Cleaning Validation

How is calculated the acceptance criteria for residues of allergens in a nondedicated equipment during the cleaning validation exercises of a Wheat Flour Company?

Hi !

Sorry if I´m not giving an answer and just asking a question.

What allergens might be involved?



Regards,

FSSM

The company manufactures cream of wheat and cream of corn using the same equipment, and we are looking to establish acceptance critera for Wheat (allergen)residues, also for Gluten. Thanks!

Dear Milagros:

It´s a hard question, but I think it is dependent on two issues, the method used to detect the allergen and how much gluten you will accept on your production line, considering maybe information like the one you can see in Table III-1. Estimated Daily Gluten Consumption from Combinations of Different Amounts of Food... of the next document:

http://www.fda.gov/F...htm#table-iii-1

I´m not aware of any standard stated in a regulation, maybe somebody else can share that kind of information.

Regards,

FSSM

Are you looking at this from an "allergen" standpoint or from a "gluten free" standpoint?

From an allergen standpoint any amount left on the machine creates a risk depending on the consumer and the severity of their reaction. We have 6 of the 8 allergens recognized by the US and unless we can definitively prove that all allergens are removed, we use the catch all of "Product run on line that also produces ----" on our labels.

If you are looking from a gluten free standpoint (to be able to declare your product gluten free), then I would think there are regulations. I don't know them off hand but there has to be something.

TS

Are you looking at this from an "allergen" standpoint or from a "gluten free" standpoint?

From an allergen standpoint any amount left on the machine creates a risk depending on the consumer and the severity of their reaction. We have 6 of the 8 allergens recognized by the US and unless we can definitively prove that all allergens are removed, we use the catch all of "Product run on line that also produces ----" on our labels.

If you are looking from a gluten free standpoint (to be able to declare your product gluten free), then I would think there are regulations. I don't know them off hand but there has to be something.

TS

Dear TS:

I assume from your lines that a total clean-up of an allergen might be achieved, I´m not so familiar, since we do not have production yet. But if a total clean-up is possible, then the acceptance criteria could be zero ppm of allergen or the limit of the detection method.

Regards,

FSSM

Dear Milagros,
If you are operating in Europe there is an specific regulation for gluten free products:
http://eur-lex.europ...003:0005:EN:PDF

"Gluten free" <20mg/kg and "low content" <100mg/kg.

And if you need a procedure to validate your cleaning methods, I suggest you to do it with a fast system like this: http://www.operon.es/eng/food.htm

Best regards,

Last I knew, in the U.S., the debate is still underway as to what 'gluten free' really means.

As for allergens - as far as the U.S. is concerned there is NO tolerance for any residue if an allergen is not on your label. This is a bit unrealistic - but individual responses to allergens vary to such an extenet, there is a belief that there is not safe harbor other than the detection limit of your test method.