Filtration in the Biopharmaceutical Industry,9780824798963

Filtration in the Biopharmaceutical Industry

by ;
ISBN13: 9780824798963
ISBN10: 0824798961
Format: Hardcover
Pub. Date: 1998-01-01
Publisher(s): CRC Pr I Llc
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Summary

Offering a comprehensive examination of developments in the field, this book delineates filtration in a host of applications. Addressing quality, security, economic, process development, and regulatory topics, the book covers pre- and sterility grade filters, charge-modified filter media, and aids to filtration, discusses filter quality assurance, pore size, extractables, and compatibilities in various filters, examines filter design and construction, analyzes integrity testing, test sensitivity, and automation, furnishes novel filtration flow methods, explains filter validation, summarizes the U.S. Food and Drug Administration regulations governing filtration, and more.

Table of Contents

Foreword v(2)
David B. Pall
Preface vii(6)
Contributors xiii
Part I Types of Filters 1(168)
1. Filter Aid Filtration
1(70)
Gordon R.S. Smith
2. Expanded Polytetrafluoroethylene Membranes and Their Applications
71(24)
Michael Wikol
Chris Bailey
Karen Lange
Michael Sutsko
Karen Tronto
3. Charge-Modified Filter Media
95(32)
Rodney A. Knight
Eugene A. Ostreicher
4. Prefilter Constructions
127(18)
Anthony C. Shucosky
5. Cartridge Filters
145(24)
Peter Soelkner
Juergen Rupp
Part II Filter Characterization 169(76)
6. Quality Assurance of Filters for Fluid Clarification
169(12)
Hyman B. Katz
7. Pore Sizes and Distributions
181(18)
C. Thomas Badenhop
8. Extractables and Compatibilities of Filters
199(46)
Oscar W. Reif
Part III Utilitarian Considerations 245(208)
9. Bacterial Biofilms in Pharmaceutical Water Systems
245(14)
Marc W. Mittelman
10. Filtrative Particle Removal from Liquids
259(48)
Maik W. Jornitz
Theodore H. Meltzer
11. Integrity Testing
307(66)
Maik W. Jornitz
A. Mark Trotter
Theodore H. Meltzer
12. Sizing Microporous Membrane Filter Systems
373(46)
Harwood Green
Larry A. Scheer
13. Filter Housing Materials and Surface Finish
419(16)
John Gulliford
14. Filter Housings for Biotechnology and Pharmaceutical Applications
435(18)
Stanley W. Tarry
Part IV Applications 453(386)
15. Detection and Measurement of Particles in Pharmaceutical Liquids
453(40)
Alvin Lieberman
16. Crossflow Ultrafiltration
493(40)
Michael Dosmar
Daniel Brose
17. Protein Adsorption in Microporous Membrane Filtration
533(44)
Srikanth Sunderam
18. Microbial Retention Testing in the Validation of Sterilizing Filtration
577(28)
Jeffrey R. Carter
Richard V. Levy
19. Limulus Amebocyte Lysate Assays and Filter Applications
605(14)
Marilyn J. Gould
20. Filtration and the Removal of Viruses from Biopharmaceuticals
619(28)
Richard V. Levy
Michael W. Phillips
Herbert Lutz
21. Aspects of Air and Gas Filtration in the Biopharmaceutical Industry
647(38)
Maik W. Jornitz
22. Air Filtration Applications in the Pharmaceutical Industry
685(40)
Holly Haughney
23. Sterility Testing with Membrane Filters
725(20)
Wayne P. Olson
24. New Membrane-Based Technologies for the Pharmaceutical Industry
745(38)
Tony Alex
Holly Haughney
25. Prefiltration Technology
783(36)
Forrest Badmington
26. The Filtration of Blood and Blood Fractions
819(20)
Wayne P. Olson
Part V Regulatory Considerations 839(86)
27. The Operation of the FDA: A Brief Summary
839(7)
Anthony C. Celeste
28. Validation of the Counting Accuracy of Particle Counters with the New Particle Counting Model
846(51)
Julius Z. Knapp
29. Validation of Filtrative Sterilizations
897(28)
Maik W. Jornitz
Theodore H. Meltzer
Index 925

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