NovaSterilis

Supercritical CO2 Solutions For Today and Tomorrow

Supercritical CO2 Offerings

Equipment

Nova8800XL

The Nova8800XL is a 100 liter vessel designed for greater volumes and longer products. This platform operates from sub-critical pressures and temperatures to supercritical conditions to meet commercial production requirements. The Nova8800XL is powered by NovaSterilis' proprietary operating software, which provides absolute control over critical operating parameters required for each product being sterilized or manufactured.

Nova8800

The Nova8800 is an 80 liter vessel designed for increased throughput. This platform operates from sub-critical pressures and temperatures to supercritical conditions to meet commercial production requirements. The Nova8800 is powered by NovaSterilis' proprietary operating software, which provides absolute control over critical operating parameters required for each product being sterilized or manufactured.

Nova2200

The Nova2200 is NovaSterilis' workhorse! It is a 20-liter vessel designed to meet both development and production needs for small to mid-sized production throughput. This platform operates from sub-critical pressures and temperatures to supercritical conditions to meet commercial production requirements. The Nova2200 is powered by NovaSterilis' proprietary operating software, which provides absolute control over critical operating parameters required for both process development and manufacturing a diversity of products.

R&D Systems

NovaGenesis

NovaGenesis brings the technology of super critical CO2 processing into laboratories at a bench top scale that is practical and affordable. Released in 2019, the NovaGenesis leverages the experience and success of the Nova2200 and Nova8800. The NovaGenesis can be configured with vessel sizes, pressure ratings and controls that align with a lab’s requirements and budget. At approximately 60 lbs., and in a form factor of 24”x 20” x 12”, the NovaGenesis will become an essential piece of equipment for innovation in biomaterials laboratories. NovaGenesis Basic Applications Features

Sterilize Pressure: 2,000 psi
Clean Temperature: 50degC
BioActivity 1Liter or 2Liter Vessel

Additive inserted Stir bar capable Upgradeable controls include semi-automated pressurization, digital pressure gauge and data recording system NovaGenesis Plus Applications Features

Sterilize Pressure: 3,000 psi
Clean Temperature: 50degC
BioActivity 600ml, 1Liter or 2Liter Vessel
De-Cellularization Additive inserted

Stir bar capable Upgradeable controls include semi-automated pressurization, digital pressure gauge and data recording system Please contact NovaSterilis for further information.

Process Development 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, 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 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.

Applications

Biomaterials

Allograft to xenograft tissue market served as the commercial launch for NovaSteirilis. Today the Nova2200 and Nova8800 platforms clean and/or sterilize a variety of biomaterials including dermis, tendons, amnion, bone, hyaluron, collagen, cellulose, alginates and silk to name a few. The Nova Process achieves industry standard sterility assurance levels of SAL6 and has been the terminal sterilization modality of choice for devices approved by both the TGA and FDA.

Drug Delivery

Efforts in drug delivery and regenerative medicine have focused on combination devices; sensitive polymers with biologic factors or bio-scaffolds impregnated with a therapeutic. These devices are often manufactured aseptically because no terminal sterilization solution exists. Development efforts have centered on constructs such as heart valves, arterial conduits hyaluronic acid and bone crunch impregnated with bioactives and endospores inoculated with therapeutics for treatment of solid tumors.

Therapeutics

The Nova Process has been vetted as a terminal sterilization modality on small molecule APIs with no impact to physical properties or biological function. Additionally, a process to extract residual ethylene oxide from finished APIs has been patented. Large molecule treatments are not only limited to sterility but it also included a process for the creation of vaccines. This is a focus area of development for NovaSterilis with a desire to grow the number of active partnerships.

Material Compatability

As scCO2 becomes more widely recognized, and the low temperature, non-reactive, penetrating attributes of the material are better appreciated, envisioned applications have grown dramatically. Despite many materials being compatible with scCO2 it can cause problems with structure and function, so NovaSterilis has evaluated hundreds of materials as well as devices (combination materials) ranging from drug eluting polymers to single use syringes to multi-use, complex devices such as endoscopes.