An exposure system for evaluating possible effects of RFID on various formulations of drug products [Supplement, Applications & Practice

Abstract

We developed hardware and software to perform exposure studies of the effects of certain RF electromagnetic fields on solid and liquid pharmaceuticals and biologies. The RF fields generated by our systems are similar to those emitted by RFID readers operating in the U.S. licensed HF and UHF bands. Our systems can expose drug samples (pharmaceuticals and biologies) to uniform electric (E) and/or magnetic (H) fields at levels that are much higher than those experienced by drugs near "worst-case" readers at a distance of 20 cm. Maximum field strengths near these readers were identified by measurements and computations of fields from commercial readers, and are extrapolated to the maximum allowable effective isotropic radiated power or field strength dictated by the U.S. Federal Communications Commission. Exposures can be performed for each drug in both its retail primary package and in 54 mm diameter culture dishes. The containers are suitable for exposing a wide variety of formulations of. Exposures of drugs in culture dishes ensure uniform induced electric fields and currents. In contrast, exposures in the primary containers allow studies that account for the interactions of RF fields with the packaging materials and container geometry. In our UHF system we can expose drugs to over 20 W effective isotropic radiated power, over five times the FCC limits. We evaluated H fields emitted by commercially available RFID readers. In our HF system we can expose drugs to at least five times the H field they produce at 20 cm from the reader. We can expose samples to 5 A/m in primary packaging or in special organ culture dishes with an outer concentric ring. The ring has inner and outer diameters of 32 mm and 55 mm, respectively. Computer monitoring of power, drug temperature, and air temperature can be performed continuously during exposure. Surrounding air temperature is monitored at all times while in our laboratory and while shipped to drug laboratories for analysis.