Packin’ ya Eskies

The objective was to document a Process Validation on the packaging of human tissue grafts using polystyrene boxes containing dry ice for short term storage. The aim was to give a high degree of assurance that the processed grafts would be maintained at −20°C for a period of time to allow distribution to customers. This study was designed to comply with the Australian GMP—Human Blood and Tissues and AATB Standards for Tissue Banking (Ed 12) American Association of Tissue Banks Section E4.141—Storage Conditions for Commonly Transplanted Human Tissue. Four Eskies were packed with 1, 4, 10 & 20 “dummy” allografts with thermocouples and Data Loggers attached with 3.5, 7, 15 and 20 kg of dry ice packed around the “dummy” allografts, respectively. All Eskies were weighed six times over a 48 h period and temperatures recorded. The results showed that one allograft in an Esky with 3.5 kg of dry ice was able to be stored for up to 31 h and fifteen allografts in an Esky containing 20 kg dry ice lasted 48 h.