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Research ArticlePDA Papers

Achieving “Zero” Defects for Visible Particles in Injectables

Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton and Rick Watson
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 640-650; DOI: https://doi.org/10.5731/pdajpst.2018.009027
Jennifer Johns
1Pfizer, Inc, N. Peapack, NJ, USA;
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Paolo Golfetto
2Stevenato Group, Via Molinella, Padua, Italy;
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Tia Bush
3Amgen Inc., West Greenwich, RI, USA;
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Gianmaurizio Fantozzi
2Stevenato Group, Via Molinella, Padua, Italy;
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John Shabushnig
4Insight Pharma Consulting, LLC, Marshall, MI, USA;
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  • For correspondence: johnshabushnig@aol.com
Anthony Perry
5Schott North America, Inc., Lebanon, PA, USA;
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Fran Degrazio
6West Pharmaceutical Services, Inc., Exton, PA, USA;
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Dorothee Streich
7Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
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Jahanvi Miller
8Parenteral Drug Association, Bethesda, MD, USA;
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Herve Soukiassian
9Becton Dickinson, Le Pont-de-Claix, France;
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Amy Stanton
10Amgen Inc., Thousand Oaks, CA, USA;
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Rick Watson
11Merck & Co., West Point, PA, USA
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Article Information

vol. 72 no. 6 640-650
DOI 
https://doi.org/10.5731/pdajpst.2018.009027
PubMed 
30232141

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 4, 2018.

Article Versions

  • previous version (September 19, 2018 - 09:44).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Jennifer Johns1,
  2. Paolo Golfetto2,
  3. Tia Bush3,
  4. Gianmaurizio Fantozzi2,
  5. John Shabushnig4,*,
  6. Anthony Perry5,
  7. Fran Degrazio6,
  8. Dorothee Streich7,
  9. Jahanvi Miller8,
  10. Herve Soukiassian9,
  11. Amy Stanton10 and
  12. Rick Watson11
  1. 1Pfizer, Inc, N. Peapack, NJ, USA;
  2. 2Stevenato Group, Via Molinella, Padua, Italy;
  3. 3Amgen Inc., West Greenwich, RI, USA;
  4. 4Insight Pharma Consulting, LLC, Marshall, MI, USA;
  5. 5Schott North America, Inc., Lebanon, PA, USA;
  6. 6West Pharmaceutical Services, Inc., Exton, PA, USA;
  7. 7Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
  8. 8Parenteral Drug Association, Bethesda, MD, USA;
  9. 9Becton Dickinson, Le Pont-de-Claix, France;
  10. 10Amgen Inc., Thousand Oaks, CA, USA;
  11. 11Merck & Co., West Point, PA, USA
  1. ↵* Corresponding Author: e-mail: johnshabushnig{at}aol.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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Achieving “Zero” Defects for Visible Particles in Injectables
Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 640-650; DOI: 10.5731/pdajpst.2018.009027

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Achieving “Zero” Defects for Visible Particles in Injectables
Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 640-650; DOI: 10.5731/pdajpst.2018.009027
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Keywords

  • Injectable Products
  • Primary packaging components
  • Process Improvement
  • Risk assessment
  • Visible particles

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