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Sanitation Standard Operating Procedures (SSOP)

Document Control

Field Value
Document ID FS-SSOP-001
Version 3.2
Effective Date 2026-01-15
Owner Sanitation Manager
Approver Food Safety Team Leader
Review Frequency Annual

1. Pre-Operational Sanitation

1.1 Scope

Pre-operational sanitation covers all cleaning activities performed before the start of production each day, following any shutdown period exceeding 4 hours.

1.2 General Pre-Op Procedure

Step Activity Detail
1 Dry Clean Remove loose debris, dust, and product residues using brushes, scrapers, or vacuum systems. No compressed air for dry cleaning unless HEPA-filtered.
2 Pre-Rinse Rinse all product contact surfaces with potable water at 38–49 °C (100–120 °F) to remove residual soils.
3 Detergent Application Apply approved detergent per Master Sanitation Schedule. Ensure foam contact time ≥ 10 minutes. Do not allow foam to dry on surfaces.
4 Manual Scrubbing Scrub all product contact surfaces with dedicated colour-coded brushes (white = food contact, blue = equipment, red = drains/floor).
5 Post-Rinse Rinse thoroughly with potable water until all chemical residues are removed. Verify with pH test strips if required (target pH 6.5–7.5).
6 Visual Inspection Conduct line-of-sight inspection under adequate lighting (≥ 500 lux). Any visible soil triggers re-cleaning.
7 Sanitisation Apply approved sanitiser per manufacturer instructions. Allow required contact time before rinse (if applicable).
8 Final Verification Swab for ATP (Section 6) or allergen ELISAs (Section 8) as scheduled. Document release on pre-op checklist.

1.3 Line Release Criteria

  • No visible soil on any product contact surface.
  • ATP readings < 30 RLU for equipment, < 10 RLU for product contact surfaces.
  • Allergen ELISA (if required): negative result (< limit of detection).
  • Pre-op checklist fully signed by sanitation lead and QA.

2. Operational Sanitation

2.1 Spill Management

Spill Type Response Documentation
Dry product spill Stop production in area, sweep/vacuum immediately, inspect for cross-contact Spill Log FS-SSOP-F02
Wet product/liquid spill Stop production, contain with absorbent pads, clean & sanitise the zone Spill Log FS-SSOP-F02
Allergen spill Stop production, zone affected area, perform allergen cleaning per Section 8, ELISA swab before restart Allergen Incident Log FS-ALC-F03
Chemical spill Evacuate area, follow SDS emergency procedures, notify EHS Chemical Spill Report FS-EHS-F01

2.2 Scheduled Break Cleaning

Break Duration Activities
Mid-morning (15 min) Line speed reduction, scrape surfaces, remove debris, spot clean Dry sweep, empty waste bins, sanitise handwash stations
Lunch (30 min) Partial shutdown: dry clean, wet clean if allergen changeover, floor scrub As per zone schedule
End-of-shift Complete wet clean per Master Sanitation Schedule Full pre-op equivalent

2.3 Allergen Changeover Cleaning

Refer to Section 8 (Allergen Clean Validation) and Allergen Control Program (FS-ALC-001). Between production of products containing different allergens, complete a full wet clean with intermediate rinse verification.


3. Master Sanitation Schedule (MSS)

3.1 Schedule Overview

The MSS covers all areas, equipment, and utilities. Tasks are assigned by frequency: daily, weekly, monthly, quarterly, semi-annual, annual.

