TY - JOUR T1 - A Consensus Rating Method for Small Virus-Retentive Filters. I. Method Development JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 318 LP - 333 VL - 62 IS - 5 AU - Scott Lute AU - William Riordan AU - Leonard F. Pease III AU - De-Hao Tsai AU - Richard Levy AU - Mohammed Haque AU - Jerold Martin AU - Ichiro Moroe AU - Terry Sato AU - Michael Morgan AU - Mani Krishnan AU - Jennifer Campbell AU - Paul Genest AU - Sherri Dolan AU - Klaus Tarrach AU - Anika Meyer AU - The PDA Virus Filter Task Force AU - Michael R. Zachariah AU - Michael J. Tarlov AU - Mark Etzel AU - Kurt Brorson Y1 - 2008/09/01 UR - http://journal.pda.org/content/62/5/318.abstract N2 - Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.g., parvoviruses) from products by a size exclusion mechanism. In 2002, the Parenteral Drug Association (PDA) organized the PDA Virus Filter Task Force to develop a common nomenclature and a standardized test method for classifying and identifying viral-retentive filters. One goal of the task force was to develop a test method for small virus-retentive filters. Because small virus-retentive filters present unique technical challenges, the test method development process was guided by laboratory studies to determine critical variables such as choice of bacteriophage challenge, choice of model protein, filtration operating parameters, target log10 reduction value, and filtration endpoint definition. Based on filtration, DLS, electrospray differential mobility analysis, and polymerase chain reaction studies, a final rating based on retention of bacteriophage PP7 was chosen by the PDA Virus Filter Task Force. The detailed final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration. ER -