Process validation is the first step to take when installing new equipment, creating new products or seeking to understand the lethality of existing equipment. It is the action to scientifically give the evidence that an industrial process has a constant effect of pathogenic destruction. The evidence can be supported by documentation5, mathematical modeling, risk assessment and evaluating preventive controls using surrogate microorganisms. The main idea is to validate the kill-step used for production, i.e. the oven, extruder, frying system etc. In other words, validating that this particular industrial process is capable of systematically eliminating a predefined ratio of undesired pathogenic microorganisms: it is called ‘the log reduction’6.
Following data analysis, a validation report needs to be prepared.