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TOC Analysis in Cleaning Validation

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  • TOC Analysis in Cleaning Validation

The primary purpose of performing cleaning validation is to prove the effectiveness and repeatability of cleaning procedures. 

In cleaning validation, it is important to determine the limits in the transport of product residues, microbiological contamination and cleaning agent residues.

Through cleaning validation, it can be shown that the cleaning processes applied consistently clean the equipment up to the predetermined limit.

For this purpose, the method performed with the "TOC device" is usually used. Substances that may cause contamination due to inadequate and inappropriate cleaning procedures may appear in the next production.

With TOC analysis, all existing organic carbon is measured, and thus all potential residues that may occur can be measured in a short time at a sensitive level such as ppb level. As a result, cleaning validation is the control of whether the residual substances formed on the equipment surfaces after cleaning are within the allowable limits.

TOC analysis is the most suitable analysis for the detection of all substances that can cause contamination at the ppb level.

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