In the chemical processing industries, there is tremendous pressure to shorten the time to market. The urgency is particularly felt in pharmaceutical industry since the development of a successful drug from concept to finished product can take over a decade. Cost is also an important issue. Effective communication plays a key role in reducing the process development time, since the conversion of a bench scale recipe to a scalable process involves different parties with divergent focus of work. It is important that critical data/information be available at the right time to expedite the work process....[ Read more ]

In the chemical processing industries, there is tremendous pressure to shorten the time to market. The urgency is particularly felt in pharmaceutical industry since the development of a successful drug from concept to finished product can take over a decade. Cost is also an important issue. Effective communication plays a key role in reducing the process development time, since the conversion of a bench scale recipe to a scalable process involves different parties with divergent focus of work. It is important that critical data/information be available at the right time to expedite the work process.

This dissertation responds to the process development challenges encountered during crystallization process synthesis, which plays an important role in generating high purity solid products. We have presented an approach for integrating chemistry research and process design with the use of composition space. The approach guides members in a process development team to identify the feasible process alternatives by integrating different activities (e.g. experiment and modeling) in an effective manner. Since the approach is intended to provide a general framework for synthesizing crystallization process for simple organic substances, further details on specific issues are required to extend its application for synthesizing organics with complex solid-liquid equilibrium phase behavior. The approach for synthesizing polymorphs and solid solutions are therefore presented as they are commonly found in specialty chemicals.

Further development efforts involving experimental work is necessary to obtain a more realistic process design. Important experimental data are first defined and then determined before process synthesis takes place. To illustrate this point, the development of separation and purification of amino acids, L-leucine and L-valine, which exhibit solid solution phase behavior, is thoroughly discussed.