ABSTRACT
Sterile filtration is widely used in the biopharmaceutical industry to remove contaminants, especially microorganisms from liquids, air, and gases (1). Microorganism removal is required either to achieve a sterile filtrate or, if the drug product is thermally sterilized, to reduce the bioburden level to avoid elevated levels of endotoxins, the remains of gram-negative organisms. Such sterilization or bioburden removal filter systems require thorough validation and qualification to confirm that the particular filter is working for its intended purpose.
