APR Sept/Oct 2023 - 114

VENDOR VIEWPOINT
Continuous & Intervention-Free
Microbial Monitoring
Innovation for a Changing Industry
Aseptic manufacturing is changing. Regulations like the EU GMP Annex
1 encourage modernization. Technologies such as gloveless isolators
and single-use systems that automate processes and limit human
interventions are becoming the norm. Regulators and manufacturers
alike recognize that highly-automating manufacturing leads to
improved quality, safety, and efficiency.
This new paradigm demands
in-depth process understanding,
fewer interruptions, and
no operator intervention.
After decades of reliable
service, traditional microbial
monitoring techniques
(i.e. growth-based detection
methods) are not capable of
meeting these demands.
Annex 1 ready, the BioTrak®
Real-Time Viable Particle
Counter (a biofluorescent
particle counter) provides real-time
viable and total particle
monitoring of critical environments, including the aseptic core,
without the need for operator intervention. The BioTrak® Real-Time
Viable Particle Counter complements manufacturing innovations to
maximize process understanding and efficiency without introducing
any risk to product
A Complete Solution for
Environmental Air Monitoring
BioTrak® Real-Time
2. Biofluorescent Particle Counter (BFPC) - Viable particles, also
referred to as autofluorescence units (AFU), are detected using
laser induced fluorescence (LIF). LIF works by detecting the
fluoresce of metabolites in viable microorganisms that are excited
as they pass through a laser beam. This requires no growth or
reagents and makes viable results available in real-time.
3. Particle Filter - A highly efficient gelatin filter can be installed to
capture the particles that pass through the BFPC. The filter can
be transferred to growth media for an opportunity to identify
culturable contaminants that were present in the sample
Key Applications
Continuous Process Monitoring
BioTrak® Real-Time Viable Particle Counter is the ideal instrument for
continuous microbial monitoring in the aseptic manufacturing core.
Real-time, interruption-free monitoring unlocks process efficiencies
and improves quality. Seamless integration with TSI Facility Monitoring
System enables complete environmental monitoring automation.
Non-Compliance Based Applications
These applications, such as root- cause investigation, room release,
and gowning training/verification, offer immediate benefit for any
manufacturing facility. BioTrak® Real Time Viable Particle Counter has
features and accessories designed for easy operation and data analysis
Viable Particle Counter provides complete
environmental monitoring of air in cleanroom spaces. Monitoring
for both total and viable particles can be performed with this one
instrument using a single isokinetic probe located within the test area.
1. Total Particle Counter - A 1 CFM (28.3 LPM) total particle counter
provides the same trusted measurements users expect from all
TSI particle counting instruments. Fully compliant to ISO 21501-4,
it is suitable for use in all GMP applications.
114
American Pharmaceutical Review | September/October 2023
Validation
TSI® has a dedicated team of professionals with knowledge and
experience to help you confidently implement the BioTrak Particle
Counter in a compliant manner.
TSI® has submitted a Type V Drug Master File with the FDA. It includes
rigorous performance qualification studies. A summary is available
upon request or via the website.
Unmatched Benefits
Regulations such as Annex 1 recognize that manufacturers need to
move past traditional growth-based monitoring methods to better
assure product quality. These methods are also incompatible with
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
