Skip to main content
  • Main menu
  • User menu
  • Search

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
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;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: andreas.schachtschneider@metall-plastic.de
Stephanie Klein
2OPTIMA pharma GmbH, Schwaebisch Hall, Germany; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kate Marshall
3Protak Scientific Ltd, Redhill, United Kingdom.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Agalloco J.,
    2. Akers J.
    , Eds. Advanced Aseptic Processing Technology, 1st ed.; CRC Press: Boca Raton, 2010; https://doi.org/10.3109/9781439825440.
    Google Scholar
  2. 2.↵
    1. Sandle T.
    Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems. J. GxP Compliance 2017, 21, 1–12.
    OpenUrlGoogle Scholar
  3. 3.↵
    U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
    Google Scholar
  4. 4.↵
    Parenteral Drug Association Inc. Technical Report No. 34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products; Bethesda, MD, 2001.
    Google Scholar
  5. 5.↵
    1. Hopkins A.
    VHP (Vapour Hydrogen Peroxide) Fragility https://mhrainspectorate.blog.gov.uk/2018/04/20/vhp-vapour-hydrogen-peroxide-fragility/ (accessed Jun 16, 2020).
    Google Scholar
  6. 6.↵
    1. Godden P.
    VHP as sterilant for use in isolators? https://www.cleanroomtechnology.com/news/article_page/VHP_as_sterilant_for_use_in_isolators/142378 (accessed Aug 19, 2020)
    Google Scholar
  7. 7.↵
    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.
    Google Scholar
  8. 8.↵
    1. Sandle T.
    Rogue Biological Indicators: Are They a Real Phenomenon? J. Valid. Technol 2020, 26 1–10.
    OpenUrlGoogle Scholar
  9. 9.↵
    International Organization for Standardization. ISO 11138-1:2017 Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements. ISO: Geneva, 2017.
    Google Scholar
  10. 10.↵
    U.S. Pharmacopeial Convention, General Chapter <55> Biological Indicators—Resistance Performance Tests. In USP 42—NF 37, USP: Rockville, MD, 2019.
    Google Scholar
  11. 11.↵
    1. McLeod N. P.,
    2. Clifford M.,
    3. Sutton J. M.
    Evaluation of Novel Process Indicators for Rapid Monitoring of Hydrogen Peroxide Decontamination Processes. PDA J. Pharm. Sci. Technol. 2017, 71 (5), 393–404. https://doi.org/10.5731/pdajpst.2016.007435.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  12. 12.↵
    1. Kleinmann S.,
    2. Scheu M.,
    3. Fecht C.
    7 Steps for a Reproducible Cycle Development Plan. PDA Lett. 2016, 30–38.
    Google Scholar
  13. 13.↵
    1. Tukey J.
    Exploratory Data Analysis, 1st ed.; Addison-Wesley Publishing Company: Reading, MA, 1977.
    Google Scholar
  14. 14.↵
    1. Thouand G.,
    2. Marks R.
    1. Lundin A.
    Optimization of the firefly luciferase reaction for analytical purposes. In Bioluminescence: Fundamentals and Applications in Biotechnology, Thouand G., Marks R., Eds.; Springer Berlin Heidelberg: Berlin, Heidelberg, 2014; Vol. 2, pp 31–62. https://doi.org/10.1007/978-3-662-43619-6_2.
    OpenUrlGoogle Scholar
  15. 15.↵
    1. Pusztai É.,
    2. Kemény S.,
    3. Vágó E.,
    4. Horváth A.
    Decision Risk Approach to the Application of Biological Indicators in Vapor Phased Hydrogen Peroxide Bio-Decontamination. J. Chemom. 2018, 32 (4), 1–12.
    OpenUrlGoogle Scholar
  16. 16.↵
    1. Halvorson H. O.,
    2. Ziegler N. R.
    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.
    OpenUrlFREE Full TextGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 76 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 1
January/February 2022
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
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
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Discussion
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgments
    • Appendix
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
  • Coring and Fragmentation of Elastomeric Needle Shield in a Pre-Filled Syringe
  • Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
Show more Research

Similar Articles

Keywords

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

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Application of Enzyme Indicators in Hydrogen Peroxide Biodecontamination Cycle Development: A Critical Evaluation of Indicator Variability and Correlation to Biological Indicator Results
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
7 + 9 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.