What often happens to change the original state of ‘hygienic design’ in a processing system and, therefore, deserves attention when it comes to maintenance?

A quick review of the FDA’s Office of Regulatory Affairs  Form 483 inspection reports of food processing operations sheds light on some of the leading conditions that may contribute to adulterated food. An FDA Form 483 is issued at the conclusion of an inspection where conditions or practices would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

Based on Form 483 data from 2015, the highest frequency of reports documented deficiencies in some aspect of plant design, GMPs (good manufacturing practices) or sanitation practices. The deficiency reports reinforce the need for plant operators to embrace a “holistic” approach to hygienic design and the link between hygienic equipment design, facility design, cleaning and sanitation. 

Facility design requirements

The deficiency reports cite numerous facility design issues beginning outside the plant. Plant exteriors should be solid, smooth, and minimize gaps and nesting spots. Exterior lighting should meet code requirements. Access ways should be paved, well-drained and maintained.  Exterior landscaping should be minimal, close to the building.

The facility layout must be designed to prevent contamination of food. Separation and traffic patterns must be established and enforced between the raw and ready to eat (RTE) workers and operations. These operations include sanitation, maintenance, management and quality assurance.  Visitors and contractor traffic must be controlled. Products, ingredients, rework, and packaging materials must be segregated.  Portable equipment must be properly identified, stored and used. 

Foot cleaning scrubbers, baths and foamers must be available and used properly. The design must provide for separate drainage outfalls between different processing operations such as RTE, raw, special or batch processing and general sanitary discharge.

Sanitation planning is fundamental to facility design. The sanitation equipment and chemistry plan must be defined prior to the process design and development.  The room and equipment design will follow with the sanitation plan in mind.

Keep it simple

Simplicity is one of the keys to interior facility design.  Materials and surfaces should be inert, non-porous, non-absorbent and cleanable, and all joints should be minimized and sealed. Refrigeration and HVAC requirements should take into account the conditions under operation as well as sanitation. 3-A SSI maintains 3-A Accepted Practice 612-00, Plant Environmental Air Quality, which is a widely used reference in new construction for the materials, design, fabrication and installation of equipment used to produce and handle plant environmental air in processing, packaging and storage areas.

It also provides guidance for the air quality to be maintained in food processing, packaging and storage areas.  These conditions are considered necessary to minimize contamination of product, product contact surfaces and open containers.

Floor drains must be properly sized, configured and positioned to allow for easy access and cleaning. 

The fundamentals

When it comes to equipment installation, hygienic welding is critically important. 3-A SSI posted a free presentation from a recent education program, Hygienic Welding: How Do You Know When It’s Right?, from the Nickel Institute (see information below). 

Whether you have some experience or you are just starting to develop expertise in hygienic design, you should check out three new e-learning modules developed by 3-A SSI which are interactive and available 24/7 at no charge:

1.0. Overview of Principles of Hygienic Design & Foundation Elements. This begins with a brief introduction to 3-A SSI and the important role it plays in hygienic design. This module emphasizes the holistic approach to hygienic design and the link between hygienic equipment design, facility design, cleaning and sanitation, operational design and the basics of quality and regulation.

2.0. The Basics of Hygienic Equipment Design. This module covers the basic principles of hygienic equipment design for equipment that will be used to produce or process a wide variety of products for human consumption, as well as pet foods.

3.0. Basics of Hygienic Facility Design & Environmental Controls. This module provides the basics of design and environmental controls for food processing facilities. This module covers non-product contact surfaces, air, water, steam utilities, as well as building interior, exterior, and the overall site location.

You can find the new modules, recent meeting presentations and many other resource papers in the Knowledge Center at www.3-a.org.