Environmental Allergen testing

Background: we don't have a lab and will rarely run the allergen product - predicting less than 10 times in a year and always scheduled last in production.

Issue: I need to validate that our allergen cleaning program.

Question: Could I use ATP testing to validate testing if we used a foaming chlorinated alkaline cleaner or a self-foaming acid cleaner

Or use ATP testing and yearly verify with a 3rd party lab that our cleaning is effective.

If not - what allergen testing kits exist for in house testing (allergens: soy, wheat, and milk).

Thanks.

I use the Neogen Reveal 3d test kits in-house. I've had to send out to a lab in the past for coconut though.

I have used Neogen 3d Reveal and Romer Agrastrip, I like Romer much better. ATP test wont cut it for validation of allergen clean up... and remember validation is basically a study with many data points with proven repeat-ability and verification is a test to verify your wash down is within your accepted criteria established by your validation. 

We use the cheap protein-detecting swabs to verify that the cleaning was effective. If there is no protein of any kind, then there can't be any allergens. If the protein swab shows positive we have the guys clean again. It has never gone to a second round.

We use the cheap protein-detecting swabs to verify that the cleaning was effective. If there is no protein of any kind, then there can't be any allergens. If the protein swab shows positive we have the guys clean again. It has never gone to a second round.

All 0's on ATP swabbing? You must have pharma grade equipment?

ATP detects adenosine triphosphate, which is a phosphated nucleoside.  All allergens are proteins, which are made of amino acids.  ATP tests look for live cells.  Allergen tests look for particular proteins.  My method looks for any protein as a shortcut/cost-saving measure. (It should be noted that our products and allergens are all dry powders.)

ATP detects adenosine triphosphate, which is a phosphated nucleoside.  All allergens are proteins, which are made of amino acids.  ATP tests look for live cells.  Allergen tests look for particular proteins.  My method looks for any protein as a shortcut/cost-saving measure. (It should be noted that our products and allergens are all dry powders.)

Hi Hank,

Yr science is tempting but may have caveats -

Neogen Blog,2019.pdf   355.42KB   66 downloads

and SQF -

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.   The  SQF Institute  does not  endorse  any  particular
technology or methodology and relies on the site to provide the evidence of a scientifically validated and effective
cleaning method.   Like any validation of any food safety control, periodic re-validation is required to account for
any changes that may have occurred.  Not all allergens have specific test kits available which includes some fin fish
and allergens that have been modified by fermentation, heating or hydrolysis.  
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.

(SQF8 Manufacturing Guidance)

FARRP, Food allergen control Strategies,2015.pdf   1.26MB   97 downloads

Charles - thanks. I looked into what SQF says. On page 64 "where there is a mixture of different allergens in use, the acceptable method for confirming the thoroughness of cleaning is to test for the highest risk allergens, the highest concentration allergens or the ones that are most difficult to remove." 

So with soy sauce and the first three ingredients being water, wheat and soybeans - which one would you test for?

KfromIA- If wheat is listed above soy on the ingredient label, I would test for wheat. This is because ingredient statements are ordered such that ingredients of higher content are listed first. However, in my opinion and prior experience you are better off testing for presence  of both allergens. This is in case of recall you show your due diligence in testing for removal of ALL allergens. It is more of a save your own butt on legal actions. In my previous experience we ran a product with both milk and egg, rather than just testing for milk since it was the higher content of finished product, we tested equipment both to ensure there could be no public harm from allergen contamination. Allergen test kits are relatively cheap, and if you schedule product runs correctly testing should not have to occur daily.

Hope this helps,

Jacob P.

Charles - thanks. I looked into what SQF says. On page 64 "where there is a mixture of different allergens in use, the acceptable method for confirming the thoroughness of cleaning is to test for the highest risk allergens, the highest concentration allergens or the ones that are most difficult to remove." 

 

So with soy sauce and the first three ingredients being water, wheat and soybeans - which one would you test for?

Hi KfromLA,

Trick question ?

As per yr OP,  risk assessment suggests the answer can vary between Nil and Indeterminate.

