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Allergen Cleaning Validation - Sulfites

allergen sulphite sulfite validation calculation

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#1 jessiburke78

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Posted 17 May 2016 - 07:48 PM

Good Afternoon,

 

Has anyone used mathematical justification as part of their allergen cleaning validation?  I have calculated the concentration of sulphite in my final product and some are above 10ppm.  For those above 10ppm how do I prove that if there was any contamination into the next product it would result in less than 10ppm.

 

 

Any advice would be greatly appreciated!

 

 

 

Thanks,

 

 



#2 clover

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Posted 18 May 2016 - 06:34 AM

Hi Jesse, 

 

not too sure about this as I've never heard of it. However, I have heard of qualitative methods of determining if a surface have protein residues (allergens) through swabbing. What does more than 10ppm of sulphite in final product mean and how do you decide to set that as your limit? And just wondering, do you validate allergen cleaning at other stages of the process besides this? Sorry, didn't quite understand your question. It may be just me and my bad English haha. Pardon mua. 



#3 yas

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Posted 18 May 2016 - 08:24 AM

Hi Jessi,

 

I would suggest;

- In house swabbing for Sulphites (I'm not sure if there are swabs available out there?) on the machine/line after producing the product you think has the allergen present. You could take a swab before clean down to check for Sulphites. If you found Sulphites, you would need to do a full clean down between line changes and swab for the allergen to validate your cleaning.

- If in house swabs aren't available, send finished product to an external lab for Sulphite testing - the ones you think may have the allergen present.

 

Hope this helps,

Yasmin



#4 Charles.C

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Posted 18 May 2016 - 11:41 AM

Good Afternoon,

 

Has anyone used mathematical justification as part of their allergen cleaning validation?  I have calculated the concentration of sulphite in my final product and some are above 10ppm.  For those above 10ppm how do I prove that if there was any contamination into the next product it would result in less than 10ppm.

 

 

Any advice would be greatly appreciated!

 

 

 

Thanks,

 

Hi Jess,

 

IMO the likelihood of a calculation only to fly requires that (a) the method of calculation can be validated (eg by a reference), (b) the values used in the calculation do not require validation (eg like E=mc2)

 

There are cheap/simple test strips for checking sulphites but whether acceptable maybe depends on the regulatory detail.

 


Kind Regards,

 

Charles.C






Also tagged with one or more of these keywords: allergen, sulphite, sulfite, validation, calculation

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