Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices PDF
Preview Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices New and Forthcoming Titles in the Pharmaceutical Sciences Nuclear Medicine in Pharmaceutical Research Perkins and Frier (Eds) 1999 0 7484 0688 3 Hbk Electrically Assisted Transdermal and Topical Drug Delivery Ajay K.Banga 1998 0 7484 0687 5 Hbk Physiological Pharmaceutics Barriers to Drug Absorption 2nd Edition Washington & Wilson 1999 0 7484 0562 3 Hbk 07484 0610 7 Pbk Pharmaceutical Aspects of Ogligonucleotides Couveur & Maevy (Eds) 2000 0 7484 0841 X Hbk Pharmaceutical Formulation Development of Peptides & Proteins Frokjaer & Hovgaard (Eds) 2000 0 7484 0745 6 Hbk The ß -Adrenoceptor 3 A.D.Strosberg (Ed) 2000 0 7484 0804 5 Hbk Microbial Quality Assurance in Cosmetics, Toiletries and Non-Sterile Pharmaceuticals 2nd Edition Baird with Bloomfield (Eds) 1996 0 7484 0437 6 Hbk Immunoassay A Practical Guide Law (Ed) 1996 0 7484 0560 7 Hbk Cytochromes P450 Structure, Function and Mechanism Lewis 1996 0 7484 0443 0 Hbk Autonomic Pharmacology Broadley 1996 0 7484 0556 9 Hbk Pharmaceutical Experimental Design and Interpretation 2nd Edition Armstrong & James 1996 0 7484 0436 8 Hbk Pharmaceutical Production Facilities 2nd Edition Cole 1998 0 7484 0438 4 Hbk full pharmaceutical science catalogue available or visit our new website on: http://www.tandf.co 29 West 35th Street, New York, NY 10001, USA Tel: (212) 216 7800 Fax: (212) 564 7854 11 New Fetter Lane London, EC4P 4EE Tel: +44 (0) 20–7583 9855 Fax: +44 (0) 20–7842 2293 Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices Edited by ROSAMUND M.BAIRD Department of Pharmacy and Pharmacology, University of Bath, UK NORMAN A.HODGES School of Pharmacy and Biomolecular Sciences, University of Brighton, UK STEPHEN P.DENYER School of Pharmacy and Biomolecular Sciences, University of Brighton, UK First published 2000 by Taylor & Francis 11 New Fetter Lane, London EC4P 4EE Simultaneously published in the USA and Canada by Taylor & Francis Inc, 29 West 35th Street, New York, NY 10001 Taylor & Francis is an imprint of the Taylor & Francis Group This edition published in the Taylor & Francis e-Library, 2005. "To purchase your own copy of this or any of Taylor & Francis or Routledge's collection of thousands of eBooks please go to WWW.eBookstore.tandf.co.uk." © Taylor & Francis and Rosamund M.Baird, Norman A.Hodges, Stephen P.Denyer All rights reserved. No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. Every effort has been made to ensure that the advice and information in this book is true and accurate at the time of going to press. However, neither the publisher nor the authors can accept any legal responsibility or liability for any errors or omissions that may be made. In the case of drug administration, any medical procedure or the use of technical equipment mentioned within this book, you are strongly advised to consult the manufacturer’s guidelines. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging in Publication Data Handbook of microbiological quality control: pharmaceuticals and medical devices/ edited by Stephen Denyer, Rosamund M.Baird, Norman A.Hodges. p. cm.—(Taylor & Francis series in pharmaceutical sciences) Includes bibliographical references and index. 1. Pharmaceutical microbiology-Handbooks, manuals, etc. 2. Drugs—Sterilization—Handbooks, manuals, etc. 3. Pharmaceutical industry—Quality control—Handbooks, Manuals, etc. I. Denyer, Stephen (Stephen Paul) II, Baird, R.M. (Rosamund M.) III. Hodges, Norman A. IV. Series. QR46.5. H36 2000 615′.19–dc21 00–041187 ISBN 0-203-30519-1 Master e-book ISBN ISBN 0-203-35192-4 (Adobe eReader Format) ISBN 0-748-40614-X (Print Edition) Contents Contributors viii Preface ix 1 Safe Microbiological Practices 1 Anthony W.Smith 2 Culture Media Used in Pharmaceutical Microbiology 23 Rosamund M.Baird 3 Sampling: Principles and Practice 40 Rosamund M.Baird 4 Enumeration of Micro-organisms 57 Ronnie Millar 5 Identification of Micro-organisms 73 Norman Hodges 6 Pharmacopoeial Methods for the Detection of Specified Micro-organisms 92 Norman Hodges 7 Rapid Methods for Enumeration and Identification in Microbiology 123 Paul Newby 8 Microbiology Laboratory Methods in Support of the Sterility Assurance 136 System Andrew Bill 9 Endotoxin Testing 