MICROBIAL PROCESS VALIDATION

Microbial Process Validation consists in validating with scientific information that a process is capable of effectively mitigating a microbial hazard of concern. The ability of a process to inactivate a target pathogen is usually measured by the log reduction of the pathogen in a target product. For instance, a 5-log reduction of Salmonella in a spice product, a nut, a flour product, etc. using a thermal process. Process validation is a cornerstone of the major international Food Safety Standards & Regulations.

Conducting a proper validation project usually requires using a combination of scientific methodologies, which can be categorized in 3 groups:

  • Literature review
  • Mathematical modeling
  • Experimental trials at lab, pilot and plant-scale

In-Plant Validations Studies

In-Plant Validation Studies are usually considered as a “gold standard” for they provide real-life data of a process efficacy. Data generated from in-plant trials provide food processors with the highest level of scientific robustness, as the tests are performed directly on the process to validate, in its real industrial environment.

Since the use of a pathogenic microorganism in processing facilities is not advised, surrogate microorganisms are used as test organisms for in-plant validation studies. Surrogates are non-pathogenic microorganisms that mimic the resistance of foodborne pathogens under different kinds of stress (heat etc.). Due to their safety, surrogates are used directly at the plant (pilot or industrial), to test the efficacy of microbial kill steps. In order to streamline in-plant process validation studies, Novolyze has developed SurroNov®, the first range of dried, ready-to-use surrogate bacteria.

THE SURROGATE IS INOCULATED AT HIGH AND CONTROLLED CONCENTRATION WITH A FOOD INGREDIENT

CONCENTRATION
8-LOG CFU/G

THE INOCULATED FOOD IS INTRODUCED IN THE PROCESS TO VALIDATE

SURROGATE
= NON-PATHOGENIC
= SAFE IN-PLANT USE

POST-PROCESS SAMPLES ARE RECEIVED AND ENUMERATED

CONCENTRATION
3-LOG CFU/G

PROCESS LETHALITY = 5 – LOG

Novolyze is able to coordinate an in-plant validation project at each step. A standard project usually includes four different steps:

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