Fraunhofer Institute for Experimental Software Engineering IESEModular Software Platform for Pharma 4.0: Virtual Planning and Certifiable Quality
Fraunhofer IESE Develops VIMOPROP for Digital Pharmaceutical Production
The Fraunhofer Institute for Experimental Software Engineering IESE has developed VIMOPROP, a modular software platform that supports pharmaceutical manufacturers in the virtual design, simulation, and commissioning of production processes. The platform makes a concrete contribution to the implementation of Pharma 4.0 by combining digital twins, modular production concepts, and integrated quality assurance in a consistent digital approach. The goal is to make complex production environments – particularly for the manufacture of Advanced Therapy Medicinal Products (ATMPs) – more flexible, efficient, and compliant with regulatory requirements.
Virtual planning and modular production design for Industry
With VIMOPROP, production facilities can be assembled from pre-planned, reusable modules with plug-and-produce capabilities. Digital twins and simulations realistically model plant components and processes, enabling virtual testing, scenario comparisons, and informed decisions regarding process planning or adaptation, product changes, and scaling – while significantly reducing the need for physical trials.
“The pharmaceutical industry faces the challenge of designing highly complex processes in a flexible manner while simultaneously meeting the strictest regulatory requirements. With VIMOPROP, we have created a digital foundation to systematically ensure quality and regulatory compliance right from the virtual development process. The project results show that production processes can be adapted more quickly, risks identified earlier, and validation efforts significantly reduced,” says Rolf van Lengen, VIMOPROP project manager and Research Manager for Digital Healthcare at Fraunhofer IESE.
Virtual Certification as an Enabler for Pharma 4.0
A key feature of VIMOPROP is the end-to-end integration of quality assurance. Concepts such as Quality by Design, real-time quality assurance, and the continuous monitoring of critical process and quality parameters during runtime are firmly embedded in the platform. Simulation results are automatically checked against defined quality and performance metrics. On this basis, virtual certification reports can be generated that specifically support and accelerate industrial validation and recertification processes.
“We developed VIMOPROP so that digital twins, simulation, and quality documentation work together seamlessly. Using the FERAL co-simulation framework, different models are executed synchronously and automatically compared against stored quality and compliance requirements. This results in transparent and traceable verification – from the individual module to the entire production process,” explains Dr. Jessica Mariño Salguero, an engineer in the Virtual Engineering division at Fraunhofer IESE.
The applicability of the approach was demonstrated using a laboratory-based use case for media preparation. The results show how industrial production processes can be validated virtually and efficiently adapted to new requirements.
With VIMOPROP, Fraunhofer IESE, together with its project partners, is creating a digital foundation for agile, scalable, and regulatory-compliant pharmaceutical production and supporting companies in the step-by-step implementation of Pharma 4.0 into industrial practice. The project was supported by the Rhineland-Palatinate Ministry of Science and Health (MWG) with a grant of 400,000 euros over one year.
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