Hugo And Russell’s Pharmaceutical Microbiology
Hugo and Russell’sPharmaceuticalMicrobiologyEDITED BYStephen P DenyerB Pharm PhD FRPharmSWelsh School of PharmacyCardiff UniversityCardiffNorman A HodgesB Pharm PhD MRPharmSSchool of Pharmacy and Biomolecular SciencesBrighton UniversityLewes RoadBrightonSean P GormanBSc PhD MPSSchool of PharmacyQueen’s University BelfastMedical Biology CentreUniversity RoadBelfastSEVENTH EDITIONBlackwellScience
Hugo and Russell’sPharmaceuticalMicrobiology
Hugo and Russell’sPharmaceuticalMicrobiologyEDITED BYStephen P DenyerB Pharm PhD FRPharmSWelsh School of PharmacyCardiff UniversityCardiffNorman A HodgesB Pharm PhD MRPharmSSchool of Pharmacy and Biomolecular SciencesBrighton UniversityLewes RoadBrightonSean P GormanBSc PhD MPSSchool of PharmacyQueen’s University BelfastMedical Biology CentreUniversity RoadBelfastSEVENTH EDITIONBlackwellScience
1977, 1980, 1983, 1987, 1992, 1998, 2004 by Blackwell Science Ltda Blackwell Publishing companyBlackwell Science, Inc., 350 Main Street, Malden, Massachusetts 02148-5020, USABlackwell Publishing Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UKBlackwell Science Asia Pty Ltd, 550 Swanston Street, Carlton, Victoria 3053, AustraliaThe right of the Author to be identified as the Author of this Work has been asserted inaccordance with the Copyright, Designs and Patents Act 1988.All rights reserved. No part of this publication may be reproduced, stored in a retrievalsystem, or transmitted, in any form or by any means, electronic, mechanical,photocopying, recording or otherwise, except as permitted by the UK Copyright, Designsand Patents Act 1988, without the prior permission of the publisher.First published 1977Second edition 1980Third edition 1983Reprinted 1986Fourth edition 1987Reprinted 1989, 1991Italian edition 1991Fifth edition 1992Reprinted 1993, 1994, 1995Sixth edition 1998Reprinted 1999, 2000, 2002, 2003Seventh edition 2004Library of Congress Cataloging-in-Publication DataHugo 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 0-632-06467-61. Pharmaceutical microbiology.[DNLM: 1. Anti-Infective Agents. 2. Technology, Pharmaceutical. QV 250H895 2004] I. Title: Pharmaceutical microbiology. II. Hugo, W. B. (WilliamBarry) III. Denyer, S. P. IV. Hodges, Norman A.V,. Gorman, S. P. VI.Pharmaceutical microbiology.QR46.5.P48 2004615 .1 01579 — dc222003024264ISBN 0–632–06467–6A catalogue record for this title is available from the British LibrarySet in Sabon 9.5/12 pt by SNP Best-set Typesetter Ltd., Hong KongPrinted and bound in the United Kingdom by Ashford Colour Press, GosportCommissioning Editor: Maria KhanManaging Editor: Rupal MaldeProduction Editor: Fiona PattisonProduction Controller: Kate CharmanFor further information on Blackwell Publishing, visit our website:http://www.blackwellpublishing.com
ContentsContributors, viiPreface to Seventh Edition, ixPreface to First Edition, xPart 1: Biology of Microorganisms1. Introduction to PharmaceuticalMicrobiology, 3Stephen Denyer, Norman Hodges andSean Gorman2. Fundamental Features ofMicrobiology, 9Norman Hodges3. Bacteria, 23David Allison and Peter Gilbert4. Fungi, 44Kevin Kavanagh and Derek Sullivan5. Viruses, 59Jean-Yves Maillard and David Stickler6. Protozoa, 82Tim Paget7. Principles of Microbial Pathogenicity andEpidemiology, 103Peter Gilbert and David AllisonPart 2: Antimicrobial Agents8. Basic Aspects of the Structure and Functioningof the Immune System, 117Mark Gumbleton and James Furr9. Vaccination and Immunization, 138Peter Gilbert and David Allison10. Types of Antibiotics and SyntheticAntimicrobial Agents, 152A Denver Russell11. Laboratory Evaluation of AntimicrobialAgents, 187JMB Smith12. Mechanisms of Action of Antibiotics andSynthetic Anti-infective Agents, 202Peter Lambert13. Bacterial Resistance to Antibiotics, 220Anthony Smith14. Clinical Uses of Antimicrobial Drugs, 233Roger FinchPart 3: Microbiological Aspects ofPharmaceutical Processing15. Ecology of Microorganisms as it Affects thePharmaceutical Industry, 251Elaine Underwood16. Microbial Spoilage, Infection Risk andContamination Control, 263Rosamund Baird17. Chemical Disinfectants, Antiseptics andPreservatives, 285Sean Gorman and Eileen Scott18. Non-Antibiotic Antibacterial Agents: Modeof Action and Resistance, 306Stephen Denyer and A Denver Russell19. Sterile Pharmaceutical Products, 323James Ford20. Sterilization Procedures and SterilityAssurance, 346Stephen Denyer and Norman Hodges21. Factory and Hospital Hygiene, 376Robert Jones22. Manufacture of Antibiotics, 387Sally Varianv
