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
1.1 Background背景
1.2 Scope andpurpose of this guide指南的目的和范围
1.3 Key features ofthis guide该指南的关键特点
1.4 Terminology Usedin this guide该指南使用的术语
1.5 Changes sincethe previous edition of this guide该指南相较上一版的变化
1.6 Considerationsfor legacy facilities遗留设施考虑事项
2. Regulatory,design concepts, and manufacturing philosophies管理、设计概念和制造哲学
2.2 Product requirements 产品需求
2.4 Risk Mitigation/” quality by design”风险缓解
2.5 Contamination Control Approaches控制污染的方法
2.6 Area classification definitions区域分级定义
2.7 Hazard and operator protection 危害及员工防护
2.8 Open/Closed processing 开放/封闭工艺
2.9 Integrated Facility Design整体设施设计
2.10 Other considerations其他考虑事项
3. Process Equipment Considerations 工艺设备考虑事项
3.1 introduction介绍
3.2 Process description 工艺描述
3.2 Process description 工艺描述
4. Architecture and Layout 建筑风格和布局
4.1 Introduction介绍
4.2 General design criteria 通用设计标准
4.3 Layout considerations 布局考虑事项
4.4 Room function房间功能
4.5 Surface finishes and materials of construction 表面抛光度和建筑材质
4.6 Transfer Zones传输区域
4.7 Support Areas 支持区域
4.8 Concept Diagrams 概念图
5. Heating, Ventilation, and Air Conditioning 空调
5.1 Introduction 介绍
5.2 Cost considerations 价值考虑
5.3 Sources of particulate contamination 颗粒污染的来源
5.4 Environmental requirements环境需求
5.5 Environmental critical parameters 环境的关键参数
5.6 Facility Layout and HVAC design 设施布局和空调设计
5.7 Process knowledge and HVAC design 工艺知识和空调设计
5.8 Monitoring 监测
5.9 Qualifications of HVAC systems 空调系统的确认
5.10 Cleaning and maintenance of HVAC systems 空调系统的清洁和维护
6. Utility Systems 共用系统
6.1 Introduction介绍
6.2 Descriptions描述
6.3 Specific service considerations 特定的服务考虑事项
7 Electrical Services 电气服务
7.1 Introduction 介绍
7.2 General requirement 通用考虑
7.3 Control system power控制系统电源
7.4 Power distribution电力分布
7.5 lighting 照明
7.6 Hazardous Environments 危险环境
7.7 Wiring 接线
7.8 Door interlocks门互锁
7.9 Outlets and Miscellaneous Equipment 出口以及其他设备
8. Control and Instrumentation控制和仪表系统
8.1 Introduction介绍
8.2 Critical Process Parameters-environmental 关键的环境工艺参数
8.3 Instrumentation仪表
8.4 Production Process Parameters 产品工艺参数
8.5 General Design lssues通用设计问题
8.6 HVAC 空调
9 Barrier and Isolator Technology 屏障及隔离器技术
9.1 Introduction介绍
9.2 System Definitions系统定义
9.3 System Comparisons系统比较
9.4 Factors to Consider when Choosing Among these Technologies在这些技术中选择是考虑的因素
9.5 Equipment design for inside an isolator or RABS隔离器或RABS
9.6 Decontamination cycle development(Isolators) 净化循环开发（隔离器）
9.7 Environmental Monitoring环境监测
9.8 Leak Rate 泄漏率
9.9 Maintenance维护
9.10 Training 培训
10. General Considerations通用考虑
10.1 introduction 介绍
10.2 Environmental-General 通用环境要求
10.3 Environmental-Waste Water 废水-环境要求
10.4 Environmental Noise环境噪声
10.5 Environmental-solid and Concentrated Wastes环境废物和集中废物
10.6 Health and Safety健康和安全
10.7 Site selection and location地点选择和位置
10.8 Energy sources 能量来源
10.9 Auditing, Monitoring, and Reporting审计，监测和报告
10.10 Security 安全
11. Appendix 1-HVAC: additional engineering information 附件1-HVAC：额外的工程信息
11.1 Introduction 介绍
11.2 Sources of particulate Contamination颗粒污染的来源
11.3 HVAC design principles 空调系统设计原则
11.4 Calculation of air change rate空气换气率计算
11.5 Process knowledge 工艺知识
11.6 HVAC system design 空调系统设计
11.7 Horizontal versus vertical unidirectional air flow (UAF)水平与垂直单向气流（UAF）
11.8 Airflow velocity considerations气流速度考虑
11.9 Differential pressure control and Alerts/Alarms压差控制和报警
11.10 Biological safety or Bio-containment (BSL)生物安全或生物密闭（BSL）
11.11 Other HVAC Considerations其他的空调考虑
11.12 Pass-Through Boxes 传递箱
12. Appendix 2-References 附录2-参考文件
13.appendix 3-Glossary-附录3 术语
翻译仅供参考，请以官网英文为准。
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