• The Journal of the Korea Contents Association
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• v.9 no.11
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• pp.240-246
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• 2009

Quality control test in this field of study were carried out in 3 categories, radionuclidic purity, chemical purity and radiochemical purity. Also, indication efficiency was tested every 3 hours changed after binding the radiopharmaceutical to see how long the medicine is available for usage after indicating. The result showed that currently used radiopharmaceutical have good radionuclidic purity and chemical purity. However, radiochemical purity indication showed small differences depending on indication method and indication period. Radiopharmaceutical are indicated by treatment providers, so they need to pay more attention to the indication process and quality control to provide more efficient treatment.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.1
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• pp.1-10
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• 2021

Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to quality control before they are administered to patients to ensure the safety of the drug. Radiopharmaceuticals for administration to humans need to be sterile and pyrogen-free. Hence, sterility tests and membrane filter integrity tests are carried out to confirm the asepticity of the finished drug product, and a bacterial endotoxin test conducted to assess contamination, if any, by pyrogens. The physical appearance and the absence of foreign insoluble substances should be confirmed by a visual inspection. The chemical purity, residual solvents, and pH should be evaluated because residual by-products and impurities in the finished product can be harmful to patients. The half-life, radiochemical purity, radionuclidic purity, and strength need to be assessed by analyzing the radiation emitted from radiopharmaceuticals to verify that the radioisotope contents are properly labeled on pharmaceuticals. Radiopharmaceuticals always carry the risk of radiation exposure. Therefore, the time taken for quality control tests should be minimized and care should be taken to prevent radiation exposure during handling. This review discusses the quality control procedures and acceptance criteria for a diagnostic radiopharmaceutical.

• The Korean Journal of Nuclear Medicine
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• v.33 no.4
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• pp.430-438
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• 1999

Purpose: We evaluated a rapid preparation procedures for the labeling and quality control of $^{99m}Tc$-ECD, $MAG_3$, and MIBI using microwave heating and Sep-Pak cartridges. Materials and Methods: $^{99m}Tc$ labeling of ECD, $MAG_3$, and MIBI kit preparation was performed according to the package inserts with microwave heating modification. Heating time was 10-15 sec, and heating was performed with 3 mm plastic bottle with screw cap to prevent radiation contamination. Labeling efficiency was obtained with $C_{18}$ or Alumina N Sep-Pak cartridges. Results: The radiochemical purity of $93{\sim}96%$ for $^{99m}Tc$-ECD and $95{\sim}99%$ for $^{99m}Tc$-MIBI was obtained using Alumina N Sep-Pak cartridge. The optimum irradiation time of microwave method for 3 ml $^{99m}Tc$-labeled radiopharmaceutical solution was 10 sec for $^{99m}Tc$-ECD and $^{99m}Tc$-MIBI, and 15 sec for $^{99m}Tc-MAG_3$. The results of quality control data with Sep-Pak cartridges were well correlated with TLC method. The total preparation time of these radiopharmcaeuticals was $5{\sim}6min$ including quality control procedure. Conclusion: This study demonstrates that radiopharmaceuticals preparation by microwave heating and quality control by Sep-Pak cartridges can be efficiently utilized as an alternative to the recommended method by manufacturer's manual.

• 동위원소뉴스
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• no.8 s.8
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• pp.5-6
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• 1997

• 동위원소뉴스
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• no.9 s.9
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• pp.5-6
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• 1997

• YAKHAK HOEJI
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• v.20 no.2
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• pp.47-61
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• 1976

• Proceedings of the Korean Radioactive Waste Society Conference
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• 2004.11a
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• pp.202-202
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• 2004

• The Journal of Korean Institute of Communications and Information Sciences
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• v.37 no.5C
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• pp.429-436
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• 2012

In this paper, an RFID system for the automatic preparation system of positron emission tomography (PET) radiopharmaceuticals is developed. Since the preparation system uses radioactive isotope, the preparation system is generally placed in lead-shielded hot-cell. Disposable cassettes including tubes and valves are used in the preparation system, since they are easily contaminated by radioactivity during preparation of radiopharmaceuticals. Currently, a system for preventing re-use of the cassette and managing the information about the preparation precess and result independently from the PC which control the preparation system is highly required for preventing danger from the radiation accident. Since RFID can store and re-write relatively large amount of information, it is suitable for the purpose. However, it is hard to read multiple cassettes' information using antennas installed on the metallic surfaces with current RFID systems. For the problem, we improve RFID system in two directions. First, the interface of the RFID reader is changed then it is possible that multiple readers can be daisy-chained. Also, antenna is tuned while inserting in a metallic coated antenna case, then the effect from the metallic surface of the preparation system is minimized. The test result using the developed system shows that the developed RFID system can read multiple tags using the antennas which are attached on the metallic surface.

• The Korean Journal of Nuclear Medicine Technology
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• v.17 no.2
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• pp.59-66
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• 2013

Purpose: Recently, there is an increase of the number of hospitals using auto dispenser to reduce occupational radiation exposure when drawing up of the $^{18}F-FDG$ dose (5.18 MBq/kg) in a syringe from the dramatic high activity of $^{18}F-FDG$ multidose vial. The aim of this study is to confirm that using auto dispenser actually reduces the radiation exposure for technologists. Also we analyzed the reproducibility of auto dispenser to find optimized dispensing method for the device. Materials and Methods: We conducted three experiments. Comparison of radiation exposure on chest and hands: The chest and hands exposure dose received by technologists during the injection were measured by electronic personal dosimeter (EPD) and ring TLD respectively. Reproducibility of dispensed volume: We draw up the normal saline into 5 and 2 mL syringe using auto dispenser by changing the volume from 1 to 15 mm for 5 times in the same setting of the volume. The weight of 5 normal saline dispensed from the device at same volume was measured using micro balance and calculated standard deviation and coefficient of variation. Reproducibility of dispensed radioactivity: We dispensed 362.6 $MBq{\pm}10%$ of $^{18}F-FDG$ in 5 and 2 mL syringes from the multidose vial of different specific activity. In the same setting of volume, we repeated dispensing for 4 times and compared standard deviation and coefficient of variation of radioactivity between 5 syringes. Results: There was significant difference in the average of chest exposure dose according to the dispensing methods (P<0.05). Also, when dispensing $^{18}F-FDG$ in manual method, exposure dose was 11.5 times higher in right hand and 4.8 times higher in left hand than in auto method. In the result of reproducibility of dispensed volume, standard deviation and coefficient of variation shows decline as the dispensing volume increases. As a result of reproducibility of dispensed radioactivity, standard deviation and coefficient of variation increases as the specific activity increases. Conclusion: We approved that the occupational radiation exposure dose of technologists were reduced when dispensing $^{18}F-FDG$ using auto dose dispenser. Secondly, using small syringes helps to increase reproducibility of auto dose dispense. And also, if you lower the specific activity of $^{18}F-FDG$ in multidose vial below 915-1,020 MBq/mL, you can use auto dispenser more effectively keeping the coefficient of variation lower than 10%.

• 대한핵의학회:학술대회논문집
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• 1976.06a
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• pp.79-79
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• 1976