Contents23. The Manufacture and Quality Control ofImmunological Products, 398Michael Corbel24. Pharmaceutical Biotechnology, 416Miguel Cámaravi25. Additional Applications of Microorganisms inthe Pharmaceutical Sciences, 441Denver RussellIndex, 459
ContributorsDr David AllisonProfessor James FordDr Robert JonesSchool of Pharmacy and PharmaceuticalSciencesUniversity of ManchesterOxford RoadManchester M13 9PLUKSchool of Pharmacy and ChemistryLiverpool John Moores UniversityByrom StreetLiverpool L3 3AFUKSchool of Pharmacy and Biomedical SciencesUniversity of PortsmouthSt Michael’s BuildingWhite Swan RoadPortsmouth PO1 2DTUKDr James FurrDr Rosamund BairdVisiting Senior LecturerSchool of Pharmacy and PharmacologyUniversity of BathClaverton DownBath BA2 7AYUKDr Miguel CámaraSenior Lecturer in Molecular MicrobiologyInstitute of Pharmaceutical SciencesSchool of Pharmaceutical SciencesUniversity of NottinghamNottingham NG7 2RDUKDr Michael CorbelNational Institute for Biological Standardsand ControlBlanche LaneSouth MimmsPotters BarHertfordshire EN6 3QGUKProfessor Stephen DenyerWelsh School of PharmacyCardiff UniversityCardiff CF10 3XFUKProfessor Roger FinchProfessor of Infectious DiseasesClinical Sciences BuildingUniversity of NottinghamThe City HospitalNottingham NG5 1PBUKWelsh School of PharmacyCardiff UniversityKing Edward VII AvenueCardiff CF10 3XFWalesProfessor Peter GilbertSchool of Pharmacy and PharmaceuticalSciencesUniversity of ManchesterOxford RdManchester M13 9PLUKDr Kevin KavanaghHead of Medical Mycology UnitDepartment of BiologyNational University of IrelandMaynoothCo. KildareIrelandDr Peter LambertAston Pharmacy SchoolAston UniversityAston TriangleBirmingham B4 7ETUKProfessor Sean GormanProfessor of Pharmaceutical MicrobiologySchool of PharmacyThe Queen’s University of BelfastBelfast BT9 7BLNorthern IrelandDr Mark GumbletonWelsh School of PharmacyCardiff UniversityKing Edward VII AvenueCardiff CF10 3XFWalesDr Jean-Yves MaillardSchool of Pharmacy and BiomolecularSciencesUniversity of BrightonLewes RdBrighton BN2 4GJUKDr Tim PagetDepartment of Biological SciencesUniversity of HullHull HU6 7RXUKDr Norman HodgesPrincipal Lecturer in PharmaceuticalMicrobiologySchool of Pharmacy and BiomolecularSciencesUniversity of BrightonLewes RoadBrighton BN2 4GJUKProfessor A Denver RussellWelsh School of PharmacyCardiff UniversityKing Edward VII AvenueCardiff CF10 3XFWalesDr Eileen ScottSchool of PharmacyThe Queen’s University of BelfastBelfast BT9 7BLNorthern Irelandvii
ContributorsDr Anthony SmithDr David SticklerDr Elaine UnderwoodDepartment of Pharmacy and PharmacologyUniversity of Bath (5 West — 2.18)Claverton DownBath BA2 7AYUKSchool of BiosciencesCardiff UniversityMain BuildingMuseum AvenuePO Box 915Cardiff CF10 3TLWalesSMA NutritionHuntercomb Lane SouthTaplowMaidenheadBerks SL6 0PHUKProfessor JMB (Sandy) SmithHead of Department of MicrobiologyOtago School of Medical SciencesUniversity of OtagoDunedinNew ZealandviiiDr Sally VarianDr Derek SullivanMicrobiology Research UnitSchool of Dental ScienceTrinity CollegeDublin 2IrelandConsultantUlverstonCumbria LA12 8PTUK
