KR101257764B1 - Apparatus for synthesis of radiopharmaceuticals - Google Patents

Abstract

The present invention relates to a radiopharmaceutical manufacturing apparatus. The radiopharmaceutical manufacturing apparatus includes a first module unit for obtaining a product synthesized through a reaction by mixing a radioisotope and a reagent, and an agent for purifying the product in conjunction with HPLC and preparing a radiopharmaceutical through the purified product. And control the second module portion, and the first module portion, the second module portion, and the HPLC to drive the manufacture of the radiopharmaceutical, wherein the first module portion, the second module portion, and the HPLC The data obtained from the controller is transmitted to an external controller so that the state of the first module unit, the second module unit, and the HPLC is monitored in the external controller, and the synthesis is performed from the external controller. And a PLC for receiving a command to be transmitted to the first module unit. According to the present invention, all steps of synthesis, purification and formulation can be automatically processed through one device, synthesis of various kinds of radiopharmaceuticals can be done through one device, and the worker is protected from radiation exposure. can do.

Description

Apparatus for synthesis of radiopharmaceuticals

The present invention relates to a radiopharmaceutical manufacturing apparatus.

In the case of the synthesis of radiopharmaceuticals with short half-lives, the synthesis is carried out through a device in which radioisotopes and reagents are mixed to react and the obtained product is purified. Certain of the components that make up such a composite device may be sensitive to radiation or chemical corrosion.

As a representative example of radiopharmaceuticals, the synthesis of radiopharmaceuticals for Positron Emission Tomography (PET) is accomplished by labeling precursors with radioisotopes produced by cyclotrons. For this synthesis, the automatic synthesis device is essential, and since the radiation is continuously emitted during the manufacturing process, the synthesis by human hands is impossible in the case of mass synthesis.

In addition, when imaging certain tissues, organs, and processes, such as the specific receptors or cell proliferation of a human body through radiopharmaceuticals, the purity of the radiopharmaceuticals is a very important factor that determines the quality of the image. to be. Therefore, in order to minimize the content of impurities in the production of radiopharmaceuticals, a separate purification and preparation device for high purity production is required.

However, if the purification and formulation process proceeds as a separate process through a device provided separately, it is difficult to expect a high yield, there was a problem to increase the exposure of the worker. In addition, the existing device for synthesizing a specific drug, which is developed for achieving a specific purpose, cannot support the synthesis of various types of radiopharmaceuticals, and thus there is a limit in applicability to development of various new drugs.

Illustratively, as an example of a radiopharmaceutical synthesis process for PET, [18 F] FP-CIT is characterized by 18F separation and drying, 18F fluorination reaction, secondary alkylation reaction, solvent removal, product recovery from reactor, High Performance Liquid Chromatography Transfer to a high performance liquid chromatography system, chemical purification, FP-CIT collection, HPLC solvent removal by solid phase extraction (SPE), FP-CIT elution, 10 steps of final formulation One time production is possible.

However, for the synthesis of [18F] FP-CIT, there is no dedicated device for synthesizing [18F] FP-CIT. Therefore, the device for synthesizing [18F] FDG has to be modified or in-house modified. In addition, in order to purify the synthesized after the synthesis of the [18F] FP-CIT to a separate purification device, there is no transport method for the purification device provided separately, the experimenter had to move by hand. In addition, refining and post-purifying processes also had to be done by the hand of the operator because there is no integrated device.

The present invention has been created to solve the problems described above, the problem to be solved by the present invention is to handle all steps of synthesis, purification, formulation, and all-in-one (all-in-one) that can support the synthesis of various types of radiopharmaceuticals It is to provide a radiopharmaceutical manufacturing apparatus of -in-one).

Radiopharmaceutical manufacturing apparatus according to an embodiment of the present invention for achieving the above object is a first module unit for obtaining a product synthesized through the reaction by mixing a radioisotope and a reagent, in conjunction with HPLC to obtain the product A second module portion for purifying and formulating a radiopharmaceutical through the purified product, and a PLC controlling a process relating to the synthesis of the first module portion, the purification and formulation of the second module portion, wherein the PLC And controlling the first module unit, the second module unit, and the HPLC to drive the radiopharmaceuticals. The data obtained from the first module unit, the second module unit, and the HPLC is transmitted to the external control device so that the monitoring can be performed to the external control device. Receives a command for synthesis from the transmission to the first module unit.

