Abstract
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 degrees 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.
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