Vironova Biosafety
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.

Column re-use
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Chromatography steps can have virus removal capacity. To show that this is a valid viral clearance step, the chromatography resin should be tested for its virus removal capacity both as a freshly packed column and after the final approved cycle.

purity-biosafety
Kinetics
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The kinetics of inactivation are important since the rapid kill of large amounts of virus is indicative of a robust virucidal step.

kinetics-graph

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Study Proposal Form

Please fill out the following information with as much detail as you can, in order for us to provide you with an accurate quote as soon as possible.

* - Compulsory fields
What is the nature of the product
If relevant, where will the product be marketed
Should the study be performed in compliance with GLP
Should the study be performed in duplicate
Will a representative from your company be present during the testing
Process steps to be tested Model viruses Processing time Number of points for sampling If representative(s) will be present, please specify for which step(s)
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