SUPERCRITICAL CO2 OFFERINGS
Services
scCO2 Exposure Testing
NovaSterilis’ contract research services start with simple feasibility studies and small-scale material exposure testing. We offer scCO2 exposure testing at a minimal cost. Exposure testing provides a basis to determine the risk associated with costs of a large project.
Concept Viability Testing
Applied research is necessary for the discovery, development, and commercialization of a scCO2 process. NovaSterilis is the leader in the processing and sterilization of biological materials using scCO2 and is your partner in making this first step a success. Our team of scientists and engineers help you identify the key scCO2 operating parameters for your application. This work consists of five to ten experiments over the course of a couple of days.
Sterilization Process Development
If terminal sterilization of your product is the desired use, SPD goes beyond the initial feasibility study; temperature, pressure, agitation and additive parameters are optimized for a given product in a specific configuration. As part of the SPD, regulatory agency requirements are considered. When development is completed, larger amounts of materials can be produced for comprehensive analysis, clinical trials, or marketing purposes.
Cleaning Process Development
If cleaning of biomaterials is the desired use, CPD goes beyond the initial feasibility study; temperature, pressure, agitation, and additive parameters are optimized for either packaged or bulk conditions. As part of the CPD, batch as well as continuous flow processing techniques are considered for ultimate commercial use. When a beta process is realized, scale up testing can be conducted on site with larger amounts of materials for further physical, chemical and biological analysis.
Biomaterial Structural Modification Development
If unique material functionality is the desired outcome, SMD goes beyond the initial feasibility; temperature, pressure, agitation, exposure times and additive parameters are explored form material response and change. As part of the SPD, regulatory requirements are considered. When this development work is completed, larger amounts of materials can be produced for comprehensive analysis, clinical trials, or marketing purposes.
Material Compatibility Testing
Medical devices are comprised of many materials with unique design elements. Initial scCO2 compatibility is determined as discreet elements and then as a unit to determine critical process considerations. NovaSterilis’ team can then optimize a process taking into account thermodynamic, fluid dynamic and chemical conditions to insure a repeatable process can be brought forward for scale up and production purposes. NovaSterilis team and laboratory is equipped to perform the process development as well as the process and material analysis along the development continuum.
Our Mission – Provide supercritical CO2 knowledge, services and tools to all companies focused on a healthier world.
Equipment for today’s needs and R&D services for tomorrow’s opportunities