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.
General
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