Skip to main content

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
Research ArticleMeeting Proceedings

A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team

Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419
Allison Scott
1Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: a.scott.x4@biovigilant.azbil.com
Ren-Yo Forng
2Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320-1799;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mike Russ
3Genentech/Roche, 1 Antibody Way, Oceanside, CA 92056;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gilberto Dalmaso
4GDM Pharma Consulting, Via Ca’ Bianca, 2 Alpo di Villafranca di Verona, Italy;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Scott Hooper
5Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Philip Villari
6Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP78-210, West Point, PA 19486;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
James Cannon
7Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
James Francis
8Micron View Limited, 1568 W. Bluff Rd., Orange, TX 77632; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mike Dingle
9TSI, Inc., 500 Cardigan Road, Shoreview, MN 55126.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

Abstract

The Process and Environmental Monitoring Methods Working Group, composed of members from industry and instrument manufacturers, met with the FDA Emerging Technology Team to discuss bio-fluorescent particle counting technology, a type of rapid microbiological method. This is a summary of the meeting including submitted questions and answers, and the Process and Environmental Monitoring Methods Working Group’s understanding of the FDA Emerging Technology Team’s points made.

  • Bio-fluorescent particle counting (BFPC)
  • rapid microbiological method (RMM)
  • FDA Emerging Technology Team (ETT)
  • environmental monitoring
  • auto-fluorescence unit (AFU)
  • © PDA, Inc. 2021
View Full Text

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: 75 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 2
March/April 2021
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email 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.
A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
(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.
7 + 8 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis, Mike Dingle
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 207-212; DOI: 10.5731/pdajpst.2020.012419

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis, Mike Dingle
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 207-212; DOI: 10.5731/pdajpst.2020.012419
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • BFPC Background
    • Meeting Objectives
    • Submitted Questions and Responses
    • Conclusion
    • Conflict of Interest Declaration
    • References
  • 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"
  • Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
  • Google Scholar

Similar Articles

Keywords

  • Bio-fluorescent particle counting (BFPC)
  • Rapid microbiological method (RMM)
  • FDA Emerging Technology Team (ETT)
  • Environmental monitoring
  • Auto-Fluorescence Unit (AFU)

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