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Designing a successful allergen cleaning validation study
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To undertake the evaluation, a work programme with several phases was agreed with the client.
Four different applications were chosen for addition of the ingredient. Each application required different processing including baking, pasteurisation, fermentation and dry blending. Concept samples were prepared in the development kitchen to assess the addition of the test ingredient into the formulations. These were compared to a control formulation.
The use of different product applications and processing could determine if there were any issues with processing or any sensory impact of the ingredient. This was important to know before scaling up to pilot scale for storage trials. The samples were also used for analytical method development and validation which was required to provide the stability data for the novel ingredient during the storage trials.
Once samples were prepared at pilot scale they were assessed over relevant storage periods for the different applications, by analytical testing and sensory evaluation. This was performed to confirm if any loss of the ingredient during processing, or over time was observed, and to ensure there was no impact on the taste of the product by the addition of the novel ingredient.
The ingredient was found to be stable through each of the processes used for product manufacture. In addition, no losses were observed during storage for each of the products. The data generated was collated into a report and provided to the client for use as part of the regulatory submission for the novel ingredient. The data provided helped to achieve novel foods approval for the client's ingredient.
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