ISPE第四卷,水系统”中英文对照.pdf,TABLE OF CONTENTS 目录 ACKNOWLEDGEMENTS 致谢 1. INTRODUCTION 1.1 BACKGROUND 1.2 SCOPE OF THIS GUIDE 1.3 SOME APPLICABLE FDA CURRENT REGULATIONS AND GUIDES FOR PHARMACEUTICAL WATER SYSTEMS. 1.4 KEY CONCEPTS 1.5 GUIDE STR
Water for Pharmaceutical Process 25 第六章 物料与产品 . 26 Chapter 6 Material and products. 26 . 第一节 原则 . 26 . Section 1 Principle 26 . 第二节 原辅料 . 27 . Section 2 Raw materials and Excipients 27 . 第三节 中间产品和待包装产品 28 . Section 3 Intermediate and Bulk products ...
ISPE酸洗钝化指南(中英对照)ISPE化学工业技术指南清洗钝化部分（11.3）
ISPE新药转移技术指南 英文 第一版 ISPE_Technology-transfer_2003.pdf,For individual use only. © Copyright ISPE 2003. All rights reserved. TECHNOLOGY TRANSFER Limitation of Liability In no event shall ISPE or any of its affiliates, or the officers, direc
TheInternational Council for Harmonization of Technical Requirements forPharmaceuticals for Human Use (ICH) guidelines contain information regardingregulatory requirements for raw materials. There should be a system forevaluating critical suppliers and a specification agreed upon with the supplierand approved by...
focusesoninternationalguidelinesandISPEReleasesGoodPracticeGuideOnProcessGases ispereleasesgoodpracticeguideonprocess-DeutscheMesseAGissteppingupitscommitmenttotheAsia- PacificRegionwithnew,largerofficepremisesinTokyoforitsJapanesesubsidiaryandanewexclusive ispegoodpracticeguides|ispe-ISPEGoodPracticeGuide:ProcessGases;ISPEGo...
water additives (e.g., chelating agents) should not be used, as they can make occupant breathing air unsafe. Steam used for humidification should comply with ASHRAE 62 (Indoor Air Quality) guidelines [17], and any locally applicable codes. Products may be sensitive to boiler additives...
ISPE酸洗钝化指南(中英对照)ISPE化学工业技术指南清洗钝化部分（11.3）
It is not intended to replace governing laws, codes, guidelines, standards, or regulations that apply to facilities of this type. The use of this document for new or existing facilities is at the discretion of the facility owner or operator. The purpose of this Guide is to focus on ...
(Ahu) 空气处理单元 30 2.5.3 Fan 风机 30 2.5.4 Fume Exhaust/ Extraction System 烟尘排除系统 31 2.5.5 Heating Coil 加热旋管 31 2.5.6 Cooling Coil 冷却盘管 31 2.5.7 Humidifier 增湿器 31 2.5.8 Dehumidifier 除湿器 31 2.5.9 Air Filtration 空气过滤器 31 2.5.10 Ductwork 管道系统 31 2.5....