global

BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER

The BioTrak® Real-Time Viable Particle Counter is one of the most advanced Alternative & Rapid Microbial Method (ARMM) real-time continuous microbial monitoring systems for aseptic manufacturing. It is a game-changer in pharmaceutical manufacturing environments that is immediately compliant with key directives in the new EU GMP Annex 1 revision. At the centre of a Contamination Control Strategy, the BioTrak provides real-time counts of total and viable particles to reduce aseptic interventions, improve root-cause investigations, and increase process knowledge.

See our white papersindustry features, and application notes.

Read more
Request Quote

Features and Benefits

  • Continuous particle counting
  • Detection of airborne viable particles in real-time
    • Fully automated process – no media or manual processing
  • Simultaneous detection of both total and viable particles
    • Complies with all requirements of ISO 21501-4
    • 1 CFM (28.3 L/min) sample flow rate
    • Only requires a single isokinetic probe at the sample site
  • Instant real-time alerts
  • In-line particle collection filter
  • Can be used as a standalone instrument
  • Can be fully integrated with FMS 5 for automated continuous environmental monitoring
  • Intuitive icon-driven touch screen Graphical User Interface
  • Stainless steel enclosure and HEPA filtered exhaust

Applications

  • Continuous automated monitoring of aseptic environments
  • Continuous automated monitoring in support environments
  • Continuous particle counting: viable and total particles
  • Microbial detection and measurement
  • Improved root cause investigations
  • Fast isolation and neutralisation of contamination sources
  • Rapid room release
  • Risk reduction
  • EU GMP Annex 1 update compliance (Grade A mandated continuous environmental monitoring)
EU GMP ANNEX 1
VIEW BROCHURE
VIEW DATASHEET

MUST READ INDUSTRY PAPERS

Source: PDA Journal of Pharmaceutical Science and Technology

Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes.
READ ABSTRACT >

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.
READ ABSTRACT >

Practical Applications of Bio-Fluorescent Particle Counting in Environmental Monitoring Investigations.
READ ABSTRACT >

Source: BioPhorum

A Clear Path to Implementing Alternative and Rapid Microbiological Methods.
READ ABSTRACT >

ON-DEMAND WEBINARS

Check out our webinar series highlighting today’s hottest topics in pharmaceutical manufacturing.

VIEW NOW

MUST READ BLOG

Read what TSI Contamination Control expert Mike Dingle is saying about data integrity in particle counting for pharmaceutical manufacturers.

READ NOW

Need advice? Get in touch now

Contact us