The cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients and cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. As a result of any pharmaceutical unit process, a residual level of the drug substance remains on the equipment and facility even after clean up. Cleaning is a challenging task and the design of the cleaning system depending upon the equipment use (dedicated/multipurpose), manufacture (continuous/batch), cleaning equipment (manual/automated), preparation (commercial product/clinical supplies), product formulation i.e., type of materials being removed from the surface, drugs (low risk/high risk), sterile/non sterile, solids/liquids and solubility (soluble/insoluble) of active ingredients. An acceptable cleaning system should incorporate the following elements. So this paper give the very good information about the cleaning procedure and develop the new method for the cleaning after the production of the tablets and do the validation of that developed analytic cleaning swam method.
Loading....