Why blending validation is required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during validation?

Blending validation is required to provide sufficient documented evidence to assure that the blending operation of the product is capable to mix the material repeatedly and reliably producing a homogeneous material to meet established specifications when operated under defined standard operating conditions.

The following Quality parameters are to be considered, but not limited:

1. Loss on Drying/ Water content

2. Bulk density/ tapped density

3.Residual solvent

4.Particle size

The following parameters are to be considered for the equipment during validation, but not limited:

1.Blender capacity

2. RPM of the blender

3.Occupancy of the blender

4.Number of individual batches to be taken for each blend

5.Mixing time