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Comment 11271
Assigned (Unresolved)
173i66 - JC Memo & Ballot.pdf (Revision 0)
Approval of 173i66 - Probiotic Viability
Comment Submitted by
Mark Jost
2022-10-28 11:02:36

What the minimum quantity in the example is trying to say or show is unclear to me. Is it saying your spec is 30 billion CFUs  but the minimum to pass is 1 Billion?

Example: Total quantity of probiotic cultures claimed on the COA or on the label is 30 billion CFU/serving (3x1010 CFU = 10.5 log10 CFU/serving). Minimum acceptable level is 1x1010 CFU = 10 log10 CFU/serving.

Submitter Proposed Solution
Marco Pane
2023-11-22 9:50 am Eastern Standard Time

In microbial enumeration practice it is recognized a general uncertanity of 0,5 log on the plate count readings (CFU). Thus I think that the example refer to the condition which, given a declared potency at the end of the shel-life, any results that are within the 0,5 log uncertainty are conform and not out of spec. 

In industrial real life practice, becasue of this issue, the producer overdose the product at t0 both to encompass reduction in stability and method variability.

Hope it helps!