SANITARY - Meat Institute

SANITARY DESIGN

PRINCIPLES FOR FACILITIES

Dr. Skip SewardAmerican Meat Institute

SANITARY DESIGN PRINCIPLES FOR FACILITIESThe Agenda

•Background Justification•Mission & Goals of the FDTF•Overview of Principles of Sanitary Design &

Development of the Principles•Checklist Tool & Data Analysis•Selection of Design/Construction

Professionals•Applying the Knowledge Gained•Cocktail Reception

SANITARY DESIGN PRINCIPLES FOR FACILITIES

The CD

•FDTF Presentation•FDTF Sanitary Design Principles•FDTF Checklist Tool•EDTF Sanitary Design Principles

DEDICATED TOHENRY A. LURIE

30 YEARS OF GLOBAL INFLUENCE ON DESIGN

1954-1993 Henry A. Lurie & Associates

Refrigeration for Meat Processing Plants (1966)

REGULATORY ENVIRONMENT

REGULATIONS & FACILITY SANITARY DESIGN

FDA 21 CFR 110 – GMPs

FSIS9 CFR 416 – Sanitation

REGULATIONS & FACILITY SANITARY DESIGN

FSIS – FMIA & PPIAproduction of meat, poultry & selected egg products

FDA - FFDCAall other products

FDA - 21 CFR 110Subpart B – Buildings & Facilities

110.20 – Plant & Grounds

• Grounds

• Plant Construction & Design


110.35 – Sanitary Operations

• Maintenance

• Pest Control


110.37 – Sanitary Facilities & Control

• Water Supply & Plumbing

• Sewage & Waste Disposal

• Hand-washing Facilities

FSIS - 9 CFR 416Sanitation416.2 – Establishment Grounds &

Facilities

• Grounds & Pest Control

• Construction

CONSTRUCTION HAZARDS

Potential Harborage Areas• Wall or ceiling that may be wet or has

absorbed enough water to support growth

• Deep within floor with previous positives for Listeria

• Drain system and soil around drains

Historical Relationship of Construction Activities to Recalls

NormalConstruction

Dennis Johnson OFW

Plant activities before a recall

CONSTRUCTION RISK

Construction in or near the cooked products area may present abnormal and unusual risks to the area, and to products stored and manufactured in that area.

CONSTRUCTION GMPS

• Control Traffic Patterns

• Use Doors Effectively

• Maintain Negative Pressure

CONSTRUCTION GMPS

• Control Traffic Patterns• Use Doors Effectively• Maintain Negative Pressure

• Restrict Entry Into Sensitive Areas

• Prevent Aerosols

• Use Temporary Partitions Effectively

WET AREA TEMPORARY PARTITION

Duration Construction Up to 2 weeks 2x4 and poly sheet, taped

joints

Up to 4 weeks 2x4 and plywood covered with poly sheet, duct taped joints

Beyond 4 weeks w/o trucking

Steel 2x4 and glass board wall, caulked joints

Beyond 4 weeks w/ trucking

Steel 2x4 and glass board wall, caulked joints. Guard to protect from trucking.

DRY AREA TEMPORARY PARTITION

Duration Construction Up to 2 weeks 2x4 and poly sheet,

taped joints

Beyond 2 weeks 2x4 and plywood (4’) covered with poly sheet, taped joints. Guard to protect from trucking.

CONSTRUCTION - HACCP

Monitoring Activities• Key measures are defined for each of the critical

control points

• Monitoring responsibilities are defined and assigned (who, what, when & how) – Construction worker movement may be an

example of a CCP monitoring activity – Predefined marked areas can be used to limit

access• Violation of these areas will invoke corrective

action

CONSTRUCTION - HACCP

Verification• Rapid microbiological tests may be

used to verify process control

• Tests such as air sampling outside of a containment area during and after critical operations can be used as verification steps


Facilities• Grounds & Pest Control• Construction

• Light

• Ventilation


Facilities• Grounds & Pest Control• Construction• Light• Ventilation

• Plumbing• Sewage Disposal

FSIS - 9 CFR 416Sanitation416.2 – Establishment Grounds & Facilities• Grounds & Pest Control• Construction• Light• Ventilation• Plumbing• Sewage Disposal