3.2 Master Sanitation Schedule Matrix

Area / Equipment Task Frequency Chemical Concentration Method Verification Responsible
Receiving Bay Floor scrub & drain clean Daily Alkaline Foam Cleaner 2–3% v/v Apply foam, dwell 10 min, pressure rinse Visual + ATP weekly Sanitation Tech
Whole Seed Silo (S-101) Dry clean interior Weekly N/A (dry clean only) Vacuum + manual wipe with food-grade cloth Visual + ATP monthly Production Lead
Flax Mill (M-201) Full wet clean Weekly (or allergen change) Chlorinated Alkaline 3% v/v, 45 °C CIP cycle per SOP-CIP-01 ATP + ELISA post-clean Sanitation Lead
Oil Press Line (P-301) CIP (alkali-acid-sanitise) Weekly See Section 5 — CIP Procedure Per CIP cycle Automated CIP ATP + pH final rinse QA QA Specialist
Screw Conveyor (C-401) Disassemble & wet clean Monthly Neutral Detergent 1.5% v/v, warm water Manual scrub with brush, rinse, sanitise Visual + ATP Sanitation Tech
Packaging Hopper (H-501) Full wet clean Weekly Acid Cleaner 2% v/v, 40 °C Circulation 15 min, rinse, visual check ATP < 10 RLU QA
Magnetic Separator Clean magnet surfaces Daily Dry brush Remove debris from magnet rods Visual Production
Sifting Screens Inspect & clean Every batch change Dry brush or compressed air (HEPA) Brush screen mesh, check for tears Visual + mesh gauge QA
Floor Drains (all) Scrub & sanitise Daily Quaternary Ammonium 200 ppm Foam, brush, rinse, sanitise ATP monthly Sanitation Tech
HVAC Vents Wipe & filter check Monthly Neutral Detergent 1% v/v Wipe louvres, replace HEPA if needed Visual Maintenance
Cold Storage Room Floor & wall wash Monthly Alkaline Foam 3% v/v Foam, dwell, pressure rinse Visual + ATP Sanitation Tech
Overhead Structures (pipes/trusses) Dust & debris removal Quarterly Dry vacuum + damp wipe Vacuum, then damp cloth Visual Sanitation Lead
Lighting Fixtures Clean & inspect Quarterly Glass/plastic-safe cleaner Per label Wipe, inspect for cracks/missing sleeves Visual Maintenance
Waste Compactor Area Pressure wash Weekly Degreaser 5% v/v Pressure wash, sanitise perimeter Visual Sanitation Tech

3.3 Seasonal / Deep Clean Tasks

Task Frequency Month(s)
Full mill disassembly & deep clean Annual Plant shutdown (August)
CIP chemical tank descaling Semi-annual March, September
Drain line jetting & camera inspection Annual January
Exterior wall & roof vent cleaning Annual May

4. Cleaning Chemical Specifications

4.1 Approved Chemical Inventory

Chemical Name Active Ingredient(s) Recommended Concentration Min Contact Time Temperature Range Approved Surfaces Rinse Required?
Alka-Clean Supreme Sodium hydroxide (10–15%), potassium hydroxide (5–10%) 2–5% v/v 10 min 40–60 °C Stainless steel, plastic, rubber (EPDM) Yes — potable water
Chlor-Alkali Foam Sodium hypochlorite (3–5%), sodium hydroxide (5–10%) 2–4% v/v 10 min 20–50 °C Stainless steel, tiled walls, floors Yes — potable water
Acid-Brite 50 Phosphoric acid (20–30%), nitric acid (5–10%) 1–3% v/v 5 min 40–65 °C Stainless steel (passivates), glass Yes — potable water
Neutral Kleen Alkyl polyglycosides, non-ionic surfactants 0.5–2% v/v 5 min 20–50 °C All food contact surfaces, soft metals Yes — potable water
Quat-San Plus Didecyl dimethyl ammonium chloride (10%) 150–200 ppm 30 sec to 1 min Cold–50 °C Stainless steel, plastic, floors, walls No (no-rinse sanitizer)
Peroxy-San 15 Peracetic acid (15%), hydrogen peroxide (10–15%) 150–250 ppm 30 sec to 2 min 10–40 °C Stainless steel, glass, plastic (verify compatibility) No (no-rinse sanitizer)
Iodophor San Iodine complex (2%), phosphoric acid (10%) 25–50 ppm iodine 2 min 20–40 °C Stainless steel, plastic No (no-rinse)

4.2 Chemical Handling Requirements

  • All chemicals stored in original containers or clearly labelled secondary containers.
  • MSDS/SDS available in the chemical storage room and sanitation office.
  • Personal protective equipment (PPE): chemical-resistant gloves, safety goggles, rubber boots, apron.
  • Chemical dispensing stations calibrated quarterly.
  • Follow all manufacturer concentration test strip verifications.

5. CIP Procedure — Oil Press Line

5.1 Equipment Covered

Oil press line including: press screw (P-301), filter housing (F-101), oil holding tank (T-201), centrifuge (C-101), transfer piping (DN50–DN100).

5.2 Standard CIP Cycle

Phase Step Solution Concentration Temperature Time Return Criteria
1 Pre-Rinse Potable water 50 °C 5 min Effluent clear
2 Alkali Wash Alka-Clean Supreme 3% v/v 60 °C 15 min Circulation flow ≥ 1.5 m/s
3 Intermediate Rinse Potable water 50 °C 5 min pH 6.5–8.0; effluent clear
4 Acid Wash Acid-Brite 50 2% v/v 55 °C 10 min
5 Final Rinse Potable water Ambient 5 min pH 6.5–7.5; conductivity < 50 µS/cm
6 Sanitise Peroxy-San 15 200 ppm Ambient 2 min Peracetic acid test strip ≥ 150 ppm
7 Final Drain 2 min

5.3 Post-CIP Verification

  • ATP swab of final rinse water in holding tank (target ≤ 10 RLU).
  • Visual inspection of interior surfaces via access ports.
  • Record all CIP parameters in CIP Log (FS-CIP-F01).

