A perspective on PSE in pharmaceutical process development and innovation

Article ID	Journal	Published Year	Pages	File Type
6595870	Computers & Chemical Engineering	2012	15 Pages	PDF

Abstract

The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper discusses the central role of Process Systems Engineering (PSE) methods and tools in pharmaceutical process development and innovation, and searches for answers to questions such as: Which PSE methods can be applied readily? Where is more method development needed? The paper covers key subjects for development of economically and environmentally sustainable pharmaceutical processes, including Process Analytical Technology in its broadest sense, continuous pharmaceutical manufacturing and green processes, and is illustrated with a series of short examples taken from the literature and ongoing research projects.

Keywords

Interval PLS NCE PDE iPLS CPM CQA MSPC API PBM CAMD OED LLE NIR Dem PLS DOE QbD ANN CPP PCA LCA Life Cycle Assessment Liquid–liquid extraction Principal component analysis Process development Pharmaceutical production Continuous pharmaceutical manufacturing Process analytical technology Partial least squares near infra-red CFD Computational fluid dynamics Finite element method Discrete element method Artificial Neural Network PMI Design of experiments Optimal experimental design Computer-aided molecular design Design space Population balance model Partial differential equation Process systems engineering Active Pharmaceutical Ingredient new chemical entity Molecular weight Critical quality attribute pat critical process parameter Sustainability Continuous processing FEM PSE Multivariate statistical process control Quality by design