Be Annex 1 Compliant | Pharma 4.0 Ready

Biofluorescent Particle Counting (BFPC) is a cutting-edge technology that enables real-time detection of viable particles in cleanroom environments. By utilizing laser-induced fluorescence (LIF), BFPC distinguishes between viable and non-viable particles instantly, enhancing contamination control in pharmaceutical manufacturing. 

Traditional microbiological methods often require days to yield results, delaying critical decisions. In contrast, BFPC provides immediate insights, allowing for prompt corrective actions and minimizing product risk. This rapid detection is crucial for maintaining stringent aseptic conditions and ensuring product quality. 

TSI's BioTrak™ Real-Time Viable Particle Counter exemplifies BFPC technology. It offers continuous, ISO-compliant monitoring by combining real-time viable particle counting with sample collection capabilities. This integration not only reduces the need for aseptic interventions but also enhances root-cause investigations and process understanding. 

Implementing BFPC aligns with the principles of Pharma 4.0, promoting digitization and improved operational control. By providing immediate data on microbiological contamination, BFPC supports continuous manufacturing processes and meets regulatory requirements, such as those outlined in Annex 1. 

In summary, Biofluorescent Particle Counting represents a significant advancement in environmental monitoring, offering rapid, reliable, and real-time detection of viable particles to uphold the highest standards in pharmaceutical production.

Learn more about the BioTrak™ Real-Time Viable Particle Counter— The Only Accepted Method to Replace Active and Passive Air Sampling in Grade A.