6. ATP Swabbing Verification

6.1 Protocol

ATP bioluminescence testing is conducted using a SystemSure Plus™ luminometer with Ultrasnap swabs.

6.2 ATP Limits

Surface Category Target Warning Action / Corrective Action
Product Contact
(e.g., mill chamber, conveyor belt, hopper interior, packaging funnel)
< 10 RLU 10–30 RLU > 30 RLU: re-clean, re-test. > 300 RLU: quarantine area, notify QA Supervisor, root cause investigation.
Non-Product Contact (Equipment)
(e.g., equipment exteriors, control panels, framework)
< 30 RLU 30–100 RLU > 100 RLU: re-clean. > 300 RLU: investigation.
Environment
(e.g., floors, walls, drains, overheads)
< 100 RLU 100–300 RLU > 300 RLU: re-clean, root cause if recurrent.

6.3 Corrective Action for ATP Exceedance (> 300 RLU)

  1. Stop line release.
  2. Isolate affected equipment.
  3. QA notifies Sanitation Lead and Production Supervisor.
  4. Re-clean per applicable MSS procedure.
  5. Re-swab within 30 minutes.
  6. If second failure: escalate to Food Safety Team for root cause investigation.
  7. Document on ATP Corrective Action Log (FS-SSOP-F03).

6.4 Sampling Frequency

  • Product contact: Every pre-op release (daily) + post-allergen changeover.
  • Non-product contact: Weekly rotating schedule.
  • Environment: Monthly rotating schedule.
  • Annual trend analysis reported to Food Safety Team.

7. Microbiological Environmental Monitoring

7.1 Zone Classification (Based on ISO 14644 / FDA Aseptic Guidance)

Zone Definition Examples Target Organisms Sampling Method
Zone 1 Direct product contact surfaces Mill interior, oil press screw, hopper interior, conveyor belt Aerobic Plate Count (APC), Enterobacteriaceae, E. coli Contact plates, swabs
Zone 2 Non-product contact adjacent to Zone 1 Equipment frame, machine guards, control panel APC, Enterobacteriaceae, yeast & mould Contact plates, swabs
Zone 3 Indirect contact — floor, walls, drains near product Production floor, drains within 3 m of equipment APC, Listeria spp., yeast & mould Sponge swabs (drains), contact plates (walls)
Zone 4 Remote environment (outside production) Warehouse, hallways, break rooms APC, yeast & mould Settle plates, air samplers

7.2 Sampling Plan

Parameter Zone 1 Zone 2 Zone 3 Zone 4
Number of sites 10 8 6 4
Frequency Weekly Weekly Monthly Monthly
APC target < 10 CFU/contact plate < 50 CFU/contact plate < 200 CFU/swab < 500 CFU/settle plate
APC action ≥ 10 CFU: investigation ≥ 100 CFU: investigation ≥ 500 CFU: cleaning ≥ 1000 CFU: cleaning
Enterobacteriaceae target < 1 CFU/plate < 5 CFU/plate
Listeria spp. Absent (in 25 g or swab)
Yeast & mould target < 5 CFU/plate < 10 CFU/plate < 50 CFU/swab < 100 CFU/plate

7.3 Corrective Actions for Pathogen Positives

  • Any Zone 1 or Zone 2 Listeria or Salmonella positive: Immediate line stop, quarantine affected product, deep clean, root cause investigation, enhanced sampling (3× frequency for 4 weeks post-clearance).
  • Zone 3 Listeria positive: Increase cleaning frequency, conduct vector analysis, swab adjacent Zone 2 sites.

8. Allergen Clean Validation — ELISA Swabbing

8.1 Purpose

Verify removal of allergen residues after changeover cleaning between products containing different allergens.

8.2 Target Allergens & ELISA Kits

Allergen ELISA Kit (Supplier) Limit of Detection (LOD) Swab Area Acceptance Criteria
Gluten R-Biopharm Ridascreen® Gliadin 5 ppm gliadin 10 cm × 10 cm < LOD (negative)
Milk (β-lactoglobulin) R-Biopharm Ridascreen® β-Lactoglobulin 2.5 ppm 10 cm × 10 cm < LOD (negative)
Soy Neogen® Veratox® Soy 2.5 ppm 10 cm × 10 cm < LOD (negative)
Flaxseed In-house developed lateral flow (or 3rd party if available) LOD per kit insert 10 cm × 10 cm < LOD (negative)
Mustard R-Biopharm Ridascreen® Mustard 2 ppm 10 cm × 10 cm < LOD (negative)

8.3 Swabbing Protocol

  1. Select target allergen(s) based on previous product run.
  2. Identify worst-case swab sites (hard-to-clean areas: crevices, gaskets, dead ends, undersides of belts).
  3. Swab a 10 cm × 10 cm (100 cm²) area using the swab provided in the kit.
  4. Process swab per ELISA kit manufacturer instructions.
  5. Read result on plate reader at specified wavelength.
  6. Record in Allergen ELISA Log (FS-ALC-F02).

