摘要
为保证制药行业洁净厂房的生产质量,国家标准GB 50457-2019《医药工业洁净厂房设计标准》规范了制药行业中洁净厂房设计的工艺标准。本文概述了该标准的历史沿革,并将2019年版的新标准与该标准的2008版进行比较,对医药工业洁净厂房的设计标准中的术语修订和增删、关键指标评价体系的变化、洁净厂房的选址与布局条款的变化、工艺设计标准的条款的调整进行了解读。
In order to ensure the production quality of clean factory in pharmaceutical industry, GB 50457-2019, Standard for design of pharmaceutical industry clean room regulates the design process of the clean workshop in pharmaceutical industry. The paper outlines the historical evolution of the standard, and compares the 2019 edition of the standard with the 2008 edition. It also analyzes the revised and added terms in the new edition, the change of key index evaluation system, the change of site selection and layout terms of clean workshop and adjustment of process design standard.
作者
安刚
史合
唐旭
谢姗姗
杨科
高志良
季启政
AN Gang;SHI He;TANG Xu;XIE Shan-shan;YANG Ke;GAO Zhi-liang;JI Qi-zheng(Xi’an Institute of Space Radio Technology;Beijing Orient Institute for Measurement&Test;Beijing Institute Space Science and Technology Information)
出处
《标准科学》
2020年第7期16-20,共5页
Standard Science
关键词
医药工业
洁净厂房
设计规范
pharmaceutical industry
clean room
the design specification