161 Alan Baines 10 Antimicrobial Preservative Efficacy Testing 188 Norman Hodges and Geoffrey Hanlon 11 Microbiological Assay of Antibiotics in Pharmaceutical Preparations 212 Colin Thompson 12 Disinfection and Cleansing 229 Norman Hodges and Rosamund M.Baird 13 Microbiological Hazard Analysis and Audit: The Practice 245 Martin Lush 14 Case Studies and Worked Examples 264 Index 276 Contributors Alan Baines is Managing Director of BioWhittaker UK Ltd, Wokingham, Berkshire, RG41 2PL, United Kingdom Rosamund M.Baird is at the Department of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom Andrew Bill is at the Medicines Control Agency, 2nd Floor, Prudential House, 28–40 Blossom Street, York, YO24 1GJ, United Kingdom Geoffrey Hanlon is at the School of Pharmacy and Biomolecular Sciences, Brighton University, BN2 4GJ, United Kingdom Norman Hodges is at the School of Pharmacy and Biomolecular Sciences, University of Brighton, BN2 4GJ, United Kingdom Martin Lush is at David Begg Associates, 10 High Market Place, Kirbymoorside, Yorkshire, YO6 6AX, United Kingdom Ronnie Millar is at GlaxoWellcome Research and Development, Ware, Hertfordshire, SG12 0DP, United Kingdom Paul Newby is at GlaxoWellcome Product Supply, Harmire Road, Barnard Castle, Co. Durham, United Kingdom Anthony W.Smith is at the Department of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, United Knigdom Colin Thompson is at GlaxoWellcome, Temple Hill, Dartford, Kent, DA1 5AH, United Kingdom Preface Microbiological concerns in product manufacture, regardless of whether it involves pharmaceuticals, cosmetics, toiletries or medical devices, continue to challenge the minds of those associated with their production. Whilst much is known about how contamination arises, and control methods are well understood, there is no room for complacency; every microbiologist knows that from time to time a contamination issue inevitably will arise and must be promptly addressed. Detailed practical guidance on appropriate microbiological methods is an absolute necessity if such problems are to be resolved speedily and to the satisfaction of all involved. This handbook attempts to fulfil this role in the laboratory, bringing together a wealth of information from diverse sources into a single volume. The reader is guided throughout the book by the advice and recommendations of expert contributors with an in-depth knowledge and personal experience of the likely practical issues to be faced by those working in the microbiology laboratory. Beginning with safety concerns and the design of laboratory facilities, guidance is provided on the choice and requirements of culture media, followed by a detailed consideration of specialized microbiological methods, including chapters on sampling, enumeration and identification of micro- organisms, involving both traditional and rapid techniques, sterility testing, environmental monitoring, preservative efficacy testing, endotoxin testing and antibiotic bioassays. Whilst established reference methods are of necessity included here, there is also an abundance of information on how these tests are interpreted in common practice. Cleaning and disinfection considerations, frequently a much neglected subject, are also addressed within this volume. Hazard analysis and audit approaches complete the routine tasks facing the company microbiologist and the reader is directed in how this might be successfully achieved. Finally, a number of worked case examples have been included to assist those involved in such every day calculations. Although the book is intended as a complete reference source in its own right, it is in fact a companion book to the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, shortly to be published in its second edition by Taylor and Francis. The intention here was to provide in the Handbook detailed practical information on methodology of the techniques advocated and identified for microbiological quality control in the Guide. The Handbook is therefore extensively cross-referenced to the Guide, and it is hoped that the collected wisdom of these two books provides the laboratory microbiologist with a unique, valued and much consulted reference source. Rosamund M.Baird Norman A.Hodges Stephen P.Denyer
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