Djefal A, Tahtat D, Khodja A Nacer, Bouzid S Saad, Remane N
Radiobiology, Centre de Recherche Nucleaire d'Alger, 2 bd, Frantz Fanon, BP 399, Alger-gare, Alger 16000, Algeria.
Cell Tissue Bank. 2007;8(1):9-12. doi: 10.1007/s10561-006-9016-x.
The validation and substantiation of sterilization dose for lyophilized human amnion membrane by gamma irradiation delivered by Co60 source were investigated. The validation experiments were conducted according to ISO 13409 method B. A total of 120 human amnion membranes were collected. Of these, 10 membranes were used for estimation of bioburden and 20 membranes were used for the individual sterility test at verification dose. The average bioburden per product unit with sample item portion (SIP = 1) for lyophilized human amnion membrane was 572 cfu. The verification dose experiments were done at dose of 8.1 kGy and the results of sterility tests showed that human amnion membrane got one positive. Consequently, the sterilization dose of 25 kGy was confirmed and substantiated.
研究了钴60源γ射线辐照冻干人羊膜的灭菌剂量验证及确证。验证实验按照ISO 13409方法B进行。共收集120片人羊膜。其中，10片用于生物负荷评估，20片用于验证剂量下的个体无菌试验。冻干人羊膜每产品单元带样品项部分（SIP = 1）的平均生物负荷为572 cfu。验证剂量实验在8.1 kGy剂量下进行，无菌试验结果显示人羊膜有一例阳性。因此，确认并确证了25 kGy的灭菌剂量。
Zotero 插件