An Interpretation of the Pharmaceutical Industry Survey of Current Sterile Filtration Practices |
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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 …

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 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 …

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

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 …

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

Since sterile filtration and purification steps are becoming more prevalent and critical within
medicinal drug manufacturing, the third edition of Filtration and Purification in the …

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 …

In this issue, the report of the second national survey of quality assurance activities for
pharmacy-prepared ster ile products (page 2591) and the editorial by Klein (page 2581) …