Emerging QC Technologies Reshaping Pharmaceutical Manufacturing

Michelle Dennis, QC Microbiology Application Specialist with MilliporeSigma and member of the PDA Week 2026 planning committee, sat down with PharmTech to discuss two cutting-edge technologies shaping the future of pharmaceutical quality control: biofluorescent particle counting and RFID-enabled traceability.

On the environmental monitoring side, Dennis highlights the transformative potential of biofluorescent particle counting as an alternative to traditional methods, adding, "Biofluorescent particle counting differs from traditional environmental monitoring techniques in that it's real-time. So instead of having to grow up the plate, wait several days, see if anything grows, you're getting real-time data, so you can take action immediately, and potentially save a batch from later failure." Beyond speed, the technology offers added efficiency by capturing both viable and non-viable particulates from passive and active air samples simultaneously, eliminating the need for two separate tests.

Regarding FDA acceptance of biofluorescent particle counters, Dennis notes that conversations with the agency have been encouraging. "It sounds like they've had the chance to interact with the FDA, and it really comes down to your validation plan, but overall, the FDA does seem to be accepting this technology," she says. Wider adoption is expected to follow.

Dennis also speaks to the promise of RFID-enabled traceability in GMP environments, particularly its impact on documentation efficiency. She is especially struck by data presented by speaker Adithya Balasubramanian, which showed that RFID labeling reduced operator documentation time by as much as 60% in some cases. She acknowledges that successful implementation will require thoughtful training around defect classification and proper use of scanning technology, but expressed confidence that teams can adapt with the right preparation.