Annex 1 Compliance Made Simple - Why Flow Rate Matters 

Traditional monitoring of aseptic manufacturing has required the installation of total particle counters, active air samplers, and open surfaces or stands to place settle plates. Biofluorescent particle counters (BFPCs) provide an alternative to active air samplers and settle plates to help make meeting the Annex 1 requirement for continuous viable air monitoring easy, with the added benefit of real-time results for improved process control. Most BFPCs can also provide total particle counts, however, unless they have a flow rate of at least 28 lpm, they cannot comply with Annex 1. Therefore, additional total particle counters would still need to be installed if these BFPCs are used. That’s where the BioTrak™ Real-Time Viable Particle Counter, a biofluorescent particle counter, sets itself apart.

BioTrak™ BFPC - A Complete Solution

Most BFPCs have a slow flow rate to allow for the detection of the relatively weak fluorescence signals from viable particles. The BioTrak BFPC utilizes a unique solution, the use of a particle concentrator between the total particle detector and the viable particle detector that allows for sampling at 28.3 lpm for total particle counting, and a slower flow for viable particle counting. 

With this higher flow rate, and the inclusion of a method for particle collection, the BioTrak BFPC is the only device that can replace all three air sampling methods in Grade A and help comply with Annex 1 by providing:

• Continuous, real-time viable particle counts (AFUs)
• Continuous total particle counts
• Sample collection for microbial identification

More Air, More Confidence

In the cleanest areas, contaminants are rare. The more air that can be sampled provides a higher chance of detecting risk events before they impact product quality.

At 28.3 lpm, the BioTrak BFPC processes:

• 28x more air than a 1 lpm BFPC
• Nearly 6x more air than a 5 lpm BFPC

This provides the best chance to detect risk.

Other Benefits of Using One Instrument for Monitoring

• Less equipment and materials in critical zones
• Easier integration with filling lines
• Reduced maintenance and calibration

Bottom Line

The BioTrak BFPC is the only proven solution for real-time air viable monitoring that can also help meet Annex 1 28.3 lpm flow rate requirement for total particle counting.

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