Biological Indicators for Sterilization

USP (United States Pharmacopoeia), EP (European Pharmacopoeia) and DAB (Deutsches Arzneibuch) standards recommend to use bioindicators during steam sterilization processes of pharmaceuticals, drugs in vials, culture media, medical instruments and more. Biological indicators are used for regular control of steam sterilization cycles (for ie. 15 minutes at 121 °C) and control of any steam autoclave functionality. Usually depending on the autoclave capacity are recommended to use 2, 3 ou more indicators, in the autoclave, just to have general control of all sterilization space. For this measurement are used different kind of indicators, such as, ampoules, self-contained tubes, strips and others, and different kind of sterilization can be regulated: steam sterilization, Dry heat, Ethylene oxide, irradiation and hydrogen peroxide sterilization. Mostly this bioindicators, are heat resistant microorganisms which in case of steam sterilization died after sterilization cycles of 121 ºC during 15 min.