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! • • • • • • • • • 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. • • • • • • • • • 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).