Isolation technology : a practical guide PDF
Preview Isolation technology : a practical guide
Isolation Technology A Practical Guide Second Edition Isolation Technology A Practical Guide Second Edition Tim Coles CRC PR ESS Boca Raton London New York Washington, D.C. (cid:3) Library of Congress Cataloging-in-Publication Data ‘Catalog record is available from the Library of Congress. This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe. Visit the CRC Press Web site at www.crcpress.com © 2004 by CRC Press LLC No claim to original U.S. Government works International Standard Book Number 0-8493-1944-7 Library of Congress Card Number XX-XXXXX Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed on acid-free paper (cid:3) Preface to Second Edition It is now some five years since the first edition of this book appeared. There have been some technological advances in this time, but perhaps the most significant changes have been in the acceptance and the understanding of isolation technology. This acceptance may best be demonstrated by the series of monographs, guidelines, and standards produced by various bodies, designed to describe best practice in the design and operation of isolators. These include: • Isolators Used for Aseptic Processing and Sterility Testing, Pharma- ceutical Inspection Cooperation Scheme (Europe) • Design and Validation of Isolator Systems for the Manufacturing and Testing of Healthcare Products, Parenteral Drug Association (USA) • Sterile Drug Products Produced by Aseptic Processing, Food and Drug Administration (USA) • ISO EN 14644 Part 7, Separative Devices • Isolators for Pharmaceutical Applications, 3rd Edition, UK Pharma- ceutical Isolator Group • Handling Cytotoxic Drugs in Isolators in NHS Pharmacies, HSE and MHRA (UK) • Recommendations for the Production, Control and Use of Biological Indicators for Sporicidal Gassing of Surfaces within Separative En- closures, PDA Committee (USA and UK) This second edition includes descriptions of and comments on these new documents. Recent technology (cid:128) such as the new breed of sanitising gas generators (cid:128) has been brought into the appropriate chapters, and the text has been updated throughout to reflect more recent thinking. Finally, minor errors in the previous edition have been corrected. The second edition draws heavily on the content of the guideline booklet, Isolator for Pharmaceutical Applications — 3rd Edition, for both information and inspiration. I was closely involved in the assembly and editing of this recent work and make no apology for trawling its content. I am, however, grateful to my co-editors and to the UK Pharmaceutical Isolator Group for allowing me this privilege. © 2004 by CRC Press LLC (cid:3) Thanks are also due to GRC Consultants; Malcolm Hughes, Dabur Oncology; Ray Collyer, Dabur Oncology; James Drinkwater, BioQuell Ltd.; and Brian Midcalf, UK Pharmaceutical Isolator Group. Tim Coles Cambridge © 2004 by CRC Press LLC The Author Tim Coles holds B.Sc. and M.Phil. degrees in environmental sciences and has been active in the field of pharmaceutical isolation technology for the last 20 years. He has worked with La Calhène SA, Cambridge Isolation Technology, and MDH (now BioQuell Ltd.), and is currently employed as an isolator specialist by GRC Consultants, part of the Mott-MacDonald group. Coles has been active in the UK Pharmaceutical Isolator Group and is on the editorial committee responsible for producing comprehensive new guidelines on isolation technology. He is also a member the PDA Biological Indicator Group and is a frequent speaker at conferences and seminars in the UK and Europe. © 2004 by CRC Press LLC Contents Chapter one Introduction The background to isolation technology Isolation technology — a definition Isolation technology versus barrier technology The aim of isolation technology Improvement in product quality Reduction in costs Improvements in safety Flexibility Special conditions Qualification Aesthetics Some typical applications of isolation technology Sterility testing Aseptic filling Toxic containment Hospital pharmacy work Biomedical isolation Surgical and other miscellaneous uses of isolation technology What isolation technology is not: a panacea Chapter two An introduction to the technology The materials Flexible film plastic Rigid plastics PVC Acrylic Polypropylene Polycarbonate Stainless steel Mild steel Air handling in isolators Filtration Pressure regimes © 2004 by CRC Press LLC Flow regimes Turbulent flow Unidirectional flow Semiunidirectional flow Air conditioning Calculations for isolator air handling systems Handling the work in isolators Gloves Half-suits Full suits Robotics and automation Chapter three Areview of transfer methods Simple doors Lockchambers Product passout ports Waste ports Rapid transfer ports Mode of operation Operational considerations Occluded surfaces “Ring of concern” Interlocking Engineering RTPcontainers Simple Gassable Autoclavable Partially disposable Totally disposable Isolator Powder transfer How good is the RTP? Afurther type of RTP: the split butterfly port Direct interface Dynamic mousehole Pipe and hose connection Services Chapter four Further design considerations Isolator control systems Simple, turbulent flow isolators Double-fan turbulent flow isolators Simple, unidirectional flow isolators Recirculating unidirectional isolators Temperature and relative humidity © 2004 by CRC Press LLC Isolator instrumentation Pressure Flow HEPA filter pressure drop Temperature and relative humidity Particle counting Air sampling Building interface Chapter five How to draw up a design specification User requirement specification (URS) Design qualification Standards and guidelines Workspace ergonomics and handling Rate of work Major equipment interface Positive pressure or negative pressure: the cytotoxic dilemma Turbulent airflow or unidirectionaldownflow Transfer The isolator room environment for sterile operations Control and instrumentation Sterilisation and decontamination Standard versus special isolator design Chapter six Seeing the project through Liaison with your designer and supplier Further project development The project plan DQ, IQ, OQ, and PQ DQ — design qualification IQ — installation qualification OQ — operational qualification PQ — performance qualification Some further points about qualification protocols Proposals and quotations Preengineering studies, models, and mockups Terms, payment structures, and guarantees The OQ in more detail HEPA/ULPAfilter test Leak testing Leak detection methods Soap test Gas leak detection tests DOP smoke tests Pressure tests Pressure hold © 2004 by CRC Press LLC Parjo The oxygen test Expression of pressure decay test results Hourly leak rate Percentage volume loss per hour Volume loss per second (or per hour) Single-hole equivalent Classification by leak rate Further discussion of leak testing: the distributed leak test Testing gloves and sleeves Further leakage considerations When should leak testing be carried out? Instrument calibration Airflow patterns Miscellaneous checks Particle counting CIP drainage and drying Alarms Breach velocity Interlocks Any other relevant parameters Manuals Chapter seven Cleaning up: sterilisation and decontamination Sterilisation — manual wet processes Fogging processes Formaldehyde PAAand other agents Gassing systems Recent developments in gas-phase sterilisation La Calhène SA Sterivap® Astec Microflow Citomat Steris VHP 1000™ BioQuell Clarus™ HPV as a sterilising agent Other gas-phase sterilising agents Ozone Ultraviolet light Validating the sterilisation process CIP in isolators Decontamination in toxic and pathogenic applications Chemical decontamination: cytotoxics Chemical decontamination: unknown hazards Biological decontamination: pathogens and recombinant DNA © 2004 by CRC Press LLC
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