Challenges
- EO is under regulatory pressure from FDA and EPA
- Recent litigation has increased risk profile of EO sterilization
- Slow turnaround times
- Expensive emissions scrubbing costs
- EO processing costs are increasing dramatically due to regulation:
- Emission standards require costly facility upgrades
- Closure of contractor EO processing facilities
Solutions
- Shorter turnaround times – (measured in hours not days)
- Environmentally friendly solution – recipient of EPA Green Chemistry Award
- FDA Challenge Grant I recipient
- Cost effective – operating costs less expensive than ethylene oxide sterilization
- Broadly compatible with biomaterials
Success Stories
FDA Story
- Agency looking to broaden commercial use of EO alternative sterilization modalities
- Selected as one of 4 Innovation Challenge Grant recipients
- Bimonthly meetings with the FDA to streamline the adoption rate of scCO2
NovaSterilis Provides
- Multiple regulatory clearances received
