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OtherPDA Paper

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 September 2018, pdajpst.2018.009027; DOI: https://doi.org/10.5731/pdajpst.2018.009027
Jennifer Johns
1 Pfizer;
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  • For correspondence: jennifer.johns@pfizer.com
Paolo Golfetto
2 Stevenato Group;
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  • For correspondence: paolo.golfetto@stevanatogroup.com
Tia Bush
3 Amgen;
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  • For correspondence: tiay@amgen.com
Gianmaurizio Fantozzi
2 Stevenato Group;
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  • For correspondence: gianmaurizio.fantozzi@stevanatogroup.com
John Shabushnig
4 Insight Pharma Consulting, LLC;
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  • For correspondence: johnshabushnig@aol.com
Anthony Perry
5 Schott;
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  • For correspondence: anthony.perry@us.schott.com
Fran DeGrazio
6 West;
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  • For correspondence: fran.degrazio@westpharma.com
Dorothee Streich
7 Bayer;
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  • For correspondence: dorothee.streich@bayer.com
Jahanvi Miller
8 Parenteral Drug Association (PDA);
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  • For correspondence: miller@pda.org
Herve Soukiassian
9 Becton Dickinson;
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  • For correspondence: herve.soukiassian@bd.com
Amy Stanton
3 Amgen;
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  • For correspondence: amgonzal@amgen.com
Rick Watson
10 Merck
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  • For correspondence: richard_watson@merck.com
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Article Information

pdajpst.2018.009027
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 
  • Received June 18, 2018
  • Accepted July 18, 2018
  • Published online September 19, 2018.

Article Versions

  • You are currently viewing a previous version of this article (September 19, 2018 - 09:44).
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Copyright & Usage 
Copyright © 2018, Parenteral Drug Association

Author Information

  1. Jennifer Johns1 (jennifer.johns{at}pfizer.com),
  2. Paolo Golfetto2 (paolo.golfetto{at}stevanatogroup.com),
  3. Tia Bush3 (tiay{at}amgen.com),
  4. Gianmaurizio Fantozzi2 (gianmaurizio.fantozzi{at}stevanatogroup.com),
  5. John Shabushnig4,11 (johnshabushnig{at}aol.com),
  6. Anthony Perry5 (anthony.perry{at}us.schott.com),
  7. Fran DeGrazio6 (fran.degrazio{at}westpharma.com),
  8. Dorothee Streich7 (dorothee.streich{at}bayer.com),
  9. Jahanvi Miller8 (miller{at}pda.org),
  10. Herve Soukiassian9 (herve.soukiassian{at}bd.com),
  11. Amy Stanton3 (amgonzal{at}amgen.com) and
  12. Rick Watson10 (richard_watson{at}merck.com)
  1. 1 Pfizer;
  2. 2 Stevenato Group;
  3. 3 Amgen;
  4. 4 Insight Pharma Consulting, LLC;
  5. 5 Schott;
  6. 6 West;
  7. 7 Bayer;
  8. 8 Parenteral Drug Association (PDA);
  9. 9 Becton Dickinson;
  10. 10 Merck
  1. ↵* Corresponding author; email: johnshabushnig{at}aol.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
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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 Sep 2018, pdajpst.2018.009027; 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 Sep 2018, pdajpst.2018.009027; 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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