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FOOD SAFETY AND

SANITATION

Sanitary Design Chapter


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Learning Objectives
• Prevent sanitary design issues from contributing to sanitation difficulties, pest infestations, airborne
contamination, drainage issues, and other food safety concerns
• Plan building improvement and construction projects in a way that addresses potential
contamination issues related to cleaning and maintenance challenges
• Isolate products that are susceptible to microbiological or allergen issues from raw and untreated
materials or those containing allergens
• Select appropriate wall and floor surfaces for the type of activity that takes place in each area of
the facility
• Use doors as a barrier between production areas and external areas, to direct equipment, people,
and product traffic patterns, and to keep pests out of the building
• Maintain an 18-inch perimeter between the wall and any stored product or raw material to allow
for inspections, cleaning, and maintenance of pest monitoring devices
• Choose food-contact surfaces, including equipment and utensils, that are durable, easily
cleanable, non-absorbent, and non-toxic
• Install and maintain equipment in a way that facilitates cleaning, maintenance, and inspection
activities
• Monitor the condition of equipment through self-inspections
• Collaborate with representatives from sanitation, quality, maintenance, the HACCP team, and
production to understand how equipment changes will affect the entire production process
• Evaluate new equipment or equipment modifications for design flaws that would inhibit good
sanitary practices

Table of Contents
What is Sanitary Design?..................................... 2 Evaluation ...........................................25
Standards for Sanitary Design .......................... 2 Sanitary Design Reference Card .............25
Outside Grounds ........................................... 3 Food-Contact Equipment Workshop .......27
Building Design and Construction .................... 5 Outside Grounds Workshop ..................28
Equipment and Utensils................................. 22 Building Construction Workshop ............29
Sanitary Design Parameters ........................... 23 Sanitary Design Considerations
Installation and Maintenance......................... 25 Workshop ............................................30

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What is Sanitary Design?


Every food manufacturing and storage facility should establish
clear guidelines for the construction of the structure and the design
and installation of equipment to produce safe, legal food products
by protecting their integrity. Proper sanitary design guidelines
will reduce food safety risks, improve the ability to properly clean
equipment and structures, and increase overall efficiency.

Improperly designed structures and equipment that are difficult to


clean and inspect may allow insects to harbor in unreached areas.
Allergen residues, food debris, microbiological organisms, and
other materials may also be located in these areas and may lead to
contamination issues for products being produced in the facility or
on the equipment.

The goal of sanitary design is to assist manufacturing and storage


facilities in the design, installation, and maintenance of buildings
and equipment to prevent the inclusion or introduction of physical,
chemical, or microbiological contaminants.

Standards for Sanitary Design


Sanitary design is not only a good practice, but it is also a regulatory
requirement in the United States. Certain sections of the FDA’s
Good Manufacturing Practices (GMPs) specify construction and
design standards for buildings, grounds, equipment, and utensils.

Section 110.20 – Buildings and grounds construction and design


Buildings and structures are required to be suitable in size,
construction, and design to facilitate maintenance and sanitary
operations for food manufacturing purposes. The objective is
to look at a facility as a whole and determine necessary design
measures for that specific environment.

Section 110.40 – Equipment and utensils construction and design


Equipment and utensils are required to be designed and constructed
of materials that are easy to adequately clean and properly
maintain. Equipment and utensils and their usage should prohibit
the adulteration of food with lubricants, fuel, metal fragments,
contaminated water, or any other contaminants. This section of the
GMPs goes into more detail and should be fully reviewed to ensure
the concepts and requirements are understood.

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Many sectors of the food industry have specific sanitary design
standards that are outlined in regulations, including: dairy, meat,
produce, and milled or grain-based materials. Each sector may
have unique challenges and require specific design requirements
to address pest issues, microbiological concerns, allergens, foreign
materials, sanitation methods and frequencies, raw materials, etc. It
is important that you understand the specific design requirements
of your industry to establish food safe buildings, equipment, and
utensils. General sanitary design considerations that are applicable
to most sectors of the food industry are discussed in this chapter.

Outside Grounds
Maintaining a sanitary food processing environment starts outside
the facility. A well-developed outside grounds program will ensure
that measures are in place to prevent pest infestations, airborne
contaminants, drainage issues, and other contaminants from
becoming a problem within the facility and help you understand
how to prevent issues from developing.

Neighboring Properties
Neighboring properties around the facility, including vacant land
should be evaluated to
rule out any possible
issues that may
impact your property
including: neglected or
run-down buildings,
storage of obsolete
materials or junk,
poorly maintained
vegetation, etc. Work
with neighbors
to maintain an
ideal environment that minimizes conditions that may hinder
the food safety condition of your facility. If potential issues are
noticed on neighboring properties, explain to your neighbor how
these conditions may impact your ability to maintain a food safe
environment. Pest harborages and other conditions that support
pest activity can be minimized by removing obsolete materials,
maintaining landscaping, and properly grading lots for appropriate
drainage. If neighbors refuse to cooperate, your local municipality
may need to get involved.

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Landscaping
Landscaping design can lead to
problems inside the building. Grass,
bushes, trees, shrubs, and other
vegetation create shelter or hiding
places for pests. Properly maintaining
these items can minimize the security
pests may feel from predators.
Trimming items away from buildings
and off the ground can greatly
minimize pest populations. When
installing plants, it is also important
to consider their growth potential to
ensure they are not planted too close
to structures where they will become
harborage issues or interfere with structures such as buildings or
fences when fully grown.

