BioTrak 9510-BD

BioTrak™ 9510-BD – Real-Time Viable Particle Counter

The BioTrak™ 9510-BD from TSI® is an advanced biofluorescent particle counter (BFPC) that delivers simultaneous real-time measurements of viable and non-viable airborne particles. Designed to meet Annex 1 and ISO 21501-4 requirements, BioTrak™ enables continuous, intervention-free microbial monitoring in aseptic manufacturing environments.

Key Features

Simultaneous detection of viable and total particle counts
Patented laser-induced fluorescence (LIF) viability detection
5 to 25 µm particle size range with up to six channels
0 CFM (28.3 L/min) sampling rate
Real-time feedback for contamination events and root cause analysis
Integrated gelatin filter for offline microbial identification
ISO 21501-4 and GMP compliant; 21 CFR Part 11 ready
Standalone or integrated use with TSI Facility Monitoring System (FMS)
10,000 sample record storage across 999 locations
VGA 5.7” touchscreen display and intuitive user interface

Applications

Continuous aseptic core monitoring (Grade A/B environments)
Regulatory compliance to EU GMP Annex 1 and ISO 14644-1
Root cause investigation and process validation
Gowning qualification and aseptic training feedback
Environmental monitoring in pharmaceutical and biotech facilities

Section 3

Advantages Over Traditional Methods

Unlike traditional growth-based methods, BioTrak™ delivers immediate feedback on viable particles using autofluorescence markers. Its dual-channel LIF technology offers superior discrimination between viable and non-viable particles, helping reduce false positives and improve process efficiency.

Ideal For

Pharmaceutical manufacturers embracing Annex 1 modernization, PAT (Process Analytical Technology), and continuous aseptic manufacturing. Ideal for minimizing interventions, reducing product loss, and enhancing contamination control strategies.

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