BFS基础输液微生物负荷实验研究

Study on the Bioburden of BFS Basic Infusions

目的：考察BFS基础输液微生物负荷，并与其他包装工艺进行比较。方法：根据BFS，软袋、塑瓶3种不同包装工艺的特点，选择容器、过滤终端和灌装过程3个取样点，对某公司生产的上述3种不同包装的5％葡萄糖注射液共计61批样品，采用TSA培养基两个温度点培养的方法检测微生物负荷；采用沸水浴30 min，薄膜过滤法处理，硫乙醇酸盐肉汤培养基30～35℃培养7 d的方法，检测耐热微生物。结果：20批次BFS样品中均未检出耐热微生物；BFS样品灭菌前药液微生物污染水平低于软袋、塑瓶样品。结论：BFS基础输液在微生物负荷控制方面较其他包装工艺产品具有优势。

Objective：To study the bioburden of BFS basic infusions and compare with the other packaging technology.Methods：A total of 61 batches of 5% Glucose Injection including 3 different packaging characteristics（ BFS,the soft bag and the plastic bottle） were investigated.All the samples including containers,filtration terminal and filling process were cultured with TSA medium at two temperature points to study the bioburden;and boiled 30 min,treated with membrane filtration to detect the heat-resistant microbial.Results：No thermophilic microorganisms were found within 20 batches of BFS samples,and the microbial contamination level of BFS samples were lower than the soft bag samples and the plastic bottle samples.Conclusion： BFS basic infusions have more advantages than the other packaging technology products in the bioburden control.