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The History of Korean GMP (우리나라 GMP 변천사)

  • Paik, Woo-Hyun
    • YAKHAK HOEJI
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    • v.59 no.1
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    • pp.40-46
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    • 2015
  • The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

In-Process Control of an Infant Formula with Rice Starch using Rheology (쌀 전분의 유동성을 함유한 영.유아용 조제분유의 공정 관리)

  • Heo, Young-Suk;Konuklar, Gul
    • Journal of Dairy Science and Biotechnology
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    • v.26 no.2
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    • pp.45-49
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    • 2008
  • We studied the feasibility of monitoring and controlling the manufacturing process of an infant formula with rice starch by testing in-process samples using rheology. We used DSC to first determine the gelatinization temperature of the rice starch, a key ingredient of this product. With this characteristic temperature and the process design known, rheological measurements were conducted on the in-process samples for detecting the presence and extent of gelatinization and retrogradation of rice starch; in-process samples were collected from the carbohydrate tank, after the homogenizer, and the finished product tank. The correlation between the rheological measurements on these samples and manufacturing performance proved that rheology is a very sensitive tool for monitoring the structural development of this infant formula during main process, and their influence on sterilization efficiency. We observed that the lower degree of gelatinization during main process, a shorter residence time in the finished product tank, and using caustic flush rather than clean-in-place additively lead to higher sterilization efficiency. These findings can be utilized for a rational design and analysis of the manufacturing process for infant formulas containing rice starch.

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Effect of Surface Roughness on Cutting Conditions in CNC lathe C-Axis Milling Arc Cutting (CNC선반 C축 밀링 원호가공에서 절삭조건이 표면 거칠기에 미치는 영향)

  • Shin, Kuk-Sik
    • Journal of the Korean Society of Manufacturing Process Engineers
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    • v.13 no.4
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    • pp.99-105
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    • 2014
  • The domestic airline industry undertakes the production of finished products by assembling existing self-described components via a design process which involves assembly and production steps, after which many of the finished products are exported. However, high reliability and stability must be guaranteed, because customers require high-precision components at the time of manufacturing. In the aircraft parts industry, the mass production of high-value-added parts is limited. Therefore, a small production scale depending on the part is used, as many types of conventional CNC lathe machines with X-axis and Z-axis as well as Z-axis and C-axis CNC milling are used. The parts also rely on high-pressure air to increase production. The most important factors are good stability during processing, as high-precision parts are required, as noted above. It was found that as the C-axis rotation speed increased, the diameter of the cutting tool decreased with a decrease in the surface roughness, while the workpiece rotation speed increased with an increase in the surface roughness.

Biodegradabilities of Cotton Fabrics treated with Silicones (실리콘 처리한 면직물의 생분해성)

  • 김보형;박정희;임승순
    • Journal of the Korean Society of Clothing and Textiles
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    • v.28 no.8
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    • pp.1048-1056
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    • 2004
  • Hydrophilicities of finished cotton fabrics were evaluated in respect of moisture regain and wickability. Changes in internal structure were determined using X-ray diffraction and surface changes in degraded samples were observed through a microscopy. Activated sludge test, soil burial test and enzyme hydrolysis were employed to evaluate the biodegradabilities. In addition, correlation analysis was done between biodegradability and the factors affecting biodegradability in each evalution methods. It was shown that hydrophilicities of silicone finished specimens were lower than that of untreated cotton and decreased in a row of PDMS(polydimethyl siloxane : -CH$_3$)>AFS(amino functional siloxane ; -C$_3$H$_{6}$ NHC$_2$H$_4$NH$_2$)>MHPS(methylhydrogen polysiloxane : -H, Cat : (C$_{17}$ H$_{35}$ COO)$_2$Zn) Although, moisture regain of mercerized cotton was higher than those of the others, wickability was shown to be lower. It was represented that crystalinities of cotton fabrics decreased by the silicone treatment. In activated sludge test and soil burial test, biodegradabilities of silicone treated specimens were lower than that of untreated cotton, where specimens of higher biodegradability exhibited higher biodegradability except mercerized ones. The results from enzyme hydrolysis, however, showed somewhat different tendency in that biodegradability was more closely related with the crystallinities of fabrics. It can be thought that enzyme hydrolysis is carried out for short time, physical accessibility becomes important.

