The application of RFID technologies along the pharmaceutical supply chain represents a guarantee of transparency in the drug flow, against the growing counterfeiting problem. Unfortunately, the large-scale deployment of these solutions is still limited because of concerns over potential deteriorating effects of RF emissions on traced pharmaceuticals. This work aims at delineating an experimental framework to evaluate potential exposure risks and get new insight into poorly explored safety issues. Heterogeneous skills (engineering, chemistry and physiology) have been recruited to draw up a suitable experimental protocol, consisting of three main steps: (i) simulation of drug exposure to electromagnetic fields generated by RFID devices in a test environment reproducing the pharmaceutical supply chain; (ii) investigation of potential drug structural changes by High Pressure Liquid Chromatography (HPLC) techniques; (iii) analysis of performance by in vitro functional assays. An example of application of this protocol on a commercial FSH (Follicle Stimulating Hormone) preparation has been reported, showing no alterations of the hormone integrity following RF exposure. Conclusively, a wide adoption of "trace and track" RFID technologies passes through the assessment of related safety issues. The varying nature of drugs as well as their different biological targets make it a hard challenge, that can be successfully overcome by multidisciplinary approaches.
Evaluation of potential effects of RFID-based item-level tracing systems on the integrity of biological pharmaceutical products
MAFFIA, Michele;MAINETTI, LUCA;PATRONO, Luigi;URSO, EMANUELA
2012-01-01
Abstract
The application of RFID technologies along the pharmaceutical supply chain represents a guarantee of transparency in the drug flow, against the growing counterfeiting problem. Unfortunately, the large-scale deployment of these solutions is still limited because of concerns over potential deteriorating effects of RF emissions on traced pharmaceuticals. This work aims at delineating an experimental framework to evaluate potential exposure risks and get new insight into poorly explored safety issues. Heterogeneous skills (engineering, chemistry and physiology) have been recruited to draw up a suitable experimental protocol, consisting of three main steps: (i) simulation of drug exposure to electromagnetic fields generated by RFID devices in a test environment reproducing the pharmaceutical supply chain; (ii) investigation of potential drug structural changes by High Pressure Liquid Chromatography (HPLC) techniques; (iii) analysis of performance by in vitro functional assays. An example of application of this protocol on a commercial FSH (Follicle Stimulating Hormone) preparation has been reported, showing no alterations of the hormone integrity following RF exposure. Conclusively, a wide adoption of "trace and track" RFID technologies passes through the assessment of related safety issues. The varying nature of drugs as well as their different biological targets make it a hard challenge, that can be successfully overcome by multidisciplinary approaches.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
