Real-time viable particle counter for pharmaceutical manufacturing
In pharmaceutical manufacturing, ensuring aseptic conditions is critical to maintain product integrity and compliance with regulatory standards. Traditional air sampling methods can delay results, increase contamination risks, and require manual processing, which affect production efficiency and safety.
Detect and differentiate viable particles in real-time
The BioTrak Real-Time Viable Particle Counter by TSI Systems is a cutting-edge biofluorescent particle detector designed for continuous monitoring of pharmaceutical environments. It provides real-time counts of both total and viable particles using an ISO-compliant system. The device effectively discriminates between viable and inert particles and uses gelatin filter technology to capture microorganisms for later identification. Integration with TSI FMS Software allows for automated data monitoring to minimize manual interventions and improve process understanding. Its 1 CFM (28.3 L/min) sample flow rate and single isokinetic probe ensure comprehensive sampling, while compliance with EU GMP Annex 1 regulations is achieved. Ideal for monitoring aseptic environments, conducting periodic testing, and root-cause investigations, the BioTrak system helps in identifying contamination sources and supports immediate room release approvals.
Benefits
- Real-time detection of airborne viable particles
- Reduces human intervention and manual processing
- Supports robust data integrity with 21 CFR Part 11 compliance
- Enhances contamination source identification
- Complies with ISO 21501-4 standards