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Research ArticleResearch

Root Cause Investigation of Rubber Seal Cracking in Pre-filled Cartridges: Ozone and Packaging Effects

Edwin K. Chan, Aaron Hubbard, Chung C. Hsu, Lionel Vedrine and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology September 2011, 65 (5) 445-456; DOI: https://doi.org/10.5731/pdajpst.2011.00769
Edwin K. Chan
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Aaron Hubbard
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Chung C. Hsu
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Lionel Vedrine
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Yuh-Fun Maa
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  • For correspondence: maa.yuhfun@gene.com
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References

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    1. Sacha G. A.,
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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 January 16, 2011).
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    The aging of rubber vulcanizates. http://www.bouncing-balls.com/chemistry_tech_conservation/ageing.htm (accessed January 20, 2011).
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    1. Kuczkowski R. L.
    Formation and structure of ozonides. Acc. Chem. Res. 1983, 16 (2),42–47.
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    1. Riter J.,
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    The effects of ozone and various sterilization techniques on elastomeric rubber needle shields and tip caps. http://www.westpharma.com/eu/en/support/Scientific%20Posters/The%20Effects%20of%20Ozone%20Various%20Sterilization%20Techniques%20on%20Needle%20Shields%20Tip%20Caps.pdf (accessed January 20, 2011).
  6. 6.↵
    1. Braden M.,
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    The attack of ozone on stretched rubber vulcanizates. II. Conditions for cut growth. J. Appl. Poly. Sci. 1960, 3 (7),100–106.
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    A study of ozone attack on elastomer surfaces by attenuated total reflectance spectroscopy J. Appl. Poly. Sci.: Polymer Letters Edition 1974, 12 (5),281–286.
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    1. Lattimer R. P.,
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    Performance Properties of Plastics and Elastomers. In Handbook of Polymer Science and Technology; CRC Press: New York 1989; Vol. 2.
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    Measurement of concentration-dependent gas diffusion in membranes from a pseudo-steady state permeation run. J. Membr. Sci. 2007, 297 (1–2),199–205.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 65 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 5
September/October 2011
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Root Cause Investigation of Rubber Seal Cracking in Pre-filled Cartridges: Ozone and Packaging Effects
Edwin K. Chan, Aaron Hubbard, Chung C. Hsu, Lionel Vedrine, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 445-456; DOI: 10.5731/pdajpst.2011.00769

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Root Cause Investigation of Rubber Seal Cracking in Pre-filled Cartridges: Ozone and Packaging Effects
Edwin K. Chan, Aaron Hubbard, Chung C. Hsu, Lionel Vedrine, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 445-456; DOI: 10.5731/pdajpst.2011.00769
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