Covers development and evaluation of cleaning and disinfection processes, including cleaning parameters, soil removal, representative surfaces, disinfectant selection, contact time, microbial challenge studies, recovery controls, and demonstration of effective cleaning and microbial control.
Cleaning validation should verify a cleaning process that has already been developed, characterized, and translated into a controlled operating procedure. Formal validation is not the appropriate stage for determining whether a detergent concentration is adequate, how long a surface should…
Disinfectant efficacy studies demonstrate that the disinfectants and sporicidal agents used in GMP cleanrooms and controlled areas can achieve the required microbiological reduction on surfaces representative of the actual facility when applied under defined operating conditions. The study should evaluate…