DESIGNING AN EFFECTIVE
SANITATION PROGRAM
BUILDING WORLD CLASS MICROBIOLOGICAL FOOD SAFETY SYSTEMS FOR THE
COMING STORM
MARCH 20- 22, 2017
David Blomquist
DFB Consulting LLC
651-324-6158
TODAY’S TOPICS
• General Goal of Sanitation
• General Sanitation Process
• Soil Types
• Sanitation Process
• Biofilms and best practices for removal
• Sanitary Design and Why it is Critical
SANITATION
• “All precautions and measures which are necessary
in the production, processing, storage and
distribution, in order to assure an unobjectionable,
sound and palatable product which is fit for human
consumption”
World Health Organization (WHO)
•1st Priority – Management Commitment
•NOT limited to Cleaning and Sanitizing
GENERAL GOALS OF SANITATION
• Removal of unwanted residues from surfaces of equipment
• Removal of soils from the environment
• Elimination of pathogenic bacteria from processing area
• Elimination or control of spoilage organisms in the environment
GENERAL CLEANING CONSIDERATIONS
• Determine appropriate level of Clean and required
cleaning methodology for each activity, taking into
account the following:
• Allergens
• Microbiological sensitivity of the food and
manufacturing system
• Regulatory requirements (USDA-FSIS, FDA, etc.)
• Cleaning restrictions (e.g. organic)
• Keep dry areas dry!
• Controlled wet cleaning in both wet and dry
facilities.
GENERAL CLEANING CONSIDERATIONS:
WHAT IS CLEANING?
REMOVAL OF ALL UNWANTED MATERIAL ON
A SURFACE.
Four Phases of Wet Cleaning:
• Soil penetration - Surface wetting
• Soil dispersion
• Soil suspension
• Prevent re-deposition of removed soil
GENERAL CLEANING CONSIDERATIONS:
What is soil & how do we classify it in the
food industry?
Soil Classification - Chemistry
• Protein
• Fat
• Carbohydrates
• Mineral Salts Inorganics
Soils generally are not a pure composition, but a mixture of all
of these.
GENERAL CLEANING CONSIDERATIONS:
• Water Soluble
• Salts & Sugars
• Water Insoluble
• Alkali Soluble
• Fats & Oils, Complex Carbohydrates
• Alkali / Oxidizer (Chlorine, Peroxide, Peracid) Soluble
• Protein
• Acid Soluble
• Inorganics/ Minerals
• Complex Carbohydrates
• Un-Denatured Protein
• Water Insoluble & Acid / Alkali Insoluble
• Fiber (Cellulose), Carbon, TiO2
FORMULATED / BUILT DETERGENTS
Optimized chemistry = Cleaning efficiency & efficacy
• Handle variety of soils
• Soils generally are not a pure composition
• Handle various water conditions
• Clean with less caustic
• Lower alkalinity
• Lower pH
• Less rinsing needed to bring back to a neutral pH
• Better at biofilm removal
• (Antoniou & Frank. 2005. JFP 68(2):277-281)
FORMULATED / BUILT DETERGENTS
Alkaline or Acid (Not normal – e.g. undenatured whey protein)
Dissolve proteins
Oxidizing Agent – e.g. chlorine or peroxyacetic acid
Hydrolyze proteins
Enzyme (protease)
Catalyst to hydrolyze proteins
However, when using these at normal concentrations, temperature
& contact time we probably do not achieve >80% hydrolysis,
which renders the protein non-allergenic.
FORMULATED / BUILT DETERGENTS
• Temperature
• Important in removal of all soils, but especially with fats &
greases.
