What Is a Bioburden Reduction Filter (ULTA Prime CG)?
Bioburden reduction filters are not defined by an industry standard. The term “bioburden reduction” is a designation used to describe a class of filters which provide a high level of microorganism retention (i.e., LRV 4-6), but do not yield a sterile effluent under the high bacterial load called for in the ASTM F838-05 test method. Manufacturer claims on bioburden reduction filters vary from “typical” retention data to full validation of a minimum LRV. In practice, most bioburden reduction filters are of a 0.45 or 0.2 m rating and may yield a sterile fluid in common usage, where bacterial loads are much lower than those used in the ASTM challenge. Nevertheless, process-specific claims of fluid sterilization through the use of a bioburden reduction filter are generally not appropriate.
