GRANULATION CPP
Critical process parameters (CPPs) in granulation, whether wet or dry, are those that directly impact the Critical Quality Attributes (CQAs) of the final granules, such as particle size distribution, bulk density, and flowability. These parameters need to be carefully monitored and controlled to ensure consistent and desired granule properties. Key CPPs in Granulation: General Granulation: Impeller/Rotor Speed: Affects granule size, density, and uniformity by influencing mixing intensity and particle interactions. Chopper Speed: Controls the size reduction of granules during the granulation process. Granulating Solution Addition Rate: Influences granule growth and homogeneity by controlling the liquid binder distribution. Massing Time: Impacts granule growth, density, and strength by controlling the duration of mixing. Moisture Content: Crucial for granule formation and stability, affecting flowability and compressibility. Drying Temperature and...