• Title/Summary/Keyword: 유럽 품질상

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Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea - (국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 -)

  • Park, Onnuri;Jang, Kyoung won;Ha, Dong mun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.3
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    • pp.137-146
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    • 2020
  • Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

A Study on the Concept and Protection System for the Geographical Indication (지리적 표시제도의 의의 및 보호체제 연구)

  • Go, Yong-Bu
    • Journal of Korea Port Economic Association
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    • v.23 no.3
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    • pp.165-184
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    • 2007
  • This study reviews the concept and protection system for the geographical Indication(GI) to support the Korea-EU FTA. A geographical indication(GI) is a name or sign used on certain products or which corresponds to a specific geographical indication or origin (eg. a town, region, or country). The use of a GI may act as a certification that the product possesses certain qualities, or enjoys a certain reputation, due to its geographical origin. In the WTO Agreement on Trade-Related Aspects of Intellectual property Rights("TRIPS"). There are, in effect, two basic obligations from Article 22 to article 23 on WTO member governments relating to GIs in the TRIPS agreement. Geographical Indications have long been associated with Europe as an entity, where there is a tradition of associating certain food products with particular regions, Under European Union Law, the protected designation of origin system which came into effect in 1992 and 2003 regulates the following geographical indications: Protected designation of origin(PDO) and protected geographical indication(PGI) and Traditional Specialty Guaranteed(TSG). They have 5,000 articles for GI. We have the GI system and 40 articles rotating to registration by the law for quality management of production in agriculture. Cinclusinally, geographical indications could potentially serve as tools to helf holders of trade benefit more equitable through the mutual Acceptance for Korea-EU FTA.

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Characteristics of Particle Number and Exhaust emission by Alteration of MTBE Contents in Gasoline (휘발유의 MTBE 함량 변화에 따른 입자개수 및 배출가스 특성)

  • Lim, Taeyoon;Song, Hoyoung;Park, Cheonkyu;Hwang, Inha;Ha, Jonghan;Na, Byungki
    • Journal of Energy Engineering
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    • v.24 no.4
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    • pp.42-47
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    • 2015
  • While the oxygen content of gasoline for automobiles in Korea is regulated to less than 2.3 weight %, European and World-Wide Fuel Charter (WWFC) regulate it to less than 2.7 weight %. The oxygen content of oxygen-containing materials increases the octane number of the fuel due to the secondary combustion in the internal combustion engine. It has been reported to be effective in reducing emissions, such as CO, HC, which is caused by incomplete combustion. Before 2000s in the United States and Europe, there has been many researches about vehicle application of the changes in oxygen content of gasoline. However, there are not many domestic researches which reflect the improvement of the fuel quality and automotive technology. In this study, fuels of three different oxygen contents were applied to GDI and MPI engines. As a result, the changes of fuel consumption and emission gas were very similar depends of the oxygen content changes. The PN in GDI engine was decreased as the oxygen content was increased.

A Study on the Development of T-DMB Frame Analysis Simulator and its Utilization in Education (T-DMB 프레임 분석 시뮬레이터 개발 및 교육활용에 관한 연구)

  • Hwang, In-Tae;Kim, Han-Jong
    • Journal of Practical Engineering Education
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    • v.7 no.1
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    • pp.31-37
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    • 2015
  • Terrestrial digital multimedia broadcasting (TDMB) is a method of bringing multimedia images, radio, internet, and television to portable devices through terrestrial digital radio transmissions. TDMB related educations being carried out in colleges are focusing on developing firmware which enables users to choose a wanted service. TDMB transmission frame is made up of synchronization channel (SC), fast information channel (FIC), and main service channel (MSC). Services such as video, audio and date are transmitted in the form of subchannel in the MSC. FIC carries information related to each services and subchannels. This paper presents a TDMB frame analysis simulator for analyzing and displaying FIC data on PC. TDMB frame analysis simulator contains functions such as controlling TDMB receiver through USB, establishing the frequency, bringing FIC to PC, displaying ensemble ID and levels, and displaying informations related to services and subchannels. In addition to that, this simulator has a function of being able to store FIC date and subchannel data. This simulator being developed with C++ is expected to be used to view those data visually so that it helps students to understand the TDMB system better and bring about the educational motivation.

Propose and Performance Analysis of Turbo Coded New T-DMB System (터보부호화된 새로운 T-DMB 시스템 제안 및 성능 분석)

  • Kim, Hanjong
    • Journal of Digital Convergence
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    • v.12 no.3
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    • pp.269-275
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    • 2014
  • The DAB system was designed to provide CD quality audio and data services for fixed, portable and mobile applications with the required BER below $10^{-4}$. However for the T-DMB system with the video service of MPEG-4 stream, BER should go down $10^{-8}$ by adding FEC blocks which consist of the Reed-Solomon (RS) encoder/decoder and convolutional interleaver/deinterleaver. In this paper we propose two types of turbo coded T-DMB system without altering the puncturing procedure and puncturing vectors defined in the standard T-DMB system for compatibility. One(Type 1) can replace the existing RS code, convolutional interleaver and RCPC code by a turbo code and the other one (Type 2) can substitute the existing RCPC code by a turbo code. Simulation results show that two new turbo coded systems are able to yield considerable performance gain after just 2 iterations. Type 2 system is better than type 1 but the amount of performance improvement is small.

