How to set the Specification limits for UOD (uniformity) for live bacteria or spores?

eg., a label claim of 1-billion count

  • can we go for 85%-115% of specification for
  • in what cases we need to go for specification of NLT 100% count

now considering , contents could be
the whole content constitutes the live cells + other excipients
OR
it could be total fill weight delivering to total assay