Why a New Graft Sterilization Process? All leading bone graft companies use Gamma Irradiation to Terminally Sterilize allograft materials. Even low irradiation is harmful to human tissue and bone. Irradiation causes damage to polymers reducing tissue strength, denatures allograft protein and causes collagen cross linking. Further, irradiation does not preserve the osteogenic and biomechanical properties of the structurally complex allograft tissue.
Now there is the new the Supercritical Fluids CO2 (SCCO2) sterilization process that penetrates to the interior of porous bone created via low surface tension. The fluids dissolve and remove virtually all blood, lipids and contaminants. The new AdvancedMatrix’s SCCO2 fluid sterilization process provides an almost "ideal" combination of cleansing of lipids, preservation of osteogenesis, strength of bone matrix, and absence of non-natural compounds or denatured protein.
See How Supercritical CO2 Fluids Work: Watch Prof. Poliakoff of the University of Nottingham demonstrate: Click: www.youtube.com/watch?v=yBRdBrnIlTQ.
MIT Professor Robert Langer and other scientists published an abstract entitled "Bacterial inactivation by using near-and supercritical carbon dioxide". For details see: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC17890. Food industry scientists had previously sterilized several bacterial microbes using Supercritical Fluid Carbon Dioxide (SCCO2). Caffeine is regularly removed from coffee beans using SCCO2. Professor Langer and others envisioned using SCCO2 in medical applications.
AdvancedMatrix Cortical Cancellous Materials are Terminally Sterilized in their final Tyvek packaging avoiding any cross contamination. The "gold standard test" set by the AATB and endorsed by the FDA requires a Sterility Assurance Level of 1 part 10-6 (SAL10-6) or the probability of one microbial survivor is one in a million. For more valuable information see the Journal of Orthopaedics peer reviewed article at: www.jortho.org/2009/6/2/e9/index.htm.
Dental Advances' Chief Scientific & Quality Officer, Dr. Raymond, explains "The Bottom Line" and "The Ideal Graft?"
"SCCO2 processed allograft materials have the potential to combine advantages of allograft and autograft without the disadvantages or potential complications of either." Dr. Raymond was formerly a faculty member in the Department of Electrical and Computer Engineering at the Massachusetts Institute of Technology (MIT) and in the Department of Anesthesia at the Harvard Medical School. Dr. Raymond holds a BS in physiology from Stanford University and a PhD in biology from MIT. In Dr. Raymond's recently authored "Power Point Presentation to the Dental Profession", he points to the SCCO2 processed graft as the possible "Ideal Graft". See Dr. Raymond's "The Ideal Graft?" on the right. Click here for the complete "Power Point Presentation to the Dental Profession" or click here to see Dr. Raymond's video explanation of the advantages of the SCCO2 sterilization process.
SCCO2 penetrates to the interior of porous materials. Tissue and bone in the SCCO2 state of low surface tension permit CO2 and and the proprietary sterilization additive to penetrate tissue and bone. The fluids dissolve and remove virtually all blood, lipids and contaminants. The new AdvancedMatrix’s SCCO2 sterilization process has an almost “ideal” combination of sterilization, cleansing of lipids, preservation of osteogenesis, strength of bone matrix, ease of use and application, and absence of non-natural compounds or denatured protein.