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PDA TR 41

M00001938

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PDA TR 41 Technical Report No. 41, Revised 2008 (TR 41) Virus Filtration

Report / Survey by Parenteral Drug Association, 11/01/2008

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This technical report addresses virus removal filters that retain viruses by a size exclusion mechanism. It explains how they work, recommends how to elect the best filter for various applications, physical and biological characterization and test methods, and validation. The 2008 revision expands the original report to cover best practices for filter qualification and validation of filters designed to remove viruses 20 nm in diameter and larger.