction device, etc.) are generally used as a system for cooperative control. Further, in the case of the second conventional example, the drug synthesizer is linked to the cyclotron, and when the irradiation with the cyclotron is completed, the synthesizer which is already waiting is linked based on the information. Is. The cyclotron and the synthesizer are driven independently, and most of them simply trigger the end of synthesis. Also,
In the case of the third conventional example, a device for controlling and recording a cyclotron (raw material production), a synthesis device (drug synthesis), and a quality inspection device (drug verification) as a system has been developed, but only a specific drug (FDG) It is limited to. Also,
In the case of the fourth conventional example, the control of the essentiality inspection device including the mechanism for transferring the medicine from the synthesis device to the quality inspection device is disclosed.

[0003]

Since the conventional control system for drug production is configured as described above,
The following issues existed. That is, in the case of the first conventional example, the entire system is used in all fields and industries, but in PET nuclear medicine using the positron tomography apparatus, there is still no system controlled as a whole. On the other hand, as a short-lived radiopharmaceutical manufacturing system, a system for controlling automation and automation exists in the world, but it is a part of control and recording and does not exist as a whole system. The records are only process records (log files, measurement result files, etc.), and environmental conditions (temperature, humidity,
Cleanliness, etc.) is not comprehensive. In addition, in the case of the second conventional example, in addition to the above reason, the cooperation between the devices is to drive the next device based on a certain trigger, which is not the control of the system. Also,
It is not possible to cope with the combinatory of changing the operation pattern of another device based on the measurement result / record of one device. In addition, in the case of the third conventional example, in addition to the above reason, it is not possible to deal with a plurality of drugs. In addition, it is not able to handle the congested control / recording such as simultaneous irradiation, simultaneous composition, and simultaneous quality inspection. Further, in the case of the fourth conventional example, the whole is not a systemized total control / recording.

The present invention has been made to solve the above problems, and in particular, it is a radioactive substance composed of a positron nuclide having an extremely short half-life (eg, 2 minutes, 10 minutes, 20 minutes, 110 minutes). An entire system for radiopharmaceutical production that controls the entire system from the beginning to the end of drug production that uses isotopes to produce drugs and controls the sequence of drug production to shorten the drug production time. It is an object to provide a control system and a method for shortening the time for producing a short-lived radiopharmaceutical.

[0005]

