Cortical Bone

Recent FDA guidelines for ensuring the sterility of musculoskeletal allografts require SAL3 or high level of disinfection (not sterilization). 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** requirement for all allografts labeled as sterile. Therefore, providing terminally sterilized allograft material (SAL6) for clinical use could significantly reduce the risk of infection for the millions of allograft recipients in the United States each year. Studies performed at NovaSterilis, and validated by our partners demonstrate that SAL6 is obtainable when the NovaSterilis Cortical Bone Cleaning/Sterilization Protocol is followed and using the Nova2200™ system.

 

** SAL6 means that there is less than or equal to one chance in a million that an item remains contaminated or nonsterile.

 

 

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, excess fluids, and organic material when cleaned and sterilized with SCCO₂. Lipid removal from the graft has been previously shown to increase graft incorporation following transplant. Lipid removal 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.

 

 

Supercritical CO₂ Sterilized BTB (shaped) Prepared for Transplant