Well statistics is all great for the academic type, but not always warranted.
Let’s say…you want to validate a tank sterilization process…let’s say a media sterilization…so basically, we ask ourselves, what is the acceptance criteria for performing a sterilization on a media in a process tank?
Success = Sterile Media after whatever predefined days of incubation, following your sterilization process
Failure = contaminated media after whatever predefined days of incubation, following your sterilization process.
Do its 3x for us in Canada/US and 5x for Eur and voila PQ performed. You’ve proven, through 3x/5x consecutive sterile media samples that your PQ of that particular piece of equipment is successful.
This is over simplied but should get the point across.
Clear as mud?