• Title/Summary/Keyword: 검사시험기술

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The Evaluation of Usefulness of 99Mo-99mTc Generator Using(n,γ)99Mo Developed by Korea Atomic Energy Research ((n,γ)99Mo를 이용한 99Mo-99mTc발생기의 유용성 평가)

  • Seo, Han Kyung;Kim, Jeong Ho;Shim, Cheol Min;Kim, Byung Cheol;Choi, Do Cheol;Gwon, Yong Ju;Park, Yung Sun;Kim, Dong Yun
    • The Korean Journal of Nuclear Medicine Technology
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    • v.17 no.2
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    • pp.48-52
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    • 2013
  • Purpose: The Molybdenum which is the raw material of $^{99}Mo-^{99m}Tc$ generator is produced from the nuclear reactor. However, output has dwindled as the two nuclear reactors supplying the bulk of radioactive material-one in Chalk River, Ontario and the other in Petten, the Netherlands-have been closed for repairs or maintenance. This resulted in the enhancement of its price. So $^{99}Mo-^{99m}Tc$ generator using$(n,{\gamma})^{99}Mo$ is developed by Korea Atomic Energy Research Institute (KAERI). Medicinal availability of this generator is evaluated in this study. Materials and Methods: The radioactivity of $^{99m}Tc$ eluted in generator 1, 2 and 3 unit developed by KAERI was measured. The quality control test of generator such as appearance test, pH test, LAL test, sterility test, chemical impurity (Al) test and radiochemical purity test were performed. Planar and SPECT/CT image sof SD rat (6 weeks, Female) at 2 hr after injection of $^{99m}Tc-HDP$ (hydroxymethylenediphosphonate) (TechneScan HDP, Malinckrodt Medical, Dutch) and $^{99m}Tc-DPD$ (diphosphono-1, 2-propanedicarboxylicacid) (TECEOS, CIS bio international, France) which were labeled with $^{99m}Tc$ eluted in KAERI and commercial generator (40.5 GBq, Malinckrodt Medical, Dutch) using SPECT/CT camera (Symbia, Siemense, Germany) were obtained respectively. Results: The mean radioactivity of $^{99m}Tc$ elution generator 1unit was 4.18 GBq (113 mCi), generator 2 unit was 4.73 GBq (128 mCi) and generator 3 unit was 3.33 GBq (90 mCi). All quality control tests were within normal limit except pyrogentest. Pyrogen test was positive. Planar and SPECT/CT images of rat injected $^{99m}Tc-HDP$ which was labeled with $^{99m}Tc$ eluted in commercial generator show increased uptake in bone, stomach and bowl. Planar images show increased uptake in liver and bone in case of $^{99m}Tc-DPD$. However, images of rat injected $^{99m}Tc-HDP$ and $^{99m}Tc-DPD$ which were labelled $^{99m}Tc$ eluted in KAERI generator show increased uptake in bone, liver and spleen. Conclusion: If shortcoming is removed such as pyrogen and liver appearance, domestic role as an alternative generator is thought to be able to fill and to secure the national medical service by supplying $^{99m}Tc$ when the supply of $^{99m}Tc$ be comes short.

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Effects of Dropwort Powder on the Quality of Castella (미나리가루의 첨가가 Castella의 품질에 미치는 영향)

  • Park, Sang-Jun;Lee, Kwang-Suck;An, Bye-Lyung
    • Journal of the East Asian Society of Dietary Life
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    • v.17 no.6
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    • pp.834-839
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    • 2007
  • This study was designed to determine the optimal ratio of dropwort powder in castella by adding the powder at levels of 0, 3, 6, 9, and 12% respectively. The properties of the castella were analyzed by specific gravity, specific volume, color determinations, texture properties and sensory evaluation. The Specific gravity increased with increasing amount of dropwort powder. However, the specific volume decreased with increasing dropwort powder. For the color values, as more dropwort powder was added, the L-value decreased. The castella with 9% dropwort powder had a higher hardness, gumminess, and chewiness. A sensory panel perceived that the external and internal color of the castella become darker with the dropwort powder substitution and the grain size decreased with increasing amount dropwort powder, while sweet taste showed no significant difference. The order of overall preference was DP 9>DP 6>DP 12>CON>DP 3. Therefore, the substitution of 9% of wheat flour with dropwort powder was recommended in the production of castella.

