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 ArticleTechnology/Application

The Application of Noninvasive Headspace Analysis to Media Fill Inspection

Derek Duncan, Tony Cundell, Lauren Levac, James Veale, Suzanne Kuiper and Ravi Rao
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 230-247; DOI: https://doi.org/10.5731/pdajpst.2015.006312
Derek Duncan
1Lighthouse Instruments BV, Amsterdam, The Netherlands;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: dduncan@lighthouseinstruments.com
Tony Cundell
3Microbiological Consulting, LLC, Scarsdale, NY, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lauren Levac
2Lighthouse Instruments LLC, Charlottesville, VA, USA; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
James Veale
2Lighthouse Instruments LLC, Charlottesville, VA, USA; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Suzanne Kuiper
1Lighthouse Instruments BV, Amsterdam, The Netherlands;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ravi Rao
1Lighthouse Instruments BV, Amsterdam, The Netherlands;
  • 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. Kreyenbuehl C.,
    2. Luemkemann J.
    Determination of Microbiological Growth in Media Filled Vials by Tuneable Diode Laser Absorption Spectroscopy (TDLAS). Presented at Pharma Kongress, Duesseldorf, Germany, April 2012.
    Google Scholar
  2. 2.↵
    1. Bjorklund G. C.
    Frequency-Modulation Spectroscopy: A New Method for Measuring Weak Absorptions and Dispersions. Optics Letters 1980, 5 (1), 15–17.
    OpenUrlCrossRefPubMedGoogle Scholar
  3. 3.↵
    1. Templeton A. C.,
    2. Han Y.-H. R.,
    3. Mahajan R.,
    4. Chern R. T.,
    5. Reed R. A.
    Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications. Pharm. Technol. 2002, 26 (7), 44–61.
    OpenUrlGoogle Scholar
  4. 4.↵
    1. Lin T. P.,
    2. Hsu C. C.,
    3. Kabakoff D. B.,
    4. Patapoff T. W.
    Application of Frequency-Modulated Spectroscopy in Vacuum Seal Integrity of Lyophilized Biological Products. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 106–115.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  5. 5.↵
    1. Mahajan R.,
    2. Templeton A. C.,
    3. Reed R. A.,
    4. Chern R. T.
    Frequency Modulation Spectroscopy: A Novel Nondestructive Approach for Measuring Moisture Activity in Pharmaceutical Samples. Pharm. Technol. 2005, 29 (10), 88–104.
    OpenUrlGoogle Scholar
  6. 6.↵
    1. Cook I.,
    2. Ward K.
    Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze-Dried Material. PDA J. Pharm. Sci. Technol. 2011, 65 (1), 2–11.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  7. 7.↵
    1. Zuleger B.,
    2. Werner U.,
    3. Kort A.,
    4. Glowienka R.,
    5. Wehnes E.,
    6. Duncan D.
    Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at –80 °C. PDA J. Pharm. Sci. Technol. 2012, 66 (1), 453–465.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  8. 8.↵
    1. Sudo H.,
    2. O'Driscoll M.,
    3. Nishiwaki K.,
    4. Kawamoto Y.,
    5. Gammel P.,
    6. Schramm G.,
    7. Wertli T.,
    8. Prinz H.,
    9. Mori A.,
    10. Sako K.
    Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 434–444.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  9. 9.↵
    1. Lysfjord J.
    1. Veale J. R.
    New Inspection Developments. In Practical Aseptic Processing Fill and Finish, Lysfjord J., Ed.; Davis Healthcare International Publishing/PDA: Bethesda, MD, 2009; pp 305–372.
    Google Scholar
  10. 10.↵
    Proposed Revisions to General Chapter Sterile Product Packaging—Integrity Evaluation <1207>. Pharmocopeial Forum, September 2014.
    Google Scholar
  11. 11.↵
    FDA Guidance for Industry. Sterile Products Produced by Aseptic Processing—Current Good Manufacturing Practice. September 2004.
    Google Scholar
  12. 12.↵
    1. McCullough K. Z.,
    2. Moldenhauer J.
    1. Cundell A.
    Failure investigations in response to adverse aseptic filling simulation results. In Microbial Risk and Investigations, McCullough K. Z., Moldenhauer J., Eds; PDA/Davis Healthcare International Publishing: Bethesda, MD, 2015; pp 541–560.
    Google Scholar
  13. 13.↵
    1. Doelle H. W.
    Bacterial Metalbolism, 2nd ed.; Academic Press: New York, 1975; pp 738.
    Google Scholar
  14. 14.↵
    1. Riedel T. E.,
    2. Berelson W. M.,
    3. Nealson K. H.,
    4. Finkel S. E.
    Oxygen Consumption Rates of Bacteria under Nutrient-Limited Conditions Appl. Environ. Microbiol. 2013, 79 (16), 4921–4931.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  15. 15.↵
    FDA Questions and Answers on Current Good Manufacturing Practices, Level 2 Guidance—Equipment. May, 2005.
    Google Scholar
  16. 16.↵
    1. Baranyl J.,
    2. Roberts T.A.
    A Dynamic Approach to Predicting Bacterial Growth in Food. Int. J. Food Microbiol. 1994, 23 (3-4), 277–294.
    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
  17. 17.↵
    1. Roesti D.
    Gas Headspace Analysis for Media Fill Inspection. Presented at the ECA Rapid Microbiological Methods Conference, Heidelberg, Germany, December 2014.
    Google Scholar
  18. 18.↵
    1. Brueckner D.
    Determination of Microbial Growth by Laser Absorption Spectroscopy. Presented at the Aseptikon Microbiology Conference, Mannheim, Germany, September 2015.
    Google Scholar
  19. 19.↵
    1. Monod J.
    Growth of Bacterial Cultures. Ann. Rev. Microbiol. 1949, 3 (1), 371–394.
    OpenUrlCrossRefWeb of ScienceGoogle Scholar
  20. 20.↵
    1. Novick A.
    Growth of Bacteria. Ann. Rev. Microbiol. 1955, 9 (1), 97–110.
    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
  21. 21.↵
    1. Zwietering M. H.,
    2. Jongenburger I.,
    3. Rombouts F. M.,
    4. Reit K. T.
    Modeling of the Bacterial Growth Curve. Appl. Environ. Microbiol. 1990, 56 (6), 1875–1811.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  22. 22.↵
    1. Lolas A. G,
    2. Metcalfe J. W.
    Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design. PDA J. Pharm. Sci. Technol. 2011, 65 (1), 63–70.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 70 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 3
May/June 2016
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
The Application of Noninvasive Headspace Analysis to Media Fill Inspection
Derek Duncan, Tony Cundell, Lauren Levac, James Veale, Suzanne Kuiper, Ravi Rao
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 230-247; DOI: 10.5731/pdajpst.2015.006312
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

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

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • Google Scholar

More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

Similar Articles

Keywords

  • microbial detection
  • microbiological test method
  • media fill inspection
  • headspace analysis
  • Headspace oxygen
  • headspace carbon dioxide
  • Microbial growth
  • Frequency modulation spectroscopy

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.
The Application of Noninvasive Headspace Analysis to Media Fill Inspection
(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.
4 + 6 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
The Application of Noninvasive Headspace Analysis to Media Fill Inspection
Derek Duncan, Tony Cundell, Lauren Levac, James Veale, Suzanne Kuiper, Ravi Rao
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 230-247; DOI: 10.5731/pdajpst.2015.006312

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.