Supercritical Carbon Dioxide

Supercritical CO2, because of its unique qualities and potent solvent properties, is being utilized in a number of commercial processes, most notable being the extraction of botanicals and caffeine. Carbon dioxide, an inexpensive, abundant, non-toxic and naturally occurring gas is ideal for commercial applications. Carbon dioxide converts to its supercritical or fluid phase at relatively low pressure and temperature making CO2 an ideal choice for items that are heat labile.

The use of supercritical fluids, especially CO2, has expanded beyond the solvent application into high tech manufacturing with applications including the manufacturing of supranamics, polymer manufacturing, silicon wafer cleaning and textile dyeing. Substituting this green material has the potential to decrease the use of toxic chemicals, reduce employee exposure to toxins, and eliminate chemical waste products. It is important to note that, since most CO2 is collected as a by-product of other industrial processes, it is an eco-friendly sustainable material.

If you see an application on our site you would like to explore, or if you have an idea regarding supercritical CO2 and wish to discuss it with NovaSterilis please contact us.  Our team of scientists and engineers are experienced and willing to explore new ideas and develop new processes and equipment to meet your requirements.

 

Pharmaceutical Sterilization

NovaSterilis Inc., a leader in the development and commercialization of supercritical carbon dioxide sterilization technology, has been granted US Patent 8,012,414 B2. The patent, dated September 6, 2011 entitled "Sterilization of Drugs Using Supercritical Carbon Dioxide Sterilant", covers a new and effective method of sterilizing pharmaceutical product without dangerous chemicals or radiation.

There is a pressing need for technology to sterilize active and inactive pharmaceutical ingredients. A 2001 PDA Technical Report #36: Current Practices in the Validation of Aseptic Processing - 2001, found that 32% of pharmaceutical manufacturing sites reported that they were aseptically processing products that could have been terminally sterilized. Another report, Drugs and Pharmaceutical Sciences, volume 142 edited by Luis Jimenez states "However, microbial contamination of pharmaceutical products is one of the major reasons for product recall and manufacturing problems". NovaSterilis produced preliminary data, and has been granted a US Patent for SCCO2 sterilization of pharmaceuticals as a viable alternative to other sterilization methods.

NovaSterilis SCCO2 sterilization of pharmaceutical product has short cycle times, is safe for employees, and is performed on site, reducing the need to transfer custody of product.  We are currently licensing this technology to interested parties.

 

Coating Materials with Pharmaceuticals or BioActive Products

NovaSterilis, in collaboration with partners, has applied coatings of drugs or bioactive compounds to the surface of material. This application was done in packaging and we were able to evenly apply the coating.

This application of SCCO2 is in part due to the solvent property of SCCO2, and in part to the environment created in the Nova2200 chamber. The Nova2200 works at 1450 psi and 35°C. Inside the chamber is a propeller that keeps the supercritical fluid in constant motion and promotes the movement of fluid and additives throughout the chamber and around the product to be coated. NovaSterilis has performed this coating process with small molecule drugs, recombinant growth factors, and preservatives.

 

Whole Cell Vaccines

NovaSterilis conducted proof of concept research, and has been granted US Patent 7,560,113 covering a SCCO2 process for the purification or inactivation of bacteria. This process inactivates bacterial pathogens without adversely affecting structures vital to immunologic recognition. The NovaSterilis process is fast, effective, and capable of inactivating large numbers of vegetative or spore bacteria in a small chamber.

With the current high level of interest in developing new and innovative vaccines for a broad range of diseases, NovaSterilis is interested in partnering with leaders in the field to apply our technology to the development of new treatments.  We are looking for a vaccine manufacturer to co-develop this new application capable of producing whole cell vaccines without toxic chemicals.

 

Implants and Devices

Supercritical carbon dioxide has little to no effect on metals and is superior for many sensitive materials. As a result, the SCCO2 sterilization process can be a viable alternative for terminal sterilization of many medical implants and devices.  As the development of medical devices continues to evolve and more products become composites of materials, or have complicated polymer or drug coatings, NovaSterilis SCCO2 sterilization is a viable sterilization option.  The NovaSterilis process is currently utilized by 2 products with regulatory approvals and multiple product submissions are expected in the near future.

NovaSterilis is currently working with a range of products from sutures, regenerative scaffolds/matrices to wound care biologic dressings and we would be happy to help determine if our technology is appropriate for your implant or device.

 

Food Sciences

Food science programs have experimented with supercritical CO2 for years, and this industry has applied SCCO2 as an alternative to harmful chemical solvents. One significant example is the use of SCCO2 to naturally decaffeinate coffee. NovaSterilis is uniquely positioned to assist or develop new applications for SCCO2 in the food industry. We have a proven track record from proof of concept to commercialization, and we can engineer systems to meet the needs of our process.

With the rising number of meat and vegetable recalls due to bacterial contamination, we are interested in developing sterilization systems to solve these issues. We envision high throughput systems incorporated into your current process, solving a problem without completely changing your business.

 

Moulding Process

NovaSterilis Inc. has been granted US Patent No 7,988,892. entitled "Preparation and Sterilization of Green State Devices Using a Supercritical Fluid Sterilant." This patent describes the use of a novel process of forming a moulded article during a terminal sterilization cycle in a high pressure supercritical carbon dioxide environment. The pressurization and depressurization of the chamber is controlled to form the finished moulded article in final packaging ready for utilization. One potential application combines this patent with other NovaSterilis patents to produce a high quality demineralised bone matrix "formed finished product" ready for surgical implantation.

This invention holds the potential to utilize numerous green state materials to manufacture sterile medical devices, hardening the material in mould without the negative effects of heat or chemical solutions. This single step method results in the formed, cured and sterilized product in final packaging using NovaSterilis established supercritical CO2 process. Carbon dioxide is nontoxic and inexpensive, making this attractive as a commercial manufacturing process.

 

Extraction of Toxic Chemicals and Solvents

NovaSterilis has worked with a number of products including pharmaceuticals that retain high levels of toxic chemicals or solvents from the manufacturing process.  We have utilized supercritical carbon dioxide’s beneficial non toxic solvent qualities to remove ethylene oxide residuals from extra cellular matrices and sutures as well as toxic solvents that remained in pharmaceutical active ingredients.  This cleaning process can be applied during or after the sterilization of product in gas permeable packaging, resulting in finished products that are cleaner and potentially free from carcinogenic, mutagenic or toxic chemicals.  

 

Other

The possibilities for NovaSterilis’s SCCO2 technology are endless. We are always looking for partners to pursue unexplored or under-served areas.

Please feel free to contact us regarding our technology or the Nova2200™ or Nova8800 SCCO2 sterilizers.