Membrane filtration for virus removal.
Incorporation of adequate clearance methodologies for viral safety assurance constitutes an integral part of the manufacturing process for plasma-derived biologicals. Filtration, being non-invasive, non-destructive and a <<robust>> mechanism for virus removal is often the method of choice. This paper discusses the virus filter performance characteristics and other process-related issues specifically applying to the Pall Ultipor VF filters (Grade DV50 and Grade DV20), which are operated in the direct flow filtration (DFF) mode and the Pall Filtron Omega VR filters (the Omega 300 K and Omega 100 K), which are operated in the tangential flow filtration (TFF) mode.
Brandwein
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Pall Corporation, Port Washington, NY 11550, USA.
Aranha-Creado
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D000818:Animals; D001688:Biological Products / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D006801:Humans; D008567:Membranes, Artificial; D008851:Micropore Filters / Q000706:statistics & numerical data*; D011145:Polyvinyls; D014780:Viruses; D005465:Fluorocarbon Polymers
D001688:Biological Products; D008567:Membranes, Artificial; D011145:Polyvinyls; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers