by Maik W. Jornitz
and Theodore H. Meltzer

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.

Contents

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

Appendix

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