The first and second module units include a cassette, a cassette unit including a cassette having a cassette valve and a cassette valve driving unit for switching a flow path of the cassette valve, a syringe accommodating the reagent and selectively connected to the cassette valve, and the A syringe including a syringe driving unit for driving a syringe, a reactor for acquiring the product through the reaction and delivering the product to the cassette unit, and maintaining a predetermined temperature for the acquisition of the product for a predetermined time; Each includes a heating furnace capable of heating, the first module unit may further include a radioisotope transfer device for receiving and transporting the radioisotope.

The cassette may be a disposable cassette.

The first and second module unit is a tube for connecting one or more of the radioisotope and the reagent to be transferred to a desired position, a valve installed in the tube to selectively block the transfer of one or more of the radioisotope and the reagent And a vacuum pump providing power to transfer at least one of the radioisotope and the reagent to a desired position through the tube, wherein the syringe unit is configured to carry the reagent together with the vacuum pump through driving of the syringe. It can provide the power to transfer the to the desired position.

The first and second module units may further include a cartridge for filtering a predetermined material from at least one of the radioisotope and the reagent.

The radioisotope transfer device may include a pinch valve for controlling the amount of radioisotope to be transferred.

The reactor may include a reactor pinch valve for controlling the pressure in the interior by opening or closing the interior when heated through the furnace.

The PLC monitors the heating state of the reactor by the heating furnace and transmits the image to the external control apparatus as an image, and the external control unit recognizes the drying state through the transmitted image and commands the heating or cooling to the reactor. It may be transmitted to the PLC to control the heating furnace.

The first module unit, the second module unit, and the PLC may control and transmit / receive data through Ethernet communication.

Radiopharmaceutical manufacturing apparatus according to an embodiment of the present invention may further include a gas supply device for supplying gas to the first and second module unit separately.

The second module unit may transmit the electrical signal of the sample analyzer of the HPLC to the PLC to output data through the sample analyzer to the external control device.

The second module unit transmits the electrical signals of the column and detector of the HPLC to the PLC so that the data obtained through the column and the detector are output to the external controller as a graph, and the external control. The device may control the purification by HPLC by recognizing a sample on the column of the HPLC through the shape of the output graph and sending a command to the PLC to separate the recognized sample.

In the radiopharmaceutical manufacturing apparatus according to an embodiment of the present invention, the PLC detects the state of the first module unit, the second module unit, and the HPLC to control the driving of the radiopharmaceutical and the external control. The apparatus may further include a sensor unit disposed in the first module unit and the second module unit to transmit data to the device.

The sensor unit includes a bubble sensor for detecting the bubble so that the sample injector is controlled by the PLC when the detection of the bubble inside the tube connected to the sample injector of the HPLC, wherein the bubble sensor is the second It may be disposed in the module unit.

The sensor unit includes a first radiation sensor at a position at which synthesis of the first module unit starts and a synthesis is terminated, and a second radiation sensor at a position at which the purification of the second module unit starts and a position at which the purification ends. And the first and second radiation sensors transmit data on the measured radiation amount to the external control device through the PLC, and the external control device is configured in the step of synthesizing through the data on the amount of radiation. Yield and yield in the step of purification can be calculated and managed.

The first and second module units include a cassette including a cassette having a cassette valve and a cassette valve driving unit for switching a flow path of the cassette valve, a syringe accommodating the reagent and selectively connected to the cassette valve, and the syringe. A syringe unit comprising a syringe driving unit for driving, a reactor for obtaining the product through the reaction and delivering the product to the cassette unit, and heating the reactor while maintaining a predetermined temperature for a predetermined time for obtaining the product. And a heating furnace capable of each, wherein the first module unit further includes a radioisotope transfer device for receiving and transporting the radioisotope, and the sensor unit operates the syringe through the PLC and the external control device. To feed back the position of the syringe so that it can be controlled An optical sensor for detecting the operation of the cassette valve so that the flow path switching of the cassette valve can be controlled through the position detector, the PLC and the external controller, and the temperature of the reactor is controlled through the PLC and the external controller. It may include a temperature sensor for feeding back the temperature of the reactor.

