Validation for food allergens in an environmental monitoring program

Allergenic food isolated on whiteCleaning in a food production environment is a critical base to any facility’s food safety program. The importance of an effective cleaning process cannot be overstated. Failures can result in biological, chemical (including allergens) or physical material contamination of future production.

The challenge for most food production facilities is in establishing objectives and standards that can be measured in a meaningful way. Since most food contaminants that can represent a safety issue for consumers are either microbial or chemical/allergenic proteins, the optimal cleaning process will result when these entities are either removed and/or rendered inert. For that reason, most facilities utilize a cleaning process, which focuses on the removal of the soil that can house these contaminants, followed by a sanitation step to render any remaining microbial organisms inert.

Allergen cleaning validation is specific to each unique product produced by the facility. Therefore, it is necessary to perform a validation for each product risk profile. Once all cleaning processes have been established, a facility may choose to operate with separate SSOPs for the allergen containing product or standardize on the most rigorous SSOP across all product lines.

Best practice for validating the cleaning process

Allergen guidelines are typically expressed in parts per million (ppm). This measurement is appropriate when considering final product concentrations but does not easily translate to environmental surfaces. For this reason it is recommended to utilize a scoring scale system for environmental swab results tested with a quantitative test. Scoring on a scale of green, yellow and red eliminates the confusion of interpreting a ppm result. With this scale a green result provides a high level of confidence that your testing results meet expectations. Results with a score of yellow can identify where additional cleaning is necessary but can also demonstrate progress toward the goal of green scores. Note: This scoring system only applies to environmental swab testing and not finished product testing.

Due to the sensitivity of the quantitative ELISA assays, any result above the published limit of detection (LOD) should be considered positive and recleaning should be done. If using a qualitative lateral flow device (such as Neogen’s Reveal 3-D tests), yellow and red will correlate to a “positive” and “high positive” score. It’s important to note that various commercially-available test kits have different LODs, hence it is not possible to correlate a quantitative result with a qualitative result down to LOD levels. The chart below is a practical method for interpreting results.

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Final product testing for allergens can be an important validation and verification tool for your overall food safety program. Neogen’s Veratox test kits determine the concentration of a target food allergen in ingredients, liquids, clean-in-place rinses and in finished foods. If during the risk analysis you’ve identified unintended food allergens as a risk, preventative controls should be in place to ensure the risk is eliminated. In this case, final product testing is encouraged.

Determining appropriate testing sites

The objective for any environmental monitoring program is to achieve a representative sampling of the area of concern. While there is no right or wrong number of test sites, the focus should be on testing each site that represents a unique surface (material, complexity, and location), unique cleaning protocol and unique product composition as well as those areas that represent unique cleaning challenges such as welds, corners and other harborage areas. Representative sampling for validation should also occur before and after thermal processes to ensure that the test can detect the allergen in raw and finished product.

Sampling areas for environmental monitoring programs may be broken down into zones based on their proximity to the product. Zone 1 would typically be defined as surfaces that come into contact with the product. Zones 2, 3 and 4 would be non-contact surfaces of lessening probability that could contribute contaminants through some type of interaction with people, equipment or air and water circulation.

Zoning allows for monitoring to be conducted in environmental areas where the product and food contact surfaces are more susceptible to allergen cross-contact, to those areas that are far removed from the product, but may still have an impact on quality.

For allergen cleaning verification, testing sites should be concentrated in Zone 1, as this is where the product is most susceptible to allergen cross-contact. Testing these surfaces/areas will help to identify hot spots of allergen cross-contact that can directly affect the product and product contact surfaces. Testing in zones 2, 3 and 4 can pinpoint allergen cross-contact sites outside of the production area.

A best practice approach to determining appropriate testing locations should include a consultation with sanitation and maintenance staff as well as equipment and sanitation chemical suppliers.

For more information about best practices for food allergen validation and verification as well as a complete line of environmental monitoring products, click here to visit Neogen’s webpage dedicated to helping facilities establish robust environmental monitoring programs. 

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