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Allergen ppm Validation and cross contamination

Validation Allergène Contamination

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CarlosAndresCamacho

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Posted 10 October 2016 - 02:46 PM

I have a question.

 

When testing for milk and soy validation of equipment, within the Canada, what level of milk and soy in the equipment is high enough to consider it contaminated?

 

The method I am using is ELISA, but I'm not sure what the minimum value in ppm to consider my validated equipment. Knowing that the sensitivity of ELISA is 0.05pp.

 

 I'm sure someone is going to say 1 ppm but I just don't know where to find the documentation

 

Thanks,

 

Carlos Andres



Charles.C

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Posted 11 October 2016 - 12:02 AM

I have a question.

 

When testing for milk and soy validation of equipment, within the Canada, what level of milk and soy in the equipment is high enough to consider it contaminated?

 

The method I am using is ELISA, but I'm not sure what the minimum value in ppm to consider my validated equipment. Knowing that the sensitivity of ELISA is 0.05pp.

 

 I'm sure someone is going to say 1 ppm but I just don't know where to find the documentation

 

Thanks,

 

Carlos Andres

 

Hi Carlos,

 

No idea about CFIA regs but I predict the answer will be if it's detectable, there is contamination. I believe ELISA kit suppliers quantittate that statement (eg LOD).

 

Other than systems like VITAL which afaik is not implemented in Canada, and a few specificic Countries, I anticipate allergens are usually zero-tolerant entities when regarded as contaminants on equipment although from a practical POV it presumably could depend on what specific processed product is going to be in contact.


Kind Regards,

 

Charles.C


Ryan M.

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Posted 11 October 2016 - 09:45 PM

Whatever the lowest level of detection is for your testing system.  So, if it is 0.5 PPB then that's your limit.

 

Allergens are considered absence/presence aside from FDA's gluten or sulfite.  There is no limit of acceptability...it is ZERO as defined by the LOD of your test method.







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