Supercritical CO2 Sterilization Development Company
Why Choose NovaSterilis for Your Sterilization Needs?
Achieve Sterility Assurance Level 10-6
Challenges
- Aseptic manufacturing is costly
- The penetration capabilities of gas modalities can result in inconsistent sterilization
- Most companies only have experience with the Overkill validation method
scCO2 is the deepest penetrating, low temperature sterilization modality and meets performance and residual requirements for FDA clearance.
Sustainable Alternative to EO Sterilization
Challenges
- EO sterilization is under regulatory pressure from the FDA and EPA
- Recent litigation has increased risk profile of EO sterilization
- Facility closures and increased processing costs could result in slower turnaround times
scCO2 sterilization offers an eco-friendly, cost-effective, risk mitigated solution.
Broader Compatibility Including Biologics
Challenges
- Novel biomaterials require gentle sterilization
- Traditional sterilization modalities have limitations with sterilizing liquid formulations
- Inactivation, Degradation, and Breakdown of materials with traditional sterilization methods
Broader compatibility and in-house processing options help R&D teams shorten turnaround times while preserving mechanical properties.
NovaSterilis offers in-house equipment and contract research services to help R&D teams benefit from the capabilities of scCO2 sterilization. Explore our suite of testing services designed to determine Supercritical CO2 compatibility with your device or material.