• Surfactants
• Wetting/penetration
• Emulsification
• Suspension
• Alkaline
• Solvents
FORMULATED / BUILT DETERGENTS
• Sugars
• Soluble in warm water
• Starches
• Alkaline or Acid Cleaner
• Sulfamic acid
• Enzyme (Amylase)
REQUIREMENTS:
• Master Sanitation Schedule
• Sanitation SSOP
• Daily Cleaning Procedure
EXAMPLE MASTER SANITATION SCHEDULE
Complete list of all equipment and areas of the facility and their cleaning frequency
EXAMPLE SANITATION SSOP
Detailed procedure for management review and documentation of process
EXAMPLE DAILY CLEANING PROCEDURE
Step by step instructions for employees performing the actual cleaning
STEPS OF EFFECTIVE WET SANITATION
1. Dry Clean - remove food and packaging
2. Pre-rinse
• Removes lose soils to allow the cleaners to penetrate the soils
3. Soap and Scrub
4. Rinse and Inspect
5. Assemble
6. Pre-Op Inspection & Cleaning Verification
7. Sanitize – EPA Registered Food Contact Sanitizer
STEPS OF EFFECTIVE WET SANITATION
1. Dry Clean - remove food and packaging
2. Pre-rinse
• Removes lose soils to allow the cleaners to penetrate the soils
3. Soap and Scrub
STEPS OF EFFECTIVE WET SANITATION
1. Dry Clean - remove food and packaging
2. Pre-rinse
• Removes lose soils to allow the cleaners to penetrate the soils
3. Soap and Scrub
4. Rinse and Inspect
STEPS OF EFFECTIVE WET SANITATION
1. Dry Clean - remove food and packaging
2. Pre-rinse
• Removes lose soils to allow the cleaners to penetrate the soils
3. Soap and Scrub
4. Rinse and Inspect
5. Assemble
STEPS OF EFFECTIVE WET SANITATION
1. Dry Clean - remove food and packaging
2. Pre-rinse
• Removes lose soils to allow the cleaners to penetrate the soils
3. Soap and Scrub
4. Rinse and Inspect
5. Assemble
6. Pre-Op Inspection & Cleaning Verification
• Visual
• ATP
• Microbial
• Allergen
STEPS OF EFFECTIVE WET SANITATION
1. Dry Clean - remove food and packaging
2. Pre-rinse
• Removes lose soils to allow the cleaners to penetrate the soils
3. Soap and Scrub
4. Rinse and Inspect
5. Assemble
6. Pre-Op Inspection & Cleaning Verification
7. Sanitize – EPA Registered Food Contact Sanitizer
STEPS OF EFFECTIVE DRY SANITATION
1. Sanitation preparation
2. Secure & disassemble equipment
3. Dry clean - (or isolated wet clean – ensure dry before
returning)
4. Detail Clean – Work Top Down – which
method will you use?
METHODS OF DRY CLEANING
• Sweeping
• Brushing / Scraping
• Vacuuming1
• Blowing – Compressed air2
• Blasting3
1 Must be HEPA Filtered
2 Not recommended – blows soil around,
not contained and captured
3 Residue must be contained
CLEANING CAPABILITIES
Soda Blast
Hard inelastic soils
ExaStrip SensiClean
Hard inelastic soils
Dry Ice Blast
Hard inelastic soils
Soils that freeze harden
Hand Clean Dry
All soil types
Photo source: Ecolab
LOW PRESSURE STEAM - AMERIVAP
Benefits
Moderate capital cost
Allows for use of wet chemistry
High temperature - sanitizing
No dust Has been shown to be effective
No media for allergen removal
Limitations
Steam vapor
Residual water
Adequate electrical supply
May not work on some soils Source: AmeriVap
STEPS OF EFFECTIVE DRY SANITATION
1. Sanitation preparation
2. Secure & disassemble equipment
3. Dry clean - (or isolated wet clean – ensure dry before
returning)
4. Detail Clean – Work top down
5. Post inspection & reclean
6. Pre-Op Inspection, cleaning verification &
reassembly
7. Sanitize – Non-aqueous EPA Registered Food
Contact Surface Sanitizer
EPA CATEGORIES
• Sterilant – Complete kill of all organisms
• Disinfectant – Complete kill of vegetative organisms
• Sanitizer - Provides a 5 log (99.999% reduction) of bacteria
within 60 seconds
Must contact the organism to kill it
SANITIZERS
• Chlorine
• Iodine
• Quaternary Ammonia
• Peroxyacetic Acid
• Mixed Peroxyacetic Acid
• Peroctanoic acid
• Persulfonate
• Aqueous Chlorine Dioxide
• Ozone
• Perquat (Hydrogen Peroxide and Quaternary Ammonia)
SANITIZERS
•Chlorine
Quick kill - oxidizer
Effective against yeast & mold
Affected by organic matter
SANITIZERS
• Chlorine
• Iodine
• Oxidizing sanitizer- quick kill and effective against yeast & mold
