Integrated Synthesis, Crystallization, Filtration, and Drying of Active Pharmaceutical Ingredients: A Model-Based Digital Design Framework for Process Optimization and Control

Daniel J. Laky, Daniel Casas-Orozco, Francesco Destro, Massimiliano Barolo, Gintaras V. Reklaitis and Zoltan K. Nagy ()
Additional contact information
Daniel J. Laky: Purdue University
Daniel Casas-Orozco: Purdue University
Francesco Destro: University of Padova
Massimiliano Barolo: University of Padova
Gintaras V. Reklaitis: Purdue University
Zoltan K. Nagy: Purdue University

A chapter in Optimization of Pharmaceutical Processes, 2022, pp 253-287 from Springer

Abstract: Abstract Over the past two decades, pharmaceutical manufacturing has seen significant modernization due to the digitalization of manufacturing as more manufacturers adopt Industry 4.0 standards. The FDA launched the quality-by-design and quality-by-control initiatives as steps to ensure this digitalization in pharmaceutical manufacturing may proceed alongside regulatory guidelines for the transition from traditional batchwise manufacturing to end-to-end continuous or hybrid batch-continuous manufacturing schemes. Adoption of a process digital twin is a pivotal step in providing quantitative justification for updating or designing new processing routes for pharmaceutical materials, especially when implementing online process control. This article presents a framework for the integrated design of continuous and hybrid systems for the synthesis-crystallization and filtration-drying steps of paracetamol using digital twins to simulate process operation and control.

Keywords: Quality-by-design; Quality-by-control; Continuous manufacturing; Process design; Process control; Digitalization; Industry 4.0 (search for similar items in EconPapers)
Date: 2022
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:spochp:978-3-030-90924-6_10

Ordering information: This item can be ordered from
http://www.springer.com/9783030909246

DOI: 10.1007/978-3-030-90924-6_10

Access Statistics for this chapter

More chapters in Springer Optimization and Its Applications from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().