title: Validation of sterilizing grade filtration.
abstract: Validation consideration of sterilizing grade filters, namely 0.2 micron, changed when FDA voiced concerns about the validity of Bacterial Challenge tests performed in the past. Such validation exercises are nowadays considered to be filter qualification. Filter validation requires more thorough analysis, especially Bacterial Challenge testing with the actual drug product under process conditions. To do so, viability testing is a necessity to determine the Bacterial Challenge test methodology. Additionally to these two compulsory tests, other evaluations like extractable, adsorption and chemical compatibility tests should be considered. PDA Technical Report # 26, Sterilizing Filtration of Liquids, describes all parameters and aspects required for the comprehensive validation of filters. The report is a most helpful tool for validation of liquid filters used in the biopharmaceutical industry. It sets the cornerstones of validation requirements and other filtration considerations.
authors: Sartorius Corp., Edgewood, NY 11717, USA. maik.jornitz@sartorius.com
authors: M W
authors: MW
authors: Jornitz
authors: T H
authors: TH
authors: Meltzer
mesh_terms: D004345:Drug Industry / Q000379:methods / Q000592:standards*; D004731:Endotoxins; D005374:Filtration / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D033161:Government Regulation; D006801:Humans; D015203:Reproducibility of Results; D013242:Sterilization / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004731:Endotoxins