Sterilization in the life sciences and healthcare sectors is under growing scrutiny as regulators tighten safety and environmental standards worldwide. Traditional ethylene oxide (EtO) methods face increasing restrictions due to toxicity, long cycle times, and environmental impact.
Supercritical CO₂ (scCO₂) technology offers a research-driven alternative that delivers faster turnaround, eliminates toxic residues, and preserves material integrity, all while reducing environmental burden. The NovaGenesis system is designed specifically for academic and corporate R&D, and enabling early compatibility and optimization studies.
While scCO₂ remains a novel sterilization method, some customers have achieved product-specific FDA and TGA clearances for devices sterilized with this approach. Larger systems in the Nova series (such as the Nova2210 and Nova8810) are being developed to support validation studies and manufacturing use.
This article explores the safety benefits, sustainability advantages, and regulatory potential of scCO₂ , and how NovaGenesis helps organizations prepare for the future of sterilization.
The New Standard for Sustainable Sterilization
For decades, ethylene oxide (EtO) has been the workhorse of low-temperature sterilization, widely used for heat- and moisture-sensitive materials. However, its dominance is increasingly challenged. Mounting scientific evidence links EtO exposure to carcinogenic, mutagenic, and neurotoxic effects (EPA, 2023), prompting tighter regulations in the EU, UK, and North America. In the United States, the EPA is now mandating stricter emissions controls, while European regulators have capped workplace exposure limits.
Beyond health concerns, EtO presents operational and environmental drawbacks:
· Extended cycle times - sterilization can take over 12 hours due to required aeration to remove toxic residues.
· Hazardous waste handling - used EtO must be carefully neutralized and disposed of under strict environmental protocols.
· Energy and compliance costs - maintaining dedicated aeration rooms and monitoring emissions increases operational overhead.
In our article on Green Initiatives, we explored how sustainability practices are transforming sterilization processes in modern labs. Supercritical Carbon Dioxide (scCO₂) sterilization addresses these issues at their root. In a supercritical state, above 31°C and 7.4 MPa, CO₂ behaves as both a gas and a liquid, enabling deep penetration into porous materials and dissolution of microbial membranes. This dual-phase behaviour allows scCO₂ to inactivate bacteria, viruses, fungi, and spores without having to apply high heat or toxic chemicals (NovaSterilis Technical Overview).
Key advantages of scCO2 over EtO:
· No toxic residues - sterilized materials are ready for use after short aeration periods.
- Research-ready platform – NovaGenesis , supports compatibility and optimization studies for academic and corporate R&D.
· Pathway to validation – larger systems (Nova2210, Nova8810) are designed for sterilization validation studies, and some customers have achieved FDA or TGA clearance for products sterilized with scCO₂.
In short, scCO₂ sterilization is not simply an alternative; it’s an upgrade, merging environmental responsibility with scientific rigour and offering research teams a way to prepare for future regulatory and market demands.
Why Supercritical CO₂ is Safer than Ethylene Oxide
Safe for People
Non-toxic and non-flammable — Supercritical CO₂ eliminates the cancer, reproductive, and respiratory health risks associated with EtO exposure, which the U.S. EPA and the European Chemicals Agency (ECHA) classify as a known human carcinogen. Unlike EtO, scCO₂ requires no explosion-proof facilities or specialized ventilation, reducing your capital and maintenance costs for safety infrastructure.
Minimal post-process aeration — scCO₂ sterilization is a batch process. All CO₂ remains contained during the cycle, avoiding leaks, carcinogenic emissions, or operator exposure. In contrast, EtO systems require extended aeration to off-gas toxic residues, with operators relying on continuous monitoring to prevent unsafe workplace concentrations. We have detailed how scCO₂ protects both people and the planet in our Green Initiatives feature.