The external control device may store data obtained from the first module unit, the second module unit, and the HPLC through the PLC, and manage and output a history of the radiopharmaceutical.

Radiopharmaceutical manufacturing apparatus according to an embodiment of the present invention may further include the external control device and the HPLC.

According to the present invention, by having a PLC, an external control unit, and a drive unit that is controlled and monitored through such a PLC and an external control unit, all steps of synthesis, purification, and preparation are automatically processed through a single device, and this processing history is managed. Can manage

In addition, the management of this history can be particularly useful in the development of new radiopharmaceuticals.

In addition, by appropriately replacing the cartridge, cassette, tube, etc. for the type of radiopharmaceuticals to be prepared, synthesis of various kinds of radiopharmaceuticals can be easily made through one device.

In addition, as described above, all steps of synthesis, purification, and preparation are performed in one device, and remote control, monitoring, and driving through Ethernet communication, etc., can protect the worker from radiation exposure.

1 is a schematic perspective view of a radiopharmaceutical manufacturing apparatus according to an embodiment of the present invention.
Figure 2 is a schematic front view of the radiopharmaceutical manufacturing apparatus of Figure 1;
Figure 3 is a conceptual diagram showing the configuration of HPLC (High Performance Liquid Chromatography, high performance liquid chromatography).

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Radiopharmaceutical manufacturing apparatus (hereinafter referred to as 'the present radiopharmaceutical manufacturing apparatus') 100 according to an embodiment of the present invention can process the whole step of the synthesis, purification, formulation, synthesis of various types of radiopharmaceuticals The present invention relates to a radiopharmaceutical manufacturing apparatus capable of supporting and being provided in an all-in-one manner to protect workers from radiation exposure.

For example, referring to Figures 1 and 2, the radiopharmaceutical manufacturing apparatus 100 may be composed of two stages of the top and bottom. For example, at the bottom, the radiopharmaceutical may be synthesized through the first module unit 1, and at the top, the radiopharmaceutical may be purified and prepared through the second module unit 2. For example, a radiopharmaceutical [18 F] FDG, which does not require purification using HPLC 400, may be treated at the bottom. In addition, if the purification should be performed using HPLC (400), such as the synthesis of the radiopharmaceutical [18F] FC119s or [18F] FLT using the second module (2) of the top that can be linked to the HPLC (400) The first module 1 allows for the purification and formulation of the synthesized material.

In the radiopharmaceutical manufacturing apparatus 100, for the radiochemical reaction required for the synthesis, chemical reaction and activation such as transfer (mixing) and substitution reaction of solvent and reagent, extraction of solvent, ion exchange, etc. Heating (cooling) may be necessary. Here, process control by various sensors may be required for the synthesis of radiopharmaceuticals of high yield and high purity.

As a device for conveyance (mixing), a syringe driving unit which may be included in the syringe unit 52, a cassette valve driving unit which may be included in the cassette unit 51, and a radioisotope transfer unit 55 ( delivery unit, gas supply unit and the like. Solutions and reagents can be moved through these devices to desired locations (such as between reservoirs) and passed through cartridges for special purposes such as organic filtration. At this time, a plurality of valves (such as 2-way valves) may be used to control the flow of the fluid (solution and reagent) to be moved.

Such a device for conveyance (mixing), a device for heating (cooling), and various sensors for process control are appropriately disposed in the first module part 1 and the second module part 2 as necessary, as will be described later. Can be.

The first module unit 1 of the radiopharmaceutical manufacturing apparatus 100 may obtain a product synthesized through a reaction by mixing a radioisotope and a reagent.

1 and 2, the first module unit 1 may include a radioisotope transfer device 55 for receiving and transporting radioisotopes. For example, the radioisotope transporting device 55 may transport the radioisotope raw material produced in cyclotron. In addition, the radioisotope transporting device 55 is preferably kept tight when transporting the radioisotope and is quietly transported so as not to adhere to the base wall. And the radioisotope transfer device 55 may include a pinch valve for controlling the amount of radioisotope to be transferred.

