18th May 2020 Content supplied by: PMT (GB) Limited
Confidence Comes With a Higher Caliber of Data - BIOTRAK® Real-Time Viable Particle Counter
The Biotrak real time microbial particle counter enables you to eliminate human interaction for microbial plate changes, allows you to reduce time for product release, stop production immediately for any ‘out of tolerance’ events. Enables continuous manufacturing without stoppages to change plates and allows data collection for superior analysis of monitoring trends.
The BIOTRAK® Real-Time Viable Particle Counter offers best-in-class features and versatility in the field of real time airborne viable particle detection. The BIOTRAK particle counter detects total and viable particle counts in real time and incorporates TSI’s field proven, patented Laser Induced Fluorescence (LIF) technology to determine particle viability. TSI's BIOTRAK Real-Time Viable Particle Counter combines viable particle detection, total particulate detection, and integrated particle collection functionality into a single portable instrument.
FEATURE AND BENEFITS
- 0.5 to 25 μm size range
- 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
- Full optical particle counter functionality
- Complies with all requirements of ISO 21501-4
- 1 CFM (28.3 L/min) sample flow rate
- 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
- Displays up to three environmental parameters
- Stand-alone operation or integrate into a facility monitoring system
- Cleanroom Certification
- Continuous Microbial Monitoring
- Online monitoring
- Trending of Biological Particulate levels
- Process Improvement
- Operator Training
- Qualification Tool
- Risk Management
- Root cause investigations
Implementation of the BioTrak Real-Time Viable Particle Counter in fill-finish spaces eliminates the need for process interruptions for environmental microbial monitoring. In many cases, payback time can be less than one year even when considering maximal costs of implementation.
For production of parenteral pharmaceuticals, real-time LIF counting of airborne microorganisms can provide additional information leading to multiple benefits over conventional monitoring methods. Viable airborne microorganisms can be discriminated and counted in real time by LIF technology and Continuous viable and total particle monitoring shows contamination events that are not captured by intermittent monitoring by active air samplers.
Date Published: 18th May 2020