Professional Documents
Culture Documents
cover n e x t pa ge >
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Edited by
Kenneth E. Avis
The University of Tennessee
Memphis, Tennessee
Herbert A. Lieberman
H.H. Lieberman Associates, Inc.
Consultant Services
Livingston, New Jersey
Leon Lachman
Lachman Consultant Services
Westbury, New York
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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 and retrieval system,
without permission in writing from the publisher.
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Preface
Volume 2 of the first edition of our two-volume treatise on parenterals was published in 1986. In keeping with the
editors' philosophy to update and adequately cover new subject matter, this second volume is now being published as
part of a three-volume second edition of the series.
Volume 1 in the second edition is devoted to parenteral drug history, administration, routes, precautions, problems,
biopharmaceutics, preformulations, small and large volume parenteral formulations, peptide and protein injectables,
sterile diagnostics, different types of parenteral primary packages and closures, and, finally, parenteral products in
hospital and home care. Volume 2 describes processing small and large volume parenterals, freeze drying, the design of
a parenteral and a biopharmaceutical facility, personnel practices and training, environmental control elements in
manufacturing, industrial sterilization, as well as an enlightening coverage of the therapeutics, types of drugs, and
formulation principles for ophthalmic preparations. The final and third volume in this series covers quality assurance,
records and reports, particulate matter, validations, federal regulations, the audit process, regulatory considerations and
other aspects of medical devices, including design, manufacture, and quality assurance.
The editors have consistently guided the contributors to cover each subject with the intent of teaching at the level of the
undergraduate, as well as the graduate student in the pharmaceutical sciences. To accomplish this goal, the writers had
to assume the readers to have little knowledge of the subject matter and then build upon the more basic concepts
presented to reach the more learned and graduate level readers. Further, the materials presented in this series are
intended to benefit the technical readers with the specific information required to guide professionals practicing
industrial or pharmaceutical pharmacy, to assist personnel involved in the design and manufacture of sterile products, as
well as to instruct lawyers and legislators concerned with all types of sterile products.
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All of the first-edition chapters included in this volume have been updated, and additional topics are included in each
revised chapter to more fully cover the changes in the subject matter since the publication of the first edition. Also, new
chapters have been added.
Chapter 1 on the processing of small volume parenterals, has been expanded to include several types of biologic
products, including biotechnology-based preparations such as vaccines and monoclonal antibodies. There is a discussion
on preparing liposomal products, as well as a brief description concerning the manufacture of ophthalmic dosage forms.
The use of form, fill, and seal equipment for small volume parenterals is described in detail with several diagrams and
illustrations included to help provide additional clarity to this subject. Many of the tables have been revised and the list
of references updated. The chapter is designed to provide all the necessary details for setting up and running a state-of-
the-art small volume parenteral facility.
In Chapter 2, the manufacturing processes describing large volume parenterals, has been considerably expanded
compared with the presentation given in the first edition. Recent developments in the technology of parenteral fluid
processing, the latest regulatory requirements, packaging (including currently employed materials), filling, sterilization,
and filtration operations, as all of them pertain to large volume parenterals, are fully covered. In addition, the various
factors involved in manufacturing large volume parenterals are reinforced by offering practical examples of situations
and processes, both for improving production and quality assurance and control purposes.
Chapter 3, "Freeze Drying: Principles and Practice," a new chapter in this edition, presents an overview of the scientific
and engineering principles of freeze drying as it is relevant to the formulation and manufacture of freeze-dried
parenteral products. Methodology for the characterization of freezing behavior is presented from the standpoint of
identifying the maximum allowable product temperature during primary drying, that is, either a collapse temperature
(amorphous solute) or a eutectic temperature (crystalline solute). Temperature and pressure measurement methods used
in freeze drying are reviewed, followed by a discussion of process monitoring strategies. General equipment and
considerations involved in designing a freeze drying system are discussed.
