• 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.

• 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.