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Why TOC measurement matters in cleaning validation
Most pharmaceutical and biopharmaceutical products contain organic molecules or proteins. That’s why total organic carbon (TOC) analysis is widely used to verify that equipment is clean after production. If organic residues from a previous batch remain, they can compromise product quality or even patient safety.
TOC measurement allows you to detect these residues—provided your sampling and handling processes are solid. Here’s how to get it right.
Two sampling techniques: swabbing vs. rinse water
When measuring TOC for cleaning validation, you typically choose between:
Both techniques are well accepted and widely used in GMP environments. But the accuracy of your TOC results depends less on the method you choose — and more on how well you apply it. From the materials you use to how you handle your samples, each detail can influence the final TOC reading.
So, how do you avoid false positives or background noise that could affect your analysis?
How to improve your TOC sampling results
Below are 4 practical tips to help ensure clean, consistent, and reliable TOC measurement results.
Conclusion: small details, big impact on TOC accuracy
Even small oversights—like using swabs with adhesives or transferring samples between containers—can compromise your data. But by following best practices, your team can achieve accurate TOC readings, meet regulatory requirements, and demonstrate effective cleaning procedures.
At QbD Group, we support pharmaceutical companies with reliable cleaning validation strategies, including TOC measurement setup, sampling plan design, and lab coordination.
Want help optimizing your cleaning validation approach?
