European pharma manufacturer sets BFPC precedent with the FDA.
Within a news report published on the TSI Inc. website entitled ‘Biofluorescent Particle Counting — Hot Topic at Global Conferences’, the company’s BioTrak product specialist, Mike Dingle, recounts what might come to be seen as a momentous piece of information shared with delegates at the ISPE Pharma 4.0 & Annex 1 Conference last December.
A highly respected conference speaker and Strategy Specialist from a renowned Scandinavian pharmaceutical manufacturer revealed that he had some “new information that was not on his presentation slide.” It related to recent interactions his company had been having with the regulatory agencies.
He announced that a meeting with the US Food & Drug Administration (FDA) had just concluded and that the federal agency regulator had accepted their use of the BioTrak Real-Time Viable Particle Counter to continuously monitor their filling isolator.
That’s big news! A concern for many involved with Biofluorescent Particle Counting (BFPC) technology that’s at the heart of BioTrak’s real-time viable particle detection capability has been its acceptance by regulators. The FDA’s approval of BFPC is a milestone that sets a precedent for applications of BioTrak – immediately in filling lines. But it also opens up many other opportunities in critical environment monitoring applications, allowing pharma and life science professionals to confidently adopt Rapid Microbial Methods using BioTrak’s BFPC technology, safe in the knowledge that it has the approval of a leading regulatory agency.
Read Mike Dingle’s report here.