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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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References

  1. Parenteral Drug Association. PDA Survey: 2014 Visual Inspection. PDA: Bethesda, Md., 2015.
  2. Parenteral Drug Association. PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals. PDA: Bethesda, Md., 2016.
    1. Langille S. E.
    Particulate Matter in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2013, 67 (3), 186–200.
    OpenUrlPubMed
    1. Davis K.,
    2. et al
    . Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Process Equipment; Bio-Process Systems Alliance (BPSA): Washington, DC, 2014.
  3. ECA Visual Inspection Group. Good Practice Paper: Visual Inspection of Medicinal Products for Parenteral Use; ECA Foundation: Heidelberg, 2014.
    1. Borchert S.,
    2. et al
    . Particulate Matter in Parenteral Products: A Review. PDA J. Pharm. Sci. Technol. 1986, 40 (5), 212–237.
    1. Kim J.,
    2. Schildt D.,
    3. et al
    . Investigation of Foreign-Particle Contamination: Practical Application of FT-IR, Raman, and SEM-EDS Technologies. BioProcess International 2016, 14 (8).
    1. Mathonet S.,
    2. et al
    . A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2016, 70 (4), 392–408.
    1. Shabushnig J.,
    2. et al
    . A Proposed Working Standard for Validation of Particulate Inspection in Sterile Solutions. Presented at PDA Annual Meeting, Philadelphia, Pa., 1995.
    1. Aldrich S.,
    2. Cherris R.,
    3. Shabushnig J.
    Visual Inspection and Particulate Control. DHI Publishing: Scottsdale, Ar., 2016. www.pda.org/bookstore.
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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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