Understand the robustness of your viral clearance steps

Validation of viral clearance robustness

An important aspect of viral clearance is how well the virus reducing steps will tolerate variations outside the limits set of the process parameters. This is referred to as robustness and is increasingly emphasized by the authorities. It should be performed in a separate set of experiments where virus reduction is measured under conditions that deviate from the original limits. The robustness studies should also be performed with several viruses with different properties.

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