• Water Supply• Dressing Rooms, Lavatories & Toilets

FSIS - 9 CFR 416Sanitation

416.3 – Equipment & Utensils

416.4 – Sanitary Operations


416.5 – Employee Hygiene

416.6 – Tagging Insanitary Equipment, Utensils, Rooms or Compartments


Sanitation SOPs

… shall describe all procedures conducted daily to prevent direct contamination or adulteration of products

CONTROLLING MICROBIOLOGICAL HAZARDS

• L. monocytogenes• E. coli O157:H7• Salmonella• Campylobacter• Legionella

… understanding the hazards, then … preventing entry points into the facility and the establishment of niches & harborages

Focus of Sanitary Design Principles for Facilities

PREVENTING GROWTH OF THE MICROBIOLOGICAL

HAZARDS• Salmonella• E. coli O157:H7• C. perfringens

… adequate chilling capacities critical to preventing growth in raw and RTE products

BIO-BURDEN

Hurdle

Finished Goods

Raw

Materials

Reduction

Sanitary design hurdle

BIO-BURDEN

Hurdle

Finished Goods

Raw

Materials

Reduction

A failure in your hurdle is like a hole in the dike … eventually it overwhelms the system

CLEAN & SANITARY

What does it mean to be clean & sanitary?

How can we measure cleanliness?

A measure of the success of sanitary design …

MEASURES OF CLEAN

Visual

… this will be the first measure, but will only take you so far because of …

THE SMALL SIZE OF BACTERIA

Salt

(120

µm)

Mol

d sp

ore

(3 µ

m)

List

eria

(0.5

µm

)

Yea

st (5

µm

)

MEASURES OF CLEAN• Swabs, sponges

& rinse samples

– <1 CFU (colony forming unit)/25 cm2

– <1 CFU/10 ml of rinse water

– Below background of protein or sugar

– Below background RLU (via ATP)

EDTF Principle 1. Cleanable to a Microbiological LevelFood 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.

L. monocytogenes

Our primary concern …

• WIDESPREAD IN THE NATURAL &• FOOD PROCESSING• ENVIRONMENTS

WHY THE CONCERN?

LISTERIA – DAIRY PLANTS (n=30)

Coolers & Freezers 47%

Dry Storage 43%

Entrance to Processing 40%

Raw Milk Receiving 39%

Drains 38%

Processing 36%

LOCATION % (+)

LISTERIA – MEAT PLANTS (n=41)

Floors 39%

Floor Drains 39%

Cleaning Aides 34%

Wash Areas 24%

Sausage 22%

Food Contact Surfaces 20%

Condensate 7%

Walls & Ceilings 5%

Compressed Air 4%

LOCATION % (+)

• HIGH MORBIDITY AND MORTALITY

• SUSCEPTIBILITY OF SELECTED CONSUMERS

WHY THE CONCERN?

48

0.3 0.3 1.1 1.5 1.95.3

11.6

21.5

0

10

20

30

40

50

<1 1-9 10-19 20-29 30-39 40-49 50-59 60-69 70+

Age group (years)

Cas

es p

er m

illio

n po

pula

tion

INCIDENCE OF LISTERIOSIS BY AGE GROUP, BY AGE GROUP, U.S.

• HIGH MORBIDITY AND MORTALITY

• SUSCEPTIBILITY OF SELECTED CONSUMERS

• FOOD IS A VEHICLE OF THE BACTERIUM

WHY THE CONCERN?

