电子束辐照对细胞工厂灭菌效果的验证  

Verification of sterilization effect of cell factory by electronic beam irradiation

作　　者：石亮[1] 黄晓娜[1] 张德利[1] 李秋睿 徐国亮[1] 闻向华 高源[1] 

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130062

出　　处：《中国生物制品学杂志》2017年第8期868-871,共4页Chinese Journal of Biologicals

摘　　要：目的验证电子束辐照对细胞工厂进行灭菌的有效性。方法采用不同剂量(20、25、30、35 kGy)电子束辐照对细胞工厂进行灭菌处理,用辐照的细胞工厂培养2BS细胞,并进行无菌、表面微生物检测,同时利用短小芽孢杆菌指示剂验证不同剂量电子束对细胞工厂灭菌的有效性。确定辐照后细胞工厂的保存时间、耐运输和潮湿性。结果20 kGy的电子束只能满足10层细胞工厂辐照灭菌要求,≥25 kGy的电子束可有效对细胞工厂进行灭菌,能够满足GMP的无菌要求;20 kGy的电子束可对细胞工厂表面10~6 cfu/ml的短小芽孢杆菌完全杀灭,≥25 kGy的电子束对放在细胞工厂中间位置的106 cfu/ml的短小芽孢杆菌能够完全杀灭,灭菌后保存6个月内能够保证无菌,且耐运输和潮湿。结论电子束可有效对细胞工厂进行灭菌处理,且具有灭菌彻底、无污染、无残留、不需加热、可自动化运行、对产品及包装材料无损伤等优点。Objective To verify the effectiveness of electronic beam irradiation in sterilization of cell factory. Methods Cell factory was sterilized by electronic beam irradiation at various dosages（20, 25, 30 and 35 kGy）, with which 2BS cells were cultured and tested for sterility and surface microorgans. The effectiveness of electronic beam irradiation in sterilization of cell factory was verified using Bacillus pumilus as an indicator. The time for storage of cell factory after irradiation was optimized, while the resistances to breakage during transport and to humidity were evaluated. Results The electron beam at a dosage of 20 kGy only met the requirements for irradiation sterilization of 10 layers of cell factory.However, the electron beam at dosages of not less than 25 kGy sterilized the cell factory effectively and met the GMP requirements for sterilization. The electron beam at a dosage of 20 kGy killed the 10^6cfu/ml B. pumilus on the surface,while that at a dosage of not less than 25 kGy killed the 10^6cfu/ml B. pumilus in the middle part of B. pumilus,completely. The cell factory stored for 6 months after irradiation was sterile, and was resistant to the breakage during transport and to humidity. Conclusion Electron beam irradiation may sterilize cell factory effectively and completely,without pollution or residue, and no heating is needed, which may be operated automatically without damage to the product and packaging materials.

关 键 词：电子束 60Co-γ射线 细胞工厂 辐照灭菌 短小芽孢杆菌指示剂 

分 类 号：R392-33[医药卫生—免疫学]