Currently trying to calculate the alert and action levels for a purified water system after completing phase 1 of PQ
Using the following equations:
Alert Level = Average + 2 x Standard Deviation
Action Level = Average + 3 x Standard Deviation
when i use these equations, my action level for microbial count is well over the specifications (no more than 100 cfu/ml)
Is this normal? Does this mean my TVC counts are too high to progress to Phase 2 of the PQ?
Any suggestions on what to do with this information would be helpful.