What will be acceptance criteria for total viable spore count verification of Biological indicator Bacillus atrophaeus ?
As per updated USP it should be 50-300% recovery of labelled claimed , in that case can we set our acceptance criteria minimum -0.3 log (50%) and maximum 0.48 log (300%) for calculated BI spore count?
Minimum acceptance criteria should be as per vendor recommendation. Especially when it purchased from outsource .
Log is based on addition or reduction by factor 10.