Tablet compression and coating equipment commissioned

Oral solids introduce a hazard sterile manufacture does not have: dust. Powder from one product travelling to another is a cross-contamination route with no downstream step that removes it, so the installation is built around containment — dedicated dust extraction, airlocks with pressure regimes that hold powder in rather than out, and cleaning procedures validated for the actual changeover matrix.

“In a tablet plant, the pressure cascade runs the other way — you are keeping powder in, not keeping air out.”

Qualification covers blend uniformity across the mixing time, compression force and weight control across the tablet press's speed range, and coating uniformity and residual solvent where a coating is applied. Each is demonstrated at the conditions the process will run at, not at a comfortable midpoint.

In-process controls — weight, hardness, thickness, friability and disintegration — are established with their sampling frequencies before the first validation batch is made.