More Information on Mineralized Cortical Bone Particulate, Large Particle
Cortical bone applications:
- extraction socket grafting
- grafting for implant placement
- ridge and sinus augmentation
About our Vendors
Hans Biomed - Exoss
Hans Biomed is an FDA registered Tissue Bank with operations worldwide.
Commitment to Quality
The advanced tissue processing and robust quality systems employed ensure each allograft meets stringent safety and regulatory requirements. Quality standards are established to meet or exceed regulations established by the U.S. Food and Drug Administration (FDA), standards of accredited tissue banks, and other state guidelines as appropriate. CLIA-certified testing laboratories are used for serology and microbiological testing and processes tissue in ISO Class 5 clean rooms designed with HEPA-filtered and environmentally and microbiologically monitored air. Reagents, equipment, instruments, and packaging materials used in processing meet the same standards as those used in the operating room.
The Tissue bank employs strict donor screening and eligibility criteria to minimize the risk of disease transmission. The initial screening involves getting and reviewing an exhaustive social and medical history of the donor. To further enhance the safety, Serum samples obtained from the donor are tested by a CLIA (clinical laboratory improvement amendment of 1988) certified laboratory for the following.
- HIV-I & II Antibodies
- Hepatitis B surface antigen
- Hepatitis B core total antibody
- Hepatitis C antibody
- HIV-I and HCV Nucleic Acid Test by Transcription Mediated Amplification
Tissue is processed when all the test results are negative. issue grafts are rinsed and soaked in various solutions to minimize transmission of bacteria and viruses. Terminal gamma irradiation ensures the sterility of the grafts released for implantation. In the case of non irradiated tissue, final release is contingent upon negative results from microbiological testing. Processing and packaging of the tissue are performed using aseptic technique and occur in a clean room.
Each donor is processed as a single lot and all the processing steps are performed aseptically in clean rooms. The steps include:
- Initial debridement and precision milling/cutting using sophisticated CNC machines
- Patented and validated process of disinfection: several cycles of soaking in mild chemical solutions and washing designed to inactivate any pathogens and remove immunogenic material Allowash (TM) processing
- Demineralization where applicable
- Lyophilization/freeze drying
- Final sterility testing by microbial culture method for aseptic allografts; gamma irradiation for sterile allografts