USDA PRODUCT TESTINGUSDA PRODUCT TESTING

% Positive Listeria monocytogenes90- 93 94 95 96 97 98 99 00

Cooked Beef 4.3 2.1 2.7 3.4 2.7 2.1 2.7 2.2Sliced Lunch Meat 7.3 5.6 5.1 7.8 4.8 4.2 4.6 3.0Cooked Sausage

Large (>1.5”) 3.2 1.1 1.1 0.9 1.1 1.2 0.4 0.5Small - franks 5.7 4.0 4.1 3.7 3.3 3.5 1.8 1.3

Jerky 0.0 2.2 0.0 0.0 0.0 1.6 0.0 0.8Cooked Poultry 2.3 2.4 2.3 3.2 1.2 2.2 1.4 1.2Salads / Spreads 3.5 2.4 4.7 2.2 3.1 3.1 1.1 1.0

Source: Various FSIS reports …1990-2000

USDA PRODUCT TESTINGCOMBINED RESULTS 2001-2002

USDA PRODUCT TESTINGCOMBINED RESULTS 2001-2002

Source: Various FSIS reports …2001 & 2002

1.214.31.20.00.0Multi-ComponentProducts

2.20.02.41.41.1Sliced, Diced, & Shredded

0.90.00.90.00.0Salads/Pates/Spreads

0.73.71.50.12.3Small MassWhole Muscle

1.00.01.50.20.0Small Mass Chopped & Formed

1.40.01.51.90.0Small Mass Whole Muscle

1.55.31.10.09.1Large MassChopped & Formed

0.72.50.50.22.0UnPeeled Sausage

1.40.01.60.07.1Peeled Sausage

Summary ByProduct Type

Product With Secondary Inhibitors

Fully CookedNot Shelf

Stable

Heat TreatedShelf Stable

Not Heat Treated

Shelf Stable

REGULATORY CONTROL

… & IMPACT

President Bush

and

Secretary Veneman

9 CFR 430 CONTROL OF L. MONOCYTOGENES IN RTE MEAT AND POULTRY PRODUCTS

• Listeria control program – shared• Inspection based on control Alternatives &

production volume• Focus on environmental monitoring &

corrective actions• Incentives for post-lethality control

measures

The Listeria Rule …

FSIS DIRECTIVE 10,240.4

• RESPONSE TO POSITIVES IN THE ENVIRONMENT

• VALIDATION OF INTERVENTIONS• STATISTICAL CONFIDENCE IN ACTIONS

BY ESTABLISHMENTS• PREREQUISITE VS. SSOP VS. HACCP• INTENSIFIED SAMPLING

2004

double Listeria testing

FSIS RECALLS

… 42% of recalls by FSIS in first 6 months of 2004 were related to Listeria monocytogenes

LINKING FOOD & CLINICAL ISOLATES

Historically

• CDC and others looked for an unusual number of cases of listeriosis using epidemiological investigations, &

• traditional microbiological procedures


Traditional Microbiological Methods

• Phage typing

• Serotyping: 4b, 1/2a, 1/2b


Currently

• IMPROVED OUTBREAK DETECTION

• LARGER NUMBERS, LONGER TIME


Innovative Modern Methods • DNA fingerprinting - PFGE

–pulsed field gel electrophoresis

• PulseNet–isolates fingerprinted by PFGE–fingerprint library for health labs–focus on increase in common PFGE

patterns

Listeria ControlListeria Control

EffectiveSanitation Procedures Controls

SanitaryDesign Equip &Facility

Clean, DryUncracked Floors

++GMP’s+ +ControlledTrafficPatterns

ROLE OF SANITARY DESIGN IN THE LISTERIA EQUATION

=

SANITARY DESIGN TO HELP PREVENT

BIOFILMS

• Bacterial growth – attached to a surface– protected by a bacterial film

• Biofilms provide increased resistance from disinfectants

HARBORAGE SITE OR NICHE

- a site within the food processing environment wherein microorganisms become established & multiply

- a reservoir from which microorganisms are dispersed & contaminate equipment, personnel & products during operation

- niches may contain spoilage organisms & pathogens

SIGNIFICANCE OF A NICHE

• Niches critical when after kill step in the process - contamination of RTE food

• Processing environment visually clean and acceptable – can be misleading

• Microbiological testing needed to detect the niche

• Certain pathogens more common in a niche

PATHOGENS ASSOCIATED WITH NICHES

Commonly involved• Salmonella• L. monocytogenesSome history or the potential exists• S. aureus• C. botulinum• E. coli O157:H7• C. perfringens• B. cereus

Commonly involved• Salmonella• L. monocytogenesSome history or the potential exists• S. aureus• C. botulinum• E. coli O157:H7• C. perfringens• B. cereus

FACTORS IMPACTING THE PRESENCE & CONCENTRATION OF PATHOGENS IN NICHES

• Temperature• Moisture• Nutrients• pH• Competitive

flora

OIG AUDIT REPORT ON FSIS

… contamination (L. monocytogenes) could be caused by poorly designed facilities or equipment … product contamination can occur if raw and finished products, equipment, or plant personnel cross between raw and finished product areas.

