Lyophilized allograft musculoskeletal tissue is generally intended to be stored at "ambient" or "room" temperature, and usually is kept in climate controlled indoor storage areas. However, there is a question of what temperature extremes tissue may see, especially during transportation, in that these extremes may exceed even the limits of "ambient" conditions. Temperatures may become quite hot, but only for a few hours and only during daytime. Damage from high temperatures, if it occurs, is expected to be evident by damage to the collagen component of bone, soft tissue, and demineralized bone, as well as to the growth factors contained in demineralized bone. If damage is significant, then temperature monitoring requirements for lyophilized allograft tissue might be necessary. To answer this question, a literature review was carried out to look at the short-term temperature resistance of collagen and demineralized bone. Both collagen and the growth factors in demineralized bone show remarkable short term tolerance to elevated temperatures in the dry state, and it was concluded that temperature excursions of 50 degrees C or less, lasting for a few days or less, would not cause any significant deterioration. This means that temperature monitoring also should not be required.
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