AOAC Gluten Quantitative Validation Guidance-Round 1(Nov 2023)

If the method is for swabbing of wet areas, the surfaces are ready for testing. If the method is meant to 115 test dried-on material, allow the gluten suspension to dry completely (overnight if necessary). 116 Cleaning solution studies for an environmental surface claim are voluntary. Cleaning solution studies are 117 to be performed as described in the following section. 118 Making Rinse Water/CIP/Cleaning Solution Study Samples 119 Make a high level suspension of gluten in kit extraction buffer or 60% ethanol, then dilute into water or 120 water/cleaning solution to the desired gluten concentrations, around the expected sensitivity level of the 121 method, as described in the validation requirements. The high level gluten solution in kit extraction buffer 122 or ethanol should not make up more than 1% of the final CIP (cleaning solution)/rinse water preparation, 123 to ensure that the sample is representative of a typical CIP (cleaning solution)/rinse water sample. If the 124 method is designed for rinse water testing, and the cleaning solution will not be tested at its 125 recommended working concentration, the dilution of the cleaning solution must be reported. 126 Cleaning solution (CIP) validations must be performed separately for each cleaning agent. Method 127 developers may choose to perform a validation in examples from each of the four main types of cleaning 128 solutions: degreasers, detergents, abrasives, and acids. But the validation will only be reported for the 129 specific cleaning agent that is used. 130 Figure 1. Options for generating bulk spike materials at various levels

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