Sterile Filtration: A Practical Approach

ISBN-13: 9780824702823 / Angielski / Twarda / 2000 / 640 str.

Maik W. Jornitz; Theodore H. Meltzer; Jornitz W. Jornitz

Opis

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.

Recenzje

"
From the foreword…
…the authors of these chapters bring an abundance of technical knowledge and experience to this endeavor. Filters are all around us in sterile product manufacturing, and their selection, use, validation, and testing represent an essential fundamental discipline. This book will provide an analytical mind with basic scientific insight into this essential, dynamic, and still somewhat controversial area of contamination prevention.
"-James E. Akers Akers, Kennedy & Associates
Kansas City, Missour

"…well referenced and supported by appropriate tables and figures….
…a very worthwhile book….contains information useful to both experienced practitioners and students alike…will be a very worthwhile contribution to a reference section.
"-Indian Journal of Toxicology

Spis treści

Filter Porosity: Its Genesis and Character
The Polymeric Matrix and Its Influences
Membrane Fouling, Cleaning, and Sanitization
Flow and Pressure, Flow Decay, and Filter Sizing
Mechanism of Particle Removal from Liquid
Mechanisms of Particle Removal from Air and Other Gases
Filter Integrity Testing
Cartridges, Cartridge Holders, and Their Care
Validation of Filtrative Sterilization

Appendix
References

O autorze

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.