An overall control system for producing a short-lived radiopharmaceutical according to the present invention comprises at least an overall control system for producing a short-lived radiopharmaceutical, which is adapted to produce a short-lived radiopharmaceutical in a facility. A raw material manufacturing process for producing a short-lived radionuclide by irradiation of a cyclotron device, a drug synthesizing process for synthesizing a drug labeled with the short-lived radionuclide by a drug synthesizing device, a carrying / moving process of the drug by a carrying device, and a quality inspection device It is configured to continuously control and record the quality inspection process of the drug by the above, the subdivision dispensing process of the drug into the syringe by the dispensing device, and the administration process of the syringe to the user. Medium Controls one device or multiple devices in conjunction.
It is a configuration for recording, and is a configuration for controlling the production of a plurality of individual medicines comprising the same process as the individual medicine device when executing the individual medicine manufacture including the respective steps, It is configured to control a schedule of manufacturing a plurality of individual medicines consisting of each of the processes based on an input, and accepts requests for medicines and / or monitors the progress of medicines related to the manufacture of each individual medicine consisting of the respective processes via the Internet. In addition, it is a configuration for performing, and a configuration for performing a collation with at least an electronic file drug production standard for each individual drug production consisting of each of the steps,
In addition, at least the temperature, humidity, cleanliness and radioactivity measurement information relating to each individual drug production consisting of the above-mentioned steps are taken in and managed, and at least hygiene control relating to each individual drug production consisting of the above-mentioned steps. And the configuration requirements of the GMP standard for managing the education and training schedule. In addition, the method for shortening the time for producing a short-lived radiopharmaceutical according to the present invention uses a system for automatically controlling each device or each process for producing an individual drug for producing a short-lived radiopharmaceutical, and executing a previous device (or process). This is a method of shortening the total time required for the individual drug production by preparing the next device (or the next process) depending on the situation, and in parallel with the production of one individual drug. If another individual drug is to be manufactured in the same way, when the next device (or the next process) is limited to one, which of the previous devices is to be used, information including at least the drug-specific half-life and It is a method of controlling based on the number of processing steps and time of the next device, information on the drug provision reservation time, and at least a cyclotron device for raw material production, which is in charge of each step of short-lived radiopharmaceutical production In case of continuously using a synthetic device for chemical synthesis, a transport device for drug delivery, a quality inspection device for quality inspection, and a dispensing device for subdivision, when one of the above devices reaches a certain process, the next process It is a method of driving the device of the above to put it in a standby state and eliminating the time loss of a series of production.Also, while producing a radioactive raw material with a cyclotron device, the production amount is calculated in real time,
When a certain ratio of the required amount is reached, a signal is given to the synthesizing device of the next device via a network to drive the next device. At least the yield condition is added based on the measured radioactivity, and calculation is performed in real time.The type of syringe used depends on the amount of radioactivity in the quality inspection device process, and the amount taken for inspection is changed. Information is given in advance to change the analysis conditions accordingly, and the quality inspection device of the next device is put in the standby state to eliminate the time loss of a series of manufacturing. When other tests are in progress at the time of measuring the radioactivity and radioactivity, this information is given to the computer via the network and the dispensing plan is calculated by this computer,
Based on the request information, determine the type of syringe to be used in the dispensing device in the next step, the amount of drug to be subdivided, whether to dilute, the amount of dilution when diluting, and set the syringe or vial to be used in advance. It is a method of eliminating the time loss of serial manufacturing by waiting for a while and also displaying the measured value and the quality result calculated from it in real time while performing the inspection with the drug quality inspection device and displaying the result. Judgment is made by comparing with the standard, and it is a method to eliminate the time loss of a series of manufacturing.Also, it is provided to the user by subdividing into a syringe with a drug dispensing device, and the dispensing process is It is a method of eliminating the time loss of a series of manufacturing by stopping once and waiting for the next dispensing operation, and the syringe containing the drug provided to the user by the drug dispensing device is described above. Return to dispenser and leave In the operation of measuring the radioactivity and measuring / calculating an accurate dose, by continuing another dispensing operation that has already been started or the dispensing operation that will be performed soon, the time loss of the series of manufacturing is lost. Is a way to eliminate.

[0006]

BEST MODE FOR CARRYING OUT THE INVENTION Preferred embodiments of an overall control system for producing a short-lived radiopharmaceutical and a time-saving method for producing a short-lived radiopharmaceutical according to the present invention will be described below with reference to the drawings. First, the overall control system will be described. FIG. 1 shows the network configuration of the overall control system of the present invention. That is, an external public network 4 having an external information public server 3 is connected to a hospital or laboratory network 1 as a facility via a firewall 2, and the external public network 4 is connected to an information system network 6 via a router 5. It is connected.

The information network 6 includes a control management server 7, a network server 8, a DB server 9, and 1.
0, a plurality of operation terminals 11, and a device control dedicated terminal 12 are connected. The operation terminal 11 is provided with a quality inspection device 15, a dispensing device 16, a pneumatic tube cell 17, and a transfer device 18 via a separating device network 13 and a quality dispensing host 14.
Is connected to the connected quality / dispensing device network 19.

The control system network 20 connected to the control management server 7 is connected to a cyclotron network 22 via a cyclo host 21, connected to a synthesizer network 23 via a synthesizer host 22, and has the above-mentioned quality. It is connected to the dispensing host 14. The cyclotron network 22 has an optical connector 24.
The cyclotron device 25 is connected via the optical connector 2 and the target 26 of the cyclotron device 25 is the optical connector 2
7 to the synthesizer network 23. The synthesizer network 23 includes an optical connector 2
8, a plurality of synthesizers 29 are connected to each other, and the synthesizer network 23 is connected to the synthesizer host 23a.
It is connected to the control system network 20 via.

