At delivery, tissues are safely collected by trained technicians. They are transported overnight to the processing facility. In addition to the serological testing in the prescreening process, culturing is performed regularly during processing. All products are retested post-processing to ensure the absence of bacterial and fungal pathogens.
During processing, a cryopreservative is introduced to the tissue to protect cell viability. Once packaged into vials, the products are sent to a third body testing facility to ensure sterility.
All products undergo a 14-day quarantine period. After 14 days, the product batches are randomly retested to demonstrate a continued absence of bacterial and fungal pathogens and are non-pyrogenic. A licensed medical director reviews all testing results before the products can be released for clinical use.