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 …

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 …

cleaning
treament

Cleaning Process Development

If cleaning of biomaterials is the desired use, CPD goes beyond the initial feasibility study; temperature, pressure, agitation, detergent 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 …

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. …