Preface to the Seventh editionWe were much honoured to be recommended byProfessor A.D. Russell to act as editors for the 7thedition of Pharmaceutical Microbiology. All threeof us have used this textbook in its various editionsthroughout our careers as teachers and researchers,and we recognize the important role it fulfils.As might be anticipated when a new editorialteam is in place, a substantial number of changeshave been made. Well over half the chapters havenew authors or co-authors. We also use Chapter 1to give a rationale for the scope and content of thebook, emphasizing the interrelated character of thediscipline of pharmaceutical microbiology. In addition, by combining and reorganizing chapters, byintroducing new material and through a revisedpage format we have tried to provide readers with adistinctive 7th edition.We must thank our contributors for theirwilling collaboration in this enterprise, especiallyProfessor Russell for his continuing contributions, and our publishers for their support andexpertise.Finally, this addition is a tribute to the farsightedness of A.D. Russell and W.B. Hugo who took upthe challenge in 1977 to produce a popular and concise read for pharmacy students required to studypharmaceutical microbiology. We are delightedthat this current edition recognizes these origins bycontinuing the association with Hugo and Russellin its revised title.S.P. DenyerS.P. GormanN.A. Hodgesix
Preface to the First EditionWhen we were first approached by the publishers towrite a textbook on pharmaceutical microbiologyto appear in the spring of 1977, it was felt that sucha task could not be accomplished satisfactorily inthe time available.However, by a process of combined editorshipand by invitation to experts to contribute to thevarious chapters this task has been accomplishedthanks to the cooperation of our collaborators.Pharmaceutical microbiology may be defined asthat part of microbiology which has a special bearing on pharmacy in all its aspects. This will rangefrom the manufacture and quality control of pharmaceutical products to an understanding of themode of action of antibiotics. The full extent ofmicrobiology on the pharmaceutical area may bejudged from the chapter contents.As this book is aimed at undergraduatepharmacy students (as well as microbiologists entering the pharmaceutical industry) we were underconstraint to limit the length of the book to retain itin a defined price range. The result is to be found inxthe following pages. The editors must bear responsibility for any omissions, a point which has mostconcerned us. Length and depth of treatment weredetermined by the dictate of our publishers. It ishoped that the book will provide a concise readingfor pharmacy students (who, at the moment, lack atextbook in this subject) and help to highlight thoseparts of a general microbiological training whichimpinge on the pharmaceutical industry.In conclusion, the editors thank most sincerelythe contributors to this book, both for complyingwith our strictures as to the length of their contribution and for providing their material on time, andour publishers for their friendly courtesy and efficiency during the production of this book. We alsowish to thank Dr H.J. Smith for his advice on various chemical aspects, Dr M.I. Barnett for usefulcomments on reverse osmosis, and Mr A. Keallwho helped with the table on sterilization methods.W.B. HugoA.D. Russell
Part 1Biology of Microorganisms
Chapter 1Introduction to pharmaceutical microbiologyStephen Denyer, Norman Hodges and Sean Gorman1 Microorganisms and medicines2 The scope and content of the book1 Microorganisms and medicinesthe most consistently successful and important industries in many countries, not only in the traditional strongholds of North America, WesternEurope and Japan but, increasingly, in Eastern Europe, the Indian subcontinent and the Far East.Worldwide sales of medicines and medical devicesare estimated to have exceeded US 401 billion (approximately 250 billion) in 2002, and this figure isrising by 8% per annum. In the UK alone, the valueof pharmaceutical exports is currently 10.03 billion each year, a figure that translates to more than 150 000 for each employee in the industry.The growth of the pharmaceutical industry in