FSIS Oversight of the Listeria Outbreak in the Northeastern U.S., USDA OIG Audit Report No. 24601-02-Hy, June 2004

RESEARCH ON SANITARY DESIGN

Butts. 2003. Seek & Destroy: Identifying & Controlling L. monocytogenes Growth Niches.

Factors that give rise to the development of growth niches include equipment design problems, and

Certain operational conditions such as product debris working its way into an un-cleanable location, …

… equipment & facility design


Lunden et al. 2003. Persistent & Non-persistent L. monocytogenesContamination in Meat & Poultry Processing Plants.

• 596 isolates from food processing plant swab & sponge samples

• Persistence determined using DNA PFGE patterns & serotyping (>5X over 3 months)


Lunden et al. 2003. Persistent & Non-persistent L. monocytogenes Contamination in Meat & Poultry Processing Plants.

• Grouping = 47 PFGE patterns & 5 serotypes

• 17 - 41% strains were “persistent”• 50% persistent strains found in all areas:

environment, equipment & products


Lunden et al. 2003. Persistent & Non-persistent L. monocytogenes Contamination in Meat & Poultry Processing Plants.

Contamination was influenced by compartmentalization of the processing line … the separation of raw & RTE areas seemed especially important …

… separation of raw & RTE


Moore et al. 2003. Transfer of Salmonella & Campylobacter from Stainless Steel to Romaine Lettuce.

3-strain cocktails in TSB – 20 µl onto 25 cm2

304 ss3 X 3-cm squares of wet or dry Romaine

lettuce Weight

Lettuce

Inoculum



Over 2 hours, transfer was as high as 60% from the inoculated stainless steel to the lettuce



High numbers of bacteria may be transferred to a food even after 1 to 2 hours after surface contamination

… persistence of contamination


Lindsay et al. 2004. Enhanced Adhesion of Spores.

Post-sanitation pH conditions can enhance adhesion of spores of B. cereus to food contact surfaces

… sanitation chemicals & construction materials


De Cesare et al. 2003. Survival & Persistence under Various Organic Loads on Food Contact Surfaces.

5-strain cocktails of Salmonella & Campylobacter

5-cm2: 304 ss, Formica laminate, ceramic tile100 μl (PBS vs. TSB) to give 107/ 5-cm2

Recovery over time & statistical analysis



Hydrophobic nature of surface affects drying time & thus the survival of enteric pathogens



Salmonella & Campylobacter persist on soiled surfaces, a factor that certainly contributes to increasing risks of cross-contamination

… construction materials

… ability to clean surfaces


Frank et al. 2003. Removal of L. monocytogenes & Poultry Soil-containing Biofilms Using Chemical Cleaning & Sanitizing Agents Under Static Conditions.

5-strain cocktail304 ss #4B finish – 7 ½ X 11 cm couponsSubmerged & incubated 24 hours in contaminationAfter drying, biofilms coated with chicken protein &

fatImmersion in cleaners or sanitizersRecovery of survivors



Alkali removed protein & fat

Sanitizers reduced L. monocytogenes 5-logs

Inefficient cleaning survival increased >100X



An important aspect of preventing L. monocytogenes contamination of RTE foods is controlling the presence of the pathogen in the processing plant environment

… integration of sanitation

EXPECTATIONS FOR CONTROL OF ALLERGENS

Graham. 2004. Using Sanitary Design to Avoid HACCP Hazards and Allergen Contamination.