FIG. 2 shows a drug manufacturing process (procedure) according to the present invention. That is, it shows a time-sequential sequence from morning till night in the above-mentioned facility (hospital, laboratory, etc.). First, a schedule request reception 30 for making a drug is performed all day, and in the preparation 31 in the morning, application startup, computer system initialization, system state grasp, manual start button press of the cyclotron device 25, cyclotron device 25 Start, preparation for quality inspection, preparation of dispensing cell, etc.

Next, in the drug production 32, the drug production is carried out according to a schedule, and a plurality of independent individual drug productions 33, 34, 35, 36, 37 shown in FIG. Be started. This drug manufacturing 3
After the end of 2, the cleaning 38 and the post-work processing 39 are performed.

The individual drug manufacturing sequence 40 of the above-described individual drug manufacturing 33 to 37 is as shown in FIG.
That is, in the individual drug manufacturing sequence 40, the white diamond mark indicates computer operation, the black diamond mark indicates system automatic operation, and the black circle mark indicates manual device operation. Irradiation 41 is performed in the cyclotron device 25, and a drug synthesis step 42 is performed in the synthesizer 29. The quality inspection device 15 performs the quality inspection process 43, and the dispensing device 16 performs the dispensing process 4
4 is performed, and thereafter, the administration process 45 and the recovery process 46 are performed.

First, a drug user orders through a network, and based on that, scheduling for short-time processing is performed. The information network 6 takes in a document based on a schedule and gives an instruction to the control network 20. The manufacturing conditions are electronic documents (GM
P compliant), and the control system network 20 manages based on the instruction. The individual devices are controlled from all terminals 11 and 12 by a server / client system such as the control management server 7 of the control system network 20. Therefore, the respective devices 15, 16, 17, 18, 25, 29 can be simultaneously driven. For example, cyclotron irradiation-drug production (synthesis device) -quality inspection-subdivision is applicable. In addition to monitoring during manufacturing, the progress of the schedule can be monitored externally via the Internet. The obtained results and measured values are recorded (stored) in the information network 6. For example, authentication and matching with standard documents (documents). As a result, the scheduled drug production is processed for a short time. The information network 6 is the other network 4, 13, 19, 2
Enables information exchange with 0, 22, 23. For example, it is possible to add monitoring of air conditioning (temperature, humidity, cleanliness, etc.) and add GMP constituent requirements (hygiene, education and training).

Next, a case will be described in which the network shown in FIG. 1 and the sequences shown in FIGS. 2 and 3 are used to carry out overall control for producing a short-lived radiopharmaceutical. First, the drug user uses the external network 4 or the information network 6
Enter the requested information such as date of use, drug, desired time, desired radioactivity. Scheduling is performed once a week based on the input request information, and the determined information is returned to the requester via the information network 6. Every morning, the schedule for the day is confirmed, and the schedule including additions and deletions is rebuilt. Manufacturing information is passed to the control system network 20 based on the determined schedule. Instructions are given to workers according to the schedule, and preparatory work is performed. Each device 15, 16, 17, 18, 2
5 and 29 are driven based on a schedule. The progress status (flight schedule) can be monitored in real time by the workers in the facility through each network 4, 6, 13, 19, 20, 22, 23, and also by the external client through the Internet in real time. The delay of the progress, the emergency interruption, etc. are adjusted in the scheduling and are immediately reflected in the control of the respective devices 15, 16, 17, 18, 25, 29. Depending on the progress status of the step (program) in the device under control, a system for starting another device with a certain step as a trigger performs control for time reduction. The information of the measurement result (for example, radioactivity) in the device under control is sent to the information system network 6 instead of being processed by the individual device, is calculated based on the information, and is given to other devices as information for preparation. By advancing, control for time reduction is performed. Each device 15,
The results of 16, 17, 18, 25 and 29 are stored / edited in the server of the information network 6 and output according to the format. Based on the result, the manufacturing manager and the quality control manager will also approve in the system and perform the authentication in compliance with GMP. The certified drug is supplied at the time desired by the user. The amount actually used by the user is also automatically measured and recorded by returning the used container (syringe). In this way, a total system has been achieved for treating radiopharmaceuticals manufactured in the hospital in a short time from request to manufacture and use.

