ABSTRACT
INTRODUCTION: CONTINUOUS PROCESSING OF SOLID DOSAGE FORMS For decades, the manufacturing of solid dosage forms in the pharmaceutical industry has been synonymous with batch processing, using a series of unit operations to modulate the properties of the material being processed. According to the FDA definition, batch manufacturing uses “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” (FDA Part 210 and 211, Current Good Manufacturing Practices for Manufacturing, Packing, or Holding of Drugs). When the predetermined endpoint of the batch process is reached the unit operation is finished and only then product quality is assessed, via off-line analysis in quality control labs using a wide array of (often destructive) analytical tools. During off-line analysis, the processing cycle is stopped and the in-process materials are stored in the manufacturing plant until it is assured that product quality meets the predefined quality parameters. If these quality standards are not met, the entire batch is either rejected or reprocessed.
