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

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 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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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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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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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations

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Keywords

Injectable Products
Primary packaging components
Process Improvement
Risk assessment
Visible particles

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Parenteral Drug Association, Inc.