PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 5 , Issue 2
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Articles
  • Yoko SEKIGUCHI, Takahiro SUZUKI, Kazuo WATANABE
    2003 Volume 5 Issue 2 Pages 96-101
    Published: 2003
    Released: July 14, 2006
    JOURNALS FREE ACCESS
      Ion chromatography (IC) is one of the popularly used techniques for determination of inorganic ions in a variety of water analysis market. Recently the target elements include small molecular organic acid. To achieve the simultaneously determination of inorganic ions and organic acids, the gradient elution for ion exchange separation is needed. The gradient elution has brought about various problems. Traditionally, eluents in ion chromatography are prepared off-line from reagent-grade chemicals. However, off-line preparation often introduces contaminants that can cause undesirable chromatographic baseline artifacts and even irreproducible retention times of target analytes during the ion chromatographic separation. Online eluent generation solve most of previous problems. In this paper, the principles of the online eluent generation and applications are described.
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  • Yushi UETERA, Hiroshi SHIGEMATSU, Zenzou BABA, Naohito KUMADA, Kunio K ...
    2003 Volume 5 Issue 2 Pages 102-107
    Published: 2003
    Released: July 14, 2006
    JOURNALS FREE ACCESS
      Recently, a wireless logger system has been developed. Physical parameters such as pressure and temperature are measured easily by use of the logger, even in the chamber of the autoclaves without sensor ports. In the present study, thermal evaluations were performed at the center of the textile pack, using the logger, in terms of thermal differences between the actual temperatures and the saturated steam temperatures calculated by the measured pressures. Thermal evaluations were performed twice using the Bowie-Dick test cycle in the prevacuum autoclave without sensor ports: before and after vacuum pump replacement. In the sterilization phase, the actual temperatures were compared with the saturated steam temperatures calculated using the measured pressures, when the calculated temperatures were over 134.0°C. Moreover, the F0 values were obtained using the actual and calculated temperatures, respectively. Furthermore, the residual air volume was estimated in the textile pack at 25°C and 1,013 mbar absolute. The first evaluation revealed that the actual temperatures were lower than the calculated temperatures by 3.6-4.8°C in the sterilization phase. The F0 value by actual temperature was also lower than the F0 value by calculated temperature, by 66.2. The estimated residual air volume was 4,281 cm3 in the textile pack. After the vacuum pump replacement, the second evaluation revealed that the actual temperatures were lower than the calculated temperatures by 0-0.9°C in the sterilization phase. The F0 value by actual temperature was also lower than the F0 value by calculated temperature, by 20.6. The estimated residual air volume was 32 cm3 in the textile pack. The present study suggested by use of the logger that thermal differences decreased between the actual and calculated temperatures, as the residual air amount decreased at the center of the textile pack after the vacuum pump replacement. Therefore, the wireless logger is considered useful when the porous loads such as textile packs are evaluated thermally.
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