Sterile Filtration: A Practical Approach - Hardcover

Jornitz, Maik W.; Meltzer, Theodore H.

Hardcover

ISBN 10: 0824702824 ISBN 13: 9780824702823

Publisher: CRC Press, 2000

Synopsis

This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals.

Addresses the complexities of globalizing redundancy in filtration!

Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration

considers how many filters should be in the process stream

examines the existence of nanobacteria and viable but nonculturable organisms

covers pore size designations, distributions, architecture, and numbers

discusses the latest findings in bubble point and diffuse flow measurements

describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations

details wetting liquid, polymer, temperature, and water purity effects

explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases

outlines filter validation, requirements, and operational specifics

and more!
Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.

About this title

About the Author

MAIK W. JORNITZ is Director of Product Management at Sartonus Headquarters, Gottingen, Germany. With over 10 years of experience in separation technologies, Mr. Jornitz supports the biopharmaceutical industry worldwide in validation, integrity testing, and air and water filtration. A member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineers, among others, he is the author, coauthor, or coeditor of numerous professional papers on membrane filters, integrity testing, and validation studies, including Filtration in the Biopharmaceurical Industry (Marcel Dekker, Inc.). Mr. Jornitz received the Diploma in Engineering from the Technical University of Hamburg, Germany. THEODORE H. MELTZER, based in Bethesda, Maryland, is a consultant on filtration and high- purity water preparation to the pharmaceutical and semiconductor industries. With over 40 years of experience in membrane separations, Dr. Meltzer holds four patents, and is the author, coauthor, or coeditor of Filtration in the Pharmaceutical Industry, Filtration in the Biopharmaceutical Industry (both titles, Marcel Dekker, Inc.), High Purity Water Preparation for the Semiconductor, Pharmaceutical and Power Industries, and Phar,naceutical Water Systems as well as many professional papers and book chapters that reflect his research interests in the structure―property relationships in membrane filters, filter systems, and their validation. A member of the American Chemical Society, the Parenteral Drug Association, and the Filtration Society, Dr. Meltzer received the Ph.D. degree in physical- organic chemistry from the University of Chicago, Illinois. He pursued postdoctoral work in polymer mechanical properties at Princeton University, Princeton, New Jersey.

From the Back Cover

This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration! Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration considers how many filters should be in the process stream examines the existence of nanobacteria and viable but nonculturable organisms covers pore size designations, distributions, architecture, and numbers discusses the latest findings in bubble point and diffuse flow measurements describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations details wetting liquid, polymer, temperature, and water purity effects explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases outlines filter validation, requirements, and operational specifics and more! Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.

Edition details

• Publisher: CRC Press
• Publication date: 2000
• Language: English
• ISBN 10: 0824702824
• ISBN 13: 9780824702823
• Binding: Hardcover
• Edition number: 1
• Number of pages: 640