Chapter 4 updates the various design considerations required for a parenteral production facility. Specific reference has
been included to small specialized batch operations where localized and self-contained sterile enclosures may be
applicable, as for example, in the manufacture of lyophilized products. A discussion of clean-in-place (CIP) and
sterilizein-place (SIP) systems has been added. The HEPA filters topic has been updated and expanded in accordance
with the current federal and Institute of Environmental Science standards. Laminar flow rooms with an illustration,
separate gowning and degowning areas, various safety, environmental, hazardous material control, energy conservation,
and building code issues have been reviewed and revised to reflect current pharmaceutical practices.
Chapter 5, which is new, describes the design of biopharmaceutical manufacturing facilities, concentrating on the
physical layout, with particular consideration for the planning and regulatory issues that need to be addressed.
Government regulatory maters, NIH guidelines, and FDA Good Manufacturing Practices as they pertain to the
manufacture of biopharmaceutical products are discussed. The role of validation in the
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planning process is presented along with a description of the design of the equipment outlay. This chapter highlights the
differences in planning for a biopharmaceutical manufacturing facility as compared with the design of aseptic facilities
for parenteral products.
No text concerned with the manufacture of sterile products would be complete without a description of "Personnel: The
Key Factor in Clean Room Operations," Chapter 6 of this text. The production personnel and the garments they wear
when processing sterile preparations can play a significant role in the risk of contaminating these products in the
manufacturing operations. To minimize this source of contamination, the chapter has provided a description of the
concepts of barrier technology and a lengthy discussion on the design of clean room uniforms, fabrics currently
prescribed, tests used to evaluate fabrics, and the effects of laundering on garment permeability. Several types of face
coverings worn by clean room operators are also described. Hand protection from microbial contamination and various
hand washing techniques utilized by employees working in aseptic areas are discussed. Overall contents of a training
program for clean room operators, as well as a section on management philosophy and their commitment to regulatory
compliance, are included in this chapter.
Chapter 7, "Environmental Control in Parenteral Drug Manufacturing," has been rewritten to include more details
regarding environmental monitoring, validation of airborne and surface contamination, and the implementation of a
routine monitoring program. This chapter discusses the hardware presently recommended for clean room construction
and air filtration and also includes current regulatory requirements on these subjects. New topics included in this chapter
are cleaning, disinfection, and personnel cleanliness requirements needed to achieve adequate environmental conditions
for an aseptic manufacturing facility.
"Industrial Sterilization: A Review of Current Principles and Practices," Chapter 8, describes many of the recent
advances that have been introduced in the health care industry. New concepts and principles relating to sterility
assurance techniques and procedures have been added in this edition. Among the new subjects described are alternatives
to ethylene oxide sterilization (e.g., vapor phase hydrogen peroxide, chlorine dioxide, and peracetic acid), parametric
release, chemical sterility indicators, and continuous sterilizers. Coverage of all the key areas of sterilization technology
have been expanded and include radiation, installation/performance qualification and validation, as well as a discussion
concerning the health effects of ethylene oxide as a sterilant.
Since ophthalmic preparations must be sterile, although not pyrogenfree, the editors have included in this series a new
chapter, Chapter 9, "Development of Ophthalmic Formulations." Although the dosage form is not a parenteral, the
techniques required for sterile formulation development are the same, and in other texts on sterile products, this topic is
not adequately covered. In this chapter, topical ophthalmic products are discussed, andunlike many other pharmacy
textsthe emphasis is on the development of intraocular preparations, particularly irrigating solutions. Included in this
chapter is a review of the anatomy of the eye and the pharmacologic/therapeutic categories of drugs used in
ophthalmology practice. It also includes a flow chart with model formulations for the development of ophthalmic
preparations. Manufacturing procedures for the preparation and packaging of ophthalmic products are briefly described.
