SpaceCode Study Confirms Safety of Low-Frequency (LF) RFID on Drug Composition
Geneva, Switzerland September 06, 2006
The effects of radio frequency energy on the active principles in drug products are largely unknown and current data in this regard is limited. Given the recent recommendations of the FDA regarding RFID and the increasing adoption of the technology within the pharmaceutical industry, it is important for all stakeholders to responsibly demonstrate and ensure that radio-frequency exposure does not impact the quality, safety, or efficacy of drug and biologic products.
With this in mind, SpaceCode undertook various studies that evaluated the effects of electric fields on the potency of selected pharmaceuticals.
Using renowned pharmacology departments, in one such study drugs were exposed to low radiofrequency (125 KHz, group LF), or maintained in ambient conditions without exposure to radiofrequency (control group). The exposure to radiofrequency was time-controlled for a total length of 80 hours, simulating 6 months exposure under real life working conditions. Frequencies delivered were defined, established, tested and controlled prior to and during the experiments. Proper functioning of the radiofrequency delivery was controlled via a linked PC computer with log files created each minute generating a full audit of the system and its functioning. All experiments were conducted in the same time, in ambient conditions without exposure to light.
Following the exposure, drugs were analysed using a combination of HPLC-UV procedures and spectrometry. Drug concentrations were statistically compared using means standard error, one-way analysis of variance. A P value < 0.05 was considered to denote statistically significant differences.
Results of the tests demonstrated that drug concentrations among all groups did not reveal any significant differences. The qualitative analysis (spectral analysis) did not reveal any difference to freshly prepared drug solutions. The retention time was unchanged under all conditions.
Conclusions of the study demonstrate that continuous exposure (80 hours) to low or high radio frequency did not result in drug degradation under a large studied range of concentrations. No significant sensitivity after prolonged exposure to SpaceCode’s Low Frequency (128 KHz) RFID solutions was established.
These results are very encouraging for the use of RFID with drugs, and support SpaceCode’s position as a uniquely ethical solution provider to the Healthcare and Pharmaceutical industries, prepared to put safety before commercial gain and provide safe and secure RFID solutions for item-level tagging of drugs and medical devices.