
The Application Notebook
During the manufacture of active pharmaceutical ingredients (APIs), the formulation of drug substances, and therapeutic fill and finish, the removal of residues from manufacturing equipment is performed by a series of cleaning procedures. It is imperative that the production equipment be properly cleaned in order to avoid cross-contamination of drug products.1-3 The efficiency of the cleaning procedures must be demonstrated through cleaning validation. This involves demonstrating that residual API, starting material, intermediates, and impurities have been removed from the production equipment.









