Application of a newly developed hydrogen peroxide vapor phase sensor to HPV sterilizer

PDA Journal of Pharmaceutical Science and Technology

Volumn 52, Issue 1, 1998, Pages 13-18

  Taizo, Ichida ^a   Sinichi, Ando ^a   Kawamura, Kunio ^b,c  

^a Taiyo Toyo Sanso Co Ltd   (Japan)

^b KINKI UNIVERSITY   (Japan)

^c OTSUKA PHARMACEUTICAL CO LTD   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROGEN PEROXIDE;

ARTICLE; CALIBRATION; DRUG MANUFACTURE; DRUG STERILITY; GOOD MANUFACTURING PRACTICE; SEMICONDUCTOR; SENSOR;

BACILLUS STEAROTHERMOPHILUS; CALIBRATION; HYDROGEN PEROXIDE; STERILIZATION; VOLATILIZATION;

EID: 0031915452     PISSN: 1076397X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. "Validation for Aseptic Pharmaceutical Processes," Eds. Frederic J. Carton and James P. Agalloco: P. 47-92, "Calibration and Certification," by Robert E. Bremmer, Marcel Dekker, Inc., New York, (1986). CFR (Code of Federal Regulation) §21,68.
2. ISO/TC-198: Ethylene Oxide Sterilization (ISO11135), Radiation Sterilization (ISO11137), Industrial Moist Heat Sterilization (ISO11134), Moist Heat Sterilization for Health Care Product (ISO/DIS13683) and Sterilization by Liquid chemical Sterilants (ISO/CD1416).
3. "Validation of Aseptic Pharmaceutical Processes," Frederick J. Carlton, James P. Agalloco; P.47 "Calibration and Certification"; Robert E. Bremmer; Marcel Deckker Inc., New York (1989).
4. ISO (International Standardizing Organization) 9004-1, 13.2 "Element of Control."
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8. G. Scatchard, G. M. Kavanagh, and L. B. Ticknor, "Vapor-liquid equilibrium. VIII. Hydrogen peroxide-water mixtures," J. A. Chem. Soc:. 74, 15, 3715, (1952).
9. W. C. Schumb, C. N. Satterfield, and R. L. Wentworth, Hydrogen Peroxide, American Chemical Society Monograph Series, Reinhold Publishing Corporation, New York, N.Y., Chapman & Hall. Ltd., London, 1955, p. 222.