• 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.

• Journal of the Korea Institute of Military Science and Technology
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• v.23 no.5
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• pp.459-465
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• 2020

In this paper, a compact antenna assembly for an amplitude comparison direction-finding(DF) method for a small flight vehicle is presented. Designed antenna assembly consists of four antennas and it is mounted on a radius of 1.45 λ_c where λ_c corresponds to the wavelength of the center frequency. To achieve compactness and robustness of the assembly, the elements are fed by end-launch feeding method and have modified aperture shapes of E- or H-sectoral horns. The feeding part consists of SMA connector, stepped impedance matching structure, and square waveguide of 0.6 λ_c × 0.6 λ_c. To achieve different main beam directions for every antenna which is required condition for amplitude comparison DF method, all apertures of the antennas are inclined and it makes the main beam direction of each antenna to top, bottom, left, and right with respect to the axis of the platform. To verify the validation of DF performance of the presented antenna assembly, amplitude comparison curves using measurement results are presented. The bandwidth of the antennas are above 3.2 % in Ku-band(VSWR ≤ 2:1).

• The Transactions of The Korean Institute of Electrical Engineers
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• v.60 no.5
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• pp.1017-1022
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• 2011

This paper describes the improvement of the calculation by using $6{\sigma}$ method on steam turbine simulator in a nuclear power plant. The simulator is essential to not only verification and validation of control logic but also making sure of control constants in upgrading the long time used control system into the new one. And the dynamic model is a key point in that simulator. The model used during the retrofit period of the turbine controller in Kori Nuclear Power Plant makes difference in calculating generator output and control valve positions. That is because such operating data as the main steam pressure, the main steam temperature and control valve positions of Yongkwang #3 are different from those of Kori #4. Therefore, the model parameters must be tuned by using actual operating data for the high fidelity of simulator in calculating the dynamic characteristic of the model. This paper describes that the $6{\sigma}$ method is used in improvement of precision of generator output calculation in the steam turbine model of the simulator.

• The Transactions of The Korean Institute of Electrical Engineers
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• v.65 no.5
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• pp.857-861
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• 2016

In this study, we proposed a new method that can be measure ECG (Electrocardiography) and PPG (Photoplethysmography) in realtime on the site of the wrist for check the state of health in daily life. For convenience measurement of ECG the lead I method was used on the wrist, and omit the reference junction ECG I was measured in the right hand and the left hand of the potential difference. Then the measured electrocardiogram was amplified by the differential amplifier and the signals were passed HPF, LPF, and BPF filters. For removing the PPG's noise from the Motion artifact and temperature, we apply the reflective photoelectric volume pulse wave measurement method using green LED as a light source. The circuits was designed to be able to check the waveform using higher active amplification method at weak signals. For the validation of our device, the measured signals were compared with E2-KIT on same time. The results shows that the error does not exceed the maximum one, most of the data is confirmed to be issued Peak inspection of the same number.

• Journal of People, Plants, and Environment
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• v.21 no.6
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• pp.485-492
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• 2018

This study aimed to develop and validate highly sensitive determination method of a prostaglandin ($PGE_1$, OP 1206) in human plasma by LC-MS/MS using column switching. Plasma stored at $-30^{\circ}C$ and treated with methanol effectively inhibited interferences synthesized post-sampling. Samples were added with internal standard and were separated by reversed-phase HPLC with a cycle time of 30min. The method was selective for OP 1206 and the regression models, based on internal standard, were linear across the concentration range 0.5-50 pg/mL with the limit of quantification of 0.5 pg/mL (limit of quantitation, LOQ) for OP 1206. The calibration curve of OP 1206 standards spiked in five individual plasma samples was linear ($r^2=0.9999$). Accuracy and precision at the concentrations of 0.5, 1.5, 5.0 and 40 pg/mL, and at the lower LOQ of 0.5 pg/mL were excellent at 20%. OP120 < 6 was stable in plasma samples for at least 24 hours at room temperature, 24 hours frozen at $-70^{\circ}C$, 24 hours in an auto sampler at $6^{\circ}C$, and for two freeze/unfreezing cycles. The validated determination method successfully quantified the concentrations of OP 1206 in plasma samples from simulated administrating a single $5{\mu}g$ OP 1206 formulation. Thus, this novel LC-MS/MS technique for drug separation, detection and quantitation is expected to become the standard highly-sensitive detection method in bioanalysis and to be applied to many low dose pharmaceutical products.

• Journal of the Korean Society of Food Science and Nutrition
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• v.46 no.9
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• pp.1091-1096
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• 2017

The aim of this study was the validation of a modified analytical method for determination of oxypaeoniflorin and paeoniflorin in Moutan Cortex Radicis extract. For validation of the analytical method, we modified established analytical methods and validated improvement. For validation, the specificity, linearity, precision, accuracy, limit of detection (LOD), and limit of quantification of oxypaeoniflorin and paeoniflorin were measured by high performance liquid chromatography. The results show that the correlation coefficients of the calibration curve for oxypaeoniflorin and paeoniflorin were 1.0000 and 0.9998, respectively. The LOD for oxypaeoniflorin and paeoniflorin were $0.23{\mu}g/mL$ and $0.25{\mu}g/mL$, respectively. The inter-day and intra-day precision values of oxypaeoniflorin and paeoniflorin were 0.70~3.19% and 1.74~2.43%, and 0.32~0.92% and 0.62~2.28%, respectively. The inter-day and intra-day accuracies of oxypaeoniflorin and paeoniflorin were 98.33~102.11% and 97.72~118.12%, and 98.44~101.56% and 97.10~112.00%, respectively. Therefore, the analytical method was validated for the detection of oxypaeoniflorin and paeoniflorin in Moutan Cortex Radicis.

