A systematic methodology for the design of continuous active pharmaceutical ingredient production processes

Albert Emili Cervera Padrell, Rafiqul Gani, Søren Kiil, Tommy Skovby, Krist Gernaey

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Abstract

Continuous pharmaceutical manufacturing (CPM) has emerged as a powerful technology to obtain higher reaction yields and improved separation efficiencies, potentially leading to simplified process flowsheets, reduced total costs, lower environmental impacts, and safer and more flexible production. However, the change from batch-wise production towards continuous operation and the definition of flexible design spaces requires a high degree of process knowledge. Process Systems Engineering (PSE) offers multiple methods and tools which can assist in efficient knowledge acquisition, structuring and representation, as well as on how to employ this knowledge for process (re-)design. The aim of this paper is to introduce a methodology that systematically identifies already existing PSE methods and tools which can assist in the design of CPM processes. This methodology has been applied to a process for the production of an API developed by H. Lundbeck A/S, demonstrating the mentioned potential benefits that CPM can offer.
Original languageEnglish
Title of host publication21st European Symposium on Computer Aided Process Engineering
PublisherElsevier
Publication date2011
Pages271-275
ISBN (Print)978-0-444-53895-6
DOIs
Publication statusPublished - 2011
Event21st European Symposium on Computer Aided Process Engineering - Chalkidiki, Greece
Duration: 29 May 20111 Jun 2011
http://www.escape-21.gr/

Conference

Conference21st European Symposium on Computer Aided Process Engineering
CountryGreece
CityChalkidiki
Period29/05/201101/06/2011
Internet address
SeriesComputer Aided Chemical Engineering
Volume29
ISSN1570-7946

Keywords

  • Process design
  • PAT
  • QbD
  • Continuous pharmaceutical production

Cite this

Cervera Padrell, A. E., Gani, R., Kiil, S., Skovby, T., & Gernaey, K. (2011). A systematic methodology for the design of continuous active pharmaceutical ingredient production processes. In 21st European Symposium on Computer Aided Process Engineering (pp. 271-275). Elsevier. Computer Aided Chemical Engineering, Vol.. 29 https://doi.org/10.1016/B978-0-444-53711-9.50055-9