Une filtration est dite stérilisante si elle satisfait au challenge bactérien. Pour plus de détails, se référer à :
-ASTM F838-05 supersedes HIMA Document No.3 Vol.4, April 1982, « Microbial Evaluation of Filters for Sterilising Liquids »)
-FDA Guidance for Industry: Sterile Drug Products, Produced by Aseptic Processing - Current Good Manufacturing Practice, September 2004
-US Parenteral Drug Association (PDA), Technical Report 40, Sterilizing Filtration of Gases, 2005.
-US Parenteral Drug Association (PDA), Technical Report 26, Sterilizing Filtration of Liquids, 2008.
-The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1 - Manufacture of Sterile Medicinal Products, 2008