Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals, 1st Edition

  • Published By:
  • ISBN-10: 1908818638
  • ISBN-13: 9781908818638
  • DDC: 615.19
  • Grade Level Range: College Freshman - College Senior
  • 362 Pages | eBook
  • Original Copyright 2013 | Published/Released June 2014
  • This publication's content originally published in print form: 2013

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Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.

Table of Contents

Front Cover.
Half Title Page.
Other Frontmatter.
Title Page.
Copyright Page.
Dedication Page.
List of Figures and Tables.
About the Author.
1: Introduction.
2: References.
3: Sterility, Sterilisation and Microorganisms.
4: Pyrogenicity and Bacterial Endotoxin.
5: Regulatory Requirements and Good Manufacturing Practices (GMP).
6: Gamma Radiation.
7: Electron Beam Processing.
8: Dry Heat Sterilisation.
9: Steam Sterilisation.
10: Gaseous Sterilisation.
11: Hydrogen Peroxide Vapour Sterilisation.
12: Sterilisation by Filtration.
13: Other Methods of Sterilisation.
14: Depyrogenation and Endotoxin.
15: Cleanrooms, Isolators and Cleanroom Technology.
16: Aseptic Processing and Filling.
17: Media Simulation Trials.
18: Cleaning and Disinfection of Sterile Processing Facilities.
19: Biological Indicators.
20: The Sterility Test.
21: Investigating Sterility Test Failures.
22: Auditing Sterilisation Processes and Facilities.