• Journal of Pharmaceutical Investigation
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• 제39권4호
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• pp.263-267
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• 2009

The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.

• 미생물학회지
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• 제41권3호
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• pp.216-224
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• 2005

혈장분획제제 중 혈액응공인자제제와 일부 면역글로불린제제는 혈장에 존재하는 다양한 단백질로부터 유효한 단백성분만을 선택적으로 분리 정제하기 위해 크로마토그래피 방법을 사용하여 생산된다. 효율적인 세척(cleaning) 공정이 이루어지지 않는다면 크로마토그래피는 다양한 종류의 불순물뿐만 아니라 혈액 중 내재 또는 오염 가능성이 있는 위해인자가 오염될 가능성이 있다. 본 연구에서는 혈장분획제제 제조공정에 사용되는 크로마토그래피의 세척 공정에서 혈장유래 바이러스의 제거 및 불활화 공정의 검토 강화로 혈장분획제제의 안전성을 확보하기 위해 크로마토그래피 세척 검증 시스템을 구축하고자 하였다. 크로마토그래피 세척 공정 중 바이러스 제거 검증을 위해 혈장유래 바이러스 중 물리${\cdot}$화학적 처리에 가장 큰 저항성을 갖는 human parvovirus B19의 모델 바이러스의 porcine parvovirus(PPV)를 대상으로 real-time PCR 정량법을 확립하였다. PPV에 특이적인 primer를 선별하였으며 형광염료 SYBR Green I을 사용하여 PPV DNA를 정량하였다. 세포배양법에 의한 감염 역가와 비교한 결과 PCR 민감도는 1.5 $TCID_{50}/ml$이었다. 확립된 검증법의 신뢰성(reliability)을 보증하기 위해 실험법의 특이성(specificity), 재현성(reproducibility) 등을 검증하였다. 구축된 검증시스템을 thrombin 분리${\cdot}$정제를 위한 SP-Sepharose 양이온 크로마토그래피 공정과 factor VIII 분리${\cdot}$정제를 위한 Q-Sepharose 음이온 크로마토그래피 공정에 적용하여 크로마토그래피 세척 검증을 실시하고, 세척 검증 시스템의 적합성을 확인하였다.

• Environmental Analysis Health and Toxicology
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• 제9권1_2호
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• pp.37-51
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• 1994

To evaluate the genotoxicities of workers exposed to glue and glue cleaning solution, ambient air monitoring of working place, animal study and human monitoring were carried out. By GC-MS analysis, air samples collected from shoesmaking plant were found to be toluene, xylene, cyclohexane, n-hexane, methyl ethyl ketone, trichloroethylene, butylacetate, isopropyl alcohol. Glue and glue cleaning solution from shoesmaking plant were applicated topically to the CD-1 mice. DNA was isolated from skin 24 hr following the application and analysed for DNA-adducts using the nuclease $P_1$version of $^{32}$P-postlabelling assay. RAL (Relative Adduct Labelling, adducts$10^8$ nucleotides) was significantly increased in a dose-dependent manner in the glue cleaning solution treated mice skin. Peripheral blood DNA-adducts of workers exposed to glue and glue cleaning solution were also analysed by the same method, but there were not significant differences in the peripheral blood DNA-adducts level between exposed and control workers. In addition, glue cleaning solution from shoes factory was evaluated for mutagenicity in the Salmonella plate incorporation assay using strains TA 100 and TA 1535 in the presence and absence of Arochlor 1254-induced rat liver S$_{9}$. There was evident mutagenicity for cleaning solution in TA 100 regardless of $S_9$, but TA 1535 showed positive only in the absence of $S_9$when predicted by Stead model of mutagenicity prediction (p=0.0000). The urine concentrates from workers and controls were also assayed for mutagenicity towards strain TA 100 of Salmonella typhimurium in the presence of $S_9$ using Kado's microsuspension assay, but their mutagenic activities were not found to be significant. These data suggest that shoesmaking workers are exposed to genotoxic compounds and need to be monitored by testing the mutagenicity of human urines. However, $^{32}$P-postlabelling application requires further validation for the routine monitoring of human exposure.osure.

