RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 318
OP 333
VO 62
IS 5
A1 Lute, Scott
A1 Riordan, William
A1 Pease, Leonard F.
A1 Tsai, De-Hao
A1 Levy, Richard
A1 Haque, Mohammed
A1 Martin, Jerold
A1 Moroe, Ichiro
A1 Sato, Terry
A1 Morgan, Michael
A1 Krishnan, Mani
A1 Campbell, Jennifer
A1 Genest, Paul
A1 Dolan, Sherri
A1 Tarrach, Klaus
A1 Meyer, Anika
A1 ,
A1 Zachariah, Michael R.
A1 Tarlov, Michael J.
A1 Etzel, Mark
A1 Brorson, Kurt
YR 2008
UL http://journal.pda.org/content/62/5/318.abstract
AB 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.