8.4 Corrective Action on Positive Result

  1. Do not release line for production.
  2. Re-clean entire line per wet clean procedure.
  3. Identify likely cause (incomplete disassembly, dead-leg, gasket residue).
  4. Re-swab.
  5. Only release after negative result.

9. Glass & Hard Plastic Register

9.1 Scope

Inventory of all brittle materials (glass, rigid plastic, ceramic, hard acrylic) in production, packaging, and storage areas.

9.2 Glass & Hard Plastic Register (Example)

Item ID Type Location Qty Condition Inspection Frequency Last Inspected Inspected By
GL-001 Light fixture tube (LED shatter-proof) Receiving bay 4 Intact Monthly 2026-06-01 M. Chen
GL-002 Observation window (tempered) Mill S-101, 450 mm 1 Intact Weekly 2026-06-05 J. Smith
GL-003 Pressure gauge lens Oil press P-301 3 Intact Daily 2026-06-07 L. Wang
GL-004 Clock face Production floor 1 Intact Monthly 2026-06-01 M. Chen
PL-001 Sanitation bucket (polycarbonate) Wet clean station 6 1 cracked (removed) Weekly 2026-06-05 J. Smith
PL-002 Scraper blade (UHMWPE) Conveyor C-401 2 Intact Weekly 2026-06-05 J. Smith
PL-003 Cutting board (HDPE) Sample prep bench 2 Intact Weekly 2026-06-05 J. Smith
CR-001 Ceramic floor tile (round access) Drain D-103 1 Intact Monthly 2026-06-01 M. Chen

9.3 Glass Breakage Procedure

  1. Stop all production in affected area immediately.
  2. Evacuate personnel from zone (+ 5 m radius).
  3. Block entry with barriers and signage.
  4. DO NOT sweep — use adhesive tape or damp cloth to pick up fragments.
  5. Inspect all product, ingredients, and packaging within zone — quarantine any potentially contaminated materials.
  6. Document in Glass Breakage Incident Log (FS-SSOP-F04).
  7. Conduct root cause analysis within 24 hours.
  8. Replace with shatter-proof alternative (polycarbonate, acrylic, or shatter-film) wherever feasible.

9.4 Register Review

  • Full inventory count: Monthly.
  • Update on any addition/removal of brittle materials within 24 hours.
  • Annual verification by Food Safety Team.
  • All lighting in production must be LED shatter-proof type with protective sleeves.

10. Sanitation Records & Review

10.1 Records Maintained

Record Retention Location
Pre-Operational Sanitation Checklist (FS-SSOP-F01) 2 years QA Office
Operational Sanitation Log (FS-SSOP-F02) 2 years Production Office
ATP Swabbing Log (FS-SSOP-F03) 2 years QA Office
Glass Breakage Incident Log (FS-SSOP-F04) 5 years Food Safety Office
Master Sanitation Schedule (MSS) Current + 2 years QA Office
CIP Cycle Log (FS-CIP-F01) 2 years Maintenance Office
Allergen ELISA Log (FS-ALC-F02) 2 years QA Office
Chemical Usage & Concentration Verification Log 2 years Sanitation Office
Microbiological Environmental Monitoring Report 3 years QA Office
Training Records — Sanitation Personnel Duration of employment + 1 year HR / QA

10.2 Review Process

  • Daily: Sanitation Lead reviews pre-op checklists and ATP results before line release.
  • Weekly: QA Manager reviews operational logs and trend data.
  • Monthly: Food Safety Team reviews all sanitation KPIs (ATP pass rate, microbiological trends, chemical usage).
  • Annual: Full SSOP review and update by Food Safety Team Leader, incorporating regulatory changes, audit findings, and incident learnings.

10.3 Continuous Improvement

  • Audit non-conformances related to sanitation trigger formal CAPA.
  • Annual SSOP training for all sanitation, production, and QA personnel.
  • Mock sanitation inspection performed once per quarter by internal audit team.

Appendices

  • Appendix A: Sanitation Zone Map (floor plan with colour-coded zones)
  • Appendix B: Chemical Dilution Chart (concentration × flow rate × time)
  • Appendix C: ATP Swab Site Map (numbered locations)
  • Appendix D: Environmental Monitoring Swab Site Map

End of Document — FS-SSOP-001