• 한국해양공학회지
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• 제34권6호
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• pp.377-386
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• 2020

This paper discusses the effectiveness of onboard measurements and data extracted from weather information for speed-power analysis. Furthermore, validation results of hull and propeller cleaning and painting during dry-docking are discussed. Wind and wave information can be obtained from onboard measurements or weather information from the National Oceanic and Atmospheric Administration (NOAA). The weather information of a specified position and time is extracted from NOAA weather data and compared with onboard measurements. In addition, to validate the effects of hull cleaning and painting during dry-docking, speed-power analysis results of before and after dry-docking are compared. The results show that both onboard measurements and weather information show acceptable reliability when added resistance and speed-power analysis results are compared with each other. Moreover, the ship performance analysis (SPA) software clearly shows the effects of hull cleaning and painting, and it can provide reliable analysis results with either onboard measurements or weather information. In conclusion, it is confirmed that the analysis method and SPA software used in this study are effective in analyzing the ship's speed-power performance.

• 로봇학회논문지
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• 제16권4호
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• pp.327-335
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• 2021

In this paper, we propose an embedded robot system based on "ROS2 on Yocto" that can support various robots. We developed a lightweight OS based on the Yocto Project as a next-generation robot platform targeting cloud robotics. Yocto Project was adopted for portability and scalability in both software and hardware, and ROS2 was adopted and optimized considering a low specification embedded hardware system. We developed SLAM, navigation, path planning, and motion for the proposed robot system validation. For verification of software packages, we applied it to home cleaning robot and indoor delivery robot that were already commercialized by LG Electronics and verified they can do autonomous driving, obstacle recognition, and avoidance driving. Memory usage and network I/O have been improved by applying the binary launch method based on shell and mmap application as opposed to the conventional Python method. Finally, we verified the possibility of mass production and commercialization of the proposed system through performance evaluation from CPU and memory perspective.

• 경영과학
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• 제29권3호
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• pp.183-192
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• 2012

For the past several decades, personnel scheduling and rostering problem has been one of the most popular research topics in optimization area. Among the numerous applications, airline (aviation) industry has been given most attention due to the economic scale and impact. Most of the literatures about the staff scheduling problem in airline industry are dealing with the air crew, pilots and flight attendances, and the rest of the literatures are about the ground staff, by whom cleaning, maintenance, fueling of aircraft and handling luggage are done from landing to taking off. None of the literatures found by the authors are dealing with the airline ground crew. In this paper roster of airline ground crew, who is responsible for issuing boarding pass, checking baggage, etc, is introduced, formulated and solved using CPLEX. Some expressions of the mathematical formulations, which are not suitable input format of the CPLEX, were transformed. Numerical examples are presented for the validation of proposed scheduling system.

• 제어로봇시스템학회:학술대회논문집
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• 제어로봇시스템학회 1994년도 Proceedings of the Korea Automatic Control Conference, 9th (KACC) ; Taejeon, Korea; 17-20 Oct. 1994
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• pp.202-206
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• 1994

Mathematical model of the pollution rate of substation insulators is constructed, taking the model parameters as wind speed, wind direction, typhoon conditions and rainfall in an hourly basis. The main feature of model construction is to distinguish the effect of each parameter by separately analyzing the positive and negative pollution causing factors. Model parameters for the insulators of Karatsu substation, Saga, Japan were estimated and model validation was done using the actual data, in which the pollution deposits on the insulators were measured using pilot insulator and 'salt meter'. The proposed model of the pollution rate [mg/cm$^{2}$/hr] enables the identification of the effective parameters and prediction of the pollution rate so that it helps for the automatic decision making for insulator cleaning or the model can be used as a tool for the substation engineers to make precautionary measures.

