All tissues are recovered after the donor's medical and social history has been reviewed and physical tests have been performed. Tissues are screened with HBs Ag, HBc Ab, HIV Ab (1 & 2), HTLV Ab (I & II), RPR (ELISA), and complementary PCR and FTA serological tests. Tissues that pass screening are preserved by lyophilization, cryopreservation, or fresh-freezing.
All processing takes place in "clean rooms" with sterility class between 100 and 1000 (varying by tissue), and is rigorously quality-controlled at every step. All application processes are carried out in accordance with the cGTP (Current Good Tissue Practice) and GMP (Good Manufacturing Practice) directives.
During processing, Class II Microbiological Cabinets are used, Hydrogen Peroxide Vapor Sterilization (Bioquell) is applied, and Gamma Sterilization is performed on products and packaging where required.
According to the standards established by AAMI (Association for the Advancement of Medical Instrumentation), all allografts have a sterility assurance level of SAL 10⁻⁶.
The aseptic recovery, processing, and distribution of all tissues is the policy of CenoBiologics and Cenomed.