ISPE 良好规范指南：HVAC及工艺设备空气过滤器-2019（中英文对照版）.pdf

GOOD PRACTICE GUIDE: 良好规范指南： HVAC and Process Equipment Air Filters HVAC 和工艺设备空气过滤器 Disclaimer: This Good Practice Guide provides guidance on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is solely created and owned by ISPE. It is not a regulation, standard or regulatory guideline document. ISPE cannot ensure and does not warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does not replace the need for hiring professional engineers or technicians. Limitation of Liability In no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each of them, or the authors, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of or in connection with the use of this information. © Copyright ISPE 2019. All rights reserved. All rights reserved. No part of this document may be reproduced or copied in any form or by any means – graphic, electronic, or mechanical, including photocopying, taping, or information storage and retrieval systems – without written permission of ISPE. All trademarks used are acknowledged. ISBN 978-1-946964-27-4 Preface 前言 Heating, Ventilation, and Air Conditioning (HVAC) systems can critically affect the ability of a pharmaceutical facility to meeting its objective of providing safe and effective product to the patient. The I