ABSTRACT

I. BATCH PROCESSES Batch is "A process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time using one or more pieces of equipment" (1). This definition of a batch process recognizes that the amount of material produced in a single batch is finite. Batch also ''means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture" (2). Unlike a continuous process, extending the run time of a batch process does not result in the production of additional product. Products manufactured in batches are dependent on three factors: the sequence of process actions used to produce the product, the quantity and quality of the material used in each process action, and the operating parameters used in executing each process action. Changes to any of these factors can alter the product produced. This has the implication that multiple products can be produced using a single recipe procedure in the same set of process equipment.