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A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Microbiological Studies on Feed Supplements (사료첨가제(飼料添加劑)의 미생물오염(微生物汚染)에 관(關)하여)

  • Park, Su Kyung;Tak, Ryun Bin
    • Current Research on Agriculture and Life Sciences
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    • v.4
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    • pp.132-140
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    • 1986
  • Eighty one products from 36 kinds of vitamin and mineral feed supplement collected during August, 1984 to February, 1985 were examined for microbiological contamination. In addition, 83 strains of coliform isolated from the samples were tested for the resistance to 8 kinds of antimicrobial drugs and distribution of R plasmid. General bacteria were detected in all of samples tested. Bacterial population was varied from less than 10 per gram of the sample to 1,400,000 per gram and 34 (42%) of 81 samples were contaminated with 100 to 1,000 cells per gram. Coliform isolation, which was more frequent in samples with larger number of general bacteria, was possible in 14 (17.3%) out of 81 samples tested and 6 (33.3%) out of 18 companies were coliform positive in their products. Forty one (49.4%) out of 83 coliform isolates were fecal coliform. The frequency of resistant strains was the highest to sulfadimethoxine (Sa) with 92.8% and followed by streptomycin (Sm, 67.5%), tetracycline (Tc, 50.6%), kanamycin (Km, 26.5%), chloramphenicol (Cm, 18.1%) and ampicillin (Am, 15.7%). No strain was resistant to nalidixic acid (Na) and gentamicin (Gm). The resistance frequency of fecal coliform strains were higher compare to non-fecal coliform strains. There were minimum inhibitory concentration (MIC) of $3,200{\mu}g/m{\ell}$ or higher in 7 strains to Am, 3 to Sm and 3 to Km, and 70 strains had MIC of $1,600{\mu}g/m{\ell}$ of higher to Sa while Tc had MICs from $1.6{\mu}g/m{\ell}$ to $400{\mu}g/m{\ell}$. All strains had MICs of $6.3{\mu}g/m{\ell}$ of lower to Na and $3.1{\mu}g/m{\ell}$ of lower to Gm. Seventy nine (95.2%) of 83 strains were resistant to one or more drugs tested. The most frequent resistance patterns were SaSm (14.5%) and followed by SaSmTc(12%), SaSmTcKm(8.4%) SaTc (8.4%) and SaSmKm (7.2%) ; total 19 different patterns were noted. Thirty two (40.5%) of 79 resistant strains were transferred all of a part of their resistance to Escherichia coli ML 1410. The frequency of transferable resistance was high in Am (100%) and Cm (80%) while low in Tc (38.1%), Sa (18.2%), Sm (17.9%) and Km (4.5%).

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A Study for the Certified Security Certification in Private Security Industry in Korea (민간경비 자격제도에 관한 연구)

  • Ahn, Hwang-Kwon
    • Korean Security Journal
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    • no.11
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    • pp.159-181
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    • 2006
  • This study is concerned on Why The Certified Security certification is needed and How to control the security quality to get better service to the clients. Theses days are required The Certified Certificate in all the industry. And in this point of view, the certified certificate is a kind of confirmation by an authority to the person who has how much special knowledge and practice in a certain field. Moreover, in the functionalism society the certified certificate system would be very positive effect to the related industry and society as official measurement by an authority. The security is freedom from fear and anxiety. Which means the security can not be operated in isolation from citizen's safe-living expectation, and which is also dealing with valuable human being's life. For getting the better purpose the security industry employees should have more organized special training and education. As my understanding the certified certificate exam system is the confirmation by an authority, the certified certificate is only neutral evidence to get the confidence and credit from the clients. In this point of view the core point is How to control The Certified Certificate by a credied authority.

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