Abstract
Human Tissue Banks (BTH) must validate the storage of collected/processed tissues ensuring physical integrity, sterility, and microbial protection for up to 5 years. (1) Is it safe to use bone tissue for transplants collected by a BTH after 5 years of storage? (2) Do the packaging of stored tissues present physical integrity, sterility, and microbial protection after 5 years? (3) What are the morphological results of bone tissues after 5 years?. 20 femoral heads were used with a storage time of between 9 and 10 years at -80 °C. From each femoral head, the following were carried out: microbiological tests for aerobic and anaerobic bacteria and fungi, collecting 3 fragments of bone tissue, 3 Stuart swabs from the inner surface of the packaging, and a sample of 0.9% SF for Bioburden examination; tissue histology; the quantitative and qualitative mechanical resistance test and pyrogenicity/cytotoxicity test were used on the packaging, pre and post storage. No bone tissue samples showed pathogenicity. Histological findings showed morphologically preserved osteocytes with points of bone degeneration and necrotic adipose tissue. No packaging showed contamination, cytotoxicity, or pyrogenicity. The mechanical properties of these packages demonstrated uniformity in thickness, high tension, and relative stiffness even after storage (p = 0.001). It is concluded that the packaging used in the study presented physical integrity, sterility, and microbial protection for bone tissues after 9 and 10 years of storage. A possible increase in the shelf life of fabrics is contemplated to up to 10 years. Such results expand future research directions to continuously improve the quality of products and services offered by BTH.