LAPSE:2025.0235v1
Published Article

LAPSE:2025.0235v1
Digital Twin supported Model-based Design of Experiments and Quality by Design
June 27, 2025
Abstract
The pharmaceutical and specialty chemical industries are challenged with the requirement of faster time-to-process to meet market demands. Here, Modular Plants made up of predesigned process equipment assemblies (PEAs) are advantageous. Moreover, equipment-based Digital Twins of these modules can further reduce the time-to-process when combined with methods such as Quality by Design (QbD) and model-based design of experiments (MBDoE) to reduce uncertainty. This paper presents a lab scale-based workflow using an equipment-based Digital Twin, which applies QbD and MbDoE methods to identify the Design Space in the lab scale which can be transferred to production scale equipment as part of a Digital Twin based workflow for scale-up in Modular Plants.
The pharmaceutical and specialty chemical industries are challenged with the requirement of faster time-to-process to meet market demands. Here, Modular Plants made up of predesigned process equipment assemblies (PEAs) are advantageous. Moreover, equipment-based Digital Twins of these modules can further reduce the time-to-process when combined with methods such as Quality by Design (QbD) and model-based design of experiments (MBDoE) to reduce uncertainty. This paper presents a lab scale-based workflow using an equipment-based Digital Twin, which applies QbD and MbDoE methods to identify the Design Space in the lab scale which can be transferred to production scale equipment as part of a Digital Twin based workflow for scale-up in Modular Plants.
Record ID
Keywords
Digital Twins, Model-based Design of Experiments, Quality by Design, Scale-up
Subject
Suggested Citation
Koch A, Ebert J, Viedt I, Bamberg A, Urbas L. Digital Twin supported Model-based Design of Experiments and Quality by Design. Systems and Control Transactions 4:521-527 (2025) https://doi.org/10.69997/sct.166037
Author Affiliations
Koch A: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering; Technische Universität Dresden, Process-to-Order Group, Process-to-Order Lab Learning Factory
Ebert J: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering
Viedt I: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering; Technische Universität Dresden, Process-to-Order Group, Process-to-Order Lab Learning Factory
Bamberg A: Merck Electronics KGaA
Urbas L: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering; Technische Universität Dresden, Process-to-Order Group, Process-to-Order Lab Learning Factory; Technische Universität Dresden, Process-to-Order Group, Chair of Process
Ebert J: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering
Viedt I: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering; Technische Universität Dresden, Process-to-Order Group, Process-to-Order Lab Learning Factory
Bamberg A: Merck Electronics KGaA
Urbas L: Technische Universität Dresden, Process-to-Order Group, Process Systems Engineering; Technische Universität Dresden, Process-to-Order Group, Process-to-Order Lab Learning Factory; Technische Universität Dresden, Process-to-Order Group, Chair of Process
Journal Name
Systems and Control Transactions
Volume
4
First Page
521
Last Page
527
Year
2025
Publication Date
2025-07-01
Version Comments
Original Submission
Other Meta
PII: 0521-0527-1443-SCT-4-2025, Publication Type: Journal Article
Record Map
Published Article

