Non-thermal effects of radio frequency exposure on biologic pharmaceuticals for RFID applications

Radio frequency identification (RFID) has been an emerging technology over the past decade with applications ranging from simple supply chain utilizations to sensory monitoring of heat and humidity sensitive products during transportation. RFID has direct implications for the area of pharmaceutical distribution especially for temperature sensitive products where they are tagged and tracked in their shipping environment. Per FDA CPG Sec.400.210, Drugs, Radiofrequency Identification, the FDA has not allowed RFID technology to be used for drugs covered under a Biologics License Application or protein drugs covered by a New Drug Application since the potential impact of radio frequency (RF) radiation on biologics and proteins is not well documented. The intent of this study is to determine the non-thermal effects on the protein structures of biopharmaceuticals by constant exposure to radio frequency energy at different wavelengths using twice the equivalent isotropically radiated power (EIRP) allowed by FCC in the United States. As a contribution of this study, the test setup and protocol provide a fundamental and universally applicable methodology which combine the hardware to generate and radiate high power RF signals at different frequencies and a temperature controlled dark anechoic chamber where the temperature and light sensitive products can be exposed to RF radiation. Five different frequencies are used which account for the majority of commercially available RFID systems adopting high frequency (13.56 MHz) or ultra-high frequency (433 MHz, 868 MHz, 915 MHz, and 2.4 GHz) radio waves as well as active or passive tags for communication. Multiple products from different pharmaceutical companies falling under three major protein groups and their integrity after exposure to 8 Watts EIRP RF radiation for a full 24 hours are investigated. The results show that even at twice the EIRP as regulated by FCC, the effects of RF energy on the purity of all the tested biopharma- - ceutical proteins remain undetectable after purity and potency stability-indicating assays.