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Innovative equipment and methodologies for APIs continuous crystallization (CCRYSTAL)
Start date: Nov 1, 2010, End date: Oct 31, 2012 PROJECT  FINISHED 

"In spite of the substantial erosion of its market share, western Europe (Italy, Spain are respectively first and second producers) still remains the worldwide leader, accounting for 38,9% of the world APIs production and Eastern Europe is growing faster (mainly represented by Hungary). It is then clear that generic APIs represent a strategic industrial field for EU competitiveness, and it is as well clear that this competitiveness is seriously threatened by the emerging competitors in the Far Eastern Countries (China and India above all). The reasons behind this loss of competitiveness is manifold: (i) lower man power costs in the Emerging countries, (ii) lack of regulatory requirements in the emerging Countries, are the most obvious. The CCRYSTAL main objective is to develop a new technology to crystallize pharmaceutical substances, affording fundamental new approaches to obtain products with high purity levels and constant and reproducible crystalline forms at a competitive price, enabling EU APIs industry to regain his competitiveness against Asian Producers. The innovative proposed technologies are based on a new concept crystallizer and on continuous mode operation. Crystallizer is designed in such a way to assure a perfect actuation of elaborated operation strategies, intended to control the main phenomena involved in crystal formation: (i) Primary nucleation; (ii) Secondary nucleation; (iii) Crystal growth. The new technology will be tested on competitive APIs, eventually developing the whole chemical scheme in a continuous manner. Further a single crystallizer (a “repeatable unit”) is then arranged in a crystallization train of three units, to allow flow operation."
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