Safe for the Environment
CO₂ usage — The process uses commercially sourced CO₂, often captured from existing industrial emissions. Supercritical CO2 is a carbon-neutral technique that utilizes liquid CO2 that is generated as a waste product from other industries
No hazardous waste streams — EtO sterilization produces toxic by-products, such as ethylene chlorohydrin and ethylene glycol, which require hazardous waste handling and disposal in compliance with strict environmental regulations. Supercritical CO₂ produces no such contaminants, reducing both environmental liability and your waste management costs.
Safe for Operations
Shorter turnaround times — EtO sterilization cycles can last more than 12 hours, with aeration alone often taking 10–12 hours to ensure no residual gas remains. This delay can cause production bottlenecks, extend lead times, and disrupt time-sensitive workflows.
Quick cycle times – scCO2 cycles are generally on the scale of 1-5 hours which improves processing times. Furthermore, scCO2 equipment can easily be installed in existing manufacturing settings, allowing for a semi-continuous assembly flow.
Reduced compliance burden — In the absence of toxic emissions, hazardous waste, or prolonged off-gassing, scCO₂ processes simplify environmental reporting, occupational health considerations, and facility risk assessments in R&D environments.
Faster, Safer, and Ready for Use
While EtO remains effective for sterilization, its lengthy cycle times and hazardous nature make it increasingly difficult to justify in a modern, sustainability-conscious environment. Supercritical CO₂ offers research teams a significantly faster, safer, and cleaner process to explore, providing a crucial advantage in settings where every hour of delay can impact research outcomes, development timelines, or patient care.
Global Regulatory Pathways and Standards
The credibility and adoption of any sterilization technology depends on meeting stringent regulatory and quality benchmarks. While supercritical CO₂ (scCO₂) remains a novel sterilization method, it is gaining momentum as research and regulatory discussions advance.
The NovaGenesis System itself is intended for academic and corporate R&D use, ensuring baseline safety compliance for research environments. It is not validated for ISO-compliant sterilization studies or manufacturing.
However, the broader scCO₂ platform is progressing:
· Product-specific clearances — some customers have received FDA or TGA clearance for devices sterilized with scCO₂, demonstrating regulatory acceptance on a case-by-case basis.
· Pathway to validation — larger systems in the Nova series (such as Nova2210 and Nova8810) are designed to support sterilization validation studies and industrial applications.
· Foundation for the future — early adoption of scCO₂ in R&D helps organizations generate data, build expertise, and prepare for smoother regulatory transitions as standards evolve.
In this way, NovaGenesis provides a research-ready starting point, while laying the groundwork for future compliance with validated sterilization platforms.
FDA Clearances (United States)
Supercritical CO₂ remains a novel sterilization method in the United States, but regulatory pathways are advancing. While the NovaGenesis system itself is intended for R&D use only and is not FDA-cleared for sterilization validation, some customers have successfully achieved product-specific FDA clearance for devices sterilized with scCO₂.
These individual clearances demonstrate that the FDA is open to reviewing and approving scCO₂ sterilization on a case-by-case basis when supported by strong validation data. For research teams, NovaGenesis provides a platform to explore compatibility and process development, helping to lay the groundwork for future regulatory submissions.
TGA Approvals (Australia)
In Australia, the Australia’s Therapeutic Goods Administration (TGA) has reviewed and granted product-specific clearances for certain medical devices sterilized using scCO₂. This demonstrates that the method can be accepted under the country’s Medical Device Regulations 2002 when supported by appropriate validation data.
The NovaGenesis system itself is designed for academic and corporate R&D and does not hold TGA approval for sterilization validation. However, it provides research teams with a platform to conduct early compatibility and optimisation studies, building the evidence base that can later support regulatory submissions for larger validated systems.
CE Registrations (European Union)
The NovaGenesis ensures baseline safety compliance for use in research and development environments. This mark applies to the system hardware itself but does not represent clearance for sterilization validation under the EU Medical Device Regulation (MDR).
For organizations in Europe, this means NovaGenesis can be used with confidence as a research platform to explore supercritical CO₂ sterilization methods. However, for validated sterilization studies and medical device applications, larger systems such as the Nova2210 or Nova8810 are required.
