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Treffer: PAT implementation for advanced process control in solid dosage manufacturing - A practical guide.

Title:
PAT implementation for advanced process control in solid dosage manufacturing - A practical guide.
Authors:
Sacher S; Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria. Electronic address: stephan.sacher@rcpe.at., Poms J; Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria., Rehrl J; Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria., Khinast JG; Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria; Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13/3, 8010 Graz, Austria.
Source:
International journal of pharmaceutics [Int J Pharm] 2022 Feb 05; Vol. 613, pp. 121408. Date of Electronic Publication: 2021 Dec 21.
Publication Type:
Journal Article; Review
Language:
English
Journal Info:
Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7804127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3476 (Electronic) Linking ISSN: 03785173 NLM ISO Abbreviation: Int J Pharm Subsets: MEDLINE
Imprint Name(s):
Original Publication: Amsterdam, Elsevier/North-Holland Biomedical Press.
MeSH Terms:
Technology, Pharmaceutical*, Quality Control
Contributed Indexing:
Keywords: Advanced process control; Continuous manufacturing; Control concept; Model predictive control; PAT
Entry Date(s):
Date Created: 20211224 Date Completed: 20220124 Latest Revision: 20220124
Update Code:
20250114
DOI:
10.1016/j.ijpharm.2021.121408
PMID:
34952147
Database:
MEDLINE

Weitere Informationen

The implementation of continuous pharmaceutical manufacturing requires advanced control strategies rather than traditional end product testing or an operation within a small range of controlled parameters. A high level of automation based on process models and hierarchical control concepts is desired. The relevant tools that have been developed and successfully tested in academic and industrial environments in recent years are now ready for utilization on the commercial scale. To date, the focus in Process Analytical Technology (PAT) has mainly been on achieving process understanding and quality control with the ultimate goal of real-time release testing (RTRT). This work describes the workflow for the development of an in-line monitoring strategy to support PAT-based real-time control actions and its integration into solid dosage manufacturing. All stages are discussed in this paper, from process analysis and definition of the monitoring task to technology assessment and selection, its process integration and the development of data acquisition.
(Copyright © 2021 Elsevier B.V. All rights reserved.)