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Hugo and Russell’s Pharmaceutical Microbiology EDITED BY Stephen P Denyer B Pharm PhD FRPharmS Welsh School of Pharmacy Cardiff University Cardiff Norman A Hodges B Pharm PhD MRPharmS School of Pharmacy and Biomolecular Sciences Brighton University Lewes Road Brighton Sean P Gorman BSc PhD MPS School of Pharmacy Queen’s University Belfast Medical Biology Centre University Road Belfast SEVENTH EDITION Blackwell Science Hugo and Russell’s Pharmaceutical Microbiology Hugo and Russell’s Pharmaceutical Microbiology EDITED BY Stephen P Denyer B Pharm PhD FRPharmS Welsh School of Pharmacy Cardiff University Cardiff Norman A Hodges B Pharm PhD MRPharmS School of Pharmacy and Biomolecular Sciences Brighton University Lewes Road Brighton Sean P Gorman BSc PhD MPS School of Pharmacy Queen’s University Belfast Medical Biology Centre University Road Belfast SEVENTH EDITION Blackwell Science © 1977, 1980, 1983, 1987, 1992, 1998, 2004 by Blackwell Science Ltd a Blackwell Publishing company Blackwell Science, Inc., 350 Main Street, Malden, Massachusetts 02148-5020, USA Blackwell Publishing Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK Blackwell Science Asia Pty Ltd, 550 Swanston Street, Carlton, Victoria 3053, Australia The right of the Author to be identified as the Author of this Work has been asserted in accordance with the Copyright, Designs and Patents Act 1988. 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, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. First published 1977 Second edition 1980 Third edition 1983 Reprinted 1986 Fourth edition 1987 Reprinted 1989, 1991 Italian edition 1991 Fifth edition 1992 Reprinted 1993, 1994, 1995 Sixth edition 1998 Reprinted 1999, 2000, 2002, 2003 Seventh edition 2004 Library of Congress Cataloging-in-Publication Data Hugo and Russell’s pharmaceutical microbiology / edited by Stephen Denyer, Norman A. Hodges, Sean P. Gorman. — 7th ed. p. cm. Rev. ed. of: Pharmaceutical microbiology / edited by W.B. Hugo and A.D. Russell. Includes bibliographical references and index. ISBN 0-632-06467-6 1. Pharmaceutical microbiology. [DNLM: 1. Anti-Infective Agents. 2. Technology, Pharmaceutical. QV 250 H895 2004] I. Title: Pharmaceutical microbiology. II. Hugo, W. B. (William Barry) III. Denyer, S. P. IV. Hodges, Norman A.V,. Gorman, S. P. VI. Pharmaceutical microbiology. QR46.5.P48 2004 615¢.1¢01579 —dc22 2003024264 ISBN 0–632–06467–6 A catalogue record for this title is available from the British Library Set in Sabon 9.5/12 pt by SNP Best-set Typesetter Ltd., Hong Kong Printed and bound in the United Kingdom by Ashford Colour Press, Gosport Commissioning Editor: Maria Khan Managing Editor: Rupal Malde Production Editor: Fiona Pattison Production Controller: Kate Charman For further information on Blackwell Publishing, visit our website: http://www.blackwellpublishing.com v Contributors, vii Preface to Seventh Edition, ix Preface to First Edition, x Part 1: Biology of Microorganisms 1. Introduction to Pharmaceutical Microbiology, 3 Stephen Denyer, Norman Hodges and Sean Gorman 2. Fundamental Features of Microbiology, 9 Norman Hodges 3. Bacteria, 23 David Allison and Peter Gilbert 4. Fungi, 44 Kevin Kavanagh and Derek Sullivan 5. Viruses, 59 Jean-Yves Maillard and David Stickler 6. Protozoa, 82 Tim Paget 7. Principles of Microbial Pathogenicity and Epidemiology, 103 Peter Gilbert and David Allison Part 2: Antimicrobial Agents 8. Basic Aspects of the Structure and Functioning of the Immune System, 117 Mark Gumbleton and James Furr 9. Vaccination and Immunization, 138 Peter Gilbert and David Allison 10. Types of Antibiotics and Synthetic Antimicrobial Agents, 152 A Denver Russell 11. Laboratory Evaluation of Antimicrobial Agents, 187 JMB Smith 12. Mechanisms of Action of Antibiotics and Synthetic Anti-infective Agents, 202 Peter Lambert 13. Bacterial Resistance to Antibiotics, 220 Anthony Smith 14. Clinical Uses of Antimicrobial Drugs, 233 Roger Finch Part 3: Microbiological Aspects of Pharmaceutical Processing 15. Ecology of Microorganisms as it Affects the Pharmaceutical Industry, 251 Elaine Underwood 16. Microbial Spoilage, Infection Risk and Contamination Control, 263 Rosamund Baird 17. Chemical Disinfectants, Antiseptics and Preservatives, 285 Sean Gorman and Eileen Scott 18. Non-Antibiotic Antibacterial Agents: Mode of Action and Resistance, 306 Stephen Denyer and A Denver Russell 19. Sterile Pharmaceutical Products, 323 James Ford 20. Sterilization Procedures and Sterility Assurance, 346 Stephen Denyer and Norman Hodges 21. Factory and Hospital Hygiene, 376 Robert Jones 22. Manufacture of Antibiotics, 387 Sally Varian Contents Contents vi 23. The Manufacture and Quality Control of Immunological Products, 398 Michael Corbel 24. Pharmaceutical Biotechnology, 416 Miguel Cámara 25. Additional Applications of Microorganisms in the Pharmaceutical Sciences, 441 Denver Russell Index, 459 vii Contributors Dr David Allison School of Pharmacy and Pharmaceutical Sciences University of Manchester Oxford