NovaSterilis Inc. a leader in the development and commercialization of supercritical carbon dioxide (scCO2) technology announces the addition of European Medical Contract Manufacturer (EMCM) as a licensee of supercritical CO2 sterilization and NovaSterilis’ exclusive agent for supercritical CO2 technology and equipment in specified territories.
European Medical Contract Manufacturing (EMCM), located at Nijmegen, in the Netherlands, is the center of excellence in developing and manufacturing sterile medicinal products in GMP and ISO accredited facilities that cater to the markets of Biomaterials, Pharmaceuticals and Tissue Engineering specialties conforming to the standards of the USFDA, EMEA & ISO.
“We have expertise in using supercritical CO2 for the cleaning and purification of biomaterials. The addition of NovaSterilis scCO2 sterilization technology is a logical progression at EMCM. We believe we will expand the application and refine its use in many new products” stated Henriette Valster, EMCM’s Managing Director. “Our goal is to provide the medical industry with sterilized, innovative materials of the highest quality in compliance with Good Manufacturing Practices (GMP) and relevant ISO regulations.”
Sterilization technologies in wide use, such as ethylene oxide, autoclaving, and gamma irradiation cannot achieve SAL6 without toxic residuals or damaging effects to the vital structure of many biologic materials.
NovaSterilis pioneered and patented the use of supercritical CO2 in combination with a small volume of biocide(s) to achieve SAL6 without damage or residual chemicals. “Partnering with EMCM is a great tactical decision; they understand CCO2, the unique applications of this fluid, and can fluently discuss the benefits of this technology with customers. This relationship is extremely exciting for NovaSterilis,” noted David Burns, President of NovaSterilis. “EMCM is a highly respected contract manufacturer with a broad reach in the industry, providing NovaSterilis with opportunity to grow their customer base and more importantly increase the acceptance of supercritical CO2 sterilization.”
This collaboration will provide European and Asian tissue processors and medical material manufacturers with access to this fast growing sterilization technology. NovaSterilis is revolutionizing allograft tissue and medical materials sterilization in the US and Australia, and collaborating with EMCM has the potential to improve the quality and safety of these materials in new markets.
There are many innovative companies in the EU, India, and China that will benefit from this technology, and they are enthusiastic about adopting new technologies. About NovaSterilis NovaSterilis currently markets terminal sterilization technology and equipment related to their supercritical carbon dioxide platform.
The supercritical or fluid phase of CO2, occurs at low pressure (72.9 atm) and moderate temperatures (31.1° C). Supercritical CO2 retains advantageous properties of the gas and liquid phases of carbon dioxide making it an ideal fluid for manufacturing processes. There are currently 4 allograft tissue processors utilizing this technology to sterilize tissue for transplant, and mutiple device manufacturers have medical devices in development.
The company currently manufactures the Nova 2200 - 20 liter, and Nova 8800 - 80 liter fully automated supercritical CO2 terminal sterilization units. NovaSterilis is the recipient of a 2007 Presidential Green Chemistry Challenge Award presented by the Environmental Protection Agency. About EMCM EMCM’s tissue business segment is active in the processing of tissue components such as bones, soft tissues, cells and skin of human as well as of animal origin. Its capabilities are in providing safe, clean and effective bone, collagen and innovative Biomaterials. EMCM has been accredited, as per the European Directive 2004/23, to function as a licensed Tissue Establishment by the Ministry of Health of the Netherlands.
Human tissue products processed at EMCM are sterile and fulfill the quality & safety requirements of the European directives for tissue and cells. EMCM complies to the norms required by the VWA Netherlands to import and handle animal by-products. Its products include Human Grafts, Xenografts and Innovative Biomaterials, which are provided to bone and tissue banks & Medtech companies alike, either as a finished product or as a contracted service.
EMCM is currently in the process of registration of its techniques and products in several countries including Germany and France. For more information about EMCM and its products please log on to www.emcm.com For more information on NovaSterilis and supercritical carbon dioxide.