Challenges facing the Market
- Aseptic manufacturing is costly
- Material not compatible with traditional sterilization modalities
- EO supply chain is increasingly uncertain
scCO2 Solution
- Deepest penetrating sterilization modality
- Double layered final packaging
- Meets performance and residual requirements for FDA clearance
- Entire cycle times measured in hours
Success Stories
- Biomaterials company had product that was not compatible with traditional sterilization methods
- NovaSterilis (NS) provided a turnkey solution moving them from proof-of-concept through development, sterilization validation, and regulatory review
- Within 18 months of engagement with NS, the 510k clearance was received
NovaSterilis Provides
- Contract sterilization development services
- Equipment and software necessary to achieve FDA clearance
- Over 500,000 surgeries have been completed using biomaterials processed with NovaSterilis’ scCO2 process
