Your FDA inspector will ask to see your validation study in your food safety plan. We have been talking to many companies who need a validation study of their kill step. In a previous post in this blog, Validation of Thermal Processes, I wrote about the need for validation of kill steps in processing. These steps are process preventive controls and part of your food safety plan.
There are options for getting the data you need for a validation of your process preventive control. You can use technical, published data; we recommend a Google Scholar search. You can partner with a local expert found at your contract lab, university, extension office, or consulting firm. While only required for manufacturers of acidified and low-acid canned foods, we like the idea of using a food process authority. A food process authority is someone who will work with you to validate your process with your equipment and with your product.
A food process authority can do many things for you. They will partner with you to evaluate the worst-case parameters of your processing equipment. Where are the cold spots? Where is the product exposed to the shortest time of processing? Does the temperature drift over the duration of a long shift? Have you scientifically determined the longest run time for your equipment? There are so many variables to assess, and a food process authority will make sure you are addressing all the variables.
A food process authority is often a food engineer or chemical engineer. You want to hire someone who has been in a lot of food facilities with a variety of processing equipment. With experience like that, they will have applied their knowledge in many operations and may have seen a set up like yours or worked with the same equipment at a different facility.
Where will you find a food process authority? At the same places listed above. Every state has a land-grant university. Every land-grant university employs university extension personnel, and it is among the extension personnel that you can expect to find a process authority. I found a listing of food process authorities by state on the website of the Association of Food & Drug Officials:
ConnectFood has a marketplace to access process authorities for acidified foods. If you are looking for process authority services, you may create a free account to access the Expert Marketplace and find one that fits your needs.
Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.