Zone 4
Locker
rooms,
halls,
cafeteria
Zone 3
Walls,
floors,
drains, fork
lifts, hand
trucks,
phones
Zone 2
Exterior of
equipment,
chill units,
framework,
equipment
housing
Zone 1
Product Contact
Surfaces: e.g. slicers,
conveyors, vats,
shredders, utensils,
racks, work tables,
employee hands
Sanitary Zones In Plan
What we
can see
and easily
reach
What we
miss
What we
miss
Cleaning Viewpoint- Line of Sight
You can not
clean what
you can not
see!
So Designs
must allow
for access!
Bob Long
Sanitary Design as Part of the Whole Program
Considerations as Developing Program
Sanitation /
Environmental
Practices
• Environmental
Pathogen Risks
• Traffic Patterns
• Sanitation Needs
• Maintenance Factor
• Facility Layout
• Floors Conditions
• Design for
Sanitation
Effectiveness
Personnel
Training
• GMPs Compliance
• Maintenance
Behaviors
• Sanitation Skills
• Developing Culture
of Food Safety
Bob Long
• 3-A Sanitary Design Standards for Cleanability
- 3-A Sanitary Standards and 3-A Accepted Practices serve a critical role in the
public health and safety of the food processing system. The TPV inspection
program is designed to enhance the integrity of the 3-A SSI programs by affirming
that equipment fabricated in accordance to 3-A Sanitary Standards or processing
systems are manufactured and installed in accordance to 3-A Accepted Practices.
The independent TPV inspection programs of 3-A SSI provide assurance of hygienic
equipment design and thereby benefits regulatory sanitarians, equipment
fabricators, processors, and consumers.
• AMI Sanitary Design Checklist for Meat Industry Processing Plants
• Dairy Products Sanitary Design Checklist
• GMA: Sanitary Design For Low-Moisture Foods
• One Voice for Hygienic Equipment Design for Low-Moisture Foods
Meeting Regulatory & Customer Requirements and Standards
HIGH RISK &
LOW IMPACT
HIGH RISK &
HIGH IMPACT
LOW RISK &
LOW IMPACT
LOW RISK &
HIGH IMPACT
DEFINED:
RISK = CHANCE OF OCCURRENCE.
IMPACT = COST OF OCCURRENCE.
Prioritize by
chance and cost
to justify per risk
mitigation. Then
can choose to
address the
worst spots first,
and work way
down the list.
HIGHEST RISK +
HIGHEST
IMPACT IF
OCCURS
(IMPACT = cost of
reactive
correction, or
product loss/cost,
or liability impact
or cost).
CHANCE (VS.) COST
Design (vs.) Cost and Risk Assessments
Bob Long
PRINCIPLES OF SANITARY DESIGN
Are there levels of cleanliness?
NO You have either clean or not clean.
There are levels of soiling that needs to be considered as
acceptable for your particular process.
Hygienic Design for Processing Equipment
March 30, 2014 • By F. Tracy Schonrock
PRINCIPLES OF SANITARY DESIGN
Does hygienic design cost more?
In the short run this is often true. The materials of
construction, often stainless steel and the design details
increase the initial cost.
The long-term benefits of hygienic design over the life of
the equipment will reduce the overall operating.
Often run times can be extended, cleaning times shortened,
cleaning chemical and water usage reduced, maintenance
costs lowered and a longer life of the equipment can occur.
Hygienic Design for Processing Equipment
March 30, 2014 • By F. Tracy Schonrock
PRINCIPLES OF SANITARY DESIGN
Hygienic design is bad, complicated engineering!?
This is false. Hygienic design when applied from the very first
steps of the design process is very good engineering.
Hygienic features, such as the removal of cracks and crevices, to
eliminate microbiological contamination can also reduce
engineering problems, such as stress and crevice corrosion.
Ease of disassembly for sanitation purposes is also ease of
disassembly for maintenance personnel, which reduces
downtime.
Hygienic Design for Processing Equipment
March 30, 2014 • By F. Tracy Schonrock
PRINCIPLES OF SANITARY DESIGN
We can modify existing designs in-house to be
just as hygienic?
In theory this is true. Any design can be retrofitted to
eliminate hygienic hazards.
It is just a matter of lots of time and money.
The end cost of retrofitting is routinely significantly higher
than the purchase of new hygienically designed equipment.
Hygienic Design for Processing Equipment
March 30, 2014 • By F. Tracy Schonrock
PRINCIPLES OF SANITARY DESIGN
The hygienic standards writing organization for
dairy and food processing equipment is 3-A Sanitary
Standards.
Its Standards and Accepted Practices are recognized
internationally.
There are 68 3-A Sanitary Standards and nine 3-A
Accepted Practices.
Hygienic Design for Processing Equipment
March 30, 2014 • By F. Tracy Schonrock
PRINCIPLES OF SANITARY DESIGN
Equipment Surfaces:
Food Product Contact Surfaces---defined as in “direct
contact with food residue, or where food can drip, drain,
diffuse or be drawn”.
Non-Food Contact Surfaces---defined as part of the
equipment that does not directly contact food.
PRINCIPLES OF SANITARY DESIGN
Food Contact Surfaces should be:
Smooth
Impervious
Free of cracks and crevices
Nonporous
Nonabsorbent
Non-Contaminating
Nonreactive
Corrosion Resistant
Durable and Maintenance Free
Nontoxic
Cleanable
PRINCIPLES OF SANITARY DESIGN
Food Contact Surfaces:
If a surface is coated with a metal alloy or non-metal (e.g.
ceramics, plastic, rubber), the final surface must meet the prior
requirements.
3A Standards require that such coatings maintain corrosion
resistance and be free of surface delamination, pitting, flaking,
chipping, blistering and distortion under conditions of intended
use.
If any other modification or process is used in fabrication (e.g.,
welded, bonded or soldered) it should be done using appropriate
materials and in a manner that ensures the final surface meets
the sanitary design criteria.
