An effective cleaning, disinfection, and biodecontamination program is essential for maintaining contamination control in controlled environments. This program can be organized using a lifecycle model that encompasses three key phases: design, qualification, and monitoring. This presentation focuses on the design phase, outlining how to systematically assess and classify cleanroom areas through a comprehensive risk assessment. By understanding the specific requirements of each area and surface, we can develop a strategic approach to cleaning, disinfection, and biodecontamination.

Additionally, aligned with the standards set forth in Annex 1, the presentation will address critical topics, including the importance of cleaning prior to disinfection and the effective removal of disinfectant residues. A brief case study will illustrate these concepts in practice, demonstrating the application of our proposed strategies.