What is Hygienic Design (Sanitary Design) and why is it important?
Hygienic design is the integration of thoughtful engineering to minimize the risk of contamination within the production environment of food and beverage production. Hygienic design should include forward-thinking ongoing sanitation and cleaning of the elements needed for food production. A proper hygienic design program will have techniques that allow for all assets to be cleaned effectively and efficiently in order to minimize the risk of any kind of contamination hazards.Hygienic design is not limited to only equipment. The building design, as well as the manufacturing infrastructure, must be considered as well. This may include appropriate zoning for segregating different hygiene areas as well as traffic patterns for employees, raw materials, and finished products.
The food industry is made up of older and newer facilities and equipment. Hygienic design is not limited to only newer facilities. It is important to develop and implement a hygienic design program in facilities that are older and/or aging, to include all infrastructure and equipment.
Since the passing of the Food Safety Modernization Act and the evolution of Whole Genome Sequencing (WGS) and its use by the FDA, there have been numerous findings from regulatory inspections and results from WGS that have shown pathogens can be and have been persistent in facilities (and equipment) for long periods of time. Repeat findings of pathogens in the environment can be a result of poor cleaning and sanitation programs. However, if there is poor hygienic design of a facility and/or equipment, even the best cleaning and sanitation program may not be enough. There are numerous warning letters issued by the Food and Drug Administration (FDA) which read something like:
This evidence demonstrates that Listeria monocytogenes has maintained its presence within your facility. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or harborage site present. These findings also demonstrate that your sanitation procedures have been inadequate to control, reduce or eliminate this pathogenic organism.
Based on FDA’s inspectional findings observed during the inspection, we determined that food manufactured in your facility is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
Hygienic Design ultimately helps support the production of quality food and helps protect public health. It can help protect your and your customer’s businesses and brands!