Allergen cleaning validation method
Started by VDM2024, Nov 19 2024 03:15 PM
Hello,
What is the appropriate quantitative method that we can use to validate the cleaning for allergen risks?
Regards
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ATP swabs of food contact surfaces
specific allergenic protein testing of food contact surfaces (swabs, rinses, etc)
specific allergenic protein testing of first products produced after cleaning.
Validation = Quantitative (how much allergen is present?)
- Your sampling validation plan should be discussed with the laboratory (the laboratory must be accredited), talk to them about factory allergens and potential cross-contamination, they should suggest ELISA tests.
- Based on the risk assessment you need to establish cross-contamination points - example : Line no.1 produces bars with almonds and, straight after production wants to switch to plain bars. Production is unable to produce plain bars first (this would eliminate your point of cross-contamination) but sometimes this is not possible. In this case, you need to validate your cleaning regime during the changeover. The best practice is to collect three separated tests of 3-4 swabs from points of contact before cleaning and again after, from the same points after cleaning. Focus on difficult-to-clean areas (worst-case scenario)
- Sometimes, the product is sticky/loose, and particles cannot be removed 100%, hence why most factories decide to use "may contain the statement" unless they are producing products with free-from claims.
- There is no internationally recognised definition of acceptable allergen levels.
- ATP swabs and lateral flow devices are good for verification (qualitative).
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