日本PDA学術誌 GMPとバリデーション
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
一般論文
Thermal Evaluations in the Textile Pack Using the Wireless Logger in the Prevacuum Autoclave with a Failing Vacuum Pump Function
Yushi UETERAHiroshi SHIGEMATSUZenzou BABANaohito KUMADAKunio KAWAMURA
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ジャーナル フリー

2003 年 5 巻 2 号 p. 102-107

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抄録
  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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© 2003 Parenteral Drug Association Japan Chapter
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