2011 Buyers' Guide 2011 Buyers' Guide - International Fiber Journal

Filter | SterilizationPoints for Validating Filter SterilizationBy Tonya Morris, Pharmaceutical Section Leader, Nelson Laboratories, Inc.that are generally used are steam,heat, ethylene oxide, and radiationsterilization. However, there are fewsterilization options for sterilizingpharmaceutical or biological products,which may be labile when exposedto heat, chemical treatment orradiation. One of the most commonoptions for sterilizing labile productsis filtration sterilization. Sterilizingsensitive pharmaceutical and biologicalproducts by filtration is becominga preferred method and the needs ofthe industry are increasing in parallelto the growth of the pharmaceuticalindustry. In September 2004, the U.S.Food and Drug Administration publisheda guideline recommending thatwhenever filtration is used in the productionprocess, validation procedureswill include microbial retentiontesting of the filters. These tests needto be conducted using simulatedpharmaceutical processing procedureswhich define “worst case” productionconditions. Parameters to be consideredinclude, but are not limited to:organism size, number of organisms,flow rate, temperature, pH, viscosity,and pressure.Sterilizing sensitive pharmaceutical andbiological products by filtration is becoming apreferred method and the needs of the industryare increasing in parallel to the growth of thepharmaceutical industry.The production of sterilepharmaceutical products andmedical devices usually encompassan approved, validated, andappropriate sterilization method. Themost common sterilization methods14 • August 2010 • www.filtnews.comThe FDA defines validation as:“Establishing documented evidencewhich provides a high degree of assurancethat a specific process will consistentlyproduce a product meeting itspre-determined specifications and qualityattributes.”Furthermore, both the FDA and theParenteral Drug Association (PDA)have concluded that when it comes tovalidation, it is the user’s responsibilityto demonstrate the complete microbialremoval from each product or productfamily using a representative challenge.In an attempt to help the user, points toconsider when developing a validationplan for filter sterilization by means offiltration are evaluated and summarizedin this article.SELECTING A STERILIZING GRADE FILTERThe accepted industry standard for