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Allergen Cleaning Validation- Control sample below detectable limits

allergen validation

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kiekeller

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Posted 24 June 2022 - 02:22 PM

Hi all

 

We are in the process of obtaining our SQF certification, and I had set up a validation scenerio for vallidating our allergen sanitation.

 

We currently have dairy, soy, anchovie and wheat in some of our products.   I chose to do my testing for dairy, as it in the more finished product than anything else ( we use it in our sausages/hotdogs) , and soy as it is in a product that is of our messiest, greasiest,  hardest products to clean, it is also the highest % of an allergen that we have in any formula..( it is a taco meat with soy/beef mixture)

 

My troubles began when i could not get positive controls back.

 

The only positive control I could get was on the raw sausage side for milk. ( and  i think that is because the nonfat dry milk sticks to the side of the equipment)    I was not able to achieve a positive control in my packaging room ( either off of my peeler, or work surfaces ) i even smeared a sausage over a stainless steel table, and then took a sample and that came back negative as well.

 

Verified with Neogen that the tests were being done properly. 

 

I sent the finished products off to Neogen for their free product testing, and they verified that the ppm were too low to be detected in their Reveal 3D allergen kits.

 

So... herein lies my question,  how do i validate a clean, when the amounts are too small to detect?  In my study, do I just document this, and say... hey...nothing works except for the raw milk...so i am only going to do this validation study on my raw allergen cleaning, and only for milk and nothing on my packaging side?

 

Also, if anyone has a template for an allergen validation study it would be greatly appreciated,  I want to make sure I am not forgetting something or leaving something out!

 

BTW  I love this forum, it has been so helpful in working through the certification process   Thank you!



kfromNE

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Posted 24 June 2022 - 02:44 PM

What ingredients have the other allergens that can't be detected.



kiekeller

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Posted 24 June 2022 - 03:51 PM

I'm not sure of what you are asking.  We use non-fat dried milk in our hotdogs/sausages.  They have the normal ingredients of Pork, seasonings and either 

e(Lm)inate® V,  or ultralac  as an inhibitor.

 

for the Taco meat we actually use soy nuggets Response 4402 and taco seasoning.   The only other product that we make that have soy in it,  the soy is in the Worcestershire sauce, which in of itself is only .25% of the entire formula.



Gelato Quality Specialist

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Posted 24 June 2022 - 06:27 PM

I am also working on conducting validations on our cleaning processes soon, but it seems that you might want to look into tests that have lower limits of detection? Otherwise, there is no point in using those swabs since they will always say that the surface is clean, whether it is actually clean or not. 

 

Not sure if this is helpful in any way, but looking forward to seeing what others have to say.



kfromNE

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Posted 24 June 2022 - 06:30 PM

I'm not sure of what you are asking.  We use non-fat dried milk in our hotdogs/sausages.  They have the normal ingredients of Pork, seasonings and either 

e(Lm)inate® V,  or ultralac  as an inhibitor.

 

for the Taco meat we actually use soy nuggets Response 4402 and taco seasoning.   The only other product that we make that have soy in it,  the soy is in the Worcestershire sauce, which in of itself is only .25% of the entire formula.

I assumed right -  Worcestershire sauce can be hard to get a positive allergen test result due to how it is made. That's why I was asking. At my old job, we made BBQ sauce with Worcestershire sauce in it - had the same problem. 



AJL

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Posted 25 June 2022 - 03:39 PM

Hi.
Have you calculated the theoretical ppm in the sausages?
Not all test kits are equal ;)
We used a test kit (LFD) from Römer labs.
It detected down to 1ppm!
Pretty impressive.



G M

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Posted 11 July 2022 - 08:27 PM

Hi all

 

We are in the process of obtaining our SQF certification, and I had set up a validation scenerio for vallidating our allergen sanitation.

 

...

 

My troubles began when i could not get positive controls back.

 

...

 

Verified with Neogen that the tests were being done properly. 

 

I sent the finished products off to Neogen for their free product testing, and they verified that the ppm were too low to be detected in their Reveal 3D allergen kits.

 

...

 

It sounds like your validation of the sanitation process was "successful"  -- no detectable allergen residue after completion.

 

 

We're in a similar situation, some of our common ingredients theoretically carry allergens, but even if we swab the product in raw or cooked stages it is undetectable.  Unfortunately FSIS doesn't recognize a safe minimum level for allergens, so everything still gets a statement on the label. 

 

When returning to a non-allergen product we complete a "Full" sanitation process, that we can through all of the validation testing rely on to eliminate any ingredient residues to less than detectable levels.  We also back that up with decades of no allergy related complaints.  None of our inspectors or auditors has had a problem with that reasoning.



Charles.C

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Posted 11 July 2022 - 10:09 PM

It sounds like your validation of the sanitation process was "successful"  -- no detectable allergen residue after completion.

 

 

We're in a similar situation, some of our common ingredients theoretically carry allergens, but even if we swab the product in raw or cooked stages it is undetectable.  Unfortunately FSIS doesn't recognize a safe minimum level for allergens, so everything still gets a statement on the label. 

 

When returning to a non-allergen product we complete a "Full" sanitation process, that we can through all of the validation testing rely on to eliminate any ingredient residues to less than detectable levels.  We also back that up with decades of no allergy related complaints.  None of our inspectors or auditors has had a problem with that reasoning.

Hi GM,

 

Note the comments  Post 6. What was yr method's LOD/LOQ ?

(IIRC the detection level in Post 1 can be further lowered using alternative Neogen products)


Kind Regards,

 

Charles.C






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