• Journal of the Korean Society of Radiology
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• v.7 no.6
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• pp.397-402
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• 2013

This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.

• Proceedings of the SAREK Conference
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• 2009.06a
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• pp.520-526
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• 2009

This study proposed the optimum design values for the biological clean room system observing the regulations of Hazard Analysis Critical Control Point (HACCP). Even though the standard for industrial clean room system has been well established, the basis for biological food clean room system is the first stage. In order to prevent the contaminations in advance for food storages, processes, and distributions, the criterion of Hazard Analysis Critical Control Point is positively required. This study also suggested the possible ways of how to avoid the hazardous contaminations.

• Air Cleaning Technology
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• v.23 no.3
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• pp.1-9
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• 2010

This study proposed the optimum design values for the biological clean room system observing the regulations of Hazard Analysis Critical Control Point (HACCP). Even though the standard for industrial clean room system has been well established, the basis for biological food clean room system is the first stage. In order to prevent the contaminations in advance for food storages, processes, and distributions, the criterion of Hazard Analysis Critical Control Point is positively required. This study also suggested the possible ways of how to avoid the hazardous contaminations.

• Journal of The Korea Institute of Healthcare Architecture
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• v.13 no.1
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• pp.7-15
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• 2007

The medicine is used for diagnosis, treatment or prevention of disease and consequently has an important influence upon human life and health. Its effectiveness and safety must be guaranteed. In order to achieve the facility that meets GMP, KFDA has provided standards for quality assurance of the manufacture, examination and tests of medical supplies. The result of this study were as follows : the GMP facilities are divided into work, lab/test and storage spaces, and the systematic corridor. The clean rooms are mainly installed in work and lab/test spaces, and maintain class 10,000 in average. The individual space for the procedures that requires class 100 is not provided as a separate division. Instead, they are performed in the clean bench of the laboratory.

• Proceedings of the Korean Society of Dyers and Finishers Conference
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• 2012.03a
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• pp.57-57
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• 2012

피부염 증상 완화특성을 갖는 힐링섬유소재 제조를 연구하였다. 면소재, 폴리에스테스/나일론 소재에 피부염 증상완화특성이 있다고 알려진 기능성물질을 바인더, 수지 등의 혼합물 페이스트로 만들어 스크린프린팅법을 사용하여 실험을 시도하였다. 제조한 힐링섬유시편소재의 항균특성은 면소재의 경우 99.9% 의 우수한 항균특성을 나타냈다. 암모니아가스의 소취성능은 시간경과에 따라 최대 68%의 소취율을 보였다. 타소재와의 오염견뢰도는 평균 4.5 ~ 5등급, 변퇴세탁견뢰도는 5등급, 마찰견뢰도는 3 ~ 4.5 등급, 일광견뢰도는 5등급을 나타냈다. 의약품 등의 독성시험기준에 따른 힐링소재의 피부자극성을 평가하기 위해 NZW토끼의 피부에 24시간 동안 부착한 후 72시간 동안 사망률, 일반증상, 체중변화 및 피부자극성을 시험한 결과 사망토끼는 관찰되지 않았고, 모든 시험동물에서 특이할 만한 이상증상은 관찰되지 않았다. 체중측정결과 모든 동물에서 정상적인 체중증가를 보였다. 시험소재의 피부자극성을 관찰한 결과 피부자극성이 관찰되지 않아 비자극성(None Irritant)섬유소재로 판단되어 피부염증상완화 특성을 갖는 힐링섬유소재 제조의 실용화 가능성을 연구하였다.

• Journal of Korean Society for Quality Management
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• v.50 no.4
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• pp.717-734
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• 2022

Purpose: The purpose of this study is to effectively detect violations that occur simultaneously against Good Manufacturing Practice, which were concealed by drug manufacturers. Methods: In this study, we present an analysis framework for analyzing regulatory violation patterns using Association Rule Mining (ARM), Text Mining, and t-distributed Stochastic Neighbor Embedding (t-SNE) to increase the effectiveness of on-site inspection. Results: A number of simultaneous violation patterns was discovered by applying Association Rule Mining to FDA's inspection data collected from October 2008 to February 2022. Among them there were 'concurrent violation patterns' derived from similar regulatory ranges of two or more regulations. These patterns do not help to predict violations that simultaneously appear but belong to different regulations. Those unnecessary patterns were excluded by applying t-SNE based on text-mining. Conclusion: Our proposed approach enables the recognition of simultaneous violation patterns during the on-site inspection. It is expected to decrease the detection time by increasing the likelihood of finding intentionally concealed violations.

• The Korean Journal of Nuclear Medicine Technology
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• v.23 no.1
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• pp.64-68
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• 2019

Purpose In the preparation process for N-13 Ammonia injections, there were radioactive medicines adsorbed on filters remarkably. Hereby, we have compared the adsorption rate and quality test on Millex GS filter and Satorious Minisart filter, both representatively hydrophilic sterilizing filters, also evaluated which filter is more accommodative for N-13 Ammonia injection. Materials and Methods The filters used for sterilization of N-13 Ammonia injections were Millex GS filter($0.22{\mu}m$) mand Satorious Minisart filter ($0.2{\mu}m$), which are generally used to strain aqueous solutions. After the N-13 Ammonia passes through each sterilization filter, the adsorption rate of the filter (n=10) is determined by measuring not only the radioactivity through the filter also the amount of radioactivity remaining in it using a Dose Calibrator. The N-13 Ammonia injections after each filter is tested by the quality control test to conform to the Samsung Medical Center standard. Results The ratio of radioactivity passed through Millex GS indicated $29.0{\pm}17.6%$. Satorious Minisart filters output was $80.9{\pm}3.2%$, respectively. Each ratio of radioactivity adsorbed on the sterile filter was $71.0{\pm}17.6%$ for Millex GS and $19.1{\pm}3.2%$ for the Satorious Minisart filters, respectively. Furthermore, on the ratio of filtered radioactivity, Using Satorious Minisart filter showed about 2.8 times higher than using Millex GS filter. The quality testing of N-13 Ammonia injections through each filter met the Samsung Medical Center standard. Conclusion The Millex GS filter is composed of cellulose acetate and cellulose nitrate, whereas the Satorious Minisart filter if composed only of cellulose acetate. Therefore, the presence of cellulose nitrate in the membrane seems to have made differences. Therefore, the use of Satorious Minisart filter in the preparation of N-13 Ammonia injection solution minimized the loss of radioactive medicines due to filter adsorption, thereby improving the synthesis yield.