Abstract
The use of bio-fluorescent particle counting technologies as a rapid, alternative method to monitor microbial contamination in water and clean room air samples has been of interest to the pharmaceutical industry for several years. These technologies are a non-growth-based method that use the detection of particle scatter and intrinsic fluorescence to categorize detected particles as biologic or non-biologic. As a result, the systems report in a unit of measure not equivalent to the colony-forming unit. Although guidance on the validation of alternative microbial methods is available, significant challenges can exist when validating non-growth-based alternative methods compared to the growth-based compendial method. Collaborators in the Modern Microbial Methods (M3) industry working group provide thoughts and recommendations on a method validation pathway for the non-growth-based bio-fluorescent particle counting technology. Technology-specific recommendations on the primary and secondary validation are provided with considerations on the applicability of individual validation parameters and associated acceptance criteria for this emerging technology that does not rely on the colony-forming unit.
- Alternative rapid microbial method (ARMM)
- Bio-fluorescent particle counting (BFPC)
- Microbiology
- USP <1223>
- Validation
- © PDA, Inc. 2025
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
Log in through your institution
Purchase access
patientACCESS
In This Issue
Jump to section
Related Articles
Cited By...
- No citing articles found.