Facility & equipment designs are key to successfully controlling potential allergen contamination

… additional benefit

EXPECTATIONS FOR CONTROL OF BSE PRIONS

• Separation of animals by age Dentition


• Separation of animals by age

• Segregation of SRMs• Waste management• Separation of products

from animals of different ages


• Separation of animals by age• Segregation of SRMs• Waste management• Separation of products from

animals of different ages

• Separate processing lines

• Age-specific equipment

… all impact facility design

PROACTIVE INDUSTRY INITIATIVE -

OCTOBER, 2001AMI BOARD OF DIRECTORS

… food safety is a non-competitive issue

AMI FACILITY DESIGN TASK FORCE


MISSION AND GOALS OF FDTF

David DixonMiddough Consulting

Establish sanitary design principles for the design, construction and renovation of food processing facilities to reduce food safety hazards

FDTF MISSION

JUSTIFICATION FOR FDTF

• Customers and consumers expect safe products



• Facility design is a critical factor in the food safety equation



• Facility design is a critical factor in the food safety equation

• AMI Board chartered the FDTF to establish best practices for facility sanitary design

FDTF GOALS

• Make the food supply safer

• Present Best Practices for sanitary design

FDTF GOALS

• Increase knowledge across a wider base

• Provide tools to identify and prioritize investments

FDTF GOALS

• Justify increased investment in food safety systems

• Establish an on-going forum

• Harmonize perceptions


OVERVIEW OF PRINCIPLES

Dave KramerSara Lee Foods

THE FOOD SAFETY EQUATION

GMPsSANITARY

EQUIPMENTDESIGN

SANITARYFACILITYDESIGN

HACCP

TRAINEDEMPLOYEES

VALIDATED & VERIFIED PROCESSES

REPEATABLE FOOD SAFETY RESULTS

CONTINUOUS IMPROVEMENT PROCESS

10 PRINCIPLES OF SANITARY EQUIPMENT DESIGN

1. Cleanable to a Microbiological Level2. Made of Compatible Materials3. Accessible for Inspection, Maintenance,

Cleaning & Sanitation4. No Product or Liquid Collection5. Hollow areas Hermetically Sealed6. No Niches7. Sanitary Operational Performance8. Hygienic design of maintenance enclosures9. Hygienic Compatibility with Other Plant Systems10. Validate Cleaning & Sanitizing Protocols

CONTRASTING EQUIPMENT & FACILITY SANITARY DESIGN

PRINCIPLESEDTF Principles focused on the micro level

•Niches/harborages for microorganisms

•Cleanability


PRINCIPLESFDTF Principles also focus on the macro level

• Niches/harborages for rodents and insects

• Site design


PRINCIPLESFDTF Principles also focus on the macro level

• Niches/harborages for rodents and insects• Site design

• Zones of control for the entire facility • People and material flows• Preventing cross-contamination

DEVELOPMENTOF THE


DEVELOPMENT OF11 PRINCIPLES

• 8 AMI member processors• 8 AMI member design firms• 17 highly paid volunteers• 400+ years of experience• Over 200 facilities• Add one Ph.D.

AMI FACILITY DESIGN TASK FORCE

Principle 1: Distinct Hygienic Zones Established In The Facility

Principle 2: Personnel & Material Flows Controlled to Reduce Hazards

Principle 3: Water Accumulation Controlled Inside Facility


Principle 4: Room Temperature & Humidity Controlled

Principle 5: Room Air Flow & Room Air Quality Controlled

Principle 6: Site Elements Facilitate Sanitary Conditions


Principle 7: Building Envelope Facilitates Sanitary Conditions

Principle 8: Interior Spatial Design Promotes Sanitation

Principle 9: Building Components & Construction Facilitate Sanitary Conditions


Principle 10: Utility Systems Designed To Prevent Contamination

Principle 11: Sanitation Integrated Into Facility Design


110

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

PRINCIPLES OF SANITARY DESIGN


AMI Checklist: 17 criteria

Key Concepts• Documents clarify hygienic zones• Physical barriers• Separate (duplicate) facilities• Clean-up vestibules• Classify products

