Advanced Real Time Process Management for Continuous Pharmaceutical Manufacturing Processes

Achievement date: 

An advanced real time process management (RTPM) framework has been developed at the Center for Structured Organic Particulate Systems (C-SOPS), an NSF-funded Engineering Research Center (ERC) based at Rutgers University, to resolve critical Quality by Design (QbD) issues in continuous pharmaceutical manufacturing processes.


Continuous pharmaceutical manufacturing currently lacks an integrated system of hardware and software elements for robust real-time execution of model-based control algorithms. While real-time process management (RTPM) is already a critical component of most QbD systems, the current state-of-the-art demands more intelligent fault diagnosis and mitigation methods for viable applications in pharmaceutical manufacturing systems.


The advanced RTPM process developed by C-SOPS resolves these issues through incorporation of automatic control, process monitoring, data reconciliation, diagnosis and exceptional events management (EEM), and real-time optimization (RTO). The framework uses process models and knowledge stored in the wider knowledge management infrastructure to derive the proper operating actions and to transmit them to the control software and hardware. The mathematical models used in this advanced RTPM system are based on contributions from the relevant model development projects throughout the C-SOPS research portfolio and all of its application testbeds.