Hugo and Russell’s

Pharmaceutical Microbiology

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Hugo and Russell’s

Pharmaceutical MicrobiologyEDITED BY

Stephen P. Denyer B Pharm PhD FRPharmSProfessor of Pharmacy and Deputy Pro Vice-Chancellor

Welsh School of Pharmacy

Cardiff University

Cardiff

Norman Hodges B Pharm PhDPrincipal Lecturer

School of Pharmacy and Biomolecular Sciences

Brighton University

Lewes Road

Brighton

Sean P. Gorman CBE BSc PhD FPSDean, Faculty of Medicine, Health and Life Sciences

Professor of Pharmaceutical Microbiology

Queen’s University Belfast

Belfast

Brendan F. Gilmore BSc, PhD, MRSC, MPSSenior Lecturer in Pharmaceutics

School of Pharmacy

Queen’s University Belfast

Medical Biology Centre

Belfast

EIGHTH EDITION

A John Wiley & Sons, Ltd., Publication

This edition fi rst published 2011 © 2011 by Blackwell Publishing Ltd

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First published 1977Second edition 1980Third edition 1983Reprinted 1986Fourth edition 1987Reprinted 1989, 1991Italian edition 1991

Fifth edition 1992Reprinted 1993, 1994, 1995Sixth edition 1998Reprinted 1999, 2000, 2002, 2003Seventh edition 2004Eighth edition 2011

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Library of Congress Cataloging-in-Publication DataHugo and Russell's pharmaceutical microbiology / edited by Stephen P. Denyer ... [et al.]. – 8th ed. p. ; cm. Includes bibliographical references and index. ISBN-13: 978-1-4443-3063-2 (pbk. : alk. paper) ISBN-10: 1-4443-3063-2 (pbk. : alk. paper) 1. Pharmaceutical microbiology. I. Denyer, S. P. II. Hugo, W. B. (William Barry). Pharmaceutical microbiology. III. Title: Pharmaceutical microbiology. [DNLM: 1. Anti-Infective Agents. 2. Microbiological Phenomena. 3. Microbiological Techniques. 4. Technology, Pharmaceutical. QV 250] QR46.5.P48 2011 615'.101579–dc22

2011007514

ISBN 9781444330632

A catalogue record for this book is available from the British Library.

Set in 9.25/11.5 pt Minion by Toppan Best-set Premedia Limited

1 2011

Contents

List of contributors vii

Preface to the eighth edition ix

Preface to the fi rst edition x

Part 1 Biology of microorganisms 1

1 Introduction to pharmaceutical microbiology 3Norman Hodges

2 Fundamental features of microbiology 9Norman Hodges

3 Bacteria 24David Allison

4 Fungi 44Kevin Kavanagh and Judy Kelly

5 Viruses 59Jean-Yves Maillard

6 Protozoa 84Tim Paget

Part 2 Pathogens and host responses 107

7 Principles of microbial pathogenicity and epidemiology 109David Allison and Andrew McBain

8 Microbial biofi lms: consequences for health 121Howard Ceri, Sean P. Gorman and Brendan F. Gilmore

9 Immunology 131Mark Gumbleton and Mathew W. Smith

10 Vaccination and immunization 151Andrew McBain and David Allison

Part 3 Prescribing therapeutics 167

11 Antibiotics and synthetic antimicrobial agents: their properties and uses 169Norman Hodges

v

vi Contents

12 Mechanisms of action of antibiotics and synthetic anti-infective agents 200Peter Lambert

13 Bacterial resistance to antibiotics 217Anthony W. Smith

14 Clinical uses of antimicrobial drugs 230Hayley Wickens and Roger Finch

15 Antibiotic prescribing and antibiotic stewardship 248Norman Hodges

16 Public health microbiology: infection prevention and control 257Brian I. Duerden

Part 4 Contamination and infection control 271

17 Microbial spoilage, infection risk and contamination control 273Rosamund M. Baird

18 Laboratory evaluation of antimicrobial agents 293Brendan F. Gilmore, Howard Ceri and Sean P. Gorman

19 Chemical disinfectants, antiseptics and preservatives 312Sean P. Gorman and Brendan F. Gilmore

20 Non-antibiotic antimicrobial agents: mode of action and resistance 334Stephen P. Denyer and Jean-Yves Maillard

21 Sterilization procedures and sterility assurance 352Stephen P. Denyer, Norman Hodges and Catherine Talbot

Part 5 Pharmaceutical production 379

22 Sterile pharmaceutical products 381James L. Ford and Robert W. Jones

23 Principles of good manufacturing practice 402Robert W. Jones, Shaqil Chaudary, Touraj Ehtezazi and James L. Ford

24 The manufacture and quality control of immunological products 416Michael Corbel and Dorothy Xing

25 Recombinant DNA technology 435Miguel Cámara and Stephan Heeb

Part 6 Current trends and new directions 461

26 The wider contribution of microbiology to the pharmaceutical sciences 463Mathew W. Smith, James C. Birchall and Sion A. Coulman