CHECKLIST CRITERIAPRINCIPLE #2 - PERSONNEL & MATERIAL FLOWS REDUCE HAZARDS

# Criteria2.1 Movement of employees throughout the facility is controlled2.2 Movement of visitors throughout the facility is controlled2.3 Movement of contractors throughout the facility is controlled2.4 Movement of maintenance personnel throughout the facility is

controlled2.5 Systems are in place for sanitary transportation of packaging materials

into RTE/high risk zones2.6 Systems are in place for sanitary transportation of ingredients into

RTE/high risk zones2.7 Systems are in place for sanitary transportation of rework into RTE/high

risk zones2.8 Systems are in place for sanitary removal of trash from RTE/high risk

zones


• Not intended as design or constructionstandards

• There are a number of design details, specifications, materials and finishes that can achieve the desired outcome - a sanitary facility. There is not necessarily one best answer.

DESIGN = DESIGN = DESIGN


Three Broad Themes

• Provide Zones of Control• Keep It Cold & Control Moisture• Design to Facilitate Sanitation

ZONES OF CONTROL

What are we controlling?People

• Production workers• Supervision/Staff• Maintenance• Quality Assurance• Medical• Sanitation• Visitors• Suppliers• Regulatory

What are we controlling?People

• Production workers• Supervision/Staff• Maintenance• Quality Assurance• Medical• Sanitation• Visitors• Suppliers• Regulatory

Materials

•Raw materials•Packaging materials•Trash•Rework•Inedible•Uniforms/laundry•Maintenance parts•Sanitation chemicals

What is our goal?

1. Control the transfer of physical, chemical or microbiological hazards into our facilities

2. Control the transfer of physical, chemical or microbiological hazards from one area of our facility to another

3. Control post-lethality cross-contamination

Create a controllable environment

PRINCIPLE #1

DISTINCT HYGIENIC ZONES ESTABLISHED IN THE FACILITY


PRINCIPLE #1


… requires a hazard analysis of your facility and the development of a plan to reduce the likelihood of the transfer of those hazards into or within your facility

Cleanroom

Raw

Processing

RawWelfare

Office

RTE

Welfare

Cook/ChillCleanroom

Cleanroom

Cleanroom

SecondaryPackaging

Maintenance

Sanitation

First Aid

Trash

InedibleShipping

ZONES OF CONTROL

ZONES OF CONTROL

RawProcessing

RawWelfare Office

RTEWelfare

Cook/Chill

Cleanroom

Cleanroom

Cleanroom

Cleanroom

SecondaryPackaging

Your goal is a logical process flowwith strict zones of control

PRINCIPLE #2

Personnel & Material Flows Controlled to Reduce Hazards


PRINCIPLE #2


You’ve established the zones of control.

… now you must establish the controls necessary to manage the flow of people and materials between zones.

Magnetic Lock

Access Control Card Reader

Active ControlPassive Control

From This To This More

Design Sanitary Design

Cross Traffic Aisle

RTE Area

KEEP IT COLD &

CONTROL MOISTURE

THE GOAL


Control two of the critical factors that affect the growth of microorganisms:

temperature and moisture

THE GOAL


Control two of the critical factors that affect the growth of microorganisms: temperature and moisture

•The drier your facility, the easier it will be to control microbial growth

•If you are designing a wet process, you need to manage the water flows to control the risks

PRINCIPLE #3

WATER ACCUMULATION CONTROLLED INSIDE FACILITY


PRINCIPLE #3


… requires designs that facilitate free draining of any moisture that is introduced into the facility environment.

Pooling water is a sign of trouble.



Ponding water

Poor repairs

PRINCIPLE #4

ROOM TEMPERATURE & HUMIDITY CONTROLLED


PRINCIPLE #4


… requires a design that maintains the prescribed temperature, controls condensation and eliminates fog during the sanitation process

Numberof

Bacteria2,097,152

Time

12

48

51264

4,05632,768

262,144

12:012:00

12:4012:20

2:001:00

4:003:00

5:006:00

7:00

Microbes grow by dividing -The rate of division is temperature dependent

Lag Phase

Log Phase

Stationary Phase

(Aw = 0.92 = no growth)

Growth of Listeria at Different Temperatures(with any free moisture) (Aw = 1.00)

23456789

10

0 48 96Time (hours)

Log

CFU

35 C (95 F)

25 C (77 F)10 C (50 F)

4 C (39.2 F)`

HOW TO CLEAN TO A MICROBIOLOGICAL LEVEL?