Well-drained yards, drives, and


parking lots will not become
a water source for pests and
will minimize mud and other
contaminants from being tracked
into the facility from people
or equipment. Properly paved
drives and parking lots will also
improve drainage and reduce dust,
which can become an airborne
contaminant during dry periods.

Waste Removal
Unmanaged trash and product
waste can cause many pest
and microbiological issues. For
example, dumping product
waste on the ground or in ditches
becomes a significant pest
attractant.

Trash containers and compactors


should be properly covered
and emptied regularly to prevent pest attraction or harborage.
Areas around trash containers and compactors must be kept clean
and free of spillage. It is essential to place the trash containers or

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compactors on a concrete pad or paved area to aid in cleaning
efforts and minimize pest harborage. Providing a water faucet or
hydrant near these areas may also allow for detailed cleaning.

Outside Lighting
Outside lighting is an
important factor for worker
safety and security concerns.
It allows outside activities
to be conducted safely and
helps to deter or detect
criminal activity. However,
lights that are improperly
positioned or located may
attract night flying insects
and some stored product insects to the building. Lights mounted
outside should be located away from the building and pointed at
the desired areas to attract insects away from the building. Different
types of lighting will also impact insect activity depending on the
UV level.

Building Design and Construction


Building design, appropriate construction materials, and proper
plant layout are key factors in sanitary design. Any company with
a comprehensive cleaning program, integrated pest management
program, proper storage practices, effective operating methods, and
quality systems will continually experience sanitation failures if the
building is poorly designed.

Every food company must ensure its buildings are designed


and constructed of materials that comply with federal, state, and
local regulatory laws or guidelines. There are industry standards
for every aspect of facility design, including building structure,
ventilation, plumbing, lighting, etc. These should all be evaluated in
the sanitary design process.

Layout
When designing a facility, whether it is brand new construction or
a building addition, the size and layout must be predetermined.
There are advantages to planning and allowing room for expansion
in the facility. Planning ahead will help to maintain a food safe
environment, avoid costly modifications, adaptations and excess
labor, and minimize other costs associated with poor planning and
construction.

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One of the first decisions to make is how many levels the facility or
addition will be. Single level buildings allow you to easily supervise
employees, provide efficient process flows, and allow maintenance
and cleanup crews to work more easily because there is more space
to move tools, equipment, and personnel from one place to the next.
Single level facilities use less equipment to move raw materials
and products. Multiple level facilities can use gravity to move raw
materials and products to lower levels, but additional equipment
may be needed to move materials to upper levels for processing.

Ceiling heights are usually


an issue in single level
buildings because they
are much higher and
harder to reach. Piping,
ductwork, and electrical
systems often create an
overcrowded ceiling area.
The maze of pipes, conduit,
and ductwork creates a
challenge for cleaning and
maintenance activities. These areas collect dust and become a
potential source of foreign material contamination, insect activity,
and mold.

Traffic patterns for


forklifts, tow motors,
people, ingredients, and
finished products should
be considered during the
layout process. Properly
designed traffic patterns
will create a more economic
operation, reduce possible
safety concerns or
accidents, and minimize
cross-contamination or
food safety concerns.
Layout considerations may include:
• Locker rooms and restrooms located near employee entrance
points
• Employee welfare areas located near work areas to minimize
unnecessary traffic to production or warehouse areas

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• A flow pattern to minimize handling and moving of materials
and equipment
• Raw ingredients segregated from finished materials
• Minimizing cross-contact concerns for allergens or
microbiological issues
• Segregate employee traffic areas from forklift and tow-motor
areas

Various manufacturing environments can change even within the


same building, which can create food safety and product integrity
challenges. Product flow sheets are useful tools that help identify
potential problems when a system or process is in the design phase.
Activities to consider in the planning and design process include:
• Identify wet and dry manufacturing areas so that walls and
barriers can be established to prevent moisture and dust from
traveling between areas
• Establish air handling systems, ventilation, filtration, and air
exchange to prevent mold and condensation problems
• Install central vacuum systems and dust control methods to
maintain a clean work environment which will also improve
employee work areas
• Identify the locations of initial raw material (e.g., grain
commodities) cleaning so that insects and other foreign material
can be removed; and provide adequate space for cleaning
activities
• Locate physical foreign material control devices in appropriate
areas and provide space to access the devices for maintenance
and cleaning
• Provide adequate lighting in all areas of the facility

Risk assessment must be included when developing flow sheets


and reviewing process and product flow. The intent is to keep
finished products that are susceptible to microbiological or allergen
issues isolated so they are not contaminated by raw and untreated
materials or those containing allergens. For example, isolating
raw milk from pasteurized finished product would reduce the
microbiological concern of the finished product. In a baking
or snack foods environment, segregation of production lines
containing different allergens would reduce the concern for allergen
cross-contamination. Building and equipment design must be
considered during the process flow review in order to establish an
efficient and food safe system.

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Foundation
Some building foundations are made of concrete blocks and
others are made of concrete footings and walls. Foundations made
of concrete blocks provide more challenges than those made of
concrete walls. The hollow core inside block walls is an ideal
harborage for pests. Solid concrete walls generally eliminate this
issue. For some areas of the country, termites may be a concern. Pre-
treatment for termites should be done just before the concrete floor
is poured and before the soil along the foundation walls is filled.

