Energy dispersive X-Ray DIFfraction for COunterfeit Medicine detection – DIFCOM

The DIFCOM project aims at proposing a new technological solution to fight against counterfeit pharmaceuticals. Medicine counterfeiting is a current problem that the whole pharmaceutical field has to deal with. Globalization of exchanges combined with development of business via internet has led to an exponential growth of pharmaceutical counterfeits, causing both serious economic and health issues. Some technological solutions exist but remain insufficient to control the whole medication distribution chain which is relatively complex and very vulnerable. In this context, it seems necessary to propose new weapons to fight against counterfeiting, most particularly new systems of counterfeit detection which could be deployed and easily used on-field, at different levels of the distribution chain.
The counterfeit detection system proposed in the DIFCOM project would be based on the technique of energy dispersive X-ray diffraction (EDXRD). The X-ray diffraction is known to provide very relevant information of the inspected molecules and the high penetrating power of X-rays make possible the control of drugs inside their sealed package. More precisely, the interest of the EDXRD technique is that it uses conventional X-ray tubes (potentially compact) and a new generation of spectrometric semiconductor based detectors, which are both compact and room temperature operating. Moreover, using recent technologies of 2D spectrometric detectors coupled with adapted collimations, one can envisage the design of compact systems performing in real-time spectral images of pharmaceuticals inside their packages.
The main purpose of the DIFCOM project is to prove the concept of such a counterfeit detection system. For that, the project will rely on existing technological bricks, including the IMADIF imager, which is an industrial 2D CdZnTe based spectrometric detector developed by the CEA-LETI and transferred to MORPHO Detection. The IMADIF module has already been successfully integrated in an EDXRD imaging system dedicated to cabin baggage scan in airports (XDi system). The DIFCOM imager we aim to develop can be considered as a kind of “miniaturization” of the XDi system. This miniaturization is not obvious and will require many adaptations concerning geometry, collimation and signal processing in order to meet the constraints of the application and of the desired modus operandi. In particular, sophisticated detector level processing will be used in the IMADIF module in order to virtually improve the spatial resolution, without degrading the energy resolution.
The project, lasting two years, appears as a feasibility demonstration with the ultimate ambition of implementing a laboratory prototype of the DIFCOM imager. This project will involve a team specialized in detector technology and EDXRD systems (CEA-LETI), a team specialized in the integration of XRD systems (ThermoFisher-INEL), a laboratory of a pharmaceutical industrial (LCAC - Sanofi), and persons from the “Direction Générale des Douanes et Droits Indirects”. The first phase of the project will consist in a performance evaluation of the EDXRD technique on a large number of pharmaceuticals, independently of the 2D architecture of the final prototype. This will be done experimentally on a EDXRD lab bench, using only one single slot collimation. The second phase will be a dimensioning study to design by simulation the architecture of the new system ‘DIFCOM imager’. Development of adapted data processing will be carried out in parallel to well evaluate the final performances of the designed system. The last phase will be the implementation of a lab prototype of the ‘DIFCOM imager’, with an experimental validation on different relevant pharmaceutical products. Finally, meeting the final experimental results with the general specifications defined at the beginning of the project, we will conclude of the feasibility of an industrial system and define the specification for its integration.