How to justify screen size in HACCP plan?

Good morning all!

Ok, this question has come up a few times under audit - we create food flavorings (liquid, powder and extract).  Our only CCP in the building is our sifters in the powder process.  We have 2 sizes that we use - 22 mesh and 48 mesh.  The reasoning behind these is 1) they are very small....they will catch anything that is larger than the FDA allowable particle size and 2) we have to use sizes that the powders will go through.  The size used during the run is dependant on the product  we are running.  If a product is more dense, it goes through the 22 mesh (larger holes).  If it's lighter, more bouyant, it goes through the 48 mesh.

Now, here's the question - I have searched everywhere I can think of for scientific reasoning for the use of these screen sizes.  I have looked in 21 CFR....I have looked on the FDA website, I have looked everywhere.  Is there anywhere that states that you HAVE to use a specific screen size in your process?

Any help or suggestions would be appreciated.

Thank you in advance!

You have to use screen sizes that eliminate or reduce to an acceptable limit potential risks that in the absence of their control is reasonably likely to cause illness or injury... the definition of a CCP.  If your screens do that then you can justify the sizes you use.

What are the potential contaminants in your process?  Can they get through a screen of that mesh?  Are those the only control measures you have in place to mitigate such risk?

Yes, these are the only controls we have - everything is pre-processed by our vendors before they come in and require sifting statements (on powder ingredients).  The only potential risk we would have would be metal or gaskets on the machinery, and the screens are very capable of catching that.

This has never been an issue before - all of a sudden, customers want scientific evidence to back everything up.  There is no science or requirements that I can find.  We've been SQF certified for 4 years and has never been an issue there either.

I know AIB has an prescribed screen size for bulk raw materials... but I'm not aware of an SQF/GFSI limit (those tend to be based on risk assessment rather than prescriptive, right?)  or FDA size requirement. 

AIB  has 600 micron (30 mesh ) or 1000 micron (16-mesh) as their size limits.

This PDF has ... a lot... of information about sieves, testing, accuracy, etc... maybe, though not much info about standards.  Might help with setting a validation trial.    http://www.solutions...-procedures.pdf

I totally forgot about checking the AIB standard!  Duh  :doh:

Thank you!  

Plus if you've haven't had any recalls or customer complaints for foreign material that is proof that your system works.

Plus if you've haven't had any recalls or customer complaints for foreign material that is proof that your system works.

Mr I. that's my go to on a lot of my validations.

Plus if you've haven't had any recalls or customer complaints for foreign material that is proof that your system works.

True, but that is not what they want to see.  They want scientific evidence as to why we picked sifting over say, magnets or metal detection.

I'm going to use the AIB standard for the corrective action that I need to write, since the auditor already saw the customer complaint log and such.  We haven't done an AIB audit in a few years since we became SQF certified, and I had totally forgotten about it being in their standard.

Thanks all for your help!

You might find this presentation useful; The Physical Hazards of Foreign Materials David Goldman, Deputy Director, Human Health Sciences Division, OPHS/FSIS/USDA Sept 24, 2002

I use the FDA as a reference 'The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly. The scientific and clinical literature supports this conclusion'

Regards,

Tony