Filters rated as having a 0.2-μm pore size (0.2-μm-rated filters) are used in laboratory and
manufacturing settings for diverse applications of bacterial and particle removal from …

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

Filtration technology has progressed from early attempts using sand, gravel and cinders to
today's membrane filters which are capable of removing microorganisms and sterilizing …

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

Brevundimonas diminuta is the organism most commonly used for challenge testing of
sterilizing-grade filter membranes. ASTM F838-05 and PDA Technical Report 26 rely on B …

Sterile products have several unique dosage form properties, such as freedom from micro-
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …

Integrity testing of sterilizing-grade membrane filters is a commonly used and needed
nondestructive test to determine whether or not the filter performs as specified or contains a …

Model organisms are useful when validating sterile filtration, but successful retention of the
model organism does not always guarantee that effluent is sterile. The authors explore the …

Until recently, the 0.2/0.22 µm-rated microporous membrane was considered the “sterilizing”
filter (1). The assumption was that on account of its resisting the passage of any of 1x107 cfu …

This chapter presents the main systems and equipment for servicing bioreactors, with the
focus on pilot and manufacturing installations. The supply of culture media and gases to …