[关键词]
[摘要]
过滤作为实现物系分离的核心关键手段,在药品生产全过程中发挥着不可替代的作用。药品生产中常见的膜过滤工艺有液体除菌过滤、气体过滤、超滤。对药品生产中3种常见的膜过滤工艺的分离特性进行分析,梳理工艺应用阶段的典型问题,并提出相应的应对措施和建议,旨在为制药企业优化过滤工艺、提升合规保障水平提供参考。
[Key word]
[Abstract]
Filtering, as the core and key means of achieving system separation, plays an irreplaceable role throughout the entire process of drug production. The common membrane filtration process in drug production include liquid sterilization filtration, gas filtration, and ultrafiltration. This article analyzes the separation characteristics of three common membrane filtration methods in drug production, sorts out typical problems during the process application stage, and proposes corresponding countermeasures and suggestions, aiming to provide reference for pharmaceutical manufacturers to optimize filtration processes and improve compliance assurance levels.
[中图分类号]
R95
[基金项目]