• Journal of Food Hygiene and Safety
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• v.32 no.2
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• pp.89-95
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• 2017

A rapid, sensitive analytical method for glucuronolactone in beverages was developed and validated using hydrophilic interaction liquid chromatography coupled to electrospray ionization tandem mass spectrometry (HILIC-ESI-MS/MS). To determine the optimum analytical conditions for glucuronolactone, three different kinds of HILIC columns and two mobile phases with different pH values were examined. An amide-bonded stationary phase with a pH 9 acetonitrile-rich mobile phase was the best condition in terms of column retention, ESI-MS/MS response area, and signal-to-noise ratio. After extraction, glucuronolactone was separated through the HILIC amide column and detected by negative ESI-MS/MS in selected reaction monitoring (SRM) mode. Nine energy drinks sold in Korea were spiked with glucuronolactone at a concentration of 5 ng/mL; the Monster $Energy^{TM}$ sample showed the smallest peak area and its signal-to-noise ratio was used for method validation. Good linearity was obtained in the concentration range from 20 to 1500 ng/mL with a correlation coefficient > 0.998. The developed method had a limit of detection (LOD) of 6 ng/mL and a limit of quantitation (LOQ) of 20 ng/mL. The recovery of this method at concentration of 20, 100, 500, and 1000 ng/mL was 96.3%-99.2% with relative standard deviations (RSD) of 1.6%-14.0%. A reproducibility precision assessment at concentration of 100 and 500 ng/mL was carried out among three laboratories. The recovery of that evaluation was 95.1%-102.3% with RSD of 2.7%-7.0%. An analysis of variance indicated that there was no difference between the recovery results of the three laboratories at the 5% significance level. The validated method is applicable to inspecting beverages adulterated with glucuronolactone in Korea.

• Journal of the Korean Geotechnical Society
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• v.26 no.1
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• pp.5-19
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• 2010

Geo-layer information is important to determine pile length and estimate residual settlement in the construction site. An overall spatial distribution of geo-layers in the entire construction site can be predicted using drill-log information. In this study, the geo-layer distribution at Song-do area was estimated by kriging and inverse distance weighting methods, and a cross validation was adopted to verify the reliability of estimation results. The analysis results indicate that the best fitted theoretical variogram model to the experimental variogram does not always provide the most reliable estimation in the kriging method. The proper $\alpha$ value of inverse distance weighting method must be determined by types of geo-layer, because the $\alpha$ value is affected by types of geo-layer. Results of the kriging method show more reliable results than those of inverse distance weighting method, and the structure of geo-layer distribution could be evaluated by variogram in the kriging method.

• Analytical Science and Technology
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• v.24 no.4
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• pp.237-242
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• 2011

In this study, an analytical method was developed for residual metamizol in beef and pork using LC/MS/MS. 4-methylaminoantipyrin (MAA), the main metabolite of metamizol was targeted for analysis instead of its parent compound. MAA was simply extracted from meat by acetonitrile, purified and then analyzed by multiple reaction monitoring method (MRM). Standard addition method was used for calibration. The calibration curves showed the linearity of $r^2$ > 0.99 for both matrices included. The developed method was validated by six-time intra-lab tests and inter-lab tests with two other institutes. The validation of the whole procedure for beef showed the intra-lab accuracies of 78-102% (CV 5.5-9.1%) and the inter-lab accuracy of 98% (CV 14%); the intra-lab accuracies of 95-99% (CV 3.9-5.6%) and the inter-lab accuracy of 111% (CV 13%).

• Journal of the Korean Society of Food Science and Nutrition
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• v.46 no.5
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• pp.646-652
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• 2017

The aim of this study was to investigate method validation for determination of sesamol, sesamin, and sesamolin in non-fermented sesame and fermented sesame by bioconversion. For validation, the specificity, linearity, precision, accuracy, limits of detection (LOD), and quantification (LOQ) of sesamol, sesamin, and sesamolin were measured by HPLC. Linearity tests showed that the coefficients of calibration correlation ($R^2$) for sesamol, sesamin, and sesamolin were 0.9999. Recovery rates of lignan contents in non-fermented and fermented sesame were high in the ranges of 100.27~115.10% and 98.43~114.90%, respectively. The inter-day and intra-day precisions of sesamin and sesamolin analyses for non-fermented and fermented sesame were 0.27~1.94% and 0.25~0.69%, respectively. The LOD and LOQ were $0.23{\sim}0.34{\mu}g/g$ and $0.70{\sim}1.03{\mu}g/g$, respectively. These results indicate that the validated method is appropriate for the determination of sesamol, sesamin, and sesamolin.