TSI FMS 6 FACILITY MONITORING SOFTWARE

The BioTrak® 9510-BD Real-Time Viable Particle Counter is unique – there is no other instrument or ARMM solution like it. The instrument provides immediate viable and inert particle counts and instant real-time alerts to confer a huge commercial advantage.

As a biofluorescent particle detector that combines viable particle counting (also called biofluorescent particle counting – BFPC) with sample capture capability and ISO-compliant continuous total particle counting, the BioTrak offers a complete solution for pharmaceutical Environmental Monitoring (EM). That continuous EM capability also makes the BioTrak GMP EU Annex 1 update-compliant, enabling faster production decisions, quick neutralisation of contamination sources, true isolation of the aseptic process and rapid resumption of production. It is a game-changer in pharmaceutical production.

Superior discrimination between viable and inert particles delivers reliable viable particle data, while time-tested gelatin filter technology featuring a nine-hour active life efficiently captures sampled microorganisms for subsequent identification.

Combined with TSI FMS Software, the BioTrak provides continuous monitoring of aseptic processes to reduce or eliminate EM interventions, improve quality, and ensure data integrity. Used as a standalone instrument, it can quickly identify sources of microbial contamination during EM investigations, provide data for immediate room release, and can aid in the identification and mitigation of risk.

This unique particle counter can be operated in Data Integrity Mode for enhanced data integrity. Used in conjunction with TSI TrakPro™ Lite Secure Software, Data Integrity Mode is designed to ALCOA+ principles that meet the demanding regulatory requirements of GMP users.

The BioTrak uses Laser Induced Fluorescence (LIF) technology deploying two wavelengths of laser light to distinguish viable microbial particles from non-viable (inert) particles in real-time, making it an compelling Alternative & Rapid Microbial Method (ARMM) and ideally suited to GMP EU Annex 1 update mandates.

The LIF identification process is quantitative, continuous and rapid. It physically detects the presence of a viable particle but does not identify its type; that is still the preserve of growth-based methods. The differences between microbial species are too subtle to identify in real-time, which is why the BioTrak also features a collection facility to harvest particles that can then be incubated for identification, thereby enabling qualitative analysis

Read our article on the adoption of technology-based Alternative & Rapid Microbial Methods (ARMM) published by Cleanroom Technology Magazine.