Biofluorescent Particle Counters — An Environmental Monitoring Solution for Annex 1 and Pharma 4.0

The draft update to Annex 1 calls for continuous viable air monitoring in aseptic environments and for that monitoring to not pose a risk to the manufacturing process. Implementation of Pharma 4.0 offers the ability to achieve improved control over operations and quality through digitization—something traditional, culture-based  microbiological testing does not allow for.

Pitfalls of Traditional Microbiological Testing

Traditional microbiological testing used for environmental monitoring is not suitable for achieving goals related to Annex 1 compliance and Pharma 4.0 implementation. Traditional methods are very manual in nature and are generally performed on a periodic basis. Multiple days of incubation are required before results are available—making them not available to proactively aid in the control of the clean pharmaceutical manufacturing process.

Advancements in Microbiological Testing

Biofluorescent Particle Counters (BFPC), like the TSI BioTrak® Real-Time Viable Particle Counter, are an alternative microbiological method that serves as the solution for Annex 1 compliance and Pharma 4.0 implementation. Unlike culture-based microbiology, biofluorescent particle counters use laser induced fluorescence (LIF) to provide fully automated, real-time, and continuous viable air monitoring capabilities. This provides the process understanding, without added process risk, that Annex 1 is calling for in pharmaceutical environmental monitoring programs. When coupled with OPC UA interoperability, an open communication platform, environmental monitoring data can easily be connected with other process data to achieve the improved process control that Pharma 4.0 is designed to achieve—with no interruptions, no data loss and no-hassle compliance.

Additional Resources

• On Demand Webinars
  • Fundamentals of Laser Induced Fluorescence for Real-Time Viable Particle Counting
  • Implementing Real-time Viable Particle Counting for Aseptic Manufacturing
• White Paper
  • Fundamentals of Real-Time Viable Particle Monitoring: How Does It Work
• Major Industry Publication Features
  • A Discussion on Bio-fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
    Source: PDA Journal of Pharmaceutical Science and Technology
  • Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
    Source: PDA Journal of Pharmaceutical Science and Technology
  • Practical Applications of Bio-Fluorescent Particle Counting in Environmental Monitoring Investigations.
    Source: PDA Journal of Pharmaceutical Science and Technology
  • Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?
    Source: Pharmaceutical Online
  • A Clear Path to Implementing Alternative and Rapid Microbiological Methods. 
    Source: BioPhorum