• Title/Summary/Keyword: reliability and safety

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Permitted Daily Exposure for Diisopropyl Ether as a Residual Solvent in Pharmaceuticals

  • Romanelli, Luca;Evandri, Maria Grazia
    • Toxicological Research
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    • v.34 no.2
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    • pp.111-125
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    • 2018
  • Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.

A Study on the Relationship between Compressive Strength and Water-Cement Ratio According to Water Reducing Ratio (감수율에 따른 압축강도와 물-시멘트비 관계에 관한 연구)

  • Kim, Kyung-Hwan;Oh, Sung-Rok;Choi, Wook;Choi, Yun-Wang
    • Journal of the Korea Concrete Institute
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    • v.26 no.5
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    • pp.591-598
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    • 2014
  • In this study, the relationship between compressive strength and water-cement ratio according to water reducing ratio was evaluated, concrete mix was prepared according to 3 level of water reducing ratio (0%, 8% and 16%) and 3 level of water-cement ratio (40%, 45% and 50%). In addition, concrete mix was carried out repetition test of three times in order to secure the reliability. As a result, compressive strength according to water reducing ratio was shown that difference of strength was about 20% occurred, effect of compressive strength according to water reducing ratio was found more than the water-cement ratio. Therefore, reflected the effect of water reducing ratio, relationship equation between new compressive strength and water-cement ratio was proposed.

Theoretical and experimental analysis of the lateral vibration of shafting system using strain gauges in 50,000-DWT oil/chemical tankers (스트레인 게이지를 이용한 5만 DWT 석유화학제품 운반선의 횡진동 분석에 관한 연구)

  • Lee, Jae-Ung
    • Journal of Advanced Marine Engineering and Technology
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    • v.40 no.4
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    • pp.301-306
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    • 2016
  • During the initial stage of propulsion shaft design, the shaft alignment process includes a thorough consideration of lateral vibration to verify the operational safety of the shaft. However, a theoretical method for analyzing forced lateral vibrations has not been clearly established. The methods currently used in classification societies and international standards can only ensure a sufficient margin to avoid the blade-passing frequency resonance speed outside the range of ${\pm}20%$ of the maximum continuous rating (MCR) for the engine. Typically, in shaft alignment analyses, longer center distances between the support bearings promote affirmative results, but the blade order resonance speed can approach the lower limit for lateral vibration. Therefore, this matter requires careful attention by engineers, and a verification of the theoretical analysis by experimental measurements is highly desirable. In this study, both theoretical and experimental analyses were conducted using strain gauges under two draught conditions of vessels used as 50,000-DWT oil/chemical tankers, introduced recently as eco-friendly ships. Based on the analyses, the influence of the lateral vibration on the shafting system and the system's reliability was reviewed.

Assess of Breakdown Characteristics about Environmentally Friendly Gases (친환경절연재의 절연성 평가)

  • Choi, Eun-Hyeok;Koo, Bon-Ho;Kim, Lee-Kook;Lee, Kwang-Sik
    • Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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    • v.23 no.5
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    • pp.96-100
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    • 2009
  • With the improvement of industrial society, the high quality electrical energy, simplification of operation and maintenance, ensuring reliability and safety are being required. This paper compares breakdown characteristics in $SF_6$ gas with $N_2/O_2$ Mixture gas($N_2:O_2=100$ : 0, 79 : 21, 60 : 40, 40 : 60) as using widely in High Voltage insulation equipment with the characteristics in different media which are focused on environmentally friendly gases. As an append result of research the results are fundamental data for electric insulation design of Distribution Power Facilities which will be studied and developed in the future. And we could make an environment friendly gas insulation material with mataining dielectric strength by $N_2/O_2$ Mixture gas which generates a lower lever of the global warming effect.

Study on the Integrated UAV Simulation Environment for the Evaluation of the Midair Collision Alarm System (공중충돌경보시스템 평가를 위한 통합 무인기 시뮬레이션환경 연구)

  • Mun, Seong-yeop;Kim, Ju-young;Lee, Dong-woo;Baek, Gyeong Min;Kim, Jin Sil;Na, Jongwhoa
    • Journal of Advanced Navigation Technology
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    • v.19 no.4
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    • pp.288-298
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    • 2015
  • For the commercialization of unmanned aircraft, we must validate the safety of the air/ground collision alert systems (CAS). The validation procedure of CAS requires the flight test which is not only expensive but also dangerous. To alleviate this problem, we need the simulation based validation process for the CAS. We developed an integrated UAV simulation (IUS) environment which interconnect the flight simulator, the Matlab/Simulink, and a target avionics simulation model. We developed the collision warning module of the TCAS and tested using IUS and flight encounter models. Using IUS, we can evaluate the performance and reliability of a target avionic system at the preliminary design stage of a development life cycle.

