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Effective Sanitation
& Verification
Elements
• Environment factors
• Continuum / continuous improvement
• Daily Sanitation: Back to basics
– Sanitation GMP / 7 Steps.
• Periodic Sanitation: Tear down & heat.
• Verification of effective sanitation.
Environment
• Staffing.
– Turnover:
• Maintaining training & documentation.
– Thirds shift dynamics.
• Necessity for flexible workforce (call-ins).
• Room and Equipment.
– HVAC (visibility during sanitation).
– Accessibility (can you touch it / see it?).
– Keep it simple (can you disassemble without tools?).
• Continuum.
– Sanitary design + Effective Sanitation + Traffic Patterns +
GMPS + Dry/un-cracked flooring.
Lead to Ineffective Sanitation!
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Aerosols.
Spraying drains & drain components.
Drains pooling/backing up.
Hollow rollers, fixed sleeved assemblies, concave
surfaces.
Cross traffic.
Lack of accessibility.
Biofilms.
Idle equipment (not being used).
Standing moisture.
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High pressure water
Compressed air
Control buttons & screens
Bearings
Congestion in RTE area
Cabinets in RTE areas
Traffic patterns
GMP requirements
Sanitation process NOT documented/sequenced.
How do you sustain protocols?
Continuous Improvement
•Traffic Patterns:
(separation between raw & rte, separation
between exposed product areas packaging, ..)
•GMPS:
(is it difficult to do the wrong thing?)
•Flooring:
(infrastructure maintained)
•Sanitary Design:
(existing equipment + new)
•Effective Sanitation Procedures:
(daily & periodic,
limitations known and controls in place)
Assess where you are at under each of the
categories.
Daily & Periodic Sanitation
Dry
Clean
1
• Pre-sanitation task completed
consistently (floors swept, equipment
covered, materials removed,..).
•Equipment disassembled to proper
level to provide accessibility.
•Dry clean completed
Hollow member + cracked weld
Pre
• Rinse until visually free of soils.
Rinse
2
• Use lowest effective pressure to
minimize aerosols and
condensation.
• Lower pressure reduces risk of
cross contamination and
machine damage.
Multiple lap joints
•Contact time, concentration, &
mechanical action!!!
Soap &
Scrub
3
•Daily scrub of product contact surfaces.
•Scour framework weekly minimum.
•Chemicals are not a substitute for mechanical
action.
•Work from walls and floor to equipment.
Mass with Protective
Film (Slime)
•
Bacterial
Attachment
Traps Nutrients
and Bacteria
•Order of applications (necessary to
reduce cross contamination potential)
Soap &
Scrub
3
•Wall/floors then equipment
•Avoid drying of chemicals
•Mechanical action
Listeria (0.5 µm, 19.7 µ-inch)
Mold spore (3 µm, 118 µ-inch)
Yeast (5 µm, 197 µ-inch)
Salt (120µm, 4724 µ-inch)
Micro-SIZE
Micron (µm)
Micro-inch(µ-inch)
1/1,000,000 meter 1/1,000,000 inch
39.37 µ-inch
0.0254 micron
• Low pressure + volume ONLY!
Post
• Rinse the walls, the floor, then the
equipment.
Rinse
4
– Minimize spraying the floor once the
equipment begins to be rinsed.
– Its clean
•Clean equipment = proper GMPs.
Remove
5
&
Assemble
•Condensate & standing moisture
removed.
•Tools Removed
•Preop & sanitize parts that are not
accessible once assembled.
Inspect
6
Sanitize
7
•Foam walls & floors with equivalent of
800-1000 ppm of quat.
•Flood rinse sanitize equipment. Target
contact 30 seconds to 2 minutes.
•Do not dilute wall & floor sanitizer prior
to 10 minute contact time.
Periodic Sanitation/ Tear Down for Access
Periodic Sanitation / Heat
Steaming(165F for 30 minutes)
Dry heat (165F for 4 hours)
Verification
Sanitation Effectiveness
Verification
Physical verification
•Organoleptic (site, smell, taste)
•Step 6
Microbiological Verification
•Bioluminescence / ATP (immediate results)
•Aerobic plate count (results in 2-3 days)
•Environmental Monitoring. (results in 3-5 days)
Main Points
1. Continuous assessment & improvement.
2. Controls for sanitary design limitations.
3. Sanitation GMP: Providing mechanical
action and limiting cross contamination
opportunities.
4. Verify: Bioluminescence (go/no-go),
Aerobic Plate Count (trend).