In this work, gamma sterilization was validated, and the impact of this sterilization process on collagen/hydroxyapatite (Col/HAp) composites was investigated. It has been already recognized that the improper sterilization of healthcare products may lead to infection and mortality/morbidity issues in patients. Gamma sterilization has emerged as a promising sterilization method because it shows advantages such as low cost, a small increase in temperature of irradiated materials, and no production of toxic residues. Moreover, gamma rays can reach the products even when contained in sealed packages. The dose of gamma radiation applied in this study ranged from 17.5 to 50 kGy. The studied samples were examined by X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), thermogravimetry (TG), and differential scanning calorimetry (DSC). No apparent effect of gamma radiation on HAp was observed even when doses as high as 50 kGy were applied. On the other hand, Col was greatly affected by gamma radiation, displaying cross-linking and degradation after sterilization. These structural changes may alter Col's properties, which could, in turn, impact its medical use. As a consequence, it is strongly recommended that the irradiation dose used to sterilize the Col/HAp composites shall be kept as low as possible to mitigate the structural changes induced in Col. It was noticed that a radiation dose of 17.5 kGy was sufficient to sterilize the examined samples because a sterility assurance level (SAL) below 10⁻⁶ was detected. Although dramatic structural changes were observed in Col when this dose was applied, the sterilized samples showed no toxicity to human mesenchymal stem cells. Based on these results, we established a VD_Max of 17.5 kGy for Col/HAp-based healthcare products.

在这项工作中，验证了伽马灭菌，并研究了这种灭菌过程对胶原蛋白/羟基磷灰石 (Col/HAp) 复合材料的影响。已经认识到，保健产品的不当灭菌可能导致患者感染和死亡率/发病率问题。伽马射线灭菌因其成本低、辐照材料温度升高小、不产生有毒残留物等优点而成为一种很有前景的灭菌方法。此外，即使装在密封包装中，伽马射线也可以到达产品。本研究中应用的伽马辐射剂量范围为 17.5 至 50 kGy。研究的样品通过 X 射线衍射 (XRD)、傅里叶变换红外光谱 (FTIR)、热重分析 (TG) 和差示扫描量热法 (DSC) 进行了检测。即使应用高达 50 kGy 的剂量，也没有观察到伽马辐射对 HAp 的明显影响。另一方面，Col 受伽马辐射影响很大，在灭菌后表现出交联和降解。这些结构变化可能会改变 Col 的特性，进而影响其医疗用途。因此，强烈建议用于灭菌 Col/HAp 复合材料的辐射剂量应保持尽可能低，以减轻 Col 引起的结构变化。注意到 17.5 kGy 的辐射剂量足以灭菌由于无菌保证水平 (SAL) 低于 10，因此检查样品 灭菌后显示交联和降解。这些结构变化可能会改变 Col 的特性，进而影响其医疗用途。因此，强烈建议用于灭菌 Col/HAp 复合材料的辐射剂量应保持尽可能低，以减轻 Col 引起的结构变化。注意到 17.5 kGy 的辐射剂量足以灭菌由于无菌保证水平 (SAL) 低于 10，因此检查样品 灭菌后显示交联和降解。这些结构变化可能会改变 Col 的特性，进而影响其医疗用途。因此，强烈建议用于灭菌 Col/HAp 复合材料的辐射剂量应保持尽可能低，以减轻 Col 引起的结构变化。注意到 17.5 kGy 的辐射剂量足以灭菌由于无菌保证水平 (SAL) 低于 10，因此检查样品检测到^-6。尽管在使用该剂量时在 Col 中观察到显着的结构变化，但灭菌的样品对人间充质干细胞没有显示毒性。基于这些结果，我们为基于 Col/HAp 的保健产品确定了17.5 kGy的 VD _Max。