Bioburden Entry Points In Downstream Processing

By Anastasia G. Lolas/M.Sc., Visionary Pharma Consulting LLC

If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.

To the extent that a downstream purification train is not a closed system, there is a potential risk of bioburden entry at any point where the system is open to the environment and human operation, or even to other parts of the system. Furthermore, parts of the bioprocessing system that cannot be easily sanitized or sterilized by steam may provide ideal conditions where microbes can hide and proliferate. Prevention of bioburden contamination requires proper procedures and training, and constant vigilance.