BioTrak for Continuous Monitoring

When deployed for the continuous environmental monitoring of airborne viable particles, BioTrak sets a new standard in maintaining cleanroom integrity and ensuring compliance with industry regulations. With its state-of-the-art Laser Induced Fluorescence (LIF) technology that accurately distinguishes viable and non-viable (inert) particles in real-time, BioTrak enables facilities to monitor airborne microbial contamination continuously without the need for manual sampling and delayed lab-based analyses.

Real-Time Detection and Analysis

By providing real-time detection of airborne viable particles, BioTrak gives immediate insights into cleanroom air quality. This enables rapid decision-making and timely responses to contamination events, which reduce potential risks to product quality and patient safety.

Less Downtime and Greater Efficiency

Traditional manual compendial methods of monitoring airborne particles and subsequent analysis often leads to significant downtime and delays in obtaining results. In contrast, the continuous monitoring capabilities of BioTrak eliminate these delays, enabling facilities to operate more efficiently and maintain optimal cleanroom conditions.

Regulatory Compliance and Data Integrity

The Pharma 4.0-ready BioTrak supports compliance with stringent industry standards, such as ISO 14644 and EU GMP regulations, by providing reliable and accurate data on airborne particle counts. The system’s Data Integrity feature ensures the traceability of monitoring data, which is crucial for audits and quality assurance.

Integration and Flexibility

BioTrak is designed for seamless integration with existing environmental monitoring systems and infrastructure. It can be easily configured to meet specific monitoring requirements, making it a versatile solution for a wide range of applications in pharmaceutical manufacturing, biotechnology, and other critical environments. Some new fully automated gloveless filling lines are specifically constructed to accommodate the installation of the BioTrak in the expectation that this will become a customer requirement. The use of the BioTrak in these applications confers the advantage of continuous monitoring and real-time particle detection, which exceeds EU GMP Annex 1 guidance, improves viable monitoring data and reduces process risk.

Operating seamlessly with the TSI FMS facility monitoring system, BioTrak delivers complete environmental monitoring automation and eliminates EM interventions while enabling better process understanding. Automated data collection with the 21 CFR Part 11 capable FMS software assures the highest level of Data Integrity.

Where Continuous Monitoring Pays Off

Continuous Monitoring with BioTrak is ideal in environments where maintaining clean air is critical, for instance pharmaceutical production areas, in the aseptic manufacturing core, and in research laboratories. By deploying continuous viable airborne particle monitoring, BioTrak helps organisations to minimise the risk of contamination. In addition, real-time, interruption-free monitoring unlocks operational process efficiencies and improves product quality.

BioTrak offers a cutting-edge solution for continuous monitoring of airborne viable particles. The instrument combines proven advanced technology with practical features to meet the evolving needs of the pharma, biotech and life sciences industries. With its real-time detection and high integrity data management capabilities, BioTrak is poised to become an essential tool in maintaining the highest standards of cleanroom environments.