Basement walls must be waterproof and effective drainage is


necessary to prevent water accumulation below grade and below
footings, which can cause structural problems over time. The type
of waterproofing method used depends on the type of soil. When
soil provides good drainage, a
waterproof covering is layered
over the outside surface of the
basement wall and then covered
with polyethylene sheeting. In
areas where drainage is poor,
a bituthene membrane covered
with Styrofoam is often used.

Drain tiles are also installed


around the foundation to move
water from the walls. Back-filled
dirt is compressed to reduce the
amount of ground settling that may take place. Any flat horizontal
surfaces around the footing should be covered with a sloped surface
to prevent ground water from accumulating and eventually seeping
into the foundation.

Framing
The most
common type
of framework
is made of
I-beams and
columns.
Many large
buildings
designed
with beams
eliminate the bar joists and trusses, which create congestion and

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cleaning challenges at the ceiling area. An I-beam can, however,
create a void when placed next to or near outside walls. The open
horizontal surfaces of the I-beam may allow dust to accumulate,
making cleaning very difficult, if not impossible, since access is
limited. This void also creates a perfect harborage area for insects,
rodents, and mold.

When I-beams are positioned at least six inches or more from the
walls, the hidden void is somewhat eliminated, and adequate
cleaning space is provided. Tubular steel is another design practice
used to eliminate cleaning and pest harborage challenges.

Support column design should also be considered. Concrete


grouting at the base of a vertical I-beam column, which is sloped
at a 45°-60° angle, creates floor surfaces around the beam that are
easier to clean.

Enclosed steel framing materials, such as square or rectangle


tubular shapes, eliminate harborage and collection areas. Voids
created when beams are placed next to each other are also
eliminated. When hollow, tubular-shaped materials are used to
frame and support structures, any open top areas must be sealed to
eliminate potential pest and filth harborages.

Concrete framing, such as reinforced concrete and composite


structures, are another alternative that provides stability and clean
design. Reinforced concrete is made with rods, rebar, or fiberglass
strands in the material. Composite structures are I-beams or
H-beams used to reinforce the concrete. These methods eliminate
ledges that create collection areas for dust and debris. Reinforced
concrete also provides some fireproofing.

Flooring
The building structure that takes more abuse than any other area
is the floor. With forklift traffic, movement of equipment, and
exposure to water, chemicals and spilled ingredients or products,
floors are constantly at risk of deterioration and damage. Damaged
floors allow water and debris to accumulate under the surface,
which contribute to further damage and accelerated deterioration
and cause unsafe working conditions and poor sanitation.

To determine the appropriate floor surface for a building, identify


the type of activity that takes place in each area of the facility.
Appropriate floor construction and materials should be selected in

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order to be compatible with operations and to provide durability


and a long lasting and cleanable surface. Operational conditions
which may affect floor surface choices may include:
• wet or high temperature (e.g., steam)
• refrigerated or frozen
• dry or acidic products
• fryers and oil

Regardless of the surface material, the floor must be suitable for


exposure, easy to clean, and able to withstand the expected traffic
load and the cleaning chemicals, oils, and products used.

A concrete floor
surface with a
hardener or sealant
is typically best
for a warehouse or
distribution center.
Tile and brick,
monolithic epoxy
with aggregates, and
single membrane
coating systems are
generally acceptable
for wet processing
environments. Resilient flooring materials, such as vinyl, asphalt
tile, and linoleum are generally used in offices and employee
welfare areas. They are generally not recommended for use in
production areas. Fiberglass or polymer resins with fiberglass
sheets placed between coatings of resins are used in some facilities,
however the possibility of toxic vapors being emitted when the
fiberglass burns is a concern. Bituminous or asphalt and crushed
rock floors are generally used in warehouses, railroad track wells,
or bulk unloading sheds and are not to be used in manufacturing
environments.

A major consideration with any floor surface is surface preparation,


which is typically recommended by the flooring manufacturer. The
quality and installation of substrate placed under the floor surface is
also extremely important to the integrity of the floor surface. Most
failures related to floor materials are due to poor surface selection
and preparation.

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Walls
There are several types of materials that can be used for food plant,
distribution center, and food warehouse walls. When considering
materials, they must be able to withstand the abuse and conditions
of the work environment. For example, if wet processing is used,
the walls must be able to withstand the moisture and chemicals
used in cleaning.

All walls must be easy to clean and prevent dirt accumulation and
pest harborages. Walls with a smooth, high gloss finish that allows
for easy cleaning are best for dusty environments. Walls with rough
textures, cracks, pits, and seams lead to major problems in most
food environments.

When choosing wall materials, consider those that will be easy to


resurface. Constant cleaning and exposure to heat, cold, water,
chemicals, etc. will eventually produce wear. Knowing the
maintenance requirements that may occur will help make your
selection less expensive in the long run.

Concrete walls are


commonly used and come
in three variations: precast,
formed and poured into
place, and poured on the
floor and tilted in place.
Concrete block walls are
also common and come
in different densities and
weights. Lightweight
block is less dense and
relatively porous, allowing
bacteria and insect development. Medium and heavyweight blocks
are preferred. Volcanic ash and cinder blocks should be avoided
because they are very porous and will allow dust and insects to
penetrate deep into the hollow core.

