we are about to test 3M coconut protein allergen as cleaning verification. it is a laminar flow device kit (LFD) - quite similar to a pregnancy test kit, w/c shows (+) or (-) to coconut protein.
lowest limit detection is 2ppm, upper limit detection is ~1.6 mg/ml or 1,600ppm.
for cleaning validation, we will run the coconut protein LFD parallel w/ 3M ATP clean trace.
target standard we would like to get:
with a (-) reading in coconut protein LFD, we shall take the corresponding ATP (RLU) reading and set that as our cleaning verification standard for ATP.
as coconut protein LFD is quite expensive, we shall retain using ATP
would you find this validation activity sound?
thanks ahead and would appreciate comments!
There may be some confusion over Validation and Verification.
Similarly to Post 3 I speculate that you are attempting to achieve Validation and Verification that your cleaning procedure achieves removal of coconut allergen from relevant surfaces.
To elaborate Post 3, here is SQF's interpretation of, as I understand from the OP, yr dual activities -
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 [which] 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.
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.
The purpose of a validated cleaning program is to confirm that the specifics of the cleaning process used are complete,effective, sufficient, and when implemented, will produce that same results every time.