By the operation of the overall control system for producing a radiopharmaceutical according to the present invention described above, at least a raw material production process for producing a short-lived radionuclide by irradiation of the cyclotron device 25, and a drug labeled with the short-lived radionuclide are synthesized. The medicine synthesizing step 42 for synthesizing by the device 29, the medicine conveying / moving step by the conveying device 18, the medicine quality inspection step 43 by the quality inspection device 15, and the dispensing device 1
6. A step 44 of dispensing the medicine into a syringe (not shown) according to 6 and a step 45 of administering the syringe to the user
Each of the networks 4, 6, 13, 19, 20, 2
Can be controlled and recorded continuously via 2, 23,
Among the respective devices 15, 16, 17, 18, 25, 29,
It is possible to control and record one device or a plurality of devices in conjunction. In addition, individual drug production 33 comprising the above-mentioned steps
To 37, it is possible to control a plurality of individual drug productions 33 to 37 including the same process as the individual drug device, and a plurality of individual drug productions based on the input of the drug manufacturing request. It is possible to control the schedule of individual drug manufacturing 34 to 37 of the above. Further, it is possible to receive request and / or monitor the progress of the drug relating to each individual drug manufacturing 33-37 consisting of the above-mentioned steps via the internet, and at least an electronic file for the individual drug manufacturing 33-37 consisting of the above-mentioned respective steps. It is possible to retrieve and manage at least the temperature, humidity, cleanliness, and radioactivity measurement values relating to the individual drug manufacturing 33 to 37 consisting of the above-mentioned respective processes by collating with the drug manufacturing standard according to It is possible to incorporate at least the constituents of the GMP standard for managing the hygiene management and the training schedule regarding the individual drug manufacturing 33 to 37.

Next, the method for shortening the time for producing a short-lived radiopharmaceutical according to the present invention will be described with reference to FIGS. First, each step is pre-read and prepared, and when continuous automation is performed for each step as the individual drug manufacturing 33 to 37, the next step (apparatus) prepares based on the execution status of the previous step. . This pre-preparation is configured not only as an operation triggered by the step or time of the previous step, but also by changing the pattern of the next step based on the measured value in the previous step. Moreover, in order to perform the parallel processing, not only one of the individual individual drug productions 33 to 37 but also another individual drug production is performed in parallel, thereby achieving a short-time process as a whole. . Further, the parallel processing includes not only parallel processing only for individual drug manufacturing but also parallel processing in a certain process (for example, quality inspection) in individual drug manufacturing.
Further, since the half-life of the drug is extremely short, for example, in the case of producing drug B having a shorter half-life than drug A,
When irradiation is started with being shifted from each other and synthesis is completed at the same time, in the next process such as quality inspection, the B drug having a short half-life must be processed first, and the individual drug sequence 40 is processed by the main computer (not shown). No.) is controlling the process.

