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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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Article Information

vol. 74 no. 5 524-562
DOI 
https://doi.org/10.5731/pdajpst.2019.011387
PubMed 
32467178

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 5, 2020.

Article Versions

  • previous version (May 28, 2020 - 09:03).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Brian Thome1,
  2. Brian Joseph2,
  3. Dawood Dassu3,
  4. Jeff Gaerke4,
  5. Leesa McBurnie5,
  6. Mandar Dixit6,
  7. Magnus Stering6,
  8. Sean Tomlinson7,
  9. Scott Mills7,
  10. Stephanie Ferrante8 and
  11. Carl Weitzmann9,*
  1. 1Biogen International GmbH, Neuhofstrasse 30, 6340 Baar, Switzerland;
  2. 2Pall Corporation World Headquarters, 25 Harbor Park Drive, Port Washington, NY 11050;
  3. 3BioPhorum Operations Group, The Gridiron Building, One Pancras Square, London N1C AG, United Kingdom;
  4. 4CAI, One Park Fletcher, 2601 Fortune Circle East, Suite 301B, Indianapolis, IN 46241;
  5. 5Meissner Filtration Products, 1001 Flynn Road, Camarillo, CA 93012;
  6. 6Sartorius Stedim North America Inc., 545 Johnson Ave., Bohemia, NY 11716;
  7. 7Pfizer Inc., 1776 Centennial Dr, McPherson, KS 67460;
  8. 8MilliporeSigma Life Science Center, 400 Summit Drive, Burlington, MA 01803; and
  9. 9Sanofi Pasteur, 1 Discovery Dr., Swiftwater, PA 18370.
  1. ↵*Corresponding Author: Sanofi Pasteur, 1 Discovery Dr., Swiftwater, PA 18370. E-mail: carl.weitzmann{at}sanofi.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
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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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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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