Sterile Filtration: A Practical Approach

By Maik W. Jornitz and Theodore H. Meltzer

Book Overview

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.

• Format: Hardcover
• Language: English
• ISBN: 0824702824
• ISBN13: 9780824702823
• Release Date: December 2000
• Publisher: CRC Press
• Length: 640 Pages
• Weight: 2.10 lbs.
• Dimensions: 1.3" x 6.0" x 9.3"