Considerations in Sterile Filtration - Part I: The Changed Role of Filter Integrity Testing | PDA
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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 …

The sterile manufacturing process using sterilizing grade membrane filtration has been
practiced reliably and safely over the years. However, to prove its reliability and safety, the …

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 …

Sterilizing grade filtration has been used for decades with reliability and assurance. The
reliability of this particular aseptic processing step increased with filter stability …

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 …

Sterilizing grade filtration has been reliably used for decades and increasingly so, as more
medicinal products are large molecule based, which requires cold sterilization, ie filtration …

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

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 …

This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing
practical applications of universal and dependable operational protocols, integrity testing …