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Research ArticleTechnology/Application

Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components

Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710
Robin Wagner
1Amgen Inc., Thousand Oaks, CA
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  • For correspondence: rowagner@amgen.com pmastani@amgen.com
Peter Masatani
1Amgen Inc., Thousand Oaks, CA
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  • For correspondence: rowagner@amgen.com pmastani@amgen.com
Dana GRACE
1Amgen Inc., Thousand Oaks, CA
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Gianpiero TORRACA
1Amgen Inc., Thousand Oaks, CA
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Stephanie Moore
1Amgen Inc., Thousand Oaks, CA
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David Semin
1Amgen Inc., Thousand Oaks, CA
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References

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    Parenteral Drug Association Inc. PDA Technical Report No. 85: Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers; Bethesda, MD, 2021.
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    Brandessence Market Research. Global Safety & Prefilled Syringe Market Size By Product Type (Retractable Safety Syringe, Non-Retractable Safety Syringe) By Application (Insulin, Others) By End User (Hospitals, Others) Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2021 – 2027. https://brandessenceresearch.com/medical-device/safety-prefilled-syringes-market (accessed August 2, 2021).
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PDA Journal of Pharmaceutical Science and Technology: 77 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 2
March/April 2023
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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore, David Semin
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 99-114; DOI: 10.5731/pdajpst.2021.012710

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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore, David Semin
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 99-114; DOI: 10.5731/pdajpst.2021.012710
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Keywords

  • Particulate matter
  • Particle load rinse method
  • Reference particles
  • Incoming quality
  • Syringes
  • Cartridges
  • Closures
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