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Research ArticleResearch

Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions

Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori and Kazuhiro Sako
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 434-444; DOI: https://doi.org/10.5731/pdajpst.2012.00882
Hirotaka Sudo
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
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Michael O'driscoll
3Astellas Ireland Co. Ltd.; and
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Kenji Nishiwaki
1Astellas Pharma Inc.;
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Yuji Kawamoto
1Astellas Pharma Inc.;
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Philip Gammell
3Astellas Ireland Co. Ltd.; and
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Gerhard Schramm
4Wilco AG
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Toni Wertli
4Wilco AG
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Heino Prinz
4Wilco AG
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Atsuhide Mori
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
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Kazuhiro Sako
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
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References

  1. 1.↵
    FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, 2004.
  2. 2.↵
    EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products, 2008.
  3. 3.↵
    Japan Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, 2011.
  4. 4.↵
    1. Möll F.,
    2. Doyle D. L.,
    3. Haerer M.,
    4. Guazzo D. M.
    Validation of a high-voltage leak detector for use with pharmaceutical blow-fill-seal containers—a practical approach. PDA J. Pharm. Sci. Technol. 1998, 52 (5), 215–227.
    OpenUrlPubMed
  5. 5.↵
    1. Wolf H.,
    2. Stauffer T.,
    3. Chen SC,
    4. Lee Y.,
    5. Forster R.,
    6. Ludzinski M.,
    7. Kamat M.,
    8. Godorov P.,
    9. Guazzo D. M.
    Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 Precision and Bias Studies. PDA J. Pharm. Sci. Technol. 2009, 63 (3), 472–488.
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    1. Wolf H.,
    2. Stauffer T.,
    3. Chen S. C.,
    4. Lee Y.,
    5. Forster R.,
    6. Ludzinski M.,
    7. Kamat M.,
    8. Mulhall B.,
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    Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests. PDA J. Pharm. Sci. Technol. 2009, 63 (5), 489–498.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Kirsch L. E.,
    2. Nguyen L.,
    3. Kirsch A. M.,
    4. Schmitt G.,
    5. Koch M.,
    6. Wertli T.,
    7. Lehmann M.,
    8. Schramm G.
    Pharmaceutical container/closure integrity V: an evaluation of the WILCO “LFC” method for leak testing pharmaceutical glass-stoppered vials. PDA J. Pharm. Sci. Technol. 1999, 53 (5), 235–239.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori, Kazuhiro Sako
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 434-444; DOI: 10.5731/pdajpst.2012.00882

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Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori, Kazuhiro Sako
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 434-444; DOI: 10.5731/pdajpst.2012.00882
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Cited By...

  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • The Application of Noninvasive Headspace Analysis to Media Fill Inspection
  • Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
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Keywords

  • Container/closure integrity
  • Integrity tester
  • Leak tester
  • Head space analysis

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