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BIOTRAK®
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Catalog excerpts

BIOTRAK® - 1

BioTrak® Real-Time Viable Particle Counter Model 9510-BD Confidence comes with a higher caliber of data BioTrak® Real-Time Viable Particle Counter offers bestin-class features and versatility in the exciting new field of real-time airborne viable particle detection— detecting total and viable particle counts in real time. It incorporates TSI® field-proven, patented laser induced fluorescence (LIF) technology to determine particle viability. The TSI® 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. Real-time viable particle detection enables: ▪ Immediate notification of contamination events allowing ▪ egregation of product potentially exposed S to contamination ▪ Initiation of root cause investigations ▪ Initiation of control measures ▪ Trending of biological particulate levels ▪ Information for process improvement (PAT) ▪ Information for process risk management (ICH Q9) ▪ Feedback for gowning and aseptic process training Features and Benefits ▪ Particulate size range: 0.5 to 25 µm ▪ p to six channels of simultaneous total and viable U particle data ▪ Patented laser induced fluorescence viability detection ▪ ntegrated particle collection filter for offline I 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 ▪ tand-alone operation or integrate into a facility S monitoring system ▪ Displays up to three en

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BIOTRAK® - 2

BioTrak® Real-Time Viable Particle Counter Model 9510-BD Particle Counting Size Range 0.5 to 25 μm Particle Channel Sizes 0.5, 0.7, 1.0, 3.0, 5.0, 10 μm Size Resolution <15% @ 0.5 μm (per ISO 21501-4) Total Particulate Counting Efficiency 50% at 0.5 μm; 100% for particles >0.75 μm, (per ISO 21501-4 and JIS) Viable Detection fluorescent channels and 1 sizing 2 channel for discrimination Sample Collection Integrated filter holder for 37-mm diameter filters Concentration Limit 820,000 particles/ft3 (29,000,000/m3) @ 10% coincidence loss Zero Count count per 5 minutes <1 (per ISO 21501-4 and...

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