制药用水和蒸汽系统指南
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A GUIDE FOR NEW FACILITIES
为新型设施准备的指南
VOLUME 4: WATER AND STEAM GUIDE
卷4：水和蒸汽系统的指导原则
EXECUTIVE SUMMARY
执行概况
DECEMBER 2000
2000年12月
A DOCUMENT DEVELOPED IN PARTNERSHIP WITH FDA
本文件由下列单位与FDA合作编写
ISPE PHARMACEUTICAL ENGINEERING GUIDE/ISPE制药工程指南
FOREWORD /序
For many years, the pharmaceutical industry has experienced increases in the cost of new facilities. These
increases in cost have been driven in part by uncertainty about the requirements for regulatory compliance.
Some significant areas of concern are validation, particularly related to automation systems, and the trend to
validate back to source utilities. The absence of a consistent and widely accepted interpretation of some
regulatory requirements has led to one-upmanship. This practice of building increasingly technically advanced
facilities has led to increased cost, longer lead times and, in some cases, delays in bringing new products to
market.
长年以来，制药行业在购进的大量新设施方面的支出一直持续增长。造成这些支出的部分原因是法规符合力度的要求的无常。验证是得到重点关注的方面之一，特别是与自动化系统、回溯验证源效用的趋势、建筑和HVAC有关的内容。一致且得到广泛接受的法规要求的欠缺造就了突出的情况：对技术先进的设施的追求导致成本的剧增、交货与订货之间所需时间的延长、以及，在某些情况下，可导致新产品上市的延期。
In May 1994, engineering representatives from the pharmaceutical industry engaged in a discussion with the
International Society for Pharmaceutical Engineering (ISPE) and the Food and Drug Administration (FDA). As a
result of that discussion in November 1994, ISPE began work on 10 facility engineering Guides, now known as
the Baseline® Pharmaceutical Engineering Guides. The first, “Bulk Pharmaceutical Chemicals,” was published in
June 1996. The second, “Oral Solid Dosage Forms,’” was published in February 1998. The third, “Sterile
Manufacturing Facilities,” was published in February 1999. This is the fourth such Guide, covering
Pharmaceutical Water and Steam Systems. Each Engineering Guide was created by, and is owned solely by
ISPE. FDA provided comments on this and previous Guides, and many of their suggestions have been
incorporated.
1994年5月，制药行业的技术代表与国际制药工程协会（ISPE）和美国食品与药品监督管理局（FDA）召开了讨论会。讨论的结果是从1994年11月起，ISPE开始致力于10本设施工程学指南的编写，这10本指南也就是现在为大家所熟知的Baseline®制药工程指南。1996年6月出版的指南的第一卷的内容是关于批量药用化学品（BPC）的，第2本，“口服固体制剂”出版于1998年2月；第3本，“无菌生产设施”出版于1999年2月。本指南是这个系列的第4卷，介绍的是制药用水和蒸汽系统的内容。每本指南都由ISPE编写，其版权归ISPE独家拥有。FDA对这本指南和本系列之前出版的指南的编写都给予了宝贵意见，这些意见很多都已经整合入本系列丛书中。
As with the BPC Guide, OSD and Sterile Guide, the Water and Steam Guide has been sponsored by ISPE’s
Pharmaceutical Advisory Council, made up of senior pharmaceutical engineering executives from owner
companies, and ISPE senior management. Overall planning, direction and technical guidance in the preparation
of the Water and Steam Guide was provided by a Steering Committee most of whom were involved in the BPC
Guide. The Water and Steam Guide itself was produced by a Task Team of individuals who expended a great
deal of their own time in its preparation and development.
与BPC指南、OSD和无菌指南相同，这本水和蒸汽系统指南也得到了ISPE的药品咨询委员会的赞助；该委员会的成员由企业自身的制药工程高中级资深管理人员、FDA和ISPE管理高层组成。指导委员会为《调试和合格确认指南》的编写提供整体规划、方向的定位和技术指导；该委员会主要由参与BPC指南编写的人员组成。《水和蒸汽系统指南》的编写工作组的成员为这本书的编写和发展花费了大量私人时间。
Editors’ Disclaimer: /编辑的声明
This Guide is meant to assist pharmaceutical manufacturers in the design and construction of new and renovated
facilities that are required to comply with the requirements of the Food and Drug Administration (FDA). The
International Society for Pharmaceutical Engineering (ISPE) cannot ensure, and does not warrant, that a facility
built in accordance with this Guide will be acceptable to FDA.
本指南旨在给药品生产者提供符合美国食品与药品监督管理局（FDA）要求的新设施的设计和构造方面的协助。国际制药工程协会（ISPE）并不为按照本指南要求建造的工厂通过FDA的检查提供担保和保证。
This document is owned by ISPE. No reproduction of the whole or any part of this document is to be made
without the written authority of ISPE.
本文件的版权归ISPE所有。任何人不得在没有得到ISPE的授权信的情况下复制本文件的全部或部分内容。 ACKNOWLEDGEMENTS /感谢
CHAPTER WRITERS AND REVIEWERS /各章的编写人和审查人
The following individuals took lead roles in the preparation of this document:
以下人士在本文件的编写过程中发挥了带头作用：
Gerald L. Geisler, Bristol-Myers Squibb Co. was Team Leader for the Pharmaceutical Water and Steam
Guide. Moe Elmorsi , Boehringer Ingelheim, acted s the Guide mentor.
Guides Steering Committee Chair
Paul Lorenzo, (Retired)/ Paul D’Eramo, Johnson & Johnson
The Core Team on the Pharmaceutical Water and Steam Guide comprised:
Gerald L. Geisler, Bristol-Myers Squibb Co.
Robert Myers, Kvaerner
Jeff Biskup, Clark, Richardson & Biskup
Bob Bader, Kinetics
The Chapter Credits are as follows:
Gerald Geisler, Bristol-Myers Squibb Co. Chapter 1: Introduction
Brian Owens, H2O Pure, Inc.
Gerald Geisler, Bristol-Myers Squibb Co. Chapter 2: Key Design Philosophies
