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contamination control method

BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER 9510-BD

The BioTrak particle counter detects total and viable particle counts in real time. It enables immediate notification of contamination events, Trending of biological particulate levels, Information for process improvement (PAT), Information for process risk management (ICH Q9), Feedback for gowning and aseptic process training.

TSI’s BioTrak Real-Time Viable Particle Counter combines real-time viable particle detection, total particulate detection, and integrated particle collection functionality into a single portable instrument.

Features and Benefits  

•    Particulate size range: 0.5 to 25 μm  
•    Up to six channels of simultaneous total and viable particle data 
•    Patented Laser Induced Fluorescence viability detection  
•    Integrated particle collection filter for off line speciation analysis  
•    Complies with all requirements of ISO 21501-4  
•    1.0 CFM (28.3 L/min) sample flow rate  
•    Full optical particle counter functionality 

    Intuitive icon driven touch screen Graphical User Interface 
    Recipe based storage and recall of sampling protocols 
    Reports for ISO-14644-1, EU GMP Annex 1, and FS209E 
    10,000 sample record storage, 999 locations 
    Ethernet and USB outputs 
    Stand-alone operation or integrate into a facility monitoring system 
    Displays up to three environmental parameters 
    Stainless steel enclosure

Applications

•    Cleanroom Certification
•    Online monitoring
•    Trending of Biological Particulate levels
•    Process Improvement
•    Operator Training
•    Qualification Tool
•    Risk Management
•    Root cause investigations

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