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 Scott Lute
A1 William Riordan
A1 Leonard F. Pease III
A1 De-Hao Tsai
A1 Richard Levy
A1 Mohammed Haque
A1 Jerold Martin
A1 Ichiro Moroe
A1 Terry Sato
A1 Michael Morgan
A1 Mani Krishnan
A1 Jennifer Campbell
A1 Paul Genest
A1 Sherri Dolan
A1 Klaus Tarrach
A1 Anika Meyer
A1 The PDA Virus Filter Task Force
A1 Michael R. Zachariah
A1 Michael J. Tarlov
A1 Mark Etzel
A1 Kurt Brorson
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.