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The multiauthor approach taken in this volume, as well as the others in the series, provides the editors and readers with
contributors who are scholars knowledgeable as well as experienced in the subject matter of their chapters. No one
author can offer the detailed and learned treatise required to adequately cover such a variety of subjects included in this
volume. The experts chosen in particular areas offer comprehensive knowledge at a level that will satisfy the
requirements of both the novice and the highly experienced reader.
The contributing authors have worked hard to provide our readers with information needed to help them solve problems
in manufacturing all types of sterile parenteral, biologic, and ophthalmic products. We are extremely grateful for the
time and effort each has given to prepare a chapter despite a busy work schedule. We hope that the extensive coverage
of the subject matter in this book will facilitate the reader's tasks, as well as elevate the present technology practiced in
developing and manufacturing parenteral, biologic, and ophthalmic products.
KENNETH E. AVIS
HERBERT A. LIEBERMAN
LEON LACHMAN
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Contents
Preface iii
Contributors ix
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Index 583
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Contributors
Krishna M. Bapatla, Ph.D. Associate Director, Project Management, Alcon Laboratories, Inc., Fort Worth, Texas
Robert Del Ciello, P.E. Director, Pharmaceutical and Biotechnology Operations, Quasar Engineering, Inc., Princeton,
New Jersey
Franco DeVecchi Chairman of the Board, Veco International, Inc., Farmington Hills, Michigan
Larry A. Gatlin, Ph.D. Section Head, Parenteral and Enteral Liquid Product Development, Pharmaceutical Research and
Development, Glaxo Research Institute, Research Triangle Park, North Carolina
Michael J. Groves, Ph.D. Director, Institute for Tuberculosis Research, College of Pharmacy, University of Illinois at
Chicago, Chicago, Illinois
Richard J. Harwood, Ph.D, Director, Technical Planning, Strategic Management Operations, Bristol-Myers Squibb,
Princeton, New Jersey
A. Michael Keller, P.E. Project Manager, Budlong & Associates, Agoura Hills, California
O. J. Lorenzetti, Ph.D. Senior Director, Therapeutic Research, Research and Development, Alcon Laboratories, Inc.,
Fort Worth, Texas
Cecelia J. Luna Validation Project Manager, Validation Services, United Engineers & Constructors, Philadelphia,
Pennsylvania
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Frank J. Marino, M.S. Corporate Consultant, Microbiology, Corporate Quality Assurance, Abbott Laboratories, North
Chicago, Illinois
Steven L. Nail, Ph.D. Associate Professor, Industrial and Physical Pharmacy, Purdue University, West Lafayette,
Indiana
Joel Benton Portnoff Executive Director of Development, Analytical and Pharmaceutical Research and Development,
The Liposome Company, Inc., Princeton, New Jersey
Edward William Sunbery, RPh. Manager, Technical Services, WarnerLambert Company, Inc., Lititz, Pennsylvania
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Volume 1
1. The Parenteral Dosage Form and Its Historical Development, Kenneth E. Avis
2. Parenteral Drug Administration: Routes, Precautions, Problems, Complications, and Drug Delivery Systems, Richard
J. Duma, Michael J. Akers, and Salvatore J. Turco
10. Use of Plastics for Parenteral Packaging, John M. Anes, Robert S. Nase, and Charles H. White
11. Elastomeric Closures for Parenterals, Edward J. Smith and Robert J. Nash
12. Parenteral Products in Hospital and Home Care Pharmacy Practice, John W. Levchuk
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Volume 3
1. Quality Assurance
Samir A. Hanna
3. Particulate Matter
Patrick P. DeLuca and Julius Z. Knapp
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Volume 1
2. Tablet Formulation and Design, George J. Baley, Vincent E. McCurdy, Garnet E. Peck, and Gilbert S. Banker
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Volume 2
1. Mixing,
Russell J. Lantz, Jr. and Joseph B. Schwartz
2. Drying,
Kurt G. Van Scoik, Michael A. Zoglio, and Jens T. Carstensen
3. Size Reduction,
Russell J. Lantz, Jr.