The potential  for allergenic cross-contamination relates to  the ingredient / overall process(es) running / segregation etc, etc, for example -

Allergens Facility Mapping Guide.pdf   694.2KB   99 downloads

PS - Perhaps SQF should clarify their interpretation of "highest risk allergens" as afaik there is no Regulatory agreement on threshold levels, eg -

threshold difficulties UK,2017.pdf   999.98KB   60 downloads

https://www.anaphyla...gen-thresholds/

 

 

If not - what allergen testing kits exist for in house testing (allergens: soy, wheat, and milk).

 

Thanks.

I use Romer Labs Agrastrip, they're easy to use and can be completed in-house in around 15 minutes. They do kits for each soy, gluten and milk.

Hi KfromLA,

 

Trick question ?

 

As per yr OP,  risk assessment suggests the answer can vary between Nil and Indeterminate.

 

The potential  for allergenic cross-contamination relates to  the ingredient / overall process(es) running / segregation etc, etc, for example -

 

Allergens Facility Mapping Guide.pdf

 

PS - Perhaps SQF should clarify their interpretation of "highest risk allergens" as afaik there is no Regulatory agreement on threshold levels, eg -

 

threshold difficulties UK,2017.pdf

 

https://www.anaphyla...gen-thresholds/

Charles it wasn't a trick question. I was just curious. I thought I would have to test for both but after reading that in the SQF manual - I may not have to. So I was curious if you knew which allergen was harder to remove (soy vs wheat) like in the examples SQF gave of cooked egg.

Question - If I end up doing the allergen testing in house vs 3rd party - is anything required for example - a designated space to perform the tests, etc.

In my past experience, we did our allergen testing on the production floor while completing pre-op. USDA never seemed to have an issue with this for us. Regardless I would contact the regulatory inspector responsible for your facility to ensure that they see no issues with this. If they do take issue it could lead to a NR if testing is done without the prior approval. I doubt they will have any issue with this, as it will not lead to equipment contamination, and swabs will already be subjected to the processing environment so it will not change test results. We used Romer Labs "agrastrips" for all allergen testing. They take a small amount of training but use is simple and fairly quick after that.

Hi Hank,

 

Yr science is tempting but may have caveats -

You are correct. Using the generic protein swabs for Validation of Allergen Control methods would be a problem. Using them for Verification of cleaning thoroughness is not, in my opinion, for the dry ingredients at my facility.

In my previous job we used Elution Technologies lateral flow allergen kits.  They were less expensive than the Neogen Reveal 3D and some of the test kits had a lower detection limit.

If you opt to use a test kit then make sure you have an SOP for it.  Train the people who are going to use it, including proper sampling of the rinse water or surface, and document it. 

Most test kits come with 10 to 15 tests and have a shelf-life of a few months or so (depends on the test kit).  Given that I'd just plan to have an allergen testing program and complete the testing after each allergen run.  This way you utilize the test kits and you provide regular verification.

OT - Minor Rant

Various threads like this one  give me a vision of arbitrary, unskilled, personnel creeping around a food manufacturing plant doing magic manipulations at random locations of the facility to assess things like ATP, allergens, Listeria, etc etc.

These tests are typically using contaminatable utensils, sensitive chemicals, sensitive microbiological materials, etc

Some of these tests may indeed be "simple" to carry out but they still have the potential to negatively interact with the environment/product/process.

I get the impression that some of the related Companies have no QA Department, a well-known financial burden having no Production-related benefit.

IMO, if there is no existing QA Dept or one which possesses only a "nominal"  existence, tests such as the above should not be carried out. For Safety reasons.

And similarly regarding the existence of an appropriately designated, equipped, staffed and maintained segregated  "area" for a QA function.

And similarly regarding a QA-related waste disposal  system.

Thanks.

I also use the Neogen Reveal 3D test kits.  They have many different allergen tests and now include coconut.  I have used the Egg, Soy, Almond, and Tree Nut kits routinely.  They take about 5-10 minutes not including time to take the sample.  Here is a link to their site: https://foodsafety.n...m/en/reveal-3-d

Hi. We use 3M Eliza kits which coming in a variety of allergen tests. Good luck with finding a solution