The probability of bacterial spores surviving a thermal process: The 12D myth and other issues with its quantitative...

The concepts of "D-value," "thermal death time" and "commercial sterility," innovative and useful at their inception, are based on untenable assumptions, notably that the log-linear isothermal inactivation model has universal applicability, that extrapolation over several orders of magnitude below the detection level is permissible, and that total microbial inactivation is theoretically impossible. Almost all commonly observed inactivation patterns, the log-linear is just a special case, can be described by both deterministic and fully stochastic models, examples of which are given. Unlike the deterministic, the stochastic models predict either complete elimination of the targeted cells or spores in realistic finite time, or residual survival. In most cases, the published survival data do not contain enough information to establish which actually happens. The microbial safety of thermally processed foods can be compromised not only by under-processing but also by a variety of mishaps whose occurrence probabilities are unrelated to the inactivation kinetics. Moreover, the available sampling plans to detect microbial contamination in sterilized containers through incubation alone are insensitive to levels of potential safety concerns. In principle, many of these issues could be resolved by developing new dramatically improved detection methods and/or verifiable methods to predict very low levels of microbial survival.