Maintaining Hygienic Design
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 (ORA) 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 to firm management 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 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.
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 and located so as not to attract insects and vermin into the building. LED lighting, unlike electric arcs or mercury-vapor lamps, can produce virtually no UV that will attract insects. 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 raw and RTE food handling 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, used properly and properly maintained. 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.
Simplicity is one of the keys to interior facility design. Materials and surfaces should be inert, non-porous, non-absorbent, 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 very 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, constructed and positioned to allow for easy access and cleaning. Walls and
penetrations, floors, ceilings, utilities and lighting all require special consideration.