• 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.

• Proceedings of the Korean Radioactive Waste Society Conference
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• 2004.06a
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• pp.219-221
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• 2004

국가의 규제기관과 처분장에서는 방사성 폐기물의 안전한 영구처분을 위하여 폐기물 수용(인수)기준을 폐기물 발생자에게 준수토록 요구하게 되는데 이러한 폐기물 수용(인수)기준은 처분시설의 가동동안 인간과 환경 보호 그리고 최대 300년간의 제도적 통제기간을 고려하여 처분장의 안전성 확보를 위하여 설정되어진다. 폐기물 수용(인수)기준중 고화체의 안정성 평가와 관련하여 미국(NRC/BTP)은 폐기물의 종류와 고화매질에 따라 유리수, 압축강도, 방사성 조사특성, 미생물 영향 특성, 침수 및 침출 특성, 열순환 특성 등에 대하여 표준시험법을 제시하였으며, 또한 그의 기술기준치도 제시하고 있다. 그리고 프랑스(DRDD/ BECC)에서는 미국보다 매우 세밀하게 평가항목들을 분류하는 등의 처분장 운영국가에서는 고화체의 안정성관련 평가시험들을 처분 환경과 처분방식에 맞게 표준화하고 있다. 한편 국내에서는 과기부 고시 제2001-32호 "중.저준위 방사성폐기물 인도규정"이 있으나 이에는 고화체 관련하여 정성적인 안정성에 대하여서만 기술되어 있다. 이에 따라 원전폐기물 고화체에 대한 안정성 평가를 위한 시험법을 선정하기 위하여 아래 그림과 같은 절차에 따라 수행토록 하였다. 우선 대표적인 천층처분 운영국가인 미국과 프랑스의 시험법 그리고 IAEA 권고 시험법과 유사관련 한국 산업표준법들을 조사하고, 이들 시험법들의 주요 차이점을 기술적 관점에서 비교평가하고, 이어서 모의 방사성 및 비방사성 고화체를 이용하여 상기 시험법들을 각각 적용하고 또한 이들 시험법들간의 차이(시험 조건, 시편의 크기 등)에 기인한 상호 비교시험을 통하여 얻어진 시험결과들을 종합적으로 비교 검토하여 보수적 관점에서 시험법을 선정하는 것으로 방향을 잡았다. 이때 시험결과를 얻기 위한 모든 과정에 품질보증 활동을 적용키로 하였으며, 시험결과 분석/평가 과정과 시험법 선정에 각계(규제기관, 학계, 발전소 현장 및 산업계 등) 전문가로부터 기술자문회의를 통하여 자문 의견을 받기로 하였다. 특히 현재 폐기물 인수 기술기준치가 설정된 국가의 시험법을 심층 있게 검토하기로 하였다.검토하기로 하였다.

• The Bulletin of The Korean Astronomical Society
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• v.37 no.2
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• pp.196.1-196.1
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• 2012

인공위성은 지상에서부터 발사 및 궤도 운용까지 다양한 전자파 환경에 노출되며 이러한 환경에서의 위성 운용을 검증하기 위하여, 다양한 전자파 환경을 모사하는 전자파 환경시험을 수행하게 된다. 특히, 궤도내에서 위성의 운용시 지상국과의 교신을 위하여 X 밴드 안테나와 S 밴드 안테나에서 지상국으로 강한 전자기파를 방사하게 되는데, 이 방사에너지가 위성에 영향을 주는지 검증하는 시험을 지상에서 수행한다. 이런 시험을 RFC (RF Auto-Compatibility) 시험이라고 부른다. RFC 시험은 위성으로부터 방사되는 전자기파가 외부에 새어나가지 않도록 전자파 챔버내에서 시험하며, 강한 전자기파를 흡수할 수 있는 고전력 전파 흡수체가 설치된 전자파 챔버가 필요하다. RFC 시험시 X 밴드 안테나와 S 밴드 안테나를 최대 전력으로 방사시키고, 이때 위성 주변에 전자파 센서를 부착하여 전계강도를 측정함으로써 위성으로 입사되는 전자기파의 세기가 적정 레벨 이하인지를 검증하고, 동시에 위성의 운용상태를 확인하여 위성에 영향이 없음을 검증한다. 본 논문에서는 다목적 실용위성 3호의 RFC 시험시 측정된 전계강도를 이론적으로 검증하고, RS 시험시 인가하는 레벨과의 상관관계를 설명한다. RS 시험 레벨의 선정은 위성 안테나의 방사레벨과 관련이 있으며 RFC 시험결과를 검토함으로써 RFC 시험 결과의 유효성과 RF 레벨 요구사항의 적절성을 검증한다.

