(655a) Quality By Design Approach for New Chemical Technology Development

In recent years, Quality by Design (QbD) has gained acceptance in the pharmaceutical industry as an efficient way of designing and controlling processes to meet regulatory requirements. QbD approach seeks to use mechanistic, risk-based, holistic and proactive approach to build-in quality into new product development processes. The key steps involves defining design space, conducting risk assessment on process parameters and identifying critical quality attribute.   

Current as well as future technology development in petrochemical industry are expected to face greater challenges including market uncertainty, better process (product) performance amidst higher technical uncertainties and stricter environmental sustainability requirement.  In this context, SABIC Technology and Innovation (T&I) has recently incorporated QbD approach into earlier stages of its new technology development projects.

This work describes the steps involved in applying QbD concept to new petrochemical process development using an example of one of SABIC technology development. We provide examples of how mechanistic reaction kinetic model was coupled with statistical DoE to enhance chemical process understanding, support assessment of parameter criticality, and help in defining parametric design space which ensure that targeted catalyst activity,  products selectivity and purity are achieved at commercial scale. Future roles of mechanistic models to support QbD application in chemical/petrochemical process are discussed.