Allergen Purge

Hi everybody. I recently spoke with a QA tech from another company and he told me about a process that they have implemented that I was wondering if you all had any experience with. He worked at a coffee plant and when changing from caffeinated to decaffeinated coffee, they found that they could purge a couple hundred pounds of product through the processing equipment and then throw that product away. He said when they swabbed and got analysis done on those swabs, the purging cleaned off all of (or at least enough to be legal) the caffeine from the equipment so that they could then run decaffeinated product and be good. By purging those couple hundred pounds, they saved a lot of money in time and labor. 

So. My question is if this could apply to allergen cleaning. I'm at a cookie dough manufacturing company and our two allergens we have to control are peanuts and tree nuts. Typically, we can create our schedule so that we only run allergen containing products at the end of the day, but every now and then, someone will have a last minute order change and we have to throw a batch in the middle of the day. This requires a deep clean of all involved equipment followed by allergen swabbing before the line can be started back up. 

I'm assuming that allergen proteins and caffeine are two different animals, but I was curious if this same purging concept might work for an allergen wash.

If there's a chance it could work, I'll try the concept. Run my allergen product, run a short purge, swab everything to send those swabs off to a 3rd party lab, clean like normal and go from there. I'll make sure it works before implementing. But looking for any feedback!

Thanks.  

What are you purging with? Are you allergen testing with a lab?  You can get swabs that will give you a very quick answer.

We run dough through a shared piece of equipment and the last product of the day has egg in it.  Before cleaning we push dough through without egg then clean the machine.  After cleaning we use neogen swabs to test for egg.  We also send out samples of the first dough out the machine to a lab to have a record that there is no egg residue or allergens in the product.

It is possible, but there is a significant risk.  It all comes down to the sanitary design of the equipment.  I'll give you examples from my experience.

1.  Fruit bases / mixes (multiple allergens handled, everything under the sun).  We batched in dedicated kettles with all ingredients on a second level.  The lower level was filling (everything gravity fed into the package).  Only one protrusion inside the kettle for the RTD and the agitators which were vertical or horizontal depending on the kettle.  We found on the vertical style kettles we could do a product purge on SOME of the products.  The more viscous the product the more difficult to have a "clean purge".  The horizontal kettles were out of the question due to agitator design.  So yes, we kind of got it to work with some products, but at the end of the day I didn't want to take the risk because of two reasons:  1.  Complexity in the sheer number of our products (varying viscosity).   2.  The very good chance for a mishap, such as an inadequate purge.

2.  Fluid milk / dairy plant producing different allergen containing fluid products (milk, almond, cashew, soy, egg).  Equipment designed for high hygiene with ease of cleaning in mind, all CIP applications, very little to disassemble.  We found that we could do product / water purges and get the allergen to a level that wasn't detectable by the test kit on the rinse water; however, it was inconsistent.  One day it would work and another day it wouldn't.  Keep in mind the cleaning / rinsing / purging is fully automated with whiteness sensors and timers as a backup so it is consistent day to day regardless of situation.  I didn't want to risk this because of the inconsistency.

Take what you will from my two experiences above, but I heed you caution on product purging out allergens.  Even in the most hygienically designed equipment and low viscous products you will likely find inconsistencies.  Additionally, if you have an FDA inspection under the new FSMA requirements they would question this practice and you would have to prove out the safety of it.  Given the history of allergen recalls in the US, is this a risk you really want to take?  Only you can answer.

So does anyone have any thoughts on the process that I outlined in the post above.  After pushing dough through we do a wash, rinse and sanitize.  Egg is the allergen that is run last on the production shift.  Then sanitation cleans the machine before the next use.  Neogen swabs for Egg have always been negative. The level of Detection is 5 ppm on the Neogen swabs.   We have tested and sent product to a lab three different times and the results have always been below the Level of Detection for the lab <2.5ppm.   I cannot find any guidance that gives a limit or threshold for the readings in ppm.  Can there still be an allergen present at <2.5 ppm that would cause a reaction in someone who is allergic to egg? 

So does anyone have any thoughts on the process that I outlined in the post above.  After pushing dough through we do a wash, rinse and sanitize.  Egg is the allergen that is run last on the production shift.  Then sanitation cleans the machine before the next use.  Neogen swabs for Egg have always been negative. The level of Detection is 5 ppm on the Neogen swabs.   We have tested and sent product to a lab three different times and the results have always been below the Level of Detection for the lab <2.5ppm.   I cannot find any guidance that gives a limit or threshold for the readings in ppm.  Can there still be an allergen present at <2.5 ppm that would cause a reaction in someone who is allergic to egg? 

Hi bakerkid,

It's related to the amount consumed but statistically, probably yes, eg you can do the maths from -

allergen reference doses.png   120.33KB   0 downloads

(eg for 50g food/egg ref dose 0.03mg, action level 1 = 0.03 x 1000 / 50 = 0.6 ppm)

taken from -

VITAL 2.0, 2012.pdf   701.73KB   39 downloads

But also see this (2012) caveat -

reference doses for allergens in foods,2012.pdf   595.17KB   47 downloads

Nonetheless, the (lowest?) test kit LOD is, afaik, the typical auditory criterion for practical validation of  cleaning systems.