Process optimization is a documented verification that the process and/or total process related system performs as intended throughout all anticipated operating ranges.

In this article we try to briefly mention the critical parameters of solid products to be optimized during a new product and process development.

Granulation Optimization

  • Granulation time
  • Speed of choppers (I & II) or mixer blades
  • Solvent addition rate and overall amount
  • Ratio of intra-granulate Disintegrant and binders agents
  • Milling Configuration, Screen size and speed
  • Evaluation of optimized granules (BD, TD & PSD)
  • Drying temperature versus target LOD and range limits and the effect on granulate and tablet properties (flow, capping, sticking).

Blending Optimization

  • Effect of level of lubricant: Lubricant Split into two parts (pre-blending and final blending).
  • Effect of Blending Time and Speed

Compression Optimization

  • Evaluation of Content Uniformity and Dissolution Profile.
  • Evaluation of unit dose sampling vs. Content Uniformity
  • Effect of hardness on tablet properties (Aging, dissolution, friability).
  • Evaluation of Hardness Range Limits
  • Evaluation of stability results of optimized mfg. process

Prepare Process Optimization Report. This Process Optimization Report forms part of the product Development Report.