Sanitary Equipment Design: Cleanable by Design, Proven by Records
Meet 21 CFR 117.40 first, write any 3-A or EHEDG criteria into the purchase specification, and review designs before buying.
In Short
- 117.40 sets the legal baseline.
- 3-A and EHEDG are voluntary.
- Review design before purchase.
The Food Processing Operations Guide
Safe changeovers. Right labels. Every lot traceable.
- The rules and the plan
- Supplier to filled tray
- Allergen changeovers and pack checks
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The Food Processing Operations Guide
Safe changeovers. Right labels. Every lot traceable.
Equipment that cannot be cleaned cannot be kept safe. For US food facilities, 21 CFR 117.40 sets baseline requirements for equipment and utensils: cleanable design, suitable materials, installation that allows cleaning, and protection against contamination and allergen cross-contact. 3-A Sanitary Standards and EHEDG guidelines are voluntary design criteria many buyers reference. This review read the current eCFR text of 21 CFR 117.35 and 117.40; 3-A and EHEDG documents were not opened. This guide summarises the sources named here; it is orientation, not legal advice. Sources checked 5 Oct 2026.
The Legal Baseline In 117.40
Section 117.40(a) requires plant equipment and utensils to be designed and made of material and workmanship that are adequately cleanable, and maintained to protect against allergen cross-contact and contamination. Equipment must avoid adulterating food with lubricants, fuel, metal fragments or contaminated water, and be installed to allow cleaning of the equipment and adjacent spaces.
21 CFR 117.40 at a glance
| Paragraph | Requirement |
|---|---|
| (a)(1) | Adequately cleanable; maintained against cross-contact and contamination |
| (a)(3) | Installed to allow cleaning of equipment and adjacent spaces |
| (a)(4)-(5) | Food-contact surfaces corrosion-resistant and nontoxic |
| (b) | Seams smoothly bonded or maintained |
- (a)(1)
- Requirement
- Adequately cleanable; maintained against cross-contact and contamination
- (a)(3)
- Requirement
- Installed to allow cleaning of equipment and adjacent spaces
- (a)(4)-(5)
- Requirement
- Food-contact surfaces corrosion-resistant and nontoxic
- (b)
- Requirement
- Seams smoothly bonded or maintained
More on the Legal Baseline In 117.40
Food-contact surfaces must be corrosion-resistant, nontoxic and able to withstand the food, cleaning compounds and sanitising agents used.
Seams, Joints and Maintenance
Section 117.40 also requires food-contact surface seams to be smoothly bonded or maintained to minimise accumulation of food particles, dirt and organic matter. Equipment in manufacturing or food-handling areas that does not contact food must be constructed so it can be kept clean.
More on seams, Joints and Maintenance
Wear changes this over time: gaskets crack, welds pit, belts fray. Planned inspection and maintenance keep equipment in the condition its original design assumed. Record what was found and fixed, so recurring wear points become visible.
Where 3-A and EHEDG fit
3-A Sanitary Standards and EHEDG guidelines are voluntary criteria developed by industry bodies for hygienic design and, in some cases, testing or certification of equipment. Buyers often specify them in purchase requirements.
More on where 3-A and EHEDG fit
They are not FDA regulations, and their texts were not opened for this review. Record in your purchase specification which criteria you require, how conformance will be shown, and who accepts the evidence at delivery. Keep that evidence with the equipment record.
Design review before purchase or modification
A short documented design review before buying or modifying equipment catches most problems: product-contact materials, surface finish, drainability, dead legs, access for inspection, disassembly needs, compatibility with your cleaning chemicals and allergen changeover. Include sanitation, maintenance and food safety people.
Design review checklist (before purchase)
More on design review before purchase or modification
Record actions and close them before commissioning. Changes to installed equipment follow the same review through change control, so the record shows who accepted each risk and why.
Linking design to cleaning and verification
Section 117.35 requires food-contact surfaces to be cleaned as frequently as necessary to protect against allergen cross-contact and contamination. Write cleaning procedures for each piece of equipment based on how it is actually built, including disassembly steps.
More on linking design to cleaning and verification
Verification such as visual inspection, swabbing or environmental monitoring shows whether the design and procedure work together. When verification fails repeatedly at one spot, treat design as a possible cause.
Questions
Is 3-A or EHEDG certification legally required?
No. They are voluntary industry criteria. US food facilities must meet 21 CFR 117.40; buyers may require 3-A or EHEDG in contracts.
What does 117.40 say about food-contact surfaces?
They must be corrosion-resistant, made of nontoxic materials, withstand the food and cleaning agents, and be maintained to protect against contamination.
Who should take part in a design review?
Engineering, sanitation, maintenance and food safety. Each brings risks the others may miss, and the record should show their sign-off.
How do we know a design is cleanable in practice?
Verification such as inspection, swabbing or environmental monitoring after cleaning shows whether the equipment and procedure work together.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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