Next, in order to actually perform the short-time processing of each of the above-mentioned steps, the following steps are processed. That is, as shown in FIGS. 1 to 3, one-day drug production consists of several types of individual drug production 33 to 37, and these individual drug productions include cyclotron irradiation 41, drug synthesis step 42, and quality inspection step 43 ( Device / cell), dispensing process 44 (device / cell)
Cells). When these series of productions are continuously performed as a system, information on the progress status of the previous process is obtained, and a preparatory process is performed for each. In addition, the cyclotron device 25
When the irradiation is performed, the "leak test" of the corresponding synthesizer 29 is started, and "preparation OK signal is input" based on the end thereof. The “irradiation end” of the cyclotron device 25 is given to the synthesizing device 29 as information, the irradiated substance (target) is supplied to the synthesizing device 29, and the synthesis is started by (“starting supply”). When this synthesis proceeds to a certain step, "pump start" for conditioning the column starts as a preparation for quality inspection, and "pump stop" is performed when a set time has elapsed. Next, the quality inspection device 15 prepares the quality inspection corresponding to the drug being synthesized, removes the pH probe from the washing / immersion tank, reads the barcode of the subdivision vial, moves the subdivision vial to the dispensing port, Preparatory steps such as moving the robot hand to the vial collection port and waiting are performed. Also, during that time, a corresponding carrier (carrier) (not shown) of the carrier device 18 moves to the shielding hood containing the synthesizing device 29 and waits for the end of synthesizing. "Synthesis completed"
Information, the lower moving device (not shown) of the carrier device 18 moves to deliver the drug vial to the carrier of the carrier device 18. This transfer device 18 moves to the collection port of the shielding hood that contains the quality inspection device 15, and the robot hand of the quality inspection device 15 collects the vial, and various quality inspections (bar code reading, radioactivity measurement, weight measurement, Start subdivision, injection into high performance liquid chromatograph, pH measurement). In addition, the software for high performance liquid chromatography (not shown) is launched based on the information on vial collection,
The method is set up and preparations for importing are performed. The data of the radioactivity measurement and the weight measurement of the quality inspection are sent to a high-order computer (not shown) at the time of measurement, and based on this data,
Dispensing pattern (diluted / not diluted), drug dispensed amount, in comparison with the request request from the user. The amount of diluent, the type of syringe to be used (5 mL / 10 mL), etc. are calculated, and the information is passed to the dispensing device 16. Based on the sent information, the dispensing device 16 takes out the corresponding syringe, removes and attaches a cap, mounts a dispensing unit (not shown), sets a dilution vial, takes out a dilution syringe,
The cap is removed, the diluent (such as physiological saline) is sucked, the diluted vial is injected, and the robot hand moves to the vial collection port and waits. In the quality inspection device 15, necessary inspection (radioactivity measurement, weight measurement) and subdivision are dispensed without waiting for the end of the quality inspection, and immediately after that, another delivery device (in this case, a pneumatic tube) transfers to the dispensing device 16. Send vials. In addition, drug identification by high performance liquid chromatography, purity test, and pH measurement are performed after vial transportation (air transportation). In the dispensing device 16, the robot hand collects the vial based on the information of “arrival of vial”, starts dispensing, and when this dispensing is completed, the vial is supplied to the user. In this way, the short-time processing method is adopted in each step, and the processing time is shortened.

By the operation of the method for shortening the time for producing a short-lived radiopharmaceutical according to the present invention, the next device (or the next device) is manufactured based on the execution status of the device (or the previous step) before the production of the short-lived radiopharmaceutical. By performing the preparation of (step), it is possible to shorten the total time required for the individual drug production, and to produce one individual drug 33-
When another individual drug is manufactured in parallel with any of 37,
When the next device (or process) is limited to one, which pre-device is used, information including at least the half-life unique to the drug, the number of processing steps and time of the next device, and the drug provision reservation time Can be controlled based on the information of. Further, at least a cyclotron device 25 for producing raw materials, a synthesizing device 29 for synthesizing a drug, a transport device 18 for delivering a drug, a quality inspection device 15 for quality inspection, a dispensing device for subdivision dispensing, which is in charge of each process of producing a short-lived radiopharmaceutical. When 16 is continuously used, when any one of the above-mentioned devices has reached a predetermined process, the device of the next process is driven to be in a standby state, so that time loss in a series of manufacturing can be eliminated. Further, the production amount of the radioactive raw material is calculated in real time by the cyclotron device 25, and when a certain ratio of the required amount is reached, a signal is given to the synthesizing device 29 of the next device via the network, The next device 29 can be driven. In addition, when the process proceeds to the process of the drug synthesizing device 29, at least the yield condition is added based on the measured value of the radioactivity, and the calculation is performed in real time. Information such as changing the type, changing the amount to be sampled for inspection, and changing analysis conditions accordingly is given in advance, the quality inspection device 15 of the next device is put in a standby state, and the time series manufacturing is performed. Loss can be eliminated. Also, while other tests are in progress at the time of measuring weight and radioactivity with the drug quality inspection device 15, this information is given to a computer via a network, and this computer calculates a dispensing plan, Based on the request information, determine the type of syringe to be used in the dispensing device in the next step, the amount of drug to be subdivided, whether to dilute, the amount of dilution when diluting, and set the syringe or vial to be used in advance. It is possible to eliminate the time loss of a series of production by waiting for a while. In addition, while displaying the measured value and the quality result calculated from the measured value during the inspection by the drug quality inspection device 15, the result is compared with the reference book and judged,
It can be displayed that the certification of the quality control manager is required, and the time loss of the series manufacturing can be eliminated. In addition, the drug dispensing device 16 dispenses a small amount into a syringe and provides it to the user. The dispensing process is temporarily stopped, and a standby state for performing the next dispensing operation is waited for. Time loss can be eliminated. In the operation of returning the syringe, which has taken the medicine provided to the user by the medicine dispensing device 16, to the dispensing device 16 and measuring the residual radioactivity amount to measure / calculate an accurate dose, By continuing another dispensing operation that has been started or a dispensing operation that will be performed soon without interruption, a time loss in the series of manufacturing can be eliminated.