recent decades has been paralleled by rising standardsfor product quality and more rigorous regulation ofmanufacturing procedures. In order to receive amanufacturing licence, a modern medicine must beshown to be effective, safe and of good quality.Most medicines consist of an active ingredient thatis formulated with a variety of other materials (excipients) that are necessary to ensure that the medicine is effective, and remains stable, palatable andsafe during storage and use. While the efficacy andsafety aspects of the active ingredient are within thedomain of the pharmacologist and toxicologist,respectively, many other disciplines contribute tothe efficacy, safety and quality of the manufacturedproduct as a whole. Analytical chemists and pharmacists take lead responsibility for ensuring thatthe components of the medicine are present inthe correct physical form and concentration, butquality is not judged solely on the physicochemicalproperties of the product: microorganisms alsohave the potential to influence efficacy and safety.It is obvious that medicines contaminated withpotentially pathogenic (disease-causing) micro-Despite continuing poverty in many parts of theworld and the devastating effects of HIV and AIDSinfection on the African continent and elsewhere,the health of the world’s population is progressivelyimproving. This is reflected in the increase in lifeexpectancy that has been recorded for the greatmajority of the countries reporting statistics to theWorld Health Organization over the last 40 years.In Central America, for example, the life expectancyhas increased from 55 years in 1960 to 71 years in2000, and the increase in North (but not subSaharan) Africa is even greater, from 47 to 68 years.Much of this improvement is due to better nutritionand sanitation, but improved health care and thegreater availability of effective medicines withwhich to treat common diseases are also majorcontributing factors. Substantial inroads have beenmade in the prevention and treatment of cancer,cardiovascular disease and other major causes ofdeath in Western society, and of infections and diarrhoeal disease that remain the big killers in developing countries. Several infectious diseases have beeneradicated completely, and others from substantialparts of the world. The global eradication of smallpox in 1977 is well documented, but 2002 saw threeof the world’s continents declared free of polio, andthe prospects are good for the total elimination ofpolio, measles and Chagas disease.The development of the many vaccines and othermedicines that have been so crucial to the improvement in world heath has been the result of the largeinvestment in research by the major internationalpharmaceutical companies. This has led to themanufacture of pharmaceuticals becoming one of3
Chapter 1organisms are a safety hazard, so medicinesadministered by vulnerable routes (e.g. injections)or to vulnerable areas of the body (e.g. the eyes)are manufactured as sterile products. What is lesspredictable is that microorganisms can, in additionto initiating infections, cause product spoilage bychemically decomposing the active ingredient orthe excipients. This may lead to the product beingunder-strength, physically or chemically unstableor possibly contaminated with toxic materials.Thus, it is clear that pharmaceutical microbiologymust encompass the subjects of sterilization andpreservation against microbial spoilage, and apharmacist with responsibility for the safe, hygienicmanufacture and use of medicines must knowwhere microorganisms arise in the environment,i.e. the sources of microbial contamination, and thefactors that predispose to, or prevent, productspoilage. In these respects, the pharmaceuticalmicrobiologist has a lot in common with food andcosmetics microbiologists, and there is substantialscope for transfer of knowledge between thesedisciplines.Disinfection and the properties of chemicals (biocides) used as antiseptics, disinfectants