27 Alternative strategies for antimicrobial therapy 483Geoff Hanlon

Index 495

List of contributors

Dr David Allison Senior Lecturer School of Pharmacy and Pharmaceutical Sciences University of Manchester Oxford Road Manchester UK

Dr Rosamund M. Baird Visiting Senior Lecturer School of Pharmacy and Pharmacology University of Bath Claverton Down Bath UK

Dr James C. Birchall Reader in Pharmaceutics Welsh School of Pharmacy Cardiff University Cardiff UK

Professor Miguel C á mara Professor of Molecular Microbiology School of Molecular Medical Sciences University of Nottingham Nottingham UK

Professor Howard Ceri Chairman Biofi lm Research Group and Professor of Biological Sciences University of Calgary Calgary Alberta Canada

Dr Shaqil Chaudary Principal Lecturer School of Pharmacy & Biomolecular Sciences Liverpool John Moores University Liverpool UK

Dr Michael Corbel Head of Division Bacteriology Division National Institute for Biological Standards and Control South Mimms Potters Bar Hertfordshire UK

Dr Sion A. Coulman Lecturer in Pharmacy Welsh School of Pharmacy Cardiff University Cardiff UK

Professor Stephen P. Denyer Professor of Pharmacy and Deputy ProVice-Chancellor Welsh School of Pharmacy Cardiff University Cardiff UK

Professor Brian I. Duerden Inspector of Microbiology and Infection Control Department of Health England; Emeritus Professor of Medical Microbiology Cardiff University Cardiff UK

Dr Touraj Ehtezazi Senior Lecturer School of Pharmacy & Biomolecular Sciences Liverpool John Moores University Liverpool UK

Professor Roger Finch Professor of Infectious Diseases The Nottingham University Hospitals NHS Trust City Hospital Campus Nottingham UK

Professor James L. Ford Director School of Pharmacy & Biomolecular Sciences Liverpool John Moores University Liverpool UK

Dr Brendan F. Gilmore Senior Lecturer in Pharmaceutics School of Pharmacy Queen ’ s University Belfast Belfast UK

Professor Sean P. Gorman Dean, Faculty of Medicine Health & Life Sciences Professor of Pharmaceutical Microbiology Queen ’ s University Belfast Belfast UK

Dr Mark Gumbleton Reader Welsh School of Pharmacy Cardiff University Cardiff UK

Professor Geoff Hanlon Professor of Pharmaceutical Microbiology School of Pharmacy and Biomolecular Sciences University of Brighton Brighton UK

vii

viii List of contributors

Dr Stephan Heeb Senior Research Fellow School of Molecular Medical Sciences University of Nottingham Nottingham UK

Dr Norman Hodges Principal Lecturer in Pharmaceutical Microbiology School of Pharmacy and Biomolecular Sciences Brighton University Brighton UK

Dr Robert W. Jones Senior Lecturer School of Pharmacy & Biomolecular Sciences Liverpool John Moores University Liverpool UK

Dr Kevin Kavanagh Head of Laboratory Medical Mycology Unit Department of Biology National University of Ireland Maynooth Co. Kildare Ireland

Dr Judy Kelly Research Fellow Department of Biology National University of Ireland Maynooth Co. Kildare Ireland

Professor Peter Lambert Professor of Microbiology School of Life and Health Sciences Aston University Birmingham UK

Dr Jean - Yves Maillard Reader in Pharmaceutical Microbiology Welsh School of Pharmacy Cardiff University Cardiff UK

Dr Andrew McBain Senior Lecturer in Microbiology School of Pharmacy and Pharmaceutical Sciences University of Manchester Manchester UK

Professor Tim Paget Professor of Chemistry and Chair Lehman College-CUNY Bronx, NY, USA

Dr Anthony W. Smith Dean The School of Pharmacy University of London London UK

Dr Mathew W. Smith Lecturer Welsh School of Pharmacy Cardiff University Cardiff UK

Mrs Catherine Talbot Education Development Offi cer, Education and Students Welsh School of Pharmacy Cardiff University Cardiff UK

