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OtherCase Studies

Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations

Aditya Prasad, Philip Villari, Robert 'Bo' Henry, Jeffrey Weber, James Hauschild, Lisa Yan, Jeff Horsch, Shebeer Shereefa, Jan Eric Rau, Annett Milling, Jay S Bolden, Lucile Plourde, Marja Claassen, Pieta IJzerman-Boon, Ren-Yo Forng, Roland Portmann, Simon Urwyler and Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology December 2019, pdajpst.2019.009969; DOI: https://doi.org/10.5731/pdajpst.2019.009969
Aditya Prasad
1 AstraZeneca;
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Philip Villari
2 Merck Inc.;
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Robert 'Bo' Henry
3 Catalent Biologics;
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Jeffrey Weber
4 Pfizer;
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James Hauschild
5 Johnson & Johnson;
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Lisa Yan
6 Takeda;
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Jeff Horsch
7 Bristol Myers Squibb;
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Shebeer Shereefa
8 Abbvie;
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Jan Eric Rau
9 Lonza;
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Annett Milling
10 CSL Behring;
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Jay S Bolden
11 Eli Lilly;
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Lucile Plourde
12 Sanofi Pasteur;
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Marja Claassen
13 Merck, Sharp & Dohme;
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Pieta IJzerman-Boon
13 Merck, Sharp & Dohme;
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Ren-Yo Forng
14 Amgen;
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Roland Portmann
10 CSL Behring;
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Simon Urwyler
10 CSL Behring;
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Dawood Dassu
15 BioPhorum
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  • For correspondence: dawood@biophorum.com
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Abstract

Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or CAPAs. This paper outlines how bio-fluorescent particle counting (BFPC) can be used in investigations to eliminate the inherent delays of culture-based methods. The application for investigations supplements routine EM; acting as a risk reduction tool enabling real-time detection of viable microorganisms in air samples − supporting root cause analysis and remedial actions. The paper includes guidance on how to use the technology, a real case study involving a mold excursion, and examples of business benefits achieved by various companies.

  • Environmental monitoring
  • Investigations
  • bio-fluorescent particle counting
  • Received January 23, 2019.
  • Accepted October 30, 2019.
  • Copyright © 2019, Parenteral Drug Association

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations
Aditya Prasad, Philip Villari, Robert 'Bo' Henry, Jeffrey Weber, James Hauschild, Lisa Yan, Jeff Horsch, Shebeer Shereefa, Jan Eric Rau, Annett Milling, Jay S Bolden, Lucile Plourde, Marja Claassen, Pieta IJzerman-Boon, Ren-Yo Forng, Roland Portmann, Simon Urwyler, Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology Dec 2019, pdajpst.2019.009969; DOI: 10.5731/pdajpst.2019.009969

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Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations
Aditya Prasad, Philip Villari, Robert 'Bo' Henry, Jeffrey Weber, James Hauschild, Lisa Yan, Jeff Horsch, Shebeer Shereefa, Jan Eric Rau, Annett Milling, Jay S Bolden, Lucile Plourde, Marja Claassen, Pieta IJzerman-Boon, Ren-Yo Forng, Roland Portmann, Simon Urwyler, Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology Dec 2019, pdajpst.2019.009969; DOI: 10.5731/pdajpst.2019.009969
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  • A Commentary on "Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit"
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  • bio-fluorescent particle counting

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