Biological Indicator -Total viable spore count

#1

Hi,

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?

(Ankur Choudhary) #2

@Renu log is different from percentage don’t confuse between those.

1 Like
(Rakesh Kumar chowdhary) #3

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.

(Albert Groeneveld) #4

Interesting that an old question is living up again :slight_smile:

I think the OP is mentioning the %CV which can go up to 300% for BI

Log reduction is as followed.

  • 1 log reduction = 90% reduction
  • 2 log reduction = 99% reduction
  • 3 log reduction = 99.9% reduction
  • 4 log reduction = 99.99% reduction
  • 5 log reduction = 99.999% reduction
  • 6 log reduction = 99.9999% reduction