Allergen Control: Top 10 Considerations

Posted by Charles Giambrone


1. .Know your processing lines and products: the number of specific allergens in specific products and the production lines on which they are produced. Understand frequency of changeovers from Product A, with Allergens 1,2,3, to Product B, with Allergens 4,5,6. 

2. Determine the typical number of allergen changeovers on a processing line/equipment units in a day, a week , and a month’s worth of production: for example, if you are going to have only 3 changeovers on a line per month, the number of allergen verifications & validations or re-validations will vary widely vs. a line that has several allergen changeovers per day.

3. Schedule the changeover from non-allergen to allergen product: proper scheduling, whether it’s on a daily or weekly basis, will then let you clean the equipment and production line to remove the allergen(s) in question to the time frame closest to the next scheduled sanitation shift.

4. Review the SSOPs for equipment and lines to determine the most effective cleaning regimen and sanitation products for the complete removal of all allergen soils: typically, you want to utilize a chlorinated alkaline cleaner with the appropriate cleaning tools to efficiently remove the protein fraction which contains the allergen[s] in question. For dry cleaning environments, effectively remove all removable sub-components to clean in a controlled wet environment, such as a washroom, and use all dry cleaning and sanitization tools and methods available to remove the allergen proteins.

5. Conduct the proper validation study to ensure cleaning to a validated standard: once the SSOPs, cleaning products and equipment have been established, a proper validation study then needs to be done for each critical allergen type for each changeover scenario on each processing line and equipment. Preferably for the initial validations, each study should consist of 2-3 replicates.

Ensure the proper, approved test kits for each allergen are employed. You can include kits both for food contact surfaces (e.g. Neogen Reveal 3D kits) and products (e.g. Neogen Alert {Qualitative} and Neogen Veratox {Quantitative}).

6. Review all scenarios of changeovers to determine proper test sites for allergen validation: not only do you need to assay the proper Zone 1 & 2 sites to test, but choose the most problematic unique sites and surfaces.

7. Based on your HACCP program risk assessment, you must determine the frequency needed for each type of allergen via validation: no government regulator or GFSI certifying-body will dictate or prescribe how often each specific allergen validation needs to be performed.

It could be yearly, semi-annual or quarterly. But it should be based on your HACCP programs risk assessment in concert with the number and frequency of allergen changeovers in your plant’s lines and equipment.

8. Verification test methods and frequency: once your initial validation studies are successively completed, you must have established rapid protein detection test procedures performed frequently on equipment and processing lines.

The verification procedures for allergens include visual, ATP and sensitive protein tests. Hygiena, 3M, Neogen, R-Biopharm all manufacture rapid protein detection kits. For example, Hygiena has both Pro Clean and Aller Snaps. While both detect general protein residues, the Aller Snaps have a greater degree of sensitivity but require a heating block for the swab samples while the Pro Clean swabs do not.

Once you have established your procedures, again allergen verification frequency, like validation, is dependent on same number of changeovers per day, and per week of production. You need to utilize verification data for both Post-OP and Pre-OP environments.

Also, verification frequencies are dependent upon your risk assessment of the products in question on the changeovers. For example, for high risk products, verification tests should be done for every changeover, while medium risk could be monthly, and low risk could be quarterly.

Post-OP verification shows the allergen residues have been removed from production surfaces. Pre-OP verification test results tell us whether it is safe to begin the next production run.

9. Ensure verified allergen-cleaned equipment is protected from cross contact: if equipment will sit for hours after its cleaned, and can get easily cross-contacted with allergens from the production environments, then the program needs certain procedures.

•  Shift the sanitation of a line to a time closer to the next production run for that line.
•  Or segregate the cleaned equipment.
•  Or cover exposed cleaned equipment with poly wrap sheets to prevent cross contact.
•  Or schedule a re-cleaning and sanitizing lighter SSOP.

10. Allergen sanitation must be fully documented with periodic finished product testing for allergens: in order to buttress your allergen sanitation validation and verification programs, the documentation must be thorough and audited by both internal and third-party consultants. This, in parallel with testing actual products for target cross- contacted allergens in high to medium risk products, will close the loop in a comprehensive program.




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