Skip to main content
  • Main menu
  • User menu
  • Search

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
OtherCommentary

Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit

Joanny Salvas, Petra Merker, Mike Dingle, Cedric Joossen, Chris Knutsen, David Govezensky, Jim Cannon, Philip Villari, Anthony M Cundell, Victoria Navarro, Margit Franz-Riethdorf and Allison Scott
PDA Journal of Pharmaceutical Science and Technology July 2023, pdajpst.2022.012790; DOI: https://doi.org/10.5731/pdajpst.2022.012790
Joanny Salvas
1 Pfizer, Kirkland, QC, Canada / BioPhorum;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: joanny.salvas@pfizer.com
Petra Merker
2 Bayer AG, Mullerstr. 178, D-13353 Berlin, Germany / BioPhorum;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: petra.merker@bayer.com
Mike Dingle
3 TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA / PEMM;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: michael.dingle@tsi.com
Cedric Joossen
4 Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium / OWBA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: cjoossen@its.jnj.com
Chris Knutsen
5 Bristol-Myers Squibb, New Brunswick, NJ, USA / BioPhorum;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: chris.knutsen@bms.com
David Govezensky
6 Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel / BioPhorum;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: david.govezensky@btgil.com
Jim Cannon
7 Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821 / PEMM;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: jim.cannon@mt.com
Philip Villari
8 Merck & Co., Inc., Kenilworth, NJ, USA / BioPhorum / PEMM;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: philip_villari@merck.com
Anthony M Cundell
9 Microbiological Consulting, LLC., Rye, NY 10580 USA / PEMM;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: tonycundell@gmail.com
Victoria Navarro
10 Pfizer, S. S. de los Reyes, Madrid, Spain / BioPhorum;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: victoria.navarrolahoz@pfizer.com
Margit Franz-Riethdorf
11 BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, UK;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: margit.franz-riethdorf@biophorum.com
Allison Scott
12 Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705 USA / PEMM
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: awilhelmscott@gmail.com
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

Abstract

Adopting emerging microbiological methods is often desirable because it enables more advantageous, real time monitoring practices. However, when the newer method measures contamination based on a different detection principle and provides results that are based on different units of measure, a paradigm shift is necessary. That shift can be one of the most difficult challenges in any such project and requires careful consideration. In this paper, we explore the challenges presented by the Bio-Fluorescent Particle Counting (BFPC) technology, when considering that the traditional Colony Forming Unit (CFU) is the gold standard which any change is measured against. We examine why attempts to correlate newer units of measure used by Bio-Fluorescent Particle Counters, namely the Auto-Fluorescent Units (AFUs), to the traditional CFUs are not necessarily appropriate. The paper explores in depth why there is no consistent correlation factor between the two units of measure, and why that should not be a barrier to fully leveraging, implementing, and using such modern technologies in routine monitoring.

  • Alternative and Rapid Microbial Methods
  • Auto-Fluorescent Units
  • Bio-fluorescent Particle Counters
  • Received August 3, 2022.
  • Accepted July 3, 2023.
  • Copyright © 2023, Parenteral Drug Association

PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.  

If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing. 

Full issue PDFs are for PDA members only.

Note to pda.org users

The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.

Log in using your username and password

Forgot your user name or password?

Log in through your institution

You may be able to gain access using your login credentials for your institution. Contact your library if you do not have a username and password.
If your organization uses OpenAthens, you can log in using your OpenAthens username and password. To check if your institution is supported, please see this list. Contact your library for more details.

Purchase access

You may purchase access to this article. This will require you to create an account if you don't already have one.

patientACCESS

patientACCESS - Patients desiring access to articles

Full issue PDFs are for PDA members only. You can join PDA at www.pda.org. 

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Download PDF
Article Alerts
Email Article
Citation Tools
Share
Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit
Joanny Salvas, Petra Merker, Mike Dingle, Cedric Joossen, Chris Knutsen, David Govezensky, Jim Cannon, Philip Villari, Anthony M Cundell, Victoria Navarro, Margit Franz-Riethdorf, Allison Scott
PDA Journal of Pharmaceutical Science and Technology Jul 2023, pdajpst.2022.012790; DOI: 10.5731/pdajpst.2022.012790
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A Commentary on "Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit"
  • Google Scholar

More in this TOC Section

  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
Show more Commentary

Similar Articles

Keywords

  • Alternative and Rapid Microbial Methods
  • Auto-Fluorescent Units
  • Bio-fluorescent Particle Counters

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
4 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit
Joanny Salvas, Petra Merker, Mike Dingle, Cedric Joossen, Chris Knutsen, David Govezensky, Jim Cannon, Philip Villari, Anthony M Cundell, Victoria Navarro, Margit Franz-Riethdorf, Allison Scott
PDA Journal of Pharmaceutical Science and Technology Jul 2023, pdajpst.2022.012790; DOI: 10.5731/pdajpst.2022.012790

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.