• Title/Summary/Keyword: Validation tests

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A Study on the Efficacy and Equivalence of D-antigen Quantitative Analysis through QbD6sigma Process (QbD6시그마 프로세스를 통한 D-항원 정량 시험법의 유효성과 동등성에 관한 연구)

  • Kim, Kang Hee;Hyun-jung, Kim
    • Journal of Korean Society for Quality Management
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    • v.50 no.4
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    • pp.831-842
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    • 2022
  • Purpose: This study carried out the Quality by Design (QbD)6σ process to verify the effectiveness and equivalence of the finished D-antigen quantitative test method, and compared the OFAT-based method validation and test result acceptance criteria with the Analytical Quality by Design (AQbD)-based method validation and test method. This is a study on how to reduce the risk of delay in permit change by increasing the reliability of permit data in the existing method by statistically analyzing the results. Methods: With the QbD6σ process, the effectiveness and equivalence of the D-antigen quantitative test method were verified with the data of the existing test method and the new test method. Results: Method validation tests are performed based on AQbD. Critical Method Parameters are identified through risk assessment, and single/combined actions are verified by designing and performing tests for Critical Method Parameters (analysis of variance, full factorial design method). Method validation can be effectively accomplished with the QbD6σ process. Conclusion: The use of QbD6σ can be used to achieve satisfactory results for both pharmaceutical companies and regulators by using appropriate statistical analytical methods for method validation as required by regulatory agencies.

On the Safety and Performance Demonstration Tests of Prototype Gen-IV Sodium-Cooled Fast Reactor and Validation and Verification of Computational Codes

  • Kim, Jong-Bum;Jeong, Ji-Young;Lee, Tae-Ho;Kim, Sungkyun;Euh, Dong-Jin;Joo, Hyung-Kook
    • Nuclear Engineering and Technology
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    • v.48 no.5
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    • pp.1083-1095
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    • 2016
  • The design of Prototype Gen-IV Sodium-Cooled Fast Reactor (PGSFR) has been developed and the validation and verification (V&V) activities to demonstrate the system performance and safety are in progress. In this paper, the current status of test activities is described briefly and significant results are discussed. The large-scale sodium thermal-hydraulic test program, Sodium Test Loop for Safety Simulation and Assessment-1 (STELLA-1), produced satisfactory results, which were used for the computer codes V&V, and the performance test results of the model pump in sodiumshowed good agreement with those in water. The second phase of the STELLA program with the integral effect tests facility, STELLA-2, is in the detailed design stage of the design process. The sodium thermal-hydraulic experiment loop for finned-tube sodium-to-air heat exchanger performance test, the intermediate heat exchanger test facility, and the test facility for the reactor flow distribution are underway. Flow characteristics test in subchannels of a wire-wrapped rod bundle has been carried out for safety analysis in the core and the dynamic characteristic test of upper internal structure has been performed for the seismic analysis model for the PGSFR. The performance tests for control rod assemblies (CRAs) have been conducted for control rod drive mechanism driving parts and drop tests of the CRA under scram condition were performed. Finally, three types of inspection sensors under development for the safe operation of the PGSFR were explained with significant results.

KA-32T Helicopter Flight Test for Full Flight Simulator Validation (KA-32T 헬기 시뮬레이터 검증을 위한 비행시험)

  • Choi, Hyoung-Sik;Jang, Jae-Won;Jeon, Dae-Keun;Jun, Hyang-Sig
    • Aerospace Engineering and Technology
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    • v.7 no.1
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    • pp.1-7
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    • 2008
  • The objective of the KA-32 Helicopter Training Simulator Development Program, executed by the Republic of Korea Government, is to acquire a helicopter simulator which meets level C requirements in accordance with the FAA AC 120-63. The Korea Aerospace Research Institute (KARI) manages the development program and is supposed to develop and validate the flight dynamics model based on simulator design data and flight test data. The helicopter chosen for this project is the Kamov KA32T, operated by the Korean Forest Aviation Office. This paper presents the test program and information about the installation and execution of the flight tests. The program consist of tests for the simulator qualification, additional tests for model data and additional tests for model validation. The flight trials were performed from 30 July to 31 August at the Iksan airbase of the Forest Aviation Office (FAO).

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Engineering-scale Validation Test for the T-H-M Behaviors of a HLW Disposal System (고준위폐기물 처분시스템의 열적-수리적-역학적 거동 규명을 위한 공학적 규모의 실증시험)

  • Lee Jae-Owan;Park Jeong-Hwa;Cho Won-Jin
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.4 no.2
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    • pp.197-207
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    • 2006
  • The engineering performance of a high level waste repository is significantly dependent upon the T-H-M behavior in the engineered barrier system. An engineering-scale test facility (KENTEX) was set up to validate the T-H-M behaviors in the buffer of a reference disposal system developed in the 2002. The validation tests started on May 31, 2005 and is now in progress. The KENTEX facility and validation test programme are introduced, and pre-operation calculations are also presented to give information on the sensitive location of sensors and operational conditions. This test will provide information (e.g., large-scale apparatus, sensors, monitoring system etc.) needed for 'in-situ' tests, make the validation of a T-H-M model for the T-H-M performance assessment of the reference disposal system, and demonstrate the engineering feasibility of fabricating and emplacing the buffer of a repository.

