Assessment of Viral Inactivation of Cleaned Surfaces Using a Chlorinated Alkaline Solution
Viral safety from endogenous and adventitious
viruses remains a concern within
biopharmaceutical manufacturing. The
risk-based approach described by regulatory
agencies incorporates three principles:
selecting raw materials for the absence of
viruses and animal-derived components;
testing at various stages of production to
ensure absence of viruses and assessing
the capability of the process to inactivate
viruses (1–3).