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

Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations

Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang and Margaret Ricci
PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 323-335; DOI: https://doi.org/10.5731/pdajpst.2013.00925
Ge Jiang
1Global Product Quality, Amgen Inc.;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: gjiang@amgen.com
Monica Goss
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Guiyang Li
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Wendy Jing
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hong Shen
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kiyoshi Fujimori
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Linda Le
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lyanne Wong
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Zai-Qing Wen
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yasser Nashed-Samuel
2Process and Product Development, Amgen Inc.; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ken Riker
1Global Product Quality, Amgen Inc.;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Abe Germansderfer
3Quality Engineering, Amgen Inc.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Paul Tsang
1Global Product Quality, Amgen Inc.;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Margaret Ricci
2Process and Product Development, Amgen Inc.; and
  • 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.↵
    Food and Drug Administration (FDA). FDA Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs. 3-25-2011 (URL as of May 30, 2013: http://www.fda.gov/Drugs/DrugSafety/ucm248490.htm).
    Google Scholar
  2. 2.↵
    Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA Web Site for Rapid Alerts on November 17, 2010 (URL as of May 30, 2013: http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON099966).
    Google Scholar
  3. 3.↵
    1. Fradkin A. H.,
    2. Carpenter J. F.,
    3. Randolph T. W.
    Glass particles as an adjuvant: a model for adverse immunogenicity of therapeutic proteins. J. Pharm. Sci. 2011, 100 (11), 4953–4964.
    OpenUrlCrossRefPubMedGoogle Scholar
  4. 4.↵
    1. Doremus R. H.
    Diffusion of water in rhyoliteglass: diffusion–reaction model. Journal of Non-Crystalline Solids 2000, 261 (1–3), 101–107.
    OpenUrlCrossRefWeb of ScienceGoogle Scholar
  5. 5.↵
    1. Doremus R. H.
    Diffusion of water in silica glass. Journal of Materials Research 2011, 10 (9), 2379–2389.
    OpenUrlGoogle Scholar
  6. 6.↵
    1. Tian L.,
    2. Dieckmann R.,
    3. Hui C.-Y.,
    4. Lin Y.-Y.,
    5. Couillard J. G.
    Effect of water incorporation on the diffusion of sodium in Type I silica glass. Journal of Non-Crystalline Solids 2001, 286 (3), 146–161.
    OpenUrlGoogle Scholar
  7. 7.↵
    1. Tomozawa M.
    Stress corrosion reaction of silica glass and water. Physics and Chemistry of Glasses - European Journal of Glass Science and Technology Part B. 1998, 39 (2), 65–69.
    OpenUrlGoogle Scholar
  8. 8.↵
    1. Yamanaka S.,
    2. Akaji J.,
    3. Hattori M.
    Reaction of pyrex type borosilicate glass with water in autoclave. Journal of Non-Crystalline Solids 1985, 70 (2), 279–290.
    OpenUrlGoogle Scholar
  9. 9.↵
    1. Clark D. E.,
    2. Zoitos B. K.
    1. White W. B.
    Theory of Corrosion of Glass and Ceramics. In Corrosion of Glass, Ceramics, and Ceramic Superconductors: Principles, Testing, Characterizaiton and Applications, 1st ed.; Clark D. E., Zoitos B. K., Eds.; Noyes Publications, Park Ridge, NJ, 1992; pp 2–26.
    Google Scholar
  10. 10.↵
    1. Iacocca R. G.,
    2. Allgeier M.
    Corrosive attack of glass by a pharmaceutical compound. Journal of Materials Science 2007, 42 (3), 801–811.
    OpenUrlGoogle Scholar
  11. 11.↵
    International Organization for Standardization (ISO). ISO 4802-1-2010: Glassware – hydrolytic resistance of the interior surfaces of glass containers – Part 1: determination by titration method and classification.
    Google Scholar
  12. 12.↵
    European Pharmacopoeia (Ph.Eur.). Test of the Hydrolytic Resistance of the Inner Surfaces of Glass Containers for Pharmaceutical Use. Ph.Eur. 7.0: Section 3.2.1. Glass containers for pharmaceutical use.
    Google Scholar
  13. 13.↵
    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 TextGoogle Scholar
  14. 14.↵
    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 PharmSciTech 2010, 11 (3), 1340–1349.