PRINCIPLE #5

ROOM AIR FLOW & ROOM AIR QUALITY CONTROLLED


PRINCIPLE #5


… addresses airflow and air quality. Controlled pressurization and air flow cures a lot of ills. It reduces infiltration of warm, humid air that can cause condensation problems. It reduces dust and dirt problems at outside openings. It allows your exhaust systems to work properly and efficiently.

Typical Unit Cooler

Make-up Air

Clean-up Purge Exhaust

Filtration

Critical Process Air Handler

FACILITATE SANITATION

THE GOAL

1. Start thinking about sanitation at the property line

2. Specify materials that are easy to clean

3. Design for the expected life-cycle of the facility

Create an environment that is easy to maintain in the required sanitary condition

PRINCIPLE #6

SITE ELEMENTS FACILITATE SANITARY CONDITIONS


PRINCIPLE #6


… addresses the outside of your facility. This is your first line of defense to control the sanitary conditions at your facility. Proper site design reduces the risk of contaminants entering your facility.

$$$$

$$$

$$

$

$$$$

Your site is your facility’s control perimeter. The cost of control increases as you move toward your intensive hygiene areas.

Building & Site Interface

Rodent control strip

Landscaping away from building

PRINCIPLE #7


BUILDING ENVELOPE FACILITATES SANITARY CONDITIONS

PRINCIPLE #7


… addresses the skin of your building- the building envelope. It keeps in what you need to keep in, keeps out what you don’t want in and allows proper transfer across the envelope when required.

Threshold fully embedded in caulkNo threshold or seal

Gaps



PRINCIPLE #8

INTERIOR SPATIAL DESIGN PROMOTES SANITATION


PRINCIPLE #8


… addresses the proper spatial layout of the facility. Is there adequate space to access equipment and building components for sanitation and maintenance?

ADEQUATE EQUIPMENT SPACING - 360o ACCESS



PRINCIPLE #9

BUILDING COMPONENTS & CONSTRUCTION FACILITATE

SANITARY CONDITIONS


PRINCIPLE #9


… addresses the elimination of niches and harborages through proper specification of materials, finishes and sanitary design details for the building components

Sloped girts

Column spaced off of IMP

Galvanized structural steel

Structural Steel Details

PRINCIPLE #10

UTILITY SYSTEMS DESIGNED TO PREVENT CONTAMINATION


PRINCIPLE #10


… addresses the elimination of niches and harborages through proper specification of materials, finishes and sanitary design details of the utility systems



PRINCIPLE #11

SANITATION INTEGRATED INTO FACILITY DESIGN


PRINCIPLE #11


… addresses the need to integrate the utilities and equipment required to support the sanitation process into the facility design

Hand wash station with floor foamer

Sanitation hose station

Vat washer

11 PRINCIPLES


3 THEMES

3 THEMES


ZONES OF CONTROL

KEEP IT COLD & CONTROL MOISTURE


11 PRINCIPLES


FACILITIES DESIGNED TO ELIMINATE CROSS-CONTAMINATION

FACILITIES DESIGNED TO ELIMINATE HARBORAGES AND GROWTH

FACILITIES DESIGNED FOR EASY SANITATION

CONTROL ZONES

PRINCIPLES 1 & 2

Joe BoveThe Stellar Group

KEEP IT COLD & CONTROL MOISTURE

PRINCIPLES 3, 4 & 5

Bob HendonHendon & Redmond


PRINCIPLES 6, 7 & 8

John SchookCarter-Burgess

James MinoHormel Foods Corporation


PRINCIPLES 9, 10, & 11

CHECKLIST TO ASSESSSANITARY DESIGN

Bradley AndersonTyson Foods

ANALYSIS OFASSESSMENT DATA

Chris HarmonHixson

CONSIDERATIONS IN SELECTING DESIGN &

CONSTRUCTION PROFESSIONALS

Bob HuntThe Haskell Company

TRANSFORMING KNOWLEDGEINTO APPLICATION

Bob ReinhardSara Lee Foods


CONTROL ZONESPRINCIPLES 1 & 2

Joe BoveThe Stellar Group

175


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.

