With conventional sterilization indicators it takes minimum 24 hours for outcome of the results to know if a sterilization process is successful or not. Now with recombinant DNA technology a steam sterilization process can judged if it is successful or not in just two hours, with the use of novel biological indicator which can give result in just two hours, making the process very speedy in medical field where surgical instruments are required to be sterilized and used again in hospitals. It can also be used for sterile pharmaceuticals manufacturing.
US FDA have approved a new sterilization indicator Verify Cronos Self Contained Biological Indicator (SCBI) (manufacturer Steris Corporation of Mentor, Ohio.), which make use of novel recombinant DNA technology. It consist of a genetically-engineered strain of gram-positive bacterium Geobacillus stearothermophilus, as biological indicator microorganism which is capable of surviving even in higher temparature. Hence if a steam sterilization process can destroy Geobacillus stearothermophilus organism the it can successfully destroy other microorganism as well, which means the sterilization process is effective.
The indicator The Verify Cronos Self Contained Biological Indicator (SCBI) is required to be placed along with instruments to be sterilized at appropriate level and position in an autoclave, and after completion of sterilization process , bacteria inoculated in the enrichment media. The strain contained in Verify Cronos Self Contained Biological Indicator (SCBI) is capable of producing an enzyme which fluoresce, which makes detection of microbial growth faster. If there is fluoresce then the sterilization process is successful and vice versa.
US FDA approved Cronos Self Contained Biological Indicator (SCBI) by “de novo classification” premarket review pathway, which facilitates speedy approval for novel drugs and devices which make use of novel technology and are in the favor of recipients or end users or patients awaiting treatments.