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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;
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  • For correspondence: jaredsbee@gmail.com
Vadim V. Frey
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Urooj Javed
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Jonathan Chung
3Drug Delivery & Devices, MedImmune, Gaithersburg, MD; and
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Marta L. Corcoran
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Paul S. Roussel
3Drug Delivery & Devices, MedImmune, Gaithersburg, MD; and
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Stephan O. Krause
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Patricia W. Cash
2Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Steven M. Bishop
1Formulation Sciences, MedImmune, Gaithersburg, MD;
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Mariana N. Dimitrova
4Protein Pharmaceutical Development, Biogen Idec Inc., Boston, MA
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PDA Journal of Pharmaceutical Science and Technology: 68 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
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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
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Cited By...

  • Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions
  • Evaluation of a Novel Prefilled Syringe Concept for Ophthalmic Applications: A Formative Human Factors Study
  • Method Comparison Study--One Step Forward toward Robust Silicone Layer Thickness Measurements
  • 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
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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
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Keywords

  • Silicone oil
  • prefilled syringe
  • Device
  • Infrared spectroscopy

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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

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