PRINCIPLES OF SANITARY DESIGN

1. DISTINCT HYGIENIC ZONES ESTABLISHED IN THE FACILITY

AMI Checklist: 17 criteria

Key Concepts• Documents clarify hygienic zones• Physical barriers• Separate (duplicate) facilities• Clean-up vestibules• Classify products

1.1 Facility drawings show hygienic zones

Receiving

Raw

RTE

FinishGoods

Raw Zone RTE Zone

Ham Manufacturing

Combo - Fresh 38 degrees AmbientCombo - Frozen Dry

Raw Material Receiving IngredientVats Receiving

Boxed - Fresh

Boxed - Frozen Spice

Storage Room

40/45 degrees

Defrost Ambient

PickleMakeup

40/45 degrees

Boning

40/45 degrees 38 degrees

Cure CoolerTrim & Pump

40/45 degrees 40 degrees

Stuff & Hang Massage

38 degrees

StaggingCooler

Ambient

Batch ContinuousCooking Cooking

Cont'd Ham ManufacturingAmbient

Batch ContinuousCooking Cooking

10/15 degrees 15/18 degrees 15/18 degrees 10/15 degreesBlast Brine Brine Blast

Chilling Chilling Chilling Chilling(Batch) (Batch) (Continuous) (Continuous)

20/28 degrees

HoldingCooler

40/45 degrees

Packaging

Sliced SlicedVac Pack Loose Gas Flush Vac Pack

Bulk Bulk

40/45 degrees Ambient

Box Packing Packaging& Palletizing Dry Storage

38 degrees

Finished GoodsStorage & Stagging

Shipping

Process Flow Sheets(Example Ham Manufacturing)

Functions, Room Temperature and Separation Requirements

1.2 Physical barriers prevent uncontrolled movement between

RTE / high-risk and non-RTE / lower risk zones

RawRTE

Color Coded Physical Barrier

Raw

RTE

1.3 Vestibules are designed to break contamination at entry to RTE/high risk

zones

Foot BathFoot Bath / Mat

1.4 Separate locker rooms exist for high risk and lower risk personnel

Raw RTE

Raw

RTE

1.5 Separate break and lunch rooms exist for high risk and lower risk

personnelZone Separation

Color Coded Seating

Physical Barrier

1.6 Restroom facilities are located away from RTE/high risk areas

RTE Production Area

Restroom AreaPath of Travel

Restroom Design - Good and Bad

Color Code

Restroom facilities should be isolated from locker areas

1.7 Separate storage areas for tools and spare parts exist to minimize

contamination for RTE/high risk and non-RTE/lower risk zones

Raw RTE

Separate Storage Areas

1.8 Separate QA labs exist for high and lower risk zones

RawRTE

Separate QA Labs

1.9 Separate sample storage areas exist for RTE/high risk and non-RTE/

lower risk zones

1.10 Separate support and storage areas for sanitation crews exist for RTE/high

risk and non-RTE/lower risk zones

RTE

Raw

Separate Support & Storage Areas

Other Considerations:• Locker rooms• COP area for tools and sanitation carts

1.11 Space is provided for clean equipment storage

1.12 Soiled laundry collection methods are established

Soiled Laundry Collection Methods

1.13 Space is provided for boot storage and cleaning

1.14 Temporary smock storage is provided during breaks

1.15 Trash collection is properly located and locations are cleanable &

maintainable

Trash Collection

Interior – path of travel and isolation are very important

Exterior – truck access and prevailing winds should be considered

1.16 Condemned storage is identified clearly

Provide posted signs

on doors

Lockable Room

Date post:	02-Nov-2021
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