Degradation

The breakdown of material during a manufacture

Degradation is defined in PDA Technical Report 49, Points to Consider for Biotechnology Cleaning Validation as "The breakdown (usually chemical) of material during manufacture, including during and after the cleaning process". Degradants are impurities resulting from the manufacturing of the product and must be assessed and understood prior to production through an assessment. A full impurity profile for the product should be assessed to determine if the product should be produced from a risk mitigation perspective and to determine how cleanability over time changes to assess campaign production length. During a cleaning process, residues may be degraded due to cleaning agents and temperatures to effectively clean surfaces.