CLEANING METHOD VALIDATIONS

During the manufacturing process, the residues of the Active Pharmaceutical Ingredient may stick to the equipment even after the cleaning process is undertaken, thus affecting the quality of next production cycle. It is also possible that the equipment gets contaminated from the residues of cleaning agents deployed like detergents or solvents. It is therefore important to ensure that the processing equipment is devoid of any potential contaminants and is suitable for pharmaceutical manufacturing.

Cleaning method validation assures that the cleaning process which has been employed not only removes residues of API but also other potential contaminants as degradation products and residues from the cleaning processes.