APR Sept/Oct 2023 - 115

VENDOR VIEWPOINT
efforts to modernize and to make Pharma 4.0 a reality. BioTrak® RealTime
Viable Particle Counter is ready to meet these demands in ways
that are not possible with historically used microbiological methods.
Improve Process Understanding - Continuous monitoring reveals
where and when microbial excursions occur. Time-resolved data
demonstrates continuous control during normal operation. In the
event an excursion does occur, immediate actions can be taken to
resolve the issues with immediate feedback on action effectiveness.
This allows for greatly improved, real-time, process control for
improved quality.
Reduce Risk by Eliminating Operator Interventions - People are
a primary source of viable contamination. Fully automating the air
sampling within the aseptic core removes the need for operator
interventions for microbial monitoring.
Reduce Loss of Product from Line Stoppages - Not only do line
stoppages require interventions that increase risk, they often result
in loss of product when the line is restarted. By eliminating the need
to change plates, BioTrak® Real-Time Viable Particle Counter allows
continuous operation during fill/finish operations.
Achieve High Level of Data Integrity - Data integrity is critical.
BioTrak Real-Time Viable Particle Counter seamlessly interfaces
with TSI Facility Monitoring Software (FMS). FMS is a fully compliant
continuous monitoring software package that trends data, triggers
alarms, and easily makes data available where and when it is needed.
Why Dual-Channel Laser Induced
Fluorescence (LIF) Technology
Microorganisms contain fluorescent molecules that produce unique
optical signatures. By measuring the size and fluorescent properties
of individual particles, TSI's BioTrak® Real-Time Viable Particle Counter
effectively distinguishes viable particles from non-viable particles.
Figure 2. Dual Channel - TSI's two channels
of fluorescence detection provides the better
measurement by clearly discriminating the
viable particles.
At the heart of the BioTrak® Real-Time Viable Particle Counter is LIF
technology. Simply stated, when microbial particles are exposed to ultraviolet
laser light, they absorb and re-emit light at higher wavelengths;
a process called fluorescence. Fluorescent cell metabolites associated
with viability, such as nucleotides, flavins, lipids, and amino acids, are
the primary markers targeted by the LIF technique.
Unlike products with just one channel of fluorescence detection,
TSI's BioTrak® Real-Time Viable Particle Counter has two channels
for better discrimination. In the example shown, it is impossible to
differentiate the pollen particles from the microorganisms using a
single florescence channel. But, when a second channel of detection is
added, the differentiation becomes clear. By collecting and processing
more optical data than other instruments, TSI® has produced the most
discriminating measurement on the market today.
Specificity
A viable particle count in the absence of a microorganism is
considered a false-positive. In critical environments, such as the
aseptic core, false-positives can adversely impact processes. With
dual-channel LIF and sophisticated discrimination algorithms,
the BioTrak® Real-Time Viable Particle Counter reliably delivers
essentially zero viable particle counts in rigorously hygienic spaces
such as Grade A / ISO 5. The graph shows actual data from realworld
manufacturing spaces. The BioTrak® Real-Time Viable Particle
Counter shows little or no signal in extremely clean environments
for as long as aseptic conditions are maintained.
Learn more at tsi.com/meet-the-biotrak
Figure 1. Single Channel - A single channel of
fluorescence makes it very difficult to discriminate
viable from non-viable particles.
115
American Pharmaceutical Review | September/October 2023
Sponsored by
http://www.tsi.com/meet-the-biotrak
APR Sept/Oct 2023

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