How RFID Labels Cut Pharma Documentation Time by 60%

Michelle Dennis, MilliporeSigma, shares her takeaways on two technologies reshaping pharmaceutical quality control, as a part of PDA Week 2026.

PharmTech: How Does Biofluorescent Particle Counting Differ from Traditional Environmental Monitoring?

Dennis: The biggest difference is that it's real-time. With traditional methods, you're growing up a plate, waiting several days, and then seeing if anything grows. By the time you have results, it may be too late to intervene. With biofluorescent particle counting, you're getting data immediately, which means you can take action right away and potentially save a batch from later failure. That real-time capability is really the heart of what makes this technology so valuable.

There's also an efficiency advantage. Traditionally, you'd run separate tests for passive air samples and active air samples. Biofluorescent particle counting looks at both simultaneously. On top of that, it captures both viable and non-viable particulates at the same time, so you're getting more complete data in a single pass, rather than running two separate tests.

Where Does the FDA Stand on Biofluorescent Particle Counting?

This came up in our conversation with Dr. James Hathcock, and the outlook is encouraging. It sounds like there has been direct interaction with the FDA on this topic, and the agency does seem to be open to accepting this technology. That said, it's not a blanket approval, it really comes down to your validation plan. A strong, well-documented validation plan is going to be key for any organization looking to adopt this method. Wider adoption will take time, but the regulatory trajectory looks positive.

What Are the Main Benefits for RFID-Enabled Traceability in GMP Environments?

In a GMP environment, time is both critical and expensive. RFID-enabled traceability gives you the ability to trace a product all the way from the drug product back to the patient and everything in between. That kind of end-to-end visibility is powerful because it helps you identify exactly where in your workflow an issue may have occurred.

One of the most impressive data points came from Adithya Balasubramanian's presentation on RFID labels and traceability. His data on documentation efficiency was striking. In some cases, the use of RFID technology reduced operator documentation time by as much as 60%. When you think about how much time operators spend documenting defects found on syringes, for example, that's a significant operational and cost savings.

What Are the Key Challenges to Implementing RFID Traceability?

Validation is one area, but the bigger day-to-day challenge is going to be consistency in how defects are identified and classified. Different users may have different ways of categorizing what they see, which can create variability in your data. There's also a practical learning curve around proper scanning technique and use of the associated technology, like the iPad interface.

Ultimately, I think successful implementation comes down to training. Training on defect classification, training on proper use of the tools, and a willingness to adjust as teams get comfortable with the technology. It's not insurmountable, but it does require intentional preparation.