PRINCIPLES OF SANITARY DESIGN
Sanitary Equipment Design Standards
The National Sanitation Foundation (NSF) has developed
standards for equipment used in food service and retail foods.
Recently NSF has been involved in developing standards for
the food processing equipment.
The NSF and 3A have recently collaborated in standards
development for meats and poultry equipment (3A/NSF
15159).
The European Hygienic Design Group (EHEDG) is the primary
organization for food equipment approval in Europe.
PRINCIPLES OF SANITARY DESIGN
Sanitary Equipment Construction and Fabrication:
Food equipment should be designed and fabricated in such a
way that all food contact surfaces are free of sharp corners
and crevices.
Construction of all food handling or processing equipment
should allow for easy disassembly for cleaning and processing.
Where appropriate, equipment should be self-draining and
pitched to a drainable port.
Piping systems not designed for routine disassembly must be
sloped to drain.
Equipment & Facility Design: Considerations
• How accessible is the equipment for cleaning?
• Can the design be changed to improve the
clean-ability of it?
• What tools or methods should be used?
• Does it mitigate pest or micro harborage?
• Is it on a PM Program?
Sanitary Design Principles for Facilities
1. Distinct Hygienic Zones Established in the Facility
2. Control the Movement of Personnel and Material
Flows to Reduce Hazards
3. Water Accumulation Controlled Inside Facility
4. Room Airflow & Room Air Quality Controlled
5. Site Elements Facilitate Sanitary Conditions
6. Building Envelope Facilitates Sanitary Conditions
7. Interior Spatial Design Facilitates Sanitation
8. Building Components and Construction Facilitate
Sanitary Conditions
9. Utility Systems Designed to Prevent Contamination
10. Sanitation Integrated Into Facility Design
• Principle 1: Distinct Hygienic Zones Established In The Facility
• Maintain strict physical separations that reduce the likelihood of transfer
of hazards from one area of the plant, or from one process, to another
area of the plant, or process, respectively. Facilitate necessary storage and
management of equipment, waste, and temporary clothing to reduce the
likelihood of transfer of hazards.
• Principle 2: Personnel & Material Flows Controlled To Reduce Hazards
• Establish traffic and process flows that control movement of production
workers, managers, visitors, QA staff, sanitation and maintenance
personnel, products, ingredients, rework, and packaging materials to
reduce food safety risks.
• Principle 3. Water Accumulation Controlled Inside Facility
• Design and construct a building system (floors, walls, ceilings, and,
supporting infrastructure) that prevents the development and
accumulation of water. Ensure that all water positively drains from the
process area and that these areas will dry during the allotted time frames.
PRINCIPLES OF SANITARY DESIGN
• Principle 4. Room Temperature & Humidity Controlled
• Control room temperature and humidity to facilitate control of microbial growth.
Keeping process areas cold and dry will reduce the likelihood of growth of
potential food borne pathogens. Ensure that the HVAC/refrigeration systems
serving process areas will maintain specified room temperatures and control room
air dew point to prevent condensation. Ensure that control systems include a
cleanup purge cycle (heated air make-up and exhaust) to manage fog during
sanitation and to dry out the room after sanitation.
• Principle 4. (cont). Room Air Flow & Room Air Quality Controlled
• Design, install and maintain HVAC/refrigeration systems serving process areas to
ensure air flow will be from more clean to less clean areas, adequately filter air to
control contaminants, provide outdoor makeup air to maintain specified airflow,
minimize condensation on exposed surfaces, and capture high concentrations of
heat, moisture and particulates at their source.
• Principle 5. Site Elements Facilitate Sanitary Conditions
• Provide site elements such as exterior grounds, lighting, grading, and water
management systems to facilitate sanitary conditions for the site. Control access to
and from the site.
PRINCIPLES OF SANITARY DESIGN
• Principle 6. Building Envelope Facilitates Sanitary Conditions
• Design and construct all openings in the building envelope (doors,
louvers, fans, and utility penetrations) so that insects and rodents
have no harborage around the building perimeter, easy route into
the facility, or harborage inside the building. Design and construct
envelope components to enable easy cleaning and inspection.
• Principle 7. Interior Spatial Design Promotes Sanitation
• Provide interior spatial design that enables cleaning, sanitation and
maintenance of building components and processing equipment.
• Principle 8. Building Components & Construction Facilitate
Sanitary Conditions
• Design building components to prevent harborage points, ensuring
sealed joints and the absence of voids. Facilitate sanitation by using
durable materials and isolating utilities with interstitial spaces and
stand offs.
PRINCIPLES OF SANITARY DESIGN
• Principle 9. Utility Systems Designed To Prevent
Contamination
• Design and install utility systems to prevent the
introduction of food safety hazards by providing surfaces
that are cleanable to a microbiological level, using
appropriate construction materials, providing access for
cleaning, inspection and maintenance, preventing water
collection points, and preventing niches and harborage
points.
• Principle 10. Sanitation Integrated Into Facility Design
• Provide proper sanitation systems to eliminate the
chemical, physical and microbiological hazards existing in a
food plant environment.
PRINCIPLES OF SANITARY DESIGN
Designing Your Plant for Sanitation, By Don Graham, Sverdrup
Facilities, Inc.
New Stresses on Food Systems:
• Increased reliance on minimally processed
products
• Emergence of new strains of food-borne bacteria
• Centralized growth of large food distributors
• Consumer preferences for ready-to-eat foods
• Growing number of people at high risk for severe or fatal food-borne illness
• In addition to these stresses on our food system, people's awareness of food
safety has dramatically increased in a very short time. In addition, the media
has played an important role in changing the concern levels of the food
consumers of today.
• To assure customers a safe, wholesome food supply, food processors are
relying on sanitation and its partner, sanitary design.
• Most of you are familiar with the need for a working sanitation program. You
are also aware of the criteria and requirements of a good sanitation program
and what it means to your operations.
Sanitary design has a similar set of criteria and requirements in order to make
the sanitation programs workable and more efficient.
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup
Facilities, Inc.
