Advanced filtration optimizes high-viscosity BFS
Filter selection can have a significant impact on the process, especially for challenging fluids.
Sterilizing-grade filtration removes bacterial contaminants throughout the drug manufacturing process to ensure safety and sterility of the final drug. From growth media to buffer additions and final filling, filter selection drives efficiencies in processing while providing confidence in achieving drug critical quality attributes (CQAs).
Not all microbial contaminants can be reliably removed using 0.2 µm filters. Mycoplasma and diminutive bacteria require 0.1 µm rated filters, optimized to achieve higher levels of process sterility where these contaminants are known to be present.
While bioburden control is an essential part of cGMP, not all process fluids require filters designed to achieve sterility under the most challenging conditions