& Verification

Effective Sanitation

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.

• 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.

Lead to Ineffective Sanitation!

• 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

1

• Pre-sanitation task completed consistently (floors swept, equipment covered, materials removed,..).

•Equipment disassembled to proper level to provide accessibility.

•Dry clean completed

Dry

Clean

Hollow member + cracked weld

• Rinse until visually free of soils.

• Use lowest effective pressure to minimize aerosols and condensation.

• Lower pressure reduces risk of cross contamination and machine damage.

2

Pre

Rinse

Multiple lap joints

3

•Contact time, concentration, & mechanical action!!!

•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.

Soap &

Scrub

• Bacterial Attachment

Mass with Protective Film (Slime)

Traps Nutrients and Bacteria

3

Soap &

Scrub

•Order of applications (necessary to reduce cross contamination potential)

•Wall/floors then equipment

•Avoid drying of chemicals

•Mechanical action

Micro-SIZE

Sal

t (1

20µ

m,

4724

µ-in

ch)

Mol

d sp

ore

(3 µ

m,

118

µ-in

ch)

List

eria

(0.

5 µ

m,

19.7

µ-in

ch)

Yea

st (

5 µ

m,

197

µ-in

ch)

Micro-inch(µ-inch)1/1,000,000 inch0.0254 micron

Micron (µm)1/1,000,000 meter

39.37 µ-inch

• Low pressure + volume ONLY!

• Rinse the walls, the floor, then the equipment.

– Minimize spraying the floor once the equipment begins to be rinsed.

– Its clean

4

Post

Rinse

5Remove

&

Assemble

•Clean equipment = proper GMPs.

•Condensate & standing moisture removed.

•Tools Removed

•Preop & sanitize parts that are not accessible once assembled.

6

Inspect

7

Sanitize

•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

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)

Sanitation Effectiveness Verification

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).