and preservatives are subjects of which pharmacists and otherpersons responsible for the manufacture of medicines should have a knowledge, both from the perspective of biocide use in product formulation andmanufacture, and because antiseptics and disinfectants are pharmaceutical products in their ownright. However, they are not the only antimicrobialsubstances that are relevant to medicine; antibioticsare of major importance and represent a productcategory that regularly features among the top fivemost frequently prescribed. The term ‘antibiotic’ isused in several different ways: originally an antibiotic was defined as a naturally occurring substancethat was produced by one microorganism thatinhibited the growth of, or killed, other microorganisms, i.e. an antibiotic was a natural product,a microbial metabolite. More recently the term hascome to encompass certain synthetic agents that areusually used systemically (throughout the body) totreat infection. A knowledge of the manufacture,quality control and, in the light of current concernsabout resistance of microorganisms, the use ofantibiotics, are other areas of knowledge that4contribute to the discipline of pharmaceuticalmicrobiology.Commercial antibiotic production began withthe manufacture of penicillin in the 1940s, and formany years antibiotics were the only significantexample of a medicinal product that was madeusing microorganisms. Following the adoption inthe 1950s of microorganisms to facilitate the manufacture of steroids and the development of recombinant DNA technology in the last three decadesof the 20th century, the use of microorganisms inthe manufacture of medicines has gathered greatmomentum. It led to more than 100 biotechnologyderived products on the market by the newmillennium and another 300 or more in clinicaltrials. While it is true to say that traditionally theprincipal pharmaceutical interest in microorganisms is that of controlling them, exploiting microbial metabolism in the manufacture of medicines isa burgeoning area of knowledge that will becomeincreasingly important, not only in the pharmacycurriculum but also in those of other disciplines employed in the pharmaceutical industry. Table 1.1summarizes these benefits and uses of microorganisms in pharmaceutical manufacturing, togetherwith the more widely recognized hazards andproblems that they present.Looking ahead to the early decades of the 21stcentury, it is clear that an understanding of thephysiology and genetics of microorganisms willalso become more important, not just in the production of new therapeutic agents but in the understanding of infections and other diseases. Several ofthe traditional diseases that were major causes ofdeath before the antibiotic era, e.g. tuberculosis anddiphtheria, are now re-emerging in resistant form —even in developed countries — adding to theproblems posed by infections in which antibiotic resistance has long been a problem, and those likeCreutzfeldt–Jakob disease, West Nile virus andsevere acute respiratory syndrome (SARS) thathave only been recognized in recent years.Not only has the development of resistance toestablished antibiotics become a challenge, so toohas the ability of microorganisms to take advantageof changing practices and procedures in medicineand surgery. Microorganisms are found almosteverywhere in our surroundings and they possess
Related study topicsGood manufacturing practiceIndustrial ‘fermentation’technologyMicrobial geneticsQuality control ofimmunological productsAssay methodsAmes mutagenicity testBenefits or usesThe manufacture of:antibioticssteroidstherapeutic enzymespolysaccharidesproducts of recombinantDNA technologyUse in the production of vaccinesAs assay organisms to determineantibiotic, vitamin and aminoacid concentrationsTo detect mutagenic orcarcinogenic activityTable 1.1 Microorganisms in pharmacy:
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 .
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