Comparison of allergen adhesion properties
Hi all,
At my facility we process powders containing various allergens (dairy, gluten/gliadin, and soy primarily). We have a history of successfully removing all allergens going back several years. We have been told previously (not sure from what source) that milk allergens are the toughest to remove. What we would like to do is perform a risk assessment to determine whether validating of gliadin/gluten or soy would be necessary if it can be demonstrated that milk allergen is successfully removed by the same cleaning procedures. I feel this risk assessment would be more convincing if there were some study demonstrating that milk allergenic compounds have a higher potential for adhesion than others. Thus far my literature review has turned up bubkis. I was hoping that perhaps someone on this forum had some resources that might be helpful, or possibly some personal experiences, or perspectives that would give me some guidance. So how about it?
Thank you in advance!
Dear,
The phenomenon of the milk allergen adhesion force is unknown to me. And even if that's the case, it might be that the difference in the adhesion forces of other allergens is negligible compared to the forces, which are applied during the cleaning process.
It means that your cleaning process is good enough (validated) for allergen removal. However, it is necessary to carry out verification tests for the allergens which run on the production lines. To check whether these have been removed and to support the validation study of the cleaning process.
Kind regards,
Gerard Heerkens
Hi all,
At my facility we process powders containing various allergens (dairy, gluten/gliadin, and soy primarily). We have a history of successfully removing all allergens going back several years. We have been told previously (not sure from what source) that milk allergens are the toughest to remove. What we would like to do is perform a risk assessment to determine whether validating of gliadin/gluten or soy would be necessary if it can be demonstrated that milk allergen is successfully removed by the same cleaning procedures. I feel this risk assessment would be more convincing if there were some study demonstrating that milk allergenic compounds have a higher potential for adhesion than others. Thus far my literature review has turned up bubkis. I was hoping that perhaps someone on this forum had some resources that might be helpful, or possibly some personal experiences, or perspectives that would give me some guidance. So how about it?
Thank you in advance!
Hi non-entitie,
I think there was a very similar post/OP to yours recently posted here, the (attractive) idea being that evidence of absence of milk allergen would be sufficient to then claim absence of various other allergens.
IIRC the response was that, as per previous post, audit bodies currently demand to see direct evidence for each potential allergen involved.
I do agree though that It would certainly be useful if someone could generate a Table of Relative Eases of Allergen Removal which was validatable for a wide range of food contact surfaces.
Would presumably also necessitate use of a standardised cleaning procedure though ?
I would surmise it is dependent on the protein content. Typical skim milk powder has about 30% to 35% protein (relatively high). No idea what soy powder or gliaden/gluten powder would have. I would say good luck trying to explain this to an auditor though.
Best to do your own in-house study which can be relatively easy with allergen swab test kits. Do production runs for each allergen type, and your normal cleaning SOP after each, then swab after the cleaning and see what results you get. If you find more "hits" with the milk powders then yes...harder to clean, if your cleaning procedures are consistent.
I would surmise it is dependent on the protein content. Typical skim milk powder has about 30% to 35% protein (relatively high). No idea what soy powder or gliaden/gluten powder would have. I would say good luck trying to explain this to an auditor though.
Best to do your own in-house study which can be relatively easy with allergen swab test kits. Do production runs for each allergen type, and your normal cleaning SOP after each, then swab after the cleaning and see what results you get. If you find more "hits" with the milk powders then yes...harder to clean, if your cleaning procedures are consistent.
I think an in house study could be successful only if the same cleaning elicited positives for the allergens which are more difficult to remove. I think our history prior to my working here may in fact bear out that the milk allergen was more likely to remain following cleaning than the other allergens, but failures of any type of allergen swabbing are few and far between. I'm afraid without some formal study or additional data to cite showing that the phenomena is not relegated to our experiences that auditors are likely to require the validations regardless of how strong our anecdotal evidence is. I suppose my hands are tied on this and we should continue on with all the allergen validations to keep all outside parties happy. Thank you all for your advice and insight into this matter.
I think an in house study could be successful only if the same cleaning elicited positives for the allergens which are more difficult to remove. I think our history prior to my working here may in fact bear out that the milk allergen was more likely to remain following cleaning than the other allergens, but failures of any type of allergen swabbing are few and far between. I'm afraid without some formal study or additional data to cite showing that the phenomena is not relegated to our experiences that auditors are likely to require the validations regardless of how strong our anecdotal evidence is. I suppose my hands are tied on this and we should continue on with all the allergen validations to keep all outside parties happy. Thank you all for your advice and insight into this matter.
Not necessarily....you would do the allergen test BEFORE the cleaning and then AFTER the cleaning to validate your cleaning activities. Can do this for each allergen type.
If you wish to have different cleaning activities / SOP's you can use the same methodology.
Hardly anecdotal, and very strong evidence if the study is done properly. IMO, it would be far better than any information you may find online.