Sterilisation of Polymer Healthcare Products

By Wayne Rogers

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The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Sterilisation has always been challenging but sterilisation of polymer healthcare products is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user This comprehensive reference supplies insights into this developing field.

Sterilisation of Polymer Healthcare Products offers a thorough description of the conventional methods of ethylene oxide, gamma and electron-beam radiation, steam and dry heat sterilisation as well as covering newer methods such as hydrogen peroxide/plasma, gluteraldehyde, steam - formaldehyde, peracetic acid, chlorine dioxide and ozone.

With the many possible ways to sterilise healthcare products, and new techniques being developed all the time, the author identifies the variety of factors and functions that must be taken into account, such as the requirement for an understanding of physical, chemical and biological properties, design and manufacturing processes, quality control and regulatory issues.

This book discusses the evaluation of candidate materials and components for compatibility with the different sterilisation methods. From this point methods may be chosen and materials screened for biocompatibility, devices manufactured and samples tested, and a validation process chosen.

Sterilisation of Healthcare Products is a necessary and worthwhile reference for medical device manufacturers and polymer suppliers, as well as purchasing and quality assurance managers in the healthcare industry. It is designed to be of use to anyone already working in the field of sterilisation of healthcare products but it will be equally useful to someone about to start working in the field.

In order to get a feel for this book, you can view Chapter 1 Free Now, simply follow the link above.

Table of Contents

 Introduction
Steam Sterilisation
Ethylene Oxide Sterilisation
Radiation Sterilisation
Dry Heat Sterilisation/Depyrogenation
Sterilisation by Filtration for Aseptic Processing
Control of Sterilisation Labelling

1 Sterilisation Qualities and Science
2 General Overview of Control Sterilisation and Related Methods for Healthcare Products and Polymers
3 Steam Sterilisation of Healthcare Products and Polymers
4 Statistics in Sterility Assurance and Sterilisation Validation of Healthcare Products
5 Radiation Sterilisation
6 Ethylene Oxide Sterilisation - Ubiquitous for Most Non Liquid Heat Sensitive Materials
7 Dry Heat Sterilisation/Depyrogenation for Extremely Heat Tolerant and Non Liquid Materials
8 Alternative Methods of Sterilisation of Healthcare Products, Polymers and Materials
9 More Recent Alternative Methods of Sterilisation of Polymer Products
10 Potential Applications and Developments of Sterilisation Techniques
11 Summary of Sterilisation for Hospital Products, Polymers and Materials
12 Definitions

About the Author
Wayne Rogers interest in sterilisation and polymers began 34 years ago when he worked at the Castle Steriliser Research Laboratory on the feasibility of using sterilisers in military field hospital units. He has since continued to work in the healthcare sector for UCLA, Pharmaseal Laboratories, Baxter Travenol, McGaw Laboratories, in Central Services at a large hospital, Syntex and for an Eli Lilly subsidiary where he developed, installed and validated a unique ethylene sterilisation process.

Wayne has served on the Editorial Advisory Board of Medical Device and Diagnostic Industry Magazine (MDDI) for over 15 years, and is also the co-author of a Rapra Review Report entitled Polymers in Medical Applications


ISBN:
978-1-85957-490-4
Pages:
326
Publisher:
Rapra Technology, 2005
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