Pharmaceuticals/Recovery study

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Question
Dear sir,

Plz. explain,
In Cleaning validation study

What is mean by recovery study and how to find out recovery factor with actually calculation?

thanks&Regard
avinash

Answer
If you placed 100 milligrams of API residue on a 25sq. cm. area of steel surface, and then used a swab to remove this; how much API material can you find when testing the swab extract? This is the recovery study. If you can only find 82% of the original API, then in future when performing your cleaning validation study you need to increase your results by 18% for a true result.

Acceptable results are where you can consistently (3 operators, each performing the study on three different samples), have results that are always over 80% recovery, and with a pooled %RSD of the nine samples showing the pooled results with a %RSD of < 5%RSD  

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