Facility Segregation for Viral Safety
It is critically important for manufacturers to design facilities to prevent contamination events and to contain one if such an incident were to occur. However, consistent practices or regulatory guidance on best approaches to facility segregation are currently lacking. The guidance that does exist is weakened by vague terminology. Regulators expect appropriate segregation and justifications for that segregation, and the CAACB is attempting to help industry meet those requirements. The goals for this project are to: 1) reach a consensus on the definition of common terms, such as “functionally closed” and “pre/post viral clearance”; 2) identify an array of facility segregation approaches that are adequate and appropriate depending on the manufacturing facility and situation; and 3) communicate these items to the industry through presentations and peer-reviewed publications.
- PW Barone, et. al. Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing. PDA J. Pharm. Sci. Tech. March 2019, 73 (2) 191-203