ISO 14937 (General Sterilization Validation)
ISO 14937 defines the requirements for characterizing a sterilizing agent and establishing validated sterilization processes. At present, NovaGenesis is not validated against ISO 14937. The system is designed for academic and corporate R&D, providing a controlled platform for early compatibility and optimisation studies.
For full sterilization validation, larger systems in the Nova series (such as the Nova2210 or Nova8810) are required. These platforms are being developed to support ISO-compliant sterilization validation and manufacturing use.
NovaGenesis helps bridge the gap by enabling researchers to generate reproducible data and explore scCO₂ processes in preparation for future validation pathways.
ISO 11138 (Biological Indicators)
ISO 11138 sets requirements for the development and use of biological indicators to confirm sterilization effectiveness. The NovaGenesis system is not validated against ISO 11138 and is intended for academic and corporate R&D use only.
While it does not provide ISO-compliant sterilization validation, NovaGenesis allows research teams to conduct early-stage studies on material compatibility and process optimisation. This research can generate valuable data to inform future validation work carried out on larger systems such as the Nova2210 or Nova8810, which are designed to support ISO-compliant sterilization studies.
By starting with NovaGenesis in the R&D phase, teams can build a stronger foundation for eventual compliance efforts when transitioning to validated sterilization platforms.
Why This Matters for Adoption:
· Builds readiness for future validation — Research with NovaGenesis helps teams generate reproducible data and develop familiarity with scCO₂ processes, laying the foundation for eventual regulatory submissions.
· Supports audit preparation in R&D — While not ISO-compliant, NovaGenesis produces standardized, exportable documentation that supports internal quality tracking and research records.
· Strengthens stakeholder confidence in innovation — Early exploration of sustainable sterilization methods demonstrates proactive leadership to partners, collaborators, and funding bodies.
In short, the NovaGenesis system does not replace validated sterilization platforms but instead provides a research-ready entry point. By enabling early exploration of scCO₂, it positions organizations to move more smoothly into validated systems (such as Nova2210 or Nova8810) as regulatory frameworks evolve.
Operational Advantages of Building Toward Compliance
Meeting, and ultimately exceeding, international sterilization standards is more than a legal obligation, it is a strategic advantage that shapes market access, operational efficiency, and reputation.
The NovaGenesis system is not ISO-validated or approved by FDA or TGA. Instead, it serves as an R&D platform where teams can:
· Generate data that informs future sterilization validation studies.
· Produce standardized documentation to support internal audits and research transparency.
· Explore sustainable sterilization methods in preparation for evolving regulatory requirements.
By starting with NovaGenesis, organizations can build familiarity with supercritical CO₂ technology today, positioning themselves for a smoother transition to larger validated systems (such as Nova2210 and Nova8810) when moving into manufacturing or clinical environments.
1. Building the Foundation for Market Entry
While NovaGenesis itself is not a validated sterilization system, it enables research teams to explore scCO₂ processes and generate reproducible data that can later support regulatory submissions. This early-stage work helps de-risk product development and smooths the pathway toward global market access once larger validated systems are in use.
2. Strengthening Stakeholder Confidence
Even in R&D, demonstrating proactive exploration of sustainable sterilization builds trust with supply chain partners, collaborators, and funding bodies. NovaGenesis provides standardized documentation and transparent records, showing stakeholders that your team is preparing responsibly for the next stage of validation.
3. Supporting Competitive Positioning
In healthcare and government tenders, sustainability and innovation are increasingly important. While NovaGenesis is not ISO-certified, showcasing R&D activity with scCO₂ highlights your commitment to safer, greener technologies, a message that resonates with partners and procurement teams looking to reduce long-term risk.
4. Accessing Sustainability-Linked Opportunities
Because scCO₂ processes eliminate toxic residues, even R&D adoption can support ESG-linked funding applications and research grants. By documenting measurable improvements in safety and sustainability, your organization gains an edge in funding and partnership opportunities where environmental metrics carry weight.
