Allergen Cleaning Validation

Most food processing plants are designed to leverage the maximum number of different products on the fewest pieces of expensive equipment. One challenge for the food industry is changeovers from a product containing allergens to a similar product that does not contain allergens (or the same allergens) produced on the same equipment. Some companies employ precautionary allergen labeling such as “may contain” to all product on the same line or in the same facility; however, this may unnecessarily limit the choices of food-allergic consumers.

Furthermore, the U.S. Food and Drug Administration (FDA) has stated that precautionary labeling cannot be used as a substitute for Good Manufacturing Practices (GMPs), which implies that companies should try to clean between formulations. Other companies follow an allergen validation protocol to demonstrate an effective sanitation changeover and limit the use of precautionary statements to provide the allergic consumer with more food choices…

Sampling Procedures
Never do testing until you have a plan about what to do if you encounter a positive result. Planning for allergen testing requires clear communication and coordination with senior management to hold or destroy product, pending results of the testing. Some companies employ a testing plan termed “safe mode” wherein they run the same allergen product before and after sanitation so that if the swabs indicate inadequate cleaning, they can proceed to ship and have not put the consumer at risk. They can then modify the sanitation procedures prior to the next allergen validation testing. Management should plan to run the formula with the highest percentage of allergen to effectively assess the sanitation. Consideration should also be given to the form of the allergen, as peanut butter may be cleaned differently than peanut granules. Particulate materials can present a sampling challenge in which numerous samples may need to be tested to offer assurance that some sample would contain a particle if any were present. Management should also consider the method of sample shipping, laboratory scheduling and availability that may impact turnaround time of the results. Prior to testing, the swabs (certified allergen-free) from the kit manufacturer must be ordered and available for use (note: other swabs or sponges may actually contain the allergen due to recyclable materials or microbiological media in sponges). Other items to order include disposable gloves, phosphate buffer (certified allergen-free), labels for samples and a shipping container.

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For a step by step guide on how to validate and verify allergen cleaning procedure where production equipment is not dedicated:

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