Sanitary Design An Introduction to Standards of Design Excellence November 2015

Sanitary Design

An Introduction to Standards of Design Excellence November 2015

Arranged & Edited by: Robert Long

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


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 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.



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.



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.



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.


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


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.


• 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.


• 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.


• 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.


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.


Don Graham

http://www.foodsafetymagazine.com/fsm/cache/file/B4D5D6CE-141B-4DD7-9E12C382B3260778.jpg

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


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.


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


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.


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.


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.


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.


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.


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


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


Types of Stainless Steel

Bead Blasted – Rough Looking Finish

Polished – Smooth Shiny Finish Mirror - Highly Polished Mirror Finish

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 Sanitary Equipment Openings, Covers and Top Rims:

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.


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!


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.


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?


Internet Article

Bad: Hollow Rollers & Sleeved Shafts

Prefer to use Solid Rollers


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.

Conveyor Wear Strips


Conveyor Scrapers


Conveyor Drives


Bits Auger


Exhaust Systems

Design Changes: •Drain Legs •Access Doors


Bearings



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.


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.


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?

Framework weld • Is this weld OK • What are the concerns?

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.

Why are good welds important?

• American Welding Society • 550 N.W. LeJeune Rd • Miami FL 33126 • 305-443-9353 • 800-443-9353 • Email: [email protected]

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mailto:[email protected]

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

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• Hygienic Floor Surfaces/Coatings

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Corners, Curbs, Footings Internet Findings

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Multiple Considerations and Zones of Risk

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Freezer HVAC, Room Tanks and Drains, Roll Up Doors

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Wall/Floor Joint Coving Internet Findings

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Concrete Burms, Tank Cone Bottoms, Leg Supports

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Floor Drains and Flooring Tiles

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Cooler Room Doors

Floor/Wall Coving and Coatings Internet Findings

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Traffic Patterns and Flows

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Specialized Wall Panels that are easily cleanable

Carefully Designed Hand Wash Stations

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Floor Coatings and Curbing around Structural Supports

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Coving Designs for floor/wall junctures Floor Structures and Coatings

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Room Air Flows

Exterior Roof Structures

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Specialized Floor Tiles and Coatings for Better Wear

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Niches and Catch Points

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• 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

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Traffic Patterns and Plant Layout Designs

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• 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.

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Plant Exteriors and Barriers

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Control of Rooms with Zones and Dedicated Powered Equipment Area Use Internet Findings

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Mitigation Steps Designed into Traffic Routes

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Physical Barriers to Insure Proper Traffic Flows

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Mitigation Devices for Personnel Traffic Internet Findings

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Solid Wall Panels, Concrete Burms, and floor coatings Internet Findings

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Air Flows designed to protect Highest to Lowest Hygiene Areas

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Sanitary Design HVAC System Designs allow for cleanability

Exterior Construction Designs to Prevent Water Pooling at Structure

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Sanitary Design Wall penetrations enclosed and sealed

Equipment and Platform Structures

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Piping and Utilities well designed and insulated as needed to prevent condensation

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Ceilings flat and sealed, with piping and utilities contained in enclosed areas above room ceiling

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Room Designs allow for appropriate cleaning with surfaces that are drainable

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Raised Platforms for Cleaning Underneath

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• 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.


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.


• 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 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.

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GRAHAM

EHEDG

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FDA

EHEDG

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FDA

MARCONNETT

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.

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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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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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.

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Eric Goan Department of Food Science Technology University of Tennessee

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Importance of Floor Systems Durability

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Durable Floor Designs Proper Equipment Footings

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Plant Processing Layout Designs

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Combining Wall Systems, Burms, Flooring Systems, and Holistic Room Approaches to promote cleanability

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Intralox Thermo Drive®

Cutting Edge Designs for Improved Conveyor Systems

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• 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

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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


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Equipment Design Problems and Their Solution

Steve Stone Wisconsin Department of Agriculture, Trade and Consumer Protection

Division of Food Safety

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Steve Stone

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Steve Stone

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Steve Stone

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Steve Stone

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Steve Stone

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Sanitary Environment and Equipment Designs Internet Findings

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Gasket Materials and Durability

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Sanitary Design Assessment

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Not Easily Cleanable Welding Examples

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COP Design

Spray Applications Application Recommended Spray

Silos, Tanks, Ducts Fixed Sprayballs Blenders, Mixers Reaction Driven Tankers Horizontal Rotary – special

Drop-in Fixed Open Vats Directional fixed sprayballs Process equipment Fixed Sprayballs

Reaction Driven Automatic RFS Fixed Spray Nozzles

Reaction Driven

Static

Dynamic

Types of Spray Devices

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How Cleanable is it? Internet Findings

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How Cleanable is it?

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How Cleanable is it?

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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 [email protected]

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Advancing Food Safety through Sanitary Design

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HVAC and Cooler/Freezer Designs

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HVAC Drain Pans

HVAC Sock Piping Internet Findings

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Interstitial Levels for Isolating Piping and Utility Functions

Running Piping/Utilities on Roofs

Sealed Pipe ways

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Hand Washing Stations

Stainless Steel Design Materials

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Poor Welds & Sandwich Joints

Covers that create Niches

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Leg Supports Internet Findings

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Casters

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Avoid Niches

Set Off From Wall for Access to clean

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Consider Step Over Designs

Pump Design Issues

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• 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

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SCL Fabric Curtain Walls

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Sanitary Hinges

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Consider Storage and Materials Handling

Holistic Layout and Design

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Power Plant/Utility Designs should also be considered in Plant Layout and Function

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Roof Areas should be self draining without pooling or puddling of water

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Example Floor Layout

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 Sanitary Design Standards 3A Standards EHEDG NSF ANSI One Voice AMI GMA Point: Plenty of Options, so pick one and start using them!

Questions?

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Documents

Sanitary Design An Introduction to Standards of Design Excellence November 2015