If we are getting nil microbial count on pure steam sample through out the phase 3rd qualification how we will set alert and action limit.
Action limit and alert limit is a based on your trend analysis report.
e.g: if you get trend analysis report will be on 50CFU you fixed to 20CFU action limit and 10CFU alert limit.
Sir is there is any guidelines which states that we can set it by taking some percentage of specification limit.
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