Purposes of Sanitary Design:
1) To Make Sanitation Programs:
• Faster
• More Efficient
• More Economical
2) To Prevent Product Adulteration
3) To Satisfy Regulatory Requirements
4) To Satisfy Consumer/Customer Demands and Requirements
Sanitary Design can be categorized into the following three basic levels:
A - Good
B - Better
C – Best
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup Facilities, Inc.
• The good level meets all regulatory requirements. It is the minimum level
of design for a food processing facility. Anything less than that is basically
illegal.
• The better level includes all regulatory requirements plus industry
recommended practices. HACCP principals as they apply to facilities and
equipment are of prime consideration at this level.
• The best level incorporates both the good and the better levels of sanitary
design plus state of the art upgrading of materials and construction
methods. This level is usually associated with highly sensitive products and
processing areas in a facility.
• Most facilities are a combination of the good and better levels. Some only
require the minimum level while others require a combination of all three.
The decision on the sanitary design level(s) to use must be based on the
products to spoilage, contamination and shelf life factors.
The entire sanitary design process - good, better, best - revolves around a
certain MIND SET.
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup
Facilities, Inc.
• Utilizing Solid Sanitary Design Principles, all areas under
consideration when renovating a food processing facility or in
the design of a new or greenfield facility should be considered
for optimal performance and cleanability. Typical areas for
consideration are:
• Floors
• Walls
• Ceilings
• HVAC
• Equipment
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup
Facilities, Inc.
Floors
• Floors are the most abused surface in a food processing
facility. They are exposed to large variations in temperature,
mechanical abuse from fork lifts, tools, equipment being
dragged or dropped, continual water flow in wet plants,
abrasion by dry material in dry processing facilities, chemical
abuse from cleaning chemicals, sanitizers, spilled product and
processing liquids to name a few. Floors are not the place to
try to save money when renovating or building a new facility.
Poor floors with cracks, holes and other damage can harbor
microbes and are extremely difficult to clean adequately.
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup
Facilities, Inc.
Walls
• Walls are the next most abused surface, especially the lower
portions near the working areas. Wall-floor junctions must be
coved to eliminate the joint. The joint at the wall floor
junction is notorious for being a dirt collection point and is
difficult and time consuming to clean correctly. Good coving
with anywhere from a 1 to 3 inch radius will make the
cleaning of this area simple and quick.
• Walls must be non-absorbent, washable, and either protected
from, or resistant to damage. Materials typically used are:
Insulated metal panels, FRP, tile, concrete and concrete block.
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup
Facilities, Inc.
Ceilings
• Ceilings are always a point of discussion when designing or renovating a food
processing facility. For good sanitary design criteria the solid walk-on type is
the best especially in a wet process. Using this type of ceiling allows placement
of all utilities above the ceiling and permits vertical drops for routing utilities
(electric, water etc.) to the equipment below. Any condensate formed follows
the vertical drops to the instead of onto food contact surfaces. Another
advantage occurs when utilities need to be serviced allowing the work to be
done out of the production shell. In addition, the underside of the walk-on
ceiling can be washed down during a sanitation shift without interference from
piping and other overhead structures.
• In dry, as well as wet processing areas, precast open double-tee ceilings work
very well.
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham,
Sverdrup Facilities, Inc.
HVAC
• The control of the air quality flow and positive air
pressure in a food processing plant has become a
major factor in designing and operating a food
processing facility today. Our air is becoming more
and more contaminated with dust and microbes.
PRINCIPLES OF SANITARY DESIGN
Don Graham
Designing Your Plant for Sanitation, By Don Graham, Sverdrup Facilities, Inc.
Equipment
• Last, but far from least, we come to equipment. When considering equipment
for the food processing plant, two things should be considered from a sanitary
design standpoint:
– The equipment must be of sanitary design.
– The food contact surfaces must be non-reactive, non-corrosive, non-
contaminating and cleanable.
– There should not be any hidden areas within the equipment that will build-
up with product or soil and allow microorganisms to grow.
– The equipment must be able to be dismantled, cleaned, sanitized and re-
assembled in the time allotted for the cleanup shift. You must be able to
take it apart, clean it, sanitize and re-assemble it without the need for
special tools, equipment, or skills. Each piece of equipment is somewhat
unique to the product being processed. It must be evaluated, from a
sanitary design standpoint, according to its function and the sensitivity of
the product being produced on or in it.
PRINCIPLES OF SANITARY DESIGN
Don Graham
3 Themes
1. Facilities Designed to Eliminate Cross-
contamination
2. Facilities Designed to Eliminate Harborage &
Growth of Pests & Microorganisms
3. Facilities Designed for Effective Sanitation
PRINCIPLES OF SANITARY DESIGN
Approved Metals for Food Processing
Stainless Steel---304, 304L, 316 & 316L
Titanium
Platinum
Gold
Limited Use Metals:
Copper
Aluminum
Carbonized metals, cast iron, galvanized iron
PRINCIPLES OF SANITARY DESIGN
How Do We Clean Various types of Stainless Steel
Bead Blasted – Various materials can be used to scrub bead
blasted stainless steel, such as brushes and/or scrub pads – can
be difficult to clean due to the porous nature of the surface.
Polished – Various materials can be used to scrub polished
stainless steel, such as brushes and/or scrub pads – is easy to
clean.
Mirror – No scrubbing or abrasive activity can be done due to the
risk of scratching the finish. Soils adhere less to this type of
finish.
PRINCIPLES OF SANITARY DESIGN
Sanitary Equipment Permanent Joints:
All joints should be smooth, durable and meet all sanitary design
criteria. Equipment standards generally require that welded joints
on stainless steel surfaces be continuous, butt-type joints (not lap
welds) and ground to at least as smooth as a No. 4 finish.
If the welded joint is at a corner, it must be coved to the
appropriate radius and ground smooth.
Use of soldered joints should be limited by application with use of
only non-toxic materials.
Press fits and shrink fits are generally discouraged and should be
limited only to applications where welded joints are not possible
(e.g. bushings).
