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
Research ArticleTechnology/Application

Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality

Kiyoshi Fujimori, Hans Lee, Christopher Sloey, Margaret S. Ricci, Zai-Qing Wen, Joseph Phillips and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 248-255; DOI: https://doi.org/10.5731/pdajpst.2015.006056
Kiyoshi Fujimori
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hans Lee
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christopher Sloey
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Margaret S. Ricci
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Zai-Qing Wen
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Joseph Phillips
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yasser Nashed-Samuel
Amgen Inc., Drug Product Development; One Amgen Center Dr., Thousand Oaks, CA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: snashed@amgen.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Adams P. B.
    Surface Properties of Glass Containers for Parenteral Solutions. Bull. Parent. Drug. Assoc. 1977, 31 (5), 213–226.
    OpenUrl
  2. 2.↵
    RX 360: An International Pharmaceutical Supply Chain Consortium. Additional Product Recalls Associated with Glass Delamination. Flash Report 2011, 186.
  3. 3.↵
    1. Borchert S. J.,
    2. Ryan M. M.,
    3. Davison R. L.,
    4. Speed W.
    Accelerated Extractable Studies of Borosilicate Glass Containers. J. Parent. Sci. Technol. 1989, 43 (2), 67–78.
    OpenUrl
  4. 4.↵
    1. Ennis R. D.,
    2. Pritchard R.,
    3. Nakamura C.,
    4. Coulon M.,
    5. Yang T.,
    6. Visor G. C.,
    7. Lee W. A.
    Glass Vials for Small Volume Parenterals: Influence of Drug and Manufacturing Processes on Glass Delamination. Pharm. Dev. Technol. 2001, 6 (3), 393–405.
    OpenUrlPubMed
  5. 5.↵
    1. Iacocca R. G.,
    2. Toltl N.,
    3. Allgeier M.,
    4. Bustard B.,
    5. Dong X.,
    6. Foubert M.,
    7. Hofer J.,
    8. Peoples S.,
    9. Shelbourn T.
    Factors Affecting the Chemical Durability of Glass Used in the Pharmaceutical Industry. AAPS Pharm. Sci. Tech. 2010, 11 (3), 1340–1349.
    OpenUrl
  6. 6.↵
    1. Collins W. D.,
    2. Riffenburg H. B.
    Contamination of Water Samples with Materials Dissolved from Glass Containers. Industrial & Engineering Chem. 1923, 15 (1), 48–49.
    OpenUrl
  7. 7.↵
    1. Shelby J. E.
    Introduction to Glass Science and Technology, 2nd ed.; The Royal Society of Chemistry: Cambridge, UK, 2005; pp 51–71, 176–179.
  8. 8.↵
    1. Sloey C.,
    2. Gleason C.,
    3. Phillips J.
    Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 35–42.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    Schott North America, Inc. Schott Technical Glasses—Physical and Technical Properties. http://www.us.schott.com/tubing/english/download/schott-brochure-technical-glasses_us.pdf, 2010.
  10. 10.↵
    1. Wen Z. Q.,
    2. Torraca G.,
    3. Masatani P.,
    4. Sloey C.,
    5. Phillips J.
    Nondestructive Detection of Glass Vial Inner Surface Morphology with Differential Interference Contrast Microscopy. J. Pharm. Sci. 2012, 101 (4), 1378–1384.
    OpenUrlPubMed
  11. 11.↵
    European Pharmacopoeia, 7.0 ed. Section 3.2.1. Glass containers for pharmaceutical use; 2008, pp 363–367.
  12. 12.↵
    1. Guadagnino E.,
    2. Zuccato D.
    Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 116–125.
    OpenUrlAbstract/FREE Full Text
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
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.
Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality
(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 + 3 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality
Kiyoshi Fujimori, Hans Lee, Christopher Sloey, Margaret S. Ricci, Zai-Qing Wen, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 248-255; DOI: 10.5731/pdajpst.2015.006056

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality
Kiyoshi Fujimori, Hans Lee, Christopher Sloey, Margaret S. Ricci, Zai-Qing Wen, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 248-255; DOI: 10.5731/pdajpst.2015.006056
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

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...

  • Measurement of Solution Composition as an Alternative to Titration for Evaluating the Hydrolytic Resistance of Glass
  • Characterization of a Novel Particle in a Pharmaceutical Drug Product
  • Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review
  • An Evaluation of the Glass Vial Hydrolytic Resistance Method
  • 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

  • Glass
  • Vials
  • Lamellae
  • Delamination
  • Alkalinity
  • conductivity
  • ICP-MS
  • flame photometry
  • Accelerated lamellae formation

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