Cortical Bone

Recent FDA guidelines for ensuring the sterility of musculoskeletal allografts require SAL3. The American Association of Tissue Banks (AATB) has adopted the more desirable SAL6 requirement for all tissue bank allografts. Therefore, providing terminally sterilized allogeneic material at SAL6 for clinical use could replace or significantly augment other methods of sterilization and improve the health of the millions of allograft recipient patients in the United States each year. Results at NovaSterilis clearly demonstrate that a SAL6 is obtainable when the NovaSterilis Cortical Bone Cleaning/Sterilization Protocol is followed and the allogenic material is sterilized for a half-cycle time of 2 hours (full cycle of 4 hours) using the Nova2200™ system.

 

 

Pre-Processed Cortical Bone (Left) Compared to Cortical Bone After Two Cleaning Runs in a Nova2200 (Right)

 

 

 

 

A comparison of unprocessed to processed bone using the Nova2200™ system.

BTB

Photos of sterilized BTBs show that SCCO₂ treated tendon is much whiter and cleaner when compared to the untreated and gamma irradiated. The BTB allografts lose around 14% of their weight due to extraction of lipids and excess fluids when sterilized with SCCO₂. Lipid removal from the graft has been previously shown to increase graft incorporation following transplant. Delipidation enhances accessibility to the structure of the bone which may improve the osteoconduction following transplant.

 

 

Photographs of bisected BTBs from a single donor with respective sterilization treatments.