Validating a Mixing Unit for consistent distribution

Your expert advice is required to all dry blending operators.

Using a ribbon style blender in the spice and seasoning mixing industry. The unit must be validated that it properly mixes all ingredients thoroughly and completely. The additive of concern is controlled substances as indicated under the Canadian Food and Drugs Act and Regulation.

The one I choose to use is sodium nitrite. thorough distribution is required to ensure that this substance is equivalently distributed in the finished product. This controls or prevents biological hazard and chemical hazard in finished product used in the dry ingredients users (meat shops).

What conditions would constitute re-validation?

change in equipment - adjustments in equipment,

change in motor drive which would affect the speed of the unit,

equipment maintenance affecting the speed or effectiveness of the mixing unit,

Others?

Collection of data is as follows:

produce batches every 4 months

batch size is 1000 kg

take 10 samples at determined number of bags (expect 10 samples every 5 bags during packaging)

samples sent to outside lab to test for nitrite (levels - %, ppm)

coefficient of variance (COV) is well below 2.0%

maximum level of COV is 10%

does several anlaysis of batches over 4-5 years suffice to validate this unit.

The only maintenance that is done is a change of busing on the unit which supports the main blending shaft which is ribbon style.

Can someone help me whether this data collection can be used to validate the ability of the mixer to blend evenly?

Can someone tell me if the time frame of data is adequate to provide for validation?

Thanks

Daryl

DRL,

Not much decisive help from me as this is not my area of expertise, but I would ask how did you arrive at your sampling plan and data collection? Is it based on Codex guidance? AQL tables?

I've blended flavored teas and tisanes, with liquid flavors, herbs and spices. IMO any change in the process has the potential to trigger the need for re-validation, including each ingredient in the mix. With the ingredients I blended the granualization size and shape of ingredients would change the time it would take to achieve a homogeneous mix. Agricultural ingredients are notorious for being inconsistent from lot to lot.

I have little experience with Canadian food codes; here in the US under FDA or USDA a history of collected data can qualify as a validation if the sampling plan is valid (tied to an accepted method) and lab test results are from an accredited lab.

Attached are some Codex documents on sampling and one document on AQL.