RU2097857C1 - Device for producing sterile radionuclides - Google Patents

Abstract

FIELD: generators of radioactive elements for producing sterile radionuclides for medicine and engineering purposes. SUBSTANCE: device has sorbent and radionuclide column placed inside radiation shield; eluent piping connects column with needle inserted in seat in device flange; eluate piping connects other side of column with other needle also inserted in seat in device flange. Eluate piping mounts filter and three-way cock. Connected to the latter is additional eluate piping with additional needle inserted in separate seat in device flange. Device also has bactericidal air filter with piping and needle inserted in seat in device flange. During device charging, process agents are fed to column and further over eluate piping to outlet bypassing the filter. Mode of operation is chosen by device depending on eluate quality. Eluate obtained may be passed either through filter or over other piping bypassing the filter. Desired mode of operation is selected by means of three-way cock. EFFECT: improved eluate quality and facilitated procedure. 2 cl, 5 dwg

Description

 The invention relates to the production of generators of radioactive elements used to produce radionuclides for medicine and technology.

 A device for the preparation of sterile radioactive isotopes [1] which consists of a column containing a sorbent and placed vertically in radiation protection from lead is known. In the upper end part, the column is connected to two pipelines, namely, the first for supplying a solution of the parent radionuclide for its sorption during the production of the generator, and the second for supplying eluent during operation of the generator. From the other end of the column comes one pipeline. When the column is charged on a sorbent, a radioactive element is fixed, for example, molyblen-99, from which the required radionuclide, for example, technetium-99m, is formed during radioactive decay. This short-lived radionuclide is removed from the column by pumping the appropriate solution, for example, an isotonic sodium chloride solution in the case of a technetium-99m generator, through an eluent-column-pipeline system. The design drawback of such a device is the impossibility of using a pipeline for supplying a solution of the parent radionuclide during generator operation.

 The closest technical solution is a generator for sterile radionuclides [2] which contains a column located vertically and placed in radiation protection from lead. An additional filter is horizontally above the column, made in the form of a tube containing filter material. The tube is sealed at the ends. The bottom end of the column is connected via a pipe to the end part of the tubular filter, and the second end of the filter is connected by a pipe to a vertical needle fixed in the socket of the generator flange (eluate pipe). The upper end of the column is connected by a pipeline to a vertical needle fixed in the second socket of the generator flange (eluent pipeline). In the same nest, a second vertical needle is installed, connected by a pipeline to an air bactericidal filter. The disadvantage of the design of the generator is the complex process of bringing the generator to working condition after charging, associated with the re-installation of technological communications (pipelines) of the generator, as well as a possible violation of sterility in this case.

 The objective of the invention is to eliminate these drawbacks, to simplify the complex process of bringing the generator to working condition after charging, associated with the disassembly and re-installation of technological communications of the generator after charging, and to replace it with a columnless charge of the column, as well as to ensure sterility of the radionuclide generator with high quality eluate.

 To achieve the specified technical result, it was proposed to install a three-way flow switch of technological reagents between the column and the eluate filter on the eluate pipeline. In this case, place the switch under the device flange and provide an additional pipeline with a needle fixed in an autonomous socket of the device flange, and close the needle with a removable sealed plug. Place the eluate filter together with the column in the vertical socket of the radiation protection and close the end cap with the general radiation protection plug.

 In FIG. 1 is a schematic hydraulic diagram of a device for producing sterile radionuclides, where 1 column with a sorbent and a radionuclide, for example, tin-113, tungsten-188, strontium-82, etc. The column is surrounded by radiation protection 2. On the pipe 3 there is a tap 4 of the flow of technological reagents, and on the pipe 5 there is a filter 6, ending with a needle 7, mounted in the flange 8. The valve 4 is equipped with a pipe 9 of the flow of technological reagents, which ends with a needle 10. On top of the column 1 is connected to the pipe 11 of the eluent, vayuschiysya needle 12 attached to the flange 8. A bactericidal filter 13 is connected to the conduit 14 with the needle 15 attached to a flange 8. Flange 8 is installed above the radiation shield 2 which is fixed in the generator case (FIG. 1 March housing not shown). When transporting the generator to the consumer, the needles 7, 10, 12 and 15 are closed with special transport caps 16 filled with a bactericidal substance. To charge the generator column with a radionuclide, a pump 17, a tank 18 with technological reagents, is used. Adapters 19 of production lines 20 are fixed on needles 10, 12. During the operation of the generator, a vacuum bottle 21 and a bottle with eluent 22 are used.

 In FIG. 2 is a schematic hydraulic diagram of a device for producing sterile radionuclides during column charging and device operation in the first mode (the tap is in the “Z / 1P” position / first mode).

 In FIG. 3 is a schematic hydraulic diagram of a device for producing sterile radionuclides and operation of the device in the second mode (the valve is in the "2P" position, the second mode).

