Implementing an allergen cleaning validation program ...

1 Test typeFrequencyVisual examinationEach changeoverATP swabsWeekly at pre-opAllergen surface swabsWeekly after a changeoverAllergen testing of productQuarterlyTable 2. A sample set-up for a clean:vacuum + brushWet clean:warm water + detergentProduct purgeSoyflourAlmondpasteLiquideggCoconut shavingsSoyflourAlmondpasteLiquideggCoco nutshavingsSoyflourAlmondpasteLiquideggC oconutshavingsSmooth stainless steel7777777 Stainless steel mesh belt77777777 Polyethylene7777777 Vinyl tubing77777777 Table 1. The crosses indicate a combination of method/surface/soil that is not in Food Hygiene Volume 26 Number 3by Stephanie Lopez and Mirka Morales,AIB International, 1213 Bakers Way,Manhattan, KS 66502, most prominent food safety topicswithin the industry are allergencontrol and cleaning validation .

2 Themost commonly issued recalls involveallergens, a life threatening contaminantwhich is often overlooked through labellingand/or operational errors, cross contact, cleaning techniques, and lack of monitoringwithin an cleaning validation is a multi-stepprocess that, in many cases, requires aperiod of data collection and trial and errorto determine the most effective cleaningmethodologies. Common practices while performing anassessment and validation may includeproduction volume changes, producthold/destruction/non-conformancep rocedures and also, costly testing and/orsampling which could lead to unexpectedresults or potential needs for root causeanalysis or immediate corrective actions toresolve such , putting consumers at risk forallergens associated with food processingpractices can be a dangerous risk and a veryfrightening situation for a business tomanage.

3 These practical tips will help you createand implement an allergen cleaningvalidation program that will handle andminimise associated risks within a awarenessEach global region has a regulatory guidancelist on what is considered a declarableallergen. It is recommended to beconscientious not only of the allergenswithin the country of processing, but alsocountries where product will be exportedto. The allergen type identified and physicalstate it is in plays an important role todetermine adequate cleaning methods forvalidation. Knowing if the allergen is presentin liquid, powder, or solid form can affectresidue removal capabilities.

4 Peanuts and tree nuts that contain a highoil content may require a detergent toeffectively remove residuals from thesurface, equipment, utensil, or area. Theobjective with allergen cleaning is toeliminate as much residual as possiblewithout compromising the area and alsomaintain within approved concentrationranges for any agents that may be used as adetergent or cleaner. Allergens in powdered form will typicallycreate a greater risk in product zones due topotential dustiness and airborne dispersal ofthe ingredient. The affected surfaces forpowdered allergens expand beyond thephysical limits of a direct food contact areasAlthough food manufacturing designstandards are improving within the industry,much of the processing equipment orproduct contact surfaces are made ofstainless steel which does not oxidise likeImplementing an allergencleaning validationprogram: practical tipsInternational Food Hygiene Volume 26 Number 319the galvanised version and is consideredsmooth and easily cleanable for allergensand other types of product residue.

5 It isimportant to inspect non-smooth areas,such as rough welds, die-cut rollers andmesh belts, and devise cleaning mechanismsto assure no residue remains hidden withinthese hard to reach product contact types of surfaces commonly foundin food plants include various types of plastic(polyethylene, UHMW, polycarbonate,PVC, vinyl), rubber, glass, wood and of these are easily cleaned on the line,while others, such as cloth, may need to belaundered to remove and smoothness are twocharacteristics of surfaces that will largelyinfluence the ability for residue ( allergen orotherwise) to be removed.

6 For this reason,the effectiveness of cleaning must bevalidated for each type of methodsThere are three categories of cleaning forallergen removal:lDry purge (can be wet or dry).Dry cleaning does not involve water orchemicals. It may be done by brushing,wiping, or vacuuming. The use of air hoses isstrongly discouraged for allergen removalsince the risk of dispersing the allergen istoo great. Dry cleaning is appropriate fordry allergens with little to no oil cleaning involves water and oftenchemicals (alkaline or acid cleaningcompounds).A great deal of emphasis is put onsanitising food contact surfaces for obviousreasons.

7 However, it must be understoodthat sanitisers do not remove residue,including allergen protein. Product purge involves running productthrough a line in an effort to remove theresidue left from prior production. Thistypically becomes an option when thesurfaces that need to be cleaned areenclosed and are not easily accessed and thematerial that will be used for the purge canbe recovered and re-used in a formula thatcontains all of the material purged or isinexpensive and can be working with product purge as theallergen removal method, the amount ofproduct that must be purged must beestablished in the procedure and validatedthrough testing.

8 Keep in mind, productpurge may address an allergen concernwithout addressing a microbial are two approaches to testing: testingthe cleaned surface and testing the productthat is produced after the surface has beencleaned. Both testing methods havelimitations, primarily from the nature ofsampling. By conducting both types oftesting, the most variables are kits may be purchased and used onsite or samples may be taken and sent to anoutside laboratory to conduct testing. Forvalidating allergen changeover cleaning , allergen specific testing is necessary, types of post- cleaning validationtests, such as general protein residual orATP tests, will not provide the specificinformation that is needed to demonstratethat allergenic protein has been removed.

9 If you are validating removal of anallergenic protein for which there has notyet been a test developed, you will need torely on results from similar allergens thatyou run on the line in combination withvisual examination and/or ATP results. Each combination of method, soil, andsurface type that will be used must bevalidated. Table 1 is an overview of thecombinations that you may have. Detailedwritten cleaning procedures must beestablished beyond the informationprovided in this steps involved in testing are:lRun a product with an the line/equipment with theestablished the surface(s) after cleaning andtest for the allergen in question and/orlSample the first bit of product from thesubsequent run (not containing the sameallergen) and test it for the allergen all products produced in thesubsequent run until results have the results indicate the absence ofdetectable allergen , the line may be usedand any held product may be the results indicate allergen carryover:the held product must be destroyed (orused in a formula that declares all carryoveringredients).

10 LThe line must be re-cleaned (with adifferent method, which could be amodification of time, temperature, and/orchemical, etc).Since there will be product held, manycompanies opt to perform the tests on siteto expedite results, especially when dealingwith short shelf-life product has shipped and has testedpositive for an undeclared allergen it willneed to be reported on the ReportableFood Registry and depending on where it isin the supply chain, is likely to be susceptibleto a Class I are some other testingconsiderations that may be made. Forexample, a company may currently have adedicated line for a given allergen .