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HFFB technique and its validation studies

  • Xie, Jiming;Garber, Jason
    • Wind and Structures
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    • v.18 no.4
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    • pp.375-389
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    • 2014
  • The high-frequency force-balance (HFFB) technique and its subsequent improvements are reviewed in this paper, including a discussion about nonlinear mode shape corrections, multi-force balance measurements, and using HFFB model to identify aeroelastic parameters. To apply the HFFB technique in engineering practice, various validation studies have been conducted. This paper presents the results from an analytical validation study for a simple building with nonlinear mode shapes, three experimental validation studies for more complicated buildings, and a field measurement comparison for a super-tall building in Hong Kong. The results of these validations confirm that the improved HFFB technique is generally adequate for engineering applications. Some technical limitations of HFFB are also discussed in this paper, especially for higher-order mode response that could be considerable for super tall buildings.

Validation of a non-linear hinge model for tensile behavior of UHPFRC using a Finite Element Model

  • Mezquida-Alcaraz, Eduardo J.;Navarro-Gregori, Juan;Lopez, Juan Angel;Serna-Ros, Pedro
    • Computers and Concrete
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    • v.23 no.1
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    • pp.11-23
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    • 2019
  • Nowadays, the characterization of Ultra-High Performance Fiber-Reinforced Concrete (UHPFRC) tensile behavior still remains a challenge for researchers. For this purpose, a simplified closed-form non-linear hinge model based on the Third Point Bending Test (ThirdPBT) was developed by the authors. This model has been used as the basis of a simplified inverse analysis methodology to derive the tensile material properties from load-deflection response obtained from ThirdPBT experimental tests. In this paper, a non-linear finite element model (FEM) is presented with the objective of validate the closed-form non-linear hinge model. The state determination of the closed-form model is straightforward, which facilitates further inverse analysis methodologies to derive the tensile properties of UHPFRC. The accuracy of the closed-form non-linear hinge model is validated by a robust non-linear FEM analysis and a set of 15 Third-Point Bending tests with variable depths and a constant slenderness ratio of 4.5. The numerical validation shows excellent results in terms of load-deflection response, bending curvatures and average longitudinal strains when resorting to the discrete crack approach.

Force-deformation relationship prediction of bridge piers through stacked LSTM network using fast and slow cyclic tests

  • Omid Yazdanpanah;Minwoo Chang;Minseok Park;Yunbyeong Chae
    • Structural Engineering and Mechanics
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    • v.85 no.4
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    • pp.469-484
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    • 2023
  • A deep recursive bidirectional Cuda Deep Neural Network Long Short Term Memory (Bi-CuDNNLSTM) layer is recruited in this paper to predict the entire force time histories, and the corresponding hysteresis and backbone curves of reinforced concrete (RC) bridge piers using experimental fast and slow cyclic tests. The proposed stacked Bi-CuDNNLSTM layers involve multiple uncertain input variables, including horizontal actuator displacements, vertical actuators axial loads, the effective height of the bridge pier, the moment of inertia, and mass. The functional application programming interface in the Keras Python library is utilized to develop a deep learning model considering all the above various input attributes. To have a robust and reliable prediction, the dataset for both the fast and slow cyclic tests is split into three mutually exclusive subsets of training, validation, and testing (unseen). The whole datasets include 17 RC bridge piers tested experimentally ten for fast and seven for slow cyclic tests. The results bring to light that the mean absolute error, as a loss function, is monotonically decreased to zero for both the training and validation datasets after 5000 epochs, and a high level of correlation is observed between the predicted and the experimentally measured values of the force time histories for all the datasets, more than 90%. It can be concluded that the maximum mean of the normalized error, obtained through Box-Whisker plot and Gaussian distribution of normalized error, associated with unseen data is about 10% and 3% for the fast and slow cyclic tests, respectively. In recapitulation, it brings to an end that the stacked Bi-CuDNNLSTM layer implemented in this study has a myriad of benefits in reducing the time and experimental costs for conducting new fast and slow cyclic tests in the future and results in a fast and accurate insight into hysteretic behavior of bridge piers.

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.

High-velocity impact of large caliber tungsten projectiles on ordinary Portland and calcium aluminate cement based HPSFRC and SIFCON slabs -Part II: numerical simulation and validation

  • Gulkan, P.;Korucu, H.
    • Structural Engineering and Mechanics
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    • v.40 no.5
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    • pp.617-636
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    • 2011
  • We present the numerical implementation, simulation, and validation of the high-velocity impact experiments that have been described in the companion article. In this part, numerical investigations and simulations performed to mimic the tests are presented. The experiments were analyzed by the explicit integration-based software ABAQUS for improved simulations. Targets were modeled with a damaged plasticity model for concrete. Computational results of residual velocity and crater dimensions yielded acceptable results.

Validation of Neurobehavioral Tests for Occupational Screening(NTOS) : results of patients of Parkinson's disease (Neurobehavioral Tests for Occupational Screening의 타당도 평가 : 파킨슨병 환자들의 검사 성적)

  • Lee, Chae-Yong
    • Journal of Preventive Medicine and Public Health
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    • v.30 no.3 s.58
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    • pp.577-584
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    • 1997
  • Validation and Standardization of neurobehavioral instrument in Korean occupational setting has not been studied ever. This study tried to validate the newly developed computerized psychomotor tests, Neurobehavioral Tests for Occupational Screening (NTOS). Male patients with Parkinson's disease(n=12) and male workers who never exposed to occupational neurotoxic materials and didn't have neurologic disease(n=21), performed some tests from NTOS; simple reaction time, choice reaction time(2 choice), and finger tapping(both hands). In simple analysis, difference between patient group and worker group was significantly great. Adjusted for age and education years, simple reaction time and finger tapping(both hand) were statistically significantly different between two groups(p<.05). Choice reaction time was also different(p<.1) but error frequency of choice reaction time test was not. Generally, this results showed NTOS could detect impairment of psychomotor function. But insensitive results of choice reaction time was partly due to small sample size and confounding variables and so required future study and refinement at improvement of NTOS.

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