Book description
Process Understanding is the underpinning knowledge that allows the
manufacture of chemical entities to be carried out routinely, robustly
and to the required standard of quality. This area has gained in
importance over the last few years, particularly due to the recent
impetus from the USA`s Food and Drug Administration. This book covers
the multidisciplinary aspects required for successful process design,
safety, modeling, scale-up, PAT, pilot plant implementation, plant
design as well the rapidly expanding area of outsourcing.
In discussing what process understanding means to different disciplines
and sectors throughout a product`s life cycle, this handbook and ready
reference reveals the factors important to the development and
manufacture of chemicals. The book focuses on the fundamental scientific
understanding necessary. for a smoother technical transfer between the
disciplines, leading to more effective and effi cient process
development and manufacturing. A range of case studies are used to
exemplify and illustrate the main issues raised.
As a result, readers will appreciate that process understanding can
deliver a real competitive advantage within the pharmaceuticals and fine
chemicals industry. This book serves as an aid to meeting the stringent
regulations required by the relevant authorities through demonstrable
understanding of the underlying science.
Jose Camacho-Paez is a scientist at the research Group of Complex
Systems in the Institute of Control Systems and Industrial Computing of
the Technical University of Valencia, in Spain. He holds a degree in
Computer Science from the University of Granada (2003) and a Ph. D. in
Control Systems and Industrial Computing from the Technical University
of Valencia (2007). His Ph. D. was awarded with the second Rosina
Ribalta Prize to the best Ph. D. projects from the EPSON Foundation, and
with the D. L. Massart Award in Chemometrics from the Belgian
Chemometrics Society. He is reviewer of Chemometrics and Intelligent
Laboratory Systems, AIChE Journal, Industrial & Engineering
Chemistry Research, Chemical Engineering Science and Biosystems
Engineering.
Jesus Pico received the M. S.Eng. degree in industrial engineering and
the Ph. D. degree in control engineering, both from the Technical
University of Valencia (UPV), Spain. Currently he is Associate Professor
at the Department of Systems Engineering and Control at the UPV. His
main research interests are in nonlinear and adaptive control, modeling
and control of fedbatch processes, and control methods in systems
biology and bioprocesses. He has been involved in several European
industry-oriented projects related to batch processes. He is member of
the Technical Comitee on Bioprocesses and Biosystems of the
International Federation of Automatic Control (IFAC).
Alberto Ferrer is Professor of Statistics at the Department of Applied
Statistics, Operation Research and Quality, and Head of the Multivariate
Statistical Engineering Research Group of the Technical University of
Valencia (Spain). He holds a M. S.Eng. in Agricultural Engineering (1987
- First Spanish National Award) and a Ph. D. in Statistics (1992) from
the Technical University of Valencia. His research focuses on
statistical techniques for quality and productivity improvement. He has
been involved in several industry-oriented research projects related to
batch and continuous processes. Prof. Ferrer is currently associate
editor of Technometrics, member of the editorial board of Quality
Engineering, member of the Council of the International Society for
Business and Industrial Statistics (ISBIS), and the European Network for
Business and Industrial Statistics (ENBIS).