Other wall surfaces to consider include epoxy coating systems or


structural insulated panels (SIP). The epoxy coating systems can be
designed for a multitude of environments and can be very durable
for the conditions identified. In SIP wall construction, various
materials can be laminated to the surface to provide the necessary
materials to withstand the environment. Glazed tile and laminated
block have been used in previous construction. The concern

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with these systems is the ongoing maintenance required, such as


regrouting of joints or repair of damaged tiles or blocks to provide
a smooth cleanable surface and prevent possible microbiological
growth.

Additional wall surfaces that may be considered include fiberglass


and plastic, metal panels, and metal panels with a lower concrete or
concrete block wall.

Roof
The main function of roofing materials is to keep the rain out.
However, the material should also be able to withstand the air
handling system, such as exhaust stacks and vents located on the
roof surface. Occasionally, processing equipment will vent to the
roof. In this case, it is likely that dust and product residue will
accumulate on the roof surface. If this occurs and is neglected, it will
attract birds, insects, and rodents seeking food and shelter. Mold
and bacterial contaminants can develop in product accumulations
and find a way into the facility.

Roofing materials include


pitch and gravel, asphalt,
metal, and membrane.
Pitch and gravel mixtures
are commonly used, but if
spillage occurs, the materials
can only be cleaned by
removing the gravel along
with the spillage. For this
reason, these materials
should not be installed
above processing areas. Metal and membrane are typically the
preferred roofing materials above processing areas where spillage
or dust accumulation is likely. Even though this type of roof is
easier to clean, employees responsible for cleaning must be careful
not to damage the roofing material with tools and equipment. It is
also recommended that smooth membrane roofs include pads or
reinforced paths where employee traffic is expected. This will help
reinforce the roof and protect it from wear and damage.

Ceilings
Many inspectors suggest that ceilings be considered the same as
a piece of equipment. Depending on the type of operation, the
ceiling may be likely to accumulate raw material or product dust,

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steam and condensation, smoke, bacteria, mold, and stored product
or structural insect pests. These concerns may be located above
product zones, product areas, or storage locations and potentially
contaminate the materials located below the ceiling. Proper
selection and installation of building materials can prevent these
issues.

Cavities formed by
corrugated metal
panel ceilings will
cause constant
problems for most
manufacturers.
Hollow voids created
by the corrugated
material are perfect
harborage areas and
are hard to clean or
seal. The surface area of the corrugated material is also very difficult
to clean. Condensate can also easily accumulate on these surfaces.
These types of ceilings should be limited to areas of the facility
where there is minimal concern for excessive dust or moisture, such
as storage or support areas.

Smooth poured concrete ceilings and precast concrete ceilings


are typically the best type of material to install for ceilings. Avoid
concrete ceilings that show pits and checks. These areas are difficult
to clean. Also avoid painting the concrete surface as it is likely
to peel and flake and contaminate the product. Instead of paint,
apply a coat of sealer and hardener or a stain which will allow the
concrete to breathe and release any moisture.

There are other choices for ceilings in high-risk environments that


are micro-sensitive or where climate control is essential. These may
include structural reinforced panels (SRP) which are suspended
from the roof. These ceilings are excellent choices for high-risk
environments as they can be washed from the floor with high
pressure water or used to cover processes with lots of overhead
piping or utilities. Other ceiling suspension systems available are
non-load bearing frame systems. If they are used in food plants, the
materials used for the ceiling panels must be constructed of durable
and cleanable materials. Materials such as FRP, vinyl, or other
synthetic water-resistant materials should be selected based on the
use of the environments and ease of maintenance.

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Windows
In most modern food facilities, windows are left out of the plans.
Though they offer natural light to brighten the workplace, they
also present facility hygiene and food safety issues. Regardless of
the effectiveness of air handling systems, employees are tempted
to open windows for ventilation and fresh air. This creates an
open passage for birds, insects, dirt, bacteria, and other airborne
contaminants. Keeping windows closed is a simple solution, but
hard to enforce.

Open windows and doors require properly installed screens to


prevent pest entry. This increases facility maintenance activities and
costs and does not prevent dirt, bacteria, and mold from entering
the building. Metal window frames are temperature-sensitive
and allow condensation to form due to differences in temperature
and humidity levels in indoor and outdoor environments. When
condensate forms, mold growth is likely to occur in a short amount
of time.

Facility windows should have


sills or ledges. Depending on
the facility and the potential
for dust accumulation,
windows should be added to
the master cleaning schedule
and the maintenance budget.
Windows made from glass,
whether tempered or not,
should follow the guidelines
of the glass, brittle plastics,
and ceramics program.

Doors
The Occupational Safety and Health Administration, the Life Safety
Code, and local municipalities regulate the number of pedestrian
doors required at a facility; however, door maintenance, pest
control, and plant hygiene are management’s responsibility. When
doors open directly into production or storage areas, unfiltered air
can be introduced into critical areas. Employees have the tendency
to leave doors open and unattended, which causes problems inside
the plant or warehouse. Doorways should be designed so that they
do not open directly into production and warehousing areas. When
possible, a double set of doors should be installed.

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Exit doors must be clearly marked
and equipped with opening devices
that allow for quick, safe, and
unobstructed exit, but should also
provide a high level of security
to prevent unauthorized persons
from entering the facility. It is also
recommended to number the interior
and exterior of all doors on the
perimeter of the facility to assist in
easy identification for inspection,
preventive maintenance, and
emergency situations.

Exterior lights should not be


mounted directly above doors. They should be placed away from
the building and directed toward the entrance so that nighttime
insects aren’t attracted to the facility.