• Journal of Radiation Protection and Research
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• v.35 no.4
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• pp.151-156
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• 2010

The types of test items which were recorded in this test report of quality control domestic $^{18}F$-FDG radiopharmaceutical which consisted of 13 different types: appearance, half-life, radioactive heterokaryosis, radiochemical Confirmation (measure of Rf value), radiochemical Purity, Ethanol, Acetonitrile, Kryptofix, Aluminium, pH, Endotoxin, aseptic test, and radioactivity${\cdot}$ml-1. The record was fully recorded in 'appearance', 'radioactive heterokaryosis', 'pH', 'Endotoxin', and 'aseptic test'. In 'half-life', 'radiochemical Confirmation (measure of Rf value), 'radiochemical Purity', 'Ethanol', 'Acetonitrile', 'Kryptofix', 'Aluminium', 'radioactivity${\cdot}$ml-1', there were differences in records of each manufacturing business on radioactive medicine and medical supplies. The result of the test showed all 13 items of quality control test were 100% suitable on the basis of recorded data. There were more radiopharmaceutical made in the laboratory than in hospitals and businesses and in for result of suitability test, the laboratory showed higher suitability than did the hospitals or businesses. Domestically, there are differences of the test report items in the safety of radiopharmaceutical of each facility, and since it is not standardized, supplements are needed. To submit standardized test reports of quality guarantee in radiopharmaceutical, GMP of U.S. and CE Mark of Europe should be referred as well as receiving advice from professionals to standardize as suitable domestic standard.

• Journal of the Korean Society for Aeronautical & Space Sciences
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• v.35 no.4
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• pp.329-337
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• 2007

This paper deals with electromagnetic tests of the GPS receiver system that should be developed to satisfy emission and susceptibility requirements for a satellite launch vehicle. Performance of the GPS receiver system against electromagnetic environment that is improved through several tests satisfies all requirements about electromagnetic tests. The outline of the electromagnetic tests and emission test results of CE102, CE106 and RE102 on MIL-STD-461E are described in Part I.

• Proceedings of the Korean Radioactive Waste Society Conference
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• 2011.10a
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• pp.521-522
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• 2011

• KSCE Journal of Civil and Environmental Engineering Research
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• v.26 no.5C
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• pp.333-342
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• 2006

In this study, a consolidometer for radially inward drainage under constant rate of strain (CRS) loading was developed. Their analytical solutions for evaluating consolidation characteristics of soils were also derived. With reconstituted kaolinite samples, comparative tests of the developed CRS loading consolidation in radially inward drainage together with incremental loading (IL) consolidation in radially inward, vertical and radially outward drainages and CRS loading consolidation in radially outward and vertical drainages were carried out. From the test results, It is confirmed that the results of the developed consolidometer were not only in good agreement with those of other consolidation tests but also they were more stable and reliable with less sample disturbance effect.

• Nuclear industry
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• v.16 no.12 s.166
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• pp.70-77
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• 1996

원자력발전소에서 발생되는 방사성 폐기물 드럼 안에 있는 핵종과 그 양을 비파괴적인 방법으로 분석할 수 있는 방사성 폐기물 핵종 분석 장치가 개발되었다. 한전 전력연구원이 한국원자력연구소와 공동으로 개발한 이 장치는 기존의 계측 방법과 달리 슬라이드형 콜리메이터를 이용해 방사선량률 변화에 따라 드럼 안의 고방사능량까지 효율적으로 측정할 수 있는 시스템을 갖추고 있다. 현재 이 시스템은 실험실 성능 시험을 마치고 고리 제4폐기물 저장고에 설치되어 시험 운전중이며, 성능 검증 시험을 마친 후 전 원전에 설치될 예정이다.

• Korean Journal of Clinical Laboratory Science
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• v.56 no.2
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• pp.171-180
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• 2024

The endotoxin test is based on the reaction between Limulus Amebocyte Lysate (LAL) and the lipopolysaccharides of Gram-negative bacteria. In this study, we sought to identify factors that interfere with the LAL testing of radiopharmaceuticals and evaluated acceptable ranges. A gel-clot LAL test and a chromogenic LAL test were used as endotoxin tests. We compared the performances of the Endosafe^Ⓡ LAL and recombinant Endosafe^Ⓡ Recombinant Cascade Reagent (rCR) cartridges for the chromogenic test. The factors that interfered with ⁶⁸Ga-DOTATOC injection were pH, 4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid (HEPES) buffer, and organic solvents, especially ethanol. However, interference by these factors was overcome by diluting the ⁶⁸Ga-DOTATOC injection tenfold. In addition, no interference was observed at pH values between 4 and 8, at a HEPES concentration of 2,000 ㎍/mL, or an ethanol concentration of <1%. Furthermore, results showed that interfering factors had similar effects on the performances of the Endosafe^Ⓡ LAL and Endosafe^Ⓡ rCR cartridges. The results of this study are expected to be useful for evaluating factors that interfere with the endotoxin testing of new radiopharmaceuticals.

• Journal of the Korea Convergence Society
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• v.8 no.7
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• pp.93-99
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• 2017

Necessity of adjustment in level of difficulty of national examination for radiological technologists is being brought up. However, objective reasons are required to make those arguments more valid. Therefore in this research, result of national examination for radiological technologists under present system was analyzed in more convergence perspective via statistical analysis. This will provide basic data which is applicable when system of national examination for radiological technologists undergo improvements. For this, statistical analysis such as descriptive statistics and correlation analysis was conducted using SPSS program. Results are as follow. First, ratio of successful applicants for radiological technologists was highly fluctuant relative to other national examinations like doctor, nurse, physical therapist, etc. Second, level of difficulty and discernment of national examination for radiological technologists were differentiated from other examinations like doctor, nurse, physical therapist. Third, the 43th examination for radiological technologists conducted in 2015 had the highest discernment as 0.41, despite of lowest level of difficulty as 89.2, for radiologic applications. The results of this research is expected to be used as basic data when system of national examination for radiological technologists undergo improvements, in accordance with increased supplying plan of work-forces in medical radiological technologists.