Allowash XG® encompassed six steps for bio-implant safety and sterility:
Step One − Bioburden Control: All donors accepted for tissue recovery are subjected to a meticulous and rigorous screening routine that exceeds the requirements set forth by the Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB). Donors are then recovered in strict aseptic conditions. This first step allows for a stringent control of bioburden on incoming tissue even before it enters our processing facilities.
Step Two − Bioburden Assessment: All recovered tissue is sampled for microbiological contamination at the time of recovery. Standard microbiological methods utilizing both aerobic and anaerobic media are employed to culture and identify bacteria and fungi. Donor blood samples are also used for required infectious disease testing and evaluated for potential hemodilution that may impact acceptability. This extensive serological testing exceeds industry standards and utilizes the latest NAT advanced testing techniques, allowing LifeNet Health to further control and eliminate incoming bioburden.
Step Three − Minimized Contamination: LifeNet Health's state-of-the-art processing facilities contribute to maintaining a low bioburden on tissues. Designed for the processing and preservation of musculoskeletal and cardiovascular tissue allograft, all processing areas have been designed to allow compliance with FDA, state and federal requirements, including Good Manufacturing Practices (GMP) for medical devices. Our facilities maintain cleanliness levels that minimize or eliminate environmentally induced graft contamination.
Step Four − Rigorous Cleaning: Through treatment with hypotonic solutions and antimicrobial reagents and/or use of processes such as ultrasonication and centrifugation, blood elements (including marrow and lipids) are solubilized and removed from the tissue. Key solutions are forced into and through the bone matrix and then directed to waste, resulting in the lysis of cells and cleaning of the tissues.
Step Five − Disinfection and Rinsing: The tissue, freed from over 99% of marrow and lipids, is subjected to an intensive decontamination, disinfection and cleaning regimen designed to remove and eliminate viruses and bacteria. Tissue then undergoes water soak mediation to remove processing reagents, followed by centrifugation and/or micro-absorption to remove excess water and any remaining processing residuals.
Step Six − Terminal Sterilization: The Allowash XG® process concludes with a controlled and validated dose of gamma irradiation administered at low temperatures after the tissue is packaged. This final step produces a Sterilization Assurance Level (SAL) of 10-6 without compromising the biomechanical or biochemical properties of the tissue needed for its intended surgical application.