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Testing Allergen Cleaning Effectiveness

Started by , Aug 24 2010 06:03 PM
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14 Replies

I was wondering if there was a way to verify that the cleaning procedure on the equipment for cleaning an allergen containing product to ensure that no allergen residue is left?



Thanks!

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Have u heard about the procedure for the sanitation process monitoring

using PocketSwab Plus and FireFly unit??

It is to validate the cleaning procedures and process effectiveness; obtaining nondetectable

levels of organic material demonstrated surfaces are cleaned and free

of any organic material such as allergens or gluten. You have to buy

Charm FireFly 2 to make tese tests.

I was wondering if there was a way to verify that the cleaning procedure on the equipment for cleaning an allergen containing product to ensure that no allergen residue is left?



Thanks!



I have had good results using the Neogen Reveal 3D rapid tests (FYI they were Tepnel, sold to Gen Probe then sold to Neogen). These kits come with all items needed to test your product or swab surfaces and give a detected/not detected result in 5 minutes.
We use a number of these tests for both gluten and nuts (gluten and nut free site) with good results.
The issue of cost usually comes into the argument at some point, but that is the cost of compliance.
We have fond the most efficient, and cost effective, rapid test is to swab for protein residues. As allergens are all proteins, and if protein residues are present then cleaning is inadequate indicating re-cleaning is required.
I agree with DavidB, We were told that swabbing for individual allergens is unreliable due to the possibility of cross reactivity giving false positives and negatives so swabbing for protein residues (ATP) is the method we are using.

I agree as well... We use the SystemSURE II from Hygiena to see if the surface is clean. You have a different 'snap' to do a ATP water test, but I haven't used it. The ELISA test (for allergen) cost a lot and takes some time. Some companies claim it's a fast test. But 60 min. waiting for the results can be still a long time.

Oh wait...

Ok maybe not all the test take 60 min... I just got a newsletter from the Allegene Consultancy in the Netherlands. They have a allergen test that's similair to a pregnancy test. The link is in Dutch but the pictures are clear even if you don't know the language. http://www.allergene...genenbeheer.pdf

I have had good results using the Neogen Reveal 3D rapid tests (FYI they were Tepnel, sold to Gen Probe then sold to Neogen). These kits come with all items needed to test your product or swab surfaces and give a detected/not detected result in 5 minutes.
We use a number of these tests for both gluten and nuts (gluten and nut free site) with good results.
The issue of cost usually comes into the argument at some point, but that is the cost of compliance.



How much do these cost? I went to the Neogen Reveal website but there is no pricing. Right now this seems like the best answer to me.
Are we talking about a process that is totally wet cleaned or is there dry cleaning involved. Our process has significant dry cleaning (some wet cleaning). We rely on ATP swbs for surface testing for cleaning effectiveness but also test purged material for a particular allergen before releasing the line. Th issue with just ATP swabs is that in most cases only a small portion of the food contact area is tested
hello,

ATP swab is most reliable for both cleaning and food residue monitoring & Validation. i am using hygenia swab. per swab is costing around USD 8.8 in india . you can swab maximum area with one swab or have to use two or more swab stick. residue contaminaiton will be based on Qualitative. depending on contamination the color will varry.

regards/bala

Attached Files

Hi All,

Based on your experiance, is ATP test result has zero value to justify that the cleaning is valid OR no cross contamination of allergen. Or, is that any maximum value to indicate the no cross contamination.

Also, is that acceptable if the ATP test only done during cleaning validation OR is should be done during verification-each cleaning?

Thank all.

Cheer,
Mientari
The original post by jenmaw asked
" if there was a way to verify that the cleaning procedure on the equipment for cleaning an allergen containing product to ensure that no allergen residue is left?"

While we agree that allergens are proteins, and any protein residue on the surface will react to an ATP swab, therefore we can assume that if the swab reacts to protein it will, in the case of the Hygenia swab, turn purple.
So a purple result indicates a protein is on the surface, but which protein?

Back to jenmaw's question.
To determine if an allergen residue is left you will need to use a specific test designed to determine the actual protein present. Before everyone clicks on the reply button, please consider that some processes tolerate a background level of protein to be present, however they then test for specific allergen proteins. (usually purged or flushed processes)

So if it is a process hygiene outcome, ATP works well, if it is for a specific allergen then a test designed for that allergenic protein needs to be used. (single it out).
As mentioned before I use rapid (5 min result, detected/not detected) (jenmaw approx $20 AUD each rapid test) and validate using elisa micro well for the specific ppm of contaminant if detected.

amandas post is a combination of these methodologies.

Cosmo

AllerSnap by Hygiena with the incubator. I believe results are in 15 minutes. Cost is relatively minimal. Annual validation with ELISA swabs at a third party lab (I believe this is about $100 per allergen).

AllerSnap by Hygiena with the incubator. I believe results are in 15 minutes. Cost is relatively minimal. Annual validation with ELISA swabs at a third party lab (I believe this is about $100 per allergen).

12-year old thread but Thanks anyway for your input.

Certainly, residual protein swabbing example: https://www.hygiena....tion/allersnap/

 

Certainly, residual protein swabbing example: https://www.hygiena....tion/allersnap/

IIRC, the only generally acceptable auditorial solution is via a specific allergen detection Procedure. It's a question of Validation.

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