Risk-based decision making in early chemical process development of pharmaceutical and fine chemical industries

Decision making under uncertainty is vital in the early chemical process development. Competing objectives such as SHE and economics are considered in a data-lean environment. Screening of potential synthetic route options is done in a team environment with experts from different disciplines such as chemists and chemical engineers. Simple ranking methods are used and those hardly reveal the rationale behind choices. A systematic framework to support better decisions based on the SELECT (Safety, Environment, Legal, Economics, Control, Throughput) criteria has been developed and demonstrated using Cephalosporin process development. This approach links three components namely uncertainty, risk and capability analyses for multi-objective decision making. Each area of the decision criteria is scored using a hierarchical data structure for comparing different options. This approach improves the decision maker's understanding on the rationale behind choices and records them explicitly for improved learning. Further development and limitations of the approach are also discussed. (C) 2013 Elsevier Ltd. All rights reserved.