1 and 2, the first module unit 1 may include a cassette unit 51. The cassette unit 51 may include a cassette 511 including a cassette valve 512, and a cassette valve driving unit that switches a flow path of the cassette valve 512.

At this time, the cassette 511 may be a disposable cassette. For example, the cassette 511 may use a disposable product made of plastic in order to increase stability and convenience in manufacturing a radiopharmaceutical.

1 and 2, the cassette 511 may include a plurality of cassette valves 512. The plurality of cassette valves 512 may be configured as three-way valves and connected to each other to form a cassette 511. That is, one of the three directions may be connected to the syringe 521, the tube, etc., and the other two directions may be connected to the plurality of cassette valves 512. As described above, a plurality of cassette valves 512 are connected to each other to form a cassette 511, and the syringe 521 and the tube are variously connected according to the radiopharmaceutical manufacturing process, and the cassette 130 serves as a flow path switching device. Will be The flow path switching device may mean a device capable of switching the flow of radioisotopes, reagents, solutions, etc. to a required place among the syringe 521, the plurality of cassette valves 512, and the reactor.

In addition, the cassette valve driving unit may be rotatable both clockwise and counterclockwise with respect to the cassette valve 512, and accurate position control is possible when the flow path is changed through the cassette valve 512 and independent of each of the cassette valves 512. It is desirable to be able to drive.

1 and 2, the first module unit 1 may include a syringe unit 52. The syringe 52 may include a syringe 521 for receiving a reagent and selectively connected to the cassette valve 512, and a syringe driver for driving the syringe 521. It is preferable that the syringe driver be precisely controlled in driving the syringe 521 to accurately transfer reagents contained in the syringe 521. In exemplary embodiments, the syringe driver may include a servo motor and a driver to control the position of the syringe 521. In addition, the syringe portion 52 may include a syringe holder for fixing the syringe 521. Such a syringe holder may be changeable in a holder to fix syringes of various sizes. In addition, the syringe unit 52 may provide power to transfer the reagent to a desired position together with the vacuum pump to be described later through the driving of the syringe 521 through the syringe driver.

Here, the fact that the syringe 521 is selectively connected to the cassette valve 512 means that the cassette valve which needs to be connected to the syringe 521 in the radiopharmaceutical manufacturing process among the plurality of cassette valves 512 provided in the cassette 511 ( 512) may be connected when necessary.

In addition, although not shown in the drawings, the first module unit 1 may include a reactor. The reactor may obtain a product through a reaction of a mixture of the radioisotope transferred from the radioisotope transfer device 55 and the reagent transferred through the cassette unit 51 and deliver the product to the cassette unit 51.

And the reactor may include a reactor pinch valve for controlling the pressure of the inside by opening or closing the inside when heated through the heating furnace 53 to be described later. This will be described again while examining the configuration of the heating furnace 53.

1 and 2, the first module unit 1 may include a heating furnace 53 capable of heating the reactor while maintaining a preset temperature for a predetermined time for obtaining a product.

The furnace 53 may be used for activating a chemical reaction in the reactor, and may directly or indirectly heat the solution contained in the reactor. For example, an electric furnace or a microwave oven may be used as a heat source for heating the solvent (reagent). In addition, the furnace 53 may also serve as a cooling device capable of rapidly cooling the reactor by using compressed air, nitrogen, helium, and the like.

The heating furnace 53 serving as the heating and cooling device may maintain a preset temperature for a predetermined time as described above for the synthesis of radiopharmaceuticals. For example, the heating furnace 53 may maintain a constant temperature for less than 300 ℃. In addition, the heating furnace 53 can control the pressure in the reactor by closing and intermittently opening the reactor using the reactor pinch valve described above.

Although not shown in the drawings, the first module unit 1 may include a tube connecting one or more of the radioisotope and the reagent to be transferred to a desired position, and selectively transfer one or more of the radioisotope and the reagent. It may include a valve (such as a 2-way valve) installed in the tube to shut off, and includes a vacuum pump that provides power to transfer one or more of the radioisotopes and reagents through the tube to a desired location. Can be.

