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Research ArticleTechnology/Application

A Potent and Safe H2O2 Fumigation Approach

Patrick Vanhecke, Volker Sigwarth and Claude Moirandat
PDA Journal of Pharmaceutical Science and Technology July 2012, 66 (4) 354-370; DOI: https://doi.org/10.5731/pdajpst.2012.00870
Patrick Vanhecke
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Volker Sigwarth
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  • For correspondence: volker.sigwarth@skan.ch
Claude Moirandat
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References

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    Technical Roules for Hazardous Products 522 (Technische Regeln für Gefahrenstoffe 522, TRGS 522), Room Disinfection using Formaldehyde; June 1992; last change: refer to: Bundesarbeitsblatt (BArbBl) edition 9/2001. Germany.
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    . Das Dampf-, Ozon-, Luftverfahren (DOL) zur Desinfektion von Oberflächen und Räumen. Concept Seminar “Gasförmige Sterilisations- und Dekontaminationsverfahren,”, March 19 and 20, 1996, Darmstadt, Germany.
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    Dry Fog Minncare Cold Sterilant, Minntech Corporation: Minneapolis, MN, USA.
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    . Hydrogen Peroxide in Pharmaceutical Isolators, Investigations about Behavior, Measurements and Effects. PhD Thesis No. 14044, ETH Zürich, 2001.
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    Chapter 〈1116〉 Microbiological Evaluation of Clean Rooms. USP 34, General Information, U.S. Pharmacopeial Convention: Rockville, MD, December 2011.
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    Chapter X. Laboratory Control, A. Environmental Monitoring. In Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—cGMP; FDA: Rockville, MD, September 2004, pp 32–35.
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    1. Wallhäuser KH
    . Praxis der Sterilisation—Desinfektion—Konservierung, 5th ed.; Georg Thieme Verlag: Stuttgart, New York, 1995; pp 643– 645.
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    . Chapter 12: Suitability of Biological Indicators for Vaporized Hydrogen Peroxide Decontamination. In Biological Indicators for Sterilization Processes; PDA: Bethesda, MD, 2009; pp 301–346.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 4
July/August 2012
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A Potent and Safe H2O2 Fumigation Approach
Patrick Vanhecke, Volker Sigwarth, Claude Moirandat
PDA Journal of Pharmaceutical Science and Technology Jul 2012, 66 (4) 354-370; DOI: 10.5731/pdajpst.2012.00870

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A Potent and Safe H2O2 Fumigation Approach
Patrick Vanhecke, Volker Sigwarth, Claude Moirandat
PDA Journal of Pharmaceutical Science and Technology Jul 2012, 66 (4) 354-370; DOI: 10.5731/pdajpst.2012.00870
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  • Article
    • Abstract
    • 1. Room Decontamination Review
    • 2. Needs for Room Sanitization and Decontamination
    • 3. New Concept for Room Fumigation by Hydrogen Peroxide
    • 4. H2O2 Fumigation Equipment
    • 5. Fumigation Process Validation
    • 6. BI Challenge Concentration
    • 7. Design of Experiment (DoE): Influence of Process Parameters
    • 8. Case Studies/Reports
    • 9. Comparison of H2O2 Fumigation Process to Other Room Decontamination Processes
    • 10. Conclusion/Summary
    • References
  • Figures & Data
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