Sterilization, according to the definition of ISO 17665, is a validated process to eliminate viable microorganisms on a product. To meet the requirements for sterility with a sterility assurance level (SAL) of < 10-6 several measures and steps have to be taken depending on the specific sterilization process.
Biological indicators are test systems containing viable microorganisms exhibiting a defined resistance to specific methods of sterilization. Biological indicators depict the direct and immediate result of the sterilization process and not just a reference parameter.
Therefore, in the evaluation of the germ-killing efficacy of sterilization processes, biological testing is superior to physical measurement.
Biological indicators are being used in the realm of validation and routine monitoring of all general sterilization methods.
Spore suspensions with Geobac. stearothermophilus are used to inoculate products for the biological performance evaluation of sterilization processes, i.e. steam sterilization 121 °C / 134 °C or low temperature gas -sterilization with steam-formaldehyde gas, hydrogen peroxide (H2O2) or peracetic acid.
To carry out the tests regarding validation and routine monitoring with SIMICON biological indicators or SIMICON test systems, a variety of manufacturer-specific adapters, process challenge devices and auxiliaries are available.