ABSTRACT
In biopharmaceutical processes, filters sterilize the culture media and gases fed into bioreactors, clarify the cultures at harvest, protect chromatography columns, purify the end product, remove viruses, and provide sterility assurance for the final packaged product. Developing and validating any filtration process requires understanding the details of the filtration operation, the structure of the filter, and the interaction of the filter with the specific process fluid. The specific tests appropriate for validating a filtration process depend on the filter and its usage.