In exemplary embodiments, a valve may be installed in a tube connecting the reactor and the cassette valve 512 to block the connection between the two components to prevent the solution inside the reactor from being moved to the cassette 511. In addition, when the product obtained after the synthesis through the reaction in the reactor is to move in the direction of the cassette 511 in the reactor can be released to block the valve for such a tube to allow the solution to move smoothly. Such a tube may also be a silicone tube.

In addition, the first module unit 1 may include a cartridge for filtering a predetermined material from at least one of a radioisotope and a reagent. Here, the predetermined material may be a material to be filtered for the preparation of the radiopharmaceutical. For example, the first module unit 1 may include a cartridge having a special purpose such as filtration of organic matter in solutions and reagents. By utilizing the above-described cassette 511, a tube, and a cartridge for such filtration purposes, the radiopharmaceutical manufacturing apparatus 100 can be applied to various radiopharmaceuticals.

On the other hand, the second module portion 2 of the radiopharmaceutical manufacturing apparatus 100 may be linked with the HPLC 400 to purify the product and to prepare a radiopharmaceutical through the purified product.

Here, the HPLC 400 interlocked with the second module portion 2 to be used for purification is a known configuration that is sold as a ready-made product. For example, as shown in FIG. 3, such an HPLC 400 may include a pump 440, an injector 410, a column 420 separating the sample, and the presence of the sample. It may include a detector 430 (detector) for recognizing the amount by a certain rule to convert the amount into an electrical signal. In order to automatically process the operation of the HPLC 400 and the detected electrical signal, the HPLC 400 is preferably linked with the second module unit 2 as described above.

1 and 2, the second module unit 2 may include a cassette unit 51. The cassette unit 51 may include a cassette 511 including a cassette valve 512, and a cassette valve driving unit that switches a flow path of the cassette valve 512. At this time, the cassette 511 may be a disposable cassette. The description of this cassette section 51 refers to the description in the first module section 1.

1 and 2, the second module part 2 may include a syringe part 52. The syringe 52 may include a syringe 521 for receiving a reagent and selectively connected to the cassette valve 512, and a syringe driver for driving the syringe 521. In addition, the syringe portion 52 may include a syringe holder for fixing the syringe 521. Such a syringe holder may be changeable in a holder to fix syringes of various sizes. In addition, the syringe unit 52 may provide power to transfer the reagent to a desired position together with the vacuum pump to be described later through the driving of the syringe 521 through the syringe driver. The description of this syringe portion 52 refers to the description in the first module portion 1.

In addition, although not shown in the drawings, the second module unit 2 may include a reactor. And the reactor may include a reactor pinch valve for controlling the pressure of the inside by opening or closing the inside when heated through the heating furnace 53 to be described later. The description of this reactor refers to the description in the first module part 1.

1 and 2, the second module unit 2 may include a heating furnace 53 capable of heating the reactor while maintaining a predetermined temperature for obtaining a product for a predetermined time. For the description of such a heating furnace, refer to the description in the first module unit 1.

Although not shown in the drawings, the second module unit 2 may include a tube connecting one or more of the radioisotope and the reagent to be transferred to a desired position, and selectively transfer one or more of the radioisotope and the reagent. It may include a valve (such as a 2-way valve) installed in the tube to shut off, and includes a vacuum pump that provides power to transfer one or more of the radioisotopes and reagents through the tube to a desired location. Can be. For an exemplary description of such tubes and valves refer to the description in the first module part 1.

In addition, the second module unit 2 may include a cartridge for filtering a predetermined material from one or more of radioisotopes and reagents. Here, the predetermined material may be a material to be filtered for the preparation of the radiopharmaceutical. For example, the second module unit 2 may include a cartridge having a special purpose such as filtration of organic matter in solutions and reagents. By utilizing the above-described cassette 511, a tube, and a cartridge for such filtration purposes, the radiopharmaceutical manufacturing apparatus 100 can be applied to various radiopharmaceuticals.

Although not shown in the drawings, the radiopharmaceutical manufacturing apparatus 100 may include a gas supply device capable of supplying gas to the first module unit 1 and the second module unit 2 separately. Such a gas supply device may be used for cleaning a device for transporting or transporting a fluid using nitrogen, compressed air, vacuum, or the like. Accordingly, the gas supply device is preferably provided to be able to provide a sufficient pressure and to be able to adjust the appropriate pressure.

