Design space strategy

The strategy of design, illustrated in Figure 8.1, consists of an evolutionary search of the feasible design space by means of a systematic combination of thermodynamic analysis, computer simulation and only limited experiments. The approach is generic for developing a RD process, at least for similar systems. The first element of similarity is the existence of an equilibrium reaction with water as product This raises the problem of possible aqueous-phase segregation. The second element is the similarity of thermodynamics properties over a class of substrates. However, while the fatty acids and fatty esters manifest a certain... 

Process analytical technology (PAT) can be developed early in development with a line of sight to commercial process control (ICH Qll 2011a). Easily integrated into the process equipment, as shown in Fig. 7.1, the application of in-line probes can provide unique opportunities to monitor processes in line. Spectroscopic techniques such as ultraviolet/visible (UV/VIS), near-infrared (NIR), and Raman can be utilized in line at the extmder die to ensure critical quality attributes (CQAs) such as composition and amorphous conversion of the API. Validation of these techniques at the pilot scale and transfer to the commercial scale allow for efficient manufacture of commercial material in a continuous manner and the implementation of a process control strategy that enables material outside the design space to be diverted to waste... 

Before describing the design space exploration strategy, we introduce first the concept of concurrency factor to measure of the degree of parallelism among subsets of shareable operations Q Q V. This concept is used extensively in resource allocation and heuristic exploration of the design space. 

Using the conflict-free allocation as guideline, a set of resource allocations ai,...,afc is specified either by the user manually or by the system automatically. Hebe supports both exact and heuristic strategies to explore the design space they are summarized below. 

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