Process Development, Optimization, and Scale-up: Powder Handling and Segregation Concerns

Publisher Summary This chapter outlines several factors that are considered in designing bulk solids handling equipment ensuring consistent, reliable flow, and minimize segregation. It also focuses on the equipment used from the final blend step to the inlet of the press/encapsulation machine used to create the unit dose. Final blending may be accomplished on a batch or continuous basis. In the pharmaceutical industry, batch blenders are used almost exclusively because the batch blending has historically provided tighter quality control in terms of better uniformity and batch integrity, as compared to continuous blending. The flowability and segregation potential of the final blend is especially critical during storage and discharge from an intermediate bulk container (IBC). The IBC may be a bin or a drum that is used to store and transfer the final blend from the blender to the press. IBCs may be used to store the blend for extended periods of time. During this time, the flowability may deteriorate as the blend is subjected to consolidation pressures, due to its own weight during storage at rest. In addition, IBCs may be used to move the blend from one process step to another, during which time the blend may be subjected to vibration that may adversely affect flowability.