title: A consensus rating method for small virus-retentive filters. II. Method evaluation.
abstract: 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. A test method based on bacteriophage PP7 retention was chosen based on developmental studies. The detailed final consensus filter method is published in the 2008 update of PDA Technical Report 41: Virus Filtration. Here, we evaluate the method and find it to be acceptable for testing scaled-down models of small virus-retentive filters from four manufacturers. Three consecutive lots of five filter types were tested (Pegasus SV4, Viresolve NFP, Planova 20N and 15N, Virosart CPV). Each passed the criteria specified in the test method (i.e., >4 log10 PP7 retention, >90% intravenous immunoglobulin passage, and passing integrity/installation testing) and was classified as PP7-LRV4.
authors.affiliation: Division of Monoclonal Antibodies, CDER/FDA, 10903 New Hampshire Blvd., Silver Spring, MD 20903, USA.
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
authors.forename: Scott
authors.initials: S
authors.lastname: Lute
authors.forename: Mohammed
authors.initials: M
authors.lastname: Haque
authors.forename: Jerold
authors.initials: J
authors.lastname: Martin
authors.forename: Terry
authors.initials: T
authors.lastname: Sato
authors.forename: Ichiro
authors.initials: I
authors.lastname: Moroe
authors.forename: Michael
authors.initials: M
authors.lastname: Morgan
authors.forename: Mani
authors.initials: M
authors.lastname: Krishnan
authors.forename: Jennifer
authors.initials: J
authors.lastname: Campbell
authors.forename: Paul
authors.initials: P
authors.lastname: Genest
authors.forename: Joseph
authors.initials: J
authors.lastname: Parrella
authors.forename: Sherri
authors.initials: S
authors.lastname: Dolan
authors.forename: Susan
authors.initials: S
authors.lastname: Martin
authors.forename: Klaus
authors.initials: K
authors.lastname: Tarrach
authors.forename: Richard
authors.initials: R
authors.lastname: Levy
authors.forename: Hazel
authors.initials: H
authors.lastname: Aranha
authors.forename: Mark
authors.initials: M
authors.lastname: Bailey
authors.forename: Jean
authors.initials: J
authors.lastname: Bender
authors.forename: Jeff
authors.initials: J
authors.lastname: Carter
authors.forename: Qi
authors.initials: Q
authors.lastname: Chen
authors.forename: Chris
authors.initials: C
authors.lastname: Dowd
authors.forename: Raj
authors.initials: R
authors.lastname: Jani
authors.forename: David
authors.initials: D
authors.lastname: Jen
authors.forename: Stanley
authors.initials: S
authors.lastname: Kidd
authors.forename: Ted
authors.initials: T
authors.lastname: Meltzer
authors.forename: Kathryn
authors.initials: K
authors.lastname: Remington
authors.forename: Iris
authors.initials: I
authors.lastname: Rice
authors.forename: Cynthia
authors.initials: C
authors.lastname: Romero
authors.forename: Terry
authors.initials: T
authors.lastname: Sato
authors.forename: Maik
authors.initials: M
authors.lastname: Jornitz
authors.forename: Carol Marcus
authors.initials: CM
authors.lastname: Sekura
authors.forename: Gail
authors.initials: G
authors.lastname: Sofer
authors.forename: Rachel
authors.initials: R
authors.lastname: Specht
authors.forename: Peter
authors.initials: P
authors.lastname: Wojciechowski
mesh_terms: D004867:Equipment Design; D017408:Guidelines as Topic; D016756:Immunoglobulins, Intravenous / Q000032:analysis; D017909:Levivirus / Q000302:isolation & purification*; D008422:Materials Testing; D008567:Membranes, Artificial; D008851:Micropore Filters / Q000592:standards; D015397:Program Evaluation; D015203:Reproducibility of Results; D013242:Sterilization / Q000295:instrumentation* / Q000592:standards
chemical_list: D016756:Immunoglobulins, Intravenous; D008567:Membranes, Artificial