Liquid- and surface-borne particle measurement handbook

926 Pages·1996·319.92 MB·English

by  Julius Z Knapp, Thomas A Barber, Alvin Lieberman

LIQUID- AND
SURFACE-BORNE
PARTICLE
MEASUREMENT
HANDBOOK
This Page Intentionally Left Blank
LIQUID- AND
SURFACE-BORNE
PARTICLE
MEASUREMENT
HANDBOOK
EDITED BY
JULIUS Z. KNAPP
Research & Development Associates, Inc.
Somerset, New Jersey
THOMAS A. BARBER
Baxter Healthcare Corporation
Round Lake, Illinois
ALVIN LIEBERMAN
Particle Measuring Systems, Inc.
Fremont, California
Marcel Dekker, Inc. New York. Basel Hong Kong
Library of Congress Cataloging-in-Publication Data
Liquid- and surface-borne particle measurement handbIo eodki ted by Julius Z.
Knapp, Thomas A. Barber, Alvin Lieberman.
cp m. .
Includes index.
ISBN 0-8247-9386-2 (alk. paper)
1. Particles-Measurement-Handbooks, manuals, etc. 2. Drugs-
Quality control-Handbooks, manuals, etc. 3. Fouling-Measurement-
Handbooks, manuals, etc. I. Knapp, Julius Z. 11. Barber, Thomas A.
111. Lieberman, Alvin.
RS190.P37L517 9 96
15'. 6 19-4~20 96-13063
CIP
Thep ublishero ffersd iscounts on thisb ookw heno rdered in bulkq uantities.F orm ore
information, writet o Special Sales/Professional Marketinga t the addressb elow.
This book is printed on acid-& paper.
Copyright 0 1996 by Marcel Dekker, Inc.A ll Rights Reserved.
Neither this book nor any part mayb e reproduced or transmitted any form or by any means,
electronic or mechanical,i ncludingp hotocopying,m icrofilming,a ndr ecording, or bya ny
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)
l 0 9 8 7 6 5 4 3 2 1
PRINTED IN THE UNITJZD STATES OF AMERICA
Preface
Accurate particle measurements are essential to the control of quality in many products. For
pharmaceuticals, the determination that particle contamination lies within specified limits is a
legal requirement prior to sale and clinical use. For high-performance hydraulic systems, particle
contamination measurement and control aisn operational requirement. These hydraulic systems
are used to control high-powered, complex mechanisms including those that operate advanced
avionic systems. In the manufacture of products ranging from pigments to photographic film
base, the determinationo f particle size and concentrationi s essential to successful production.
The information and techniques neededt o measure and understand particle contamination
have been developed by specialists in many disciplines. As a result, the reports of their work are
distributed in the literatuoref their respective disciplineTs.h is handbook provides a convenient,
intelligible,s ingler eferences ourcef ort hep articlem easurementp ractitioner. It hasb een
assembled by a selected team of specialists with the capabilittoy make many facetso f particle
measurement understandable and usable.
This handbook provideasn accurate descriptionof current particle measurement information
and technology.I t is our hope thiatt will not only make available the knowledge that is presently
needed, but provide a sound foundation upon which new particle measurement develop
also
ments can be successfully added.
Julius Z. Knapp
Thomas A. Barber
Alvin Lieberman
if i
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Contents
Prefaici ei
Contributovri si
1. Particle Characterization in Liquids: Background Information 1
Alvin Lieberman
Microscopy: The Setup and Operation of the Polarized-Light MicroscopyL ab
2.
forP articleI dentification 29
John Gustav Delly
3. Image Analysis (Automated Microscopy) for Particle Analysis 61
Thomas A. Barber
4. The Electrical Sensing Zone Method (The Coulter Principle) 113
Roy W.L ines
5. Particle Sizing Using Ensemble Averaging Techniques 155
Bruce B. Weiner
6. In Situ Particle Measurement 173
Alvin Lieberman
7. HolographicM ethods 197
Brian J. Thompson
8. Instrumental Analysis of Particulate Matter 235
Thomas A. Barber
9. Evaluation and Validation of Nondestructive Particle Inspection Methods
andS ystems 295
Julius Z. Knapp and Lee R. Abramson
10. Validation of Counting Accuracy in Single-Particle Counters:
Application of a New Coincidence Model 451
Julius Z. Knapp and Lee R. Abramson
V
Contents
vi
11. Particles in Semiconductor Manufacturing Process Liquids 569
Donald C. Grant and Alvin Lieberman
12. A Systematic Approachf or Particle Counting Petroleum Oils 585
Barry M. Verdegan, BrianW . Schwandt, and ChristopherE . Holm
13. Sources of Particulate Matter in Pharmaceutical and Medical Products 637
Thomas A. Barber
14. Physiological Consequences of Injected Particulates 661
Lawrence John Pesko
15. Diagnostic Applications of Microspheres 687
Leigh B. Bangs
16. Reference Materials in Particle Measurements 709
Renliang Xu
Selective Particle Capture with Transparent Sieves in the Evaluation
17.
of Contamination in Parenteral Solutions 721
Julius Z. Knapp
18. Particle Size Distribution Analysis Using Light Scattering 745
Renliang Xu
Industry’s Role int he Development of Standards and Controls
19.
for Particulate Matter in Small Volume Injectables 779
John A. Syverson
20. Pharmaceutical Clean Laboratory Operations 791
Thomas A. Barber
21. Particles in Fluids and on Surfaces: Specialized Bibliography 825
Alvin Lieberman
Index 871
Contributors
Lee R. Abramson Statistical Consultant, Washington, D.C.
Leigh B. Bangs Bangs Laboratories, Inc., Carmel, Indiana
Thomas A. Barber Corporate Research and Technical Services, Baxter Healthcare Corpora-
tion, Round Lake, Illinois
John Gustav Delly fimile Chamot Laboratory, McCrone Research Institute, Chicago, Illinois
Donald C. Grant CT Associates, Inc., Excelsior, Minnesota
Christopher E. Holm Coprate Research, Nelson Industries, Inc., Stoughton, Wisconsin
Julius Z. Knapp Research & Development Associates, Inc., Somerset, New Jersey
Alvin Lieberman Particle Measuring Systems, Inc., Fremont, California
Roy W. Lines Coulter Electronics Ltd., Luton, Bedfordshire, England
LawrenceJ ohnP esko Department of PharmaceuticalC are,S t. Viicent MedicalC enter,
Toledo, Ohio
Brian W. Schwandt Corporate Research, Nelson Industries, Inc., Stoughton, Wisconsin
John A. Syverson* pfzer, Inc., New York, New York
Brian J. Thompson University of Rochester, Rochester, New York
*Retired.
vii