An allergen changeover must prevent unintended transfer from the previous product to the next. Validation establishes whether a defined cleaning procedure can achieve the required control under relevant conditions; routine verification checks whether that procedure continues to be followed and effective.
Choose the changeover conditions that present the greatest credible challenge, including the allergenic material, equipment surfaces and areas that are difficult to clean. Document the cleaning steps, dismantling, chemicals and operating conditions. Select sampling locations and methods that can detect the relevant allergen; a general hygiene result does not automatically demonstrate allergen removal.
Agree on acceptance criteria before collecting results. Record the method's limitations and how the sampling plan addresses the production sequence. A passing result from an easily reached surface is weak evidence if residue can remain elsewhere and enter the next batch.
Keep the study, raw results and approved procedure together. Define routine checks and the response to a failed changeover. Reassess the evidence after changes to recipes, equipment, cleaning methods or the production sequence rather than assuming the original study covers every future product.
Codex codes of practice: allergen management
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