PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 6 , Issue 2
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  • Goran MITULOVIC, Thomas JACOB, Robert VAN LING, Remco SWART, Jean-Pier ...
    2004 Volume 6 Issue 2 Pages 86-92
    Published: 2004
    Released: July 11, 2006
    JOURNALS FREE ACCESS
      A new two dimensional (2D) nano liquid chromatographic (LC) method for mass spectrometric (MS) detection was developed, applying linear salt gradient elution to first micro ion exchange separation with successive nano reverse phase separation. Compared with conventional 2D LC based on salt plug gradient, separation was much more improved and almost no interference from highly abundant peptides with the detection of low-abundant peptides was observed. Eventually, the number of identified protein increased double, almost to the estimated number of protein in sample.
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  • Yushi UETERA, Hiroshi SHIGEMATSU, Zenzou BABA, Naohito KUMADA
    2004 Volume 6 Issue 2 Pages 93-97
    Published: 2004
    Released: July 11, 2006
    JOURNALS FREE ACCESS
      Physical parameters such as pressure and temperature are measured easily by use of the wireless logger even in the autoclaves without sensor ports, because it has a wireless structure. In the present preliminary report, evaluations were performed twice using the logger in the prevacuum autoclave without sensor ports: before and after it underwent the mechanical repair of air leak into the chamber. Temperature and pressure were measured using the logger at the center of the textile pack when the Bowie-Dick test cycle was operated. In the sterilization phase, the measured temperatures were compared with the saturated steam temperatures calculated at the measured pressures, when the calculated temperatures were over 134.0°C. Moreover, the F0 values were computed using the measured and calculated temperatures, respectively. Furthermore, the residual air volume was estimated in the textile pack at 25°C and 1013 mbar absolute. The first evaluation revealed that the measured temperatures were lower than the calculated temperatures by 1.1-1.7°C. The F0 value of the measured temperatures was also lower than the F0 value of the calculated temperatures by 33.1. The estimated residual air volume was 913 cm3 in the textile pack. After the repair of air leak into the chamber at the door seal gasket, the second evaluation revealed that the measured temperatures were lower than the calculated temperatures by 0.1-1.2°C. The F0 value of the measured temperatures was also lower than the F0 value of the calculated temperatures by 24.5. The estimated residual air volume was 325 cm3 in the textile pack. This preliminary report suggested that the wireless logger system is useful to understand how air leak into the chamber impairs the thermal process at the center of the textile pack.
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