Simon Tebb, EMEA Sales Manager at TSI, presented the subject of “Real World Applications of Biofluorescent Particle Counting” at the recent PHSS Conference. As anticipated and agreed widely among conference delegates, it was an informative and insightful presentation.

For his introduction, Simon started by covering how BFPC happened and what’s coming next. Part of his agenda was to show that BFPC – the methodology at the heart of the BioTrak™ Real-Time Viable Particle Counter – is a valid alternative to compendial methods.

Simon pointed out that it is now possible to use BFPC, as embodied in the BioTrak, for air testing in an isolator. A Grade A filling line that uses Biofluorescent Particle Counting to monitor airborne contamination has been approved for use by the FDA and the EMA. So there are pharma manufacturing facilities using the BioTrak, which means no need for Active Air Sampling, no Passive Sampling and no additional particle counting requirements as the BioTrak does it all (viable and non-viable particle counts and particle collection for speciation).

The secret to the successful implementation of the BioTrak for pharma customers is the expertise we’ve amassed here at FMS, supported by TSI as our Gold Channel partner. We can help BioTrak users identify their operational and business needs and create a User Requirement Spec (URS), taking into account factors like Data Integrity, Annex 1 compliance, process understanding, real-time data, zero manual interventions and the commercial advantages of reduced risk that’s a key benefit of BFPC in Grade A monitoring applications. Simon covered all these aspects in his presentation.

One of the conference delegates enthused about Simon’s presentation with a review. Details were shared on LinkedIn about BioTrak’s particle counting capabilities and the agar plate for speciation (the 3-in-1 aspect that’s a key USP for BioTrak). The delegate pointed out that there are numerous benefits for businesses, that BFPC technology is becoming more widely embraced, and that the regulatory authorities are welcoming the innovation and continuous improvements, having seen cases where this technology is used.

Simon summed up his presentation with a final analysis of the value of three key BFPC features in the BioTrak:

• Combined total particle and viable particle measurement means a single ideal location for both critical EM metrics (with no compromises for plate access and no need for two separate instruments).
• That in-line sample collection satisfies the requirement to ID any hits (by collecting the same air that went through the particle detector optics).
• How an airflow rate of 28.3 litres per minute mitigates concerns over particle loss and detection efficiency (due to typical air sample volumes for BFPC being six times that of an Active Air Sampler).

Importantly, these were three of the key arguments presented to regulators to secure approval of BFPC in Grade A monitoring applications. The flow rate used by BioTrak is a key element of the instrument’s capability in the context of Annex 1, where it is actually a requirement. Annex 1 paragraph 9.17 clearly states: “The Grade A area should be monitored continuously… and with a suitable sample airflow rate (of at least 28 litres per minute/one cubic foot per minute).” In addition, the 28.3 litres/min flow rate of BioTrak matches the flow rate of other particle counters, meaning that the non-viable particle results from BioTrak are directly comparable.

Needless to say, we were pleased to be part of the team on the day with a BioTrak™ Real-Time Viable Particle Counter instrument on our stand at the conference for delegates to get familiar with after Simon’s enlightening presentation.