Batch Tray dryer PQ

I’m gonna do the PQ of Batch Tray dryer for granulation process.

What kind of test item should be checked?

Temperature? Right?

Ok! Then, What kind of temp.?

Penetration? or Just Loading distribution?

I’m confusing. As I think it’s useless to check the penetration temp.

Whether do I check penetration temp or distribution temp.

How could I establish a acceptance criteria.

Pre Test result was horrible. There was no pattern.

Probably the dryers are not good condition to perform a good performance.

But, I want to know what is the right item and right acceptance criteria.

Please help me.

from South Korea.

Penetration is usually not a requirement, as you don’t want to contaminate your product. Unless you use a placebo of course. However; differing bulk densities , differing moisture content, granule bed depth, available tray surface areas all contribute. These are factors which should be controlled via Process Validation, not PQ.

For this particular PQ, I would redo the oven mapping exercise with granule in the trays, ensuring that the testing is done in such a manner so as to ensure that the range of granule bulk densities is sufficiently covered. I would position my thermocouples in such a fashion that I would be able to place some sensors in the airstream as the air passes over the granule in the trays (ensure that potential contamination is eliminated by placing the sensors on the extract side of the racking), as well as distributing thermocouples throughout the chamber to check for temperature distribution uniformity. The difference in temperature between those sensors distributed in the chamber on the supply air side versus the sensors on the return air side of the airstream would give a base indication of how much heat is absorbed into the granule. The uniformity of that difference from top shelf to bottom would be an indicator of the efficiency and consistency of the drying process.

The only check remaining would then be to perform moisture analysis on the dried granule from top shelf to bottom shelf in the rack to check for conformance to specification and moisture uniformity. The uniformity of the results would be an indirect indicator of how well heat has penetrated the granule and confirm the performance of your dryer.

That’s how I would do it. Hope this helps.

I’m very thank you for your help.

We’ve exchange some test method and mapping location.

And LOD(loss on drying) was already our test item using IR moisture analyer.

We check LOD before and after the drying process.

Very thank you.

what acceptance criteria would you recommend for temperature homogeinity in such a dryer?
Any ideas?