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Parallel test of 3M coconut protein allergen w/ 3M ATP test

allergen management tree nut allergen coconut protein allergen validation

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#1 JR Ball

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Posted 23 June 2020 - 03:53 AM

we are about to test 3M coconut protein allergen as cleaning verification. it is a laminar flow device kit (LFD) - quite similar to a pregnancy test kit, w/c shows (+) or (-) to coconut protein.

lowest limit detection is 2ppm, upper limit detection is ~1.6 mg/ml or 1,600ppm.

 

for cleaning validation, we will run the coconut protein LFD parallel w/ 3M ATP clean trace.

 

target standard we would like to get:

 

with a (-) reading in coconut protein LFD, we shall take the corresponding ATP (RLU) reading and set that as our cleaning verification standard for ATP. 

 

as coconut protein LFD is quite expensive, we shall retain using ATP 

 

would you find this validation activity sound?

 

thanks ahead and would appreciate comments!

 

 



#2 Mathieu Colmant

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Posted 23 June 2020 - 07:25 AM

Hi JR Ball,

 

I am not sure if you will have any correlation... because I am not sure there is any ATP in coconut proteins...

 

However, if anyone has some recent comparison between ATP(rlu) and bacteriological contamination (cfu), I would love to see it. Mine is quite old and ATP was not sufficient to validate desinfection.


Edited by Mathieu Colmant, 23 June 2020 - 07:25 AM.

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Consultant in Food Safety - Brussels & London

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FollowFoodLaw.eu ltd


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#3 GMO

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Posted 23 June 2020 - 08:09 AM

It is valid to undertake an extensive cleaning validation activity and then use a different method as monitoring or verification.  So for example, some sites validate their cleaning using ELISA and then use "visually clean" as ongoing monitoring with ATP swabs as verification then repeating that validation on a periodic basis.

 

It doesn't mean that ATP or visual inspection is directly comparable to the swabbing, but it does mean that if we clean to our normal standards, as seen via visual clean standard, swabs have validated this is clear of allergenic protein.  If you think about it, that's similar to microbiological cleaning.  You can't get a micro result back in the time you need to use equipment so you use visual inspection and sometimes ATP as a monitor or verification.

 

Not all countries though see coconut as a significant allergen.  It's not covered in EU law for example but that's another question.



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#4 Charles.C

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Posted 23 June 2020 - 08:43 PM

we are about to test 3M coconut protein allergen as cleaning verification. it is a laminar flow device kit (LFD) - quite similar to a pregnancy test kit, w/c shows (+) or (-) to coconut protein.

lowest limit detection is 2ppm, upper limit detection is ~1.6 mg/ml or 1,600ppm.

 

for cleaning validation, we will run the coconut protein LFD parallel w/ 3M ATP clean trace.

 

target standard we would like to get:

 

with a (-) reading in coconut protein LFD, we shall take the corresponding ATP (RLU) reading and set that as our cleaning verification standard for ATP. 

 

as coconut protein LFD is quite expensive, we shall retain using ATP 

 

would you find this validation activity sound?

 

thanks ahead and would appreciate comments!

There may be some confusion over Validation and Verification.

 

Similarly to Post 3  I speculate that you are attempting to achieve Validation and Verification  that your cleaning procedure achieves removal of coconut allergen from relevant surfaces.

 

To elaborate Post 3, here is SQF's  interpretation of, as I understand from the OP, yr dual activities -

 

A program of verification needs to be built on an initial validation study that identifies the target allergen(s), threshold levels, and the severity of contamination, and shows the cleaning process and testing used are effective to give the desired  results  consistently.  Once  the  cleaning  process  has  been  validated  as  effective,  a verification/monitoring/inspection program shall be established to assure that the validated cleaning process [which] is being used, is maintained and effective.

 

Validation 

 
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of concern.

 

This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure.  Therefore, only an allergen specific test will provide that evidence. The acceptable validation testing methods involve the use of a test specific to the allergen being removed.  These generally require  the  use  of a  test  method  which  uses  an  antigen  (the  allergen)  and  an  antibody specific  to  the antigen.  One example of the antigen and antibody test is the enzyme linked immuno-assay or ELISA method.  The ELISA method can be either quantitative or qualitative and can be conducted in a laboratory or with test kits available for in plant use; either is acceptable.  ELISA test kits are available from several manufacturers and are commonly used in the food processing industry.  Lateral flow test devices also use an ELISA-based method and are also effective in detecting specific allergens.  While lateral flow devices are qualitative only, most have sensitivities around 10 parts per million (ppm) and are available for most of the common allergens and are designed for use in a plant environment. Both the ELISA tests and lateral flow test kits have been accepted by recognized allergen research scientists and meet  the  requirements  for  sanitation  validation  of  the  SQF  Code.  It  must  be  noted  that  there  may  be  other ‘acceptable’ tests for validation methods that can be used but the test must meet the “allergen specific” criteria or provide  some  other  evidence  that  the  validation  is effective.   

 
Verification

Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time.

This verification must be documented by a responsible person from the site who has been trained in the validated cleaning method.  The most common method used is direct observation of the validated cleaning procedure during the sanitation process.  Another acceptable verification method is the use of highly sensitive swabs that test for proteins.  These recently developed swabs will detect total protein at approximately 20 ppm.  Since these devices only test for total protein and not specific allergens, they are not acceptable for validation but will serve to verify that equipment has been thoroughly cleaned.  There are also sensitive ATP test swabs available however the presence of ATP does not indicate the presence of protein which is the allergenic material.  The use of these total protein swabs or the ATP sensitive swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated method is used and recording the results of both the allergen specific test and the protein or ATP swab test.   It is also to ensure surface swabbing is occurring at corners, joins, and crevices in the equipment as well as open surfaces, to check for protein held up in equipment. 

The purpose of a validated cleaning program is to confirm that the specifics of the cleaning process used are complete,effective, sufficient, and when implemented, will produce that same results every time.

 


Kind Regards,

 

Charles.C


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#5 moskito

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Posted 24 June 2020 - 12:19 PM

Hi JR Ball,

 

process? 

Proposal to save money

1) clean to "protein free" with a cheap but sensitive protein test over the whole equipment; define worst case positions regarding protein removal
  -> as long as the reading is protein positive - repeat cleaning

2) check for allergen contamination at worst case positions with allergen test

 

In general: Cleaning validation and verification work only with homogeneous distributed allergens.

 

Rgds

moskito



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#6 JR Ball

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Posted 30 June 2020 - 11:34 PM

good day,

 

we ran the tests: 

- ATP results were below 50 RLU, no visible trace of residues, and

- coconut coconut protein tests were all positive

 

out of we got faint as per 3M, a faint bar on the Test line (T) meant a positive for coconut protein

 

For now, we are trying to validate cleaning 

- prolong contact time of chemical, 

- increase chemical concentration, or

- look for an alternative cleaning agent for coconut protein

 

thank you for the insights.

appreciate the feedback







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