摘要
目的:建立配液系统(含微孔过滤器)在线灭菌(SIP)后残留水的干燥方法,实现设备干燥存放,杜绝微生物的滋生,确保灌装后的药液质量。方法:采用压缩空气,通过控制吹扫的温度、压力等,对配液系统(含微孔过滤器)SIP后的残留水进行吹干。结果:确定了采用旁吹顶排的方式,将压缩空气加热至70℃~80℃,保持压力为0.2 MPa,并将排气阀门调至最大开度,能有效且快速地吹扫干燥配液系统(含微孔过滤器)。结论:建立了一种可应用于实际工作中配液系统SIP后的干燥方法,能有效去除残留水分,以控制配液系统的微生物。
Objective:To establish a drying method for the residual water after Sterilization-In-Place(SIP)of the liquid dispensing system(including microporous filter),to realize the storage of equipment in a dry condition,eliminate the production of microbial/bacterial endotoxins,and ensure the quality of the liquid after filling.Methods:Compressed air was used to dry the residual water of the liquid dispensing system(including microporous filter)after SIP by controlling the temperature and pressure of purging.Results:The results indicate that the liquid dispensing system(including microporous filter)can be effectively and quickly purged and dried by heating the compressed air to 70℃~80℃,keeping the pressure at 0.2 MPa and adjusting the exhaust valve to the maximum opening.Conclusion:A drying method that can be used in practical work for liquid dispensing system after SIP is established,which can eliminate residual water and effectively control microorganisms in the liquid dispensing system.
作者
张方丽
沈春丽
何文键
Zhang Fangli;Shen Chunli;He Wenjian(Limin Pharmaceutical Factory,Livzon Group Limited,Guangdong Corporate Key Laboratory of High-End Liquid Medicine R&D,Industrilization,Shaoguan Branch of National Engineering Technology Research Center for Traditional Chinese Medicine Modernization,Shaoguan 512028,China)
出处
《广东化工》
CAS
2024年第16期31-33,共3页
Guangdong Chemical Industry
基金
广东省科技创新战略“大专项+任务清单”项目“新型黄体酮制剂工艺研究及产业化”(210908154532839)。
关键词
配液系统
微孔滤芯
SIP
残留水
压缩空气
liquid dispensing system
microporous filter
sterilization-In-Place
residual water
compressed air
