PECM Issue 16 2015 | Page 128

Introduction A new generation of continuous small-scale reactors been developed, that promise to revolutionise the manufacture of high-value, low volume products. These micro reactors can be used in parallel, to achieve production scale-up without the complexity of large-plant design and operation. They offer extraordinary flexibility and efficiency, enabling the manufacture of a number of products by rapidly adjusting operating parameters between recipes. Their design reduces waste, reduces energy consumption, and requires a much smaller solvent inventory than equivalent bath reactors. To exploit the full potential offered by these reactors, two distinct areas needed to be addressed. First, for existing products: improved automation is required during normal manufacturing, to better reject external disturbances such as feedstock variation, to minimise waste. Second, for new formulations: the ability to identify - and drive the process to - the operating conditions required for achieving on-spec products more rapidly, reducing timeto-market. Finding a Solution To address these challenges, Perceptive Engineering led a collaborative R&D project, in partnership with AstraZeneca, the Centre for Process Innovation Limited (CPI) and the EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation (CMAC), based at the University of Strathclyde. Perceptive Engineering Limited is based at Sci-Tech in Daresbury, one of the UK Government’s national Science and Innovation campuses. Drawing on their extensive experience in Advanced Monitoring and Model- 128 PECM Issue 16 Predictive Control (MPC), Perceptive used their proven software platform PharmaMV™ to deliver far more precise control of the reactor, achieving the desired product quality while optimising production yield, ready for commercial scaleup. Results The results have been demonstrated on model compounds such as lactose, as well as products of true industrial interest and the project has shown a significant improvement in yield and in the ability to tightly control particle size distribution (PSD). KǀĞƌůĂLJŽĨ WĂƌƚŝĐůĞ^ŝnjĞŝƐƚƌŝďƵƚŝŽŶ ĨƌŽŵŵƵůƚŝƉůĞďĂƚĐŚĞƐ ǁŝƚŚĚǀĂŶĐĞĚŽŶƚƌŽů ϭϮ ϭϬ Perceptive used their proven software platform PharmaMV™ to deliver far more precise control of the reactor • Increased yield: 26% higher yield (vs batch) in continuous crystallisation • Consistent & higher product quality: 2 fold reduction in span of PSD vs stirred tank reactor • Process intensification: Reduction in Lactose crystallisation time from 16 hour to 5 hours • Reduced resources: less operator intervention, less waste ϭϰ ǀŽůƵŵĞĚĞŶƐŝƚLJй However, these units do require high levels of manual intervention, to identify suitable operating conditions and adjust the process as needed to maintain final product quality. This can be challenging: the design of the reactors, and the ancillary equipment they require, often results in complex system interactions. • ‘Dial a Particle’: user-defined particle size characteristics, automatically delivered by MPC ϴ ϲ ϰ Ϯ Ϭ ϭ ϭϬ ϭϬϬ WĂƌƚŝĐůĞƐŝnjĞђŵ Three demonstrator systems, complete with Perceptive Engineering’s Advanced Control and Monitoring platform, are now available to the wider industrial community through the CPI’s role as a national CATAPULT centre and CMAC’s status as an EPSRC national centre. The project has been shortlisted for the IChemE Global Innovation award. To learn more about this project, or about how PharmaMV™ can help your own processes meet or exceed their goals, please contact Perceptive Engineering. Perceptive Engineering Limited Vanguard House Keckwick Lane Sci-Tech Daresbury Cheshire WA4 4AB United Kingdom T: +44 1925 607150 W www.PerceptiveAPC.com @ [email protected]