A little about Cleaning Validation…

Cleaning Validation (CV) is driven by regulatory expectations to ensure that residues from one product will not carry over and cross contaminate the next product. Regulatory scrutiny is more rigorous in a multi-product facility compared to a single product establishment. Companies are usually cited either for not having a sound cleaning validation or not meeting the protocol acceptance criteria. Because failing protocol acceptance criteria is considered a substantial regulatory risk, companies tend to spend money and resources even though there is minimal or no product risk.

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Visual inspection is a tool commonly used during cleaning validation. Visual inspections are used to verify there is no residue or excessive water pooling etc.

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Cleaning Validation is handled by taking rinse water samples and by taking Total Organic Carbon (TOC) swab samples of the equipment. There are four different samples taken to be tested by Quality Control (QC) and they are Bioburden, Endotoxin, Conductivity and Total Organic Carbon (TOC).

Written By: Tim Cronin, Consultant II

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1 Comment

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  1. Some of my recent experience with regulatory agency has reinforced the need to assure that there is clear and detailed documented rationale for your choice of swabbing locations. So general statement of ” Worst case locations were chosen for swab locations.” may not be acceptable without documented rationale and or studies to determine how those worst case locations were established.

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