PRINCIPLES OF SANITARY DESIGN
Sanitary Connections, Attachments and Ancillary Equipment:
When connecting pipes, gauges, thermometers, probes or other
equipment to food contact surfaces, be sure the connection does
not create a dead end or an area where food product can
accumulate and is not accessible to cleaning solutions.
Such connections should be closed coupled, e.g., pipe connections should
not be of length greater than 1.0 times the pipe diameter.
Shafts, bearings agitators and other attachments or ancillary
components should be attached to food equipment in such a
manner that the food contact zone is sealed from contamination
caused by leakage of lubricants or other contaminants into the
product zone.
Such components should be accessible and easily removable for cleaning.
PRINCIPLES OF SANITARY DESIGN
Sanitary Equipment Openings, Covers and Top Rims:
Any opening or cove should be designed, fabricated and
constructed in such a manner as to adequately protect food
products from contamination and to divert potential
contamination away from the food product zone.
Openings should be lipped and covered with a shoe box type
design.
Top rims of equipment should be constructed and fabricated
to avoid the collection of water droplets or dust.
PRINCIPLES OF SANITARY DESIGN
Non-Product Contact Surfaces:
Non-product surfaces of equipment should be constructed
with appropriate materials and fabricated in such a manner as
to be reasonably cleanable, corrosion resistant and
maintenance free.
Tubular (stainless preferred) steel equipment framework
should be entirely sealed and not penetrated (e.g., bolts,
studs, etc.) to avoid creating niches for microorganisms. It is
best practice to use open designed legs and framework for
easier cleaning and inspection.
Beware Penetrations in Framework
Welded on
Threaded Studs
No Hollow Frames
PRINCIPLES OF SANITARY DESIGN
Non-Product Contact Surfaces:
Top Six Floor Failures!
• If you know what failures your floor will be
subject to, you know what type of floor you need.
Drum roll, please:
#1 Excessive Moisture Content
The dreaded moisture begins to slowly seep
through the floor. Sounds like a horror movie,
doesn't it? If the moisture content of your floor
slab is too high, it can be a horror for your facility.
Excessive moisture severely limits the types of
floor topping you can install. Furthermore, this
moisture migrates from the ground under your
slab and causes cracks, potholes, and other
inconvenient openings.
PRINCIPLES OF SANITARY DESIGN
Internet Article
Top Six Floor Failures!
#2 – Insufficient Chemical Resistance
Chemicals can kill you. I got your attention, right?
Good, because chemicals can also kill your floors. Make
sure that your product selection has sufficient data for
resistance to the chemicals to which it will be exposed.
Some materials (like grease) are harmless at normal
temperatures, yet prove to be decisively corrosive
when heated.
#3 – Poor Thermal Shock Resistance
Do you work inside an active volcano? Probably not,
but there are some very hot materials out there. For
example, daily maintenance of food processing plants
involves cleaning with hot water or steam. Thermal
shock resistant surfaces do exist, and we can help you
find them!
PRINCIPLES OF SANITARY DESIGN
Internet Article
Top Six Floor Failures!
#4 – Inadequate Surface Preparation
Oh, no! Someone made a mistake! Thankfully, we're here to clean up that
mess with the power of knowledge. Sounds cheesy, but it's true. If you
don't prepare your floor properly, it may need to be completely replaced
soon after the installation process. Mechanically abrading the floor with
steel shot is a good idea. Don't just leave it there though; vacuum it up for
further use (this saves you money of course)! Water blasting can also be
used. If oils or fats have penetrated the surface, use a chemical degreaser.
#5 – Poor Slip Resistance
Don't forget that "wet floor" sign! Or, with the right type of flooring, you
can use that sign less often. You don't want employees to slip and crack
their heads because that results in serious injury (and high insurance
premiums)! The surface texture of floors in wet areas should be skid
resistant and not subject to removal of the texture during exposure to
daily wear and tear. Remember to request a sample of the product! This
way, you can compare it to the finished texture of the floor.
PRINCIPLES OF SANITARY DESIGN
Internet Article
Top Six Floor Failures!
#6 – Unrealistic Expectations
Ah, this is something we are all guilty of. Do not expect a
miracle floor that will last forever, win you an award, pay
your debts, or make your spouse eternally happy with
your anniversary gifts. Seriously though, the floor that
looks the best may not prove to be the best long term
performer. Make sure you know the following:
• What maintenance steps are necessary to keep the floor
in best possible shape?
• Are there important product limitations?
• What is the floor's service life?
• What constitutes normal wear and tear?
• Are the warrantee terms and conditions reasonable?
PRINCIPLES OF SANITARY DESIGN
Internet Article
Bad: Hollow Rollers & Sleeved Shafts
Prefer to use Solid Rollers
PRINCIPLES OF SANITARY DESIGN
PRINCIPLES OF SANITARY DESIGN
Non-Product Contact Surfaces:
Attachments should be welded to the surface of the tubing
and not attached via drilled and tapped holes.
Ledges or areas where dust can collect should be avoided.
Tops of equipment, shields, covers or boxes should be sloped
at a 45 degree angle or more.
Threads on leg levelers should be of the enclosed design to
shield the threads from environmental contamination.
PRINCIPLES OF SANITARY DESIGN
Food Equipment Installation:
Food equipment should be installed in a logical sequence
(process flow) to avoid cross contamination.
Space around and between equipment and walls should be
adequate to allow for sufficient cleaning.
Do not create harborage areas for insects and rodents.
Best practice is to mount all equipment at least 4 inches from
the walls. If not possible, make sure the equipment is
completely sealed to the wall.
PRINCIPLES OF SANITARY DESIGN
Food Equipment Installation:
Floor mounted equipment should be sealed to the floor,
platform, or pedestal or should be no less than 6 inches from
the floor to allow access for cleaning and inspection. Best
practice is to design pedestals made of the same material as
the floor as one continuous piece…no cracks or joints for all
equipment to mount on. (12” now considered best).