• More tolerant of soil than chlorine
• Can cause staining and can be corrosive
• If temperatures are >100 degrees it will sublime and deposit
iodine on equipment surfaces
SANITIZERS
• Chlorine
• Iodine
•Quaternary Ammonia
• Soft metal safe
• Provides residual effect so is useful for environmental
sanitizing
• Works on cell wall
SANITIZERS
• Chlorine
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
• Requires low pH <3.8 -4.0
• Effective against bacteriophage
• Low pH provides control of minerals
• pH must be below 3.0
• Chlorine SANITIZERS
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
•Fatty Acid Sanitizers
• Low foam for CIP application
• Efficacious up to pH 3.8 – 4.0
SANITIZERS
• Chlorine
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
• Fatty Acid Sanitizers
•Peracetic Acid Sanitizers
• Oxidizing sanitizers
• Not as affected by organic materials
• Fast acting oxidizing sanitizer
SANITIZERS
• Chlorine
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
• Fatty Acid Sanitizers
• Peracetic Acid Sanitizers
•Mixed Peracetic Acid Sanitizers
• Peroctanoic acid
• More efficacious on yeast & mold
SANITIZERS
• Chlorine
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
• Fatty Acid Sanitizers
• Peracetic Acid Sanitizers
• Mixed Peracetic Acid Sanitizers
• Ozone
• Strong oxidizer
• Quick kill but not very soluble in water
SANITIZERS
• Chlorine
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
• Fatty Acid Sanitizers
• Peracetic Acid Sanitizers
• Mixed Peracetic Acid Sanitizers
• Ozone
• Aqueous Chlorine Dioxide
• Strong oxidizer
• Quick kill but not very soluble in water (more soluble than ozone)
• Chlorine
SANITIZERS
• Iodine
• Quaternary Ammonia
• Acid Anionic Sanitizers
• Fatty Acid Sanitizers
• Peracetic Acid Sanitizers
• Mixed Peracetic Acid Sanitizers
• Ozone
• Aqueous Chlorine Dioxide
• Perquat disinfectant
• Both powdered and liquid forms available
• 2 part liquid mixed together create bubbles that penetrate otherwise inaccessible areas
• Have been shown to be very effective in reducing environmental contaminants e.g. salmonella
or Listeria
BIOFILMS
A biofilm is any group of microorganisms in
which cells stick to each other and often these
cells adhere to a surface. These adherent cells
are frequently embedded within a self-
produced matrix of extracellular polymeric
substance (EPS).
Source: Wikipedia
New Approaches to Improving Your Profitability by
Controlling Spores
3-A SSI 2015 Education Conference
- The Bridge to Hygienic Design
May 12 2015
David Blomquist Executive Technical Affairs Specialist
©2015 Ecolab Inc. All Rights Reserved
CAUSES OF SPOILAGE – PASTEURIZED
REFRIGERATED DAIRY PRODUCTS
• Gram Negative Bacteria
• Post pasteurization contamination
• Gram Positive Bacteria
• Can survive pasteurization
• Heat Tolerant Enzymes
• Rare occurrence but are due to raw milk
issues
©2015 Ecolab Inc. All Rights Reserved
AS SHELF LIFE HAS INCREASED, GRAM
POSITIVE ORGANISM ISSUES HAVE TOO.
©2015 Ecolab Inc. All Rights Reserved
WHERE DO HEAT RESISTANT PSYCHROTROPHS (HRP’S)
COME FROM?
One problem is the low level of
contamination in the raw milk:
•Dr Mansel Griffiths of the University of
Guelph reported the average
contamination level of Heat Resistant
Psychrotrophs (HRP’s) at 17 cfu/L
Chances of finding it in a typical 5 mL lab
pasteurization (SMEDP 17th edition) sample
is approximately 1 in 60
Data Courtesy of Darryl Bigalke
QMI Systems
What are build-up points?
Paper from the Australian Journal of Dairy Technology Volume 47 – May 1992
Bacterial Growth During Continuous Milk Pasteurisation – F.L. Lehmann,
P.S. Russell, L.S. Solomon and K.D Murphy
“Total Bacterial numbers increased slightly over the
initial 8-9 h, then more rapidly, sometimes
exponentially, over the remaining period of
operation, reaching in excess of one million per mL
and exceeding the total bacterial numbers in the
raw milk…. A 20 minute caustic miniwash of
pasteurisers after 10 h of continuous operation was
shown to reduce bacterial numbers in pasteurized
milk…”
©2015 Ecolab Inc. All Rights Reserved
What are build-up points?