• 한국전산유체공학회:학술대회논문집
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• 한국전산유체공학회 1998년도 춘계 학술대회논문집
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• pp.110-115
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• 1998

An axisymmetric Navier-Stokes procedure has been developed to analyze the pulse jet flow in a ceramic filter unit for the dust dislodging process. Using Baldwin-Lomax turbulence model as a closure relationship, the SIAF(Scalar Implicit Approximate Factorization) algorithm together with the ${\delta}^k-Correction$ iterative time marching scheme is adopted to solve the unsteady compressible Navier-Stokes equations. After some validation tests, the code has been applied to solve the pulse jet flow and examine the effects of geometry and reservoir pressure condition on the pressure level inside the filter unit. To avoid dealing with the uncertainty of such factors as the cohesion of the collected dust and the adhesion of the dust to the medium and also to simplify the analysis, the filter wall is assumed to be impermeable. The results for various test cases are presented.

• 대한산업공학회지
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• 제36권1호
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• pp.69-77
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• 2010

The failure rate model of External Environment Maintenance(EEM) for a system under severe environment is investigated. EEM, which is recently introduced concept, is a maintenance activity controlling external environment factors that potentially cause system failure such as cleaning equipment, controlling temperature (humidity) and removing dust inside of electronic appliances. EEM can not have any influence on the inherent failure rate of a system but reduce the severity of the external environment causing failure since it deals with only external environment factors. Therefore, we propose two failure rate models to express the improvement effect of EEM: The intensity reduction model and age reduction model. The intensity and age reduction models of EEM are developed assuming the quality of improvement effect is proportioned to an extra intensity or age respectively. The validation of proposed failure rate models is performed in order of data generation, parameter estimation and test for goodness-of-fit.

• 지능정보연구
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• 제10권3호
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• pp.39-57
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• 2004

우유생산 농가에서는 그들 젖소의 우유를 저장하는 탱크 (bulk tank milk: BTM)로부터 채취된 샘플로부터 분석된 우유에 대한 품질관련 항목들, 즉 체세포 수 (somatic cell count: SCC), 표준 plate count (standard plate count: SPC), 사전 incubation count (preliminary incubation count: PIC) 등에 관한 정보를 정기적으로 제공 받는다. 이러한 정보는 일정기간 쌓이게 되면 우유의 품질을 유지하고 목장을 관리할 수 있는 중요한 지식 베이스가 될 수 있다. 그러나 우유 품질이나 목장의 관리상태를 평가하는 기준은 모호하고 퍼지한 용어로 많이 표현되고 있다. 즉 우유 품질을 최상급, 상급, 중간, 불량으로 표시하거나 목장의 관리상태를 아주 양호, 양호, 미흡 등으로 표시한다. 이러한 서술방식은 퍼지이론에서의 모호한 상태를 표현하는 기준과 많이 부합되고 있다. 본 연구의 목적은 BTM으로부터 추출한 샘플로부터 미생물학적 분석을 통해서 나온 결과를 이용해서 BTM의 품질과 목장의 관리상태에 대하여 추론하는 것을 목표로 하고 있다. 따라서 퍼지추론엔진에 기초하여 퍼지로직 기반의 추론방법을 개발하고 실제 데이터를 이용해서 평가하였다. 입력 데이터로는 Bulk Tank SCC, SPC, PIC, laboratory pasteurization count (LPC), non agalactiae Streptococci, Streptococci like organisms, Staphylococcus aureus등이다. 이러한 입력자료에 근거하여 BTM의 품질상태를 아주 양호, 양호, cooling문제, 청결문제, 환경적 mastitis, 환경적/청결 복합문제로 분류하고, 낙농가로부터 채취한 실제 데이터를 이용하여 추론하였다. 본 퍼지 추론 결과는 낙농생산자, 컨설턴트, 수의사 등 관련 종사자들에게 의사결정을 위한 참고자료로서 활용이 가능하다.