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Cleaning Validation Glossary


Resilience to variations

Robustness is defined in PDA Technical Report 57, Analytical Method Validation and Transfer for Biotechnology Products, as "The measure of capacity to remain unaffected by small, but deliberate, variations in method parameters and provides an indication of its reliability during normal usage" in cleaning robustness is used to refer to variation between cleaning process parameters that are documented and compared against eachother during cleaning validation to establish a cleaning process.

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