Cleaning and Disinfection Validation

Abstract

Cleaning and disinfection validation, a good manufacturing practice (GMP), is a process undertaken to ensure that the cleaning and disinfection programme is capable of controlling all its identified hazard objectives. Such hazards could include pathogenic microorganisms, allergens, cleaning chemical residues and equipment lubricants. Validation establishes the absence of such hazards when the cleaning programme is undertaken under the worst-case scenario. This is typically the hardest soil to remove, from the most difficult area of the equipment to clean using a cleaning programme at its minimal acceptable parameters (times, temperatures and chemical strengths). Validation via experimental testing can be prospective (for new process lines) or concurrent (for existing lines) or can be retrospective for long established lines using established data. Once a cleaning programme has been validated, it is then routinely applied, monitored (is it working) and verified (did it work).