TOC method for cleaning validation
Started by MDG, Jul 27 2017 09:53 AM
Hello,
Guidance require for the usability of the Total organic method in dairy /food industries . As per the US FDA same is valid in pharmaceutical industry.
Thank you,
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I would suggest doing a swab and rinse water study. Validate your limits of detection using known standards of what ever you are cleaning. 3 replicates.
Then figure out how effective your cleaning methods are and set a tolerance for "clean". Once you start testing rinse water samples/swab samples of clean equipment, anything over that tolerance would have to be re-cleaned.
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