Entrance and exit doors that lead directly into or out of the plant
should be made of strong metal and a solid insulating core.
They must be welded at the seams to prevent damage and pest
infestation. They must also fit snugly into the doorframe and should
not allow any gaps that may allow rodents or other pests to enter.
All perimeter doors should have proper security systems installed
to manage access control into the operation.

Roll up or pull up
doors must also
be made of quality
materials. They should
either be hollow or
made with a solid
inner insulating core.
It is also imperative
that overhead
doors be installed
and maintained to
fit snugly into the
doorframe. Loose
fitting or damaged
doors allow pests, dirt, and debris to enter the building, causing
plant hygiene issues.

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Strip doors, roll-up doors, and bi-fold doors provide barriers from
one area of the facility to another. Each has advantages and serves
specific purposes. Strip doors create temperature and humidity
barriers from freezers, coolers, shipping docks, etc. They are also
effective in providing a barrier against some pests and debris.
However, they require extra cleaning as they become dirty from
forklift and human traffic rubbing against them. They can also
become a safety concern as it may be difficult to see through the
strips when they become dirty. When possible, roll-up or rapid roll
doors would be a better choice to separate areas.

Roll-up or rapid roll doors are typically used to isolate various areas
of the facility. These doors can be equipped with devices that allow
forklift or equipment operators to open the door quickly allowing
easy and efficient traffic within the plant. They can also be installed
to provide a good seal, preventing the passage of pests, dirt, or
other contaminants from one area of the plant to another. Bi-fold
doors are a different type of construction and provide a barrier
between work areas. Roll-up and bi-fold doors open and close
quickly, provide protection between work areas, save energy, and
are easily maintained. It is also recommended that pedestrian doors
be installed next to any large doorways that will be used for vehicle
traffic in order to allow separation of human and forklift traffic to
reduce potential accidents.

Electrical
Electrical systems
can be a place for
harborage or create
sanitation/cleaning
challenges if they
are installed without
proper access.
Electrical power
conduits should be
sealed where they
enter the plant to
prevent them from
becoming passageways for insects or rodents. Electrical power
disconnect panels and motor control panels should be located in
rooms that are dust- and water-tight and pressurized with filtered
air. When possible, the control panels should be placed back to back
in the center of the control room, leaving workspace along the walls.
All electrical conduits should be off the floor and out of the way of

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processing movements and cleaning. Conduits that are placed along
walls should be attached with spacers to prevent ingredient dust
from accumulating between the conduits and wall. Electrical boxes
that are mounted on walls should be completely sealed to the wall
or should be a sufficient distance from the wall to provide access for
cleaning. The selection of motors and conduits will largely depend
on the process to be conducted.

Conduits, switch boxes, and motors should be designed to be


waterproof in areas where a wet process or wet washing is used.
Special wiring requirements are needed in areas where dust
explosions are a possibility. Food residues and crumbs will often
build up in electrical conduits that have worked loose from junction
boxes or motors. These areas then become insect harborages. Non-
sealed electrical panels must be cleaned at least monthly to prevent
pest harborage and infestation.

Ventilation
Properly installed
ventilation
systems reduce
condensation,
dust
accumulation,
and pest
infestations by
removing heat
and moisture
through
evaporation and exhaust. Since each facility is different, variations
in the number of necessary air exchanges will be a factor in
ventilation design. Potential problems are eliminated when a system
that can handle the amount of exchanges is installed.

Regardless of the system, it is best to have a slightly positive air


pressure environment in the building. When a door leading to the
plant is opened, you should feel air rushing out. This will help
prevent insects, dirt, bacteria, and mold from entering the facility.
It is not always easy to achieve a positive airflow due to the use
and demand for air in the process (e.g., baking, drying, product
movement, etc.). As a rule, a slightly positive pressure situation will
exist when supply air is approximately 10% greater than exhaust
air. It may also be necessary to maintain different air pressures in
different parts of the building. An example may be positive pressure

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in a packaging room to prevent dust in mixing areas from migrating


to the packaging area.

Air supplied to the facility for ambient air should be filtered to


remove pests, dust, bacteria, and mold. Airborne particulates can be
removed by a filter size of 50 microns unless product or production
needs indicate the requirement for a smaller filter size. Renewable
media filters are designed to change used filter surfaces indicated
by a timer or pressure switch. Fixed filter units are replaceable and
sometimes cleanable. Cartridge filters are disposable and formed to
fit the aperture of the air handling system. They are typically made
of fiberglass, cellulose fiber, wool felt, or synthetic materials and
are considered for special filtering requirements. High efficiency
particulate arrestor (HEPA) filters are very efficient systems and
capable of removing very small particles and microorganisms.
HEPA filters are typically used in dairies to filter air used in
powdered milk dryers and aseptic packaging systems.

Additional information about ventilation systems is available in the


Air and Water Quality Chapter.

Compressed Air
Compressed air used in processing areas must be properly filtered
to remove particles of 5 microns or larger. Compressed air must not
contain dirt, oil, or water that may contaminate product. Air traps
and filters should be located and designed so that when they are
inspected or changed, they do not contaminate product.

Plumbing
Improperly installed water and sewage systems can lead to serious
food safety concerns and direct contamination. Most water supplies
are safe and plentiful; however, if systems do not eliminate the
possibility for sewage water to contaminate potable water, disaster
will occur. Potable water is
safe for consumption and
is the source for ingredient
water, cleaning water, and
water used for employee
needs. Public water
systems remove impurities
and contaminants and
provide water that meets
the Drinking Water
Standards established by

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the United States Public Health Service, Department of Health and
Human Services.