Development of 25.8kV class solid insulated switchgear (25.8kV 고체절연스위치기어 개발)

  • Lee, J.H.;Ma, J.H.;Yu, L.;Lee, J.G.;Won, S.Y.;Lee, S.W.;Kim, Y.G.;Kil, G.S.
    • Proceedings of the KIEE Conference
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    • 2008.10c
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    • pp.226-228
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    • 2008
  • In recent years, the companies of electric power equipment for MV and HV classes trend to develop the eco-friendly insulated(solid, eco-gas, air etc.) switchgear which replaces existent SF6 gas insulated switchgear due to environmental problems such as global warming and so on. This paper makes reference to the newly developed Solid Insulated Switchgear (SIS) which uses the eco-friendly material such as epoxy for insulation. The insulation of the solid insulated switchgear (SIS) is composed of an epoxy, vacuum and air. The solid insulated switchgear (SIS) is a slate of the art product. The advantages of SIS are advanced reliability, economical efficiency, safety, maintenance free, reduction of installation area and the protection of environment. The solid insulated switchgear (SIS) is FE Analyzed such as electromagnetic, mechanical, thermal and fluid in order to find the optimal design. Thens SIS has been verified by international standard test. (IEC 62271 - 100 and so on.) As a result of this, the solid insulated switchgear (SIS) has been estimated as an alternative for eco-friendly MV class switchgear.

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Fatigue Characteristics and Compressive Residual Stress of Shot Peened Alloy 600 Under High Temperature (쇼트피닝 가공된 Alloy 600 재료의 고온환경하에서의 잔류응력 및 피로특성)

  • Kim, Jong Cheon;Cho, Hong Seok;Cheong, Seong Kyun
    • Transactions of the Korean Society of Mechanical Engineers A
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    • v.37 no.3
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    • pp.333-338
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    • 2013
  • The compressive residual stress and fatigue behavior of shot peened alloy 600 under a high-temperature environment is investigated in this study. Alloy 600 is used in the main parts of nuclear power plants, and the compressive residual stress induced by the shot peening process is considered to prevent SCC (stress corrosion cracking). To obtain practical results, the fatigue characteristics and compressive residual stress are evaluated under the actual operating temperature of a domestic nuclear power plant, as well as a high-temperature environment. The experimental results show that the peening effects are valid at a high temperature lower than approximately $538^{\circ}C$, which is the threshold temperature. The fatigue life was maintained at temperatures lower than $538^{\circ}C$, and the compressive residual stress at $538^{\circ}C$ was 68.2% of that at room temperature. The present results are expected to be used to obtain basic safety and reliability data.

Development of the Maintenance Process by the Servo Manipulator for the Parts of the Equipment outside the MSM′s Workspace in a Hot Cell (소형 고하중 조작기를 이용한 사각지역 내 장치부품 보수공정 개발)

  • 이종열;김성현;송태길;박병석;윤지섭
    • Proceedings of the Korean Radioactive Waste Society Conference
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    • 2003.11a
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    • pp.337-344
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    • 2003
  • In this study, the maintenance process by the servo manipulator for the parts of the equipment that cannot be reached by MSM in the hot cell was developed. To do this, the virtual mock up is implemented using virtual prototyping technology. And, Using this mock-up, the workspace of the manipulators In the hot cell and the operator's view through the wall-mounted lead glass are analyzed. And the path planning of the servo manipulator using the collision detection of the virtual mockup is established. Also, the maintenance process for the parts of the equipment that are located out area of the MSM's workspace by the servo manipulator is proposed and verified through the graphic simulation. The proposed remote maintenance process of the equipment can be effectively used in the real hot cell operation. Also, the implemented virtual mock-up of the hot cell can be effectively used in analyzing the various hot cell operation and in enhancing the reliability and safety of the spent fuel management.

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Technologies and Standards of Future Railway Mobile Telecommunication (차세대 철도 통합무선망 기술 및 표준화 동향)

  • Yoon, Byungsik;Kim, Junsik;Lee, Sukjin;Kim, Kyung-Hee;Kim, Yong-Kyu;Park, Duk-Kyu
    • Journal of the Korean Society for Railway
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    • v.16 no.6
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    • pp.519-527
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    • 2013
  • Mobile radio technologies have evolved in the railway industry offering seamless connectivity and various functionalities to improve railway service. Recently, advanced mobile communication technologies have enabled a new level of railway customer services with more efficient railway operation. Since the LTE mobile communication technology offers many benefits and better performance for new railway services, it is considered to be a strong candidate for the future railway mobile telecommunication. However, communication networks in the railway sector are critical for secure operation and have stringent requirements for reliability and safety. In this paper, we explain the requirements for the future railway mobile telecommunication. The LTE, which would be the future railway mobile technology, is analyzed against these requirements. We also introduce the current state of standardization for the future railway mobile telecommunication and its implementation plan.

Burst Test of Cast Al-Alloy Casing for Liquid Rocket Engine Turbopump (액체로켓엔진 터보펌프 알루미늄합금 주조케이싱 파열시험)

  • Yoon, Suk-Hwan;Jeon, Seong-Min;Kim, Jin-Han
    • Proceedings of the Korean Society of Propulsion Engineers Conference
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    • 2012.05a
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    • pp.616-623
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    • 2012
  • Turbopump is a key component in liquid rocket engines, and reducing weight while maintaining structural safety is one of the major concerns of turbopump designers. To reduce the weight aluminium alloy castings instead of steel casings are introduced. The casting process is especially useful for enhancement of productivity and for reduction of product costs. But, since castings are used in space vehicle engines, reliability cannot be compromised therefore proper design, production process and thorough investigation should be performed to ensure structural integrity. In this study inlet casings for a fuel pump are casted with A356.0-T6 alloy and using one of them a burst test is conducted to ensure structural integrity. Structural analysis is performed for simulation, and with multiple strain gages strains are measured and compared with predictions.

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