【正文】 Dosage Forms: Parenteral Medications Third Edition Volume 2: Facility Design, Sterilization and Processing Edited by . Sandeep Nema healthcare John D. Ludwig Pharmaceutical Dosage FormsThis page intentionally left blankPharmaceutical Dosage Forms Parenteral Medications Third Edition Volume 2 Facility Design, Sterilization and Processing Edited by Sandeep Nema Pfizer, Inc. Chesterfield, Missouri， . John D. Ludwig Pfizer， Inc. Chesterfield, Missouri， . informa healthcare First published in 1984 by Marcel Dekker, Inc., New York, New York. This edition published in 2010 by Informa Healthcare, Telephone House, 6977 Paul Street, London EC2A 4La UK. Simultaneously published in the USA by Informa Healthcare, 52 Vanderbilt Avenue, 7th Floor, New York, NY 10017, USA. Infomia Healthcare is a trading division of Informa UK Ltd. Registered Office: 3741 Mortimer Street, London WIT 3JH, UK. Registered in England and Wales number 1072954. ( 2010 Informa Healthcare, except as otherwise indicated No claim to original . Government works Reprinted material is quoted with permission. Although every effort has been made to ensure that all owners of copyright material have been acknowledged in this publication, we would be glad to acknowledge in subsequent reprints or editions any omissions brought to our attention. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, unless with the prior written permission of the publisher or in accordance with the provisions of the Copyright, Designs and Patents Act 1988 or under the terms of any licence permitting limited copying issued by the Copyright Licensing Agency, 90 Tottenham Court Road, London W1P 0LP, UK, or the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA ( ). Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. This book contains information from reputable sources and although reasonable efforts have been made to publish accurate information, the publisher makes no warranties (either express or implied) as to the accuracy or fitness for a particular purpose of the information or advice contained herein. The publisher wishes to make it clear that any views or opinions expressed in this book by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the publisher. Any information or guidance contained in this book is intended for use solely by medical professionals strictly as a supplement to the medical professionars own judgement, knowledge of the patient39。s medical history, relevant manufacturer39。s instructions and the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice on dosages, procedures, or diagnoses should be independently verified. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the mt^ica 】 professional to make his or her own professional judgements, so as appropriately to advise and treat patients. Save for death or personal injury caused by the publisher39。s negligence and to the fullest extent otherwise permitted by law, neither the publisher nor any person engaged or employed by the publisher shall be responsible or liable for any loss, injury or damage caused to any person or property arising in any way from the use of this book. A CIP record for this book is available from the British Library. Library of Congress CataloginginPublication Data available on application ISBN13: 9781420086454 ISBN13: 9781420086539 (threevolume set) Orders may be sont to: Informa Healthcare, Sheepen Place, Colchester, Essex C03 3LP, UK Telephone: +44 (0)20 7017 5540 Email: Website： : / / / For corporate sales please contact: CorporateBooksIHC174。 For foreign rights please contact: For reprint permissions please contact: Typeset by MPS Limited, A Macmillan Company Printed and bound in India We dedicate this work to those who have inspired us. To my parents Walter and Ruth Ludwig and my wife Sue Ludwig To my parents Hari and Pratiblm Nema and my wife Tina BuschNemaThis page intentionally left blankForeword I was a faculty member at the University of Tennessee and a colleague of Dr. Kenh Avis when he conceived, organized, and edited (along with . Lieberman and L. Lachman) the first edition of this book series that was published in 1984. It was so well received by the pharmaceutical science munity that an expanded threevolume second edition was published in 1992. Dr. Avis did not survive long enough to oversee a third edition, and it was questionable whether a third edition would ever be published until two of his graduate students, Drs. Nema and Ludwig, took it upon themselves to carry on Dr. Avis39。 tradition. Their oversight of this third edition is work that their mentor would be highly pleased and proud of. From 29 chapters in the second edition to 43 chapters in this new edition, this threevolume series prehensively covers both the traditional subjects in parenteral science and technology as well as new and expanded subjects. For example, separate chapter topics in this edition not found in previous editions include solubility and solubilization, depot delivery systems, biophysical and biochemical characterization of peptides and proteins, container closure integrity testing, water systems, endotoxin testing, focused chapters on different sterilization methods, risk assessment in aseptic processing, visual inspection, advances in injection devices, RNA