Backflow preventers or vacuum breakers should be used where


required by code to prevent potable water from being contaminated
by reused water or other systems that could cause back siphoning
through negative pressure. Submerged water lines increase the
threat of back siphonage. When submerged water lines cannot be
avoided, vacuum breakers must be installed and used.

Sanitary restroom plumbing, including toilets, urinals, and sinks


must not be connected with any other process drains, including
floor drains. Sanitary lines must not discharge into grease traps or
other liquid waste separation equipment. They cannot discharge
into main sewer lines in order to prevent the sanitary sewage from
backing up into the plant drainage system. Sanitary sewage lines
must not be installed over or near any food processing equipment
or storage areas as contamination from these lines will cause illness.

Proper water drainage from the production room floor is often


neglected in design considerations or realized only after an
addition is planned. Proper drainage must be realized throughout
all manufacturing areas and must meet all local and national
codes. Floor drains must be included in every food processing
facility’s design and cleaning schedules established. The integrity
of each drain and the slope of floors leading to each drain are
critical in maintaining a clean and efficient work and production
environment. The location and placement of drains in relation to
equipment must also be considered. If drains are located under
equipment, there may be concern for limited access to clean the
drains and for backpressure to create contamination concerns.

Additional information about plumbing can be found in the Air and


Water Quality Chapter.

Toilet Facilities
Toilet facilities that do not open directly into a production area
must be provided. This requirement may be satisfied with a double-
door entrance that is long enough that a person cannot hold both
doors open at the same time or by having the toilet room open into
a locker room that opens into the processing area. Toilet rooms
should be equipped with an exhaust fan that discharges to the
outside. All toilet and locker room doors should be self-closing.
Hand washing stations must be provided. These stations must

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supply hot and cold (or warm) running water, soap, sanitizers,
towels or hand drying devices, and covered waste containers. Hand
washing signs should be posted in all the toilet rooms.

Perimeters
Many food safety
standards recommend
providing an 18-inch
perimeter between
the wall and any
stored product or raw
material to allow for
inspections, cleaning,
and maintenance of pest
monitoring devices.
Though 18 inches is the
recommended standard
for perimeter lines,
there is not always enough space, especially in production areas.
Sometimes, if adequate space is not available, racks with bottom
shelves to keep pallets or items off the floor and allow access for
cleaning, housekeeping, and pest control can be installed close to
the wall. Maintaining floor perimeters is an important element for
any food plant’s product safety program.

Perimeters are in place to designate an area of the floor that is off


limits for storage. Racks or pallets should not be placed over the
border. This allows at least an 18-inch space between walls and any
storage areas, provides easier access, and makes it easier to clean
spills and perform routine inspections. The perimeter spacing also
provides a means for personnel to evacuate the building in the
event of an emergency when aisles may be blocked.

One way to quickly tell if a facility has been cleaned is to check


the perimeter line. Since most of these lines are white or light in
color, dirt, product residue, and debris can be easily spotted. If the
perimeter at your facility is not as neat and tidy at it should be, it
is a sure sign that some tasks identified in the sanitation program
are being overlooked. The white line also serves as a guideline for
storing pallets and other materials and helps forklift and pallet jack
operators from damaging wall structures and creating additional
structural problems within the facility.

Facility perimeters also benefit the integrated pest management

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program. Rodent traps are commonly placed against wall
perimeters on the interior of the building because pests prefer to
travel along walls where they feel safe and secure. If these lines
are white or light in color, rodent droppings can be easily spotted
and action can be taken to quickly identify and eliminate the issue
before a full-blown infestation occurs. Pest monitoring devices, such
as traps and glue boards, are especially important in areas where
received materials are stored and on both sides of all doors. These
areas are the most likely places where rodents will enter the facility.
With a maintained interior perimeter, pest monitoring devices can
be properly placed, inspected, and replaced as necessary.

Lighting
Some plants try to
cut costs by reducing
the amount of lights
used. However, a well-
lit facility improves
productivity,
security, food safety
and sanitation, and
employee morale.
Cleaning issues and
food safety issues
are more quickly
identified with adequate lighting. Also, insect pests are attracted
to ultraviolet light, which is produced by various types of lighting.
The type of lighting chosen should be evaluated for the specific
area. Factors influencing the type of lighting may be: insect
attraction, quality inspections, security camera usage, worker safety,
neighboring issues around the perimeter, etc. It is also important to
consider adequate lighting to prevent glare, reflections, shadows,
contrasts, and proper lighting levels. The food facility should
consult lighting experts to ensure proper illumination is provided in
all work areas on the interior and exterior of the building.

As discussed in the Glass, Brittle Plastics, and Ceramics Chapter,


glass is one of the most serious forms of physical foreign material
contamination. Lighting fixtures must be provided with shatter-
resistant bulbs or protected with plastic shields or some other type
of protection to prevent the glass tube or globe from becoming
damaged and contaminating raw material, packaging, processing
equipment, or finished product.

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Equipment and Utensils


Many different types of equipment and utensils are used every
day in the food industry. This includes such items as sifters, ovens,
knives, conveyors, belts, chutes, product totes, gloves, tools,
cutting boards, tables, and packing scales. Although each item
has its own specific design standards based on the manufacturers’
recommendations and the type of products being produced, there
are several general sanitary design guidelines that are applicable to
all. All equipment should be designed, constructed, and installed to
facilitate cleaning and preventive maintenance.

