• Title/Summary/Keyword: Evaluation and Validation Test

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Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products (생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증)

  • Kim, Byung-Chul;Kim, Do-Keun;Hong, Sung-Hwa;Kim, Yeon-Hee;Lim, Jong-Mi;Won, Yun-Jung;Kim, Seok-Hwan;Hong, Ji-Young;Yun, Young-Min;Kim, Jae-Ok
    • YAKHAK HOEJI
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    • v.55 no.4
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    • pp.284-288
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    • 2011
  • The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.

Preliminary Validation of Wind Turbine Generator System Performance Analysis S/W, WINSIM (풍력발전시스템 성능 해석 S/W의 초기 검증에 관한 연구)

  • Mun, Jung-Heu;No, Tae-Soo;Park, Jong-Hyuk;Kim, Sung-Ju
    • Journal of the Korean Society for Aeronautical & Space Sciences
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    • v.37 no.2
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    • pp.209-214
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    • 2009
  • The simulation software for predicting the performance of a wind turbine generator system (WTGS) is validated using the field measured data obtained from the idling test run of a dual rotor wind turbine recently developed and installed in Korea. Both steady-state and transient responses at low and high wind conditions are compared with the theoretically predicted ones from the simulation software WINSIM.

Design of Compressed Gas Supply System for Combustion Chamber Test Facility (연소기 연소시험설비 고압가스 공급시스템 설계)

  • Chung, Yonggahp;Cho, Namkyung;Han, Yeoungmin
    • Journal of the Korean Society of Propulsion Engineers
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    • v.18 no.1
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    • pp.85-90
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    • 2014
  • To develop liquid propulsion engine, the development of combustion chamber must be preceded. For performance validation of the combustion chamber, the designed and manufactured combustion chamber should be tested in combustion chamber test facility (CCTF). The CCTF is the test facility to develop the combustor of rocket engine, which uses liquid oxygen as a oxidizer and kerosene as a fuel. Present paper introduces the detailed design results of compressed gas supply system of CCTF, which is planned to be installed at Naro Space Center.

On Improving the Verification, Validation and Accreditation Process by Including Safety Requirements in M&S-Based Development of Weapon Systems (M&S기반 무기체계개발에서 시스템 안전요건 반영을 통한 VV&A 프로세스 개선에 관한 연구)

  • Sim, Sang Hyun;Lee, Jae-Chon
    • Journal of the Korea Safety Management & Science
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    • v.16 no.4
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    • pp.123-131
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    • 2014
  • Modern weapon systems are getting more complex in terms of the functionality and also the conditions on the environment and range in which they are deployed and used. Therefore, many development programs can easily be exposed to a variety of risks, resulting in delayed schedules and cost overrun. As such, effective means are necessary to keep the defence budget at an affordable level while competitive edges on technological aspects are retained. As one way to meet those need, modeling and simulation (M&S) methods have widely been used, particularly in the test and evaluation (T&E) process for weapon systems development. The result of M&S-based systems development should be evaluated by the verification, validation & accreditation (VV&A) process to assure keeping reliability at a desired level. On the other hand, due to the explosiveness, the weapons systems development naturally requires to consider safety issues in both the T&E and operational periods. The purpose of this paper is to improve the VV&A process by reflecting the safety requirements therein. To do so, the VV&A process has been analyzed and graphically modeled first and then safety elements have been incorporated effectively. The use of the improved process in the war ships development has also been discussed. Based on the process proposed and the consequent database constructed, the target system can be expected to benefit from reducing development risks while assuring systems safety.

A Preliminary Study for the Development of An Assessment Scale for Early Childhood Programs in Korea (유아교육 프로그램 평가척도 개발에 관한 예비 연구)

  • Rhee, Un Hai;Lee, Ki Sook
    • Korean Journal of Child Studies
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    • v.15 no.1
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    • pp.5-21
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    • 1994
  • The purpose of this study was to develop a scale for evaluation of early childhood programs in Korea. The procedures included content validation and a pilot test. A total of 192 items in 10 major areas was developed based on the review of literature and discussions with professionals in early childhood education. The 10 areas include: scheduling, curriculum, interation, physical environment, materials, nutrition, health and safety, administration, staff qualifications, relationships with parents, and evaluation. The pilot scale was administered to 428 classroom teachers and directors, and 47 college professors in early childhood education. The items were rated on a 3-point scale in terms of importance as evaluation criteria. The methods for data analysis included item means and standard deviations for content validation, Cronbach ${\alpha}$ for reliability, and factor analysis for construct validity. Most items in 10 areas were rated as moderate to highly important (average 2.3), especially items in curriculum and staff qualifications. Two factors emerged from the data: institutional management, and curricular planning and implementation. The Cronbach ${\alpha}$ levels were .70 or higher in most areas, but the range covers from .48 to .91. Based on the pilot data, 143 items were selected for the second year study.

