Cleaning Validation and Verification
One of the areas of possible confusion is the requirements for allergen cleaning validation and verification.
Section 22.214.171.124.vii [Ver 9 >126.96.36.199] states; “Cleaning and sanitation of product contact surfaces between line changeovers shall be
effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from
product contact surfaces, including aerosols as appropriate, to prevent cross-contact.”
Section 188.8.131.52.viii [Ver 9 >184.108.40.206] states “Based on risk assessment, procedures for validation and verification of the effectiveness
of the cleaning and sanitizing of areas and equipment in which allergens are used shall be effectively implemented.
The SQF Code requires validation and verification of cleaning and sanitizing procedures for the product contact
equipment, and therefore the use of finished product testing for validation of cleaning is not considered adequate.
A program of verification needs to be built on an initial validation study that identifies the target allergen(s),
threshold levels, and the severity of contamination, and shows the cleaning process and testing used are effective
to give the desired results consistently. Once the cleaning process has been validated as effective, a
verification/monitoring/inspection program shall be established to assure that the validated cleaning process is
being used, is maintained and effective.
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of
concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable
level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being removed. These
generally require the use of a test method which uses an antigen (the allergen) and an antibody specific to the
antigen. One example of the antigen and antibody test is the enzyme linked immuno-assay or ELISA method. The
ELISA method can be either quantitative or qualitative and can be conducted in a laboratory or with test kits
available for in plant use; either is acceptable. ELISA test kits are available from several manufacturers and are
commonly used in the food processing industry. Lateral flow test devices also use an ELISA-based method and are
also effective in detecting specific allergens. While lateral flow devices are qualitative only, most have sensitivities
around 10 parts per million (ppm) and are available for most of the common allergens and are designed for use in
a plant environment.
Both the ELISA tests and lateral flow test kits have been accepted by recognized allergen research scientists and
meet the requirements for sanitation validation of the SQF Code. It must be noted that there may be other
‘acceptable’ tests for validation methods that can be used but the test must meet the “allergen specific” criteria or
provide some other evidence that the validation is effective. The SQF Institute does not endorse any particular
technology or methodology and relies on the site to provide the evidence of a scientifically validated and effective
cleaning method. Like any validation of any food safety control, periodic re-validation is required to account for
any changes that may have occurred. Not all allergens have specific test kits available which includes some fin fish
and allergens that have been modified by fermentation, heating or hydrolysis.
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must
verify that the validated procedures were used each time. This verification must be documented by a responsible
person from the site who has been trained in the validated cleaning method. The most common method used is
direct observation of the validated cleaning procedure during the sanitation process. Another acceptable
verification method is the use of highly sensitive swabs that test for proteins. These recently developed swabs will
detect total protein at approximately 20 ppm. Since these devices only test for total protein and not specific
allergens, they are not acceptable for validation but will serve to verify that equipment has been thoroughly
cleaned. There are also sensitive ATP test swabs available however the presence of ATP does not indicate the
presence of protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive
swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated
method is used and recording the results of both the allergen specific test and the protein or ATP swab test. It is
also to ensure surface swabbing is occurring at corners, joins, and crevices in the equipment as well as open
surfaces, to check for protein held up in equipment.