Road Manchester M13 9PL UK Dr Rosamund Baird Visiting Senior Lecturer School of Pharmacy and Pharmacology University of Bath Claverton Down Bath BA2 7AY UK Dr Miguel Cámara Senior Lecturer in Molecular Microbiology Institute of Pharmaceutical Sciences School of Pharmaceutical Sciences University of Nottingham Nottingham NG7 2RD UK Dr Michael Corbel National Institute for Biological Standards and Control Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK Professor Stephen Denyer Welsh School of Pharmacy Cardiff University Cardiff CF10 3XF UK Professor Roger Finch Professor of Infectious Diseases Clinical Sciences Building University of Nottingham The City Hospital Nottingham NG5 1PB UK Dr Robert Jones School of Pharmacy and Biomedical Sciences University of Portsmouth St Michael’s Building White Swan Road Portsmouth PO1 2DT UK Dr Kevin Kavanagh Head of Medical Mycology Unit Department of Biology National University of Ireland Maynooth Co. Kildare Ireland Dr Peter Lambert Aston Pharmacy School Aston University Aston Triangle Birmingham B4 7ET UK Dr Jean-Yves Maillard School of Pharmacy and Biomolecular Sciences University of Brighton Lewes Rd Brighton BN2 4GJ UK Dr Tim Paget Department of Biological Sciences University of Hull Hull HU6 7RX UK Professor A Denver Russell Welsh School of Pharmacy Cardiff University King Edward VII Avenue Cardiff CF10 3XF Wales Dr Eileen Scott School of Pharmacy The Queen’s University of Belfast Belfast BT9 7BL Northern Ireland Professor James Ford School of Pharmacy and Chemistry Liverpool John Moores University Byrom Street Liverpool L3 3AF UK Dr James Furr Welsh School of Pharmacy Cardiff University King Edward VII Avenue Cardiff CF10 3XF Wales Professor Peter Gilbert School of Pharmacy and Pharmaceutical Sciences University of Manchester Oxford Rd Manchester M13 9PL UK Professor Sean Gorman Professor of Pharmaceutical Microbiology School of Pharmacy The Queen’s University of Belfast Belfast BT9 7BL Northern Ireland Dr Mark Gumbleton Welsh School of Pharmacy Cardiff University King Edward VII Avenue Cardiff CF10 3XF Wales Dr Norman Hodges Principal Lecturer in Pharmaceutical Microbiology School of Pharmacy and Biomolecular Sciences University of Brighton Lewes Road Brighton BN2 4GJ UK Contributors viii Dr Anthony Smith Department of Pharmacy and Pharmacology University of Bath (5 West — 2.18) Claverton Down Bath BA2 7AY UK Professor JMB (Sandy) Smith Head of Department of Microbiology Otago School of Medical Sciences University of Otago Dunedin New Zealand Dr Elaine Underwood SMA Nutrition Huntercomb Lane South Taplow Maidenhead Berks SL6 0PH UK Dr Sally Varian Consultant Ulverston Cumbria LA12 8PT UK Dr David Stickler School of Biosciences Cardiff University Main Building Museum Avenue PO Box 915 Cardiff CF10 3TL Wales Dr Derek Sullivan Microbiology Research Unit School of Dental Science Trinity College Dublin 2 Ireland ix Preface to the Seventh edition We were much honoured to be recommended by Professor A.D. Russell to act as editors for the 7th edition of Pharmaceutical Microbiology. All three of us have used this textbook in its various editions throughout our careers as teachers and researchers, and we recognize the important role it fulfils. As might be anticipated when a new editorial team is in place, a substantial number of changes have been made. Well over half the chapters have new authors or co-authors. We also use Chapter 1 to give a rationale for the scope and content of the book, emphasizing the interrelated character of the discipline of pharmaceutical microbiology. In addi- tion, by combining and reorganizing chapters, by introducing new material and through a revised page format we have tried to provide readers with a distinctive 7th edition. We must thank our contributors for their willing collaboration in this enterprise, especially Professor Russell for his continuing contri- butions, and our publishers for their support and expertise. Finally, this addition is a tribute to the farsighted- ness of A.D. Russell and W.B. Hugo who took up the challenge in 1977 to produce a popular and con- cise read for pharmacy students required to study pharmaceutical microbiology. We are delighted that this current edition recognizes these origins by continuing the association with Hugo and Russell in its revised title. S.P. Denyer S.P. Gorman N.A. Hodges x When we were first approached by the publishers to write a textbook on pharmaceutical microbiology to appear in the spring of 1977, it was felt that such a task could not be accomplished satisfactorily in the time available. However, by a process of combined editorship and by invitation to experts to contribute to the various chapters this task has been accomplished thanks to the cooperation of our collaborators. Pharmaceutical microbiology may be defined as that part of microbiology which has a special bear- ing on pharmacy in all its aspects. This will range from the manufacture and quality control of phar- maceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged from the chapter