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Research ArticleResearch

Application of Enzyme Indicators in Hydrogen Peroxide Biodecontamination Cycle Development: A Critical Evaluation of Indicator Variability and Correlation to Biological Indicator Results

Andreas Schachtschneider, Stephanie Klein and Kate Marshall
PDA Journal of Pharmaceutical Science and Technology January 2022, 76 (1) 34-51; DOI: https://doi.org/10.5731/pdajpst.2020.012294
Andreas Schachtschneider
1METALL+PLASTIC GmbH, Radolfzell, Germany;
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Stephanie Klein
2OPTIMA pharma GmbH, Schwaebisch Hall, Germany; and
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Kate Marshall
3Protak Scientific Ltd, Redhill, United Kingdom.
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References

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    VHP (Vapour Hydrogen Peroxide) Fragility https://mhrainspectorate.blog.gov.uk/2018/04/20/vhp-vapour-hydrogen-peroxide-fragility/ (accessed Jun 16, 2020).
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    Parenteral Drug Association Inc. Technical Report No. 51: Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use; Bethesda, MD, 2010.
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    1. Sandle T.
    Rogue Biological Indicators: Are They a Real Phenomenon? J. Valid. Technol 2020, 26 1–10.
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    International Organization for Standardization. ISO 11138-1:2017 Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements. ISO: Geneva, 2017.
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    U.S. Pharmacopeial Convention, General Chapter <55> Biological Indicators—Resistance Performance Tests. In USP 42—NF 37, USP: Rockville, MD, 2019.
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    1. Pusztai É.,
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    Decision Risk Approach to the Application of Biological Indicators in Vapor Phased Hydrogen Peroxide Bio-Decontamination. J. Chemom. 2018, 32 (4), 1–12.
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    Application of Statistics to Problems in Bacteriology: I. A Means of Determining Bacterial Population by the Dilution Method. J. Bacteriol. 1933, 25 (2), 101–121.
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PDA Journal of Pharmaceutical Science and Technology: 76 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 1
January/February 2022
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Application of Enzyme Indicators in Hydrogen Peroxide Biodecontamination Cycle Development: A Critical Evaluation of Indicator Variability and Correlation to Biological Indicator Results
Andreas Schachtschneider, Stephanie Klein, Kate Marshall
PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 34-51; DOI: 10.5731/pdajpst.2020.012294

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Application of Enzyme Indicators in Hydrogen Peroxide Biodecontamination Cycle Development: A Critical Evaluation of Indicator Variability and Correlation to Biological Indicator Results
Andreas Schachtschneider, Stephanie Klein, Kate Marshall
PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 34-51; DOI: 10.5731/pdajpst.2020.012294
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Keywords

  • Hydrogen peroxide
  • Decontamination cycle development
  • Isolator validation
  • Enzyme indicator
  • Thermostable adenylate kinase (tAK)
  • Biological indicator (BI)
  • Geobacillus stearothermophilus

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