In an exemplary embodiment, the gas supply device may simultaneously use gases such as nitrogen, compressed air, vacuum, and helium in the first module 1 and the second module 2, and the driving unit for transporting (mixing) the gas supply device. Individual gas supply and pressure regulation may be possible, regardless of In addition, the gas supply device may be connected to the cassette unit 51 for gas supply, for example, to the cassette unit 51 by using a connector having a silicon tube and a thread.

Hereinafter, the configuration related to the process control for the synthesis of radiopharmaceuticals of high yield and high purity will be examined.

Referring to FIG. 4, in the radiopharmaceutical manufacturing apparatus 100, the process control is a driving unit required for synthesis through a PLC to be described later according to a process command of an external control device 300 (eg, a PC unit as shown in FIG. 3). It may be to control the (actuator). For example, the external control device 300 may move or turn on / off each driver to a predetermined position through a PLC. Here, the driving unit is a device for transferring (mixing) the salping syringe drive unit, the cassette valve driving unit, the radioisotope transfer device 55, the gas supply device, or the like, and the heating furnace 53, the reactor pinch valve, and the like ( Cooling).

Referring to FIG. 4, when the external control apparatus 300 collectively transmits a process to an IO map for controlling the driving unit, the PLC may sequentially proceed. The PLC may control the driving unit and the HPLC using information obtained from various sensors to be described later for the synthesis of radiopharmaceuticals, and the data regarding the state and the position of the driving unit and the HPLC for monitoring in the external control device 300. It can be transmitted to the external control device 300. In addition, as shown in FIG. 4, the external controller 300 stores data obtained from the first module unit 1, the second module unit 2, and the HPLC 400 through a PLC, and records the radiopharmaceutical history. Can manage and print

The radiopharmaceutical manufacturing apparatus 100 may be synthesized, purified, and formulated with a single data transmission through control by the external controller 300 and the PLC. The radiopharmaceutical manufacturing apparatus 100 may further include such an external control device (300).

In addition, Ethernet communication and, consequently, serial communication may be used to transmit and receive data between the PLC and the driver or between the PLC and the external control device 300 in real time. That is, the salping first module unit 1, the second module unit 2, and the PLC may be capable of controlling and transmitting and receiving data through Ethernet communication.

1 to 4, a programmable logic controller (PLC) controls processes related to synthesis of the first module unit 1, purification and formulation of the second module unit 2. More specifically, the PLC controls the first module unit 1, the second module unit 2, and HPLC 400 (High Performance Liquid Chromatography) to drive the radiopharmaceuticals for manufacturing. The first module unit 1, the second module 2, and the second module unit 1, the second module unit 2, and the state of the HPLC 400 may be monitored by the external controller 300. The module unit 2 and the data obtained from the HPLC 400 may be transmitted to the external control device 300, and the synthesis command is received from the external control device 300 and transmitted to the first module unit 1. Can be.

For example, the PLC monitors the heating state of the reactor by the heating furnace 53 and transmits the image to the external control device 300 as an image, and the external control device 300 recognizes the dry state through the transmitted image and the reactor. The heating furnace 53 can be controlled by sending a heating or cooling command to the PLC.

In addition, the second module 2 may transmit the electrical signal of the sample analyzer of the HPLC 400 to the PLC so that the data through the sample analyzer is output to the external control device 300.

The second module unit 2 transmits the electrical signal of the column 420 of the HPLC 400 and the electrical signal of the detector 430 of the HPLC 400 to the PLC so that the column 420 and Data acquired through the detector 430 may be output as a graph to the external control device 300.

In addition, the second module unit 2 recognizes the sample on the column 420 of the HPLC 400 and transmits a command to separate the recognized sample to the PLC through the shape of the output graph to the PLC Purification by HPLC 400 can be controlled.

On the other hand, look at the sensor used for the process control as follows.

