Chemical sterilization of allograft dermal tissues

This article describes the validation of the peracetic acid and ethanol-based (PAAE) chemical sterilization process for allograft dermal tissues at the Musculoskeletal Transplant Foundation (MTF, Edison, NJ). The sterilization capability of the PAAE solution used during routine production of aseptically processed dermal tissue forms was determined based on requirements of relevant ISO standards, ISO 14161:2009 and ISO 14937:2009. The resistance of spores ofBacillus subtilis,Clostridium sporogenes,Mycobacterium terrae,Pseudomonas aeruginosa,Enterococcus faecium,and Staphylococcus aureus to the chemical sterilization process employed by MTF was determined. Using a worst-case scenario testing strategy, theD value was calculated for the most resistant microorganism,Bacillus. The 12D time parameter determined the minimum time required to achieve a SAL of 10−6. Microbiological performance qualification demonstrated a complete kill of 106 spores at just a quarter of the full cycle time. The validation demonstrated that the PAAE sterilization process is robust, achieves sterilization of allograft dermal tissue to a SAL 10−6, and that in combination with aseptic processing secures the microbiological safety of allograft dermal tissue while avoiding structural and biochemical tissue damage previously observed with other sterilization methods such as ionizing irradiation.
Source: Cell and Tissue Banking - Category: Stem Cells Source Type: research