Development
Infections from transplanted tissue have always been a concern, but recently the FDA has expressed a desire for increased oversight of tissue transplantation.
Patient safety is always a concern. Processors strive to achieve sterilization of allograft tissue. Current terminal sterilization techniques that utilize chemicals or other washes often leave residues. Similarly, gamma irradiation is used for terminal sterilization, but can have adverse effects upon proteins and the mechanical strength of allografts. The Gamma Radiation dosage required to achieve a SAL6 renders the graft useless. Therefore attempts are made to reduce the bioburden prior to a lower level of Gamma Radiation. NovaSterilis’ process achieves terminal sterilization to SAL6 without any deleterious effects on the product. The innovations achieved by NovaSterilis act to raise the bar for patient safety as well as the expectations of what should be used for allograph transplants. NovaSterilis delivers a complete terminal sterilization process for use in all tissue banks.
NovaSterilis developed the Nova2200™ which allows users to terminally sterilize allograph tissue on site, maintaining quality standards of the tissue bank. NovaSterilis can provide consumable supplies such as gas permeable packaging, Biological Indicators (BI’s), and a proprietary additive, "NovaKill.“ NovaSterilis is currently working on pressure resistant self contained BI's. This product will allow the user parametric release of the processed tissue product.
At NovaSterilis, we are constantly working to improve our supercritical carbon dioxide technology, from the currently available 20 liter Nova2200™ to larger, faster and more efficient equipment. We will continue to fine tune our process to exceed current industry standards. Our goal is to provide safe, clean and environmentally friendly terminal sterilization technology to the medical community.
NovaSterilis is actively pursuing partners in a number of different fields such as pharmaceuticals, vaccines, engineered tissue companies, researchers, and device and implant manufacturers.
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