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Sterility Assurance Level (SAL)

A statistical measure defining the probability that a product is free from viable microorganisms, typically expressed as 10−610^{-6} (a one-in-a-million chance of non-sterility).
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The statement of the theorem

Define the Sterility Assurance Level (SAL) as the probability P(N>0)P(N>0) that a product contains at least one viable microorganism NN. If the probability of non-sterility is PfailP_{fail}, then SAL=Pfail\text{SAL} = P_{fail}. For a target SAL of 10−610^{-6}, the probability of failure is defined as: Pfail=10−6P_{fail} = 10^{-6} This implies that the probability of sterility, PsterileP_{sterile}, is Psterile=1−10−6P_{sterile} = 1 - 10^{-6}. This level is typically achieved by ensuring the total log reduction log⁡10(N0/Nf)\log_{10}(N_0/N_f) exceeds the required safety margin.