ABSTRACT
The development of many different pharmaceutical processes is facilitated by execution at an intermediate scale of operation in a facility that is often called a “pilot plant.” Pilot plants in the global health care industry are used in support of bulk pharmaceutical chemicals, biotechnology processes, and dosage form manufacturing to define the process beyond what discovery scale efforts can. They often utilize small scale or lower throughput pieces of equipment requiring lesser quantities of material substantially reducing the consumption of what is often very expensive developmental material. Pilot plants are utilized for a variety of reasons including: preparation of materials for clinical or toxicology evaluation, optimization of process parameters, and evaluation of different lots of active raw materials.