The equipment and tools


used in a food plant can
be potential sources of
biological, chemical, and
physical contamination.
Equipment and utensils
that have not been
properly sanitized are
a common source of
biological contamination
such as E. coli, Listeria, and Salmonella. Chemical hazards from
processing equipment may include such things as industrial
lubricants from bearings and gearboxes or hydraulic fluid from
equipment or overhead lines. Physical hazards may include nuts
and bolts, machinery parts, or metal fragments that come loose from
equipment.

New Equipment or Equipment Modification Approval


The cGMPs require that production equipment is approved by
a recognized certification organization whenever possible and
practical. Each facility should select an equipment approval team
to authorize new equipment selections or current equipment
modifications. Representatives from sanitation, quality,
maintenance, the HACCP team, and production should be included
on the team in order to understand how equipment changes
will affect the entire production process. Whenever possible,
equipment and utensils designed with food safety in mind should
be purchased. Food production machinery should conform to the
design standards of the ANSI/ASB Z50.2 2012 Standards, the 3-A
Standards for Dairy Equipment, the National Sanitation Foundation
(NSF), USDA Equipment Guidelines, European Hygienic
Engineering and Design Group (EHEDG), or other certifying bodies

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or guidelines. These organizations have established written sanitary
design criteria to ensure that machines bearing their seals are easily
cleanable and of good sanitary design.

Sanitary Design Parameters


Almost all food processing and packaging equipment contains
direct and indirect food-contact surfaces. A direct food-contact
surface is any surface that comes in direct contact with food.
An indirect food-contact surface is a component of the system
where product residue or potential contaminants may collect and
be incorporated into the food product. For example, a drip or
condensation pan on refrigeration units is an indirect food-contact
surface because condensate can collect and drip into the products
below. It is essential that these surfaces are kept clean and sanitary
to prevent them from becoming potential sources of contamination.

One of
the main
requirements
of the GMPs is
that seams on
food-contact
surfaces are
smoothly
bonded or
maintained to minimize accumulation of food particles, dirt, and
organic matter. This will reduce the opportunity for bacterial
growth. Rough surfaces support product buildup, bacterial growth,
and insect activity. They are also difficult to clean. Metal-to-metal
contamination is another issue related to unsmooth surfaces.
Fragments can be transferred to the product if rough surfaces rub
together.

All food-contact surfaces should be durable, easily cleanable,


non-absorbent, and non-toxic. Suitable, non-corrosive materials
should be used and smooth welds made to prevent ingredient or
product buildup. The plant should select equipment that is easy to
disassemble for cleaning and sanitizing activities. When purchasing
new equipment, it should be designed to withstand the environment
of its intended use and the action of the cleaning compounds and
sanitizing agents used in the facility.

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Another important factor to consider when selecting equipment


and utensils is the type of materials used. Materials selected must
be compatible with the foods produced. If not, issues such as odor,
taste, discoloration, and contamination from the breakdown of
the materials may occur. Additionally, unwanted reactions may
occur when using certain cleaning chemicals, sanitizing solutions,
or pesticides. It is very important that equipment is constructed of
food-grade materials so as not to create a consumer health hazard.

Not all materials are acceptable for use in a food plant. For example,
wood is generally not an acceptable material because it absorbs
liquid, produces odor, is porous, and cracks. Utensils with wooden
handles should not be used because they are difficult to sanitize
(biological hazard) and they can produce splinters (physical
hazard). Some types of stainless steel are not acceptable because
they can corrode. You also have to be cautious when choosing
coating systems. All coating systems used in the food plant
environment should be approved for food-grade usage. Many
epoxy coatings meet this requirement.

Sanitary design also addresses lubricants, metal fragments, and


contaminated water. Overhead lines that drip condensation or
over lubricated machinery can be contamination issues. The goal
of sanitary design is to design the system to eliminate the potential
for product contamination. Too often, equipment manufacturers or
maintenance staff fabricating or installing equipment will rely on
the use of catch pans or deflection plates to control these hazards.
Sanitary design should be such that few or no catch pans or
deflection plates are needed. When catch pans or deflection plates
are installed, they create another cleaning task and potential for
contamination if not properly maintained.

Production equipment and utensils that facilitate minimum hand


contact with raw materials, work-in-progress, or finished product
are best for food operations. Additionally, all ingredient, product-
holding, and packaging conveying and processing systems used
in the facility must be designed and constructed so they can be
adequately cleaned and inspected. This may include easy access
panels, restricted or limited usage of tools to open equipment,
limiting void or dead spaces, etc.

Nonfood-contact equipment used in the production area needs to


be designed and maintained to minimize the potential for product
contamination. This will include proper maintenance and sanitation

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programs for the equipment. The condition of the equipment is
monitored through self-inspections with corrections made as noted.

Installation and Maintenance


All equipment should be installed and maintained to facilitate
cleaning, maintenance, and inspection of the equipment and all
adjacent spaces and to prevent contamination. Equipment should
be elevated at least six inches from the floor. Large equipment
(e.g., cookers, dryers, etc.) that takes a lot of floor space should be
elevated 24 inches to facilitate cleaning. If equipment is not elevated,
attempt to leave the base open to remain accessible for cleaning and
inspection or attempt to seal it completely. It can be sealed to the
floor with an appropriate sealant as long as it approved for usage in
a food plant. Place such equipment on the preventive maintenance
program for frequent inspection to verify the integrity of the sealant
is maintained.