contents. As this book is aimed at undergraduate pharmacy students (as well as microbiologists en- tering the pharmaceutical industry) we were under constraint to limit the length of the book to retain it in a defined price range. The result is to be found in the following pages. The editors must bear respon- sibility for any omissions, a point which has most concerned us. Length and depth of treatment were determined by the dictate of our publishers. It is hoped that the book will provide a concise reading for pharmacy students (who, at the moment, lack a textbook in this subject) and help to highlight those parts of a general microbiological training which impinge on the pharmaceutical industry. In conclusion, the editors thank most sincerely the contributors to this book, both for complying with our strictures as to the length of their contribu- tion and for providing their material on time, and our publishers for their friendly courtesy and effi- ciency during the production of this book. We also wish to thank Dr H.J. Smith for his advice on vari- ous chemical aspects, Dr M.I. Barnett for useful comments on reverse osmosis, and Mr A. Keall who helped with the table on sterilization methods. W.B. Hugo A.D. Russell Preface to the First Edition Part 1 Biology of Microorganisms 3 1 Microorganisms and medicines Despite continuing poverty in many parts of the world and the devastating effects of HIV and AIDS infection on the African continent and elsewhere, the health of the world’s population is progressively improving. This is reflected in the increase in life expectancy that has been recorded for the great majority of the countries reporting statistics to the World Health Organization over the last 40 years. In Central America, for example, the life expectancy has increased from 55 years in 1960 to 71 years in 2000, and the increase in North (but not sub- Saharan) Africa is even greater, from 47 to 68 years. Much of this improvement is due to better nutrition and sanitation, but improved health care and the greater availability of effective medicines with which to treat common diseases are also major contributing factors. Substantial inroads have been made in the prevention and treatment of cancer, cardiovascular disease and other major causes of death in Western society, and of infections and diar- rhoeal disease that remain the big killers in develop- ing countries. Several infectious diseases have been eradicated completely, and others from substantial parts of the world. The global eradication of small- pox in 1977 is well documented, but 2002 saw three of the world’s continents declared free of polio, and the prospects are good for the total elimination of polio, measles and Chagas disease. The development of the many vaccines and other medicines that have been so crucial to the improve- ment in world heath has been the result of the large investment in research by the major international pharmaceutical companies. This has led to the manufacture of pharmaceuticals becoming one of the most consistently successful and important in- dustries in many countries, not only in the tradi- tional strongholds of North America, Western Europe and Japan but, increasingly, in Eastern Eu- rope, the Indian subcontinent and the Far East. Worldwide sales of medicines and medical devices are estimated to have exceeded $US 401 billion (ap- proximately £250 billion) in 2002, and this figure is rising by 8% per annum. In the UK alone, the value of pharmaceutical exports is currently £10.03 bil- lion each year, a figure that translates to more than £150 000 for each employee in the industry. The growth of the pharmaceutical industry in re- cent decades has been paralleled by rising standards for product quality and more rigorous regulation of manufacturing procedures. In order to receive a manufacturing licence, a modern medicine must be shown to be effective, safe and of good quality. Most medicines consist of an active ingredient that is formulated with a variety of other materials (ex- cipients) that are necessary to ensure that the medi- cine is effective, and remains stable, palatable and safe during storage and use. While the efficacy and safety aspects of the active ingredient are within the domain of the pharmacologist and toxicologist, respectively, many other disciplines contribute to the efficacy, safety and quality of the manufactured product as a whole. Analytical chemists and phar- macists take lead responsibility for ensuring that the components of the medicine are present in the correct physical form and concentration, but quality is not judged solely on the physicochemical properties of the product: microorganisms also have the potential to influence efficacy and safety. It is obvious that medicines contaminated with potentially pathogenic (disease-causing) micro- Chapter 1 Introduction to pharmaceutical microbiology Stephen Denyer, Norman Hodges and Sean Gorman 1 Microorganisms and medicines 2 The scope and content of the book

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