• Title/Summary/Keyword: good manufacturing practice

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Characterizing a full spectrum of physico-chemical properties of (20S)-and (20R)-ginsenoside Rg3 to be proposed as standard reference materials

  • Kim, Il-Woung;Sun, Won Suk;Yun, Bong-Sik;Kim, Na-Ri;Min, Dongsun;Kim, Si-Kwan
    • Journal of Ginseng Research
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    • v.37 no.1
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    • pp.124-134
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    • 2013
  • The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.

The Research Relating to QA of the Absorbed Dose in the 10 MeV E-beam Facility in Accordance with the International Standards (국제표준에 따른 10 MeV급 전자빔 조사시설의 흡수선량 품질보증에 관한 연구)

  • Ha, Tae-Sung;Ahn, Cheol;Jung, Pyeong-Hwan;Cho, Jeong-Hee;Lee, Jong-Seok;Lee, Hye-Nam;Yoo, Beong-Gyu
    • Journal of radiological science and technology
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    • v.33 no.4
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    • pp.387-394
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    • 2010
  • In the field of healthcare, the conventional sterilization treatments have been replaced by irradiation methods which are in accordance with internationally well established quality standards. The quality control in radiation sterilization assures that the absorbed dose of the irradiated material is in agreement with its requirements and standards. The electron beam irradiation requires technical assessments of more process parameters than gamma irradiation does. Korea has witnessed wide uses of electron accelerators since early 2000 but there hasn't been research experiences relating to quality system in accordance with international standards. The new large scale e-beam irradiation system with the specification of 10 MeV, 8 kW was installed and operated in 2008 by Seoul Radiology Services Co. It consists of the electron accelerator, product handling system, safety, documentation and control subsystems into an integrated system to meet the requirement of the Good Manufacturing Practice such as process quality assurance and management of product tracking records. To implement the international standard such as EN ISO11137, it is necessary to understand the purposes aimed in the standard and carry out the tests following the procedures required. This study presented the specification of the e-beam facility and showed what its design requirements and features are. The test results on a variety of process parameters were presented and validated it they are within the required limits.

Modern Paper Quality Control

  • Olavi Komppa
    • Proceedings of the Korea Technical Association of the Pulp and Paper Industry Conference
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    • 2000.06a
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    • pp.16-23
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    • 2000
  • The increasing functional needs of top-quality printing papers and packaging paperboards, and especially the rapid developments in electronic printing processes and various computer printers during past few years, set new targets and requirements for modern paper quality. Most of these paper grades of today have relatively high filler content, are moderately or heavily calendered , and have many coating layers for the best appearance and performance. In practice, this means that many of the traditional quality assurance methods, mostly designed to measure papers made of pure. native pulp only, can not reliably (or at all) be used to analyze or rank the quality of modern papers. Hence, introduction of new measurement techniques is necessary to assure and further develop the paper quality today and in the future. Paper formation , i.e. small scale (millimeter scale) variation of basis weight, is the most important quality parameter of paper-making due to its influence on practically all the other quality properties of paper. The ideal paper would be completely uniform so that the basis weight of each small point (area) measured would be the same. In practice, of course, this is not possible because there always exists relatively large local variations in paper. However, these small scale basis weight variations are the major reason for many other quality problems, including calender blacking uneven coating result, uneven printing result, etc. The traditionally used visual inspection or optical measurement of the paper does not give us a reliable understanding of the material variations in the paper because in modern paper making process the optical behavior of paper is strongly affected by using e.g. fillers, dye or coating colors. Futhermore, the opacity (optical density) of the paper is changed at different process stages like wet pressing and calendering. The greatest advantage of using beta transmission method to measure paper formation is that it can be very reliably calibrated to measure true basis weight variation of all kinds of paper and board, independently on sample basis weight or paper grade. This gives us the possibility to measure, compare and judge papers made of different raw materials, different color, or even to measure heavily calendered, coated or printed papers. Scientific research of paper physics has shown that the orientation of the top layer (paper surface) fibers of the sheet paly the key role in paper curling and cockling , causing the typical practical problems (paper jam) with modern fax and copy machines, electronic printing , etc. On the other hand, the fiber orientation at the surface and middle layer of the sheet controls the bending stiffness of paperboard . Therefore, a reliable measurement of paper surface fiber orientation gives us a magnificent tool to investigate and predict paper curling and coclking tendency, and provides the necessary information to finetune, the manufacturing process for optimum quality. many papers, especially heavily calendered and coated grades, do resist liquid and gas penetration very much, bing beyond the measurement range of the traditional instruments or resulting invonveniently long measuring time per sample . The increased surface hardness and use of filler minerals and mechanical pulp make a reliable, nonleaking sample contact to the measurement head a challenge of its own. Paper surface coating causes, as expected, a layer which has completely different permeability characteristics compared to the other layer of the sheet. The latest developments in sensor technologies have made it possible to reliably measure gas flow in well controlled conditions, allowing us to investigate the gas penetration of open structures, such as cigarette paper, tissue or sack paper, and in the low permeability range analyze even fully greaseproof papers, silicon papers, heavily coated papers and boards or even detect defects in barrier coatings ! Even nitrogen or helium may be used as the gas, giving us completely new possibilities to rank the products or to find correlation to critical process or converting parameters. All the modern paper machines include many on-line measuring instruments which are used to give the necessary information for automatic process control systems. hence, the reliability of this information obtained from different sensors is vital for good optimizing and process stability. If any of these on-line sensors do not operate perfectly ass planned (having even small measurement error or malfunction ), the process control will set the machine to operate away from the optimum , resulting loss of profit or eventual problems in quality or runnability. To assure optimum operation of the paper machines, a novel quality assurance policy for the on-line measurements has been developed, including control procedures utilizing traceable, accredited standards for the best reliability and performance.