Filtration in the Biopharmaceutical Industry  book cover
1st Edition

Filtration in the Biopharmaceutical Industry



  • This version cannot be shipped to your selected country.
ISBN 9780824798963
Published January 5, 1998 by CRC Press
950 Pages

USD $279.95

Prices & shipping based on shipping country


Preview

Book Description

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

TYPES OF FILTERS
Filter Aid Filtration, G.R. S. Smith
Expanded Polytetrafluoroethylene Membranes and Their Applications, M. Wikol, C. Bailey, K. Lange, M. Sutsko, and K. Tronto
Charge-Modified Filter Media, R.A. Knight and E.A. Ostreicher
Prefilter Constructions, A.C. Shucosky
Cartridge Filters, P. Soelkner and J. Rupp

FILTER CHARACTERIZATION
Quality Assurance of Filters for Fluid Clarification, H.B. Katz
The Determination of the Pore Size of Fine Filtration Media, C.T. Badenhop
Extractables and Compatibilities of Filters, O.W. Reif

UTILITARIAN CONSIDERATIONS
Bacterial Biofilms in Pharmaceutical Water Systems, M.W. Mittelman
Filtrative Particle Removal from Liquids, M.W. Jornitz and T.H. Meltzer
Integrity Testing, M.W. Jornitz, A.M. Trotter, and T.H. Meltzer
Sizing Microporous Membrane Filter Systems, H. Green and L.A. Scheer
Filter Housing Materials and Surface Finish, J. Gulliford
Filter Housings for Biotechnology and Pharmaceutical Applications, S.. Tarry

APPLICATIONS
Detection and Measurement of Particles in Pharmaceutical Liquids, A. Lieberman
Crossflow Ultrafiltration, M. Dosmar and D. Brose
Protein Adsorption in Microporous Membrane Filtration, S. Sunderam
Microbial Retention Testing in the Validation of Sterilizing Filtration, J. Carter and R.Levy
Limulus Amebocyte Lysate Assays and Filter Applications, M.J. Gould
Filtration and the Removal of Viruses from Biopharmaceuticals, R.V. Levy, M. Phillips, and H. Lutz
Aspects of Air and Gas Filtration in the Biopharmaceutical Industry, M.W. Jornitz
Air Filtration Applications in the Pharmaceutical Industry, H. Haughney
Sterility Testing with Membrane Filters, W.P. Olson
New Membrane-Based Technologies for the Pharmaceutical Industry, T. Alex and H. Haughney
Prefiltration Technology, F. Badmington
The Filtration of Blood and Blood Fractions, W. P. Olson


REGULATORY CONSIDERATIONS
The Operation of the FDA: A Brief Summary, A.C. Celeste
Validation of the Counting Accuracy of Particle Counters with the New Particle Counting Model, J.Z. Knapp
Validation of Filtrative Sterilizations, M.W. Jornitz and T.H. Meltzer

...
View More

Reviews

"…As the authors so correctly state, the responsibility for validation remains exclusively that of the drug manufacturer. To understand the claims of the filter companies, however, the drug manufacturer needs the knowledge contained in this relevant, comprehensive book."
-European Journal of Pharmaceutics and Biopharmaceutics

Promo Copy