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Allergen Verification v validation

allergen aib sanitation verification validation in-house testing

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#1 KMA

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Posted 07 November 2018 - 04:40 PM

Hello,

     I am trying to determine what is an acceptable way of validating sanitation between products of a different allergens. I work in a very small family owned facility so our tree nuts and peanuts are separated but there are no physical barriers in between where the products are cooked/prepared so all out product labels state that they are manufactured in a facility that also processes all our other allergens.  We cook peanuts and tree nuts in separate oil vats and if there was a situation requiring the vats to be used for a different product they would undergo a full allergen clean, butter is added during the cooling step of some products but not others and scheduling is such that products with dairy added are made later in the day or week when possible, this equipment is cleaned prior to use on product that does not contain dairy. 

    Cleaning is routinely verified by visual inspection and has previously been validated by sending out allergen swabs to a third party lab annually.  I have experience using Neogen Alert and  3-D test kits from a previous job and think the 3-D test kits would work very well for these checks and would be convenient and affordable enough we could validated the cleaning more frequently.  I believe our allergen control program was validated in this way because the previous quality control personnel did not have the formal laboratory training to do the testing in-house however before changing the protocol I want to be sure there are not regulations that require the testing to be done via a certain method or by a third party lab.   Are there any rules for how allergen cleans are validated that I should be aware of?



#2 Scampi

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Posted 07 November 2018 - 06:08 PM

are you following a GFSI or just FDA?


Because we always have is never an appropriate response!


#3 KMA

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Posted 07 November 2018 - 06:35 PM

We have inspections from FDA and AIB



#4 Scampi

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Posted 07 November 2018 - 06:49 PM

I am not aware of any specific requirement as to HOW the protocol is validated or verified

 

The issue here is, you will need to run a complete trial now to VALIDATE that the process your using if adequate to remove all of the allergens---regardless of whether you use Neogen swabs or send them out. You need to clean under the worst possible scenario (not enough detergent used/contact time etc) then swab (repeatedly) to be sure.

Then you can write your program and put the verification on a schedule (weekly/every other day etc) of swabbing to make sure it's working

 

Or given your complexity, you probably want to perform this after EVERY sanitation shift


Because we always have is never an appropriate response!






Also tagged with one or more of these keywords: allergen, aib, sanitation, verification, validation, in-house testing

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