Good morning MDaleDDF,
Thank you for your answer !
We currently have 5 allergens in our building. It isn't possible to have them all in all products, as it would change the recipes.
Currently, we have :
- All products have Milk;
- Some of them have Wheat, Gluten (due to beer added);
- One of them have Eggs (due to the raw material containing egg);
- Some have Soy - They are made in different equipment and in a different area of the plant.
We were able to validate our cleaning process for eggs. However, for wheat, it seems that there isn't any surface testing available, nor is there a lab test that exists (ELISA). I know PCR exists, but it wouldn't quite work from what my understanding....
Hi OP, I'm not sure why you're seeing gluten ELISA as a problem. It's quantitative. PCR is not. It's not a problem to be testing for gluten as gluten will be present in wheat and is often the causative protein for allergy. PCR is testing for DNA which is not a direct test of an allergen and not indicative that the allergen is present.
In the UK at least, retailers see ELISA as the gold standard for testing.
Many years ago, I trawled through all the UK retailer standards for their protocols for allergen testing. I know you're not UK but I actually think this is probably as belt and braces as you'll get.
Positive controls:
- Test your product containing wheat
- Test a swab on a dirty surface after wheat has been used
Why? This might assuage some of your concerns above. It proves that the allergen is present in the material before you get going. It might not be there because of the processing or it might be at low concentrations. There's no point proceeding before you know that it's present and recoverable.
Once you know the above testing, I'd then repeat that and do the following:
Test protocol
- Test product containing wheat (you can probably get away without testing this again to save cost)
- Dirty swab in minimum 3 locations which might be hard to clean (e.g. inside pipework, around moving parts).
- Clean using normal cleaning procedure.
- Clean swab in the same 3 locations.
- Take off first 3 products after the clean and test for the allergen.
Obviously you're hoping that it will all come back clear. Ideally I'd then repeat that 3 times as well. Expensive but worth it for due diligence. If, for example, your dirty swab in the positive control test didn't come back with a positive, then either you could use rinse water (depending on your process) or just miss this and the clean swabs in the second protocol and write it up explaining as it's not recoverable, there's no point doing swabs either dirty or clean.
Lastly a point on lateral flow swabs. They are not suitable IMO for validation. You need to validate them in themselves that they can recover the allergen effectively and give you an accurate reading in the presence of the food matrix (or how much the matrix effect impacts them). If you do all that, then it's possible but it's a lot of work. I see a lot of plants using them without doing that first in the belief the sensitivity on the pack is what they're getting.
Some plants use them for in process post clean verification but IMO, if you've properly validated the cleaning process using ELISA, visual clean is no worse. A swab will only tell you the place you swabbed after all and can give people a false sense of security. The swab tells them it's clean but they see some residue? Well they might just trust the swab. Sadly I've been there with a QA once who I then had a bit of a coaching conversation with... But that's another story.
Answered