Table mounted equipment should either be sealed to the
table or be no less than 4 inches from the table or counter
top.
PRINCIPLES OF SANITARY DESIGN
The following is a review of Principles of
Sanitary Design from the American Meat
Institute.
The key to a good sanitary design of equipment
is that it be easy to disassemble for cleaning,
avoid harborage points, so the operator will
take the time to clean it correctly each and
every occasion.
PRINCIPLES OF SANITARY DESIGN
1. Cleanable to a Microbiological Level
Food equipment must be constructed and be maintainable to ensure that the
equipment can be effectively and efficiently cleaned and sanitized over the life of
the equipment. The removal of all food materials is critical. This means
preventing bacterial ingress, survival, growth and reproduction. This includes
product and non product contact surfaces of the equipment.
2. Made of Compatible Materials
Construction materials used for equipment must be completely compatible with
the product, environment, cleaning & sanitizing chemicals, and the methods of
cleaning & sanitation. Equipment materials of construction must be inert,
corrosion resistant, nonporous and nonabsorbent.
3. Accessible for Inspection, Maintenance, Cleaning & Sanitation
All parts of the equipment shall be readily accessible for inspection,
maintenance, cleaning and/or sanitation. Accessibility should be easily
accomplished by an individual without tools. Disassembly and assembly should
be facilitated by the equipment design to optimize sanitary conditions.
PRINCIPLES OF SANITARY DESIGN
4. No Product or Liquid Collection
Equipment shall be self-draining to assure that food product, water, or product liquid
does not accumulate, pool or condense on the equipment or product zone areas.
5. Hollow areas Hermetically Sealed
Hollow areas of equipment (e.g., frames, rollers) must be eliminated where possible
or permanently sealed (caulking not acceptable). Bolts, studs, mounting plates,
brackets, junction boxes, name plates, end caps, sleeves, etc. must be continuously
welded to the surface of the equipment and not attached via drilled and tapped
holes.
6. No Niches
All parts of the equipment shall be free of niches such as pits, cracks, corrosion,
recesses, open seams, gaps, lap seams, protruding ledges, inside threads, bolt rivets
and dead ends. All welds must be continuous and fully penetrating.
7. Sanitary Operational Performance
During normal operations, the equipment must perform so it does not contribute to
unsanitary conditions or the harborage and growth of bacteria.
PRINCIPLES OF SANITARY DESIGN
8. Hygienic Design of Maintenance Enclosures
Maintenance enclosures (e.g., electrical control panels, chain guards, belt guards,
gear enclosures, junction boxes, pneumatic/hydraulic enclosures) and human
machine interfaces (e.g., pushbuttons, valve handles, switches, touch screens )
must be designed, constructed and be maintainable to ensure food product,
water, or product liquid does not penetrate into, or accumulate in or on the
enclosure and interface. The physical design of the enclosures should be sloped
or pitched to avoid use as a storage area .
9. Hygienic Compatibility with Other Plant Systems
Design of equipment must ensure hygienic compatibility with other equipment
and systems, e.g., electrical, hydraulics, steam, air, water.
10. Validate Cleaning & Sanitizing Protocols
The procedures prescribed for cleaning and sanitation must be clearly written,
designed and proven to be effective and efficient. Chemicals recommended for
cleaning & sanitation must be compatible with the equipment, as well as
compatible with the manufacturing environment.
Sanitary Design
“ If you can not describe what you are doing as a
process, you do not know what you are doing.”
W. Edward Deming
W. Edward Deming
SANITARY DESIGN DAIRY CHECKLIST
• PRINCIPLE #1 - MICROBIOLIGICALLY CLEANABLE
• PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
• PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION,
MAINTENANCE, & CLEANING/SANITATION
• PRINCIPLE #4 - NO LIQUID COLLECTION
• PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
• PRINCIPLE #6 - NO NICHES
• PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
• PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE
ENCLOSURES
• PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER
SYSTEMS
• PRINCIPLE #10 - VALIDATED CLEANING & SANITIZING
PROTOCOLS
Sanitary Design
GENERAL HYGIENIC DESIGN PRINCIPLES
• Good hygienic design practices indicate the approach to be
taken to reduce risks of product contamination arising from
equipment operation. They seek to inhibit the opportunity
for microbial build-up and prevent the introduction of non-
ingredients material. This is achieved by promoting design
features which:
a) Minimize the possibility of product stagnation in the
product area and reduce the possibility of spillage and
soiling outside the equipment,
b) Allow and assist thorough cleaning and disinfecting of
product contact surfaces and all external parts of the
equipment.
c) Prevent material or parts from the equipment entering
or affecting the product.
d) Prevent external foreign matter entering the product
areas.
Sanitary Design
• GENERAL HYGIENIC DESIGN PRINCIPLES
• Good hygienic design should take into account HACCP and
full process considerations in order to ensure that potential
hazards are identified and design measures put in place to
ensure the suitability of equipment for the particular
purpose to which it is to be put, minimizing potential
negative impact on the final product.
• The general principles apply to overall systems as well as to
independent items of equipment. In subsequent sections of
the guidelines, the principles are extended in the detailed
application to various classifications, e.g. framework,
welding etc. Most mechanical handling equipment has
design elements referred to in the guidelines.
• Equipment materials in contact with the product must
be Food and Drug Administration (FDA) approved and
conform with The Materials and Articles in Contact
with Food Regulations 1987, as amended.
• All contact surfaces must be inert to food products
• All surfaces must be safely accessible for cleaning and
for visual examination as manual cleaning is carried
out.
• Product contact surfaces must be smooth, seamless
and scratch free.
Sanitary Design
• Products must move through the processing areas
completely and with no temporary retention. The
design should be for streamlined flow over product
contact surfaces.
• Spillage of food materials is not acceptable. The system
design must minimize all possibility of spillage and
provide hygienic methods of coping with instances
where spilling, splashing, blowing or other leakage may
occur.
• The design should be as simple as possible. This may
be achieved by using fewer parts but of heavier design.
