Sanitary Design Connections - Summer 2019

Sanitary Design Connections - Summer 2019

Jun 2019

While often overshadowed by other factors in epidemiological reports, hygienic/sanitary design of facilities and equipment is often the root cause of foodborne illness outbreaks or allergen issues, and is certainly an important element in creating and maintaining a desirable food safety culture. Inadequate cleaning and sanitizing programs and poor equipment design, construction and maintenance may be a direct, or an indirect, causative factor in foodborne illness outbreaks as well as being a factor in food allergen issues.

Food processors can choose from multiple rules, models and principles that will help formulate an effective writtenFood Safety Plan, which is now required by the Preventive Controls rules for both human and animal foods under the Food Safety Modernization Act. So how exactly can ‘3-A hygienic design principles’ really help?

The principles or models widely used state an outcome or goal, leaving the user wide discretion on how to attain theobjective. 3-A SSI design criteria spelled out in the American National Standard, 3-A Sanitary Standard for GeneralRequirements, ANSI/3-A 00-012018 can help processors ‘fill the gap’ by documenting the safety of equipment used in food processing in the following important respects:

Cleanable to a microbiological level

Surface finishes must be durable, free of cracks and crevices, and smooth to a minimum measure of 32 Ra(roughness average) for a product contact surface.

Made of compatible materials

Materials of construction, whether metals or on-metals, must be inert, non-toxic, non-corrosive, non-contaminating,and impervious to moisture.

Accessible for inspection, maintenance, cleaning and sanitation

3-A SSI criteria distinguish between equipment designed and fabricated for COP or manual cleaning and CIP cleaning. All product contact surfaces, including all CIP surfaces, shall be readily accessible and inspectable.

No product or liquid collection

All surfaces must be free draining and properly pitched or sloped to prevent any liquid (cleaning/sanitizing solutions, water or product) pooling.

Hollow areas should be hermetically sealed and no niches

Construction elements such as dead ends, gaskets, gasket retaining grooves, O-rings and seals, threads, springs, shafts and bearings must be bacteria-tight and accessible for cleaning, sanitizing and inspection. Joints of various types must be cleanable, crevice-free and bacteria-tight.

Sanitary operational performance and hygienic compatibility

3-A SSI requirements include the provision of instructions for installation of equipment and associated components, and instruction on the use of this equipment so that when installed and operated correctly, the product is not exposed to factors that can lead to contamination. This includes specific information on the materials and usages of gaskets, seals or O-ring materials when the product characteristics (e.g. high fat or high acid) or operational characteristics (e.g. vacuum or steam applications, or when used to create a bacterial tight seal between product contact surfaces and non-sanitary threads) demand a special application.

Hygienic design of maintenance enclosures

For non-product contact surfaces, 3-A SSI addresses surfaces, joints, coatings, cleaning and inspectability, draining, threads, hinges, panels, doors and access ports, guards and other safety devices, supports, and more.

Recent recall data shows the presence of undeclared allergens in foods and is viewed as a serious public health issue by the FDA. Recommendations regarding best practices for controlling allergens in a food manufacturing facility are available from the Food Allergen Research and Resource Program (FARRP), University of Nebraska-Lincoln, see Components of an Effective Allergen Control Plan: A Framework for Food Processors at .

When it comes to the design of equipment, vendor qualification is critical, and probably more so for suppliers of ‘non-standard’ equipment or processing systems. Nothing in the FSMA or the Preventive Controls rules specify design requirements, but the rules do call out the requirements for processor documentation of how they minimize or eliminate hazards. Food manufacturing firms must demonstrate due diligence in manufacturing products in a sanitary environment and sanitary design is key part of such demonstration.

3-A Sanitary Standards for equipment and 3-A Accepted Practices for processing systems are designed to provide assurance to food processors, audit professionals and regulatory sanitarians that the integrity of the food processing system and the safety of food is secure. The 3-A Symbol is available to equipment fabricators on a voluntary basis to signify the equipment was designed, manufactured and verified by independent inspection to conform to a 3-A Sanitary Standard. Without proper hygienic design and construction, validation of cleaning efficacy under varying conditions would not be feasible.

You can find information on obtaining 3-A Sanitary Standards and 3-A Symbol-authorized equipment at

PH 703.790.0295   |   FX 703.761.6284