从微生物控制角度探讨制药纯化水系统的工艺设计
Discussion on the Process Design of Pharmaceutical Purified Water Systems from the Perspective of Microbial Control
朱罗茵 1梁毅 1叶勋2
作者信息
- 1. 中国药科大学国际医药商学院,江苏南京 211112
- 2. 费森尤斯卡比华瑞制药有限公司,江苏无锡 214101
- 折叠
摘要
微生物污染是制药纯化水应用中面临的一大问题.微生物可附着在固体表面,通过产生细胞外聚合物而形成生物膜,从而降低过滤单元的过滤效率,并且可能脱落并进入纯化水分配系统,进而对药品的质量安全构成风险.因此,有必要从制药纯化水系统中微生物生长的三大要素(即过滤介质表面积、吸附的营养物质、浮游微生物数量)出发,结合质量源于设计的理念,探讨优化目前制药纯化水系统工艺的方法,以期为药品生产企业制药纯化水系统的微生物控制问题提供借鉴与参考.
Abstract
Microbial contamination is a major problem in the application of pharmaceutical purified water.Microorganisms can attach to solid surfaces and form biofilms by producing extracellular polymers,which can reduce the filtration efficiency of filtration units.They may also detach and enter the purified water distribution system,posing a risk to the quality and safety of pharmaceutical products.Therefore,it is necessary to explore methods for optimizing the current pharmaceutical purified water system process from the perspective of the three major factors influencing microbial growth in such systems:the surface area of the filtration media,the adsorbed nutrients,and the quantity of planktonic microorganisms.This exploration,combined with the concept of quality by design(QbD),aims to provide valuable insights and references for pharmaceutical manufacturers in addressing microbial control issues in pharmaceutical purified water systems.
关键词
制药纯化水/微生物控制/生物膜/工艺优化Key words
pharmaceutical purified water/microbial control/biofilm/process optimization引用本文复制引用
出版年
2024
NETL
NSTL
万方数据