This entails grabbing samples from the test mixer that have a size equal to the scale of scrutiny (the size of the desired product, whether it’s a tablet or another shape). To be certain a new mixer will achieve a blend within our product’s acceptable variation, we need to perform testing on a pilot or lab-scale mixer.
This is within acceptable USP monograph requirements. Yet, with standard variation, each tablet’s acetaminophen content might be anywhere between 300 and 350 milligrams. Each tablet is supposed to contain 325 milligrams of acetaminophen. We want our blend to be such that every tablet will contain the perfect amount of the key ingredient, acetaminophen, but this won’t always happen. For example, let’s say our end product is acetaminophen pain-relieving tablets. Every blend has a key ingredient or two that must be distributed appropriately throughout the blend. Instead, a good random mix is the desired goal.
There’s variation with every mixer and every blend, so an ideal or perfectly ordered mix can’t be achieved. How do we know? What criteria do we use to determine if the mixer we’ve chosen will do a good job? In this column, we’re going to revisit a past column on how you can use testing to do just that. So, let’s assume that we need to buy a new mixer and, after doing some research, believe that we have chosen a good mixer for one blend. Achieving a good material mix depends on achieving an effective “marriage” of the particle characteristics, process conditions, and mixer type.
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