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

Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy

Jared S. Bee, Vadim V. Frey, Urooj Javed, Jonathan Chung, Marta L. Corcoran, Paul S. Roussel, Stephan O. Krause, Patricia W. Cash, Steven M. Bishop and Mariana N. Dimitrova
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 494-503; DOI: https://doi.org/10.5731/pdajpst.2014.00991
Jared S. Bee
1Formulation Sciences, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: jaredsbee@gmail.com
Vadim V. Frey
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Urooj Javed
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jonathan Chung
3Drug Delivery & Devices, MedImmune, Gaithersburg, MD; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Marta L. Corcoran
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Paul S. Roussel
3Drug Delivery & Devices, MedImmune, Gaithersburg, MD; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Stephan O. Krause
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Patricia W. Cash
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Steven M. Bishop
1Formulation Sciences, MedImmune, Gaithersburg, MD;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mariana N. Dimitrova
4Protein Pharmaceutical Development, Biogen Idec Inc., Boston, 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

References

  1. 1.↵
    1. Eu B.,
    2. Cairns A.,
    3. Ding G.,
    4. Cao X.,
    5. Wen Z. Q.
    Direct visualization of protein adsorption to primary containers by gold nanoparticles. J. Pharm. Sci. 2011, 100 (5), 1663–1670.
    OpenUrlPubMed
  2. 2.↵
    1. Auge K. B.,
    2. Blake-Haskins A. W.,
    3. Devine S.,
    4. Rizvi S.,
    5. Li Y. M.,
    6. Hesselberg M.,
    7. Orvisky E.,
    8. Affleck R. P.,
    9. Spitznagel T. M.,
    10. Perkins M. D.
    Demonstrating the stability of albinterferon alfa-2b in the presence of silicone oil. J. Pharm. Sci. 2011, 100 (12), 5100–5114.
    OpenUrlPubMed
  3. 3.↵
    1. Bernstein R. K.
    Clouding and deactivation of clear (regular) human insulin: association with silicone oil from disposable syringes? Diabetes Care 1987, 10 (6), 786–787.
    OpenUrlFREE Full Text
  4. 4.↵
    1. Chantelau E.,
    2. Berger M.,
    3. Bohlken B.
    Silicone oil released from disposable insulin syringes. Diabetes Care 1986, 9 (6), 672–673.
    OpenUrlFREE Full Text
  5. 5.↵
    1. Lubiniecki A.,
    2. Volkin D. B.,
    3. Federici M.,
    4. Bond M. D.,
    5. Nedved M. L.,
    6. Hendricks L.,
    7. Mehndiratta P.,
    8. Bruner M.,
    9. Burman S.,
    10. DalMonte P.,
    11. Kline J.,
    12. Ni A.,
    13. Panek M. E.,
    14. Pikounis B.,
    15. Powers G.,
    16. Vafa O.,
    17. Siegel R.
    Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals 2011, 39 (1), 9–22.
    OpenUrlPubMed
  6. 6.↵
    1. Majumdar S.,
    2. Ford B. M.,
    3. Mar K. D.,
    4. Sullivan V. J.,
    5. Ulrich R. G.,
    6. D'souza A. J. M.
    Evaluation of the effect of syringe surfaces on protein formulations. J. Pharm. Sci. 2011, 100 (7), 2563–2573.
    OpenUrlPubMed
  7. 7.↵
    Product Information, Healthcare, DOW CORNING® 360 Medical Fluid. Dow Corning Corp. Ref. No. 51-0374N-01, 2006, www.dowcorning.com.
  8. 8.↵
    1. Kennan J. J.,
    2. Breen L. L. M.,
    3. Lane T. H.,
    4. Taylor R. B.
    Methods for detecting silicones in biological matrixes. Anal. Chem. 1999, 71 (15), 3054–3060.
    OpenUrlPubMed
  9. 9.↵
    1. Varaprath S.,
    2. Stutts D. H.,
    3. Kozerski G. E.
    A primer on the analytical aspects of silicones at trace levels-challenges and artifacts—a review. Silicon Chemistry 2006, 3 (1–2), 79–102.
    OpenUrl
  10. 10.↵
    1. Mundry T.,
    2. Surmann P.,
    3. Schurreit T.
    Trace analysis of silicone oil in aqueous parenteral formulations and glass containers by graphite furnace atomic absorption spectrometry. Pharmazeutische Industrie 2001, 63 (3), 301–311.
    OpenUrl
  11. 11.↵
    How the Layer Explorer Works, rap.ID Particle Systems GmbH, Berlin, Germany. www.rap-ID.com. 2011, 2013.
  12. 12.↵
    1. Coleman P. B.
    Practical Sampling Techniques for Infrared Analysis; Coleman P. B., Ed.; CRC Press: Boca Raton, FL, 1993; pp 236–238.
  13. 13.↵
    1. Falk M.,
    2. Seto P.
    Determination of traces of silicones by FT-IR spectroscopy. Can. J. Spectrosc. 1988, 33 (1), 153–155.
    OpenUrl
  14. 14.↵
    1. Garton A.,
    2. Stolow A.,
    3. Wiles D. M.
    Infra-red spectroscopic characterization of surface coatings on glass fibres. J. Mater. Sci. 1981, 16 (11), 3211–3214.
    OpenUrl
  15. 15.↵
    1. Ludwig B. D.,
    2. Carpenter J. F.,
    3. Hamel J. B.,
    4. Randolph T. W.
    Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J. Pharm. Sci. 2010, 99 (4), 1721–1733.
    OpenUrlPubMedWeb of Science
  16. 16.↵
    1. Crampton S.,
    2. Ricci M.
    Development and Application of a Fourier Transform Infrared (FTIR) Spectroscopy Method to Quantify Silicone Oil Extracted from Syringes. The American Association of Pharmaceutical Scientists National BioTechnology Conference, San Francisco, CA, 2010.
  17. 17.↵
    ICH harmonized tripartite guideline validation of analytical procedures: text and methodology Q2 (R1); 2005.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 68 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
  • 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.
Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy
(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.
9 + 8 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy
Jared S. Bee, Vadim V. Frey, Urooj Javed, Jonathan Chung, Marta L. Corcoran, Paul S. Roussel, Stephan O. Krause, Patricia W. Cash, Steven M. Bishop, Mariana N. Dimitrova
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 494-503; DOI: 10.5731/pdajpst.2014.00991

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy
Jared S. Bee, Vadim V. Frey, Urooj Javed, Jonathan Chung, Marta L. Corcoran, Paul S. Roussel, Stephan O. Krause, Patricia W. Cash, Steven M. Bishop, Mariana N. Dimitrova
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 494-503; DOI: 10.5731/pdajpst.2014.00991
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Experimental
    • Results and Discussion
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
  • Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
  • Methods To Determine the Silicone Oil Layer Thickness in Sprayed-On Siliconized Syringes
  • Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
  • Google Scholar

More in this TOC Section

  • Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
  • Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
  • An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
Show more Technology/Application

Similar Articles

Keywords

  • Silicone oil
  • Prefilled syringe
  • Device
  • Infrared 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

© 2023 PDA Journal of Pharmaceutical Science and Technology ISSN: 1079-7440

Powered by HighWire