TSI BioTrak II 6510-BD Biofluorescent Particle Counter, 28.3 L/min

Description of TSI BioTrak II 6510-BD

TSI BioTrak II 6510-BD is a biofluorescent particle counter manufactured by TSI for continuous monitoring of viable particles and total particle counts in Grade A aseptic pharmaceutical manufacturing areas. The instrument provides real-time results and alerts users when monitored parameters exceed established limits, enabling prompt corrective action without interrupting the process to replace agar plates.

The instrument simultaneously monitors viable particles and total particle counts. Total particle counting is performed in two size channels: 0.5 and 5.0 µm. The sample flow rate is 28.3 L/min, maintained from the previous generation to meet Annex 1 requirements for particle and viable air contamination monitoring.

The system combines total particle counting, biofluorescent detection of viable particles, and particle collection for offline processing.

The BioTrak II has been redesigned to simplify integration into modern isolators. Compared with the BioTrak I, the BioTrak II has a reduced depth and can be installed vertically or horizontally. Horizontal installation raises the instrument above the floor, providing toe clearance for operators and facilitating cleaning. The filter holder is positioned farther from the floor, improving ergonomics and reducing the risk of contamination. The lower inlet position allows for a more optimized tubing configuration.

The BioTrak II features a more robust filter cartridge that is easier to disassemble and reassemble for cleaning and sterilization, while protecting the filter from contamination. The particle collection mechanism has also been improved for greater robustness.

The measurement components used for total particle counting and viable particle detection remain unchanged from the BioTrak I. TSI also highlights the instrument’s well-established calibration history, based on years of testing.

The BioTrak II has no built-in display. Results can be accessed through software solutions for remote or portable use. The displayed data include the total autofluorescent unit (AFU) count and particle counts for the 0.5 and 5.0 µm size channels.

Key Features

• Continuous, real-time monitoring of viable particles and total particle counts.
• Designed for air monitoring in Grade A aseptic pharmaceutical manufacturing areas.
• Sample flow rate of 28.3 L/min.
• Total particle counting size channels: 0.5 and 5.0 µm.
• Automated sampling without process interruptions for agar plate changes.
• Reduced depth compared with the BioTrak I, with vertical or horizontal installation options.
• More robust filter cartridge that is easier to disassemble and reassemble for cleaning and sterilization.
• Results displayed through software solutions or a portable device; no built-in display.
• Particle collection for subsequent offline analysis.
• Measurement components for total particle counting and viable particle detection unchanged from the BioTrak I.
• Established calibration history based on years of testing.

Applications

• Air monitoring in Grade A aseptic pharmaceutical manufacturing areas — continuous monitoring of viable particles and total particle counts.
• Integration into modern isolators — instrument design tailored to the installation and integration requirements of modern isolators.
• Continuous monitoring of aseptic processes — automated sampling without process interruptions for agar plate changes.
• Prompt detection of deviations — real-time monitoring results and alerts when measured parameters exceed established limits.
• Sample collection for subsequent analysis — collection of particles for further investigation outside the instrument.

Technical specifications of TSI BioTrak II 6510-BD