Correlation Power Analysis Attacks on the Software based Salsa20/12 Stream Cipher (소프트웨어 기반 스트림 암호 Salsa20/12에 대한 상관도 전력분석 공격)

  • Park, Young-Goo;Bae, Ki-Seok;Moon, Sang-Jae;Lee, Hoon-Jae;Ha, Jae-Cheul;Ahn, Mahn-Ki
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.21 no.5
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    • pp.35-45
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    • 2011
  • The Salsa20/12 stream cipher selected for the final eSTREAM portfolio has a better performance than software implementation of AES using an 8-bit microprocessor with restricted memory space, In the theoretical approach, the evaluation of exploitable timing vulnerability was 'none' and the complexity of side-channel analysis was 'low', but there is no literature of the practical result of power analysis attack. Thus we propose the correlation power analysis attack method and prove the feasibility of our proposed method by practical experiments, We used an 8-bit RISC AVR microprocessor (ATmegal128L chip) to implement Salsa20/12 stream cipher without any countermeasures, and performed the experiments of power analysis based on Hamming weight model.

Optimization of Automated Solid Phase Extraction-based Synthesis of [18F]Fluorocholine (고체상 추출법을 기반으로 한 [18F]Fluorocholine 합성법의 최적화 연구)

  • Jun Young PARK;Jeongmin SON;Won Jun KANG
    • Korean Journal of Clinical Laboratory Science
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    • v.55 no.4
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    • pp.261-268
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    • 2023
  • [18F]Fluorocholine is a radiopharmaceutical used non-invasively in positron emission tomography to diagnose parathyroid adenoma, prostate cancer, and hepatocellular carcinoma by evaluating the choline metabolism. In this study, a radiolabeling method for [18F]fluorocholine was optimized using a solid phase extraction (SPE) cartridge. [18F]Fluorocholine was labeled in two steps using an automated synthesizer. In the first step, dibromomethane was reacted with [18F]KF/K2.2.2/K2CO3 to obtain the intermediate [18F]fluorobromomethane. In the second step, [18F]fluorobromomethane was passed through a Sep-Pak Silica SPE cartridge to remove the impurities and then reacted with N,N-dimethylaminoethanol (DMAE) in a Sep-Pak C18 SPE cartridge to label [18F]fluorocholine. The reaction conditions of [18F]fluorocholine were optimized. The synthesis yield was confirmed according to the number of silica cartridges and DMAE concentration. No statistically significant difference in the synthesis yield of [18F]fluorocholine was observed when using four or three silica cartridges (P>0.05). The labeling yield was 11.5±0.5% (N=4) when DMAE was used as its original solution. On the other hand, when diluted to 10% with dimethyl sulfoxide, the radiochemical yield increased significantly to 30.1±5.2% (N=20). In conclusion, [18F]Fluorocholine for clinical use can be synthesized stably in high yield by applying an optimized synthesis method.

Introduction on the Products and the Quality Management Plans for GOCI-II (천리안 해양위성 2호 산출물 및 품질관리 계획)

  • Lee, Sun-Ju;Lee, Kyeong-Sang;Han, Tae Hyun;Moon, Jeong-Eon;Bae, Sujung;Choi, Jong-kuk
    • Korean Journal of Remote Sensing
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    • v.37 no.5_2
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    • pp.1245-1257
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    • 2021
  • GOCI-II, succeeding the mission of GOCI, was launched in February 2020 and has been in regular operation since October 2020. Korea Institute of Ocean Science and Technology (KIOST) processes and produces in real time Level-1B and 26 Level-2 outputs, which then are provided by Korea Hydrographic and Oceanographic Agency (KHOA). We introduced current status of regular GOCI-II operation and showed future improvement. Basic GOCI-II products including chlorophyll-a, total suspended materials, and colored dissolved organic matter concentration, are induced by OC4 and YOC algorithms, which were described in detail. For the full disk (FD), imaging schedule was established considering solar zenith angle and sun glint during the in-orbital test, but improved by further considering satellite zenith angle. The number of slots satisfying the condition 'Best Ocean' significantly increased from 15 to 78. GOCI-II calibration requirements were presented based on that by European Space Agency (ESA) and candidate fixed locations for calibrating local observation area were. The quality management of FD uses research ships and overseas bases of KIOST, but it is necessary to establish an international calibration/validation network. These results are expected to enhance the understanding of users for output processing and help establish detailed plans for future quality management tasks.

