The platform combines digital twins, modular production concepts, and integrated quality assurance into a seamless digital approach. With VIMOPROP, production facilities can be assembled from pre-planned, reusable modules with plug-and-produce capabilities. Simulations and digital twins realistically model components and processes, enabling virtual testing, scenario comparisons, and informed decisions regarding process planning, product changeovers, and scaling—all while significantly reducing the need for physical testing.
A key feature of VIMOPROP is the integration of quality assurance and compliance right from the virtual development process. Concepts such as Quality by Design, real-time quality monitoring, and continuous testing of critical process and quality parameters are firmly embedded in the platform. Simulation results are automatically checked against defined quality and performance metrics, and virtual certification reports are generated to accelerate industrial validation and recertification processes.
To date, the development of ATMPs has been characterized by manual manufacturing steps, high costs, and regulatory hurdles. VIMOPROP addresses these challenges by breaking down the manufacturing process into individual components, which are represented as digital twins. This database enables flexible adjustments to the production facility, comprehensive consistency checks, and audit trails, and facilitates rapid recertification—a crucial step for implementing “Plug & Produce” concepts in the pharmaceutical industry.
The approach was successfully demonstrated using a use case involving sterile media preparation. The results show that industrial production processes can be virtually validated and efficiently adapted to new requirements. In this way, VIMOPROP creates a digital foundation for agile, scalable, and regulatory-compliant pharmaceutical production and supports companies in the step-by-step implementation of Pharma 4.0 into industrial practice.
The project received 400,000 euros in funding from the Rhineland-Palatinate Ministry of Science and Health (MWG) over the course of one year.
Fraunhofer Institute for Experimental Software Engineering IESE