NovaStudies
NovaSterilis is actively engaged in acquiring a deeper understanding of terminal sterilization utilizing supercritical CO2 (SCCO2) as a safe, environmentally friendly means of achieving a SAL6. It is our passion, as shown through our commitment and drive of continued investigation that enables us to find new uses for this emerging technology. We have collected statistically meaningful data using our patented NovaSterilis technology. The successful results as indicated by such data, allow us to continually expand the basis of products that can be sterilized. Below, is a short list of the studies we have conducted. The data we have collected indicates the success of the system and the future applications it possesses. Below are some of the reports we have had published:
Science Direct 15 December, 2005 Effective terminal sterilization using supercritical carbon dioxide
We are actively pursuing publications with this data.
• NS-100-01-00 Bioindicator Selection - Study of microorganisms and selection of specific Bioindicator that is most challenging to obtain total kill.
• NS-200-01-00 Biomechanical testing Tendon (Bone-Tendon-Bone) - Hemi bone - tendon - bone grafts procured from Community Tissue Services (Dayton Ohio). BTB's were put into one of 3 groups; NovaSterilis sterilized product, Gamma irradiated (15-25kGy), or control. These data demonstrate supercritical CO2 sterilization achieves a sterilization level of SAL6 while preserving the biomechanical properties of tendon.
• NS-200-02-00 Nova2200 Sterilization - Tendon Demonstrates terminal sterilization (SAL6) of tendon when subjected to Nova2200™ sterilization protocol.
• NS-300-04-00 Penetration of Nova2200™ sterilization in Femoral Heads
• NS-300-01-00 Bone strength following Nova2200 terminal sterilization. 3 sets of cortical bone struts (untreated control, Nova2200™ sterilized, gamma irradiate) were tested via ash testing, density and strength. Each bone group was procured from a single donor and same femoral location and with the same orientation harvested from consenting donors.
• NS-300-03-00 Sterilization of Demineralized Bone Matrix (DBM)
• NS-300-05-00 Lumens/Endoscopes - Proof of concept to demonstrate ability to sterilize rigid and semi-rigid lumens that are representative of endoscopes. Rigid lumens were stainless steel, 18 inches in length by 0.5,1.0, and 2.0mm. Flexible and semi flexible lumens consisted of conduit extracted from surrounding wires. Lumens were inoculated with Bacillus stearothermophilis endospore steel wires, rope or Bacillus atrophaeus lipid spores (NovaSpores) packages in single Tyvek and subjected to Nova2200™ sterilization.
• NS-400-03-00 Preliminary Viral Inactivation - Analysis of ability of supercritical CO2 process to inactivate viral contaminates.
• NS-000-03-00 Water Residual Testing
