Processing / Sterilization
Tissue is processed aseptically in a cleanroom environment using a validated method to remove the epidermis, cells, and cell remnants. Preparation exposes the skin to antibiotics-- gentamicin, nystatin, vancomycin, Primaxin IV, polymixin B —and processing reagents including sodium dodecyl sulphate, DNase, RNase, and glycerol. Tissue is treated to reduce residual content of reagents; however traces may remain.
NOTE: Follow instructions for allograft preparation prior to application.
Tissue labeled as sterile has been sterilized using gamma irradiation to Sterility Assurance Level (SAL) of 10-6.