NovaSterilis is committed to sterilization and has developed a process that achieves a sterility assurance level of 10-6 (SAL6), or the probability of one contaminated item in one million. We are also constantly working to improve the process and test organisms that are important to our customers including bacterial spores, viruses, yeast and molds.
We currently use Bacillus atrophaeus as our biologic indicator because it has proven very resistant to our system. When we assist customers to develop a cycle time for their product, we utilize the overkill method and inoculate that product with 2 X 106 Bacillus atrophaeus to ensure that we are getting SAL6 efficacy. NovaSterilis has achieved SAL6 with the bacteria listed below, and we have found that viral pathogens are easily inactivated in SCCO2, which is not the case with gamma irradiation. If you have a specific pathogen you wish to test, please contact us to discuss.