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& Verification

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:

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& Verification

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  1. Effective Sanitation & Verification

  2. Elements • Environment factors • Continuum / continuous improvement • Daily Sanitation: Back to basics • Sanitation GMP / 7 Steps. • Periodic Sanitation: Tear down & heat. • Verification of effective sanitation.

  3. 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.

  4. 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.

  5. 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?

  6. 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.

  7. Daily & Periodic Sanitation

  8. Dry Clean • Pre-sanitation task completed consistently (floors swept, equipment covered, materials removed,..). • Equipment disassembled to proper level to provide accessibility. • Dry clean completed 1 Hollow member + cracked weld

  9. 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. Pre Rinse 2 Multiple lap joints

  10. 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 3 Traps Nutrients and Bacteria Mass with Protective Film (Slime) • Bacterial Attachment

  11. Order of applications (necessary to reduce cross contamination potential) • Wall/floors then equipment • Avoid drying of chemicals • Mechanical action Soap & Scrub 3

  12. Micro-SIZE Micron (µm) • 1/1,000,000 meter • 39.37 µ-inch Micro-inch(µ-inch) • 1/1,000,000 inch • 0.0254 micron Mold spore (3 µm, 118 µ-inch) Listeria (0.5 µm, 19.7 µ-inch) Yeast (5 µm, 197 µ-inch) Salt (120µm, 4724 µ-inch)

  13. Post Rinse 4 • 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 • Clean equipment = proper GMPs. • Condensate & standing moisture removed. • Tools Removed • Preop & sanitize parts that are not accessible once assembled. Remove 5 & Assemble

  14. Inspect 6 • 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. Sanitize 7

  15. Periodic Sanitation/ Tear Down for Access

  16. Periodic Sanitation / Heat Steaming(165F for 30 minutes) Dry heat (165F for 4 hours)

  17. Verification

  18. 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)

  19. Main Points • Continuous assessment & improvement. • Controls for sanitary design limitations. • Sanitation GMP: Providing mechanical action and limiting cross contamination opportunities. • Verify: Bioluminescence (go/no-go), Aerobic Plate Count (trend).

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