[0018]

The overall control system for producing a short-lived radiopharmaceutical and the time-saving method for producing a short-lived radiopharmaceutical according to the present invention are configured as described above.
The following effects can be obtained. That is, a facility including control, management / recording, and external communication from the beginning to the end of drug production for producing a drug having an extremely short half-life (eg, 2 minutes, 10 minutes, 20 minutes, 110 minutes). A total network system (internal control system) for internal preparations can control the sequence of all operations from request, manufacturing, and use. This overall control achieves short-time processing of overall control, and each user On the other hand, a drug with a short half-life can be rapidly and highly efficiently produced in a short time and provided while the half-life remains.

[Brief description of drawings]

FIG. 1 is a configuration diagram showing a network system in the present invention.

FIG. 2 is a process drawing showing a drug manufacturing process in the present invention.

FIG. 3 is an explanatory diagram showing a specific sequence of drug production in FIG.

[Explanation of symbols]

1 facility network 4 External public network 6 Information network 13 Separator network 15 Quality inspection equipment 16 dispensing device 17 Pneumatic tube cell 18 Conveyor 19 Quality / Dispensing Equipment Network 20 Control network 22 Cyclotron network 23 Synthesizer network 25 Cyclotron device 29 synthesizer 33-37 Individual drug manufacturing

   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Kazutoshi Suzuki             4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba             National Institute of Radiological Sciences (72) Inventor Hyoda Yoshida             2-2-1 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa               Japan Steel Works, Ltd. (72) Inventor, Hisashi Suzuki             2-2-1 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa               Japan Steel Works, Ltd. (72) Inventor Toshimitsu Fukumura             2-2-1 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa               Japan Steel Works, Ltd. (72) Inventor Mitsuaki Yuasa             2-2-1 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa               Japan Steel Works, Ltd. F term (reference) 3C100 AA05 AA29 BB03 BB14 BB27                       BB33 CC12                 4C085 HH03 KA29

Claims (17)

