Sterilization
Issue
Upcoming ban of ethylene oxide (EtO)
- Due to environmental and health concerns, EtO will be gradually phased out (50 % of market share)
Trend for internalizing sterilization process in order to reduce time & cost and to customize MD
Limitations of current methods
- Cold plasma: potential modification of polymer surface
- Beta/gamma: potential chemical degradation of polymer surface
Sc CO2 solution
Sc CO2 is a highly promising alternative
- potentially replacing EtO sterilization in 30% of cases
Clean, competitive process
- Relevant for all materials and customized Medical Device
- No waste, no residue, no solvent, non toxic
- Low T° (T > 31°C) with high penetrating power
- Biocidal properties highly effective sterilant, killing all forms of microorganisms, including bacterial spores
- Reduced process time (5 to 10 times)
- Reduced operation cost (from to 2 to 4 times)
- Meets requirements ISO 14 937 and FDA - 510(k) clearance
Market applications
Medical device, Tissue engineering, Pharma, Cosmetics, Food
- Medical and healthcare: Sterilizing instruments and supplies.
- Pharmaceutical: Ensuring drug safety. APIs sterilization
- Food: Extending shelf life.
- Laboratory and research: Creating sterile environments.
- Cosmetics and personal care: Ensuring product safety.
Competitive advantages
CO2 above a certain temperature and pressure (*)
offers the advantages of both a gas and a liquid:
CLEAN
- Zero waste, no residue, no solvent. Nontoxic
ADDED VALUE
- Low T° (32°C): heat-sensitive products
- (currently solvent often T° > 60°C)
- Penetrating power (density of a liquid, diffusivity of a gas)
- Highly selective product extraction
- Minimizes risk of thermal/chemical degradation
- Avoids formation of unwanted by-products
- Better control of product properties (encapsulation)
- Biocidal properties of CO2 (sterilization)
COMPETITIVE and EFFICIENT
- Reduced process time 30 min to 1 hour (5 to 10 times)
- Reduced operation cost (from to 2 to 4 times)
- Compact, modular and integrated process
(*) Tc=31°C, PC=73,8 bar
How does it work ?
Sterilization is the process of eliminating microorganisms such as bacteria, fungi, and viruses. Traditionally, this has been accomplished by subjecting the objects or substances to high temperatures for an extended duration. Alternatively, chemicals, irradiation, and high pressure have also been employed.
The utilization of CO2 offers distinct advantages over conventional methods, as it eliminates the risk of contamination or damage associated with those techniques. CO2 effectively permeates the lipid membrane of bacteria, causing it to rupture
Services
- Contract Research Service: Feasibility, optimization, scale-up
- Patent licensing and co-development
- Production
To further expand our impact, we are actively seeking partnerships for collaborative development initiatives.
Join us in exploring co-developing innovative solutions that drive progress in the industry.
Patent Licencing
Patents:
- Sterilization with pouches or blisters
- Encapsulation using nanoliposomes or LNPs (process and equipment patent)
Production
Providing a Global Alternative Solution
BiotechOne offers a global alternative solution
- Perform feasibility study on your specific Medical Device
- Define optimal operating conditions and scale-up the Sc CO2 sterilization process
- Dimension the scalable modular sterilization unit near your production sites
- Implement the sterilization unit
- Finance and manage the sterilization unit
Reduce OPEX & CAPEX
Optimizing Engineering Techniques for Cost-effective Results
Our engineering techniques prioritize minimizing pressure, process volume, flow, and time in CO2 extraction to reduce operational (OPEX) and capital expenditures (CAPEX). However, it is crucial to balance these parameters with product yield and quality. The combination of product quality, yield, and costs determines the economic viability of our sterilization process.