Need help to make Cleaning Validation document. We have a produce washing machine which was reloacted and modified. The cleaning is done manually (no CIPs or COPs) and is done with brush and mops. I have made a Cleaning validation document which I am attaching herewith. Please go thru it and give me your thoughts.
Cleaning Validation for Regular Tomato Machine (Compac Machine)
Objective of Validation
The Regular Tomato Machine was relocated from “A” location to “B” location and the equipment has been modified. This requires a cleaning validation.
Responsibilities for performing and approving the Validation Study
Validation Done by :______________________________ HACCP Coordinator
Approving Authority : ____________________________ Director Risk Management.
Person Responsible for Cleaning & Sanitation : __________________ Sanitation Lead Hand
Cleaning Equipments to be used :
1. Long handle mop.
2. Hand brush
4. Chemicals – Cleaning and sanitizing chemicals.
5. 150-200 ppm Peracetic Acid solution as Sanitizer.
Date : _____________
Time Production Finished :_______________
Time Cleaning Started:_________________
Lot Nos. manufactured before cleaning : _____________________________________________
General Procedure of how the cleaning process would be validated.
· Cleaning is generally carried out by trained personnel only and is performed at the end of each days’ production.
· The cleaning of Dumping Line Stainless Steel, White Roller, Blue Curtain, Small Blue Brush and White Brush of the equipment is done using water and cleaning chemical and then sanitized using 150-200 ppm Peracetic acid.
· Green Feed Belt, , Load Belt, Diverging Belt, Outlets, Pads/Flaps, Wide return Black Belt, Small Return Belt Black and Mountain Belt are cleaned using wet wipes till all the dirt and debris are removed.
· The Blue brushes are taken out and cleaned thoroughly with chemical.
· The Black cups are steam cleaned using a Steam Cleaner.
· Finally, all the food and non-Food contact surfaces are sanitized using 150-200 ppm Peracetic acid solution.
· Refer SOP 20.04.04 for Cleaning procedure.
Analytical Method to verify Cleaning
Verification of Cleaning and Sanitation is done using ATP swab method.
Equipment used : Hygiena Luminometer
Swabs : SuperSnap ATP test swabs ( Scigiene Corporation)
Acceptance Criteria: < 300 RLUs. for consecutive 3 days.
ATP swab will be done to the following locations on the Regular Tomato Machine.
1Dumping Line Stainless Steel
Big Blue Brushes ®
3Blue Curtain (4pcs)
Big Blue Brushes (L)
4Green Feed Belt
5Metering Elevator (Blue Roller)
6Wide Return Belt Black
7Small Return Belt Black
8Small Blue Brush
Black Cups or Carrier
Record the swab results in Form # 13.02.11 A
Residual chemical concern :
The level of residual Peracetic acid when used in concentration of 150-200 ppm on the food contact surface is not a concern and does not require a rinse, since it gets degraded into Acetic Acid and water.
Deviation and Corrective Action
If the swab readings are over 300 RLU, re-sanitize the surface and if above 300 readings are observed more often, cleaning procedure will be reviewed and revalidated.
Review of Cleaning Procedure will be done after 3 months to confirm that the procedure being followed is effective and consistency is observed in the swab results. Any deviation during this period should be investigated and documented.
Re-validation will be required if major changes are done to the equipment.
1. Cleaning SOP 20.04.04
2. Form # 13.02.09 A Daily Sanitation Log
3. Form # 13.02.11 A Daily Microbiological Verification Form