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TOC method for cleaning validation

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MDG

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Posted 27 July 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,



rtanit

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Posted 11 August 2017 - 03:55 PM

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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