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即使静脉注射用免疫球蛋白(IVIG)和其他血浆治疗制品具有良好的安全性,但仍在不断评估改良的病毒清除法,并将其应用到新的生产工艺中。通常应用γ射线照射来确保保健产品和医疗设备的无菌,但还未将其作为生物制品的病毒灭活方法。此项研究旨在检测杀病毒剂量(50kGy)的γ射线能
Even with good safety of intravenous immunoglobulin (IVIG) and other plasma-based products, improved virus clearance is continually evaluated and applied to new manufacturing processes. Gamma irradiation is commonly used to ensure the sterility of health care products and medical devices but has not been used as a viral inactivation method for biological products. The aim of this study was to examine the gamma-ray energy at the virucidal dose (50 kGy)