PDA Letter Article

Viruses on the Surface

by Jennifer Loughman and Paul Lopolito, STERIS

Microbiology

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).

Members can read the full article in the March 2019 PDA Letter (PDF)