4. Compression,
Eugene L. Parrott
Volume 3
3. Particle-Coating Methods,
Dale E. Wurster
6. Tablet Production,
Robert Connelly, Frank Berstler, and David Coffin-Beach
7. Stability/Kinetics,
Samir A. Hanna
8. Quality Assurance,
Samir A. Hanna
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Volume 1
1. Introduction,
Norman Weiner
2. Theory of Suspensions,
Michael J. Falkowicz
3. Theory of Emulsions,
Stig E. Friberg, Lisa B. Goldsmith, and Martha L. Hilton
4. Theory of Colloids,
John Vanderhoff and Mohamed S. El-Aasser
5. Pharmaceutical Suspensions,
Robert A. Nash
6. Pharmaceutical Emulsions,
Bernard Idson
8. Surfactants,
Martin M. Rieger
10. Experimental Design, Modeling, and Optimization Strategies for Product and Process Development,
Robert M. Franz, Jeffrey E. Browne, and Allen R. Lewis
Volume 2
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7. Topical Suspensions
Hridaya N. Bhargava and Daniel W. Nicolai
8. Reconstitutable Suspensions
Clyde M. Ofner III, Roger L. Schaare, and Joseph B. Schwartz
13. Gels
Joel L. Zatz and Gregory P. Kushla
14. Toothpastes
David Garlen
16. Liposomes
Mohammad Riaz, Norman Weiner, and Frank Martin
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Index
planning, 321
filtration, 346-347
pressurization, 343-346
Chlorobutanol, 558-559
Cleanrooms
isolation, 438-439
Contamination
Current Good Manufacturing Practices (CGMP) regulations of the Food and Drug Administration, 94
Cycloplegics, 549-550
Density, 98-99
steam, 289-293
warehousing, 263-264
energy, 237-238
water, 238
Distribution records, 5, 7
D value
cleanrooms, 438-451
isolation, 438-439
Environmental records, 5, 6
conjunctiva, 542
cornea, 544-546
refrigeration, 225
F0 value, 478-479
Gels, 576
toxoids, 68-69
viral vaccines, 68
ventilation, 432
conduction, 102
convection, 103
radiation, 103
formaldehyde, 500-501
radiation, 491-495
packaging, 479
pyrogen, 482
sterility, 473-474
calibration, 523-525
packaging, 503-504
equipment, 514
specifications, 515
technology, 513-514
caps, 151
materials, 144-146
filling, 154
filtration, 119-136
labeling, 155-157
definition, 110-111
receiving, 112
sealing, 154-155
definition, 106
distillation, 108-110
pretreatment, 106-107
Manufacturing large and small volume parenterals [see Large volume parenterals (LVPs), manufacture of; Small
volume parenterals (SVPs), manufacture of products]
Master file, 5
materials, 268-269
valving, 270-273
Methylparaben, 559
Miotics, 550
Mydriatics, 549-550
Ointments, 577
conjunctiva, 542
cornea; 544-546
gels, 576
ointments, 577
[Ophthalmic formulations]
suspension products, 66
solutions, 571-574
antioxidants, 573
buffers, 572
preservatives, 571-572
Packaging, 479
Parasympathomimetics, 549
copper, 268-269
Process logs, 5, 6
Propylparaben, 559
Pyrogens, 482
energy, 237-238
water, 238
labeling, 87-89
overview of, 2, 3
sealing, 80-82
materials management, 4
personnel management, 4
Stability records, 5, 6
Sterilization (see also Industrial sterilization) sterilization assurance, definition of, 482-486
Surfactants, 561
Suspensions, 574-576
Sympathomimetics, 549
Thimerosal, 558
Toxoids, 68-69
documentation, 400
evaluation, 400-403
Viral vaccines, 68
Viscosity, 95-98
Water, 238
definition, 106
distribution, 309-311
pretreatment, 106-107
storage, 306-309
Z value, 476-478
Start of Citation[PU]Marcel Dekker, Inc.[/PU][DP]1992[/DP]End of Citation