SELECTION OF CLEANING AGENTS AND PARAMETERS FOR CGMP PROCESSES by GeorgeVerghese

Selecting suitable cleaning agents and determining justifiable cleaning process parameters are critical prerequisites for cleaning validation. Proper selection of these cleaning agents and parameters could simplify cleaning validation efforts immensely. Process cleaners may range from a single component, such as an organic solvent, to multicomponent formulations that use multiple cleaning mechanisms such as solvency, solubilization, emulsification, wetting, chelation, dispersion, hydrolysis, and oxidation. Although the most important cleaning parameters are cleaning time, impingement-level, cleaning solution concentration and temperature, other factors that influence cleaning performance may include, nature of the substrate, surface finish, soil conditions, soil levels before cleaning, level of mixing, water quality, and rinsing. Proper selection of cleaning agents and parameters can be achieved through laboratory evaluation followed by field confirmation, and requires an understanding of substrate and design constraints, residue limits, desired cleaning objectives, cleaning chemistry and the contribution of various parameters to performance.