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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values

Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387
Brian Thome
1Biogen International GmbH, Neuhofstrasse 30, 6340 Baar, Switzerland;
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Brian Joseph
2Pall Corporation World Headquarters, 25 Harbor Park Drive, Port Washington, NY 11050;
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Dawood Dassu
3BioPhorum Operations Group, The Gridiron Building, One Pancras Square, London N1C AG, United Kingdom;
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Jeff Gaerke
4CAI, One Park Fletcher, 2601 Fortune Circle East, Suite 301B, Indianapolis, IN 46241;
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Leesa McBurnie
5Meissner Filtration Products, 1001 Flynn Road, Camarillo, CA 93012;
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Mandar Dixit
6Sartorius Stedim North America Inc., 545 Johnson Ave., Bohemia, NY 11716;
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Magnus Stering
6Sartorius Stedim North America Inc., 545 Johnson Ave., Bohemia, NY 11716;
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Sean Tomlinson
7Pfizer Inc., 1776 Centennial Dr, McPherson, KS 67460;
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Scott Mills
7Pfizer Inc., 1776 Centennial Dr, McPherson, KS 67460;
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Stephanie Ferrante
8MilliporeSigma Life Science Center, 400 Summit Drive, Burlington, MA 01803; and
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Carl Weitzmann
9Sanofi Pasteur, 1 Discovery Dr., Swiftwater, PA 18370.
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  • For correspondence: carl.weitzmann@sanofi.com
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References

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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante, Carl Weitzmann
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 524-562; DOI: 10.5731/pdajpst.2019.011387
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Keywords

  • Annex 1
  • Bacterial challenge test
  • Bubble Point
  • Filtration risk management
  • PUPSIT
  • Sterile drug products
  • Sterilizing-grade filters

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Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante, Carl Weitzmann
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 524-562; DOI: 10.5731/pdajpst.2019.011387

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