5. Reducing Long-Term Risk
Relying on EtO leaves organizations exposed to regulatory crackdowns, infrastructure retrofit costs, and reputational damage. NovaGenesis helps reduce this risk by giving teams an R&D platform to explore validated alternatives early. This preparation builds resilience against sudden compliance shifts and supports operational stability in the long run.
In short: While NovaGenesis is not a compliance-certified sterilization system, it is a strategic investment in preparation, helping organizations build data, reduce uncertainty, and position themselves for smoother transitions to validated platforms as regulatory standards evolve.
HHC’s Role in Advancing Safe, Sustainable Sterilization
At Helvetica Health Care (HHC), we understand that adopting a new sterilization technology is more than a purchase decision, it’s a strategic step that impacts safety, sustainability, and long-term operational planning. Our role is to make that transition seamless, measurable, and aligned with the evolving needs of research teams and industry innovators.
1. Providing Access to NovaGenesis scCO₂ Systems for Research
We supply the NovaGenesis supercritical CO₂ system, which is designed specifically for academic and corporate R&D use. While not validated under FDA, TGA, or ISO sterilization standards, NovaGenesis enables research teams to conduct compatibility and optimisation studies that inform future validation efforts on larger systems such as the Nova2210 or Nova8810.
2. Supporting Integration from Day One
Successful adoption of scCO₂ technology depends on more than equipment delivery. HHC provides:
· On-site and virtual training to help operational teams use NovaGenesis effectively in R&D.
· Guidance on developing research protocols tailored to specific materials and applications.
· Documentation tools to support reproducibility, audit preparation, and research transparency.
3. Ensuring Ongoing Technical and Research Support
Our technical team works proactively to:
· Monitor performance and recommend process improvements.
· Provide rapid-response troubleshooting to minimize disruption.
· Share updates on best practices and emerging regulatory developments around scCO₂.
4. Backed by ISO 13485 Quality Management Certification
Every solution we deliver is backed by our SO 13485 certified quality management system, ensuring consistent quality, traceability, and reliability across each order, installation, and service interaction. This reflects our commitment to supporting safe, high-quality research in the life sciences and healthcare sectors.
In essence, HHC’s role goes beyond supplying equipment. We act as a research partner, helping organizations explore scCO₂ technology today while preparing them for the validated sterilization platforms of tomorrow.
Safety and Innovation Without Compromise
In a world where regulatory demands are becoming more stringent and sustainability targets are non-negotiable, sterilization methods must go beyond meeting minimum requirements. They need to actively advance safety, sustainability, and research readiness.
Supercritical CO₂ technology delivers on these fronts. By eliminating toxic residues, preserving the integrity of even the most sensitive biomaterials, and supporting environmentally responsible processes, it helps organizations prepare for the regulatory and market expectations of tomorrow.
The transition away from ethylene oxide is not only a technological shift, it is a strategic decision that protects people, safeguards the planet, and strengthens organizational reputation. With shorter cycle times, and compatibility with delicate research materials, NovaGenesis provides a research-ready platform to begin this transition today, while larger validated systems pave the way for future compliance.
Our Next Step to Safer, Sustainable Sterilization Research
Don’t wait for the next regulatory change or compliance audit to force action. Move ahead of the curve by exploring sterilization technologies that are sustainable, research-driven, and aligned with the future direction of global standards.
With NovaGenesis, you can safeguard people and the environment while conducting meaningful R&D that informs tomorrow’s compliance strategies. Our experts guide you at every stage of the process, helping you generate reproducible data, reduce uncertainty, and build confidence in your next steps.
Partner with Helvetica Health Care to:
· Access NovaGenesis scCO₂ systems designed specifically for academic and corporate R&D.
· Integrate scCO₂ technology into your workflows with minimal disruption.
· Reduce environmental impact while preparing for future validation with larger systems.
Choose innovation today and prepare your organization for a more sustainable tomorrow. Your facility deserves technology that supports discovery and lays the foundation for validated solutions ahead.
Contact our specialists today to book a no-obligation consultation and learn how NovaGenesis can support your sterilization research.