    OpenUrlPubMedGoogle Scholar
  15. 15.↵
    1. Rupertus V.
    White paper by Schott Pharmaceutical Packaging: Two ways to minimize the delamination risk of glass containers. PDA Letter, January 2012 (URL as of May 30, 2013: http://www.pharmaceutical-technology.com/downloads/whitepapers/packaging/fileminimize-delamination-risk-of-glass-containers/get/).
    Google Scholar
  16. 16.↵
    1. Bacon F. R.,
    2. Raggon F. C.
    Promotion of attack on glass and silica by citrate and other anions in neutral solution. Journal of the American Ceramic Society 1959, 42 (4), 199–205.
    OpenUrlGoogle Scholar
  17. 17.↵
    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 TextGoogle Scholar
  18. 18.↵
    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.
    OpenUrlPubMedGoogle Scholar
  19. 19.↵
    1. Bohrer D.,
    2. Bortoluzzi F.,
    3. Nascimento P. C.,
    4. Carvalho L. M.,
    5. Ramirez A. G.
    Silicate release from glass for pharmaceutical preparations. Int. J. Pharm. 2008, 355 (1–2), 174–183.
    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
  20. 20.↵
    Rx-360. Report 09-July-2011: Highlights from June 2011 Glass Container Delamination Scientific Symposium (URL as May 30, 2013: http://www.rx-360.org/LinkClick.aspx?fileticket=0XvULtp2yrk%3D&tabid=234).
    Google Scholar
  21. 21.↵
    1. Jiang G.,
    2. Akers M.,
    3. Jain M.,
    4. Guo J.,
    5. Distler A.,
    6. Swift R.,
    7. Wadhwa M. V.,
    8. Jameel F.,
    9. Patro S.,
    10. Freund E.
    Mechanistic studies of glass vial breakage for frozen formulations. II. Vial breakage caused by amorphous protein formulations. PDA J. Pharm. Sci. Technol. 2007, 61 (6), 452–460.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  22. 22.↵
    1. Kolhe P.,
    2. Badkar A.
    Protein and solute distribution in drug substance containers during frozen storage and post-thawing: a tool to understand and define freezing-thawing parameters in biotechnology process development. Biotechnol. Progress 2011, 27 (2), 494–504.
    OpenUrlPubMedGoogle Scholar
  23. 23.↵
    1. Singh S. K.,
    2. Kolhe P.,
    3. Wang W.,
    4. Nema S.
    Large-scale freezing of biologics: a practitioner's review. Part one: fundamental aspects. BioProcess International October 2009.
    Google Scholar
  24. 24.↵
    1. Goldstein J.,
    2. Newbury D.,
    3. Joy D.,
    4. Lyman C.,
    5. Echlin P.,
    6. Lifshin E.,
    7. Sawyer L.,
    8. Michael J.
    Scanning Electron Microscopy and X-Ray Microanalysis, 3rd ed.; Springer: New York, 2003; pp 99–192.
    Google Scholar
  25. 25.↵
    1. Smith B.
    Chapter 7. Inorganic Compounds. In Infrared Spectral Interpretation: A Systematic Approach; CRC Press, LLC: Boca Raton, FL, 1999; pp 165–175.
    Google Scholar
  26. 26.↵
    1. Sun D.,
    2. Zhang R.,
    3. Liu Z.,
    4. Huang Y.,
    5. Wang Y.,
    6. He J.,
    7. Han B.,
    8. Yang G.
    Polypropylene/silica nanocomposites prepared by in-situ sol–gel reaction with the aid of CO2. Macromolecules 2005, 38 (13), 5617–5624.
    OpenUrlGoogle Scholar
  27. 27.↵
    1. Jiang G.,
    2. Akers M.,
    3. Jain M.,
    4. Guo J.,
    5. Distler A.,
    6. Swift R.,
    7. Wadhwa M. V.,
    8. Jameel F.,
    9. Patro S.,
    10. Freund E.
    Mechanistic studies of glass vial breakage for frozen formulations. I. Vial breakage caused by crystallizable excipient mannitol. PDA J. Pharm. Sci. Technol. 2007, 61 (6), 441–451.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 4
July/August 2013
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang, Margaret Ricci
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 323-335; DOI: 10.5731/pdajpst.2013.00925
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...

  • Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry
  • A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
  • Google Scholar

More in this TOC Section

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Show more Research

Similar Articles

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.
Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
(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.
1 + 3 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang, Margaret Ricci
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 323-335; DOI: 10.5731/pdajpst.2013.00925

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.