Flowsheet Modeling and Simulation Software License Support and Maintenance

Summary (Newest Update)

Background The U.S. Food and Drug Administration (FDA) is seeking to enhance the efficiency and quality assurance of the pharmaceutical sector through continuous manufacturing technologies. This emerging technology differs from traditional batch manufacturing by maintaining critical process parameters close to target values during normal operations, which can be affected by transient disturbances. The FDA recognizes the need for specific modeling and simulation tools to assess the impact of process dynamics on product quality and to support advanced control strategies in continuous manufacturing. Work Details The contract aims to procure a new license for gPROMS or an equivalent flowsheet modeling and simulation platform. The software must include model libraries for various processes such as blending, granulation, milling, feeding, compression, tablet coating, oral absorption, crystallization, and drying. The salient characteristics required for the software include: 1. A flowsheet modeling environment with a graphical interface and drag-and-drop functionality. 2. Intelligent line routing with differentiated stream types. 3. Steady-state and dynamic models for common process equipment (reactors, separators, flow transportation, heat exchangers). 4. Custom modeling capabilities for user-defined models. 5. Dynamic flowsheet models incorporating process control elements. 6. Parameter estimation from experimental data for model validation. 7. Global sensitivity analysis capabilities. 8. Estimation of physical properties using databases like Multiflash or DIPPR. 9. Steady-state optimization handling multiple decision variables simultaneously. 10. Support for multiple activities using the same model including simulations and optimizations. Period of Performance The total duration of this contract may not exceed five (5) years. Place of Performance The specific geographic location(s) for performance are not explicitly stated but will likely be within facilities associated with the FDA.