A new approach to vapor hydrogen peroxide decontamination of isolators and cleanrooms

Pharmaceutical Engineering

Volumn 26, Issue 3, 2006, Pages 96-104

  Imai, Kunihiro ^a   Watanabe, Soma ^a   Oshima, Yasusuke ^a,b   Kokubo, Mamoru ^a   Akers, Jim ^d   Akers, James E ^c  

^a Shibuya Kogyo Co Ltd   (Japan)

^b Plant Production Administration Division   (Japan)

^c Akers Kennedy and Associates   (United States)

^d Morimoto Factory ^*

Author keywords

[No Author keywords available]

Indexed keywords

HYDROGEN PEROXIDE;

AERATION; ARTICLE; BACTERIAL SPORE; CLEANING; CONTROLLED STUDY; HUMIDIFIER; HUMIDITY; NONHUMAN; VAPOR; WASTE MANAGEMENT;

EID: 33745287148     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. Kokubo, M., Inoue, T., and Akers, J., "Resistance of Common Environmental Spores of the Genus Bacillus to Vapor Hydrogen Peroxide," PDA Journal of Pharmaceutical Science and Technology, September-October 1998, 52(5), pp 228-231.
2. Sigwarth, V. and Stärk, A., "Effect of Carrier Materials on the Resistance of Spores of Bacillus stearothermophilus to Gaseous Hydrogen Peroxide," PDA Journal of Pharmaceutical Science and Technology, January-February 2003, 57(1), pp. 3-11.
3. Pflug, I.J., "Variability in the Data Generated by Laboratories Measuring D-Values of Bacterial Spores," PDA Journal of Pharmaceutical Science and Technology, January/February 2005, 59(1), pp. 3-9.
4. USP 29, Chapter 〈1208〉 Sterility Testing-Validation of Isolator Systems, pp. 3037-3039, 2006.
5. USP 29, Chapter 〈55〉 Biological Indicators-Resistance Performanc Tests, pp. 2501-2503, 2006.
6. PDA Technical Report No. 34, "Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products," PDA Journal of Pharmaceutical Science and Technology, September/October 2001 Supplement TR34, Vol. 55, No. 5.
7. Kawasaki, C., Nagano, H., Ito, T., and Kondo, M., "Mechanism of Bactericidal Action of Hydrogen Peroxide," J. Food Hydg. Soc. Jpn., 11, 1970, pp. 155-160.
8. Rickloff, J.R., "Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems," Journal of Validation Technology, pp. 61-71, November 1998.
9. Steris Co. Mentor, Ohio, Vapor Phase Hydrogen Peroxide Cycle Development Guide, 2001.
10. Food and Drug Administration (FDA), Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (Appendix 1: Aseptic Processing Isolators), September 2004, pp. 44-48.
11. Joslyn, L.J., Gaseous Chemical Sterilization, in S.S. Block Disinfection, Sterilization and Preservation, pp. 337-359.
12. Block S.S., Peroxygen Compounds, in S.S. Block, Disinfection, Sterilization, and Preservation, pp. 185-204.