Cleaning Validation—Is it Required?

United States

z Food: No?
Hygienic Design Criteria and Cleaning z CGMP for food Manufacturers requires that food contact
surfaces shall be cleaned, and equipment designed for
Validation for Dairy Equipment & CIP adequate cleaning.

Systems z Milk Ordinance requires cleaning records and identifies

cleaning frequency. Regualtory agency shall test to determine
efficiency of sanitization.
Debra Henyon z Biotech and Pharmaceuticals: Yes
Manager, Food Science & Technology z CGMP for Drug manufacturers part 211 requires that they
develop and verify procedures for cleaning their
Elopak, Inc manufacturing equipment. Cleaning schedules are required
USA along with inspections for cleanliness.
z Cleaning Validation required to obtain facility operating
license.

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Cleaning Validation—Is it Required?

Machinery Directive 98/37/EC Why Validate Cleaning Processes?

z 2.1 Agri-foodstuffs machinery z The combined component applications are equally as

z Where machinery is intended to prepare and process
foodstuffs…must be so designed and constructed as to
avoid any risk of infection, sickness or contagion and
observe the following hygiene rules…
ƒ Materials: Food-grade and designed for cleaning
ƒ Surfaces: smooth and without ridges nor crevices,
radii to allow for thorough cleaning
ƒ Liquids: foodstuffs, cleaning & disinfectant fluids
must be drainable without impediment
important as the equipment standard for sanitary design.
z To improve the level of food safety
z Reduce liability by showing due diligence
z Confirm and Document:
z Reproducibility of CIP system
z Reproducibility of Manual Cleaning Procedures
z Removal of allergens, product residues and cleaning solutions
z Cleaning System Performance
z Master plan for inspection, Start-Up and Cleaning operations

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What makes a surface cleanable?

z Hygienic Design
z Surface Finish: No pits, cracks, crevices, smooth welds…
z No dead ends
z Self-Draining
z Compatible Materials
z Accessibility

150 Grit (No. 4) Stainless Steel

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Zoltai, 2004E.A. Zottola and L.L. McKay. 1981. J. Food Prot. 44 (3) 206
P.T.,

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 Rubber surface
after 30 soiling/
Surface roughness vs. Biofilm formation washing cycles.

Dunsmore D. G., A Twomey,

W. G. Whittlestone and
H. W. Morgan. 1981 J. Food
Relationships between a machined surface ( Ra 1.0 µ ) and different Protection 44 (3) 222.

organisms Source: Biological Handbook for Engineers-, Marshall Space Flight Center, NASA, 31 March
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1968.
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Choosing CIP Chemicals

Based on: Surface To Be Cleaned
Joints

• Composition
– Resistance to chemicals
• Smoothness
• Corrosion / Degradation
– pH (acidic)
– Chloride concentration
Factors That – Contact Time
Influence
– Temperature
Corrosion
Potential:
– Equipment Composition & Condition
– Passive Layer

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What is Soil?

Soil is unwanted matter on the surface to be

removed prior to sanitizing.

z Product Residue
z Water
z Airborne Contamination
z Transient Soil from Workers
z Detergent Ingredients
z Microorganisms

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 Authors

Not only can they multiply quickly!! Mark Wiencek

Environmental Biofilms: Rohm Haas Company

Sources of contamination Springhouse, Pennsylvania

19477
USA

Email: rsixmw@rohmhaas.com

Illustration of Aquatic Biofilm Formation Sequence

They can hang on!!!

