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#1 Saurabh

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Posted 15 December 2011 - 03:32 PM

Hi all,

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.
Thanks.
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

3. Wipes

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.



Swab Locations

ATP swab will be done to the following locations on the Regular Tomato Machine.

1

Dumping Line Stainless Steel

11

White Brush



2

White Roller

12

Big Blue Brushes ®



3

Blue Curtain (4pcs)

13

Big Blue Brushes (L)



4

Green Feed Belt

14

Outlets ®



5

Metering Elevator (Blue Roller)

15

Pads/Flaps ®



6

Wide Return Belt Black

16

Outlets (L)



7

Small Return Belt Black

17

Pads/Flaps (L)



8

Small Blue Brush

18

Black Cups or Carrier



9

Load Belt

19

Mountain Belt



10

Diverging Belt





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.



Re-Validation

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.



Enclosed documents

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



#2 Saurabh

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Posted 15 December 2011 - 03:39 PM

I do apologize for poor formating, since I was not able to attach the file.



#3 Charles.C

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Posted 15 December 2011 - 07:15 PM

I do apologize for poor formating, since I was not able to attach the file.


Dear Saurabh,

Sorry for this problem. Can you explain the difficulty, maybe the "site" can help ?? :smile:

Basic layout looks typical(no idea of yr specific standard) but it may depend on yr SOP details etc, eg justification for atp criteria ?

example 3 in this well-known codex document may be of some interest -

Attached File  validation codex.pdf   206.56KB   638 downloads

Rgds / Charles.C

Kind Regards,

 

Charles.C


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#4 RMAV

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Posted 16 December 2011 - 04:04 AM

Just some thoughts that may or may not apply:

-What is the required contact time for the peroxyacetic acid sanitizer?
-Do you have specifications/justification on your threshold of 300 RLU? What is the volume or size of area you are measuring at 300 RLU?
-If you apply your sanitizer and re-test ATP, are you sure your sanitizer will not interfere with the ATP test?
-Why are you only relying on ATP and not utilizing microbiological testing?
-Will you do organoleptic inspection as well?
-Do you verify your cleaning equipment is clean and do you have a procedure for cleaning the cleaning equipment?
-Name your cleaning chemical, use the trade name or generic name or both including proper concentration



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