Potential of HAZ Property Improvement through Control of Grain Boundary Character in a Wrought Ni-based Superalloy (단련용 Ni기 초내열합금의 입계구조 제어를 통한 HAZ 특성 향상 가능성 고찰)

  • Hong, H.U.;Kim, I.S.;Choi, B.G.;Jeong, H.W.;Yoo, Y.S.;Jo, C.Y.
    • Proceedings of the KWS Conference
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    • 2009.11a
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    • pp.43-43
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    • 2009
  • 단련용 다결정 Ni기 초내열합금은 우수한 가공성, 내산화성, 고온특성 등으로 가스터빈 연소기, 디스크, 증기발생기 전열관 등 발전용 고온부품 소재에 널리 적용되고 있다. 최근 발전설비의 고효율화를 꾀하기 위해 작동 온도를 현격히 증가시키는 기술방향으로 발전하고 있고, 소재측면에서는 기존의 초내열합금 대비 고기능성을 확보할 수 있는 차세대 Ni기 초내열합금 개발이 유럽, 미국, 일본, 중국 등을 중심으로 활발히 이루어지고 있다. 이러한 소재의 고온강도 (온도수용성)를 향상시키기 위해서는 통상 규칙격자 금속간화합물인 $Ni_3(Al,Ti)-{\gamma}'$상의 분율을 증가시킬 수 있지만, ${\gamma}'$상분율이 증가할 경우 용접 및 후열처리 동안 용접열영향부 (HAZ)에서 액화균열이 발생할 가능성이 높아진다. 결정립계를 따라 발생하는 HAZ 액화균열은 입계특성에 의해 크게 영향을 받을 것으로 판단된다. 한편, 본 연구자들은 최근 입계 serration 현상을 단련용 합금에 도입시키는 특별한 열처리를 이론적 접근법을 통해 개발하였다. 형성된 파형입계는 결정학적인 관점에서 조밀 {111} 입계면을 갖도록 분해 (dissociation)되어 낮은 계면에너지를 갖게 됨을 확인하였으며, 입계형상 변화뿐만 아니라 탄화물 특성변화까지 유도하여 크리프 수명을 기존대비 약 40% 정도 향상시킴을 확인하였다. 이러한 직선형 입계 대비 'special boundary'로 간주되는 파형입계가 도입될 경우, HAZ 결정립크기 변화 및 액화거동에 미치는 영향을 고찰하고, 아울러 입계특성 제어가 용접성/용접부 품질 향상에 기여할 수 있는 가능성도 토의하고자 하였다. 본 연구에서는 재현 HAZ 열사이클 시험을 통해 미세구조를 정량적으로 비교하였다. 상대적으로 입계구조가 안정된 파형입계의 이동속도가 高계면 에너지를 갖는 직선형 입계보다 느려 HAZ 결정립 성장이 효과적으로 억제됨을 확인할 수 있었다. 입계 액화거동을 살펴보면, 두 시편 모두 $M_{23}C_6$, MC 등 입계탄화물 계면이 빠른 승온중 액화반응 (constitutional liquation)에 의해 입계가 액화되었으며, 이후 급냉에 의해 입계에 액상막이 존재한 흔적이 발견되었다. 최고온도별로 입계액화 폭/비율을 정량적으로 비교한 결과, 파형입계가 직선입계 대비 대체로 낮음을 확인할 수 있었으며, 때때로 액화되지 않고 잔존하는 입계 탄화물이 관찰되었다. 재현 HAZ 미세조직을 통해 Hot ductility 시험 결과를 유추하자면, 파형입계가 직선입계 보다 좁은 취성온도영역 (Brittle Temperature Range)을 나타낼 것으로 예상되어, 입계특성제어에 의해 Ni기 초내열합금의 용접성을 향상 가능성을 확인하였다.

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Current status and future of insect smart factory farm using ICT technology (ICT기술을 활용한 곤충스마트팩토리팜의 현황과 미래)

  • Seok, Young-Seek
    • Food Science and Industry
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    • v.55 no.2
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    • pp.188-202
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    • 2022
  • In the insect industry, as the scope of application of insects is expanded from pet insects and natural enemies to feed, edible and medicinal insects, the demand for quality control of insect raw materials is increasing, and interest in securing the safety of insect products is increasing. In the process of expanding the industrial scale, controlling the temperature and humidity and air quality in the insect breeding room and preventing the spread of pathogens and other pollutants are important success factors. It requires a controlled environment under the operating system. European commercial insect breeding facilities have attracted considerable investor interest, and insect companies are building large-scale production facilities, which became possible after the EU approved the use of insect protein as feedstock for fish farming in July 2017. Other fields, such as food and medicine, have also accelerated the application of cutting-edge technology. In the future, the global insect industry will purchase eggs or small larvae from suppliers and a system that focuses on the larval fattening, i.e., production raw material, until the insects mature, and a system that handles the entire production process from egg laying, harvesting, and initial pre-treatment of larvae., increasingly subdivided into large-scale production systems that cover all stages of insect larvae production and further processing steps such as milling, fat removal and protein or fat fractionation. In Korea, research and development of insect smart factory farms using artificial intelligence and ICT is accelerating, so insects can be used as carbon-free materials in secondary industries such as natural plastics or natural molding materials as well as existing feed and food. A Korean-style customized breeding system for shortening the breeding period or enhancing functionality is expected to be developed soon.