As per 21 CFR 880.2800(b) Sterilization indicators are defined as a device which are to monitor efficacy of sterilization process by monitoring the temperature, and other sterilizing conditions. A chemical indicator is required to be used along with a biological sterilization indicator.
There are many line in chemical sterilization indicators available which and be used and a it can be attached with process document as proof of process completeness. A sterilization indicators consists chemicals which melts down at set higher temperature, or vials of bacterial spores which are destroyed at higher temperature are kept along with articles being sterilized. These spores up on inoculation in to microbial enrichment media must not give microbial growth.
Biological Sterilization Indicators for different sterilization process.
Dry heat sterilization: Spores of Bacillus subtilis
Moist heat sterilization : Spores of Bacillus stearothermophilus , Clostridium sporogenes , Bacillus subtilis, bacillus coagulans are used.
Vapour Phase hydrogen peroxide : Spores of Bacillus stearothermophilus ,Clostridium sporogenes and Bacillus subtilis.
Ionising Radiation: Spores of Bacillus pumilus
Ethylene oxide : Spores of Bacillus subtilis var. Niger
There spores are placed over suitable carrier made of glass and gas impervious system, made of suitable material and placed along with articles being sterilized.