LAPSE:2025.0235v1
This Record
External Link

https://doi.org/10.69997/sct.166037
Article DOI
Download
Meta
Record Statistics
Record Views
1071
Version History
[v1] (Original Submission)
Jun 27, 2025
Verified by curator on
Jun 27, 2025
This Version Number
v1
Citations
Most Recent
This Version
URL Here
https://psecommunity.org/LAPSE:2025.0235v1
Record Owner
PSE Press
Links to Related Works
References Cited
- VDI 2776 Blatt 1, Process engineering plants - Modular plants - Fundamentals and planning modular plants. 2020
- A. Koch, J. Mädler, A. Bamberg, and L. Urbas, "Digital Twins for Scale-Up in Modular Plants: Requirements, Concept, and Roadmap," in Computer Aided Chemical Engineering, vol. 52, Elsevier, 2023, pp. 2063-2068. https://doi.org/10.1016/B978-0-443-15274-0.50328-0
- J. Mädler, A. Koch, A. Bamberg, and L. Urbas, "Process Validation in Modular Plants considering the Scale-Up and Prior Knowledge," in Computer Aided Chemical Engineering, vol. 52, A. C. Kokossis, M. C. Georgiadis, and E. Pistikopoulos, Eds., Elsevier, 2023, pp. 2057-2062. https://doi.org/10.1016/B978-0-443-15274-0.50327-9
- VDI/VDE/NAMUR 2658-1:2019, Automation engineering of modular systems in the process industry - General concept and interfaces, Oct. 2019
- A. Klose et al., "Anforderungen an die Orchestrierung modularer Prozessanlagen," 2019,
- R. Rosen, J. Fischer, and S. Boschert, "Next Generation Digital Twin: an Ecosystem for Mechatronic Systems?," IFAC-Pap., vol. 52, no. 15, pp. 265-270, Jan. 2019, https://doi.org/10.1016/j.ifacol.2019.11.685
- A. Bamberg, L. Urbas, S. Bröcker, M. Bortz, and N. Kockmann, "The Digital Twin - Your Ingenious Companion for Process Engineering and Smart Production," Chem. Eng. Technol., vol. 44, no. 6, pp. 954-961, 2021, https://doi.org/10.1002/ceat.202000562
- M. Schleipen, A. Lüder, O. Sauer, H. Flatt, and J. Jasperneite, "Requirements and concept for Plug-and-Work: Adaptivity in the context of Industry 4.0," - Autom., vol. 63, no. 10, pp. 801-820, Oct. 2015, https://doi.org/10.1515/auto-2015-0015
- J. Pfrommer, D. Stogl, K. Aleksandrov, S. Escaida Navarro, B. Hein, and J. Beyerer, "Plug & produce by modelling skills and service-oriented orchestration of reconfigurable manufacturing systems," - Autom., vol. 63, no. 10, pp. 790-800, Oct. 2015, https://doi.org/10.1515/auto-2014-1157
- J. Pfrommer et al., "An ontology for remanufacturing systems," - Autom., vol. 70, no. 6, pp. 534-541, Jun. 2022, https://doi.org/10.1515/auto-2021-0156
- S. Chatterjee, C. M. V. Moore, and M. M. Nasr, "An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture," in Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture, 2017, pp. 9-24. https://doi.org/10.1002/9781119356189.ch2
- D. M. Bates and D. G. Watts, Eds., Nonlinear Regression Analysis and Its Applications. in Wiley Series in Probability and Statistics. Hoboken, NJ, USA: John Wiley & Sons, Inc., 1988. https://doi.org/10.1002/9780470316757
- N. Asprion et al., "Implementation and Application of Model-Based Design of Experiments in a Flowsheet Simulator," J. Chem. Eng. Data, vol. 65, no. 3, pp. 1135-1145, 2020a, https://doi.org/10.1021/acs.jced.9b00494
- G. Franceschini and S. Macchietto, "Macchietto, S.: Model-based design of experiments for parameter precision: State of the art. Chemical Engineering Science 63(19), 4846-4872," Chem. Eng. Sci., vol. 63, pp. 4846-4872, Oct. 2008, https://doi.org/10.1016/j.ces.2007.11.034
- J. Mädler, Smarte Process Equipment Assemblies für die Unterstützung der Prozessvalidierung in modularen Anlagen, Als Manuskript gedruckt. in VDI Fortschritt-Berichte Reihe 20, Rechnerunterstützte Verfahren, no. Nr. 480. Düsseldorf: VDI Verlag GmbH, 2023
- A. Koch, J. Madler, A. Bamberg, and L. Urbas, "Towards PEA Matching from Simulation as Part of a Digital Twin Concept for Scale-Up in Modular Plants," in Computer Aided Chemical Engineering, vol. 53, Elsevier, 2024, pp. 595-600. https://doi.org/10.1016/B978-0-443-28824-1.50100-9
- R. Soni and G. Jyoti, "Kinetics of esterification of acetic acid with n-butanol over different homogeneous acid catalysts," Int. J. Chem. Kinet., vol. 56, no. 2, pp. 96-104, Feb. 2024, https://doi.org/10.1002/kin.21694
- M. P. Ochoa, S. García-Muñoz, S. Stamatis, and I. E. Grossmann, "Novel flexibility index formulations for the selection of the operating range within a design space," Comput. Chem. Eng., vol. 149, p. 107284, 2021, doi: https://doi.org/10.1016/j.compchemeng.2021.107284
(0.13 seconds)
[0.13 s]

