Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations (Woodhead Publishing Series in Biomedicine) - Image 1

£133.38

Woodhead Publishing Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations (Woodhead Publishing Series in Biomedicine)

Name: Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations (Woodhead Publishing Series in Biomedicine)
Brand: Woodhead Publishing
Price: 133.38 GBP
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Quality Assurance & Total Quality Management

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Description

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. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Key Features

Sterility, Sterilization and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations (Woodhead Publishing Series in Biomedicine, Volume 32)

Product type: ABIS BOOK

Brand: Woodhead Publishing

Product Specifications

Brand: Woodhead Publishing
Format: hardcover
ASIN: 1907568387
Category: Books > Subjects > Business, Finance & Law > Management > Quality Assurance & Total Quality Management
Domain: Amazon UK
Release Date: 31 October 2013
Listed Since: 15 October 2012

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Woodhead Publishing Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations (Woodhead Publishing Series in Biomedicine)

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