2024年4月11日发(作者：谷歌框架三件套下载)
ISPE发布新指南：无菌生产设施（第三版）
ISPE在2018年4月发布了最新的指南：无菌产品生产设施（第三版），总页码为
244页。本文对该指南的主要内容及目录进行了翻译，下面英文来自ISPE官网及指南节
选。
The ISPE Baseline Guide: SterileProduct Manufacturing Facilities (Third Edition)
covers engineering aspects ofdesigning new sterile products manufacturing
facilities and modifications ofexisting facilities. The Guide focuses on how to
provide cost-effectivefacilities which make best use of available modern
technologies to ensure thatproducts of the highest quality are consistently
manufactured.
ISPE基准指南：无菌产品生产设施(第三版)涵盖了工程方面关于设计新的无菌产品生
产设施和修改现有的设施。该指南着重于如何提供具有成本效益的设施，以充分利用现有
的现代技术，确保始终如一地生产高质量的产品。
Uncertainty about the requirements for regulatory compliance maydiscourage
technological advancement, and can drive up investment andoperational
costs. ISPE Baseline® Guide: SterileProduct Manufacturing Facilities (Third Edition)
aims to offer a consistentinterpretation of the latest FDA and EMA guidance, while
allowing a flexibleand innovative approach to facility design. The Guide is based
on keyprinciples such as: the need to understand product and process
requirements,use of risk-based approaches, role of barrier and isolator technology,
use ofconsistent terminology for classified environments, categories for
processing(open versus closed), and an integrated facility design approach.
对法规符合性要求的不确定性可能阻碍技术进步，并可能导致投资和运营成本上升。
ISPE基准指南:无菌产品生产设施(第三版)旨在提供对最新的FDA和EMA指导的一致解
释，同时允许灵活和创新的设施设计方法。该指南基于以下关键原则:需要理解产品和工
艺需求，使用基于风险的方法，屏障和隔离技术的作用，使用一致环境分类方法，工艺分
类（开放与封闭）和整合的设施设计方法。
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third
Edition) isintended for a global audience of engineers, designers, and other
professionalsinvolved with facility design for sterile products manufacturing.
Updates forthe third edition of the Guide include: harmonized area classification,
globalfacility design approach, Local Protection/Grade A Air Supply (LP/GAAS)
forareas within lower classified areas, additional details about barrier andisolator
technology, and practical information for particulate monitoring.
ISPE基准指南：无菌产品生产设施(第三版)的目的是面向全球的工程师、设计师和其
他从事无菌产品制造设施设计的专业人员。《指南》第三版更新部分包括:协调区域分级、
全球设施设计方法、地方保护/A级空气供应(LP/GAAS)和针对较低级别的区域，关于屏
障和隔离器技术的额外细节，以及用于微粒监测的实用信息。
该指南主要内容和目录如下：
1. Introduction介绍
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