配液系统在线灭菌后残留水干燥方法研究  

Study on the Drying Method of Residual Water after Sterilization-In-Place of Liquid Preparation 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)

机构地区：[1]丽珠医药集团利民制药厂,广东省高端液体药物制剂研发及产业化企业重点实验室,国家中药现代化工程技术研究中心韶关分中心,广东韶关512028

出　　处：《广东化工》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)。

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.

关 键 词：配液系统 微孔滤芯 SIP 残留水 压缩空气 

分 类 号：TQ[化学工程]