About this course
Contamination risk in a food facility is often designed in or out of the building long before any product is made. This course covers hygienic design and zoning principles — how facility layout, traffic flow, and equipment design either support or undermine food safety — and ties those principles to FDA's current Good Manufacturing Practice (CGMP) requirements in 21 CFR Part 117.
21 CFR Part 117, Subpart B sets CGMP requirements for plant and grounds, sanitary operations, and facility design, including adequate water supply, proper drainage, and controls to prevent contamination of food, food-contact surfaces, and packaging. Building on that regulatory floor, established hygienic design practice separates a facility into zones — commonly described as raw/high-risk, low-risk, and ready-to-eat (RTE) areas — with controlled personnel, equipment, and airflow movement between them, because FDA defines ready-to-eat food as food that is normally eaten without further processing that would significantly reduce biological hazards, making cross-contamination from raw zones into RTE zones a serious risk.
This course is intended for production, sanitation, quality assurance, and facility engineering employees, as well as anyone involved in equipment selection or facility layout decisions. It provides the conceptual foundation; specific zoning maps, traffic-flow rules, and equipment specifications should be documented in the facility's own food safety plan.
After completing this course, learners will be able to explain why raw and ready-to-eat zones must be separated, identify common causes of cross-contamination such as shared equipment, tools, or personnel movement, describe basic sanitary equipment design principles, and recognize facility conditions that create contamination risk.
Topics covered
- Zoning concepts: raw/high-risk, low-risk, and ready-to-eat areas
- Personnel, tool, and equipment movement controls between zones
- Sanitary equipment design basics (cleanable surfaces, drainage, no harborage points)
- FDA CGMP requirements for plant and grounds under 21 CFR 117, Subpart B
- Common causes of cross-contamination in facility layout
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