Detecting changes in levels of airborne microbiological contamination in real time in all areas of a life science manufacturing facility is now a reality. Instruments such as TSI’s BioTrak™ Real-Time Viable Particle Counter facilitate proactive Quality Assurance based approaches.
BioTrak™ belongs to a new category of Rapid Microbiological Methods using Laser Induced Fluorescence ( LIF). The BioTrak detector logs total and viable particle counts in six size categories, with selectable time resolution from one second to many hours. The BioTrak detector supports downloading data to a USB flash drive for transfer to user reporting, LIMS, or SPC software.
Real-time response means that product, potentially at risk of airborne microbiological contamination, can be immediately segregated. End users will now know the exact moment in time when an airborne viable particle excursion took place and gain a real-time understanding of the in-process microbiological quality of the air, in line with the principles of ICH Q8 Quality Risk Management (QRM), ICH Q9 Quality by Design (QbD) and Process Analytical Technology (PAT).
As a portable instrument, the BioTrak™ detector beeps every time an airborne viable particle is detected. End users can quickly 'sniff out' the exact location of a contamination source in minutes instead of days or weeks.
In addition to reducing risk and improving patient safety, BioTrak™ can reduce product release cycle time, cost, and labor via automation, high throughput, real-time data analysis, and time-sensitive outputs. BioTrak™ facilitates investigations by providing results quickly.
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