水痘减毒活疫苗的无菌生产工艺验证  

Validation of an aseptic process for live attenuated varicella

作　　者：马相虎[1] 陈哲文[2] 晏子厚[2] 

机构地区：[1]上海生物制品研究所有限责任公司总经理办公室,200052 [2]上海生物制品研究所有限责任公司质量保证部,200052

出　　处：《国际生物制品学杂志》2015年第3期116-120,共5页International Journal of Biologicals

摘　　要：目的通过培养基模拟灌装试验，验证水痘减毒活疫苗（水痘疫苗）无菌生产工艺的有效性。方法模拟水痘疫苗的无菌灌装工艺，对胰酪胨大豆肉汤培养基（TSB）按0．6ml／瓶进行模拟灌装，对灌装后小瓶进行培养，根据小瓶内培养基的污染情况，评估现行水痘疫苗无菌生产工艺的有效性。结果3次TSB模拟灌装试验的灌装批量分别为10160、10181和10175瓶，经20-25℃和30-35℃先后培养后，均未出现TSB污染。在水痘疫苗生产区域的各监测点，≥0．5μm悬浮粒子均≤70粒／甜，≥5．0μm悬浮粒子均为0；沉降菌和表面微生物的菌落计数均为0；培养基灵敏度检查和微生物挑战试验均合格。结论水痘疫苗的无菌生产工艺符合药品生产质量管理规范的要求，可确保产品的无菌性。Objective To validate the effectiveness of the aseptic production process of live attenuated varieella vaccine （chickenpox vaccine） by media fill test. Methods The aseptic filling of the vaccine was simulated using Trypticase Soy Broth （TSB, 3. 2%）, with filling volume of 0. 6 ml per vial. The vials were incubated after filling, and the sterility of current production process was evaluated by the contamination situation of the media inside the vials. Results The filling batch numbers of 3 media fill tests were 10 160, 10 181 and 10 175 vials, respectively. After successive incubation at 20-25℃ and 30-35 ℃, contamination rates of TSB all were 0.≥0. 5 μm airborne particulates were less than 70 per cubic meter at each sampling point in the production area. No ≥ 5. 0μm airborne particulate was detected. There was no colony of settle plate and surface microbial. The growth promotion test and microbial challenging test of TSB were both qualified. Conclusion The aseptic production process of chickenpox vaccine is conformed with good manufacture practice, which can assure its sterility.

关 键 词：水痘疫苗 无菌工艺 培养基模拟灌装试验 

分 类 号：R511.5[医药卫生—内科学]