Evaluation
Before using any new production equipment or systems, conduct
tests to verify that systems function as expected and to verify
cleaning procedures. Minor, but important, adjustments may be
needed on new systems. Some cleaning procedures may need to
be validated to confirm the procedures meet requirements. Others
simply require verification that they are conducted in the manner
intended in order to meet the goals.

Sanitary Design Reference Card


Use this Sanitary Design Reference Card as you contribute to your
company’s sanitary design program. When you are ready, proceed
to the workshops to apply what you have learned to real-life
situations.

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Sanitary Design FOOD SAFETY AND SANITATION

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Sanitary Design
Reference Card

Sanitary Design
• Ceilings
• Support cleaning and maintenance of o Smooth surfaces free of voids
equipment and structures o Minimize paint or coatings
• Written set of standards o Materials appropriate for high-risk
• Reviewed by a design team environments
• Windows
Outside Grounds o Natural light
o Screening and ventilation
• Maintaining neighboring properties o Should be minimized
Use this Sanitary
• Minimize vegetation and debris • Doors
Design Reference • Proper drainage and paved drives and o Appropriate number for safety and
Card as you parking lots evacuation
contribute to • Managing trash and receptacles o Proper security of perimeter doors
your company’s • Lighting that minimizes pest attraction o Appropriate doors for separation of
sanitary design areas
program. When Building Design and Construction • Plumbing
you are ready, • Layout o Separation of sanitary and potable
o Planning for future expansion plumbing
proceed to the
o Evaluate process flows and traffic o Backflow/back siphonage
workshops to prevention
patterns
apply what you o Risk assessment of flow sheets o Drainage and location of drains
have learned to • Foundation • Perimeters
real-life situations. o Prevent pest entry o 18-inch perimeter in storage areas
o Consider if termites are a concern o Allow for cleaning, inspection, and
• Framing pest control
o Minimize voids o Painted white line perimeters
o Sloped surfaces to assist in cleaning
o Enclosed framing to eliminate Equipment and Utensils
harborage • Equipment approval
• Flooring o Recognized certification
o Evaluate type of activity, processes, o Equipment approval team
and products • Design parameters
o Preparation and treatment of floor o Direct contact surface
surface Š Comes in contact with food
• Walls o Indirect food-contact surface
o Evaluate process and cleaning Š Residue may contact product or
activities direct contact surface
o Smooth surfaces to prevent o Smoothly bonded seams
harborage o Suitable contact materials
o Withstand chemicals and environment o Prevention of lubrication, metal
• Roof fragments, or contaminated water
o Cleanability of roof materials o Reduce hand contact with materials
o Reinforced walkways o Adequate spacing for cleaning,
maintenance, and inspection
o Evaluate equipment and utensils
prior to use
A I B I N T E R N AT I O N A L - R e f e r e n c e C a r d s
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Food-Contact Equipment
FOOD SAFETY AND SANITATION
Workshop

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A new blender will be purchased for use in a product blending area. The process will require wet cleaning
of the blender. Identify the items that would not be suitable for a blender in a wet wash area or items that
would not apply to the principles of sanitary design.

• Glass windows in the covers for viewing

• Blender mounted 24 inches off the floor

• Sealed electrical panels

• Wood handles for the cover

• Gearbox above the blender opening

• Polycarbonate window in the cover for viewing

• Mild steel that has been painted

• Nonsealed electrical panels

• Gearbox mounted below the blender

• Tubular framework with open ends

• Stainless steel construction

• Work stand beside blender to allow access for cleaning inside the blender

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Outside Grounds
FOOD SAFETY AND SANITATION
Workshop

8 } Chapter

1. What is the landscaping concern in this photo and why is it an issue?

2. What are short-term and long-term sanitary design solutions?

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Building Construction
FOOD SAFETY AND SANITATION
Workshop

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In this picture, cement grouting has been installed at the base of the support column.

1. How will the cement grouting assist in cleaning?

2. Name at least two food safety issues the cement grouting may prevent.

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Considerations Workshop

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Your company will be building a new facility for producing cooked hamburger patties which will then
be frozen, packaged, and shipped. The raw material is raw, ground beef. You must evaluate some of the
sanitary design considerations for the facility and the process flow. In the scenarios below, select the most
appropriate, or best possible, considerations that aid in sanitary design and minimize microbiological risk.

1. Air flow within the facility

Air should flow from the raw to the cooked area


Air should flow from the cooked to the raw area

2. Location of the employee lunchroom

Lunchroom adjacent to the raw areas for all employees so there are fewer lunchrooms to clean
Lunchroom adjacent to the cooked areas for all employees so there are fewer lunchrooms to clean
Lunchroom adjacent to both the cooked and raw areas so employees do not cross into other areas

3. Exterior lighting around the perimeter of the facility

Installed away from the building and pointed at the building


Installed directly above doors to provide better lighting
Installed on the ground, near the building
Installed at very few locations so it remains relatively dark to reduce insect attraction

4. Wet washes will be conducted in this operation. Where should floor drains be installed?

At the highest points in the floor


At very few locations to minimize cleaning
Directly below equipment to remove water quickly
At appropriate locations that are accessible to allow detailed cleaning of the drains

5. Write three important points to consider for design of the toilet facilities

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