Dr Hayley Wickens Senior Lead Pharmacist, Antibiotic Audit and Research Imperial College Healthcare NHS Trust Pharmacy Department St Mary ’ s Hospital London UK

Dr Dorothy Xing Principal Scientist Bacteriology Division National Institute for Biological Standards and Control South Mimms Potters Bar Hertfordshire UK

Preface to the eighth edition

We have been enthusiastic participants in the preparation of this 8 th edition of Pharmaceutical Microbiology, a textbook which has again grown in size, refl ecting advances in knowledge and the sustained relevance of microbiology in pharmacy. We have continued to develop the theme of recent editions, strengthening the connec-tion between the basic sciences and clinical practice with an increased emphasis on pathogens and the host response, prescribing therapeutics and public health microbiology.

ix

Once again, the editors must pay tribute to the willing efforts of our contributors, some of whom join us for the fi rst time. So too must we thank our publishers for their support and expertise.

A book that outlasts its original editors is a tribute to their far - sightedness. It is with great sadness but much respect that the editors record the passing of Denver Russell in 2004. This edition is dedicated to him.

S.P. Denyer B. Gilmore

S.P. Gorman N.A. Hodges

Preface to the fi rst edition

When we were fi rst 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 coopera-tion of our collaborators.

Pharmaceutical microbiology may be defi ned as that part of microbiology which has a special bearing on phar-macy in all its aspects. This will range from the manufac-ture and quality control of pharmaceutical 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 stu-dents (as well as microbiologists entering the pharmaceu-tical industry) we were under constraint to limit the length of the book to retain it in a defi ned price range. The result is to be found in the following pages. The editors must bear responsibility for any omissions, a

point which has most concerned us. Length and depth of treatment were determined by the dictate of our publish-ers. 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 contribution and for providing their material on time, and our publishers for their friendly courtesy and effi ciency during the produc-tion of this book. We also wish to thank Dr H.J. Smith for his advice on various 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

x

Part 1 Biology of m icroorganisms

1 Introduction to p harmaceutical m icrobiology

3

Norman Hodges Brighton University, Brighton, UK

1 Microorganisms and medicines 3 2 Scope and content of the book 6

1 Microorganisms and m edicines

The opening paragraph of the previous edition of this book published in 2004 stated that ‘ despite continuing poverty in many parts of the world and the devastating effects of HIV and AIDS, the health of the world’s popula-tion is progressively improving ’ . That trend has been sus-tained in recent years with the number of AIDS deaths reaching a peak in 2006 and the number of new HIV infec-tions falling 16% between 2000 and 2008. During that same period life expectancy rose in 157 out of the 193 countries reporting data to the World Health Organization and declined in only 9. 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 human and animal diseases are also major contributing factors. Substantial inroads have been made in both the prevention and treatment of cancer, cardiovascular disease and other major causes of death in Western society, and of infections and diarrhoeal disease that remain the big killers in developing countries. Several infectious diseases have been eradicated completely, and others from substantial parts of the world. The global eradication of smallpox in 1977 is well documented, and in 2011 rinderpest, the high - mortality cattle disease

which, for centuries, has contributed to poverty and famine in Africa and Asia, will also formally be declared extinct; polio and guinea - worm infection are expected to follow in the next few years.

The development of the many vaccines and other medicines that have been so crucial to the improvement in world health has been the result of the large investment in research by the major international pharmaceutical companies. This has led to the manufacture of pharma-ceuticals becoming one of the most consistently success-ful and important industries in many countries, not only in the traditional strongholds of North America, Western Europe and Japan but, increasingly, in Eastern Europe, the Indian subcontinent and the Far East. Worldwide sales of medicines and medical devices are estimated to have exceeded $711 billion in 2007 (the latest year for which statistics are available), and in the UK pharmaceu-ticals was the industry sector with the largest trade surplus in 2007 having exports of £ 14.6 billion — a fi gure that translates into more than £ 235 000 for each employee in the industry. The growth of the pharmaceutical indus-try in recent decades has been paralleled by rising stand-ards for product quality and more rigorous regulation of manufacturing procedures. In order to receive a manu-facturing licence, a modern medicine must be shown to be effective, safe and of good quality. Most medicines

Hugo and Russell’s Pharmaceutical Microbiology, Eighth Edition. Edited by Stephen P. Denyer, Norman Hodges, Sean P. Gorman, Brendan F. Gilmore.© 2011 Blackwell Publishing Ltd. Published 2011 by Blackwell Publishing Ltd.