PDA Letter Article

Viruses on the Surface

by Jennifer Loughman and Paul Lopolito, STERIS


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).