a) Determine the worst case situation (if possible). As long as you can determine the most contaminating process and link it to an individual clean room, the validation study will be able to be conducted only in that clean room and consider it as a representative case.
b) The disinfection procedure will be applied three consecutive times immediately after three processing activities. This means that the disinfection procedure will always have to be applied immediately after the processing activities in routine.
c) The alternation of the disinfection products is strongly recommended so the disinfection procedure must be applied using all the products involved in the disinfection program. Consequently at least six runs will be needed.
d) The period of time while the disinfection efficiency is kept must be determined through microbial monitoring.