As per I.P. for a batch size of 100 numbers (ampules, vials, etc) of a parenteral product, minimum numbers recommended to be tested for sterility are
1
10% or 4 numbers, whichever is greater
2
10% or 6 numbers, whichever is greater
3
05% or 2 numbers, whichever is greater
4
05% or 3 numbers, whichever is greater