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Development and Validation of Safety Performance Evaluation Scenarios of Autonomous Vehicle (자율주행 안전성 평가 시나리오 개발 및 검증)

  • Chae, Heungseok;Jeong, Yonghwan;Lee, Myungsu;Shin, Jaekon;Yi, Kyongsu
    • Journal of Auto-vehicle Safety Association
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    • v.9 no.1
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    • pp.6-12
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    • 2017
  • Regulation for the testing and operation of automated vehicles on public roadways has been recently developed all over the world. For example, the licensing standards and the evaluation technology for automated vehicles have been proposed in California, Nevada and EU. But specific safety evaluation scenarios for automated vehicles have not been proposed yet. This paper presents safety evaluation scenarios for extraordinary service permission of automated vehicles on highways. A total of seven scenarios are selected in consideration of safety priority and real traffic situation. Six scenarios are relevant with lane keeping and one scenario is relevant with lane change. All scenarios are developed based on existing ADAS evaluation scenarios and repeated simulation of automated vehicle algorithm. Safety evaluation factors as well as scenarios are developed. The safety factors are based on existing ADAS ISO requirements, ADAS safety factors and current traffic regulations. For the scenarios, a hunter vehicle is needed in addition to automated vehicle evaluated. The hunter vehicle performs multiple roles like preceding vehicle, cut-in vehicle and so on. The hunter vehicle is also automated vehicle equipped with high performance GPS, radar and Lidar. All the scenarios can be implemented by driving a lap on a KATRI ITS test track. These scenarios and safety evaluation factors are investigated via both a computer simulation and an experimental vehicle test on the test track. The experimental vehicle test was conducted with two automated vehicles, which are the evaluated vehicle and the hunter vehicle.

Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets (이토프리드염산염 정과 티로프라미드염산염 정의 용출시험법 개발)

  • Kim, Jung Hyun;Lee, Jong Hwa;Choi, Lan;Choi, Yeon Hee;Lee, Jong Chul;An, Ji Hye;Lee, Gwang Moon;Shim, Young Hoon;Kang, Shin-Jung;Sah, Hong-Kee;Choi, Hoo-Kyun;Kim, In-Kyu
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.205-212
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    • 2013
  • Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the "Manual for Guideline Application for Validation of Analytical Procedures" and "Guidelines on Specification of Dissolution test for Oral dosage form" of Korean Pharmacopoeia (KP), we validated and established each development method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.

Evaluation of cryogenic mechanical properties of aluminum alloy using small punch test

  • Hojun Cha;Seungmin Jeon;Donghyeon Yoon;Jisung Yoo;Seunggun Lee;Seokho Kim
    • Progress in Superconductivity and Cryogenics
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    • v.25 no.4
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    • pp.70-74
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    • 2023
  • The Small Punch Test (SPT) was developed to evaluate the softening and embrittlement of materials such as power plants and nuclear fusion reactors by taking samples in the field. Specimens used in the SPT are very thin and small disk-shaped compared to specimens for general tensile test, and thus have economic advantages in terms of miniaturization and repeatability of the test. The cryogenic SPT can also be miniaturized and has a significantly lower heat capacity than conventional universal test machines. This leads to reduced cooling and warm-up times. In this study, the cryogenic SPT was developed by modifying the existing room temperature SPT to be cooled by liquid nitrogen using a super bellows and a thermal insulation structure. Since the cryogenic SPT was first developed, basic experiments were conducted to verify the effectiveness of it. For the validation, aluminum alloy 6061- T6 specimens were tested for mechanical properties at room and cryogenic temperature. The results of the corrected tensile properties from the SPT experiment results were compared with known room temperature and cryogenic properties. Based on the correction results, the effectiveness of the cryogenic SPT test was confirmed, and the surface fracture characteristics of the material were analyzed using a 3d image scanner. In the future, we plan to conduct property evaluation according to the development of various alloy materials.

Utilizing virtual vibration tests to optimize physical endurance tests

  • Kihm, Frederic
    • Advances in aircraft and spacecraft science
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    • v.5 no.2
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    • pp.239-249
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    • 2018
  • Physical tests are performed at various stages of the development cycle of a product, from prototype validation to product qualification. Although costly, there are growing demands for qualification tests like endurance vibration testing to be more representative of the real world. At the same time there are growing demands to assess the durability of these items based on FEA simulation. In this paper, we will explain how to set up a CAE-based test and how to correlate the results with some physical measurements. Specific assumptions will be explained and some advantages of using virtual tests will be highlighted such as the reduction of the number of prototypes needed, investigations on failures, evaluation of the level of reliability via sensitivity analysis, evaluation of the margins are at the end of a successful test. This presentation will therefore focus on explaining and showing how virtual tests can enrich the exploitation of physical tests.

Development of high-pressure Type 3 composite cylinder for compressed hydrogen storage of fuel cell vehicle (차량용 200bar 급 Type 3 복합재 압력용기의 개발 및 설계인증시험)

  • Chung, Sang-Su;Park, Ji-Sang;Kim, Tae-Wook;Chung, Jae-Han
    • Proceedings of the Korean Society For Composite Materials Conference
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    • 2005.04a
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    • pp.203-206
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    • 2005
  • The objective of study on composite cylinder for alternative fuel vehicle is to develop safe, efficient, and commercially viable, on-board fuel storage system for the fuel cell vehicle or natural gas vehicle that use highly compressed gaseous fuel such as hydrogen or natural gas. This study presents the whole procedure of development and certification of a type 3 composite cylinder of 207bar service pressure and 70 liter water capacity, which includes design/analysis, processing of filament winding, and validation through various testing and evaluation. Design methods of liner configuration and winding patterns are presented. Three dimensional, nonlinear finite element analysis techniques are used to predict burst pressure and failure mode. Design and analysis techniques are verified through burst and cycling tests. The full qualification test methods and results for validation and certification are presented.

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