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Time Sequence of Bacterium Growing on a Stainless Steel Surface

(1 hr intervals)
General Guideline for
Disinfectant/Sanitizer Application
Paul Stoodley

Center for Biofilm Engineering

Montana State University

Bozeman, Montana 59715

1. Disinfectant applied as the final step in the cleaning program
USA

Email:
paul_s@erc.montana.edu 2. Re-disinfect if time between completion of disinfection program
Zbigniew Lewandowski and startup exceeds four hours
Center for Biofilm Engineering

Montana State University

Bozeman, Montana 59715 256

128
USA 64
Number 32
Ursula Charaf
of Bacteria 16 Rapid
S. C. Johnson Wax Company

Racine, Wisconsin 53403

Lag Phase 8 Growth
USA

Paul Stoodley
0 20 40 60 80 100 120 140 160 180 200 220 etc.
Center for Biofilm Engineering
Minutes After Cleaning
Montana State University

Bozeman, Montana 59715

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Email:
paul s@erc montana edu

S. typhimurium biofilm with extra-cellular matrix on Buna-n

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Pseudomonas fragi 4973 on stainless steel. Sustainable Cleaning Systems
WDS 2004B. and Amy C. L. Wong. 1993. J. Food Protect. 56 (9) 753.
Ronner, Amy
Zoltai, P.T., E.A. Zottola and L.L. McKay. 1981. J. Food Prot. 44 (3) 207

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L. Monocytogenes attached to a polyester belt.
Krysinski, E. P., L. J. Brown, and T. J. Marchisello. 1992. J. Food Protection 55 (4) 248
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Pitting corrosion in type 304 stainless steel
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WDS 2004 WDS 2004 Bohner, H. F. and R. L. Bradley. 1991. J. Dairy Sci. 74 (10) 3351

Choosing CIP Chemicals

Cleaning
Based on: SOIL CONDITIONS

z High or low solids z Clean—What is it?

z Burnt or cooked soils z adj.-- free from dirt: unsoiled; unstained
z Fat, grease, or protein z v.— to perform or undergo a process of cleaning by the
removal of soil particles from surfaces by manual, mechanical
z Fluid milk, yogurt, ice cream, buttermilk, cheese,
or chemical methods
condensed, culture.
z Critical Cleaning Steps
z Nuts, fruit portions
1. Time
z Stabilizers, flavoring, chocolate 2. Temperature
z Biofilms 3. Concentration
4. Mechanical Action/Turbulent Flow

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CIP SYSTEM DESIGN CRITERIA CIP System Design Criteria

z Largest/ smallest lines to be cleaned z Spray devices

z Largest/ smallest tanks to be cleaned z Tank outlet sizes / height
z Length of lines /fittings / devices z Return lines
z Type of equipment / fillers, dryers, evaporators, pasteurizers, z Valve clusters
etc. z Detergent Cleaning regimen/ built product or add CL2
z Equipment Manufacturers recommendations/ limitations z Number / type detergent pumps / controls
z What are the expectations for system performance? z Acid wash/ override / Method of sanitizing
z Total quantity of CIP & sanitize cycles

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Methods of Cleaning Validation
z Visual Inspection
z Soiling
z Fluorescence detection with UV
z Inoculation
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Signs of Poor Cleaning
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Fill Nozzle CIP Enclosure
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Improperly cleaned milking systems can be visually
determined by the dairyman and the employees. Careful
inspection of equipment or utensils will result in the
detection of various films or deposits. The following
cleaning and sanitizing trouble table describe the
various types of films and deposits, the visible signs,
the causes, a means for removal and methods for
prevention.
http://www.ces.uga.edu/pubcd/B1025-W.HTML
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Hygienic Challenge Test for Filling Machines
“Buttermilk Test”
Principle Verification Test
z Provide cleaning treatment z Circulate full fat
to filler product contact buttermilk with
z Assure adequate chemical fluorescent dye for 3
contact time. hours through filler
z Assure no product safety z Allow to dry minimum of
issues 1 hour
Criteria z Run CIP with low level
cleaning chemicals, rinse
z Adequate cleaning of
with water, dry overnight
various products
z Tear down filler and
observe for fluorescent
residuals with black light.
Verify product with ATP.
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Soiled Filler Nozzles with Buttermilk & Dye
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Manually Cleaned, only one flex nozzle removed Fill Nozzles after CIP

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European Hygienic Engineering & Design Group

Fill Nozzle CIP Enclosure Drain
(EHEDG)

z This test method was adopted z A method for the assessment

by EHEDG, July 2000-- Doc 21
“Challenge tests for the
evaluation of the hygienic
characteristics of packing
machines”.
of in-place cleanability of
food processing equipment,
Document No. 2 (2000).
z Test item soiled with soured
milk containing spores
z Pressurized @ 5 bar
z Cleaned, drained and
dismantles
z Item covered with pH
sensitive agar and incubated
@ 58 C

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Cleanability Trials on Pipe Joints.

