Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit
A Special Webinar Event Presented by Modern Microbial Methods
Program Overview
- Introduction to Bio-fluorescent particle counting technology (BFPC).
- Comparison between traditional CFUs and AFUs.
- Limitations associated with CFUs and why equivalency cannot be expected.
- Discussion on the consequences associated with this transition on validation of the method and/or setting new limits.
Bio-fluorescent particle counting technology (BFPC), an alternative microbiological monitoring method, uses the detection of intrinsic fluorescence of microbial cells to enumerate bioburden levels in air or water samples, continuously and in “real-time”. Embracing the significant advantages of this technology requires shattering some deep-rooted paradigms in pharmaceutical microbiology, given the long history of use of traditional methods that generate results as CFUs (Colony-forming units). The basis for this is understanding the “non-equivalency” of the BFPC output signal produced, commonly referred to as an auto-fluorescent unit (AFU), which is not dependent upon growth, unlike the CFU.
This expert panel hosted by METTLER TOLEDO on behalf of M3 offers a deep dive into the differences between the AFU and the CFU, discusses the limitations associated with the CFU, and why equivalency between the AFU and the CFU cannot be expected. The perspective of the Modern Microbial Methods Collaboration (M3) will be given on the consequences associated with this transition on validation of the method and/or setting new limits. This understanding will serve as a foundation to navigate challenges encountered when implementing this modern technology.
Speakers and Moderators
Mike Dingle (Speaker)
TSI
Mike Dingle is a Senior Product Specialist at TSI where he provides application support for the BioTrak Real-Time Viable Particle Counter and other TSI products used to test and monitor controlled environments. Prior to joining TSI, Mike worked as a QC Microbiologist in the pharmaceutical and medical device industries for over 20 years where he developed and managed environmental monitoring programs for a wide variety of controlled environments.
Joanny Salvas (Speaker)
Pfizer
Joanny Salvas is a senior manager at Pfizer, in the Global Technology and Engineering, Manufacturing Intelligence group. She has been developing and implementing Process Analytical Technologies and Rapid Micro Methods for more than 10 years and is certified 6sigma Black Belt, Project Management Professional (PMP) and Innovation Coach with a background in engineering, process control, and multivariate data analysis. She leads the Pfizer Rapid Micro Method steering team responsible for establishing the strategy, the evaluation and implementation as well as the development of future microbiology analytics.
Petra Merker (Speaker)
Bayer
Petra Merker is the Biological Quality Control Expert at Bayer. Petra is holding a PhD with emphasis on Molecular Biology and Microbiology and is working as a "Biological Quality Control and Aseptic Production Expert" at Bayer in Berlin. She is supporting aseptic production processes as well as new technologies and filling lines. She has been a group leader of several QC laboratories within Biological QC at Bayer, like Sterility testing, Monitoring, and the Identification of germs. Petra is a member of different industry working groups, who aim to support the implementation of Rapid Microbiological Methods, esp. Alternative Monitoring Methods such as Biofluorescent Particle Counting (BFPCs).
Allison Scott (Moderator)
Particle Measuring Systems
Allison Scott is a staff scientist at Particle Measuring Systems. She has evaluated modern microbial methods including bio-fluorescent particle counters for over thirteen years, focusing on diverse technology applications in air and water monitoring and supporting end user implementation. Allison facilitates the Steering Committee and one of the sub-teams for the Modern Microbial Methods collaboration.
Jim Cannon (Moderator)
Mettler Toledo
Jim Cannon is Head of OEM and Markets at Mettler-Toledo Thornton. After receiving a B.S. in Biology, he continued with graduate degrees in Microbiology and Biophysics, and an MBA in Marketing and International Management. Mr. Cannon has over 35 years of experience managing, designing, and developing ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialization of electrodeionization modules. He has been involved in the development and commercialization of alternative online microbial detection technology.
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