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Research ArticleTECHNOLOGY/APPLICATIONS

Application of a Newly Developed Hydrogen Peroxide Vapor Phase Sensor to HPV Sterilizer

Ichida Taizo, Ando Sinichi and Kunio Kawamura
PDA Journal of Pharmaceutical Science and Technology January 1998, 52 (1) 13-18;
Ichida Taizo
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Ando Sinichi
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Kunio Kawamura
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Abstract

A new type of concentration sensor for hydrogen peroxide vapor has been developed by making use of a semiconductor. Output from the vapor sensor has been shown to have a good linear relationship with the logarithm of the concentration of hydrogen peroxide vapor. Concentration of hydrogen peroxide vapor introduced into the sterilization chamber could be kept constant by monitoring the concentration of the hydrogen peroxide vapor continuously and controlling the vapor supply. Temperature and humidity have also been kept constant. D-values for B. stearothermophilus ATCC 12980 at various concentrations of hydrogen peroxide vapor have been determined by using the combination system of the hydrogen peroxide vapor sensor, the hydrogen peroxide vapor supplier, thermosensor and humidity sensor. D-values at the temperature of 30°C and the absolute humidity of 0.7 mg H2O/L thus obtained, were 0.2 minutes at hydrogen peroxide concentration of 600 ppm and 1.2 minutes at 200 ppm at the temperature of 30°C and 0.7 mg/L absolute humidity. D-values for B. stearothermophilus ATCC 12980 at various temperatures, humidity and levels of hydrogen peroxide concentration have also been determined. These fundamental data indicate that the sterilization by hydrogen peroxide vapor can be validated as precisely as steam sterilization by measuring and controlling the concentration of hydrogen peroxide vapor using a combination of the hydrogen peroxide concentration sensor and the vapor generator. Influence of temperature and humidity have also been studied. The hydrogen peroxide sensor has been calibrated and standardized by using the standard hydrogen peroxide vapor whose concentration has been determined by calculating partial pressure of hydrogen peroxide over the water-hydrogen peroxide solution.

Footnotes

    • Received April 23, 1997.
    • Accepted August 22, 1997.
  • Copyright © Parenteral Drug Association. All rights reserved.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 52, Issue 1
January/February 1998
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Application of a Newly Developed Hydrogen Peroxide Vapor Phase Sensor to HPV Sterilizer
Ichida Taizo, Ando Sinichi, Kunio Kawamura
PDA Journal of Pharmaceutical Science and Technology Jan 1998, 52 (1) 13-18;

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Application of a Newly Developed Hydrogen Peroxide Vapor Phase Sensor to HPV Sterilizer
Ichida Taizo, Ando Sinichi, Kunio Kawamura
PDA Journal of Pharmaceutical Science and Technology Jan 1998, 52 (1) 13-18;
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More in this TOC Section

  • Evaluation of Steam Sterilization Processes: Comparing Calculations Using Temperature Data and Biointegrator Reduction Data and Calculation of Theoretical Temperature Difference
  • Optimization of the Drug Solution Preparation Process for a Production-Scale Crossflow Ultrafiltration System
  • Bacterial Adhesion: Considerations Within A Risk-Based Approach To Cleaning Validation
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