Sanitary Design
• The design must be kept as open as possible, avoiding
corners that are difficult to reach.
• There should be no seams, gaps, crevices or any
inaccessible recesses that are difficult to clean even on
exterior non-contact surfaces. Ledges or horizontal surfaces
must be avoided, particularly where difficult to clean.
Contour such surfaces to ensure drainage.
• The hose-down procedure should anticipate any heavy run-
off so as not to pass over cleaner parts. Ensure that run-off
from external surfaces never flows across product contact
surfaces.
• The system design must allow good housekeeping
practices.
Sanitary Design
• Where appropriate, the system should demarcate
boundaries, e.g. between high and low risk areas.
• Small detachable parts of machines should be properly
secured. The use of Nyloc nuts or Aero self-locking nuts
is recommended.
• Parts of the equipment where product is open to the
atmosphere should be covered to prevent foreign
matter falling into the product area.
• Equipment should be free-draining inside and out to
the atmosphere, and should have no stagnant regions.
• All equipment must be designed to withstand alkaline
washing solutions and hosing where HACCP demands.
• As much fabrication as practicable should be carried
out off-site under clean workshop conditions.
Sanitary Design
New Construction Inspections
• When inspecting a new area you need to be
looking at not only the equipment but ability
to clean the equipment and area.
• On the initial inspection, items to consider are
product protection, equipment protection,
personnel protection, and environment
protection
New Construction Inspection Cont.
• What are some the things you have discovered
during new start-ups at your facility?
• How thorough is your inspection – how thorough
should it be.
• Who should go with you during the inspection.
• Who is responsible for getting the issues found
corrected?
• What do you do if these items are not getting
completed?
Welded Surface
• Need to inspect welds
around the entire
welded surface
• When should you check
the new area?
• How often should it be
checked.
• Who should be
checking it?
Bulk off or hand stack
• What is the issue here?
• What needs to be
corrected
• How would you address
this?
• Who do you talk to?
Hard to find places
• Sometimes you may
need to look in areas
that are hard to see.
• It pays to look
everywhere.
Other places to look
• You will need to check the slope of the floor and ensure that
pooling does not occur.
• Check catwalks that any holes drilled are not above conveyors
• Need to ensure that steps and catwalks are protected from
items on the bottom of shoes when above product zones.
• Need to make sure that ceilings, walls, and floors are
completely sealed to ensure proper cleanliness.
• Insulation must be sealed as well as all escusheons.
Continuous weld
• A weld that extends continuously from one end of a joint to the
other
• Where the joint is essentially circular, it extends completely
around the joint
Penetration
• A nonstandard term when used for depth of fusion,
joint penetration, or root penetration.
Melting point
• 304L stainless steel melts from 2550-2650 degrees
Fahrenheit
– Oxides
• Melts about 500 degrees hotter
• Burn thru is an oxide
Sanitary Design
• Hygienic Floor Surfaces/Coatings
Sanitary Design
Internet Findings
• The art of producing a product without
(unintentionally) changing it - good hygienic
design maintains product in the main product
flow
• The art of producing a product without adding
anything to it - good hygienic design prevents the
transfer of hazards
• The ability to (dismantle) access all product
contact areas to facilitate cleaning in an economic
time frame
Sanitary Design
• Vitrified Tile Systems
• Vitrified tile systems offer optimal aesthetics
and durability.
• A vitrified tile finished floor is chemically
resistant to food and its byproducts as well as
aggressive CIP and other cleaning compounds.
Its antimicrobial design and ease of
cleanability produce a sanitary floor for many
years of service.
Sanitary Design
Internet Findings
• Zones of control
• To prevent cross contamination, the design and
construction of any food processing facility
should incorporate a complete separation of
production areas that house uncooked (raw) from
cooked, ready-to-eat (RTE) products.
Construction must also include the segregation of
welfare areas for employees who handle raw
products from those who handle RTE products.
Such welfare areas include locker rooms, wash
stations, cafeterias and other such support areas.
Sanitary Design
Chilled Food Association
HYGIENIC DESIGN GUIDELINES
First Edition 2002
Temperature and moisture control
• Cold food processors should also grasp a clear understanding of
each room’s function to ensure sufficient humidity control and
corresponding room temperatures are reached.
• Installing reliable mechanical systems to control humidity within the
plant is critical to eliminating potential food safety and bacteria
harborage issues. For example, listeria can multiply between the
temperatures of 86-98.6°F. Listeria can also still live in refrigerated
spaces.
• Indoor air quality issues such as mold, odors, allergens, bacteria
growth/accumulation and suspended organic particles can be
improved through proper humidity control. Humidity is also an
important consideration in the design of WIP coolers, freezers and
finished goods storage areas because moisture depletion can cause
ingredient deterioration, which ultimately affects the quality of the
product.
Sanitary Design
Chilled Food Association
HYGIENIC DESIGN GUIDELINES
First Edition 2002
Temperature and moisture control
• Humidity sensors can be used to monitor and control
humidity levels within the proper ranges. Typical
dehumidification is performed by mechanical
dehumidifiers, which over-cool incoming air below the
point where the water condenses on the cooling coils
(dewpoint temperature). Afterwards, the cold dry air is
heated up to the desired temperature again and/or is
mixed with untreated air to provide air at both the desired
temperature and humidity to occupied spaces.
• Desiccant dehumidification is also a common and effective
way to lower humidity. Air is passed through a porous
wheel of solid desiccant, or through a shower of liquid
desiccant, and its humidity is lowered. Roughly 75% of the
time, the desiccant absorbs moisture out of incoming air.
The remaining 25% of the time, it will be regenerated by
passing heated air over the media.
Sanitary Design
Chilled Food Association
HYGIENIC DESIGN GUIDELINES
First Edition 2002
• Ability to clean and maintain the facility
• Materials used in both food manufacturing plant
construction and for process equipment fabrication should
be selected for both durability and cleanability. Consider
different materials’ ability to withstand harsh cleaning
chemicals and temperature variations.