Paper from the Australian Journal of Dairy Technology Volume 47 – May 1992
Bacterial Growth During Continuous Milk Pasteurisation – F.L. Lehmann,
P.S. Russell, L.S. Solomon and K.D Murphy
A 20 minute caustic miniwash of pasteurisers after
10 h of continuous operation was shown to reduce
bacterial numbers in pasteurized milk…”
Unfortunately this biofilm is not completely removed by
conventional short washes and returns more quickly the second
time
©2015 Ecolab Inc. All Rights Reserved
Biofilm Formation
• Vegetative cell population is needed to get spores
• Residual soil acts as hybrid biofilm/soil matrix
• Nooks and Crannies
– Gasketed joints
– Valves
– Plate heat exchangers
– Evaporators
• Low flow areas
• Biofilms generated/rejuvenated during long runs
• Spores quickly attach and are TENACIOUS
©2015 Ecolab Inc. All Rights Reserved
SPORES ARE TENACIOUS
102 cfu/ml spores in suspension
316 Stainless Steel coupons
Soaked in dairy plant isolate spore cocktail suspended in milk
Rinsed THOROUGHLY with sterile DI water
Covered in nutrient agar w/ metabolic dye (dark spots)
SPORE ADHESION TO STAINLESS STEEL
Cleaning with strong caustic DID NOT REMOVE THE SPORES
Peroxide/peracid cleaning removed most of the soil but did not get all the
bacterial residue off the surface. (No viable cells recovered)
What are build-up points?
©2015 Ecolab Inc. All Rights Reserved
SEPARATOR/CLARIFIER
©2015 Ecolab Inc. All Rights Reserved
FOULING MECHANISM THEORY TUBE
EXAMPLE
How does fouling build-up in heat exchangers?
The fouling layer is built-up by two different types of
*. deposit:
*.
On the stainless steel surfaces of the pipe a dense
; ; mineral deposit layers is formed
° °
; ;
: : On top of this first layer forms a second layer
; ; consisting of a matrix of proteins, fat, and
: : carbohydrate depending on process stream
; ;
©2015 Ecolab Inc. All Rights Reserved
CAUSTIC CLEANING DETAILS DAIRY
EXAMPLE
The influence of NaOH concentration
High caustic concentrations cause the fouling
layer to swell causing gel formation of the
*.*. *.*.
protein (rubber-like top layer), thus preventing
;;
;;
°° °° further penetration of the alkaline cleaning
;; ;; solution into the soil layer.
:: :: Consequently the soil removal takes more time.
;; ;;
:: :: The degree of “polymerisation” depends on
;; ;; NaOH concentration, soil temperature and
contact time.
©2015 Ecolab Inc. All Rights Reserved
STEP-BY-STEP CLEANING APPROACH
• STEP 1: The pre-treatment product (peroxide/peracid) is circulated through system prior to alkaline
wash - active ingredients penetrate the soil layer
• STEP 2: Immediately following Step 1, an alkaline detergent is circulated through the system; the rise
in pH triggers Step 3
• STEP 3: The hydroxide ions interact with the oxygen components, triggering a reaction that ruptures
the burnt-on soil matrix into pieces
• STEP 4: With the soil removed from the surface and broken into smaller pieces the mixed cleaning
solution easily removes the remaining soil
OH-
Step 1 Step 2 Step 3 Step 4
©2015 Ecolab Inc. All Rights Reserved
NEW CLEANING PROCEDURE – HEATED
SURFACES
• Pre-Rinse
• Alkaline Wash
• Add peroxide/peracid additive
• Circulate for 1-2 circuits (time varies with size of equipment)
• Add caustic and heat to 170o F
• Post Rinse
• Normal acid wash
• Post Rinse
• Sanitize with mixed peracid at 140 degrees
NEW PROCEDURE – COLD WALL EQUIPMENT – FILLERS,
LINES, TANKS, TRUCKS
• Prerinse
• Alkaline wash with peroxide/peracid additive
• Add peroxide/peracid and circulate for 1-2 rounds
as it is heating up
• Add alkaline cleaner as heating continues and wash
at normal temperatures
• Post rinse
• Sanitize with mixed peracid sanitizer at 140 degrees
• If needed, cool the surfaces with sanitizer at ambient
CASE STUDY: SKIM MILK EVAPORATOR
• Challenge:
• Soiled evaporator that was not passing inspection
• Fouled and plugged tubes reducing efficiency
• Results:
• Significantly improved cleaning results
• Reduction in plugging of tubes
CONTROL AFTER CONVENTIONAL CIP AFTER ADVANCED CLEANING CIP PROGRAM
PROGRAM
Photos: Paul Schacht - Ecolab
©2015 Ecolab Inc. All Rights Reserved
PEROXIDE CLEANING PROGRAM BENEFITS
• Penetration of cracks and crevices for better cleaning – helps
remove soils in damaged gaskets
• Temperatures above 170o F and alkaline solutions break down
peroxide & peracid to give mechanical action
• The oxidizing effect of the additives and the additional mechanical
action have shown to remove soils more effectively
• Time savings have been achieved by faster removal of soils
• Significantly lower SPC counts have been documented in powder
operations
• Spore related defects have been eliminated in Swiss cheese
• Late blowing defect has been controlled in cheddar cheese
©2015 Ecolab Inc. All Rights Reserved
PEROXIDE CLEANING PROGRAM
POTENTIAL DRAWBACKS
• Oxidizing effects of products may decrease life of
gaskets
o Effect is not likely to be more than the use of
nitric acid
• Odor of high temperature peracid may be
objectionable
o Reduced with new peracid - Synergex
©2015 Ecolab Inc. All Rights Reserved
COST BENEFITS OF THE PROGRAM
• Powder plant was able to make 8 fold increase in low spore count product.
