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Research ArticleResearch

Syringe Siliconization Process Investigation and Optimization

Edwin Chan, Aaron Hubbard, Samir Sane and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology March 2012, 66 (2) 136-150; DOI: https://doi.org/10.5731/pdajpst.2012.00856
Edwin Chan
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Aaron Hubbard
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Samir Sane
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Yuh-Fun Maa
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  • For correspondence: maay@gene.com
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References

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    1. Romacker M.,
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    The Rise of Prefilled Syringes from Niche Product to Primary Container of Choice: A Short History. Presented in a PDA Conference on The Universe of Pre-filled Syringes and Injection Devices, 2008, www.pda.org/prefilled2008 (accessed May 24, 2011).
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    Technical considerations in the development of prefilled syringes for protein products. Am. Pharm. Rev. 2006, 9 (6), 77–83.
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    Development of biotechnology products in pre-filled syringes: technical considerations and approaches. AAPS PharmSciTech 2011, online publication, DOI: 10.1208/s12249-011-9617-y.
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    1. Sardella A.
    Fine tuning of process parameters for improving biocompatibility of prefilled syringes. ONdrugDELIVERY (www.ondrugdelivery.com) 2010, “Prefilled Syringes: New Idea for the New Decade” issue, 18–22.
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    1. Yin F.,
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    3. Marquardt D.,
    4. Lux B.,
    5. McGarvey B.,
    6. Roe M.,
    7. Van Scoik K.
    Glass Siliconization: Development and Characterization. Presented in a PDA Conference on The Universe of Pre-filled Syringes and Injection Devices, Las Vegas, NV, October 18–21, 2010, http://www.pda.org/Presentation/The-Universe-of-Pre-filled-Syringes-and-Injection-Devices—Missing-Presentations/Fangdong-Yin.aspx (accessed May 24, 2011).
  7. 7.↵
    1. Jones L. S.,
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    Silicone oil induced aggregation of proteins. J. Pharm. Sci. 2005, 94 (4), 918–927.
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    1. Thirumangalathu R.,
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    Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J. Pharm. Sci. 2009, 98 (9), 3167–3181.
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    1. Ludwig D. B.,
    2. Carpenter J. F.,
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    4. Randolph T. W.
    Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J. Pharm. Sci. 2010, 99 (4), 1721–1733.
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    1. Narhi L. O.,
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    1. Eakins M. N.
    Trends in the availability, siliconization, filling, inspection and labelling of pre-filled syringes. Am. Pharm Rev. 2009, 12 (3), 45–50.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 66 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 2
March/April 2012
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Syringe Siliconization Process Investigation and Optimization
Edwin Chan, Aaron Hubbard, Samir Sane, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 136-150; DOI: 10.5731/pdajpst.2012.00856

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Syringe Siliconization Process Investigation and Optimization
Edwin Chan, Aaron Hubbard, Samir Sane, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 136-150; DOI: 10.5731/pdajpst.2012.00856
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    • Abstract
    • Introduction
    • Materials and Methods
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Cited By...

  • Prefilled Syringe Injection Force Impact Assessment from Back Pressure: An Approach for Testing Syringe Injectability In Situ vs. In Vitro
  • Replacing the Emulsion for Bake-on Siliconization of Containers--Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations
  • Method Comparison Study--One Step Forward toward Robust Silicone Layer Thickness Measurements
  • Methods To Determine the Silicone Oil Layer Thickness in Sprayed-On Siliconized Syringes
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