Skip to main content

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
Case ReportCase Studies

Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters

Sal Giglia, John Caulmare, David Nhiem and David Porreca
PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 577-590; DOI: https://doi.org/10.5731/pdajpst.2016.006437
Sal Giglia
MilliporeSigma, Bedford, MA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: sal.giglia@emdmillipore.com
John Caulmare
MilliporeSigma, Bedford, MA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David Nhiem
MilliporeSigma, Bedford, MA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David Porreca
MilliporeSigma, Bedford, MA
  • 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

Reference

  1. 1.↵
    Multi-Tier Approach to Assuring Virus Retention and Integrity of Viresolve® Pro Devices; EMD Millipore Corporation, 2013; http://www.emdmillipore.com/Web-US-Site/en_CA/-/USD/ShowDocument-Pronet?id=201306.11360
  2. 2.↵
    PDA Technical Report No. 26. Sterilizing Filtration of Liquids. PDA J. Pharm. Sci. Technol. 1998, 52.
  3. 3.↵
    PDA Virus Filter Task Force. PDA Technical Report No. 41: Virus Filtration. PDA J. Pharm. Sci. Technol. 2005, 59 (2).
  4. 4.↵
    1. Emory S. F.
    Principles of Integrity-testing Hydrophilic Microporous Membrane Filters, Part I. Pharm. Technol. 1989, 13 (9), 68–77.
    OpenUrl
  5. 5.↵
    1. Emory S. F.
    Principles of Integrity-testing Hydrophilic Microporous Membrane Filters, Part II. Pharm. Technol. 1989, 13 (10), 36–46.
    OpenUrl
  6. 6.↵
    1. Phillips M. W.,
    2. DiLeo A. J.
    A Validatable Porosimetric Technique for Verifying the Integrity of Virus-retentive Membranes. Biologicals 1996, 24 (3), 243–253.
    OpenUrlCrossRefPubMed
  7. 7.↵
    1. Phillips M. W.
    Integrity Testing Virus-retentive Membranes. In Proceedings of the PDA Fourth International Congress, Vienna, Austria, 1996.
  8. 8.↵
    1. Jornitz M. W.,
    2. Agalloco J. P.,
    3. Akers J. E.,
    4. Madsen R. E.,
    5. Meltzer T. H.
    Filter Integrity Testing in Liquid Applications, Revisited. Part I. Pharm. Technol. 2001, October.
  9. 9.↵
    1. Jornitz M. W.,
    2. Agalloco J. P.,
    3. Akers J. E.,
    4. Madsen R. E.,
    5. Meltzer T. H.
    Filter Integrity Testing in Liquid Applications, Revisited. Part II. Pharm. Technol. 2001, November.
  10. 10.↵
    1. Guo H.,
    2. Wyart Y.,
    3. Perot J.,
    4. Nauleau F.,
    5. Moulin P.
    Low-pressure Membrane Integrity Tests for Drinking Water Treatment: A Review. Water Res. 2010, 44 (1), 41–57.
    OpenUrlPubMed
  11. 11.↵
    1. Gitis V.,
    2. Rothenberg G.
    Membrane Integrity Monitoring. In Encyclopedia of Membrane Science and Technology; John Wiley & Sons, Hoboken, NJ, 2013.
  12. 12.↵
    1. Jornitz M. W.,
    2. Meltzer T. H.
    Sterile Filtration: A Practical Approach; Marcel Dekker, Inc.: New York, 2001.
  13. 13.↵
    1. Giglia S.,
    2. Krishnan M.
    High Sensitivity Binary Gas Integrity Test for Membrane Filters. J. Membr. Sci. 2008, 323 (1), 60–66.
    OpenUrl
  14. 14.↵
    1. Lewnard J. J.,
    2. Giglia S.,
    3. Krishnan M.
    Methods and Systems for Integrity Testing of Porous Materials. U.S. Patent 7,594,425, September 29, 2009.
  15. 15.↵
    1. Weller S.,
    2. Steiner W.
    Separation of gases by fractional permeation through membranes. J. Appl. Phys. 1950, 21 (4), 279–283.
    OpenUrl
  16. 16.↵
    1. Lide D. R.
    CRC Handbook of Chemistry and Physics, Lide D. R., Ed.; CRC Press: Boca Raton, FL, 2004.
  17. 17.↵
    Perry's Chemical Engineers' Handbook; McGraw-Hill: New York, 2008; Vol. 796.
  18. 18.↵
    1. Verhallen P. T. H. M.,
    2. Oomen L. J. P.,
    3. Elsen A. J. J. M.,
    4. Kruger J.,
    5. Fortuin J. M.
    H. The Diffusion Coefficients of Helium, Hydrogen, Oxygen and Nitrogen in Water Determined from the Permeability of a Stagnant Liquid Layer in the Quasi-s. Chemical Engineering Sci. 1984, 39 (11), 1535–1541.
    OpenUrl
  19. 19.↵
    1. Hofmann F.
    Integrity Testing of Microfiltration Membranes. PDA J. Pharm. Sci. Technol. 1984, 38 (4), 148–159.
    OpenUrlAbstract/FREE Full Text
  20. 20.↵
    1. Hao J.,
    2. Giglia S.,
    3. Joens M.,
    4. Tuccelli R.
    Accelerated Mixed Gas Integrity Testing of Porous Materials. U.S. Patent 9,108,138, August 18, 2015.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 70 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 6
November/December 2016
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email 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.
Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
(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.
10 + 6 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
Sal Giglia, John Caulmare, David Nhiem, David Porreca
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 577-590; DOI: 10.5731/pdajpst.2016.006437

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
Sal Giglia, John Caulmare, David Nhiem, David Porreca
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 577-590; DOI: 10.5731/pdajpst.2016.006437
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Theoretical Background
    • 3. Materials and Methods
    • 4. Results and Discussion
    • 5. Conclusions
    • Conflict of Interest Declaration
    • Reference
  • 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

  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
Show more Case Studies

Similar Articles

Keywords

  • Sterilizing Filter
  • Virus Filter
  • Integrity Test

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