Feeding strategies and ageing time alter calpain system proteins activities and meat quality of Braford steers

  • Coria, Maria Sumampa;Pighin, Dario;Grigioni, Gabriela;Palma, Gustavo Adolfo
    • Animal Bioscience
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    • v.35 no.2
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    • pp.272-280
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    • 2022
  • Objective: The aim of this study was to evaluate the effect of ageing and feeding strategies on the calpain protease system and meat quality traits in Braford steers. Methods: Thirty Braford steers were employed; 15 animals were supplemented with corn silage during finishing and 15 were kept only on pasture. Meat quality traits and calpain system protein activity were evaluated in longissimus thoracis et lumborum (LTL) steaks aged for 2, 7, 14, and 21 days. Results: Aged meat showed higher pH and calcium content, while Warner Bratzler shear force (WBSF) decreased to day 21. No interaction between ageing and diet was seen for quality traits. Steers finished with corn silage showed higher values of water holding capacity, WBSF and free calcium, and lower values of pH and cooking loss. Calpain and calpastatin activities decreased with ageing. Finishing steers on pasture produced higher values of calpains and lower values of calpastatin activities. The higher values of calpain 1 activity were observed in muscles aged 2 days from pasture finished animals, and the lower activity of the inhibitor in the 21 days aged samples of the same group. Conclusion: These results suggest a diet by ageing interaction in calpains and calpastatin and this interaction impact in Warner Bratzler Shear Force in Braford LTL muscle.

Centreless precision grinding of camshafts as an automated operation

  • Petterson, Roger;Lundberg, Torbjorn
    • Journal of the korean Society of Automotive Engineers
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    • v.11 no.3
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    • pp.8-12
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    • 1989
  • The development of a microprocessor-controlled centreless grinding station has opened the way for the production of automobile camshafts-from raw casting to precision-finished part-as a fully automated operation. This results in manufacture to finer tolerances, with part-to-part consistency and a floor-to-floor time of half that needed for alternative production methods. Shafts with a grinding length of up to 700 mm can be processed.

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154KV개봉. 오류 지중송전선로 준공보고

  • 김성곤;정수근
    • 전기의세계
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    • v.29 no.11
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    • pp.693-698
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    • 1980
  • We T.E.C. have commenced to develop the O.F. cable in April, 1977. Now we have finished the Type-Test and produced in full-operation of 154KV 1x600mm$^{2}$ and 154KV 1x1200mm$^{2}$ O.F. cables. Especially we have completed pulling and splicing of the 24.82kms O.F. cable in KaeBong-OuRyu Route, and now it is operating well. This has important meaning that Extra High Voltage Under Ground Transmission Line has constructed by domastic engineers for the first time in Korea. Thank to arrange and publish it, and hope it can be helpful to the related.

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On the Size of the Constraint Buffer in the TOC(Theory of Constraints) (제약이론에서 제약버퍼의 크기 결정)

  • Koh, Shie-Gheun;Yoon, Hoon-Yong
    • IE interfaces
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    • v.14 no.4
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    • pp.334-340
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    • 2001
  • The theory of constraints (TOC) has become a valuable system in modern operations management. Using the ideas and methods of the TOC, companies can achieve a large reduction of work-in-process and finished-goods inventories, significant improvement in scheduling performance, and substantial earnings increase. The purpose of this paper is to calculate the optimal size of the time buffer which is used to accommodate disruptions in production processes and provide maximum productivity of capacity constrained resources. After the problem formulation in terms of single server queueing model, we observed the system behavior by sensitivity analyses.

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Optimal size of the constraint buffer in TOC (제약자원 버퍼의 최적 크기 결정)

  • Go Si Geun
    • Proceedings of the Korean Operations and Management Science Society Conference
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    • 2002.05a
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    • pp.476-480
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    • 2002
  • The theory of constraints (TOC) has become a valuable system in modern operations management. Using the ideas and methods of the TOC, companies can achieve a large reduction of work-in-process and finished-goods inventories, significant improvement in scheduling performance, and substantial earnings increase. The purpose of this paper is to calculate the optimal size of the time buffer which is used to accommodate disruptions in production processes and provide maximum productivity of capacity constrained resources. After the problem formulation in terms of single server queueing model, we observed the system behavior by sensitivity analyses.

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Enzymatic Chillproofing and Beer Foam Stability- Part 1. Foam Deterioration during Manufacturing Processes (효소에 의한 제탁조작과 맥주의 발포성 제I보. 제조공정중의 발포성상실)

  • Pack, M.Y.
    • Microbiology and Biotechnology Letters
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    • v.3 no.2
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    • pp.83-87
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    • 1975
  • An excellent foam stability in the freshly fermented green beer of a commercial brewery was found to be destroyed substantially by the time it was finished. A further survey proved that the processes of aging and pasteurization accompanied by enzymatic chillproofing were responsible for the foam deterioration.

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