Food Allergens - Validation or Verification
To some, this determination may seem straightforward, but for many new to Quality Control or for those that have just been voluntold that their plant is going to start making a product that contains an allergen, the question of what is needed to control or mitigate cross-contamination can come up quite quickly and seem quite daunting. Q Laboratories is happy to help by giving a quick primer on the differences, the similarities, and what type of testing may be right for your plant.
Regarding allergens, typically, the goal is to ensure the absence of detectable allergenic proteins in products that undergo processing in the plant. Products can range from those produced on lines that routinely run allergens following sanitation or any product produced in the plant if the facility is allergen free.
A good first step in the process of determining if a validation or verification is needed is to determine what allergens if any are in the plant. This step may seem obvious, but as those of us who work/have worked in operations know, a second look at the way things have always been done can be quite helpful. Items to consider may range from how raw materials come into the plant to what employees are or are not allowed to bring in their lunches. After taking a holistic look at your site, it is important to consider the way allergens are controlled in the plant (stored, moved around, applied/mixed, exc.) or if there are no allergens in the plant, how the plant makes sure they stay out (employee food policies, testing of incoming ingredients, etc.). From there, the facility can determine what type of testing they will need to perform, if that testing is verification or validation, and if they feel they should send out or do it themselves.
Sorting it out
Verification is testing to verify that the specifications/requirements you have are met. For example, testing your gluten free product to ensure that it is truly gluten-free to meet your labeling claim or testing your raw materials to ensure they match the COA and are allergen free.
Validation is testing your process to ensure it enables you to meet those specifications / requirements. For example, you test your line that is soiled with gluten, you preform your sanitation SOP and test again (at least 3 times) to ensure that after following the SSOP for that line there is no longer any gluten proteins present. In other words:
Validation: Are we using the correct system?
Verification: Are we using the system correctly?
What type of sampling is needed?
If performing a verification, the most likely type of sampling will be of raw materials as they come into the plant, swabs/rinse water samples from the line post sanitation to confirm the sanitation process eliminated the allergen proteins, or finished product samples from the beginning, middle, and end of the production run following an allergen changeover.
If performing a validation, the most likely type of sampling will be swabs from the line pre and post sanitation along with rinse samples/swabs from the line post sanitation to confirm there is no allergen present. This can be further proven with product testing from the first, middle, and end of the production run post sanitation. Regardless of the initiative, the more data points a facility can collect the better as it helps make the validation data set more robust.
DIY or send out?
Allergen testing, whether for a verification or validation, can be accomplished via ELISA methods, lateral flow devices, or PCR from several manufacturers. With this in mind, it is important to remember that not all tests are created equal. Different kits used to detect the same allergen may have different limits of detection (LOD) depending on manufacturer and technology (lateral flow, PCR, or ELISA). Also, worth noting is how well technicians performing the test are trained, whether they are internal or at a third-party lab, as this can lead to large variations in your data set or worse erroneous results. Last, the cost. Will you have to spend large amounts of your quality budget buying kits, training your staff, and interpreting the results, or would it be cheaper and faster to send out? If you do the testing in house, can you prove that it's valid during an audit? If sending out, is the lab ISO 17025 accredited to run allergen testing?
In conclusion, allergen validations and verifications aren’t as daunting as they seem when you ask the right questions, get help if you need it, and have reliable resources like Q Laboratories to help guide you through the process. If you have questions or are interested in learning more about how Q Laboratories can help you with your validation or verifications, please contact us. We can test almost any matrix for almost any allergen in an ISO 17025 accredited lab with 5-day turnaround time or less.
One Call. One Shipment. One Lab