A new book of interest has been published. The book is titled ‘Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations’ and it has been written by Tim Sandle. The book has been published by Woodhead Biomedicine, an imprint of Elsevier.
The
book addresses the following concerns:
- The main sterilisation methods of physical removal, physical alteration and inactivation.
- Discussions relating to medical devices, aseptically filled products and terminally sterilised products.
- Bacterial, pyrogenic, and endotoxin risks to devices and products.
- The latest technology in the field.
- Current thinking behind risk assessment and good manufacturing practices.
Throughout
18 chapters, the book outlines and discusses sterilization technology and the
biopharmaceutical manufacturing process, including aseptic filling, as well as
aspects of the design of containers and packaging and addresses the cleanroom
environments in which products are prepared.
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.
The
book is available directly from the publisher or via Amazon and other good
booksellers (such as Waterstones and Powells).
The
Amazon links are:
Amazon U.K.
Amazon Canada
Amazon China
Amazon France
Amazon Germany
Amazon Austria
Amazon Italy
Amazon Spain
Amazon India
Amazon Japan
An
e-book version is available from the publisher.
Tim
Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and
a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences,
Manchester University, UK
Reference:
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