The sensor unit detects the states of the first module unit 1, the second module unit 2, and the HPLC 400 to control the driving of the radiopharmaceuticals and transmit data to the external controller 300. In order to do this, the first module unit 1 and the second module unit 2 may be arranged with various sensors.

1 and 2, the bubble sensor 71 is a sample injector 410 by the PLC when the detection of the bubbles in the tube connected to the sample injector 410 (injector) of the HPLC 400 is made The bubble can be detected so that it is controlled.

1 and 2, the first radiation sensor 721 may be provided at a position at which synthesis of the first module unit 1 starts and at a position at which synthesis ends. In addition, the second radiation sensor 722 may be provided at the position where the purification of the second module unit 2 starts and the position where the purification ends. The first radiation sensor 721 and the second radiation sensor 722 may transmit data on the measured radiation amount to the external control device 300 through the PLC, the external control device 300 is related to the amount of radiation The data can be used to estimate and manage the yield at the stage of synthesis and the yield at the stage of purification.

The position detector may feed back the position of the syringe 521 so that the operation of the syringe 521 may be controlled through the PLC and the external controller 300.

In addition, the optical sensor may detect the operation of the cassette valve 512 so that the flow path switching of the cassette valve 512 can be controlled through the PLC and the external controller 300.

The temperature sensor may feed back the temperature of the reactor so that the temperature of the reactor can be controlled through the PLC and the external controller 300. The temperature sensor for measuring the temperature of such a reactor may be a thermocouple sensor or an infrared sensor. For accurate temperature control, the temperature sensor is preferably a sensor capable of real-time temperature measurement.

According to the present invention, it is possible to process all steps of synthesis, purification, formulation through a single device, and to support the synthesis of various types of radiopharmaceuticals by replacing the cassette 511, tube, cartridge, etc. As such, a single device is provided to perform all steps of synthesis, purification, and preparation, and remote control, monitoring, and driving through Ethernet communication, etc., may protect the operator from radiation exposure.

While the present invention has been particularly shown and described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments, but, on the contrary, And all changes and modifications to the scope of the invention.

100. Radiopharmaceutical manufacturing apparatus
1. First module part 2. Second module part
51. Cassette section 511. Cassette
512. Cassette valve 52. Syringe section
521. Syringes 53. Furnaces
55. Radioisotope transfer device
71. Bubble sensor 721. First radiation sensor
722. The second radiation sensor
400.HPLC 410.Sample Injector
420. Column 430. Detector
440. Pump

Claims (18)

