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Validation of Cleaning to remove allergens

Allergens validation methods cleaning

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DRL

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Posted 13 April 2015 - 10:54 PM

I need to know if anyone has used a test swab kit that can be used to validate removal of a less persistent allergen. The removal of soy protein ( a persistent protein) would be a lot harder than removal of sulphite(a salt). Can one be so bold as to make that assumption if soy tests negative using a test kit that detects down 20 ppm that one can assert that sulphite is also removed?

 

Or should one validate each allergen used in a facility and its removal?

 

Please help. Just wondering if my logic is sound or absolutely broken.

 

Thanks



MWidra

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Posted 14 April 2015 - 01:26 AM

I'm not sure that you can get a test kit for sulfite similar to those for soy or peanut, since it is not a protein. I did not see one at the site that has all the allergen test kits. Those normal test kits are based on antibody reactions, and you can't make an antibody to a salt.

 

You can get chemical test strips to detect sulfite in water or wine.  You may be able to show that you can detect sulfites before cleaning using a test strip moistened with deionized water and not after cleaning.  Since it is a check for cleaning, you may get away with not using a test that is certified.

 

Martha


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Charles.C

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Posted 14 April 2015 - 07:11 AM

Can one be so bold as to make that assumption if soy tests negative using a test kit that detects down 20 ppm that one can assert that sulphite is also removed?

 

 

Hi DRL,

 

It seems you need a relationship between soy protein and sulphite content for yr unknown product.

 

I fear not unless some of the "S" is absorbed into the "protein" in a known  way which is I guess highly unlikely.

 

As per MWidra, IMEX the strips are easy to use but accuracy on, say, stainless steel, I'm uncertain. (For actual products, analytical options are available.)


Kind Regards,

 

Charles.C


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trubertq

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Posted 14 April 2015 - 08:59 AM

There's titration for sulphites, but I agree with Martha, the strips could show presence/absence which is all you really need to show efficacy of cleaning


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Posted 14 April 2015 - 11:15 PM

Hi DRL,

The only allergen I have to deal with is sulphites.  I work in a fruit juice/concentrate manufacturing factility.  Not all of our products contain sulphur.  I validate the process by the following procedure

1. Product with sulphites if packed out

2. Then Cleaning and Sanitation conducted

3. Next product without sulphites is blended.

4. Collect product from the very begining of the process, ie. first bottle off the line or first concentrate being packed off. 

5. Conduct a Sulphur test (we do this by titration) on the product.  This confirms absence/ presence of sulphur.  If present the clean in inadequate. 

 

Hope this helps. 



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Posted 15 April 2015 - 10:40 AM

Hi DRL,

The only allergen I have to deal with is sulphites.  I work in a fruit juice/concentrate manufacturing factility.  Not all of our products contain sulphur.  I validate the process by the following procedure

1. Product with sulphites if packed out

2. Then Cleaning and Sanitation conducted

3. Next product without sulphites is blended.

4. Collect product from the very begining of the process, ie. first bottle off the line or first concentrate being packed off. 

5. Conduct a Sulphur test (we do this by titration) on the product.  This confirms absence/ presence of sulphur.  If present the clean in inadequate. 

 

Hope this helps. 

That is an awesome thought process.  

 

Martha


"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

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Posted 15 April 2015 - 12:31 PM

I suppose it might be easier to first do the products without sulpur (sulphites) present


Kind Regards,

 

Charles.C


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Tony-C

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Posted 15 April 2015 - 12:54 PM

Hi DRL,

The only allergen I have to deal with is sulphites.  I work in a fruit juice/concentrate manufacturing factility.  Not all of our products contain sulphur.  I validate the process by the following procedure

1. Product with sulphites if packed out

2. Then Cleaning and Sanitation conducted

3. Next product without sulphites is blended.

4. Collect product from the very begining of the process, ie. first bottle off the line or first concentrate being packed off. 

5. Conduct a Sulphur test (we do this by titration) on the product.  This confirms absence/ presence of sulphur.  If present the clean in inadequate. 

 

Hope this helps. 

 

Yes I like this providing your test methods is sensitive enough. You could also test the final rinse water.

 

Under EU law: Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers:
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers;

Sulphite Test Kit
 

As I'm going to explain below SQF don't like it so much for validation of cleaning due to dilution by the product but for me if your first off product is clear then there is a high confidence in your clean. The problem arises with equipment which is more difficult to clean and has 'traps' where allergen could possibly accumulate.

 

Or should one validate each allergen used in a facility and its removal?

 

Please help. Just wondering if my logic is sound or absolutely broken.

 

Thanks

 

Here are some extracts from SQF Guidance on Validation of 'Allergen Cleans' that you might find useful:

 

The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.

 

When there is a mixture of different allergens in use, the acceptable method for confirming the thoroughness of cleaning is to test for the highest risk allergens, the highest concentration allergens, or the ones that are most difficult to remove. Examples of difficult to remove allergens include milk proteins, such as in chocolates or caramels, and cooked eggs. In some cases, a supplier may choose to test for an allergen protein which is lower in concentration.

 

Finished product testing is not sufficient by itself to validate cleaning methods since any allergen present is diluted by the product and can become nearly undetectable thus rendering a questionable result. However, finished product testing can be useful when an allergenic ingredient might be mistakenly added to a product during the manufacturing process. Extensive finished product testing conducted in conjunction with visual inspections of operating equipment may provide the evidence that the allergen removal verification method is working. Further evaluation on a case by case basis may be needed in some of these situations.

Regards,

 

Tony
 



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Posted 15 April 2015 - 03:25 PM

Thanks everyone!

 

A lot of great information. This forum is fantastic! And all of you have been a great help to me.

 

Thanks, Daryl



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Posted 24 March 2016 - 02:43 PM

Does anyone have supporting science of which allergens are harder to remove? Crustaceans or fish?



GMO

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Posted 24 March 2016 - 09:15 PM

On the sulphites question; it might have all been answered for you but it's the only serious allergen of concern in one of my factories and, happily, testing is cheap at a lab because as others have said, it's a chemical test.  Also you can't swab for it so you save on swab testing too.

 

What we do (a fairly low risk process) is once a year validate our cleaning is effective by choosing the most highly concentrated source of sulphites then testing for presence in that product, cleaning down then testing the next three products (i.e. the first three) of a non sulphite containing batch made directly after the sulphite then the clean.  We repeat that in triplicate.

 

In the past when we used to process more allergens, we would do the same but also throw in a dirty swab and three clean swabs of key parts of machinery.  I suppose you could then conclude that if your first set of results prove removal of both then that's enough to only test for soy next year, however, if you look at the prices of ELISA for soy (when you'd be testing swabs as well) vs. the chemical test for sulphites the savings wouldn't be massive.

 

As for the other question on crustaceans vs. fish?  I personally have no idea which is more persistent of those two but if you were doing a cooking process, e.g. making a sauce and wanting to chose suitable allergens to check your clean is effective when you process multiple types, I would always chose egg or milk because logically, they stick!

 

Personally I wouldn't use the quick tests you can use on site apart from if they are as monitoring or verification of your process because they aren't as sensitive and may give you false comfort.  The idea is to validate the level of cleaning you would do for a "normal clean" which is microbiologically sound is also safe from an allergenic perspective.  I don't know if this is a fair analogy but I think of those quick allergen tests as being like ATP swabs.  They can have their place but they aren't to be 100% relied on.







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