Elements for the development of a validation study plan

First, it is recommended that a qualitative risk assessment and then a semi-quantitative risk assessment be carried out to establish whether analytical testing is necessary or applicable.

Determining the level of allergen migration is essential for quantitative allergen risk assessment. So it is necessary to know that the "worst-case scenario calculation" can be used to estimate the level of allergen migration from one production run to another. Examples:

• Through the weighing of brushed waste or based on the thickness of a film on a piece of equipment, a measurement can be made of the total amount of material lost during a production process, which represents a high risk of cross-contamination.

• By measuring the levels of material lost in production, once dissolved in the next product or process step.

• By measuring how many materials are allergens, the level of allergens that can be consumed in the final product is determined.

When it is necessary to conduct an analytical study, it should be kept in mind that in order to use accurate and reliable results, it must be ensured that the sampling used is established within a properly designed study.

Subsequent sampling and analytical procedures must therefore be chosen and carried out appropriately. The "worst case" must be selected for the validation of a production line.

Of all the formulas in the production line, the one with the highest levels of allergens, and therefore the most difficult to clean, should be used, followed by an allergen-free marker formula or protein.

Visual inspection procedures and subsequent compliance with the "visually clean" standard should be followed in cases where commercial test kits are not available for analytical validation and other marker proteins cannot be used.

Analytical tests could generate unreliable results, in those foods such as dried fruit pieces, where contamination is not homogeneously distributed and could not be representative in the sampling, because it depends on the size of the particles.

Therefore, in cases where an analytical assay cannot be performed, the only alternative to carry out a successful validation study is to perform a visual inspection and ensure that there are no product residues through complianc