This book offers a thorough description of the conventional sterilization methods — ethylene oxide, gamma and electron-beam radiation, steam and dry heat — as well as providing coverage of newer methods such as hydrogen peroxide/plasma, gluteraldehyde, steam/formaldehyde, peracetic acid, chlorine dioxide, and ozone. It discusses the evaluation of candidate materials and components for compatibility with the differenct sterilization methods. From this point, methods may be chosen and materials screened for biocompatibility, devices manufactured and samples tested, and a validation process chosen.

From the Preface: “...Sterilisation is not a singular problem nor discipline, but an interfacial area of investigation of materials, biology, chemistry, product design development, manufacturing, environmental control, biocompatibility, microbiology, engineering, material/drug safety, mathematics, manufacturing, R & D, and quality and product/package design, particularly in a new era of device/drug combinations. It requires a multidisciplinary effort...”

Target Audience: Medical device manufacturers and polymer suppliers, as well as purchasing and quality assurance managers in the healthcare industry.

Table of Contents:

Introduction

Sterilisation Qualities and Science

General Overview of Sterilisation and Related Methods for Healthcare Products and Polymers

Steam Sterilisation of Healthcare Products and Polymers

Statistics in Sterility Assurance and Sterilisation Validation of Healthcare Products

Radiation Sterilisation

Ethylene Oxide Sterilisation — Ubiquitous for Most Non Liquid Heat Sensitive Materials

Dry Heat Sterilisation/Depyrogenation for Extremely Heat Tolerant and Non Liquid Materials

Alternative Methods of Sterilisation of Healthcare Products, Polymers and Materials

More Recent Alternative Methods of Sterilisation of Polymer Products

Potential Applications and Developments of Sterilisation Techniques

Summary of Sterilisation for Hospital Products, Polymers and Materials

Definitions

Index