Michael J. Akers - Parenteral quality control: sterility, pyrogen, particulate, and package integrity testing
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Parenteral quality control: sterility, pyrogen, particulate, and package integrity testing
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This second edition details current methods of testing parenteral quality control and discusses new techniques and emerging trends. It combines principles with practical information on how the tests are conducted, their strengths and limitations, and possible forthcoming changes. Coverage includes global testing requirements; new issues and approaches involving retesting of lots that failed initial sterility tests; and new technologies such as barrier systems for conducting sterility testing.
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Center for Health Sciences University of Wisconsin Madison, Wisconsin
1. Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing, by Michael J. Akers 2. Pyrogens: Endotoxins, LAL Testing, and Depyrogenation, by Frederick C. Pearson III 3. Filtration in the Pharmaceutical Industry, by Theodore H. Meltzer 4. Peptide and Protein Drug Delivery, edited by Vincent H. L. Lee 5. Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing, Second Edition, Revised and Expanded, by Michael J. Akers Additional Volumes in Preparation
Page i
Parenteral Quality Control
Sterility, Pyrogen, Particulate, and Package Integrity Testing Second Edition, Revised and Expanded
Michael J. Akers
Eli Lilly and Company Indianapolis, Indiana
With a Contribution by Dana Morton Guazzo
MARCEL DEKKER, INC NEW YORK BASEL
Page ii
Library of Congress Cataloging-in-Publication Data
Akers, Michael J. Parenteral quality control : sterility, pyrogen, particulate, and package integrity testing / Michael J. Akers ; with a contribution by Dana Morton Guazzo. 2nd ed., rev. and expanded. p. cm. (Advances in parenteral sciences ; 5) Includes bibliographical references and index. ISBN 082479088X 1. Parenteral solutionsAnalysis. 2. Parenteral solutions -Standards. 3. Pharmaceutical industryQuality control. I. Guazzo, Dana Morton. II. Title. III. Series. RS201.P37A54 1994 615'.19dc20 9325667 CIP
The publisher offers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales/Professional Marketing at the address below.
This book is printed on acid-free paper.
Copyright 1994 by MARCEL DEKKER, INC. All Rights Reserved.
Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, micro filming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher.
MARCEL DEKKER, INC. 270 Madison Avenue, New York, New York 10016
Current printing (last digit): 10 9 8 7 6 5
PRINTED IN THE UNITED STATES OF AMERICA
Page iii
This book is dedicated to Mary, Scott, Ryan, and Allison, my beloved wife and children
Page v
Series Introduction
The field of parenterals has seen substantial technical and scientific growth over the past two decades, with the expectation of even greater activity during the last half of the 1980s and through the 1990s. This growth is due, in part, to the expected surge in the number of very potent and sensitive peptides that are arising out of the proliferating genetic engineering programs; an expected increase in the number and type of nutritional products; and the increasing demand for expanded home health care. It is entirely appropriate, therefore, that a scientific/technical series be established not only to report on advances in this field but also to help integrate the various disciplines that impact on parenteral products.
To place the series in perspective it may be useful to provide a personal impression of the level and complexity of the parenteral field. Parenteral activities can arbitrarily be divided into (1) those devoted to making an elegant, safe and effective product, (2) the interface of that product with the route of administration, and (3) the influence of the product on the time course and biological activity of the drug in question. Naturally, all three areas are related and are not easily segregated, especially the latter two.
Page vi
The technical aspects of parenterals include assurance of stability, sterility, and freedom from particulates as major concerns. These areas have received considerable attention and significant advances have been made in conventional, that is, non-sustained release parenterals. Sustained forms of parenteral products require special consideration from a preparation and quality assurance point of view.
Less well studied is the interaction of the product with the biological interface, for example, biocompatibility, local metabolism and immunological reaction. These areas require a variety of disciplines to fully understand the parenteral product-biological interface. This is a field that has been studied in an uneven manner over the years, providing a less than satisfactory data base.
The last area is the influence of the product on the time course and biological activity of the drug, the so-called bioavailability issue. In the absence of a suitable understanding of the product-biological interface, that is, point number two, it is difficult to provide a thorough mechanistic description.
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