• For example, the industry is using higher-end finishes and
grades of stainless steel to resist daily exposure to an array
of chemicals used in sanitation cycles. Type 316 has
become the most common stainless-steel alloy used for
food applications, along with higher-end finishes such as
2BA and No. 3, which often exceed regulatory requirements
and provide better bacterial resistance and improved
cleaning capabilities.
Sanitary Design
Chilled Food Association
HYGIENIC DESIGN GUIDELINES
First Edition 2002
Sanitary Design and Construction of Food
Equipment
Ronald H. Schmidt and Daniel J. Erickson
• Food Product Contact Surfaces
• In terms of sanitary design, all food contact surfaces should be:
• smooth;
• impervious;
• free of cracks and crevices;
• nonporous;
• nonabsorbent;
• non-contaminating;
• nonreactive;
• corrosion resistant;
• durable and maintenance free;
• nontoxic; and
• cleanable.
Food Processing Plant Design Stellar
• What Is Zoning?
• Identification and differentiation of the processing areas within
the
• manufacturing facility.
• Where microbiological cross contamination by relevant spoilage or
pathogenic
• organisms may occur during the receipt, storage, processing and
packaging of
• products.
• Separation may include :
• • Personnel and materials traffic.
• • Air handling.
• • Equipment.
• • Effluent, drains and waste systems.
• • Locker rooms.
• • Others ,that could result in transfer of microorganisms. Stellar
• Food processing environments are often wet and
highly moisture laden. The nature of the process
and the need for constant sanitation (often
accomplished with hot water) means that there
are copious amounts of moisture being
introduced into the environment. Additionally,
these processing rooms are generally held at low
temperatures in order to aid contamination
control and product enhancement. Cold space
temperatures exacerbate condensation
problems.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• To truly understand how to control this problem, one must
first understand how and why condensation forms. The key is
understanding a simple principal of psychrometrics known as
dewpoint. By definition, dewpoint is the temperature at which
existing moisture vapor in a given air sample will condense
from the air, forming dew. For example, if a room contains air
at a dry bulb temperature of 40 º F and a dew point
temperature of 35 º F, then any surface in the room that has a
temperature of 35 º F or less will generate condensate. This
occurs as the air that is in contact with the cool surface is
chilled and reaches its dew point, releasing moisture to the
surface as liquid droplets.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Preventing room condensation from occurring is
simple in concept but not necessarily in
implementation. The air within the space must be
controlled such that its dewpoint is never equal to or
higher than the lowest surface temperature within
the space. If dew point control is implemented, it is
impossible for dew or condensation to occur in the
space. Sanitation of the room and quality the
product are maintained.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Dewpoint control may be accomplished two ways.
Either heat the cool surface to a temperature that is
greater than dew point of the air or reduce the
dewpoint of the air to a temperature that is less than
sensible temperature of the surface. Either of these
solutions is acceptable, but the later is often the most
practical and therefore the one we will explore in more
depth.
• Reducing the dewpoint of the air within a space may
be accomplished by introducing and treating outdoor
air, dehumidifying the air with refrigeration, or
dehumidifying the air with dry desiccant technology.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• The introduction of outdoor air to the space
can be an effective dew point control
approach, but only when the dew point of the
ambient air, through Mother Nature’s graces,
is less than that to which you are looking to
control. Of course this generally implies that
the outdoor temperatures are low and often
this will require some heating to prevent the
space from being overcooled. The energy
required for this can be large during winter
months, especially in Northern Climates.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• When the dew point of the make up air is higher than the
dew point to which you are looking to control, this
approach is completely useless and will exacerbate the
problem rather than solve it (since you are now introducing
more moisture to the environment). To battle this, many of
these systems employ refrigeration to mechanically induce
what nature does for us during cooler seasons. This will
also consume substantial amounts of energy. For instance,
on a day where the weather is 85 º F db, 78 º F wb for every
1,000 CFM of outdoor air introduced, eleven Tons of
refrigeration are required simply to achieve a neutral
dewpoint of 35 º F. Delivering air at a dewpoint less than 35
º F is not practical since the coil surface temperature would
need to be less than 32 º F, generating ice and reducing
effective cooling.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Dehumidification through refrigeration is a method
worth exploring. Facilities with rooms like our example
will already be employing refrigeration for the sensible
cooling of the space. Therefore, it is often a natural
tendency to gravitate to this approach. Undoubtedly,
refrigeration can efficiently remove large quantities of
vaporized moisture from air. It is however limited by
the ice-over threshold (+32 º F). Since a coil will start to
generate frost whenever the coil surface temperature
is less than 32 º F, the practical limit to which the air
can be cooled and effectively dehumidified is 35-40 º F.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• An argument can made that the refrigeration routinely
occurs at temperatures below 35 º F. However for this to
occur, some special and often costly modifications need to
be employed. Mainly the implementation of a defrost cycle
for the coil is required. This makes the delivered
temperature and dew point difficult to predict and often
will require multiple evaporators in order to compensate. If
we look at one evaporator we would see a moisture
removal performance curve that would be bell-shaped over
time. The coil initially out of defrost would perform well,
but would quickly deteriorate in capacity as frost and ice
form (insulating the coils’ cooling fins from the air to be
refrigerated). Leaving air temperature would climb until it
again became essential to defrost the coil. This cyclical
performance curve, especially when employed in an air
handler, will make the ability to achieve predicable and
reliable dew point control impossible.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• This refrigeration approach is “employment of the problem
as a solution”. Refrigeration pipes, specialties, evaporator
condensation pans and condensation drain lines are often
the greatest sources of condensation in the room since
they have the lowest surface temperatures. Likewise,
structural surfaces in the room that are near to the
evaporator or air handler discharge become condensation
points as their surface temperatures are cooled by the low
temperature air. This makes getting ahead of condensation
problematic. Reducing evaporator temperature to achieve
lower discharge air temperatures increases the likelihood
that condensation will form.
