药物无菌环境污染控制研究现状  

Research status of drug aseptic environmental pollution control

作　　者：夏昊昱 XIA Haoyu(North Best Branch Factory of North China Pharmaceutical Co.,Ltd.,Shijiazhuang Hebei,050000,China)

机构地区：[1]华北制药股份有限公司北元分厂,河北石家庄050000

出　　处：《质量安全与检验检测》2025年第2期58-61,共4页QUALITY SAFETY INSPECTION AND TESTING

摘　　要：药物无菌环境污染控制是无菌药品生产管理的核心内容。本文基于药品生产质量管理的基本要求,对药物无菌环境污染控制研究现状的要点进行了概述。通过对无菌环境污染源的分析,总结了污染控制策略的制定方法及质量管理体系在其中发挥的重要作用。同时概述了污染控制策略实施过程中的厂房设施控制、人员控制、物料与设备控制和工艺控制等关键要素。最后,本文总结了新型药物和工艺的发展对无菌环境控制带来的挑战,并提出了应对策略。Sterile pharmaceutical environmental contamination control is a core aspect of sterile drug production management.This paper provides an overview of the current research status of sterile pharmaceutical environmental contamination control based on the fundamental requirements of pharmaceutical production quality management.By analyzing the sources of contamination in sterile environments,the paper summarizes the development methods of the contamination control strategy and the significant role of the quality management system within it.It also outlines key elements such as facility control,personnel control,material and equipment control,and process control in the implementation of the contamination control strategy.Finally,the paper concludes with the challenges that the development of new drugs and processes poses to sterile environment control and proposes corresponding strategies to address these challenges.

关 键 词：无菌药品生产 污染控制策略 质量管理体系 生产控制 

分 类 号：TQ460.63[化学工程—制药化工]