Analysis of an Aseptic Process and Defining a Cleaning and Sanitization Plan
Cleaning and disinfection plans are a complex strategy to manage contamination risk in classified areas. Production residues (powder, oil, salts, etc.) and personnel-related contamination risk (production line in isolator, RABs, open line) should be e1aluated first before preparing and implementing cleaning and disinfection plans. The key aspects of decontamination should be defined according to the risk management approach. Variables that increase or decrease risk should be identified, analyzed and assessed in order to develop, maintain and improve process control.