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Spray Performance Testing Summary of Cleaning Verification Methods

z Spray Pattern Testing Confirms Spray Device Coverage z Visual

z Soiling with product
z Typical Procedure
z Equipment Product Contact Surfaces Coated with Riboflavin
z Fluorescent dye
Solution z Bacterial spores
z Equipment is rinsed Using CIP Spray Devices for a Volumetric
Preset, and Drained
z Riboflavin Spray
z Equipment inspected with UV light for Fluorescence z Chemical/Microbial Testing

z Indication of Spray Performance and Equipment

Cleanability

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 Tools for Cleaning Verification & Surface Hygiene
Tools for Cleaning Verification & Surface Hygiene

z ATP ATP
(Adenosine Triphosphate)

z Sugar z ATP is the universal energy

carrier in all living organisms.
z Protein z Microorganisms, milk, juice
z Allergen contain large amounts of ATP
z ATP + luciferine/luciferase=light
z Agars Methods (BAM)
z Product residues and micro-
z Modified Agar Methods organisms
z Surface or water testing

z AccuPoint
z Biotrace Uni-Lite XCEL
z Charm Lum-T / Firefly
z BioControl Lightning MVP

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Tools for Cleaning Verification & Surface Hygiene Tools for Cleaning Verification & Surface Hygiene

Sugar Tests
Protein Tests
z Pro-Tect (reducing sugars)
z Pro-Tect (Biotrace)
z Spot check (glucose) z VERIcleen (Charm Sciences)
z Spot check+ (glucose/lactose) z Flash (BioControl)

z Protein (and reducing sugars) reduces copper (Cu++ to Cu+) from

z Simple sugars are oxidized using Benedict’s reagent to
the copper sulphate. Bicinchoninic acid (BCA) under alkaline
produce a color change. conditions forms a purple complex.

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Tools for Cleaning Verification & Surface Hygiene Tools for Cleaning Verification & Surface Hygiene

Allergen Tests
z Allergenic Proteins: “The Big 8” Allergens
z Screening or Quantitative
z Compare against known
controls
z CIP, Swab or Product (in- Negative Positive
process or finished)

Quantitative – 5 controls

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Tools for Cleaning Verification & Surface Hygiene Tools for Cleaning Verification & Surface Hygiene

Modified Agar Methods

Agar Methods
z Iso-Grid Total Bacteria Count
z Traditional Methods (Swab, RODAC)
z Acumedia
z Difco/BBL
z EM Science

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Tools for Cleaning Verification & Surface Hygiene Summary of Verification Tools
Listed by test time to get result

z ATP – quick results but general information

z Protein / Sugar Tests (10 minutes) more specific, groups of
Modified Agar Methods
proteins & sugars
z Agar Paddles
z Allergen (10-60 minutes) more specific; specific proteins are
z 3M Petrifilm concern
z Hycheck (Difco) z Agar (24 - 72 hours) more specific; groups and specific organisms
z Advantages and disadvantages with each method regarding test
time, cost and specificity.

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Making the Right Choice for Food Safety

Design, Operation, Maintenance

z Hygienic Design Equipment

z Food Grade Materials
z Operational Plant Lay-Out
z Valve Clusters
z No dead-ends
z CIP System Design
(Clean In Place—Not Just Circulate in Place)
z Spray devices
z Return lines
z Appropriate Chemical Selection
z Validation
Results: Clean Equipment, Tanks and Lines

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