Second Edition, May 2017 - Sterilization is a heat treatment aimed at destroying all vegetative microorganisms and spores to create a product which can be stored at ambient temperature yet minimizing public health hazard. There are however many reasons why, in practice sterilized products may present a microbiological health hazard. Due to the sterilizer process design, the operation and control or inspection and maintenance of the sterilizer there are a risk of untreated or recontaminated product may reach the consumer. This document provides guidelines to avoid these issues.