Considerations in Sterile Filtration. Part II: The Sterilizing Filter and Its Organism Challenge:
A Critique of Regulatory Standards | PDA Journal of Pharmaceutical Science and …

This chapter examines microbiological considerations of filtration in depth.“Worst-case” in
the realm of microbiological validation of filters can be a very difficult condition to define, and …

This chapter starts with a historical overview, description of sterile filtration applications, and
performance requirements. Special attention is paid to the sterilizing final fill application for …

Filtration is a useful separation technique for the removal of par-ticles from fluid
suspensions. Sterile filtration constitutes an important application whereby liquid drug …

The removal rating of a given membrane filter type refers to the size, or narrower dimension,
of microorganisms and particles removed by the filter, rather than the actual size or shape …

Sterilizing grade membrane filters are widely used for the intermediate and final filtration of
liquid drug products. Their function is either to reduce the bioburden level within the liquid …

The ideal filter medium to remove microorganisms from solutions destined for parenteral
administration should offer the following characteristics: efficient removal of particles above …

The authors have, in this report, assembled information which others may find useful in
evaluating their filtration processes. We emphasize that there is no single “right way” to …

Sterilizing filtration process variables can cause unpredictable results and post-filtration
integrity test values that are not representative of those obtained during validation of the …

Validation consideration of sterilizing grade filters, namely 0.2 micron, changed when FDA
voiced concerns about the validity of Bacterial Challenge tests performed in the past. Such …