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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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Article Information

vol. 77 no. 2 99-114
DOI 
https://doi.org/10.5731/pdajpst.2021.012710
PubMed 
36572486

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 10, 2023.

Article Versions

  • previous version (December 26, 2022 - 08:20).
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Copyright & Usage 
© PDA, Inc. 2023

Author Information

  1. Robin Wagner1,*,
  2. Peter Masatani1,*,
  3. Dana GRACE1,
  4. Gianpiero TORRACA1,
  5. Stephanie Moore1 and
  6. David Semin1
  1. 1Amgen Inc., Thousand Oaks, CA
  1. ↵*Co-first and Corresponding Authors: One Amgen Center Dr., Thousand Oaks, CA 91320; Telephone: 805-447-0058, 805-447-0689, E-mail: rowagner{at}amgen.com & pmastani{at}amgen.com
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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
  • Ready to use

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