Increased sales dollars by approximately $15,000,000
• Farm saw LPC counts stabilize. Monthly Premium was $25,000 when average
<50
Initial avg. = 88
With new methods avg. = 37
©2015 Ecolab Inc. All Rights Reserved
FARM PROGRAM CHALLENGES &
SOLUTIONS
• Most farms can’t achieve high temperature
o Even at temperatures below 170 degrees, the peroxide/peracid
additive provides oxidizing ability which will remove soils
o Alternately a low temperature two part cleaner provides
mechanical action to achieve better soil removal
• Most farms use a chlorinated alkaline cleaner
o The peroxide and chlorine produce an “exited oxygen molecule”
(singlet oxygen species) that also enhances the soil removal
©2015 Ecolab Inc. All Rights Reserved
HOW DO YOU DETECT A BIOFILM?
HOW DO YOU DETECT A BIOFILM?
• ATP testing can provide an indicator:
©2015 Ecolab Inc. All Rights Reserved
HOW DO YOU DETECT A BIOFILM?
• ATP testing can provide an indicator:
Sample Source ATP – RLU
1. Conveyor in photo – Just past 151967
Labeler
1. Re-cleaned with HC-10 768
1. 2nd recleaning with HC-10 0
1. Cleaned using Bonfoam plus 1253
chlorine
1. Repeat cleaning using Bonfoam 0
and chlorine
©2015 Ecolab Inc. All Rights Reserved
EQUIPMENT SANITARY DESIGN
FDA inspectors now consider ANY area
in a RTE plant of <20,000 square feet
outside of zone 1 areas to be a zone 2
Any environmental positive will be
considered a significant issue
EQUIPMENT SANITARY DESIGN
As FDA continues with new
FSMA regulations, elimination
of pathogens in the plant
production environment will
become more important
EQUIPMENT SANITARY DESIGN
Design of equipment to allow
better cleanability will
become paramount to success.
EQUIPMENT SANITARY DESIGN:
AMI SANITARY DESIGN PRINCIPLES
1. Cleanable to a microbiological level
2. Made of compatible material
3. Accessible for inspection, maintenance, cleaning and sanitation
4. No product or liquid collection
5. Hollow areas should be hermetically sealed
6. No niches
7. Sanitary operational performance
8. Hygienic design of maintenance enclosures
9. Hygienic compatibility with other plant systems
10. Validated cleaning and sanitizing protocols
SOURCE: [Link]
[Link]
series/hydroclean/[Link]
From [Link]
series/hydroclean/[Link]
Resources:
[Link]
archive1/junejuly-2003/10-principles-of-equipment-
design-for-ready-to-eat-processing-operations/
[Link]
archive1/december-2012january-2013/food-equipment-
hygienic-design-an-important-element-of-a-food-safety-
program/
RECOMMENDATION:
Start making design improvements in equipment
NOW making changes every year to prevent
HUGE expenditures that will be needed when
FSMA is fully enforced by FDA
SUMMARY
• Review your cleaning program to determine gaps
• Review your equipment design for areas to improve
• Review your process to determine areas where biofilm
are likely
QUESTIONS?
Dave Blomquist
DFB Consulting LLC
651-324-6158