摘要
各国GMP及PDA技术报告早已推行无菌工艺模拟试验。结合法规要求,从培养基模拟灌装方案的设计,风险评估工具,前提条件确认,模拟介质选择,灌装批次与数量,容器装量,最差条件选择,环境监测频率,目检,培养与观察,促生长试验、操作记录、总结报告等方面进行分析,并结合实例探讨西林瓶生产线无菌工艺模拟试验的策略,以提高生物制药行业非最终灭菌产品的无菌保障水平。
In many country’s GMP and PDA technical reports,aseptic process simulation test has been implemented.In this article,combined with the requirements in codes,the analysis for many aspects were carried out,including the design of scheme for culture medium filling simulation,risk assessment tool,condition approval,selection of simulation medium,filling batches,filling volume of vessel,selection of most severe condition,frequency of monitoring environment,visual examination,culturing and observation,growth promotion test,operation record,and final report.Also,to promote aseptic level for non-final sterilization products from biopharmaceutical industry,combined with the example of penicillin bottle production line,the strategy for aseptic process simulation test was discussed.
作者
周海霞
Zhou Haixia(Shanghai Junshi Biotechnology Co.,Ltd,Shanghai 201203)
出处
《化工与医药工程》
2020年第3期25-27,共3页
Chemical and Pharmaceutical Engineering
关键词
无菌工艺
培养基模拟灌装
试验方案
策略
aseptic process
culture medium filling simulation
test scheme
strategy
作者简介
周海霞(1983-),女,工程师,从事生物制药行业洁净公用系统、生产设备、无菌工艺等验证工作。
