• Journal of Pharmaceutical Investigation
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• v.39 no.4
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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.

• Korean Journal of Microbiology
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• v.41 no.3
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• pp.216-224
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• 2005

Chromatography has now been used successfully to provide the requisite purity for human plasma-derived biop-harmaceuticals such as coagulation factors and immunoglobulins. Recently, increasing attention has been focused on establishing efficient cleaning procedures to prevent potential contamination by microorganisms as well as carry-over contamination from batch to batch. The purpose of present study was to develop a cleaning validation system for the assurance of virus removal and/or inactivation during chromatography process. In order to establish an assay system for the validation of virus clearance during chromatography cleaning process, a quantitative real-time PCR method for porcine parvovirus(PPV) was developed, since PPV, a model virus for human parvovirus B19, has a high resistance to a range of physico-chemical treatment. Specific primers for amplification of PPV DNA was selected, and PPV DNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be 1.5 $TCID_{50}/ml$. The established real-time PCR assay was successfully applied to the validation of PPV removal and cleaning during SP-Sepharose cation chromatography for thrombin purification and Q-Sepharose anion chromatography for factor VIII purification. The comparative results obtained by real-time PCR assay and infectivity titrations suggested that the real-time PCR assay could be a useful method for chromatography cleaning validation and that it could have an additive effect on the interpretation and evaluation of virus clearance during the virus removal process.

• Environmental Analysis Health and Toxicology
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• v.9 no.1_2
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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.

• Journal of Ocean Engineering and Technology
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• v.34 no.6
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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.

• The Journal of Korea Robotics Society
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• v.16 no.4
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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.

• Korean Management Science Review
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• v.29 no.3
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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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• 1994.10a
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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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• 1998.05a
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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.

• Journal of Korean Institute of Industrial Engineers
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• v.36 no.1
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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.

• Journal of Intelligence and Information Systems
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• v.10 no.3
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• pp.39-57
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• 2004

Many dairy producers periodically receive information about their bulk tank milk with reference to bulk tank somatic cell counts, standard plate counts, and preliminary incubation counts. This information, when collected over a period of time, in combination with bulk tank mastitis culture reports can become a significant knowledge base. Several guidelines have been proposed to interpret farm bulk tank milk bacterial counts. However many of the suggested interpretive criteria lack validation, and provide little insight to the interrelationship between different groups of bacteria found in bulk tank milk. Also the linguistic terms describing bulk tank milk quality or herd management status are rather vague or fuzzy such as excellent, good or unsatisfactory. The objective of this paper was to develop a set of fuzzy descriptors to evaluate bulk tank milk quality and herd's milking practice based on bulk tank milk microbiology test results. Thus, fuzzy logic based reasoning methodologies were developed based on fuzzy inference engine. Input parameters were bulk tank somatic cell counts, standard plate counts, preliminary incubation counts, laboratory pasteurization counts, non agalactiae-Streptococci and Streptococci like organisms, and Staphylococcus aureus. Based on the input data, bulk tank milk quality was classified as excellent, good, milk cooling problem, cleaning problem, environmental mastitis, or mixed with mastitis and cleaning problems. The results from fuzzy reasoning would provide a reference regarding a good management practice for milk producers, dairy health consultants, and veterinarians.