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

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 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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For correspondence: andreas.schachtschneider@metall-plastic.de

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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vol. 76 no. 1 34-51

DOI

https://doi.org/10.5731/pdajpst.2020.012294

PubMed

34131011

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online February 1, 2022.

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previous version (June 15, 2021 - 08:06).
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Andreas Schachtschneider^1,*,
Stephanie Klein² and
Kate Marshall³

¹METALL+PLASTIC GmbH, Radolfzell, Germany;
²OPTIMA pharma GmbH, Schwaebisch Hall, Germany; and
³Protak Scientific Ltd, Redhill, United Kingdom.

↵*Corresponding Author: METALL+PLASTIC GmbH, Bodmaner Straße 2, 78315 Radolfzell, Germany; Telephone: +49 (0) 7738 9280101; E-mail: andreas.schachtschneider{at}metall-plastic.de

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Birte Scharf, Marina Gole, Marcel Kötter

EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES 2023

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

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