[Claims] 1. A raw material manufacturing process (100) for producing a short-lived radionuclide by irradiation of at least a cyclotron device (25) in an overall control system for producing a short-lived radiopharmaceutical for producing a short-lived radiopharmaceutical in a facility. , A drug synthesizing step (42) for synthesizing a drug labeled with the short-lived radionuclide by a synthesizing device (29), a transporting / moving process (101) of the drug by a transporting device (18), and a quality inspection device (15) The step (43) for inspecting the drug by the step (4), the step (44) for dispensing the drug into the syringe by the dispensing device (16) and the step (45) for administering the syringe to the user are continuously controlled. Total control system for radiopharmaceutical production characterized by recording. 2. Among the respective devices (25, 29, 18, 15, 16),
The overall control system for producing a short-lived radiopharmaceutical according to claim 1, wherein one device or a plurality of devices are controlled and recorded in association with each other. 3. When performing an individual drug manufacturing (33) including each of the steps (100, 42, 101, 43, 44, 45), a plurality of the same steps as the individual drug device (33) are formed. Individual drug manufacturing (34-3
The total control system for producing a short-lived radiopharmaceutical according to claim 1 or 2, wherein 7) is controlled. 4. The method for producing a short-lived radiopharmaceutical according to claim 1, wherein the schedule of a plurality of individual drug productions (33 to 37) consisting of the respective steps is controlled based on the input of the drug production request. Overall control system. 5. Each individual drug production (33) comprising the above steps
37) The overall control system for producing a short-lived radiopharmaceutical according to any one of claims 1 to 4, wherein the request reception and / or the progress status monitoring of the drug relating to (37) are performed via the Internet. 6. Each individual drug production (33) comprising the above steps
To 37), the overall control system for producing a short-lived radiopharmaceutical according to any one of claims 1 to 5, wherein at least an electronic file is compared with a drug production standard. 7. Each individual drug production (33) comprising the above steps
7. The overall control system for producing a short-lived radiopharmaceutical according to any one of claims 1 to 6, wherein at least temperature, humidity, cleanliness, and measured values of radioactivity relating to . 8. Each individual drug production (33) comprising each of the above steps
37. The overall control system for manufacturing a short-lived radiopharmaceutical according to any one of claims 1 to 7, which incorporates at least the constituent requirements of the GMP standard for managing the schedule of hygiene control and education and training. 9. Each device (25, 29, 18, 15, 16) or each step (100, 42,) for producing an individual drug for producing a short-lived radiopharmaceutical
101, 43, 44, 45) using the system that automatically controls the individual drug by preparing the next device (or the next process) based on the execution status of the previous device (or the previous process). A method for shortening the time for producing a short-lived radiopharmaceutical characterized by shortening the total time required for production. 10. When performing production of one individual drug in parallel with another individual drug production, which of the preceding devices is used when the next device (or next step) is limited to one The method for shortening the time for producing a short-lived radiopharmaceutical is characterized in that it is controlled based on at least information including a half-life unique to the drug, the number of processing steps and time of the next device, and information on the drug provision reservation time. . 11. A cyclotron device (25) for producing raw materials, a synthesizing device (29) for synthesizing a drug, a transport device (18) for delivering a drug, and a quality inspection device for quality inspection, which are in charge of each process of producing a short-lived radiopharmaceutical. (15), when continuously using the dispensing device (16) for subdivision, when one of the devices has reached a certain process, the device for the next process is driven to a standby state, and a series of The method for reducing the time for producing a short-lived radiopharmaceutical according to claim 9, wherein the time loss of the production is eliminated. 12. The cyclotron device calculates the production amount of the radioactive raw material in real time during production, and when a certain ratio of the required amount is reached, a signal is sent to a synthesis device (29) of the next device via a network. 10. The method for reducing the time for producing a short-lived radiopharmaceutical according to claim 9, wherein the following device is driven. 13. A syringe to be used in accordance with the amount of radioactivity in the process of the quality inspection device, which is calculated in real time by adding at least the condition of the yield based on the measured value of radioactivity when the process proceeds to the process of the drug synthesizing device. Change the type, change the sampling amount for inspection, and change the analysis conditions accordingly, put the quality inspection device (15) of the next device in the standby state, and perform a series of manufacturing. 10. The method for shortening the time for producing a short-lived radiopharmaceutical according to claim 9, wherein the time loss is eliminated. 14. This quality information is given to a computer via a network and dispensed by this computer while other tests are in progress at the time of measuring the weight and radioactivity by the drug quality inspection device (15). Calculate the plan, and based on the request information, determine the type of syringe used in the dispensing device in the next step, the amount of the drug to be subdivided, whether to dilute, the amount of dilution when diluting, and the syringe or vial to be used 10. The method for shortening the time for the production of a short-lived radiopharmaceutical according to claim 9, characterized in that the above is set in advance and waited to eliminate the time loss of the series production. 15. A measurement value and a quality result calculated from the measurement value are displayed in real time during an inspection by a drug quality inspection apparatus, and the result is compared with a standard document to determine the result of a series of production. The method for reducing time for producing a short-lived radiopharmaceutical according to claim 9, wherein time loss is eliminated. 16. The medicine dispensing device (16) dispenses a small amount into a syringe and provides it to the user, and the dispensing process is temporarily stopped and waits for the next dispensing operation. 10. The method for shortening the time for producing a short-lived radiopharmaceutical according to claim 9, wherein the time loss in the series production is eliminated. 17. The syringe for taking the medicine provided to the user by the medicine dispensing device (16) is returned to the dispensing device, and the residual radioactivity is measured to measure / calculate an accurate dose. In operation, by continuing another dosing operation that has already started or will be done soon,
The method for reducing the time for producing a short-lived radiopharmaceutical according to claim 9, wherein the time loss of the series production is eliminated.