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Case ReportCase Study

Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations

Aditya Prasad, Philip Villari, Robert “Bo” Henry, Jeffrey Weber, James Hauschild, Lisa Yan, Jeff Horsch, Shebeer Shereefa, Jan Erik 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 May 2020, 74 (3) 318-323; DOI: https://doi.org/10.5731/pdajpst.2019.009969
Aditya Prasad
1AstraZeneca, Philadelphia, PA, USA;
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Philip Villari
10Merck, West Point, PA, USA;
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Robert “Bo” Henry
12Catalent Biologics, Bloomington, IN, USA;
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Jeffrey Weber
6Pfizer, Kalamazoo, MI, USA;
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James Hauschild
3Johnson & Johnson, East Raritan, NJ, USA;
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Lisa Yan
7Shire, Los Angeles, CA, USA;
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Jeff Horsch
5Bristol-Myers Squibb, New Brunswick, NJ, USA;
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Shebeer Shereefa
14Abbvie, North Chicago, IL, USA;
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Jan Erik Rau
16Lonza Group Ltd, Basel, Switzerland; and
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Annett Milling
2CSL Behring, Bradley, IL, USA;
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Jay S. Bolden
17Eli Lilly and Company, Indianapolis, IN, USA
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Lucile Plourde
8Sanofi Pasteur, Marcy-l’Étoile, France;
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Marja Claassen
9Merck, Sharp & Dohme, Oss, The Netherlands;
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Pieta IJzerman-Boon
9Merck, Sharp & Dohme, Oss, The Netherlands;
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Ren-Yo Forng
11Amgen, Thousand Oaks, CA, USA;
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Roland Portmann
13CSL Behring, Bern, Switzerland;
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Simon Urwyler
13CSL Behring, Bern, Switzerland;
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Dawood Dassu
15BioPhorum, Sheffield, UK;
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Abstract

Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or corrective and preventative actions. This article outlines how biofluorescent 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 and supporting root cause analysis and remedial actions. The article 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.

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PDA Journal of Pharmaceutical Science and Technology: 74 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 3
May/June 2020
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Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations
Aditya Prasad, Philip Villari, Robert “Bo” Henry, Jeffrey Weber, James Hauschild, Lisa Yan, Jeff Horsch, Shebeer Shereefa, Jan Erik 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 May 2020, 74 (3) 318-323; DOI: 10.5731/pdajpst.2019.009969

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Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations
Aditya Prasad, Philip Villari, Robert “Bo” Henry, Jeffrey Weber, James Hauschild, Lisa Yan, Jeff Horsch, Shebeer Shereefa, Jan Erik 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 May 2020, 74 (3) 318-323; DOI: 10.5731/pdajpst.2019.009969
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  • Article
    • Abstract
    • Introduction to Biofluorescent Particle Counting
    • Opportunities for the Use of BFPC for Investigations
    • Proposed Method for Investigations Using BFPC
    • Case Study: Identification of a Contamination Source
    • Business Benefits of Using BFPC for Investigations
    • Other Applications of BFPC
    • Conclusions
    • References
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Cited By...

  • A Commentary on "Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit"
  • Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
  • A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
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