• By utilizing a re-heat coil, the impact of discharge air
cooling surfaces can be reduced, but cannot accommodate
the other performance shortcomings.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Given the problems associate with the freeze
threshold, the difference between delivered
air dewpoint and the desired room dewpoint
is minimal. The best case scenario is limited to
a 4-8 º F difference between delivered air and
room design dewpoint. As a result, a system
designed to control dewpoint using
refrigeration must utilize high air exchange
rates in order to counterbalance the space
moisture load. This adds even more associated
mechanical and operating cost to the room.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• The most efficient and effective path to humidity control in
a space such as our example is dry desiccant technology.
These systems generally utilize a desiccant rotor to
accomplish the drying process. The rotor is comprised of a
substrate that has a desiccant material bonded to it. The
substrate most commonly is a high surface area fluted mass
formed into a rotor, through which air can pass. As the air
passes through, the desiccant removes moisture from the
air in a vapor phase. The air then exits the rotor
significantly dryer than it entered. Because moisture
removed by the desiccant eventually will saturate the
material it must be continuously regenerated. A secondary
air stream, normally designated as “regeneration” or
“reactivation”, is heated and passed across a smaller
segment of the rotor. The rotor revolves at a constant
speed between these airstreams, generating a predictable
and reliable dehumidification performance.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Desiccant technology can readily achieve
delivered supply dewpoints of 0 º F or lower.
This provides a significant difference between
delivered air conditions and design room
dewpoint control levels. Humidity can be
controlled effectively with appreciably lower
air exchange rates than by other technologies.
System air volumes necessary to achieve
adequate control will be minimized as
compared to a cooling-based system.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Because the process of drying occurs in a vapor state,
moisture is easily rejected by the regeneration air
stream. This eliminates the need for consequent
removal of condensed liquids which compromise the
hygiene of the conditioned space. Most applications
allow the desiccant system to be located on a roof or
other space remote from the control environment.
• This technology also allows the room dewpoint (source
of condensation) to be independently controlled from
the room sensible temperature. This means that the
space can be easily controlled at specified temperature
and dewpoint.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• The desiccant approach works symbiotically with the refrigeration
system in the room. Refrigeration capacity and operation are
enhanced by the reduction in the latent load in the space provided
by the desiccant system. The reduced latent loading on the
evaporator coils serves to allow the refrigeration to more
effortlessly accomplish its dedicated mission; reducing space
temperature. The desiccant system can achieve its mission which is
to control the dewpoint in the room low enough as to virtually
guarantee that no condensation will occur.
• Dehumidification from dry desiccants provides the most reliable,
consistent and tangible control of condensation within food
processing environments, without implementing costly make-up or
frost control options. Desiccant Dehumidifiers benefits to the
hygienic integrity of the space have been well proven. Many within
the food processing industry have had the opportunity to
experience it first hand.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
Guidelines on air handling in the food
industry
Trends in Food Science & Technology 17 (2006) 331–336
Differential operational states
Normal production
• In the normal operational state, the air handling system will
correctly distribute fully conditioned (i.e. filtered, controlled
temperature and humidity) air into the production area at
the required rate and recirculate it (typically 85%
recirculation and 15% exhaust/replenishment) through the
system.
Cleaning
• The air handling system may need an additional operational
state during factory cleaning, which will input filtered fresh
air into the production area via the ducting, to maintain the
overpressure and protect the filters from moisture damage,
but will extract moisture-laden air directly to exhaust without
re-circulation. If there is no extract system, then aerosols
should be allowed to settle and appropriate drying and
disinfection completed.
Sanitary Design
Kevin Smith
Concepts and Designs, Inc.
• Intralox ThermoDrive belting is installed with ZERO
PRE-TENSION. Since a belt installed properly will be
loose on the conveyor, belt sag in the return-way
should be expected. In order to properly control the
shape and location of this sag while ensuring the belt is
not pre-tensioned, the belt must have sufficient
support in the return-way.
• Catenary sag, when implemented correctly, is critical
because:
• It indicates zero pre-tension in the belt
• It accommodates belt storage from changes in length
due to load or changes in temperature
• It enables belt lifting and access for sanitation
Sanitary Design
STONCLAD® G2
PRODUCT DESCRIPTION
• Stonclad G2 is a four-component, trowel applied, polyurethane
mortar system designed with sustainability in mind. Stonclad G2
consists of a urethane-urea binder, pigments, graded quartz
aggregates and recycled glass aggregate. Stonclad G2 incorporates
• 25% post industrial recycled glass in the system. It can be applied at
thickness ranging from 1/8 in./3 mm to 1/4 in./6 mm depending on
application requirements and cures to an hard, high impact
resistant mortar which exhibits excellent abrasion, wear, and
chemical resistance. Also uniquely formulated to withstand thermal
cycling.
USES, APPLICATIONS
• Stonclad G2 is formulated specifically for the food and beverage
industry, using a multi-functional urethane-urea resin.
Specialized Flooring Concepts
Equipment Design Problems and Their Solution
Steve Stone
Wisconsin Department of Agriculture, Trade and Consumer Protection
Division of Food Safety
Sanitary Design
Reducing Contamination Risks of Compressed Air
in Food Plants: Benchmarking Good
Manufacturing Practices A GMP Template for Food
Plants using risk-based systems: HACCP Procedures
GFSI - SQF Code Lee Scott
Market Development Manager
Food & Beverage
Parker Filtration & Separation Division
Haverhill, MA 01835
Ph: 978-478-2750
Lscott@parker.com
Sanitary Design
• GMA Principles of Sanitary Design
• Cleanable to GMP, product hazard (microbiological, chemical,
physical), and quality levels
• Made of compatible materials
• Accessible for inspection, maintenance, and cleaning/sanitation
• No liquid collection
• Hollow areas hermetically sealed
• No niches
• Sanitary operational performance
• – Hygienic design of maintenance enclosures
• – Hygienic compatibility with other systems
• Validated cleaning and sanitizing protocols
• Separate processes wherever possible
• Equipment and personnel at installation meet
• hygiene and sanitation requirements
Sanitary Design