Abstract
A radiation sterilisation dose (RSD) of 25 kGy is commonly recommended for sterilisation of allograft bone. However, the mechanical and biological performance of allograft bone is gamma dose-dependent. Therefore, this study aimed to apply Method 1 – ISO 11137–2: 2006 to establish a low RSD for frozen bone allografts. Two groups of allograft bones were used: 110 femoral heads (FH) and 130 structural and morselized bones (SMB).
The method included the following stages: bioburden determination using 10 FHs and 30 SMBs; verification dose selection using table six in the ISO standard and bioburden; the verification dose was used to irradiate 100 samples from each group; then irradiated bone segments were tested for sterility. The criterion for accepting the RSD as valid is that there must be no more than two non-sterile samples out of 100. The radiation sterilisation dose is then established based on table five, ISO 11137– 2: 2006.
The bioburden of both types of frozen allograft was zero. The verification dose chosen was 1.3 kGy. Two hundred bone segments were irradiated at 1.3 kGy. The average delivery gamma dose was 1.23 kGy (with minimum dose of 1.05 kGy maximum dose of 1.41kGy), which is acceptable according to the ISO standard. Sterility tests achieved 100% sterility. Accordingly, 11 kGy was established as a valid RSD for those frozen bone allografts. A reduction in the RSD from 25 kGy to 11 kGy will significantly improve bone allograft mechanical and biological performance because our data show that this dose level improves the mechanical toughness and osteoclast activity of the allograft by more than 10 and 100 percent, respectively, compared with bone allografts irradiated at 25 kGy.
A low RSD of 11 kGy was established for allograft bones manufactured at Queensland Bone Bank by applying dose validation method 1 (ISO 11137.2-2006) that is internationally accepted.
