Allograft and Engineered Tissue

The Nova2200™ is currently being used to sterilize all types of allograft and engineered tissues including skin, ligament, tendon and bone.  NovaSterilis has been able to achieve a SAL6 for all allograft tissue processed in our system.  Because SCCO2 possesses excellent solvent and cleaning capabilities, a sterilization cycle utilizing SCCO2 will leave the tissue or bone substantially cleaner than simply washing it would. The end result of the sterilization treatment will be an incredibly clean, terminally sterilized product.

 

Below we've documented a typical process cycle for sterilizing bone in our lab.

 

Samples are prepped and visual phenotypic observations documented

 

Preparation of spores and inoculation of bone

 

Dried samples are heat sealed in gas permeable pouches

 

Double pouching ensures terminal steriliztion

 

Inoculated samples placed into baskets

 

Additive pad placed into chamber, baskets loaded above

 

Nova2200™ programmed with specific run ID and runtime