Sterile Filtration: A Practical Approach

Sterile Filtration: A Practical Approach

Hardback (18 Dec 2000)

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Publisher's 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.
  • Book information

    ISBN: 9780824702823
    Publisher: CRC Press
    Imprint: CRC Press
    Pub date:
    DEWEY: 615.19
    DEWEY edition: 21
    Language: English
    Number of pages: 623
    Weight: 953g
    Height: 279mm
    Width: 216mm
    Spine width: 33mm