A first module unit for obtaining a product synthesized through a reaction by mixing a radioisotope and a reagent,
A second module unit for purifying the product in conjunction with HPLC and preparing a radiopharmaceutical through the purified product, and
A PLC for controlling processes relating to synthesis of the first module portion, purification and formulation of the second module portion,
The PLC controls the first module unit, the second module unit, and the HPLC to drive for the manufacture of the radiopharmaceutical, wherein the first module unit, the second module unit, and The data obtained from the first module unit, the second module unit, and the HPLC is transmitted to the external controller so as to monitor the state of the HPLC, and receives a command for synthesis from the external controller. Radiopharmaceutical manufacturing apparatus for transmitting to the first module unit. In claim 1,
The first and second module unit
A cassette unit including a cassette having a cassette valve and a cassette valve driving unit for switching a flow path of the cassette valve;
A syringe unit including a syringe which receives the reagent and is selectively connected to the cassette valve, and a syringe driver for driving the syringe;
A reactor for obtaining the product through the reaction and delivering the product to the cassette part, and
Each comprising a heating furnace capable of heating the reactor while maintaining a preset temperature for obtaining the product for a preset time;
The first module portion radiopharmaceutical manufacturing apparatus further comprises a radioisotope transfer device for receiving and transporting the radioisotope. In claim 2,
The cassette is a radiopharmaceutical manufacturing apparatus is a disposable cassette. In claim 2,
The first and second module unit
A tube connecting the radioisotope and one or more of the reagents to be transferred to a desired position,
A valve installed on the tube to selectively block the transport of at least one of the radioisotope and the reagent, and
Further comprising a vacuum pump for providing power to transfer one or more of the radioisotope and the reagent through the tube to a desired position,
The syringe unit provides a radiopharmaceutical device for providing power to transfer the reagent to the desired position with the vacuum pump through the drive of the syringe. In claim 2,
The first and second module portion radiopharmaceutical manufacturing apparatus further comprises a cartridge for filtering a predetermined material from at least one of the radioisotope and the reagent. In claim 2,
The radioisotope transport apparatus comprises a pinch valve for controlling the amount of the radioisotope is transported radiopharmaceutical manufacturing apparatus. In claim 2,
The reactor is a radiopharmaceutical manufacturing apparatus comprising a reactor pinch valve for controlling the pressure inside the opening or closing the inside when heated through the heating furnace. In claim 2,
The PLC monitors the heating state of the reactor by the heating furnace and transmits the image to the external control device as an image.
The external controller is a radiopharmaceutical manufacturing apparatus for controlling the heating furnace by recognizing a drying state through the transmitted image and transmitting a heating or cooling command for the reactor to the PLC. In claim 1,
The first module unit, the second module unit, and the PLC is a radiopharmaceutical manufacturing apparatus capable of transmitting and receiving data and control via Ethernet (ethernet) communication. In claim 1,
Radiopharmaceutical manufacturing apparatus further comprises a gas supply device for supplying gas to the first and second module unit separately. In claim 1,
The second module unit is a radiopharmaceutical manufacturing apparatus for transmitting the electrical signal of the sample analyzer of the HPLC to the PLC to output the data through the sample analyzer to the external control device. In claim 1,
The second module unit transmits the electrical signals of the column and the detector of the HPLC to the PLC so that the data obtained through the column and the detector are output as a graph to the external controller,
The external control device is a radiopharmaceutical manufacturing apparatus for controlling the purification by the HPLC by transmitting a command to recognize the sample on the column of the HPLC through the shape of the output graph and to separate the recognized sample. In claim 1,
The first module unit, the second module unit, and the state of the HPLC to grasp the state of the radiopharmaceuticals for the control of the drive and the transmission of data to the external control device, so as to enable Radiopharmaceutical manufacturing apparatus further comprises a module unit and a sensor unit disposed in the second module unit. In claim 13,
The sensor unit includes a bubble sensor for sensing the bubble so that the sample injector is controlled by the PLC when the detection of the bubble inside the tube connected to the sample injector of the HPLC,
The bubble sensor is a radiopharmaceutical manufacturing apparatus disposed in the second module portion. In claim 13,
The sensor unit
The first radioactivity sensor is provided at a position at which synthesis of the first module unit starts and synthesis ends.
A second radioactive sensor is provided at a position at which the purification of the second module unit starts and at the end of the purification;
The first and second radiation sensors transmit the data on the measured radiation amount to the external control device through the PLC,
The external control device for radiopharmaceutical manufacturing apparatus for calculating and managing the yield in the step of synthesis and the yield in the step of purification through the data on the amount of radioactivity. In claim 13,
The first and second module unit
A cassette unit including a cassette having a cassette valve and a cassette valve driving unit for switching a flow path of the cassette valve;
A syringe unit including a syringe which receives the reagent and is selectively connected to the cassette valve, and a syringe driver for driving the syringe;
A reactor for obtaining the product through the reaction and delivering the product to the cassette part, and
Each comprising a heating furnace capable of heating the reactor while maintaining a preset temperature for obtaining the product for a preset time;
The first module unit further comprises a radioisotope transfer device for receiving and transporting the radioisotope,
The sensor unit
A position detector for feeding back the position of the syringe so that the operation of the syringe can be controlled through the PLC and the external controller;
An optical sensor for sensing the operation of the cassette valve so that the flow path switching of the cassette valve can be controlled through the PLC and the external controller; and
Radiopharmaceutical manufacturing apparatus comprising a temperature sensor for feeding back the temperature of the reactor so that the temperature of the reactor can be controlled through the PLC and the external control device. In claim 1,
The external control device is a radiopharmaceutical manufacturing apparatus for storing the data obtained from the first module unit, the second module unit and the HPLC through the PLC to manage and output the history of the radiopharmaceutical. The method according to any one of claims 1 to 17,
Radiopharmaceutical manufacturing apparatus further comprising the external control device and the HPLC.

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