 In FIG. 4 is a vertical section through a device for producing sterile radionuclides, where 23 is a device body; 24 socket flange device; 25 crane control handle 4 (additional axial radiation protection); 26 vertical socket of radiation protection.

 In FIG. 5 shows a diagram of the placement of needles on the flange of the device and the switch control handle.

 A device for producing sterile radionuclides works as follows.

 First, after assembly of the device under sterile conditions, column 1 is charged with a radionuclide. To do this, the needle 10 is docked with the adapter 19 of the production line 20 connected to the tank 18, and the needle 12 is the adapter 19 of the production line 20 connected to the pump 17, which, in turn, is connected to the tank 18 containing the technological reagents. Charging is as follows. Turn on the pump 17, which delivers from the tank 18 technological reagents containing a radionuclide. These technological reagents through the injection technological line 20 through the adapter 19, the needle 12 and the pipeline of the eluent 11 enter the column 1, on the sorbent of which is fixed part of the radionuclide from the technological reagents. The technological reagents depleted in the parent radionuclide pass through the valve 4, which is in the “Z / 1P” position, charging. The crane 4 directs the flow of technological reagents to the pipe 9 and then to the needle 10, through the adapter 19 and along the discharge technological line 20, the reagents are returned to the container 18. After charging the column of the device, it is washed and dried, and then the adapters 19 are removed to the needles 10, 12 and 15 set the transport caps 16. Next, select the operating mode of the device, which is determined by the quality of the eluate. For the main mode of operation, the first mode is selected. Subject to the standards prescribed by the pharmacopoeial article, the work in the first mode is maintained, if they are violated, the system switches to the second mode. These features of the operating modes are determined by the application for the production of devices of activation radionuclides with a long half-life, for example, tin-113, tungsten-188, strontium-82, etc. As a result, the device can be charged by the manufacturer in a wide time interval. To meet the needs of customers in high-activity devices, before the manufacturer receives a new batch of the radioactive parent radioisotope, it is necessary to load into the device column an ever-increasing amount of the manufacturer’s previous radionuclide production. Due to the fixed sorption capacity of the column, the content of impurities in the eluate increases with increasing load of the radionuclide and at a certain point in time begins to exceed the normalized limit. To bring the quality of the eluate in accordance with the prescribed requirements, it is necessary from now on to use the operation of the device in the second mode with additional purification of the eluate. The selected mode of operation of the device cannot be changed by the consumer. In this form, the device is prepared for transportation. When working in a medical facility, the crane 4 is either in the position "Z / 1P" or "2P". In this case, either needle 10 or needle 7 is used in the work. The needle that is not used in the selected operating mode is muffled by the manufacturer with a volumetric sealed plug.

 As an example, the operation of the generator in the most complex second mode is described.

 Example. A bottle 22 with an eluent is installed on the needles 12 and 15, and a vacuum bottle 21 is installed on the needle 7. Due to the difference in atmospheric pressure and vacuum, the liquid from the bottle 22 is sucked in through the needle 12 and flows through the pipe 11 to column 1. The eluent flushes the daughter radionuclide from the sorbent columns and through pipeline 3, through valve 4, through pipeline 5 enters filter 6. In filter 6, the eluate is purified from impurities exceeding pharmacological standards to acceptable values, and through the needle 7, the eluate enters the evacuated bottle 21. As the eluent decreases from the bottle 22 into the vacated volume through the bactericidal filter 13, the pipe 14 and the needle 15 receives purified air. The remains of the eluent from the bottle 22, pipelines and columns are squeezed out by air, the appearance of which in the eluate of the bottle 21 in the form of bubbles indicates the end of the elution process. After elution is complete, the bottles 21 and 22 are removed, and the needles are closed with caps 16.

 Using the invention will simplify the process of bringing the device to a usable state after charging and to ensure high quality of the resulting eluate.

Sources of information
1. Technetium-99m generator. Production versus quality. IAEA Report (IAEA-SR-131/48), 1986, 18 pp.

 2. Patent GDR N 209171, IPC C 01 G 57/00, G 21 G 4/08, 1984.

Claims (2)

 1. A device for producing sterile radionuclides, comprising a column with a sorbent and a radionuclide surrounded by radiation protection, an eluent piping connected to a column and a needle fixed in a socket of a device flange, a bactericidal filter with a pipe and a needle fixed in a socket of a device flange, an eluate pipe, connected to the column and the needle with the eluate filter installed on it, characterized in that a three-way valve with an additional connected to it is installed on the pipeline of the eluate between the column and the eluate filter by the eluate filling pipe and an additional needle fixed in an autonomous socket of the device flange and closed by a removable sealed plug.  2. The device according to claim 1, characterized in that the eluate filter is placed together with the column in a vertical socket of radiation protection and is closed at the end with a common tube of radiation protection.

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